CITATION: Endean et al. v. St. Joseph’s General Hospital, 2017 ONSC 2632

COURT FILE NO.: CV-97-0701, CV-96-0342, CV-97-0271 & CV-14-0209

DATE: 2017-04-27

ONTARIO

SUPERIOR COURT OF JUSTICE

B E T W E E N:

Court File No: CV-97-0701

Paulette M. Endean, Frank William Endean and Debbie Endean,

Plaintiffs,

J. Legge, D. Steeves and P. Orr for the Plaintiffs

• and -

St. Joseph’s General Hospital, Defendant

S. Wojciechowski and D. Latta, for the Defendant

A N D B E T W E E N:

Court File No: CV-96-0342

Janet Hearsey and Leslie Hearsey,

Plaintiffs,

• and -

St. Joseph’s General Hospital, Defendant

A N D B E T W E E N:

Andrew Karam,

Plaintiff,

• and -

St. Joseph’s General Hospital, Defendant

A N D B E T W E E N:

J. Legge, D. Steeves and P. Orr for the Plaintiffs

S. Wojciechowski and D.A. Latta, for the Defendant

Court File No: CV-97-0271

J. Legge, D. Steeves and P. Orr for the Plaintiffs

S. Wojciechowski and D. Latta, for the Defendant

Court File No: CV-14-0209

Sherry Lind, Gino Deamicis, Lorraine Lind and Lauri Lind, Crystal Lind, Donald Deamicis, Daniel Deamicis,

Plaintiffs,

• and -

St. Joseph’s General Hospital, Defendant

J. Legge, D. Steeves and P. Orr for the Plaintiffs

S. Wojciechowski and D. Latta, for the Defendant

HEARD: Various dates September 12, 2016 through to December 19, 2016,

at Thunder Bay

Mr. Justice F. Bruce Fitzpatrick

Judgment on Liability

Introduction

[1] This is a consolidated medical malpractice action by four plaintiffs and related Family Law Act claimants against St. Joseph’s General Hospital (the “Hospital”) located in Thunder Bay, Ontario. The action is in respect of implant surgeries done at the Hospital on the plaintiffs’ temporomandibular joints (the “TMJ”) in the mid-1980s.

[2] The first portion of this complicated medical malpractice case was completed on December 19, 2016. At the opening of trial, the parties agreed to bifurcate the trial, dealing first with the evidence related to liability. At the request of the parties, I endorsed the file on January 5, 2017 indicating my views as to liability in general terms. This was done for efficiency purposes as several more weeks of trial had been scheduled on the issues of damages in January 2017. As there was a limitation defence, the parties wanted to hear my ruling on liability to determine if it was most efficient to continue the proceeding or await my full reasons. They have elected to wait to determine next steps until after receiving these full reasons. To the extent that any portion of the endorsement is not accurately reflected in these reasons, I adopt those reasons in my endorsement as part of this judgment. Counsel will note some similarities in the wording of this judgment and the endorsement. I did not propose to reinvent the wheel (or the words) if they worked for me previously. As noted in the endorsement, the appeal period for my ruling on liability starts to run from the date of the delivery of these reasons.

[3] The four actions have been ongoing for almost twenty years. They were commenced in 1996 and 1997. The four consolidated actions were extensively case managed and pre-tried (along with a number of other files) by several experienced justices of this court. This trial was also subject to a number of trial management conferences before me which commenced in March 2016 and continued until the end of August 2016. In June 2013, the pretrial process resulted in the plaintiffs settling their claims against three named defendant oral surgeons, Dr. Danny Tomlak, Dr. Eric Orpana and Dr. William Dowhos. These oral surgeons actually did the implant surgeries and in one case an explant surgery involving these plaintiffs. The settlement was made the subject of a Pierrenger order in all four actions which affected the conduct of this trial.

[4] In April 2015, the trial for the issue of liability and damages was scheduled for twelve weeks commencing September 12, 2016. Unfortunately, the action did not roll along exactly as anticipated and the parties were only able to complete the evidence and submissions on the issue of liability alone after the court had sat for 10 weeks.

[5] The “thing” at the heart of this case was the Vitek Proplast Teflon Interpositional implant (the “implant” or the “device”). It was a regulated medical device within the meaning of medical device regulations promulgated under the Food and Drugs Act R.S.C. 1985 c.F-27 as amended.

[6] The implant device at issue was made by an American company, Vitek Inc. based in Houston, Texas. It was introduced to the Canadian market in early 1983. The implant at issue in this litigation was made of two materials mainly, Teflon and Proplast. In very simple terms, the implant was designed to replace a meniscus inside the TMJ that acts as a kind of cushion between a portion of the skull and a mandibular condyle that forms a portion of the jaw that allows a person to talk, chew, swallow, yawn, etc. The TMJ is a complex load bearing joint.

[7] The nature of the TMJ, the difficulties these plaintiffs and persons in general experienced with the TMJ, and the surgery that was done to put the implants in and take them out, was the subject of much evidence at this trial. In the 1980s, in Ontario, the implantation of the device required surgery and an extended stay in a public hospital. Unfortunately, the materials Teflon and Proplast, when combined in the Vitek implant, failed to perform as advertised. It was not pretty. The implant delaminated inside the plaintiffs’ TMJ, leaving microscopic particulate residue that, over time, caused degenerative bone loss in the area at and around the plaintiffs’ TMJ. All four plaintiffs have evidence of perforations in their skull in the area of the TMJ. The defence has admitted that the Vitek device implanted in the plaintiffs’ heads caused the plaintiffs personal injury type damage.

[8] Ultimately, Vitek ceased selling the implant in 1988. Vitek went bankrupt shortly thereafter. The company that distributed the device in Canada settled with these plaintiffs among many other persons in whom the devices had been implanted. It too went bankrupt.

Agreed Facts

[9] Having sat through 10 weeks of trial evidence, which included 19 live witnesses and one expert, whose evidence was received by report on consent, it seems to me that a great number of the facts on this liability portion of this trial could have been agreed by the parties. I do not know why this did not occur. Despite my requests for the parties to develop an extensive agreed statement of facts during the trial management phase of this matter, the only agreed facts which the parties could come up with at the opening of trial was a chart containing the dates the plaintiffs were implanted with the device and the date they were explanted. The chart is as follows:

NAME

IMPLANT

SIDE

EXPLANT

Endean

1985-Oct-08

Right

1997-Jan-21 [TORONTO]

Hearsey

1986-Mar-05

Bilateral

1996-Oct-03 [WINNIPEG]

Karam

1985-Nov-21

Left

1998-Mar-19 [WINNIPEG]

Lind (DeAmicis)

1985-Jun-17

Left

1986-Jun-05

[10] Much of the evidence, and the cross-examinations of the 19 witnesses in this liability portion of the trial, both lay and expert, consisted of counsel referring the witnesses to documents, expert reports or transcript evidence, and having the witness read the contents out loud into the record. In my view, this demonstrated that the facts of the case were well documented. When the witnesses were referred to the documents often there was little else in the way of questioning beyond asking the witnesses to confirm what was written in black and white on the exhibit at issue. Because of the passage of time and the reality that most of the facts involving this portion of the trial occurred between 1983 and the commencement of the litigation in 1996 or 1997, the memories of all of the fact witnesses had to be refreshed by referring to the documents. The memories of the witnesses generally accorded with what was written in the documents. Accordingly, I find that there are many facts which were not contested and can be recited first, both by way of context and as the foundation for my reasons for the decision I am about to make about the liability of the Hospital. I appreciate there are disputes about what I am to do about the facts and disputes regarding the conclusions that can be drawn from the facts, but nevertheless I think it is helpful to set out the uncontroverted facts in this matter.

The Uncontroverted Facts

[11] In 1983, Dr. Dowhos and Dr. Orpana were established oral surgeons practicing in Thunder Bay. Dr. Dowhos had been practicing in the area since 1967. Dr. Orpana joined in 1974. They had a busy practice. They were the only oral surgeons practicing in a huge geographic area. Essentially their catchment area ran from White River in the east, to the Manitoba border in the west. Today if you drove, it would take you at least 12 hours to go from one end to the other. This does not count the travel distances from Thunder Bay north to other communities by road and the various First Nations reserves, some accessible by all season road and some by air and winter road only.

[12] In this large oral surgery practice, the oral surgeons had a large number of patients who suffered from difficulties with their TMJ. Dr. Dowhos and Dr. Orpana had been trained to treat these problems conservatively. Conservative treatment did not generally involve surgery.

[13] In 1983, Dr. Dowhos and Dr. Orpana were approached by a new graduate from the University of Connecticut (“UConn”) school of dentistry, Dr. Tomlak. Dr. Tomlak had graduated from University of Western Ontario dental school in 1979. He then did an internship at Toronto Western Hospital and post-graduate work at UConn. Dr. Tomlak grew up in Thunder Bay. When he graduated from UConn, he wanted to come back to practice in the region he had grown up in. He had a very personally positive experience with Dr. Dowhos during his hockey career when he was a teenager. This experience put Dr. Tomlak on the road to becoming an oral surgeon.

[14] Dr. Tomlak had been introduced to the Vitek device when he was being trained at UConn. He had also done brief placements at an oral surgery practice in Ft. Worth Texas where a prominent oral surgeon, Dr. Wolford, had used the device and the surgical procedure required to implant it. Dr. Tomlak was convinced that, in appropriate cases, using the implant could alleviate pain and dysfunction in the TMJ for patients on a long term basis. Dr. Tomlak was also trained in another number of new oral surgery techniques which he was prepared to introduce to Dr. Dowhos’ and Dr. Orpana’s practice. Dr. Tomlak graduated from UConn in May 1983. On September 12, 1983, he was licenced by the Royal College of Dental Surgeons as a specialist in oral and maxillofacial surgery.

[15] In the 1980s, all physicians and oral surgeons were required to submit applications to the Board of Directors of public hospitals in order to be granted privileges to treat patients in those hospitals. The process of granting these privileges was delegated, in the case of the Hospital, to a credentials committee. For historic reasons and reasons of efficiency, the credentials committee of the Hospital was shared with another public hospital in Thunder Bay, the Port Arthur General (“PAGH”).

[16] In the early 1980s, there were five public hospitals in Thunder Bay. Three hospitals did acute care and offered the oral surgeons facilities where they could provide services to patients which could only be performed in a public hospital. Until 1970, the Thunder Bay area had two major municipalities, Fort William and Port Arthur. The Hospital was located in the geographic area that was formerly called Port Arthur. For reasons not expressly explained in the evidence, but which from my experience of living in this area for five years likely arose from the historic fact of the two cities, the two public hospitals located in the geographic area that had formerly been called the “City of Port Arthur” cooperated on certain issues. As the Hospital was located in what had once been Port Arthur, it had a joint credentialing committee with PAGH.

[17] Dr. Orpana and Dr. Dowhos had been historically credentialed in the Hospital for a list of procedures that were non-controversial and were traditionally performed in the course of an oral surgeon’s work. When they decided to invite Dr. Tomlak to join their practice, they applied to increase the procedures for which they were credentialed.

[18] The Vitek devices were implanted and explanted in the four plaintiffs as per the agreed fact chart which was referenced earlier in this judgment.

[19] The implant was a regulated medical device.

[20] In my endorsement of January 5, 2017, I set out the issues on the liability portion as I saw them. I will set them out again and then discuss the facts as I find them that affect a determination of each particular issue.

The Issues

[21] Both parties sought to define the issues to be decided on this liability portion of the trial. In my view, while their articulations of the issues were somewhat different, the substance of what they said to be truly at issue was very similar.

[22] There is a preliminary discrete issue as to whether or not a statutory limitation defence is available to the Hospital in this matter. If it is available, the plaintiffs’ claims are at an end as against the Hospital. If it is not available, then consideration of liability involves an inquiry as to whether the damages suffered by the plaintiffs were caused by a breach of a duty of care that the Hospital owed to the plaintiffs.

[23] It is admitted for the purposes of this portion of the trial that the plaintiffs did suffer damages as the result of the failure of the Vitek device implanted in them. The plaintiffs assert they are entitled to a finding of liability against the Hospital because of the Hospital’s negligence. In the event there is a finding of liability, the defence sought a ruling on the apportionment of liability. The plaintiffs took the position that any determination of apportionment should await the end of the damages portion of the trial.

[24] In my view, the issues to be resolved, in the form of questions, are as follows:

1. Does a limitation defence apply?

If not, has the Hospital breached a standard of care owed to the plaintiffs which has caused the plaintiffs damage by:

2. Purchasing devices, the Vitek implants, which were used in the Hospital by the oral surgeons to place in the plaintiffs’ TMJs, which at the time were not approved for sale or use in Canada?

3. Allowing unqualified oral surgeons to do unapproved surgical procedures to implant an unapproved (and therefore illegal) Vitek device?

4. Allowing a newly licenced oral surgeon (Dr. Tomlak) to train other oral surgeons (Drs. Orpana and Dowhos) in the methodology of the TMJ implant procedure when it was represented that Dr. Tomlak would in fact be preceptored in his first year of practice by Dr. Dowhos?

5. Not obtaining an informed consent by the plaintiffs to the implant operation in the first place?

6. Not more carefully monitoring the content and handling of the patient files involving the plaintiffs?

7. Not actively assisting in contacting the plaintiffs once it became apparent that the Vitek implant was regularly failing in patients and was causing them damage, and further not ensuring that the plaintiffs were subject to regular follow up on the condition of their TMJ once the implant had been removed?

8. Failing to abide by its own bylaws in respect of the treatment and care of the plaintiffs?

9. Has the Hospital committed the tort of spoliation in this litigation as the result of which the plaintiffs have suffered damages?

10. Has the Hospital breached a statutory duty of care (duty to recall) contained in sections 31 and 34 of the Public Hospitals Act?

11. If there is a finding of liability, what is the portion of the damages attributable to the Hospital and is it appropriate to apportion at this point in the trial process?

Decision on Issue 1: the Limitation Defence

[25] I agree with the submissions of the defence that the claims of the plaintiffs, Paulette Endean, Sherry Lind, and Andrew Karam (and related Family Law Act claimants), in this matter are statute barred. However, I find that the claims of Janet Hearsey and Leslie Hearsey are not so barred. I find this for the following reasons.

[26] The language of the relevant limitation section contained in the Public Hospitals Act was as follows:

Any action against a hospital or any nurse or person employed therein for damages for injury caused by negligence in the admission, care, treatment or discharge of a patient shall be brought within two years after the patient is discharged from or ceases to receive treatment at the hospital and not afterwards.

[27] In my view, the relevant time frame for the consideration of the applicability of the limitation section in the Public Hospitals Act was between 1985 and 1994 for all these matters. The section at issue was numbered differently in the Public Hospitals Act during these times. From 1985 to 1990 it was section 28 of the Act c. 410. From 1990 to 1994, it was section 31.

[28] I find that all four plaintiffs received “care” and “treatment” within the meaning of the Public Hospitals Act from the Hospital for matters relevant to the negligence alleged during the times set out below:

Sherry Lind: June 17, 1985; June 5, 1986; and November 26, 1991;

Paulette Endean: October 8, 1985;

Andrew Karam: November 21, 1985;

Janet Hearsey: March 5, 1986 and June 9 1994.

[29] Section 28 of the R.S.O. 1980 statute applied to Ms. Endean and Mr. Karam. In addition, the provisions of both sections, 28 and 31, of the 1990 to 1994 statute applied in respect of both Ms. Lind and Mrs. Hearsey.

[30] Ms. Endean and Mr. Karam attended in the Hospital for only one extended stay regarding their implant surgery. They were explanted elsewhere later.

[31] Mrs. Hearsey had an overnight extended stay when she was implanted in 1986. She also had a radiological procedure, a tomogram, in the Hospital related to the failure of the implant in June 1994. In my view, this 1994 procedure was “treatment” and “care” within the meaning of the Public Hospitals Act. I find this visit to the Hospital was related to the original treatment which saw the implant placed in her head in 1986. However, no negligence is alleged specifically against the Hospital as a result of this specific occasion of treatment and care. The treatment and care which Mrs. Hearsey alleges caused her damages was the negligence of the Hospital in obtaining a device which was not approved for use in Canada in 1986. Further, she alleges the Hospital was negligent in allowing the oral surgeons to use the unapproved device at the time they did the implant in 1986.

[32] From the evidence led at this trial, by 1994 it was clear that oral surgeons in Ontario, such as the three named defendants in this action, had received advice from various reputable professional sources that ongoing radiography was necessary to monitor persons in whom the device had been implanted. I heard a great deal of evidence concerning what a tomogram was and how in the 1990s it was usually done in a public hospital. I therefore find that by receiving a tomogram in June 1994, Mrs. Hearsey was given “treatment” and “care” at the Hospital. I also find it was only done on Mrs. Hearsey as the result of the original implant and can therefore be said to be clearly connected to the original negligence which she alleges. For whatever reason, the oral surgeons did not call the other plaintiffs in for such radiological procedures or the plaintiffs declined the oral surgeons’ invitation to have same done at St. Joseph’s. This, however, is not something that counts against the Hospital in my view.

[33] Sherry Lind was in the Hospital on three separate occasions related to her TMJ implant. She also attended the Hospital on a number of occasions from 1994 to 1996. In evidence, she was asked about an out-patient surgery she received in February 1996. She testified that this did not relate to her TMJ. In submissions, the defendant referenced Ms. Lind attending the Hospital in the two years prior to issuing her claim on two issues. One related to pain in her right TMJ and right facial numbness. The implant at issue was placed and removed at the Hospital, but on her left side. In my review of the actual evidence heard at trial, I could not locate any references to specific attendances relating to right side TMJ pain in that period. The only evidence I have about the last date that Ms. Lind received “treatments” or “care” related to the left TMJ was the November 1991 surgery where Dr. Dowhos cleaned out debris from the left TMJ and performed an eminectomy.

[34] From the evidence I find any visits to the Hospital by Ms. Lind after November 26, 1991, did not relate to the negligence alleged, or the damages, or the care and treatment which is the subject of her claim.

[35] In any event, I find that the “treatment” and “care” for all four plaintiffs ceased upon their being discharged from the Hospital on the last occasion they attended for a TMJ implant issue.

[36] The plaintiffs commenced their actions against the Hospital on the following dates:

Janet Hearsey: March 21, 1996;

Sherry Lind: August 20, 1996;

Andrew Karam: March 14, 1997;

Paulette Endean: July 11, 1997.

[37] I find that the dates on which the plaintiffs’ claims were barred by the operation of the limitation provision of the Public Hospitals Act are as follows:

Janet Hearsey: June 10, 1996;

Sherry Lind: November 27, 1993;

Andrew Karam: November 22, 1987;

Paulette Endean: October 9, 1987.

[38] Practically speaking, this means only Mrs. Hearsey’s action was commenced in time.

[39] In my view, a straightforward common sense assessment of what occurred to the plaintiffs while in-patients at the Hospital can only be interpreted as constituting “care” or “treatment.” Also, I am not prepared to find on the evidence that treatment and care continued beyond the time they were discharged from the Hospital. In my view, in this case, discharge and cessation of care and treatment were synonymous.

[40] I find that the series of events which occurred to the plaintiffs is one that fits clearly and easily within the limitation wording of the Public Hospitals Act as set out above.

[41] I heard a great deal of evidence on the following topics:

• what the oral surgeons thought was wrong with the plaintiffs TMJs;

• the anatomy of the TMJ and how the oral surgeons thought the device was going to represent a longer term solution to the pain and dysfunction experienced by the plaintiffs TMJs;

• the course of conservative treatment administered by the oral surgeons that occurred prior to the plaintiffs being admitted;

• that the admission of the plaintiffs to the Hospital was done by an actual physician and not by the oral surgeons alone;

• how the surgery was actually physically carried out on these plaintiffs;

• how the surgery required a general anaesthetic, the type of surgical cuts needed, and the fact that two oral surgeons were involved in all the surgeries;

• the role and tasks of the nurses who assisted in the surgery;

• the details of the surgery and the pathology reports for the actual implant surgeries and the explant surgeries, even where that particular procedure was not done in the Hospital but at another public hospital;

• the process whereby the Hospital decided to buy the implant and then how they went about physically acquiring it;

• how the plaintiffs were required to stay in Hospital for a number of days recovering from the surgery;

• how the oral surgeons followed up with the individual plaintiffs in their clinic and not in the Hospital.

[42] Having heard all that evidence I conclude all the plaintiffs had a device surgically implanted in their heads while in the Hospital. The device had been purchased by the Hospital for use by the oral surgeons who did the actual surgery. The plaintiffs stayed in Hospital and then were discharged. To my mind, this was plainly “treatment” and “care” which ceased upon their discharge.

[43] The plaintiffs argue that the limitation should not apply by operation of the equitable jurisdiction of this court. They also argue that principles of discoverability apply. The plaintiffs had no idea anything was wrong with them until 1994 at the earliest and therefore the limitation provision does not apply as they commenced their claims within two years of knowing that the implant had failed and caused them damage. Further, the plaintiffs argue that Dr. Dowhos and Dr. Orpana in their capacities as officers of the Hospital failed to communicate a significant problem with patient-care up the appropriate reporting chain as they were obliged to by section 34 of the Public Hospitals Act (the 1990 to 1994 version). I do not accept all of these arguments as being dispositive of the issue of whether or not a statutory limitation applies for a number of reasons.

[44] The plaintiffs rely on the decision of the Ontario Court of Appeal in Giroux Estate v. Trillium Health Centre, 2005 CanLII 1488 (ON CA), 74 O.R. (3d) 341. It dealt with the application of the limitation period in the Trustee Act, R.S.O. 1990, c. T.23. It stands for the proposition that the common law doctrine of fraudulent concealment can be used to toll a limitation period. It holds that unscrupulous defendants standing in a special relationship with an injured party cannot use a limitation period as an instrument of fraud.

[45] First of all, this argument was only raised by the plaintiffs in reply, on the very last day of submissions. I do not think this was an argument that arose only out of some surprise submission of the defence that could not reasonably have been anticipated previously by the plaintiffs. (As an aside, it seemed to me that there was not a great deal of difference in the closing submissions of either party when contrasted with their openings.)

[46] Second, I do not see any such reference to “fraud” or “fraudulent concealment” in any of the pleadings in this matter. Third, and most importantly, I am not persuaded that the evidence at this trial has proven, or even suggested, that the Hospital was an unscrupulous defendant or that the acts or even failings of any of its employees or directors or agents came anywhere close to what any reasonable person could describe as constituting “fraud” or a “fraudulent concealment.”

[47] At its highest, the plaintiffs argue that because they were not told the device that was implanted was unapproved, this constituted a fraudulent concealment. With respect, it is plain and obvious to me from the evidence that neither the oral surgeons nor the Hospital knew that the device had not received a notice of compliance from Health Canada during the period 1984 to 1986. This lack of knowledge cannot be elevated to fraud. This evidence may have some impact on a decision regarding the negligence of the Hospital, but until the limitation hurdle is cleared, this is of no assistance to the three plaintiffs who did not commence their actions within the two years from their discharge from the Hospital as set out in the Public Hospitals Act.

[48] In my view, the decision of the Ontario Court of Appeal in Van Cramm v. Riverside Hospital of Ottawa et al., (1986) 1986 CanLII 2584 (ON CA), 56 O.R. (2d) 700, is directly on point as to the operation of the limitation section in the Public Hospitals Act that is at issue in this case. The case held that there is no discoverability principle applicable to issues involving the operation of section 28 (and by implication the later section 31). Justice Cory stated:

It may seem harsh to apply limitation provisions under the Public Hospitals Act in a situation such as this where the plaintiff could not have known or reasonably have been expected to know of the negligence of the hospital until long after the limitation period had expired; but s. 28 is quite clear and we must give effect to it. The wording is precise and there is no valid ground for avoiding it.

[49] This position was adopted by Shaugnessy J. in Hay v. Canadian Red Cross Society, [2004] O.J. No. 2887 (OSCJ) at para. 16. I agree with Shaugnessy J. that the application of the discoverability rule depends on the wording of the statute and does not apply when the limitation runs from a fixed event unrelated to the knowledge of the party. This reasoning was further adopted by A. Hoy J. in Purtell v. Royal Ottawa Hospital, [2005] O.J. No. 2965. An appeal of this decision was dismissed in [2007] O.J. No. 1891 and leave to the Supreme Court of Canada was denied in [2007] S.C.C.A. No. 362.

[50] The claim of Mrs. Hearsey survives the limitation attack as the result of the reasoning of the Ontario Court of Appeal in a decision Fiorelli v. St. Mary’s General Hospital, 1995 CarswellOnt 3945, [1995] O.J. No. 631 (ONCA). The full text of the decision is as follows:

The following judgment was delivered by

1 THE COURT (orally): -- If the hospital had clearly proved that the treatments received by the plaintiff in 1987 and 1988 had no connection with the treatment that the plaintiff received in 1983, counsel for the appellant conceded that the Motions Court judge would have been correct in dismissing the action. In our opinion, the limitation period in s.31 of the Public Hospitals Act does not mean that the limitation period is two years from the time that the patient leaves the hospital following the original treatment.

2 The affidavit of Harrison S. Arrell was hearsay on a point on which expert evidence was required, and on the material before the learned Motions Court judge, we do not believe that she should have dismissed the action.

3 Accordingly, the appeal is allowed, the order below set aside and in its place there will be an order dismissing the motion. Costs here and below will be to the appellant in any event of the cause.

HOULDEN J.A.

MCKINLAY J.A.

CARTHY J.A. -- I agree.

[51] In my view this decision does not overturn the reasoning given earlier by the Court of Appeal in Van Cramm, supra, concerning the general proposition that the discoverability principle does not apply to cases governed by operation of section 31 of the Public Hospitals Act. Rather it clarifies that if there is clear proof that one treatment in a public hospital can be connected to another where there is an allegation of negligence, the time limit for the commencement of any action runs from the date of the latest treatment. In this case, only Mrs. Hearsey had a treatment connected to the alleged negligent purchase of the implant by the Hospital that came within two years of her commencing her action.

[52] I turn now to the plaintiffs’ arguments regarding the applicability of section 34 of the Public Hospitals Act as it applies to the applicability of a limitation defence. Section 34 reads as follows:

34. (1) Where the medical staff of a hospital is not divided into medical departments, the chief of the medical staff or, where there is no chief, the president of the medical staff may be made responsible by by-law of the hospital to advise the medical advisory committee with respect to the quality of medical diagnosis, care and treatment provided to the patients and out-patients of the hospital.

(2) Where the medical staff of a hospital is divided into medical departments, the head of each department may be made responsible by by-law of the hospital, through and with the chief of the medical staff, or where there is no chief, through and with the president of the medical staff, to advise the medical advisory committee with respect to the quality of medical diagnosis, care and treatment provided to the patients and out-patients of his or her department.

(3) Where an officer of the medical staff who is responsible under subsection (1) or (2) becomes aware that, in his or her opinion a serious problem exists in the diagnosis, care or treatment of a patient or out-patient, the officer shall forthwith discuss the condition, diagnosis, care and treatment of the patient or out-patient with the attending physician, and, if changes in diagnosis, care or treatment satisfactory to the officer are not made promptly, he or she shall assume forthwith the duty of investigating, diagnosing, prescribing for and treating the patient or out-patient, as the case may be, and shall notify the attending physician, the administrator and, if possible, the patient or out-patient that the member of the medical staff who was in attendance will cease forthwith to have any hospital privileges as the attending physician for the patient or out-patient.

(4) Where the officer of the medical staff who is responsible under this section is unable to discuss the problem with the attending physician as required by subsection (3), the officer shall proceed with his or her duties as prescribed in this section as if he or she had had the discussion with the attending physician.

(5) The officer of the medical staff who is responsible under this section shall inform two members of the medical advisory committee within twenty-four hours of his or her action under subsection (3) or (4) and shall file a written report with the secretary of the medical advisory committee within forty-eight hours of his or her action under subsection (3) or (4).

(6) The officer of the medical staff who is responsible under this section may delegate any or all of his or her responsibilities and duties under this section to a member of his or her medical staff or of his or her medical department, as the case may be, but the officer remains accountable to the medical advisory committee for the management of the patient by that member of the medical staff to whom any such responsibility or duty is delegated.

(7) Where the medical advisory committee concurs in the opinion of the officer of the medical staff who has taken action under subsection (3) or (4) that the action was necessary, the secretary of the medical advisory committee shall forthwith make a detailed written report to the administrator of the problem and the action taken. R.S.O. 1980, c. 410, s. 31.

[53] With regard to the section 34 argument, which I characterize as the “duty to report” argument, I do not see how this has anything to do with the limitation issue although it was put forward by the plaintiffs as an answer to the limitation defence. Arguably, it is a circumstance that could be said to represent possible occasions of “negligence” on the part of the Hospital. However, the relevant limitation section, 28 and 31, ties the ability of any plaintiff to allege negligence by a public hospital to the date of their discharge or cessation of treatment at a hospital. Therefore, for this aspect of the plaintiffs’ limitation act argument to succeed, I would have to find that section 34 creates some independent tort or triggers a duty upon a physician to reengage a patient in treatment or care that would be only undertaken in a hospital. I do not find section 34 imposes such duties on the Hospital.

[54] In my view, a plain reading of section 34 indicates that any duty created by the section is not of a quality as urged upon me by the plaintiffs. Section 34 does not create a duty on the part of an officer, or the Hospital, to start recalling patients who may have been effected by a “serious problem” as set out in that section. What the section does do is oblige the officer to “discuss” the problem with the attending physician. If the attending physician is not prepared to alter the alleged offending methodology, then the officer is obliged to take steps to have that physician’s privileges revoked. The section is aimed at stopping poor treatment on an ongoing basis rather than creating a duty of recall for patients who may have received inappropriate diagnosis, treatment or care.

[55] I find the section is clearly aimed at interactions among physicians. It does not even mention anything about fixing any past errors; it just speaks about changes to future care. At most it requires the director who notices a problem to file a report. Clearly no such reports were filed regarding these plaintiffs. I find that failure to file did not create any additional duties on the Hospital, non-delegable or otherwise, to step in and begin to actively become initiators of treatment or care of patients or out patients or even ex-patients.

[56] This aspect of the plaintiffs’ argument really goes to allegations of negligence against the oral surgeons. It has been expressed as a separate issue by the parties in their submissions. I appreciate the position of the plaintiffs that the three oral surgeons should never have considered using the Vitek implant on these four plaintiffs in the first place for a whole number of scientific, physiological and patient care reasons. But they did. I accept the evidence given at trial, vive voce and transcript that Dr. Dowhos, Dr. Orpana and Dr. Tomlak felt they were treating their TMJ patients appropriately at all times. While it appears to me that they did not vigorously pursue the recall process once they had overwhelming evidence (particularly from their insurer) that the Vitek implants were failing and causing ongoing problems, this fact does nothing to assist any argument by the plaintiffs that the limitation does not apply as against the Hospital.

[57] I am therefore not persuaded that this particular aspect of the plaintiffs’ submissions impacts my decision concerning the application of the limitations defence. I deal with my views on the alleged duty of recall later in this judgment.

[58] I find the plaintiffs have not proven on the balance of probabilities that after 1986, Dr. Dowhos as chief of the dentistry department and therefore an officer of the medical staff, was wrongly of the opinion that his, Dr. Tomlak’s and Dr. Orpana’s diagnosis, care or treatment of the plaintiffs should have triggered the duties set out in section 31 or 34 (as applicable based on time) of the Public Hospitals Act. I come to this view because the oral surgeons stopped doing the implant surgery in 1986. The focus of the oral surgeons after that time was either removing the implants or monitoring their patients on an ongoing basis. Their approach to the patients’ TMJ problems changed. Implants were no longer considered part of the solution. To me this indicates that they did realize there was a problem and they began to deal with it by not implanting anyone else. However, while this was an exercise of their judgment, it goes only to the issue of fulfilling their duty of care to the plaintiffs. It does not create a corresponding duty on the Hospital to do anything more than was actually done by the oral surgeons. In my view, this aspect of the case did nothing to change the basis upon which the limitation provisions apply to these plaintiffs. There were no intervening actions or events outside of the process of being treated and then discharged for the TMJ surgery problems that would have anything to do with the calculation of when the plaintiffs could or could not commence their actions against the Hospital.

[59] The plaintiffs also argue that they did not consent to the treatments as they were not aware the device was not approved for use in Canada. The plaintiffs, however, have conceded that their claim in this regard sounds in negligence as opposed to battery. As such, in my view, the provisions of section 28 continue to apply as the section clearly limits the timing for actions brought against a public hospital alleging negligence. I will deal more specifically with the issue of consent later in my reasons below.

[60] If I am wrong in my ruling regarding the application of the limitation section in the Public Hospitals Act for the three plaintiffs, and in any event for the purpose of the continuation of Mrs. Hearsey’s case, I will set out my reasons on the issue of liability.

Decision on Issues 3 and 4

[61] In the endorsement of January 5, 2017, I stated that I had found the Hospital breached a standard of care owed to one of the four plaintiffs which caused that plaintiff damage by the Hospital purchasing devices (the Vitek implants) which were used in the Hospital when the oral surgeons placed the devices in the plaintiff’s TMJs. The devices at the time were not approved for sale or use in Canada. This was noted as issue 2 in the endorsement.

[62] After reviewing the endorsement of January 5, 2017, in order to explain my finding in regard to issue 2, I must first deal with my findings and conclusions regarding issues 3 and 4. I do this because the facts most relevant to issues 3 and 4 (for which I have indicated there is no liability) occurred in time before the Hospital actually purchased the devices, actions for which I have indicated the Hospital is liable to the plaintiffs.

[63] The facts and conclusions with regard to issues 3 and 4 were interconnected so I propose to deal with them together. These issues first involve the plaintiffs’ allegation that the Hospital was negligent in allowing people they characterize as “unqualified oral surgeons” to do what they characterize as an “unapproved surgical procedure” to implant an unapproved (and therefore illegal) Vitek device. The plaintiffs also allege that the Hospital was negligent in allowing a newly licenced oral surgeon (Dr. Tomlak) to train other oral surgeons (Drs. Orpana and Dowhos) in the methodology of the TMJ implant procedure when it was represented that Dr. Tomlak would in fact be preceptored in his first year of practice by Dr. Dowhos. I do not accept that the Hospital is liable to the plaintiffs on either of these issues.

[64] To begin, in coming to my decision on issues 2, 3 and 4, I separate the fact that the device was unapproved for sale in Canada from the allegations of negligence arising strictly from the oral surgeons’ qualifications, the approval process for the procedure in the Hospital, and the representations the oral surgeons made to the Hospital as to the preceptorship program that would be undertaken by Dr. Tomlak. I do this because, in my view, the Hospital was doing two separate acts in first, approving the oral surgeons to do the procedure and then second, in making the decision to buy the device. I am led to this conclusion because I find the Hospital had to make two types decisions, each with a different quality respecting these issues. The first decision was the result of what I call a “permissive process” which allowed the oral surgeons to do the procedure. The second decision was the decision to actually go out and acquire the devices. For me this “buying decision” is a different type of a decision. This is because in both cases the Hospital had to rely or interact with two different types of intermediaries. The oral surgeons and staff professional with regard to the “permissive process” in the first place and then secondly, the Federal Government with respect to the “buying decision.”

[65] I accept the submission of the defence that the Hospital was entitled to rely on the expertise and experience of the oral surgeons in assessing if, by whom and how the procedure was to be undertaken. The Hospital did have a credentialing committee which was designed to assess the applications of the three oral surgeons. I heard competing expert evidence on the degree to which the credentialing committee properly assessed the application of Dr. Tomlak, and the other oral surgeons, to do TMJ surgeries using the device in the Hospital. However, that area of dispute, to my mind, is contrasted with the interaction, or lack thereof, that the Hospital had with the Federal Government concerning the purchase of the implant. The interaction with the Federal Government I find to have been completely independent of the process and information relating to the decision to allow the oral surgeons the privileges to do the procedure in the first place. To me there is a different quality in the duty of care owed by the Hospital to the plaintiffs with respect to the credentialing committee and its process as opposed to the stand alone allegation that the Hospital should not have bought the device at all.

[66] As I have stated earlier in these reasons, there was no real dispute about how the oral surgeons came to do the implant surgery in the Hospital. However, the plaintiffs assert that the credentialing process allowing the oral surgeons to do the implant surgery was flawed and therefore represented an occasion of negligence on the part of the Hospital. I will now set out the facts regarding the “permissive process” which the parties referred to as the credentialing process because I find it is determinative of this portion of the plaintiffs’ allegations concerning the negligence of the Hospital.

[67] Dr. Orpana and Dr. Tomlak testified as to the circumstances under which Dr. Tomlak was recruited to come back to Thunder Bay in 1983. The practice of Drs. Orpana and Dowhos covered a huge geographic area. Correspondingly they had a large practice. They had an unusually high number of TMJ patients because their treatment of these patients had been confined to non-surgical conservative measures. Dr. Tomlak presented with a new solution for some of these patients. According to Dr. Orpana, and I accept this evidence, he and Dr. Dowhos were looking for a way to better treat their TMJ patients in the mid-1980s. Dr. Tomlak had graduated from an excellent post-graduate school of dentistry and oral surgery. He represented that he knew how to do the procedure. Dr. Orpana and he had further checked out the procedure and the viability of the Vitek device by attending a conference in Toronto. According to Dr. Orpana, the distances and realities of delivering health care in Northwestern Ontario at that time did not make it feasible to bring a person with more experience than Dr. Tomlak up from Southern Ontario to teach all three the procedure.

[68] In asserting the Hospital was negligent in regard to the credentialing of the oral surgeons, the plaintiffs’ relied on the expert evidence of Allan Greve, Dr. John H. Gryfe, Dr. Robert Pilliar and Dr. Mansour Ahmad. I also considered the vive voce testimony given at trial by Dr. Tomlak, Dr. Orpana and from Dr. Dowhos’ transcripts in globally considering these particular issues. The Hospital relied on the expert evidence of Terry Fadelle and Angela Kane which was in stark contrast to the positions taken by the plaintiffs’ experts.

[69] I have analyzed this evidence and come to my conclusion about these two particular issues by breaking down the plaintiffs’ allegation into four separate parts. In my view, these parts represent the constituent acts for which negligence is alleged. The plaintiffs allege the Hospital was negligent because:

1. The oral surgeons were unqualified to;

2. Do an unapproved procedure with;

3. An unapproved device; and

4. Allowed Dr. Tomlak to train Drs. Orpana and Dowhos.

[70] In dealing with the entirety of the plaintiffs’ submission on these two issues I was struck by the fact that it skirted what I felt was a very critical element of the case. No witness in this trial suggested the actual surgical technique or procedure done on these plaintiffs was executed in an improper or negligent manner. The evidence of the actual results of the surgery was clearly to the contrary. There were no complications, problems or long term problems for these plaintiffs arising, per se, from the surgical technique or the application of the procedure to put in the implant. What happed was that the device failed. Badly. However, it was not shown by the evidence that the failure of the device in and of itself arose from any act of the Hospital or the oral surgeons.

[71] The evidence at trial was clear that it was the oral surgeons alone who recommended the device be implanted. The oral surgeons did the implantation. They also took it out of one of the four plaintiffs, Ms. Lind. Ms. Lind had her device removed in June 5, 1986 almost within a year of it being implanted June 17, 1985. Her evidence was that initially the surgery had caused a reduction in her TMJ pain but the pain came back. She was in quite a bit of pain when the decision was made to explant the device. However, I did not hear or receive any evidence that her (or any other of the plaintiffs’) alleged damages were caused by a failure of technique or procedure as opposed to the failure of the device.

[72] There was no dispute that all three oral surgeons held valid Ontario licences to practice oral and maxillofacial surgery at the time the four plaintiffs received their implant or implants. In my view, the fact that there were no complications from the surgery itself coupled with the fact that all three were duly licenced indicate to me that the oral surgeons were certainly qualified to do the procedure. Dr. Tomlak had left Thunder Bay and moved to Kingston by the time the other two oral surgeons became aware that the weight of scientific, medical and clinical evidence had turned against the implant. Accordingly, Dr. Orpana and Dr. Dowhos took upon themselves the so called “recall procedures” for these plaintiffs. Their office had some limited interactions with the Hospital but not of a nature sufficient to bring the Hospital into the orbit of a finding of negligence. In my view, there was no other evidence that suggested that the actions of the Hospital contributed to the plaintiffs’ injuries save and except the decision to buy the device at the request of the oral surgeons. I find that the decision to implant, and the decisions for treatment post-implant, were completely made by the oral surgeons in consultation with the plaintiffs. The Hospital had nothing to do with those decisions and cannot be held responsible for them. I will elaborate more on this point in the sections dealing with consent and the alleged duty of recall.

[73] I find that the plaintiffs have not proven on the balance of probabilities that Dr. Dowhos, or Dr. Orpana or Dr. Tomlak were not qualified to do the procedure at issue. I heard some evidence in cross-examination from Dr. Pierre Blais that he thought the implantation of a Teflon proplast implant in the TMJ of any patient was, in principle and practice, “quackery.” However, Dr. Blais was not qualified to give such opinion evidence in this trial.

[74] In coming to this conclusion concerning the qualifications of the oral surgeons, I have taken account of the unchallenged expert evidence of Dr. Robert Pilliar. His discussion of the history of certain materials being implanted in patients was thorough and very well written and understandable. His discussion about the Vitek device was useful for context in this matter. However, I find specifically that his opinion evidence was unhelpful at least as it related to any liability of the Hospital. In my view, Dr. Pilliar’s opinion spoke solely to liability that might be assessed against the oral surgeons but not as against the Hospital. I took from Dr. Pilliar’s report that in the medical and scientific community in both North America and Europe in the early 1980s, there were warning signs as to the possibility that the Teflon proplast implant would not perform as advertised and could be expected to cause patients damages. Notwithstanding, the scientific opinions outlined at length in Dr. Pilliar’s report, there were clearly actions taken by a great number of oral surgeons and hospitals in North America to utilize the implant from 1983 to 1988. This does not excuse that behaviour. However, in my view, it does nothing to advance the negligence claim by these plaintiffs against the Hospital. I cannot find on the basis of Dr. Pilliar’s evidence that the Hospital or its credentialing committee was sufficiently aware of the possible dangers of the Vitek device or that it was negligent of them to simply accept the representations made by the oral surgeons that the device was safe and efficacious.

[75] Dr. Tomlak and Dr. Orpana testified they were not aware of those opinions or facts as expressed by Dr. Pilliar such that it would have led them to reconsider the implant as an option for the plaintiffs from 1983 to 1986. That fact does not neutralize or negate the veracity or quality of Dr. Pilliar’s opinion. However, I find his report speaks solely to potential liability of the oral surgeons and not the Hospital. There was not sufficient evidence led to connect the knowledge of the Hospital to the history of the level of knowledge about the implant in the scientific and medical community as set out in the report of Dr. Pilliar such that I can find any liability arises from an alleged lack of the knowledge outlined in his report.

[76] Dr. Pilliar’s report did not opine on the qualifications of the oral surgeons. It did not opine on the approval of the procedure in any particular hospital for at least the period 1983 to 1986. It was useful background but did not assist the plaintiffs in proving their case against the Hospital.

[77] The opinion of Dr. Ahmad was of similar value at least for this portion of the trial. It was important context material. It opined solely on the damages experienced by these plaintiffs. However it did not give me any basis by itself to find the Hospital liable to the plaintiffs.

[78] It is clear from the evidence that that surgical methodology deployed to open the TMJ joint and remove the meniscus was not new or so radical so as to allow me to find, that it was an “unapproved procedure” in terms of general hospital surgical procedures being conducted at the time in Ontario. A respected textbook from the period was shown to Dr. Tomlak in the context of discussing what he had been taught at UConn, a respected graduate school of dentistry, regarding the procedure. His evidence satisfied me that it was a procedure with which he was fully familiar having learned about it and done it while at UConn. I, therefore, conclude it was not an “unapproved procedure” among practicing oral surgeons in North America at the time.

[79] I took from the evidence that as the procedure was being done for the first time at the Hospital, the plaintiffs allege the manner in which the Hospital credentials committee allowed privileges to Dr. Tomlak and increased the privileges to Drs. Orpana and Dowhos to do the implant surgery was done negligently. I do not accept this for a variety of reasons.

[80] There was nothing in the evidence as to the backgrounds, or training or experience of any of these three oral surgeons that I find would give the Hospital or its credentialing committee any reasonable cause to reconsider allowing the procedure to be done by any of the three oral surgeons for the 1983 to 1986 period. I appreciate it was Allan Greve’s opinion that the credentials committee of the Hospital was not sufficiently diligent in following up on Dr. Tomlak’s background when he applied for privileges in 1983. The evidence of Terry Fadelle was to the contrary. I prefer the evidence of Terry Fadelle on this point. In coming to that conclusion, context of when these actions were occurring is important.

[81] I accept the opinion of Terry Fadelle that indeed Dr. Tomlak’s prior training and credentials had been adequately explained to the credentials committee of the Hospital. As such, the Hospital did not breach any standard of care in accepting Dr. Tomlak’s credentials granted from the McKellar hospital as the basis to grant privileges at St. Joseph’s.

[82] Mr. Greve opines that the Hospital credentialing committee should have made independent inquires of the Federal Government to determine if the device was approved. I find this opinion to have been made rather baldly without sufficient basis in fact other than an assertion by Mr. Greve that it had been his experience that the chief of dental surgery should have done this. I agree that the Hospital as a purchaser of a product should have made inquiries about it with the Federal Government. I come to that conclusion on the basis of common sense. However, as the evidence was given about how these credentials committees operated in the 1980s, I do not see how that extra level of responsibility could have been found to rest with either the Chief of Dentistry or the credentialing committee. The process was described as a kind of peer review. In the main, the Hospital relied on the expertise of the doctors on the committees to assess the qualifications of their peers. This was confirmed by the evidence of Carl White, the CEO of the Hospital from 1990 to 2005.

[83] The evidence was clear that the Vitek implant had just been introduced in Canada in 1983. I do not accept, therefore, Mr. Greve’s opinion that all three oral surgeons should have arranged to attend a teaching hospital in southern Ontario to become better acquainted with the procedure. This opinion ignores the reality of the circumstances of these oral surgeons who after all, all lived in Thunder Bay. They had a busy practice and travel to southern Ontario was not convenient.

[84] On the specific issue of whether or not the oral surgeons were unqualified or did an unapproved procedure or that the Hospital was negligent in handling the implementation of the procedure through the preceptorship process, I prefer the evidence of Dr. Orpana, Dr. Tomlak and Terry Fadelle over the expert opinion given by Allan Greve and Dr. Gryfe on behalf of the plaintiffs.

[85] I did find Dr. Gryfe’s evidence extremely helpful in understanding the anatomy of the TMJ, the problems that were associated with TMJs in people in general and the mechanical and physiological reasons for the problems in patients and in the plaintiffs. Also, I found his evidence to have been helpful concerning how, in the main, these TMJ problems could be largely treated conservatively without surgical intervention. While Dr. Gryfe was certainly able to explain how the implant surgery was done, he had never actually done one himself. I find that Dr. Gryfe’s opinion evidence was directed at the question of whether or not the surgery should have been done at all as opposed to whether the oral surgeons were qualified to do the surgery. For me, this is a valid professional opinion but not one that could be used to extrapolate that the members of a peer review type body like the credentialing committee should have been automatically of the same opinion. In my view, Dr. Gryfe’s opinion was “inside baseball,” that is to say, to people particularly specialized in the area it could have made sense, but it was so particular to the area and assumed a lot of other knowledge such that it could not have reasonably been expected to be shared by other physicians who were assessing the ability of these oral surgeons to perform the procedure with the device. I, therefore, do not accept Dr. Gryfe’s opinion as to any negligence on behalf of the Hospital.

[86] To me, this was an important distinction in the context of what is actually before me to decide. I am dealing with the negligence of the Hospital. Any negligence of the oral surgeons certainly bears on the issue, but it is not first and foremost in my decision-making process as would normally be the case if the oral surgeons had not settled and entered into the Pierrenger agreement in this case. The evidence of the oral surgeons was key to understanding what actually happened to these plaintiffs. However, as a result of the Pierrenger agreement in place, I am not prepared to do as detailed an analysis of the oral surgeons’ actions as they relate to any alleged breach of duty the oral surgeons owed to the plaintiffs as would normally be expected for a trial of this type.

[87] In my view, Dr. Gryfe’s opinion was aimed squarely and solely at the particulars of negligence of the oral surgeons. I was not persuaded that Dr. Gryfe’s opinion evidence leads to a conclusion that negligence of the oral surgeons in how they expected they could treat these patients can be legitimately attributed to the Hospital. I do not accept that his opinion of the poor performance of the oral surgeons leads to a conclusion that the Hospital should not have allowed the oral surgeons to do the TMJ surgery.

[88] I understood Dr. Gryfe’s very clear opinion that these four plaintiffs should never have had the implant surgery. In his opinion, these people should have only received a conservative course of treatment with no surgery. Yet when I consider all the evidence of the treatment these plaintiffs received prior to the implants going in between 1985 and 1986, it seems to me that all the plaintiffs were first treated conservatively. This was contrary to what Dr. Gryfe asserted in his testimony and it causes me to discount the value of his testimony as to any alleged negligence of the Hospital. I come to this decision based on the letters written by the oral surgeons at the time which documented their progress with the plaintiffs and based on the vive voce evidence of the plaintiffs and the two oral surgeons who testified. Contrary to the evidence of Dr. Gryfe, the plaintiffs were all treated conservatively first, before the decision to implant.

[89] The nature of the treatment received by the plaintiffs pre-implant was well-documented. The plaintiffs and the oral surgeons were referred to various pieces of correspondence and charting to refresh their memories about the state of affairs in 1983 to 1986. Given the history of the case and how long it has taken to get to trial and the fact that memories tend to fade over time, this does not surprise me.

[90] With respect to the course of treatment for Mr. Karam, he testified that he met Dr. Tomlak in June 1984. He testified that he was still in hospital as the result of a significant motor vehicle accident. According to Mr. Karam, it was Dr. Tomlak’s advice that the problems he was having with his TMJ could be repaired. Mr. Karam says that this was a two minute long consultation. Dr. Tomlak could not recall the alleged in-hospital consultation in 1984. Over a year later, in late October 1985, Mr. Karam was referred to the oral surgeons by his doctor, Dr. Hoffman.

[91] Mr. Karam was seen by Dr. Orpana. Dr. Orpana took a conservative approach by recommending against surgery at the present time and waiting until his symptoms became worse and he developed an increase in pain and locking. This was set out in a letter from Dr. Orpana to Dr. Hoffman dated October 22, 1985 which was entered into evidence at Exhibit 11.22.

[92] About a month later, Mr. Karam had his implant surgery. On cross-examination, he could not recall how he got from “wait and see” to surgery in 30 days. He did testify that he was to receive an arthroplasty and that it would serve to take the pain away. In any event, it is clear to me that Dr. Orpana was leaving the choice of surgery up to Mr. Karam and whether or not he felt the pain was within his subjective comfort level to move to the next step. He testified in-chief that he did not understand what had happened to him. He alleged that he did not consent to the implant surgery and in general, seemed to forget facts which were not favourable to the narrative that the oral surgeons had recklessly gone forward with the implant surgery. However when confronted in cross-examination with several of his answers given on his examination for discovery, which had been taken in April 2000, there were a number of inconsistencies with that evidence and his evidence in-chief which leads me to discount Mr. Karam as a reliable witness.

[93] Chief among these inconsistencies was Mr. Karam’s assertion in-chief that he did not understand he was receiving an implant when his answers on discovery were clearly to the contrary. On discovery, he had clearly answered he knew the implant was made of Teflon Proplast. This answer is inconsistent with an assertion in his trial evidence that he did not understand the nature of the implant. Also it seems to me from his answers given on discovery that he knew something was going to be placed in his TMJ which was designed to alleviate his pain. This is contrary to his assertion at trial that he did not consent to the operation and that it was not explained to him.

[94] I find Mr. Karam’s initial treatment by the oral surgeons was in the nature of a conservative treatment. I find Mr. Karam did understand that he was going to have a surgical procedure designed to alleviate the pain in his TMJ. I find it was his decision to do so in consultation with the oral surgeons. This for me, however, would not have vitiated the initial conservative approach recommended by Dr. Orpana.

[95] With regard to the course of treatment for Ms. Endean, her evidence in-chief was given primarily by affidavit. This was on agreement of the parties because of personal difficulties Ms. Endean was having testifying for prolonged periods. She first saw Dr. Tomlak in November 1984. This followed closely behind the second serious motor vehicle accident Ms. Endean had endured. She was rear-ended on September 24, 1984. She had also been in a car accident in 1980. I understood from the evidence of Dr. Gryfe that these types of rear-end collisions can have a devastating impact on the TMJ because of the whiplash motion and can cause the disc to be displaced or to be significantly damaged.

[96] Following the first visit in November 1984, Dr. Tomlak wrote to Ms. Endean’s family doctor, Dr. Krupa. This letter was entered as Exhibit 3.21. It stated in part:

Her chief complaint is pain and clicking in her right TMJ since a whiplash injury suffered in a motor vehicle accident on September 24/84. Apparently this popping and clicking in her right TMJ was not present previous to the accident… Exam at this time shows patient with exquisite pain over the right facial region and neck region…Suggested plan at this time is to eliminate the muscle component and the edema and give a good environment for recapturing of the right TMJ disc. I have prescribed warm soaks to the muscles, ice to the joint and suggested to the patient to restrict her opening and continue soft foods for a number of weeks. The patient will be continued on her present muscle relaxants and antiarthritics. Once the edema and muscle spasms have subsided to a great degree I would suggest a partial lower denture construction to give her good glides of her lower jaw against her upper denture and increase the posterior support. Reassessment will be done only after the above two steps are carried out. There is an outside chance that the disc cannot be recaptured by nonsurgical conservative means. If this is the case then the surgical approach may involve shortening of the posterior ligament and relocation of the anteriorly displaced disc. This is a possibility although most of these signs and symptoms following accidents such as this can be carried out conservatively through non-surgical means.

[97] Ms. Endean was seen again by Dr. Orpana in January 1985. He wrote to Dr. Krupa on January 4, 1985 confirming among other things that the oral surgeons would continue with a conservative approach toward her treatment. In July 1985, Ms. Endean was continuing to suffer severe pain in her TMJ. A decision was made to try the surgical route. She had her implant surgery on October 8, 1985.

[98] In a post-operative letter to her family doctor, dated October 9, 1985, Dr. Tomlak confirmed the results of the surgery, the fact of the implant and the reason it had been done. Ms. Endean had “a large, well-defined, well-shaped hole in the middle of the meniscus extending well to the medial condylar head where the patient was articulating on the glenoid fossa fibrocartilage with the condylar head, thereby the main reason for her pain and limitation in opening and closing at times.”

[99] In my view, the evidence at trial indicates Ms. Endean was in fact first treated conservatively for at least a year before she had the implant surgery.

[100] With respect to the course of treatment of Sherry Lind, she was first seen by the oral surgeons in April 1985. In a letter to her family doctor, dated April 16, 1985, Dr. Tomlak set out a conservative course of therapy for Ms. Lind. He expressly stated there was no consideration of surgery at that time. He also stated, “[a] surgical procedure will only be contemplated if her signs and symptoms continue and the patient cannot live with the pain or has a history of open lock or closed lock situations which she cannot live with.” The letter continued to set out that an “artificial Teflon proplast” disc replacement would be used on Ms. Lind.

[101] This proposed course of treatment is contrary to what Ms. Lind described during her testimony in-chief about the treatment she said she was getting before she was implanted. However in cross-examination, her admission that “her memory was gone” made it difficult to accept a number of assertions she had previously made during her evidence. I accept that indeed she was to be treated conservatively prior to the implant surgery but made her own choice to try surgery because of pain management issues that were subjective.

[102] Like Mr. Karam, Ms. Lind attempted to assert in her trial evidence that she did not appreciate that one of the results of the surgery she underwent on June 17, 1985 was the implantation of the Vitek device. Like Mr. Karam, Ms. Lind was expressly asked questions about this during her examination for discovery which took place in April 2004. She answered in April 2004 that she understood she was getting an implant.

[103] I find Ms. Lind was treated conservatively prior to the implant surgery.

[104] With respect to Mrs. Hearsey, her evidence was taken solely from her discovery transcripts and documentary evidence introduced at this trial. This is because I found she was incapable of testifying at this trial for reasons I set out mid-trial.

[105] Mrs. Hearsey had a lengthy history of TMJ dysfunction before she was treated by the oral surgeons. She had lost all her teeth well prior to coming into their care in February 1986. She had her surgery very shortly thereafter. Dr. Dowhos saw Mrs. Hearsey once before the decision was made to operate. This was set out in a letter from Dr. Dowhos to Dr. Kraft dated February 25, 1986. Unlike the other three plaintiffs, it does not specifically propose a conservative course of treatment prior to surgery. However in the letter, Dr. Dowhos only mentions that there is a possibility of “interpositionals” which I understand from all the evidence given at this trial meant the implantation of a Vitek device. On discovery in March 2000, Mrs. Hearsey could not remember many details of her interactions with Dr. Dowhos prior to surgery. She stated at the time she had been in pain for “quite some time.” Also, she did remember that he suggested to her that he could help her TMJ problem by putting in “cushions” and she did consent to major surgery.

[106] Dr. Gryfe took exception to the decision to implant Mrs. Hearsey on the basis that a more conservative treatment could have been tried given she had been in pain for a long time and in effect she could continue to endure it for a further period. This for me was putting too fine a point on matters.

[107] It was clear from the evidence given at trial that no final decision to do the implant was made until the oral surgeons were actually in the operating room and the surgeons had opened up the joint and could see the actual state of the meniscus of the patient’s TMJ. Then, and only then, was the actual decision made as to whether or not it made sense to put in the implant. I accept the evidence of Dr. Tomlak and Dr. Orpana as to how they actually went about the surgery and how when two of them were doing the surgery together, they would consult on an appropriate course of action. This makes sense to me and was a reasonable approach given all of them were in their professional careers at the time the actual implant surgeries were done. This is what was proposed for Mrs. Hearsey. While it was not a course of treatment that took place over time, it was conservative in the sense that it was predicated on an actual inspection of the status of both her joints before the device was implanted.

[108] Overall, I find that Dr. Gryfe’s testimony demonstrated a legitimate difference of opinion when it came to how these plaintiffs were treated. However, I did not find his opinions on the conservative approach to treatment persuasive in light of the evidence on how all four were treated prior to the implants. His opinions on how the plaintiffs were treated only speaks to issues of possible negligence of the oral surgeons and has nothing to do with any evidence of negligence of the Hospital. This lessened the weight I was prepared to give his overall opinions about the negligence of the Hospital.

[109] I also understood Dr. Gryfe’s criticisms of the charting habits of the oral surgeons. Again, I do not accept it as persuasive evidence of negligence on the part of the Hospital. In the case of Paulette Endean, her post-operative report of the implant surgery was prepared six weeks after the surgery. Dr. Gryfe described this as a “lifetime” in the surgery business. I agree. He also described the report as minimal, general and non-informative. I agree with this assessment as well. However, this to me represented evidence of negligence of Dr. Dowhos and not the Hospital.

[110] In considering how this case was presented from start to finish, there was no question that plaintiffs’ counsel took every opportunity to place his theory of the case before the Court. Unfortunately for the plaintiffs, having considered all of the evidence on liability, I do not think the evidence allows me to draw some of the conclusions urged by the plaintiffs.

[111] The evidence of Dr. Gryfe was a case in point for me. It seemed to me that the plaintiffs were urging an oversight role for the Hospital and attempting to fix the Hospital with knowledge of the treatment and care for these plaintiffs that I find unrealistic when I consider all the evidence. This started with the assertion that the credentialing process was part of some integrated regulatory or safety regime. The key word is “integrated.” Clearly, the credentialing process was designed to protect patients. However, the mere existence of that particular tool to assist in patient protection was not sufficient to vault the Hospital into a position where it became responsible to a parallel degree with the oral surgeons when it came to the overall treatment that the plaintiffs received. In my view, the plaintiffs were patients of the oral surgeons. No witness disputed this. The oral surgeons had the primary responsibility for the health care of these people as it related to their TMJ problems. No witness disputed this. It seems to me the deficiencies alleged by the plaintiffs are valid only if one accepts that the Hospital was in effect a complete overseer of all aspects of care delivered to the plaintiffs while they were in the Hospital and after they were discharged. I find this unrealistic and not in accordance with any evidence given at this trial. Clearly, the Hospital does have a role and a duty of care to the patients. But in my mind, it was of a far lesser scope than that urged by the plaintiffs.

[112] The allegation that somehow the oral surgeons were unqualified and this procedure was “illegal” was an example of a submission that is simply not borne out by the evidence in this matter.

[113] I was able to consider the evidence of Dr. Tomlak and Dr. Orpana carefully as the result of their presence in court. Granted, it came 30 years after the fact. However, they presented as professional, calm, knowledgeable and competent oral surgeons. I was able to understand their explanations of the treatment they undertook with these plaintiffs. I accept that they thought what they were doing at the time was appropriate and true to their duty of care to the patient. It seems to me they might have made further and better inquiries about the efficacy of the implant at the time. I do think things were different pre-Internet. However, I do not need to comment any further on that issue in order to deal with the liability issue for the Hospital.

[114] Dr. Gryfe candidly admitted he had never been a member of hospital administration. While he had requested hospital administration to allow him to use a new device or a new procedure, he had never been on the hospital side of the process that led to either a “yes” or “no” answer for the use of a new device. He admitted he had never done the implant surgery at issue. I, therefore, find his evidence was not helpful in dealing with the issue of whether or not the Hospital should have allowed this procedure.

[115] I also did not find the evidence of Allan Greve overall particularly compelling in many respects. Mr. Greve was testifying for the first time as an expert. On occasion, I found that I could not understand his testimony as it rambled and did not directly answer the question that was asked. For example:

MR. LEGGE: Q. So Mr. Greve, on the narrow issue of whether or not Dr. Tomlak should have been accredited to do TMJ surgery in the first place, was there an adequate record to substantiate that appointment in your opinion?

A. Well, I have to start from the point that, that the question about what would be implanted was not divulged or it was not part of that process, so if, if that, that was and, and the question was asked is it approved the answer is they, they should not have given that particular privilege to him. There’s no doubt that in Thunder Bay that the oral surgeons had a very robust practice and if the hospital thought that, that we needed additional oral surgeons then that is the, the hospital decides that on, on, recommendations from the Credentials Committee and the Medical Advisory Committee and it would go through to the Board. So the answer is as long as we’re not implanting anything that is not, is not against the regulations or the statutes I then would - - and we could, number one as a , as a hospital afford this and in all resources meaning medical as well as all the supportive ones.

Q. You have a series of conclusions under the heading “Conclusions” and without reading them could you explain your conclusions to the court, please? Provide a synopsis of your conclusions, please.

A. Thank you. I was asked to address these questions and as you can see a question is, is what is the - - an appropriate approval process in allowing implants in a facility and I believe I’ve spoken to that and I guess the issue here is the basis of, of this, every patient coming to St. Joe’s Hospital can and should expect that the hospital is delivering patient care within the laws and the statutes and the regulations of the federal and the, and the Public Hospital Act, so that should, that should be a given. And then obviously from the Board’s point of view and the CEO’s point of view we are enforcing those, the results of that. And then we, we talk about the patients being admitted and we know that the, again, the Public Hospitals Act is very clear that patients admitted for these implants have to, have to be to meet the criteria and the Public Hospitals Act they must be admitted by an MD and an, an oral surgeon in this case, so both of them.

THE COURT: What, physician or an oral surgeon?

A. Pardon me?

THE COURT: What did - - you said it’s clear that the admissions have to meet the criteria of a physician or an oral surgeon?

MR . LEGGE: And.

A. And, and an oral surgeon.

THE COURT: And an oral surgeon?

A. Has to be admitted by both.

THE COURT: Oh, okay.

A. And the same thing for discharging a patient and the third, sorry, may I….

THE COURT: Well, okay, go ahead.

A. And the third thing it says, “Should the hospital have independently determined whether the oral surgeon had appropriate experience”. Well, I’ve, I’ve addressed that. On the basis to say that this - - there was no, in my opinion, a person in the hospital who could be or should have been the preceptor if they haven’t been able to be or did the operation themselves because that’s the kind of training and skill is necessary in order to make a judgment on that. And second of all, I indicated that if that happened then they should bring someone to the hospital to, in actual fact, do that review of Dr. Tomlak’s skill and abilities or arrange for them to go to a teaching hospital where this is done. The fourth thing is, “Did the hospital implement the appropriate periodic review of implants and patient outcomes” and I couldn’t see any evidence where they did that review. I think we’ve spoken to that and there perhaps - - and that is right in the medical - - sorry, that is right in the dental staff bylaws of St. Joe’s Hospital where it is, it’s the chief’s responsibility to make that happen and obviously if it doesn’t happen then the Chief of Dentistry reports to the Chief of Surgery and so that, those are the two people that should or could make that happen. I think that’s….

Q. And my question was, is it acceptable that the hospital didn’t notify Andrew Karam directly?

A. The process that would happen in the hospital that I was the CEO is that immediately upon knowing that there would have been a discussion between the chief of, of dentistry, the - - and the chief of surgery, plus the chief of staff in respect to this, along with the senior members of the administration that are involved . And in order to find out what is going to be the action as a result of this and then decide on a course of action as to who is going to take the responsibility of making or the patient, client, known as to what is, is going to be the action and that dependent on that discussion is - - would be an action plan; however, I guess the issue is that if this, this last letter that we looked at of which I believe is just signed by oral surgeon, surgery that they, that if, if that was not going to take place then I believe that the hospital has a responsibility to make that happen.

[116] These were specific answers that in isolation did not answer the question in my view. I appreciate it is easy to “cherry pick” after the fact using transcripts. However during his evidence, I was not impressed that he was certain about some conclusions that ultimately the plaintiffs argued I should take from his evidence. Mr. Greve made at least two important factual assertions in support of his opinion that the Hospital was negligent which proved to be incorrect.

[117] First was his assertion that certain charting procedures were not done as it related to three of the four plaintiffs. This involved the evidence about the Hospital Medical Records Institute (“HMRI”) notations on the patients’ charts. Second, Mr. Greve had opined that these plaintiffs had not been admitted to the Hospital by a physician, a circumstance he found to indicate negligence on the part of the Hospital.

[118] A review of the charts during cross-examination clearly showed that all the plaintiffs had been admitted to the Hospital under the signature of a physician. It also showed the HMRI stamps on records which Mr. Greve indicated he had not seen before. It was plain and obvious that contrary to Mr. Greve’s opinion, the charts had been looked at or scanned for HMRI purposes. For me, these errors diminished the weight I was prepared to give his testimony.

[119] Based on all the evidence I heard at the trial, I find no fault in the manner in which both the oral surgeons and the Hospital approached the introduction of this new technique to the Hospital. I do not agree with the argument of the plaintiffs that what was in effect occurring was unapproved clinical trials or human experimentation.

[120] It is clear from the evidence that in the beginning of the fall in 1983, newly licenced oral surgeon, Dr. Tomlak, took the lead on behalf of the other oral surgeons in requesting that the Hospital allow these people to do the implant surgery in the Hospital.

[121] Dr. Tomlak had done post-graduate work at a leading North American school of dentistry at UConn. He had been properly trained in the procedure. Dr. Dowhos and Dr. Orpana were skilled oral surgeons. They were not aware of the technique. Dr. Orpana testified that at that time that it was how new procedures were introduced to the practice of medicine in Northwestern Ontario. I accept his evidence as an appropriate description of the standard of care on the narrow issue of the introduction of new surgical procedures at the time. The oral surgeons did not have the luxury of making a two to three hour drive as any oral surgeon could do in the Greater Toronto Area or indeed anywhere in southern Ontario in the 1980s, to either watch or have someone come to teach. Dr. Tomlak was licenced to do the procedure. It was an accepted procedure. There was textbook evidence introduced at this trial indicating that in the 1980s the implantation technique was an accepted surgical procedure aimed at reducing or eliminating dysfunction and pain in patients’ TMJs. In this trial, I find that the evidence was overwhelming that the procedure did not go wrong; it was the defect in the device that caused the plaintiffs damages. Dr. Tomlak was trained in the procedure and was licenced in Ontario at the time to perform dental surgery. That was sufficient in my view for him to teach the technique to the others and, in permitting that to occur, the Hospital did not breach a duty of care owed to the plaintiffs.

[122] Also, I am convinced by the evidence that the damages suffered by the plaintiffs did not arise from the failure of technique or deficient skills on the part of the oral surgeons when they did the surgery. From the evidence it is clear to me, the plaintiffs’ damages have been mainly caused by the failure of the device and the failure of the oral surgeons to make due inquiries of the efficacy of the device before they decided to use it. In all four cases before me, there were no complications from the surgery itself. It was the delamination and destruction of the device that caused destructive debris in the plaintiffs’ TMJs which has led to their suffering damages such as, among other things, progressive bone loss.

[123] From the Hospital’s perspective, I agree that they were entitled to rely on the assumption that the oral surgeons were sufficiently skilled and knowledgeable that they would not seek to introduce an unsafe procedure or device to the Hospital. Dr. Dowhos and Dr. Orpana had been credentialed in the Hospital for many years. I heard no evidence that their reputation as surgeons and patient caregivers was anything less than stellar. I do not find that there was anything in Dr. Tomlak’s background that would give cause for the oral surgeons or the Hospital’s credentialing committee to do anything less than agree to credential Dr. Tomlak and allow an increase in the scope of the privileges of Dr. Orpana and Dr. Dowhos to perform the TMJ surgery.

[124] I appreciate that both the device and the procedure were new to the Hospital. Dr. Orpana testified directly on the circumstances of introducing new procedures to his practice at the time. I prefer his evidence to that of the plaintiffs’ expert, Mr. Greve, to the effect that the credentialing committee should have done more to inquire about the device. I will describe later what the credentialing committee would have heard from the Federal Government had it inquired about a Notice of Compliance for the device. Dr. Orpana’s testimony to the effect that the way the Vitek device was introduced to himself and Dr. Dowhos by Dr. Tomlak struck me as a reasonable and appropriate method for trying to advance patient care at that time. I, therefore, cannot find that the Hospital was negligent for how the credentialing committee dealt with the procedure by allowing it to proceed in the Hospital and by allowing the oral surgeons to perform the procedure. I find the credentialing committee was entitled to rely on the doctors as to the efficacy of the product. Once the Hospital decided to purchase the product the oral surgeons requested, the Hospital’s duty to the plaintiffs changed, which I will explain below.

[125] The plaintiffs relied on two decisions to argue the proposition that by virtue of credentialing these oral surgeons to do implant surgery, the Hospital then had a duty of oversight and became responsible for the damaging results occasioned by the failure of the implant. I do not agree that the cases put forward by the plaintiffs stand for such a proposition or would persuade me to extend the duty of care of the Hospital to the plaintiffs at least as it concerned the issue of how the oral surgeons came to be credentialed.

[126] The first case was a decision of the Ontario Court of Appeal in Buchan v. Ortho Pharmaceutical (Canada) Ltd., 1986 CanLII 114 (ON CA), [1986] O.J. No. 2331. It was a products liability case involving the manufacturer of birth control pills. In my view, the case stands for the proposition that a manufacturer of a product has a duty to warn consumers of dangers inherent in the use of its product of which it knows or ought to know. The case discussed the applicability of the “learned intermediary rule” as it applied to drug companies discharging their duties to their patients by warning physicians as opposed to patients or consumers directly. The plaintiffs argue the ratio in this case should persuade me that once the Hospital had actual knowledge of harm occurring to the plaintiffs, the Hospital had a positive duty to those parties injured by the product they received while in the Hospital. I disagree that the case persuades me to that conclusion.

[127] There was no evidence presented at this trial, expert or otherwise, that would allow me to equate the role of a drug manufacturer to that of a hospital in the provision of health care to persons in Ontario in the mid-1980s. Common sense tells me they are very different actors, with very different duties of care to patients and the public. On that basis alone, Buchan, supra, can be distinguished for the purposes of any applicability to this case. Additionally, a key finding made by the Court of Appeal at paragraph 51 of the decision was that drug manufacturers occupy the position of an expert in the field of their own products. This is because of the rigorous testing, development and scientific knowledge that is applied to such products before they are brought to market. In this case, at best, the Hospital was in the shoes of a consumer of a medical device manufactured by Vitek. No evidence was led that suggested the Hospital should have been, or was, an expert in assessing all products or devices used within its walls.

[128] The plaintiffs also argue that the credentialing process had the quality of being a part of an integrated regulatory regime. In this respect, the plaintiffs rely on the decision of the Federal Court of Appeal in the decision of Swanson Estate v. Canada, 1991 CanLII 8226 (FCA). The case involved an action against Transport Canada for failing to properly regulate an airline that had a plane crash. The decision found that Transport Canada as a regulatory agency was negligent in allowing a particular airline to continue operating in the face of numerous violations which contributed to the circumstances leading to the plane crash. The plaintiffs rely on portions of the judgment finding that officials charged with a duty of maintaining safety must carry out their duties carefully. I do not agree the ratio applies in this case.

[129] I disagree that the evidence led at this trial would permit me to find that the credentialing committee or the credentialing process for the three oral surgeons undertaken by the Hospital in the mid-1980s had the quality of an overseer of safety in the same nature and degree as Transport Canada oversees airline safety. Clearly, the credentialing process is designed to ensure that competent physicians do medically efficacious procedures in a hospital. I had before me the credentialing policy of the Hospital. It set out the process to be followed and the documents that were required to be submitted by physicians seeking privileges. The evidence I heard indicated that Dr. Dowhos and Dr. Orpana were not being treated as new applicants in 1983. In my view, this was reasonable based on their experience and length of time they had been affiliated with the Hospital.

[130] I do not accept the plaintiffs’ argument that information available to the credentialing committee or the Hospital in the mid-1980s would have caused them to consider the proposed procedure to be in the nature of a great hazard such that they should have taken more steps than they did in credentialing these three oral surgeons to do this procedure. Counsel for the plaintiffs urged me to accept this based on the decision in Swanson Estate, supra. Counsel also relied on the decision of the Supreme Court of Canada in Rothfield v. Manolakos, 1989 CanLII 17 (SCC), [1989] 2 S.C.R. 1259. I disagree that this case is applicable to this matter.

[131] I find Rothfield v. Manolakos, supra, is not applicable because it can be distinguished on its facts. The case was about the liability of a municipality to building owners whose plans and construction had been inspected by municipal employees. I find the Hospital to be in a different type of position vis-a-vis the plaintiffs when contrasted with the municipality in that case. The municipality regulated construction activities within its municipality and made construction contingent on compliance with their imposed regulatory scheme. That is simply not the same type of activity that was occurring for these plaintiffs when they attended at the Hospital to have the implants done in the mid-1980s.

[132] I appreciate the plaintiffs’ desire to have me accept this theory of an overarching regulatory function of the Hospital over the oral surgeons. Counsel for the plaintiffs described the Hospital as the “dominant regulator” over the activities of the oral surgeons with a corresponding duty of mature and sober oversight. With respect, I was not presented with any acceptable expert evidence supporting that proposition nor do I extrapolate the same kind of duties from the statutes at issue or the Hospital bylaws at issue.

[133] In my view the plaintiffs’ argument ignores the fundamental relationship between the oral surgeon and the patient. No evidence was led which in my view indicated that the Hospital was equipped, or in fact wanted to, exercise an oversight capacity over the oral surgeons to the degree that was urged by the plaintiffs. The credentialing process was not designed to be an ongoing guarantee of the professional work of the oral surgeons. At best, it was designed to ensure a minimal level of competence and qualifications of persons who were allowed to perform surgery at the Hospital.

[134] The plaintiffs also allege that the credentialing committee gave Dr. Orpana and Dr. Dowhos privileges to do the TMJ surgery before Dr. Tomlak arrived in Thunder Bay. I find this argument to be a bit of a red herring. This is because the evidence I heard was that none of the plaintiffs were implanted during the year in which Dr. Dowhos was supposed to be overseeing Dr. Tomlak. Also, as I have mentioned before, I find that none of the damages occasioned by the plaintiffs relate to the technique the oral surgeons employed. Also, from the vive voce evidence of Dr. Orpana and Dr. Dowhos, I find that there were always two oral surgeons doing the technique at any time. I cannot, therefore, find that if the credentialing committee technically approved Dr. Orpana and Dr. Dowhos before Dr. Tomlak, it had any impact whatsoever on these plaintiffs. To that extent, I was not persuaded by that narrow aspect of the argument of the plaintiffs.

[135] Based on the facts presented, I was not persuaded that simply because the procedure was new, and the device was new, that this created a greater degree of diligence on the part of the credentialing committee in assessing the application of these three oral surgeons. I heard the argument of the plaintiffs to the effect that Dr. Tomlak’s earnest beliefs lead the Hospital to occasions of catastrophic error. That argument may make sense if the issue is the negligence of Dr. Tomlak. But that was not the issue at this trial. With regard to issues 3 and 4, I do not find that the plaintiffs proved, on a balance of probabilities, that the Hospital was in any way negligent in allowing these three oral surgeons to do this particular procedure to these particular plaintiffs.

Decision on Issue 2

[136] As I noted in my endorsement of January 5, 2017, I have found that the Hospital breached a duty of care to one of the plaintiffs in purchasing devices (the Vitek implant) which were used in the Hospital by the oral surgeons and placed in the plaintiffs’ TMJs. At the time, the device was not approved for sale or use in Canada. I will now set out the facts that support that conclusion.

[137] In the mid-1980s, physicians and oral surgeons were required to make a business case to Hospital administration for the introduction of a new procedure or technique. The hospital would consider if its budget, manpower allocations and physical plant could support the request. To this end, Dr. Tomlak approached the OR manager of the Hospital, Linda Bobinski, in the fall of 1983 regarding the oral surgeons doing the TMJ surgery with the Vitek device.

[138] Ms. Bobinski referred Dr. Tomlak to a sales representative of a company called La Corporation Instrumentarium Inc. (“Instrumentarium”). This company was based out of Quebec but had an Ontario office in Kingston. I heard evidence from several Hospital witnesses that in the 1980s, Instrumentarium was a respected Canadian distributor of medical devices, among other things. They had the exclusive right to distribute the Vitek implant in Canada.

[139] Dr. Tomlak obtained prices for the device from an Instrumentarium sales representative, Lorne Flower. With pricing information in hand, Dr. Tomlak then submitted a handwritten proposal to the Hospital via Ms. Bobinksi. The prices of the individual implants were relatively modest. The actual 1.3 mm implant used in all four plaintiffs cost $71.00. The Hospital had a purchasing policy at the time that any non-capital items worth under $1,000.00 per item could be acquired on requisition under the signature of a department manager. A requisition was sent to the one person in purchasing who was responsible for sending out orders. On this basis, the Hospital acquired its first batch of Vitek implants in November 1983.

[140] Prior to April 1, 1983, the Hospital had no duty to check to see if a device, like the Vitek implant was approved. The law in Canada regarding medical devices changed on that date. Effective April 1, 1983, regulations governing the use of medical devices in Canada were amended. The amendment P.C. 1982-3105 provided that any device designed to be implanted into the tissues or body cavities of a person for 30 days or more were required to have a notice of compliance issued for the device by Health and Welfare Canada.

[141] The Hospital received an Information Letter dated January 12, 1983 from the Health Protection Branch of Health and Welfare Canada. This letter set out the need for manufacturers of any implantable type devices to comply with the new regulations by April 1, 1983. The letter stated that the regulations only applied to “new devices.” Also the letter said:

A notice of compliance issued by the Branch after evaluation of the submission does not signify approval. It does, however, provide users with the assurance that the Branch is satisfied that the manufacturer has carried out tests and has submitted appropriate results to demonstrate a reasonable probability of safety and effectiveness in humans. The onus of ensuring safety and effectiveness of the device remains with the manufacturer.

Since all new devices will not be labeled to indicate that the products have received Notices of Compliance, purchasers of these devices may obtain information about the status of the device by writing to the Director, Bureau of Medical Devices, Environmental Health Directorate, Health Protection Branch, Tunney’s Pasture Ottawa Ontario.

[142] After the Hospital had bought its first batch of Vitek devices, but before any of the plaintiffs in this case were implanted, the Hospital received a visit from an inspector from Health and Welfare Canada in September 1985. It was not an enforcement visit. Rather, it was a meeting designed to share information about Health and Welfare Canada’s role in regulating medical devices. Apparently, the issue of the Vitek implant did not come up.

[143] Vitek Inc. never successfully applied to Health and Welfare Canada to obtain a Notice of Compliance for its implant devices.

[144] No Notice of Compliance was ever issued for the Vitek devices which were implanted in all four plaintiffs in this action.

[145] Neither the oral surgeons nor the Hospital were aware of the changes to the device regulations in April 1983. I do not accept the arguments of the defence that because the law was new it was not negligent of the Hospital to ignore the regulations. I appreciate the law as enunciated by the Supreme Court of Canada in Canada v. Saskatchewan Wheat Pool, 1983 CanLII 21 (SCC), [1983] 1 S.C.R. 205: The breach of a statute is not per se negligence but it can be considered evidence of negligence.

[146] It was interesting that the notice from Health Canada of January 1983 said if purchasers of any device wanted information they “may” obtain same by inquiring by letter. This to me sounds “permissive” or “optional.” I appreciate that this use of language could lead to misunderstanding or to lay persons disregarding the inquiry process as unimportant. The reasons for the use of the word “may,” as opposed to “shall” or “must,” by the Federal Government communications was clearly explained by the evidence of Dr. Pierre Blais, which I will discuss below.

[147] In any event, in my view, it would not have taken a lot for somebody from the Hospital to pick up a phone and call Health Canada or to write a letter, before they bought the first batch of the product. The procedure was new to the Hospital. The device was new to the Hospital. The implants were designed to be placed in a patient for an extended period of time. I agree with the argument of counsel for the plaintiffs that a reasonable person would think “maybe we should check to see if the device is approved” before it was acquired. I find the Hospital in purchasing the product was in a different position and acting in a different capacity than when it is relying on the credentialing committee to evaluate the oral surgeons’ ability to do the procedure and use the device.

[148] In my view, the fact that the Hospital did not check, does not permit the logical leap to find that this act of negligence then flows onto or over or taints any other decisions, or parts of decisions, that involved the use of the device in the Hospital. I separate them notionally.

[149] I accept the submissions of the plaintiffs that the Hospital’s failure at various times, between 1984 and 1986, to inquire of Health Canada if a notice of compliance had been issued for the implant, constituted a breach of the duty of care owed to the plaintiffs to ensure that only approved devices were used by oral surgeons operating in the Hospital.

[150] I found this aspect of the plaintiffs’ submissions persuasive. Given that the device at issue would be placed in a person’s body potentially for life and given that there was a government regulatory regime in place allowing or not allowing distribution of a device by manufacturers, failure to inquire about the use of the device is evidence of negligence. The onus would then shift to the Hospital to rebut this presumption by demonstrating due diligence in dealing with the acquisition of the device. However, I find this duty of care is quite limited and specific and does not in any way, shape or form create an overarching duty as urged by the plaintiffs.

[151] I do not find, for example, that the Hospital “sold” the device to the plaintiffs such that any liability would attach to the Hospital on that basis. The applicable portion of the medical device regulations (s. 33 of RRC C. 871 as amended) prohibits sale of a new device by a manufacturer unless a notice of compliance has been obtained. In my view there was no evidence led at this trial that would allow me to equate the Hospital to a manufacturer under the medical device regulations. Also there was no evidence of commercial activity between the Hospital and the oral surgeons or the plaintiffs, at least as far as the device was concerned. The evidence was that purchase of the device fell under a global budget of the Hospital and was not charged back in some way to the oral surgeons or the patients. I am also persuaded by the ratio of the decision placed before me by the defendants of Harrison v. Alexa Life Sciences Inc., 2015 BCSC 638, to the effect that the Food and Drug Act, R.S.C. 1985, c. F-27, constitutes a complete code, thereby barring any independent civil cause of action based on allegations of breach of that statute.

[152] I considered the expert evidence of Angela Kane on behalf of the Hospital about the standard of care in obtaining and supplying devices for implantation in patients in the mid- 1980s. I did not find Ms. Kane’s evidence particularly persuasive. First of all, her experience from that time was not in Ontario. She was working in Alberta at the time. I appreciate her opinion that the standard of care was similar all across Canada for that period. I did not have enough evidence from her to simply accept that proposition without anything further. Also, I understood Ms. Kane’s evidence to be premised on discovery evidence of certain hospital witnesses, in particular the OR manager at the time, Ms. Bobinski, and what Ms. Bobinski said about the practice at the Hospital and, therefore, in Ontario. I heard live evidence from an OR manager of the Hospital, Joan Wekner, but she held the position in 1990 and did not deal with purchasing the Vitek device. Be that as it may, Ms. Wekner, like Ms. Kane, testified that essentially the practice at the Hospital in the late 1980s and early 1990s was that if a doctor wanted something, they received it if the budget allowed.

[153] This may well have been the practice but I think it ignores the sea change that happened in April 1983, regarding the issuing of Notices of Compliance. The duty of care of a hospital increased at that time. In my view, it increased the diligence a hospital had to exhibit when buying things that were designed to go into patients for an extended period of time. It did not increase, however, in such a way that the Hospital became an overseer and guarantor of the result of every surgery that utilized the device.

[154] Based on the evidence I heard at this trial, I find that this breach of duty did cause damage to the plaintiffs. But for their acquisition of the device, the oral surgeons could not have done the procedure, at least not at St. Joseph’s Hospital. This finding, however, cannot stand without a discussion of the evidence concerning what would have happened if the Hospital had made the inquiry. In my mind, evidence on this point was instructive in respect to the issue of apportionment of damages rather than causation. This is because I accept the submission of the defence that nothing would have changed for the plaintiffs if the Hospital had made the inquiry of Health Canada at the time the devices were first acquired. However for me, this does not change the breach of the duty of care when the Hospital failed to make any inquires once it decided it was going to acquire the device for use by the oral surgeons in their patients.

[155] The only evidence on this very narrow but significant point, of what the Hospital might have been told at the time had the inquiry been made, came from Dr. Pierre Blais. He was involved in responding to any person, company, or group who made inquiries about the changes to the medical device regulations. Dr. Blais testified that there were zero inquiries about the Vitek implant from any consumer or possible consumer of the product up until the end of 1986. This meant that no hospitals in Canada asked about the Vitek implant at any relevant time to this litigation. Vitek at some point in 1987 tried to have their entire product line, over 500 products, exempted from the regulations but this was not successful. In any event, for the inquiries that were made about other products, Dr. Blais had been instructed by “upper levels of the department” to be very careful in answering any inquiries. He testified that there were written guidelines, not produced at this trial, as to what could be said and what could not be said.

[156] Dr. Blais testified that essentially any inquiry would first be met with a request to get back to the caller. A second call which was to be recorded was arranged. The caller was not told that the call was being recorded. The guiding principle was that there was “a substantial uncertainty in the response if it pertained to a medical device as to the status of the product and also its risk.” This was designed to cater to the needs of the medical device industry, according to Dr. Blais. Further, if the department had received no information about a product that fact was not to be conveyed to an inquirer. In addition, if the department did have information it was not disclosed to a caller or a person who wrote looking for an answer. He was instructed to use words like “maybe” or “possibly” or “subject to review” and then only after consulting with his “echelons.”

[157] In responding to a direct question about what his response would have been to an inquiry about the Vitek implant received by a Canadian hospital prior to the end of 1986, Dr. Blais testified to the effect that:

we would have acknowledged about the product and the text would say essentially nothing in words. It would say something to the effect that the product is deemed to be in clinical use at present and it may be in compliance with the regulations as they stand at the time. It may have said we have no knowledge of adverse events or it may also have said that the product is not controversial in one way or another or whatever. No matter how couched the language would be there would be a necessary component of uncertainty so that if there ever was a challenge about what we said that we could say “well we said maybe. A very firm maybe.”

[158] Specifically, if the inquiry had been made about a notice of compliance, the answer would have been the same as a general inquiry (i.e. the necessary component of uncertainty). In addition, the inquirer would have been told the device may not be subject to the new regulations or that the manufacturer would have been deemed to have applied for commercialization before the enactment of the regulations.

[159] As bizarre as all of that evidence sounded to me, it was not contradicted. I am, therefore, left to accept Dr. Blais’ evidence that had the Hospital made an inquiry about the Vitek implant in the 1983 to 1986 period, they would have been given an answer by Health Canada that would have been equivocal as to the status of the Vitek implant. It is difficult to determine on the other evidence whether or not this kind of answer would or would not have been expected to raise any alarm bells with an actor like the Hospital. It is difficult for me to say if the answer would not have led a reasonable hospital purchasing agent to change their decision to purchase the implant. According to Dr. Blais, the government of the time wanted to regulate devices but did not want to create unnecessary trade barriers between Canada and the United States and Europe. The official policy was to provide answers that were uncertain.

[160] It seems to me that if the Hospital had the opportunity to prevent any damages to these plaintiffs, it was a very narrow window which in turn limits their exposure to any liability from an apportionment perspective. I also do not think the credentialing process would have reasonably been able to turn up any negative information about the implant. In my view, the scope of the Hospital’s duty in the mid-1980s to inquire as a consumer or purchaser of a medical device product was less than the duty of a prescribing oral surgeon, or even a commercial distributor of the product.

[161] While I did find it unreasonable that the Hospital failed to inquire, I cannot ignore the equivocal answer they would have received. I cannot say one way or the other if the Hospital would have bought the device anyway. There was no evidence on this specific point because it called for the fact witnesses to speculate. However the fact that the Hospital did buy it, in light of what they would have been told about, goes to the issue of apportionment, which I will explain later in this judgment.

Decision on Issue 5

[162] The next issue I will deal with was numbered 5 on the endorsement of January 5, 2017. The issue is whether or not the Hospital was negligent in not obtaining an informed consent by the plaintiffs to the implant operation in the first place. In the endorsement, I answered “No.” Here are my reasons for that decision.

[163] I accept the submission of the defence that the Hospital’s role in obtaining consent to treatment for these plaintiffs was “secretarial only,” adopting the description of the process used by counsel for the Hospital. Not one witness in this trial gave any evidence that would suggest the scope of the Hospital’s duty was greater than that of simply and only taking note that consent was obtained from the patient, which is in the nature of a secretarial function. In my view, for the period 1983 to 1986, the responsibility for obtaining consent to the particular treatment in this matter fell completely to the oral surgeons. The nurses who worked for the Hospital were responsible for seeing that the consent to treatment form was signed. I do not find that this created an independent duty on the Hospital to ensure that the patients actually understood the form, other than understanding it was a written affirmation that the patients had been consulted on the issue of consent by the oral surgeons. There was no evidence led, lay or expert, in this trial that could lead me to any other conclusion in that regard.

[164] I acknowledge the plaintiffs’ position that none of them were told the device did not have a Notice of Compliance. However, counsel for the plaintiffs was clear that this fact did not change the quality of their claim to make it one of battery. The plaintiffs allege negligence alone against the Hospital. I simply do not accept that the Hospital had as extensive a duty of care to these plaintiffs in regard to the issue of consent as urged by the plaintiffs.

[165] All the plaintiffs who gave vive voce evidence in-chief said that they did not consent to the treatments. I do not accept their evidence on that point. I make this finding on the basis of evidence to the contrary, which shows they all knew they were undergoing a surgical procedure to attempt to remedy the significant problems they were having with their TMJs. I find this on the basis of cross-examination evidence given at trial where discovery transcripts were put to the witnesses. Consent is typically front and centre in medical malpractice cases. The issue was addressed when the plaintiffs were discovered. They all gave answers under oath at that time, which detracted from the credibility of their trial evidence in-chief that “they did not consent” credible. For example: Ms. Lind was cross-examined on her discovery transcript evidence. During discovery, she admitted that she knew she was going to get an implant which was designed to give her relief. She admitted on cross-examination that she “vaguely” remembered Dr. Tomlak telling her she was to receive an implant. In my view, this is clear evidence of her consent to the treatment at issue.

[166] Mr. Karam was cross-examined on the issue of consent. He acknowledged he had discussed the surgery with Dr. Tomlak prior to him getting an implant. He knew that an oral surgeon was going to take out the damaged cartilage in his left TMJ and do an “arthroplasty or something along those lines” that would take away both the pain and the clicking in his joint. He was shown his discovery transcript evidence during cross-examination. His evidence at trial differed from his discovery evidence about the issue of his knowledge of what was being implanted. At trial, he quite clearly testified he did not know he was getting a proplast implant. This is different from what he said on discovery. During discovery, he admitted he knew there was an option that he would get a “proplast” or a “Teflon” implant. I find his memory was better about what occurred in 1985 when he was discovered in 2000 than when he gave his evidence at trial. In my view, he was well advised by the oral surgeons about what was going to happen when he went into the hospital. I do not accept his trial evidence that he did not consent to the treatment he received.

[167] Ms. Endean was cross-examined on the issue of consent. In cross-examination, she clearly agreed that in July 1985 “nothing was working” to relieve her pain. She agreed that she was told she had a perforated disc. She agreed that she was told that the perforated disc was to be removed surgically and an implant would replace the disc. In my view, this is clear evidence of her consent to the treatment at issue.

[168] Mrs. Hearsey, in her discovery, clearly agreed that she knew she was undergoing major surgery. She testified that she assumed she needed it because of the “bone on bone” status of her TMJ and the prolonged period of pain she had been experiencing. In my view, this is clear evidence of consent to the treatment at issue.

[169] Also, all the plaintiffs signed the consent forms. This is strong evidence of consent to treatment in my view. It can be rebutted of course. In this case, the plaintiffs’ evidence did not rebut the written evidence of consent.

[170] I accept the submission of the defence that it is well established at common law that doctors are required to disclose all material risks to patients before proceeding to treatment. However, this is the doctor’s responsibility. It is not the Hospital’s responsibility. This makes sense as the patient is first and foremost the doctor’s patient. There was no issue that the plaintiffs became a patient of the Hospital when they came onto the premises for treatment. However, that does not extend the duty of care regarding consent beyond that of the Hospital ensuring there is some written acknowledgement of the process of obtaining consent. I accept the submission that case law in this matter is clear that consent is a matter strictly between doctor and patient. In the decision, Augustine v. Lopes, [1994] O.J. No. 2646 (OCGD), Rosenberg J. stated at paras. 19 and 21:

19. …In this regard it should be kept in mind that the nurses have a nursing function and that doctors have a different function. It is the doctor’s obligation to explain the procedure so that the patient may make an informed consent. There are matters that should be looked for by the nurse as part of the nursing function such as whether the patient has false teeth that have to be removed or the patient is not ambulatory and has to be taken from place to place, whether the patient has a special diet, etc. It is not part of the nursing function to review the complete records to make sure that the consent form signed is in accordance with the patient’s understanding….

20. As Denning L.J. said in Roe v. Minister of Health et al.; Woolley v. Same, [1954] 2 Q.B. 66 at 83; [2954] 2 All E.R. 131: It is so easy to be wise after the event and to condemn as negligence that which was only a misadventure. We ought always to be on our guard against it, especially in cases against hospitals and doctors.

In my view that quote is peculiarly applicable to the claim against the hospital in this case. The fact that it might have been prudent given unlimited time to have the nurse monitor the doctor and the patient to make sure that the patient has a complete understanding of the procedure to which she has consented, does not make the hospital liable for failure to do so.

[171] The appeal of this decision was dismissed in 1998 by the Ontario Court of Appeal (1998 CanLII 2560) which expressly confirmed Rosenberg J.’s analysis of the principles governing a hospital’s role in obtaining consent to treatment from a patient.

Decision on Issue 6

[172] In my endorsement of January 5, 2017, I identified issue 6 as an issue if the Hospital was negligent in not more carefully monitoring the content and handling of patient files involving the plaintiffs. In the endorsement, I answered “No.” Here are my reasons for that particular decision.

[173] Overall, I think this issue is really a subset of the complaint by the plaintiffs that the Hospital breached an alleged duty to recall once it became apparent from a variety of sources, starting for certain in 1990, that the device had established a track record of failure which caused serious damage to patients. During the trial, much was made by plaintiffs’ counsel about his inability during the pretrial process to obtain his clients’ records from the Hospital and the lack of certain records being produced. These claims were all vigorously disputed by counsel for the defence. The disputes about documentary production came up numerous times during the trial, and were all addressed by way of argument at many different points in the trial when procedural issues were raised.

[174] When the trial began, the parties filed 36 Exhibits which were housed in 12 bankers boxes. Among those exhibits were clinical notes and records (“CNRs”) for all four plaintiffs. Not all of the CNRs came from Hospital records. Yet, I had in front of me at least 21 two inch, three ring binders filled with the CNRs of all four plaintiffs. Three binders for Ms. Endean. Four binders for Mrs. Hearsey. Six binders for Mr. Karam. Eight binders for Ms. Lind. The record will speak for itself, but it seems to me from the sheer volume of CNR type documents produced that the Hospital had a more than adequate system for storing and handling the files of the plaintiffs.

[175] The plaintiffs’ position on this issue was based on the expert evidence of Dr. Gryfe and Mr. Greve. Overall, I find the concerns Mr. Greve and Dr. Gryfe expressed about the record keeping of the oral surgeons, and in turn the Hospital, of no consequence to any finding concerning the liability of the Hospital. Both experts’ opinions focused on deficiencies in the charts and records relating to general lack of detail, late recording of events, and actual lack of recording of events one would have expected to see. Both experts’ opinion in this regard were premised, in my view, on a belief that the Hospital had an additional oversight and follow up role with the plaintiffs once they had completed their treatment at the Hospital.

[176] I have discussed Dr. Gryfe’s comments about the record keeping earlier. Again, I find that his complaints speak to the issue of negligence of the oral surgeons and not the Hospital. His evidence, therefore, was not helpful for the plaintiffs in regard to issue 6.

[177] Mr. Greve’s opinion was more focused in this regard. He opined that the Hospital had a duty to have an appropriate system in place to track records and which treatment patients received. He specifically testified that it should have been simple for the Hospital to have pulled together a list or the actual files of all patients who had the Vitek implant. It turns out the Hospital apparently did have such a capacity at least to find all patients who had received an arthroplasty procedure. This was verified by the evidence of Mary Jane Ryder. How and when Ms. Ryder testified at this trial bears repeating but it will make more sense to do it in the context of the discussion of issue 7, which is the duty of recall.

[178] The allegations of negligence concerning handling of records also relied on an assertion by Mr. Greve that it appeared to him that the oral surgeons were routinely taking Hospital patient charts out of the Hospital and back to their offices. He testified “we know that the oral surgeons took health records from the hospital to their offices and used them as part of their day to day management” (transcript of evidence of Alan Greve, dated September 14, 2016 p. 39, lines 6 – 8). This was expressly contradicted by the vive voce testimony of Carol Dowhos. Mrs. Dowhos testified at this trial as the representative of her deceased husband, who was the Chief of Dental Surgery at the Hospital in 1983 to 1986. She was also the office manager at the oral surgeons’ office and could testify about conditions in the office relative to patient records. She testified that she never saw Hospital charts coming back to the oral surgeons’ office. She also said she did not see original Hospital records in the oral surgeons’ files. I prefer the evidence of Mrs. Dowhos. She would have occasion to directly observe this fact. The fact that Mr. Greve made this rather bald assertion is another reason why I have in the main discounted his opinion evidence. In any event, I do not understand how taking Hospital records out of the Hospital (which I find did not happen) would have anything to do with damages to the plaintiffs, except if one accepts that the Hospital had a duty of recall. As noted in my endorsement, I do not accept that proposition.

[179] I have also discussed Mr. Greve’s erroneous assertion that, other than Mr. Karam, the Hospital records of the other three plaintiffs had not been properly recorded in the HMRI system. Overall, I find no basis in the evidence that the Hospital breached any duty to the plaintiffs in respect of the content or handling of their files.

Decision on Issue No. 7

[180] In my endorsement of January 5, 2017, this issue was described as an allegation that the Hospital was not active in assisting to contact the plaintiffs once it became apparent that the Vitek implant was regularly failing in patients and was causing them damage. Further, the plaintiffs alleged that the Hospital was not active in ensuring that the plaintiffs were subject to regular follow up on the condition of their TMJ once the implant had been removed. This allegation of a “duty to recall” was a significant aspect of the plaintiffs’ claims against the Hospital. I do not agree such a duty existed for the Hospital on the facts of this case. The following are my reasons for that decision.

[181] From the evidence I heard at this trial, I find that the weight of scientific, medical and clinical evidence had clearly turned against the Vitek implant by 1990. The implant also became a target of the enforcement side of the U.S. Food and Drug Administration by that time. This caused oral surgeons all over North America to begin to take the implants out of patients. During the trial, a great number of documents were entered which outlined the evolution of this process. First of all, it involved contacting patients. Regardless of any duty of the Hospital, the oral surgeons initiated their own recall process for the plaintiffs in this matter. This started in 1991. From the trial evidence, it is clear that the Hospital did not actively participate in any recall process. It maintained that it had no such responsibility. It did gather together the patient files of those persons who had an arthroplasty procedure, including the plaintiffs. It did this in January 1995. The Hospital had been served with a statement of claim almost exactly a year earlier in January 1994. The claim was for a TMJ implant patient who was not before this court. The Hospital did not reach out to the plaintiffs to discuss their treatment. I will first deal with the efforts of the oral surgeons, as I heard much evidence about what they did, which was useful for context.

[182] When it became evident that the Vitek implant was a clear hazard, any outreach to the plaintiffs was handled exclusively by the oral surgeons. This process took several years. As noted previously, Mrs. Dowhos testified at this trial as the representative of her deceased husband. She testified that she was asked by her husband and Dr. Orpana to start to do the recall process in 1991. At the time, the oral surgeons’ office was on a complete paper system. They had no computers. She was not told why the patients had to be recalled. She was only asked to identify patients who had an arthroplasty and then arrange for an office visit for them. Mrs. Dowhos had to search through the oral surgeons’ paper records for the period from 1983 to 1986. Together with other office staff, a manual check of records and charts was undertaken of what she described as “thousands” of patients. Ultimately, the recall process identified about 170 patients who had the arthroplasty procedure.

[183] As noted previously, the actions of the oral surgeons are not on trial here. Nevertheless, I did hear extensive evidence from Mrs. Dowhos and Dr. Orpana, as well as reviewing Dr. Dowhos’ transcript on the process they undertook to try and recall patients. Ms. Lind was never contacted by the oral surgeons as she had been explanted in 1986. Mrs. Hearsey was sent a letter on December 5, 1995. On November 15, 1996, Mr. Karam and Ms. Endean were both sent a letter containing exactly the same text asking them to contact the office of the oral surgeons to discuss explanation. It was clear from Dr. Dowhos’ transcript that the matter was being left to the office staff. Mrs. Dowhos could not recall the overall time the recall process took. She did the work on weekends. She testified it was started in 1991. The evidence indicates that at least three of the patients were contacted in 1995 – 1996. These time markers speak for themselves.

[184] What is of concern for this matter is the allegation that the Hospital knew of the hazard and did not do anything. Mrs. Dowhos recalled having at least two distinct series of interactions with the Hospital concerning the TMJ patients. Her evidence on this point lacked specificity. One interaction occurred in September 1996. I will discuss the details further in this judgment. However, the plaintiffs argue that the Hospital knew about the problem with certainty because of events that happened in 1990.

[185] The Hospital regularly received medical bulletin letters from a non-profit American source, the ECRI Institute (Emergency Care Research Institute). On or about May 25, 1990, the Hospital received an ECRI bulletin that said:

The Vitek Temporomandibular Joint (TMJ) Interpositional Implant (IPI) may fragment or delaminate or be otherwise damaged or punctured. Debris in the joint from the implant can contribute to progressive degenerative bone changes and giant cell reaction… Action needed: if you have any of the affected TMJ IPI devices in stock do not implant them. Return them to Vitek for credit…closely monitor your patients; include clinical and readiographic examination… source FDA Enforcement Rep 1990.

[186] The Hospital got another ECRI bulletin on or about July 6, 1990 containing the same information but adding that Vitek was going into “Chapter 7 bankruptcy.”

[187] On August 21, 1990, Instrumentarium wrote the department of materials management of the Hospital. The letter advised that the Vitek implants were being voluntarily recalled. The letter noted that the company had sold the Hospital these implants between 1983 and 1987. The letter asked the Hospital to return any unused products. In addition, the letter stated: “we request that you notify us by return fax the names of surgeons who have implanted these products so that we may provide them some additional safety information.”

[188] This letter landed on the desk of Joan Wekner at the Hospital. In 1990, Ms. Wekner was the nurse manager in the operating room of the Hospital. While employed by the Hospital, she had never worked with the TMJ implant. She received the letter from Instrumentarium, but she did not recall exactly how it came to her attention. She immediately went to the OR supply room and took out whatever implants she found in the supplies cabinets. She took them to Jack Tallon, who was the purchasing agent for the Hospital. Ms. Wekner also testified that upon receipt of this letter, she called the office of the oral surgeons. She spoke to a person, she could not remember if they were male or female, and told them that the Hospital was returning the implants.

[189] Ms. Wekner called the oral surgeons for two reasons. First, to ensure that the oral surgeons would not seek to book any further surgeries at the Hospital involving these implants because she told them she was sending them all back. Second, she wanted to know if the oral surgeons had seen the letter. She was advised that the oral surgeons had seen the letter. She was cross-examined on that very point. Her evidence did not change. Mrs. Dowhos was asked about this conversation and did not recall it. In any event, on the basis of the oral surgeons indicating they knew about the letter, Ms. Wekner did not fax Instrumentarium a list of the surgeons who had implanted the products. In cross-examination, Ms. Wekner indicated that she had no knowledge the devices were causing damages to the plaintiffs.

[190] In addition, Mr. Jack Tallon testified that he was specifically in touch with the Instrumentarium representative Mr. Flower in September 1991 as the result of receiving the letter. He wrote a memo to Judy Warwick, a Hospital Director of Patient services, about the phone call in May 1994. Mr. Tallon testified that Instrumentarium already knew the three oral surgeons had used the Vitek devices and that they themselves had contacted the oral surgeons. That information was also set out in the May 2, 1994 memo. On September 21, 1990, the Hospital sent back thirteen unused Vitek implants to Instrumentarium. A credit was given by Instrumentarium to the Hospital.

[191] Mr. Tallon also contacted Health and Welfare Canada on May 16, 1994. A note of the discussion was submitted in evidence. I did not give it any weight in my decision as it was certainly hearsay as to the position of Health and Welfare Canada on the issue of the implant. In any event, the Hospital did not take any actions as the result of the phone call initiated by Mr. Tallon.

[192] The Hospital did not initiate any other actions in respect of any TMJ patients between September 1990 and January 1995. There was certainly some contact between a representative of the Hospital and Mrs. Dowhos in September 1996. However, throughout this period the Hospital continued to receive ECRI and other medical bulletins that amplified and repeated the problems with the Vitek implant. These bulletins included ones that were received and March 1, 1991 and on January 14, 1994.

[193] The plaintiffs argue that this knowledge created a circumstance where a “critical incident” had occurred at the Hospital. They argue that this “critical incident” was known to the Hospital such that it required a corresponding positive action on the part of the Hospital regarding the plaintiffs’ records. The plaintiffs submitted that the Hospital was a dominant regulator in respect of procedures that had been done in the Hospital by the oral surgeons. It was suggested that a high standard of duty is imposed because the Hospital had been dealing with a dangerous thing. The plaintiffs argue that the Hospital should have contacted the offices of the oral surgeons to see what was being done to protect the implant patients.

[194] I reject those arguments.

[195] To begin, counsel for the plaintiffs had referred to R.R.O 1990, Regulation 965 under the Public Hospitals Act section 3(b) as the statutory basis for the obligation of reporting a “critical incident.” Counsel for the defence pointed out that the particular wording relied on by the plaintiffs did not come into effect until 2008. The litigation had been underway for ten years by that time. It appears that a large portion of the underpinning of the plaintiffs’ duty of recall theory was non-existent at any time prior to 2008.

[196] The plaintiffs also argued that this regulation simply codified the common law regarding the Hospital’s duty. According to counsel for the plaintiffs, support for this proposition comes from the decision of Lang J. in Pittman Estate v. Bain, 1994 CanLII 7489 (Ont. Ct. Gen. Div.). The case involved a claim by an estate of a person who died of HIV tainted blood. The decision as it related to the Hospital was instructive for this case.

[197] In my view, Pittman, supra, can be distinguished on its facts. The plaintiff’s claim against the hospital in Pittman, supra, proceeded along two tracks. First, it alleged in contract there was a breach of an implied warranty of the fitness of the blood product supplied to Mr. Pittman. Second, it alleged negligence on the part of the hospital for the delay and implementation of a so called “look back” program. Lang J. described the “look back” program at para. 468 as one which started with a blood donor who was infected and then “looked back” to identify any other recipients of that donor’s earlier potentially tainted blood products.

[198] Lang J. at para. 456 clearly found that the hospital defendant was not strictly liable in contract for the provision of tainted blood. Lang J. also found at para. 556 that the hospital had no obligation to directly warn its patients of the possibility they had been infected with tainted blood. However, at para. 552 of the decision, Lang J. found that the hospital had undertaken to trace and notify recipients of potentially tainted transfusions. In this, Lang J. found an acknowledged and accepted duty.

[199] In this case, the Hospital was neither under such a duty, like a duty to recall, nor did it undertake such a duty by the actions I have outlined previously. Lang J. found at para. 556 of Pittman that the hospital had no duty to warn the plaintiff directly of the possibility he had transfusion associated aids and further it was reasonable that such warning be done by the patients’ family physician. However, having undertaken the duty. Lang J. found the hospital negligent in the implementation and design of the program to locate Mr. Pittman (para. 607).

[200] I was not provided with any other authorities which supported the plaintiffs’ contention that there was, at any time material to this action, a common law duty on the part of the Hospital to be involved in recalling the plaintiffs to remediate the damage that was being caused by the Vitek implants.

[201] I am not prepared now to impose or find such a duty on the part of the Hospital. I do so because, first and foremost, the plaintiffs were the patients of the oral surgeons. Earlier in this judgment, I outlined the very clear and uncontroverted evidence I received from all the witnesses who had medical training, or were actually employed in the provision of care to patients, of the primacy of the oral surgeon/patient relationship. In my view, Carl White described it best when he testified that recall was a physician’s problem. In his capacity as a CEO, he had never been involved in a recall of patients which was to be contrasted with a recall of medical products. The expert called by the Hospital on standard of care, Terry Fadelle, also confirmed he was not aware of any hospital in Canada self-initiating a recall of patients. The Hospital had no independent ability to treat patients. It could not write orders for tests. It could not book patients for treatment absent a physician’s approval. I accept Mr. White’s evidence in that regard particularly as it applied to this aspect of the plaintiffs’ claim.

[202] The only circumstance where the facts of this case might have remotely compared with the “look back” duty the defendant hospital took upon itself in Pittman, supra, occurred when Mrs. Dowhos apparently approached the Hospital for help in locating TMJ patients. Her evidence about the incident or incidents bears careful analysis.

[203] While undertaking the recall process, Mrs. Dowhos testified that she made one phone call to a person who did bookings of OR time. She made the phone call to “whomever answered the phone in the OR.” She made one phone call. It was not made to the CEO of the hospital. It was not made to the records department of the Hospital. Mrs. Dowhos called a person with whom she was familiar. A person who did OR bookings. This does not sound to me like the call was made to a senior person at the Hospital.

[204] At the time she made the call, the oral surgeons’ recall process had been going on to the point that the oral surgeons could not find some of their TMJ patients. However, she did testify it was near the beginning of the process in maybe “1992 or 1993.” She did not expressly ask the Hospital to track down the implant patients. What she did ask was if the Hospital had a “method or any way of finding out who had Vitek implants. And the names, that’s what I wanted.” Also, she wanted to know if there was a way to associate names with the procedure undertaken. The person answering at OR bookings said that the Hospital had no capacity to do that, as it needed patient names. Mrs. Dowhos did not pursue this line of inquiry with anyone else at the Hospital. She did not tell the person she spoke to her reasons for asking or that there was an issue. She did not understand that the Hospital was unwilling to assist her.

[205] The next specific interaction between the office of the oral surgeons and the Hospital occurred in early fall 1996. In September 1996, Mrs. Dowhos sent two letters by fax to an employee at the Hospital, “M.J.,” about the persons who had Vitek implants. The redacted letters were entered as exhibits in this trial. The plaintiffs were listed in the body of the faxed letters. The identity of the person to whom the faxes were addressed, “M.J.,” was a mystery to all concerned in this twenty year old litigation until junior counsel for the plaintiffs figured it out on November 28, 2016 near the end of the liability portion of the trial but after the plaintiff had closed its case. It was determined that this person was Mary Jean Ryder, the Director of Patient Health records at the Hospital from the early 1990s until she retired in 1997. There was a dispute as to whether or not Ms. Ryder should be allowed to testify at this trial. For written reasons released mid-trial, I allowed her to testify.

[206] The evidence of Ms. Ryder was instructive and important in the context of what the oral surgeons did, or did not do, with regard to engaging the Hospital in their efforts to recall the patients. The Hospital was served with the first TMJ claim in January 1994. A year later on January 4, 1995, Ms. Ryder in a relatively short time frame was able to gather together patient records of all those people who had arthroplasties done in the Hospital. It was clear from the evidence of Dr. Tomlak and Dr. Dowhos that every arthroplasty they performed did not necessarily result in a person receiving an implant. Ms. Ryder did not do this collection at the request of the oral surgeons. Neither Mrs. Dowhos, nor any of the individual oral surgeons, ever asked Ms. Ryder’s department for such information. She did it at the request of a Hospital manager, Tracey Buckler. Ms. Ryder could not recall why she had been asked to pull these records. The records were taken to a particular room in the Hospital and left on a table. A “gentleman” was sitting in the room but Ms. Ryder could not recall the name or occupation of that person.

[207] Some communication must have occurred between Mrs. Dowhos and Ms. Ryder at some point between January 4, 1995, when Ms. Ryder pulled out the TMJ patient files, and September 5, 1996. I say this because of the two faxed letters that Mrs. Dowhos sent to “M.J.” on September 5, 1996 and September 6, 1996. Unfortunately, neither witness could recall anything about the details of why the faxes were sent. Ms. Ryder could not recall receiving the fax. Ms. Ryder could not recall speaking with Mrs. Dowhos. Mrs. Dowhos could not recall speaking to Ms. Ryder and did not recall her name when she gave her evidence.

[208] The lack of recall by either of these two witnesses makes it impossible for me to draw any substantive conclusions from the existence of the two faxes and their contents, other than to say that the faxes were sent to, and received by, the Hospital. Interestingly, Ms. Lind and Mrs. Hearsey had already commenced their actions by the time the faxes were created. However, I do not find any insidious, or improper, or negligent act has been proven by the plaintiffs on the balance of probabilities regarding this particular exchange of faxes. While it was clear the Hospital did have the capacity to gather together patient files of persons who had received the implants as of 1995, I am not prepared to make the leap that this ability created a corresponding obligation to share that information with the oral surgeons, absent any specific request from the oral surgeons.

[209] I find based on the testimony of the witnesses, and in particular the testimony of Mrs. Dowhos, that Mrs. Dowhos did make one inquiry of the Hospital at some time in 1992 or 1993, at a time prior to the commencement of litigation. However, the person to whom the inquiry was directed could not have reasonably been expected to be in a position to have offered Mrs. Dowhos the information she sought. Mrs. Dowhos decided who to call. She was acting under the instruction of the oral surgeons, who were the persons primarily responsible for care of the patients. Further, the lack of detail provided to that Hospital employee about why Mrs. Dowhos was asking questions, was such that, in my view, it would not have caused the Hospital to make any internal or even external inquiries with regard to the TMJ patients. Further, none of this inquiry would bring the Hospital into the necessary legal proximity to the problems which the oral surgeons were attempting to address such that negligence can be found on the part of the Hospital.

[210] In my view, the plaintiffs seek to put over onto the Hospital what is plainly and obviously the oral surgeons’ duty of care to the plaintiffs. I accept the evidence of Carl White and Terry Fadelle as to what role the Hospital undertook at the relevant time regarding patient care. These witnesses testified that the Hospital could not order an oral surgeon to do any procedure on a patient. The Hospital could not call people in for treatment. That was completely up to the oral surgeons. The fact that they could offer facilities to do the service does not create a duty to direct if or how the surgeons perform the procedures. The Hospital can govern when a procedure is done because it controls the physical space. After that, it is strictly a matter between the oral surgeon and the patient as to what gets done, how, and on what timeline.

[211] Mr. Greve testified that the Hospital should have had an active quality assurance program in place to continue to track the status of the plaintiffs once they left the Hospital. From that premise, he opined that the Hospital should have participated in the recall of the plaintiffs. I do not accept his evidence in this regard. It did not have any foundation other than his simply expressing the opinion. I was not given any evidence that such quality assurance programs were in place in any other hospitals in Ontario at the relevant time. I was not provided with any statutory reference that the province directed by legislation that such a program exist at the relevant time. I was not provided with any evidence that it was the policy of the Hospital to provide such oversight to patients once they had left the hospital. I was not provided with any evidence that it was the policy of the Ministry of Health between 1985 and 1996 that public hospitals were to have tracking systems in place to regularly follow up with patients. Suggesting such a duty on the part of a public hospital also seems to fly in the face of the very significant primary relationship between the oral surgeons and the plaintiffs.

[212] Part of Mr. Greve’s opinion concerning the duty to recall rested on the assertion that the Hospital’s records were kept so poorly that it was impossible for the Hospital to assist in recalling the patients. Perhaps Mr. Greve maintained this position throughout the trial because of the fact that the name and nature of the evidence of the chief hospital record keeper was not “discovered” until near the end of the trial. I have not found that the Hospital records were poorly or negligently maintained, as discussed earlier.

[213] For these reasons, I was not persuaded by Mr. Greve’s opinion evidence on the subject of the alleged duty of recall on the part of the Hospital.

[214] To me, after hearing all the evidence in this trial and being confronted by a large number of documents entered as exhibits, I find that many of the records necessary to consider the issue of liability of the Hospital were records created and kept by the oral surgeons or other physicians treating the plaintiffs. This is because the documents recording the treatment of the plaintiffs was the work product and the responsibility of the oral surgeons. These were documents such as the CNRs prepared by the oral surgeons, including the letters from the oral surgeons to the plaintiffs referring physicians or dentists. Even when in Hospital, the charts and surgical reports concerning the plaintiffs were prepared by the oral surgeons. For me, the authorship of these important documents underlines and emphasizes the proximity of the oral surgeons and the plaintiffs with respect to the allegations of negligence in this case. That primary relationship is contrasted with what I would describe as the secondary nature of the relationship between the Hospital and the plaintiffs. As noted above, this had a very significant impact on my decision about this alleged “duty to recall.”

[215] The bottom line is the plaintiffs were first and foremost the oral surgeons’ patients. Using the records of the patients as an example, the oral surgeons had a primary duty to make whatever recordings were necessary to promote appropriate care for them. There is, of course, no question that the Hospital had a duty to keep records of what happened to the plaintiffs while they were in the Hospital. The Hospital had some duty to review the in-hospital records to ensure that they were being kept in a timely way. Carl White testified about this when he spoke about the “off staff” process. This was a process whereby the Hospital could suspend a practitioner’s privileges for failure to keep complete or timely records. No such “off staff” letters were produced at this trial in regard to the three oral surgeons who treated these plaintiffs. I appreciate counsel for the plaintiffs complained of this. However, I find that based on the evidence given by Carl White there was no need to issue such letters for the three oral surgeons whose patients were the plaintiffs in this action. If there were problems with charting, they were not sufficient to make an express finding of negligence on this narrow aspect of the overall theory that the Hospital had a duty to recall.

[216] What was of concern to any issue of liability in this trial was the contacts or interactions between the oral surgeons and the Hospital after the oral surgeons stopped doing implant surgery in 1986.

[217] The evidence of Ms. Ryder indicated the Hospital had control of its records. Ultimately, due to restructuring initiatives imposed on the Hospital by the Province, some of the paper records were destroyed. I will deal with that during the discussion of the plaintiffs’ arguments regarding spoliation. However, for the purpose of simply assessing the plaintiffs’ assertion that the Hospital was negligent in the regular handling of the patients files, I find that on the evidence the plaintiffs have not proven this proposition on a balance of probabilities.

[218] No evidence was led that suggested the Hospital should have been, or was, expert in assessing all products or devices used within its walls. Clearly, it had information about the device starting in the early 1990s that suggested the Vitek implants were not working as advertised. The plaintiffs argue that this knowledge should have caused someone in the Hospital to approach the oral surgeons to discuss what was being done with the patients. In fact, the evidence of Joan Weckner given on behalf of the Hospital did address that point.

[219] In my view, Ms. Weckner’s actions were appropriate and within the scope of the global standard of care imposed upon the Hospital at the time. She let the oral surgeons know the devices were being recalled. If this was the only information the oral surgeons had at the time about the deficiencies in the implant, in my view, the fact of a “recall” would have been sufficient for the oral surgeons to begin to make some independent inquiry of their patients about the implanted device. I did not hear any other evidence that would permit me to attribute this duty to the Hospital. First and foremost, the oral surgeons had the primary duty of care to the patients. Ms. Weckner took reasonable steps to return the devices and notify the oral surgeons that she had done so. This act does not represent some kind of admission of a greater duty of oversight or care that should be imposed upon the Hospital.

[220] The Hospital had purchased the device from Instrumentarium. Instrumentarium was a reputable specialized distributor of a specialized product doing direct sales to a specialized market with the use of a specialized sales force. Upon receiving the August 1990 recall letter from such a company, a reasonable person would assume and could rest assured that Instrumentarium was following up with the oral surgeons to provide them with additional safety information about the device. This is consistent with the defence submissions on the extent of the duty of care at the time. The Hospital was not in an equal position with either the oral surgeons or the distributor Instrumentarium in terms of (1) expert type first-hand knowledge of the product and (2) what to do with the product which had been implanted in patients if it failed. I do not see how it is appropriate, based on the evidence I heard at this trial, to elevate the Hospital to an oversight role over the oral surgeons or to place the Hospital in the same position as the oral surgeons vis-a-vis a duty to warn or to further treat the plaintiffs. I think Buchan, supra, speaks to the duties a drug company or even a medical device manufacturer like Vitek would have to an end user of a device. The case, however, does not persuade me to extend that aspect of a duty of care to the Hospital as urged by the plaintiffs.

Decision on Issue 8

[221] In my endorsement of January 5, 2017, I described issue number 8 as being an allegation by the plaintiffs that the Hospital was negligent by failing to abide by its own bylaws in respect of the treatment and care of the plaintiffs. I indicated that I did not believe the Hospital was negligent in this regard. The following are my reasons for that decision.

[222] Portions of this argument have already been dealt with in the discussion of other issues in this matter. For example, a portion of the plaintiffs’ argument about the credentialing process relied on a suggestion that the Hospital bylaws were not followed when the three oral surgeons were granted privileges. Those particular bylaws were as follows:

44.(1) The Credentials Committee shall: -

a) Keep a record of the qualifications and professional career of all members of the Medical Staff and Dental Staff,

b) Investigate the professional experience and reputation and the authenticity of the qualifications of each applicant for membership on the Medical Staff, and of each applicant for increased privileges,

c) Submit to the committee, at or before its next regular meeting, a report of the findings made under subparagraph (b), together with the Credentials Committee’s recommendation that the application be accepted, rejected or deferred for further investigation,

d) Consider every application for surgical and anaesthetic privileges, or for an extension of previously granted privileges and make a report to the committee in accordance with the provisions of paragraph 27,

e) Recommend to the committee the kind and extent of privileges, other than the privilege referred to in subparagraph (d) to be granted by the Board to an applicant for membership on the Medical Staff, or to an applicant for promotion or increased privileges on the Medical Staff, after consideration of:

(i) The applicant’s previous training and experience,

(ii) The applicant’s reputation concerning the quality of his/her professional work,

(iii) The amount of professional knowledge and skill he/she has demonstrated in any services performed by him/her for the Hospital.

[223] I have discussed earlier in the judgment my findings concerning the operation of the credentials committee. I found no fault in the manner in which the oral surgeons were credentialed to do the implant surgery in the Hospital. In my view, the Hospital by-laws were followed because a process was in place which allowed the collection of relevant material in respect of the candidates. This is what was provided in the Hospital by-laws. The fact that the Hospital had a joint credentialing committee with McKellar Hospital made sense from an efficiency perspective. It is clear from the evidence given by Dr. Tomlak that his application did provide the requisite information about his background and ability to do the work which I have described earlier in this judgment. I find the Hospital did not breach its by-laws in regard to the credentialing of Dr. Tomlak or the increase in privileges given to Dr. Dowhos and Dr. Orpana. This is because the by-laws required certain things to be obtained from candidates such as Dr. Tomlak. The plaintiffs argue that because no additional inquiries were made by the credentialing committee or the medical advisory committee or the Board that somehow that represents a breach of the Hospital by-laws. As I have found, the actions of all these committees were appropriate and they were entitled to rely on the representations made by Dr. Tomlak as to his qualifications and abilities.

[224] The evidence of Mr. Greve took great exception to the charting done by the oral surgeons. He opined that it should also have been the responsibility of the Hospital to monitor the charting of the oral surgeons. The plaintiffs point to general duties outlined in the medical and dental bylaws of the Hospital produced at this trial. One such bylaw, for example, stated:

Medical Staff Duties

17.1(1) Every member of the Medical Staff, to give the best possible care to every patient in the Hospital, shall co-operate with: -

a) The Board;

b) The Executive Director,

c) The Chief-of-Staff and Medical Advisory Committee,

d) The Head of the Department to which the physician has been assigned.

(2) Each member of the Medical Staff shall: -

a) Give such instructions as is required of him/her for the training of other members of the Medical Staff, interns and nurses, and other Hospital personnel,

b) Obtain a consultant to examine and report in writing on any patient under his/her care on whom a consultation is indicated, or is required by Regulations under the Public Hospitals Act, or by these by-laws,

c) Notify the Board through the Executive Director, in writing of any additional professional degree or qualifications obtained by him/her,

d) Endeavour to secure the written consent of the executor, the spouse, or the next-of-kin of a deceased person for the performance of a post-mortem examination on the body of the deceased,

e) For every patient, under his/her care, within 48 hours after the admission of the patient, enter on the patient’s case record:

(i) The patient’s medical history,

(ii) The findings of a physical examination made on the patient, and

(iii) A provisional diagnosis.

[225] In my view, there was no evidence at this trial which indicates actions taken by the Hospital breached any duties acknowledged by these bylaws. I have discussed earlier what I thought of Mr. Greve’s opinions about charting. I was not persuaded by them. Further, in my view, the damages to these plaintiffs would not have been affected one way or the other by better charting by the oral surgeons. I did not hear any evidence that suggested that when the plaintiffs were explanted their earlier charts were requisitioned by the treating oral surgeons at other hospitals. In my view, there was no causation proven between this particular aspect of the plaintiffs’ allegation and any actions of the Hospital. As I have found, the oral surgeons charting could have been better, but that is an issue of their negligence and not that of the Hospital.

[226] Mr. Greve also testified that when the deficiencies about the operation of the implant became known, certainly after the recall in 1990, the dental advisory committee mandated by the bylaws should have reported these problems to the medical advisory committee. In my view, this opinion only makes sense if one subscribes to the view that the Hospital had the oversight duties as advocated by the plaintiffs. I have found that the Hospital had no such duty. Again, the plaintiffs argue that the Hospital should have stepped in and taken charge of the recall process. In this way, the plaintiffs argue, they may have heard about their problems earlier than they did.

[227] It is quite clear that the time it took to contact the plaintiffs arose from decisions made solely by the oral surgeons. Objectively, the oral surgeons did appear to take a very long time, several years, to figure out that about 70 of their patients had an arthroplasty done between 1983 and 1986. This is not the Hospital’s fault or problem. The dental committee at all material times consisted only of the oral surgeons, who were at one time defendants in this matter. They were undertaking their own recall procedure. They decided, in their professional judgment, not to notify the Hospital about what they were doing, other than have an office staff member call once to the OR bookings to see if some names could be obtained. In my view, this does not represent a factual basis on which to find negligence of the Hospital based on a breach of its bylaws.

Decision on Issue 9

[228] In my endorsement of January 5, 2017, I described issue number 9 as the following question: has the Hospital committed the tort of spoliation in this litigation as the result of which the plaintiffs have suffered damages? I answered that specific question “No.” The following are my reasons for that decision.

[229] To begin, counsel for the plaintiffs made it abundantly clear they were not arguing that an independent tort of spoliation had been committed by the defendants. Accordingly, I do not feel it necessary to recite the law concerning spoliation which was very eloquently summarized by Lax J. in another medical device malfunction case: Andersen v. St. Jude Medical Inc., 2012 ONSC 3660 (ONSC) at paragraphs 306 to 313. Rather, the plaintiffs submitted that I should draw adverse inferences against the defence because of the lack of documentary disclosure. They point specifically to the provisions of Rule 30.08(1) which states:

EFFECT OF FAILURE TO DISCLOSE OR PRODUCE FOR INSPECTION

Failure to Disclose or Produce Document

30.08 (1) Where a party fails to disclose a document in an affidavit of documents or a supplementary affidavit, or fails to produce a document for inspection in compliance with these rules, an order of the court or an undertaking,

(a) if the document is favourable to the party’s case, the party may not use the document at the trial, except with leave of the trial judge; or

(b) if the document is not favourable to the party’s case, the court may make such order as is just. R.R.O. 1990, Reg. 194, r. 30.08 (1); O. Reg. 504/00, s. 3.

[230] The plaintiffs acknowledged that issues of documentary production were extensively dealt with by the various case management judges who have worked on this file. Yet for the purpose of this trial, the plaintiffs argued there was positive evidence that certain documents existed, which were not produced by the defence throughout the pretrial discovery or production of document phase of the litigation. These documents fell into three categories: (1) the contents of a file or files that Jack Tallon had, or did not have, concerning purchasing the Vitek implant; (2) the policy and procedure manuals for various departments in the Hospital; and (3) a “pull list” of patient records, or a Hospital HMRI list, that M.J. Ryder produced or used when, in January 1995, she was asked to pull together patient files of persons who had TMJ arthroplasties at the Hospital. Also, the plaintiffs had an ongoing complaint that originals of the patient records had been destroyed and only microfiched copies of certain documents had been produced.

[231] This lack of production argument also relied on a submission that if I accept that certain relevant documents were not produced I must, therefore, “assume that everything must be properly and rightly done and the Hospital should have done everything that they ought to have done.” Boiled down this means two things in the plaintiffs view: Firstly, the plaintiff argued that the Hospital should have asked about a notice of compliance for the device. As indicated earlier, I agree with that proposition. Secondly, the plaintiff argued that the Hospital should have participated in the recall process. As indicated earlier, I do not agree with that proposition.

[232] There was some important contextual background evidence given by Carl White about what had actually happened to all patient records kept by the Hospital at the time just after the litigation was commenced. It related to the control of patient records when the Hospital was “restructured” in the mid-1990s as part of an overall provincial initiative. The Hospital ceased to do acute care. It decided to focus on everything that was not acute care, such as addiction, mental health and chronic care. Three of the major acute care hospitals in Thunder Bay were amalgamated into the Thunder Bay Regional Hospital. The Hospital, as the result of divesting itself of the acute care “business,” had a file management problem on its hands. I accept Mr. White’s evidence on the steps taken to deal with the files. For example even after the Hospital was no longer doing acute care, staff had to pull out charts for the emergency department of the new Thunder Bay Regional Hospital. To the extent that patient files were microfilmed in an attempt to better deal with the files, I find no negligence or nefarious purpose that could in any way cause an adverse inference to be drawn against the Hospital. Also, I accept the submission of the defence that all relevant documents were actually produced in this litigation. I come to this conclusion by considering the submissions and the evidence related to the three general types of documents about which the plaintiffs took issue.

[233] With respect to the files kept by Jack Tallon, he testified that he did keep a separate file for his correspondence with Instrumentarium and his correspondence with Health and Welfare Canada concerning the implant. Documents from these files were indeed produced and entered as exhibits at this trial. Order forms, correspondence and the letters returning the implants were produced. Apparently when the implant was ordered, Mr. Tallon would have received a requisition from the OR department asking for the devices to be purchased. These particular requisitions were not produced. The plaintiffs argue these documents are relevant because after April 1, 1983, they “should have” had a tick box indicating if a medical device was approved or not. I think this argument is speculative and was of no value to the issue of whether or not the Hospital should or should not have inquired about the notice of compliance.

[234] The cases before me were commenced in 1995 and 1996. It seems to me if the plaintiffs had retained experts at that time to address the issue of the alleged negligence of the Hospital administration, it would have been a simple matter to procure hospital requisition forms that either had, or did not have, a tick box about medical device approval. However, such forms did not make it into evidence at this trial. The plaintiffs argue that this is because they were not produced. The defence counters that this is because the documents did not exist. In the end, I am not prepared to draw an adverse inference against the defence in regard to these documents.

[235] In my view, the thrust of the “non-production” Rule 30.08 is to prevent trial by ambush. Plaintiffs’ counsel repeatedly reminded me of the admonitions of the pretrial judges in this case that all documents were to be produced, “no lying in the weeds, all cards on the table.” I accept that all relevant documents were produced in this case. I do not see this Rule as being designed to permit a party to create a sword by which duties of care can be created for opposing parties through speculation about the lack of production of what are arguably trivial documents. In my view, that is exactly what the plaintiffs were trying to do with respect to this issue. I am also mindful of the decision of the Court of Appeal in Kiden Used Furniture v. Pearson, 2015 ONCA 170 at paragraph 17. In that decision, the Court stated, “the usual remedy for spoliation is the presumption that the destroyed evidence would have been unfavourable to the party who destroyed it. But this adverse inference is not capable of positive proof of the landlord’s negligence.” The failure to produce documents on its own, even if proven and I find it has not been proven, is not a basis for a finding of liability. I have found that the Hospital breached a duty of care by not inquiring about the notice of compliance. However, whether or not the Hospital requisition forms did or did not have tick boxes for notice of compliance approval does not advance the existence of that duty one way or the other.

[236] The next group of documents were policy and procedural manuals. I am sure the manuals existed. Various Hospital witnesses were asked in cross-examination if there were policy and procedural manuals for their various departments. They all answered yes. That is not the end of the matter. The question is, were those manuals relevant to matters at issue? For example, could the manuals have had anything to say about a hospital having to independently recall patients if at the hospital some defective device was implanted in them? It seems to me that experts in hospital administration, such as Mr. Greve and Mr. Fadelle, would have seen such manuals with such directions if they in fact existed. The Hospital CEO was also on the witness stand. He could have been asked if there was a procedure manual that had such directives. However, in the testimony of Mr. Greve, Mr. Fadelle and Mr. White, there was no direct testimony that they knew there was such information contained in policy and procedural manuals in any hospitals in Ontario at the relevant times. As I have indicated previously, I find that the lack of a duty to recall by the Hospital exists mainly because there was an intervening relationship, namely that between oral surgeon and patient which made any suggestion of the Hospital doing the recall impractical. The production of a procedure manual that might have said something to the contrary would be unlikely to change my mind about that fact. Again, I found this aspect of the plaintiffs’ argument to be highly speculative and non-persuasive.

[237] I turn now to any records that may have been created by the witness, M.J. Ryder. It was clear from her evidence that in January 1995, after the Hospital was served with the first TMJ claim, it had the capacity to figure out who had arthroplasties done by the three oral surgeons. Ms. Ryder’s evidence was that she may have created a pull list, but she did not know what she did with it. In my view, that does not create a positive duty on counsel for the defence to have disclosed such a document in either schedule A or B or even C. This was some piece of paper, created in the ordinary course of her duties, for which she was not apprised of the significance of the files she was pulling. I find no fault that this was not discovered or even referred to until she got in the witness box. However that fact, or the existence of some list or the capacity to review patient files, does not impose a positive duty on the Hospital of calling these people back into the Hospital to have procedures done that could only be have been performed by the oral surgeons and at their direction. I also find that it does not amount to negligent concealment for reasons I discussed when I dealt with the limitation issue. I am not prepared to draw any adverse inference against the Hospital as the result of alleged spoliation or alleged failure to produce documents in this litigation.

Decision on Issue 10

[238] In my endorsement of January 5, 2017, I described issue number 10 as the following question: Has the Hospital breached a statutory duty of care (duty to recall) contained in sections 31 and 34 of the Public Hospitals Act? I answered that specific question “No.” The following are my reasons for that decision.

[239] I have described in detail my views of the meaning of sections 31 and 34 earlier in these reasons in the discussion regarding the limitations argument. In my view, the sections create clear duties on a physician to report deficiencies in what they perceive to be poor or negligent or dangerous treatment of patients. It even creates a duty on that physician to begin to treat patients if the original treating physician is unable or unwilling to do so. However as I have stated, these are duties that fell to the oral surgeons and not the Hospital. I do not believe this section creates a duty of recall on the part of the Hospital. In my discussion about the duty to recall I have discussed why I found no such duty on the part of the Hospital. Sections 31 and 34 do not add or create duties on the Hospital to engage in treating persons independent of a physician. I do not think it even requires the Hospital per se to assist in that treatment, absent a clear request by the physician to do so.

Decision on Issue 11

[240] In my endorsement of January 5, 2017, I described issue number 11 as the following question: If there is a finding of liability what is the portion of the damages attributable to the Hospital and is it appropriate to do so at this point in the trial process? I answered that specific question as being “yes” and the apportionment should be 5%. The following are my reasons for that decision.

[241] The plaintiffs submitted that I should not make any findings concerning apportionment at this point in the trial. The defence submitted no liability rested with the Hospital but if it did, that several liability should be limited to 5% of the plaintiffs’ damages. In broad terms, the evidence that I heard on this trial indicated that the Hospital’s role in contributing to the damages of these plaintiffs was minimal when compared to the role of Vitek, Instrumentarium and the oral surgeons. Therefore I accept the position of the defence in regard to apportionment.

[242] The plaintiffs resisted a finding of apportionment at this point in the trial on a number of bases. First they argued that in the normal course, apportionment is determined once all the damages evidence is heard. Second, in written reply to the defendant’s submission that apportionment of damages to the Hospital necessarily requires a consideration of the fault of Vitek and Instrumentarium, the plaintiffs relied on the decision from the Ontario Court of Appeal in Martin v. Listowel Memorial Hospital et al., 2000 CanLII 16947, for the proposition that a court may not apportion fault to non-parties. In this case, Vitek and Instrumentarium were not parties to this action. Third, the plaintiffs have a claim for aggravated and exemplary damages that the plaintiffs submit are non-apportionable and the plaintiffs submit this claim requires a more fulsome appreciation of the damages evidence.

[243] To begin, I do not think that any further evidence of the damages to these plaintiffs would do anything to influence or change my views on liability. Based on all the evidence I heard during the liability portion of this trial, I have no difficulty setting out that I find the physical damages to the plaintiffs were caused by:

• defects in the implant manufactured by Vitek Inc. of Houston Texas;

• the decision by the exclusive distributor of the implant in Canada, Instrumentatium, not to inquire of Health Canada if a notice of compliance was received for the implant and the decision to continue to sell it and represent to consumers (ie. doctors) that it was safe and efficacious;

• the decision of the three oral surgeons to put the implant in the TMJs of the plaintiffs; and

• the decision of the Hospital not to inquire of Health Canada if the device was approved for use in Canada.

[244] There were four tortfeasors about whom I heard evidence. I understand some people are also pursuing the Federal Government in a class action basis in a case called Taylor. Presumably, that matter is one and the same in which preliminary rulings were given in a case I was provided with by the defence, Taylor v. Canada (Health), 2009 ONCA 487. In any event, I did not hear or receive any evidence regarding whether or not these plaintiffs are participating in that class action. Be that as it may, while I did hear evidence from Dr. Blais about what Health Canada might or might not have said had inquiries been made about the implant in the mid- 1980s, there was insufficient evidence and no one suggested in argument that any apportionment should be made in respect to the Government of Canada as a result of the injuries to these plaintiffs. Accordingly, I make no such findings.

[245] In my view, what I have found as fact concerning liability allows me to make an apportionment finding now. I will discuss how these findings impacted my decision regarding the Hospital’s portion of overall liability after I first address why I was not persuaded by the plaintiffs to hold off from this type of finding until the damages evidence was complete.

[246] In response to the plaintiffs’ first point, in my view, I did hear a sufficient amount of evidence concerning the plaintiffs’ injuries to give me comfort in assigning an apportionment number now, rather than at the end of the damages portion of the trial. I appreciate that there is much more to come on the precise details of the plaintiffs’ damages. However, in chief, and in the transcripts of Mrs. Hearsey, I was given evidence of the nature of the plaintiffs’ injuries and how they say the injuries impacted their day to day lives. I also received into evidence the expert report of Dr. Ahmad in regard to the specific injuries of all four plaintiffs. A number of the witnesses, including the non-expert fact witnesses of the Hospital were asked questions about the findings in Dr. Ahmad’s report, which served to highlight the very significant personal injuries these people have suffered as the result of the failure of the Vitek implant.

[247] As far as the contribution to the plaintiffs’ injuries by the Hospital, I have already set out that I find that the physical damage to the plaintiffs was caused by the failure of the implant. It was not caused by negligence of the oral surgeons, at least not in the manner in which they did the implant. Of course, there was a chain of events in which all four tortfeasors participated to varying degrees which led to the device being implanted. I heard no other evidence that would give rise to an explanation of the cause of the actual physical symptoms these people are experiencing other than the failure of the implant. I appreciate the plaintiffs’ position that damages to them may have been lessened had the implant been removed much earlier. Interestingly, we have one plaintiff for whom the implant was removed after one year as compared to the other three who had the implants in their heads for anywhere from ten to twelve and half years. However, I have found that the Hospital had no duty to recall these patients. Accordingly, no additional evidence from the damages portion of this trial would have any impact on my view of apportionment.

[248] With respect to the second point, interestingly, the decision of the Ontario Court of Appeal in Taylor v. Canada (Health), supra, deals with the plaintiffs’ submissions regarding apportioning fault to non-parties. It expressly determined that a court can apportion fault to a person who is not a party to an action. The case relied upon by the plaintiffs, Martin v. Listowel Memorial Hospital, supra, has been “overtaken.” At paragraph 24 – 28 of Taylor v. Canada (Health), supra, Laskin J.A. said:

24 ... In my view, the excerpts from Martin v. Listowel to which I have referred are not dispositive of this appeal.

25 As my colleague, Rosenberg J.A. observed in the later case of Misko v. Doe (2007), 2007 ONCA 660, 87 O.R. (3d) 517, at para. 20, these excerpts are obiter statements and therefore, strictly speaking, not a precedent binding on this court. Indeed, in Martin v. Listowel itself, the court accepted the trial judge’s apportionment against two doctors who had been sued but had settled before trial, and therefore were not parties at the trial.

26 Moreover, the statement in Martin v. Listowel that a court has no jurisdiction to apportion fault against a non-party has been overtaken by later decisions of this court. In different factual settings, this court held that a judge has jurisdiction under s. 1 of the Negligence Act to apportion fault against a person who is not a party to the action, and can exercise this jurisdiction in an appropriate case. See M.(J.) v. B.(W.) (2004), 2004 CanLII 8541 (ON CA), 71 O.R. (3d) 171 (C.A.), where Cronk J.A. discussed and distinguished Martin v. Listowel; and Misko v. Doe.

27 Both statutory interpretation and policy support the holdings in B.(W.) and Misko. I think it noteworthy - although the panel in Martin v. Listowel did not - that s. 1 of the Negligence Act speaks of apportioning fault between “persons”, not between “parties.” And s. 5 speaks of adding a “person” not already a party to the action. As a matter of statutory interpretation it seems to me the Act itself recognizes that a court has jurisdiction to apportion fault against a person not a party to the action. Put differently, nothing in the language of s. 1 precludes a court from doing so.

28 Interpreting s. 1 of the Negligence Act to permit a court to apportion fault against a non-party makes good sense.

[249] Accordingly, I am prepared to exercise my discretion to apportion fault against the non-parties, Vitek and Instrumentarium.

[250] Finally, the evidence to date has not persuaded me that the Hospital would be liable for aggravated or exemplary damages. I did not find that the actions of the Hospital were in any way highhanded such that they could be said to have aggravated the injuries to the plaintiffs. I understand the plaintiffs’ theory that the longer the implant was left in, the greater the deterioration of the plaintiffs’ health and, therefore, the greater their damages. The plaintiffs blame the Hospital for not assisting the oral surgeons in locating them faster which presumably would have led to faster explants. As noted previously, I have found there was no duty on the Hospital to recall these patients. On that basis, I would not be prepared to find the Hospital liable for aggravated or exemplary damages. In my view, further damages evidence would not assist the plaintiffs in persuading me to change the apportionment or to grant these types of damages based on a theory of a breach of a duty to recall.

[251] In the opening statement of the plaintiffs, there was reference to some duty of the Hospital to provide specialized ongoing care to these plaintiffs. After hearing the trial evidence, I could not determine if this was a different type of duty than the “duty to recall” urged by the plaintiffs. This is because I heard no evidence about what this ongoing treatment might have entailed, or how the Hospital was supposed to do it when they were effectively out of the acute care business in the mid-1990s. Further, I heard no expert evidence as to why the Hospital should have such duty or upon what basis such a duty could be imposed, based on accepted standards and practices. I can understand that if there was a duty to provide ongoing care, evidence about what damages were experienced up to the present date might be relevant to both the issue of apportionment and the issue of aggravated or punitive damages. However, I did not hear any evidence that would permit me to make such a finding. In my view, this is another reason why further damages evidence would not assist the plaintiffs’ claim against the Hospital as it relates to apportionment or to aggravated or exemplary damages.

[252] For these reasons, I was not persuaded to withhold a finding of apportionment until after the damages evidence was completed for Mrs. Hearsey.

[253] In my view, I had more than ample evidence to find that the implant was a defective product. It failed to operate in the manner advertised. It delaminated and left destructive microscopic particulate in the plaintiffs’ TMJs. I find this microscopic particulate is a major cause of the physical injuries, including destructive bone loss, that the plaintiffs suffered.

[254] Dealing first with Vitek, the law in Canada is clear. Manufacturers of products owe a duty of care to the consumers of their products to protect them from foreseeable injury. They must exercise reasonable care to prevent injury to the consumer. Vitek was subject to such a duty.

[255] I had the benefit, through the plaintiffs’ expert witnesses and through cross-examinations of the oral surgeons and several of the Hospital witnesses, of hearing the story of the “rise and fall” of the Vitek implant. The promotional and user information materials which came with the devices as they were purchased by the Hospital were entered into evidence. Those materials set out the representations made by Vitek as to the safety and efficacy of their product. Most significant for the purpose of apportioning fault was the representation in the product material (Exhibit 30 Tab 1) that the implant was:

biologically and mechanically well tolerated by the human body, these laminated products achieve long term stabilization by fibrous tissue ingrowth into the porosity of the PROPLAST material of adjacent tissue. The tissue ingrowth mechanism is well documented for PROPLAST.

[256] In some places, this kind of statement might now be called “an alternative fact.” In this matter, it was clear to me it was at best a misrepresentation and at worst a lie. Vitek was not forthcoming as to the viability, safety and efficacy of the implant. As an American manufacturer, Vitek was subject to one of the most rigorous medical device regulatory regimes in the world. Regrettably that regime failed in allowing the product to come to market. However, the American Food and Drug Administration moved vigorously to stop the manufacture, distribution and implantation of the devices once the science and clinical evidence demonstrated that the devices were causing serious harm to patients. This finding is supported by testimony of the experts in this trial and their use of many documents entered into evidence, including publications by the FDA, ECRI, American Association of Oral and Maxillofacial Surgeons, Canadian sources, Health and Welfare Canada as well as warnings, correspondence and journal articles received by the oral surgeons and the Hospital.

[257] A manufacturer of a product occupies the position of an expert. Vitek had an ongoing duty to warn consumers of dangers with the product. Vitek was in a superior position to discover defects in their product. It was a major defect in this product that caused damages to these plaintiffs. This means to me, from a global perspective, Vitek would bear a majority share of any fault arising from the use of its products both in fact and in law. I apportion Vitek’s fault at 50%.

[258] I agree with the submission of the defence that a distributor of a product would be in a different position regarding fault as compared to a manufacturer. A lower standard of care applies to such actors because they have no reason to suspect the presence of a defect and no means of avoiding it. The distributor of the implants in this case was Instrumentarium. There was not a great deal of direct evidence about the relationship between Instrumentarium and Vitek. There was evidence from several witnesses that Instrumentarium was considered a reputable marketer of specialized medical goods. There was evidence of how Instrumentarium arranged for Dr. Tomlak to source the Vitek device. We heard a great deal of evidence about the significant change to the Canadian medical device regulation regime in 1983. On a common sense basis, I have found that the Hospital should have made inquiries of Health Canada concerning the device. I would apply such logic to Instrumentarium as well. It seems to me more evident that they would have been aware or should have been aware of the change to the regulation of the very specialized types of products they had an exclusive right to market and sell in Canada, namely the Vitek implant. There was evidence that they were aware of the failure of the device as they initiated procedures directly with the Hospital to get the products back in August 1990. That letter indicated they were going to do further outreach to the oral surgeons to provide them with “safety advice.”

[259] On the basis of all this evidence, I find that Instrumentarium’s duty to make due inquiry of a regulatory authority was different and more extensive than that of the Hospital. Instrumentarium was in the business of importing the implant. They commercially benefitted from its sale. They knew or ought to have known that the hospital customers to whom they sold the product would have relied upon them to sell only approved medical devices. The specific regulation creating the obligation to obtain a notice of compliance put the responsibility to obtain same on a manufacturer of a device. This is to be contrasted to a purchaser of a device.

[260] Instrumentarium purchased the implant from Vitek. They distributed the implant in Canada. In my view, they were a “manufacturer” within the meaning of the Food and Drugs Act R.S.C. 1985 c. F-27 as amended. As such they had a duty to inquire. They breached that duty. Despite the evidence of Pierre Blais, I find that even upon receiving such an equivocal response as to the legality to sell the device, Instrumentarium was in a much better position to determine if it was appropriate to continue distribution of this device than a hospital customer. As such, in my view, their negligence caused damages to the plaintiffs. I apportion Instrumentarium’s fault at 25%.

[261] It is plain and obvious the oral surgeons owed a duty of care to the plaintiffs. In my view, as between themselves and the Hospital, they were the only ones who could assess the safety and efficacy of the implant for the individual plaintiffs. I agree with the submissions of the defence that decisions for treatment can only be made between a patient and a physician. The implant was a new product with a new procedure. I find the oral surgeons failed to take due care when assessing the viability of the product for the plaintiffs. They were learned professionals. They had the wherewithal to research the product. I agree with the assertion made by Dr. Tomlak in his evidence and I find the oral surgeons were misled by the representations of Vitek through literature provided with the product from Vitek. I agree with the evidence of Dr. Tomlak that the oral surgeons were “hoodwinked.” However, the evidence I heard indicated they did independently attempt to make inquiries about the product. Having entered into that inquiry, it appears from the expert evidence of Dr. Pilliar that in the mid-1980s there was alternative scientific evidence which contraindicated use of the device. I can understand the argument that the oral surgeons were not sufficiently diligent before they went ahead and decided to place the implant in the patients. This would represent a breach of their duty. The plaintiffs suffered damages when the oral surgeons decided to go ahead with the implant surgery, despite some warning signs available in 1983 that a proplast Teflon implant would fail in a patient’s TMJ.

[262] From the evidence I heard at this trial, the oral surgeons were also in the sole position of being able to recall their patients to either perform an explant or evaluate how the implant was affecting the patients. Both oral surgeons who testified readily acknowledged they had such a duty to their patients. It was clear to me from their evidence that they genuinely cared for their patients and acted at all times in a manner they believed was in accordance with their professional responsibilities to their patients. The time it took to recall seemed lengthy from an objective perspective. However, I have kept in mind the direction of the Supreme Court of Canada in Ter Neuzen v. Korn, 1995 CanLII 72 (SCC), [1995] 3 S.C.R. 674, at paragraph 34 which stated:

It is also particularly important to emphasize, in the context of this case, that the conduct of physicians must be judged in the light of the knowledge that ought to have been reasonably possessed at the time of the alleged act of negligence. As Denning L.J. eloquently stated in Roe v. Ministry of Health, [1954] 2 All E.R. 131 (C.A.), at p. 137, “[w]e must not look at the 1947 accident with 1954 spectacles”. That is, courts must not, with the benefit of hindsight, judge too harshly doctors who act in accordance with prevailing standards of professional knowledge. This point was also emphasized by this Court in Lapointe, supra, at pp. 362-63:

... courts should be careful not to rely upon the perfect vision afforded by hindsight. In order to evaluate a particular exercise of judgment fairly, the doctor's limited ability to foresee future events when determining a course of conduct must be borne in mind. Otherwise, the doctor will not be assessed according to the norms of the average doctor of reasonable ability in the same circumstances, but rather will be held accountable for mistakes that are apparent only after the fact.

[263] Overall, I find that the oral surgeons’ degree of fault in this matter is less than that of Vitek and Instrumentarium, but far more than the Hospital. As such, I apportion fault to the oral surgeons at 20%.

[264] I come to a decision about the percentage for the Hospital based on my assessment of all the evidence. As indicated, I am not prepared to find that the Hospital breached any other duty to the plaintiffs other than a duty to inquire of Health Canada prior to purchasing the implant. I was not persuaded by the arguments of the plaintiffs that they had proven on the balance of probabilities that the Hospital had any relevant further duty of care, or that any deficiencies in Hospital conduct caused damages to the plaintiffs. In my view, the Hospital bears a very small portion of any fault for the damages that have been outlined at this trial. This is because of the major portion of fault attributable to other actors. It was largely the actions of other actors which caused damages to the plaintiffs, whose damages I will be at some future time assessing, namely Janet and Leslie Hearsey. Accordingly, I assess the portion of the Hospital’s several liability, as between the other tortfeasors responsible for the damages to these plaintiffs, at 5%. I would make the very same finding of apportionment for the other three plaintiffs had I not dismissed their claim based on the limitation set out in the Public Hospitals Act.

[265] At this point in the trial, there is also the issue of costs. It seems to me, absent any agreement between the parties or offers to settle, that the defendant is entitled to costs of the action for the three plaintiffs whose claims have been dismissed. The issue of costs for Mrs. Hearsey and Mr. Hearsey is a live issue. I leave it to the parties to decide if they want to address costs now or wait until they have completed the damages portion of this trial before they schedule how submissions regarding costs will be handled.

[266] This judgment reflects how I have decided to deal with the issue of liability. I have accepted the defendant’s argument that the plaintiffs’ claims are statute barred for three of the four actions before me. I have found the Hospital is liable to Mrs. Hearsey and her husband, but only for 5% of their damages. Accordingly, the claims of Paulette M. Endean, Frank William Endean, Debbie Endean, Andrew Karam, Sherry Lind, Gino Deamicis, Lorraine Lind, Lauri Lind, Crystal Lind, Donald Deamicis, and Daniel Deamicis are hereby dismissed subject to submissions on costs. The evidence regarding the assessment of the damages of Janet and Leslie Hearsey shall be scheduled for further trial in consultation with myself and the trial co-ordinator at Thunder Bay.

[267] In my initial endorsement, I indicated that the period for launching any appeal of this

decision shall run from the date of the release of these reasons.

[268] For all the foregoing reasons, order to go accordingly.

_______”original signed by”

The Hon. Mr. Justice F.B. Fitzpatrick

Released: April 27, 2017

CITATION: Endean et al. v. St. Joseph’s General Hospital, 2017 ONSC 2632

COURT FILE NO.: CV-97-0701, CV-96-0342, CV-97-0271 & CV-14-0209

DATE: 2017-04-27

ONTARIO

SUPERIOR COURT OF JUSTICE

B E T W E E N:

CV-97-0701: Endean et al, Plaintiffs, vs. St. Joseph’s General Hospital, Defendant

CV-96-0341: Hearsey et al, Plaintiffs, vs. St. Joseph’s General Hospital, Defendant

CV-97-0271: Karam, Plaintiff, vs. St. Joseph’s General Hospital, Defendant

CV-14-0209: Lind et al, Plaintiffs, vs. St. Joseph’s General Hospital, Defendant

JUDGMENT ON LIABILITY

Fitzpatrick J.

Released: April 27, 2017

/sab