DIVISIONAL COURT FILE NOS.: 191/04

192/04

COURT FILE NO. : 00-CV195906CP

DATE: 20050128

ONTARIO

SUPERIOR COURT OF JUSTICE

B E T W E E N:

ERIK ANDERSEN, YVONNE ANDERSEN and SHARON FROST

Plaintiffs/Respondents

• and -

ST. JUDE MEDICAL, INC. and ST. JUDE MEDICAL CANADA, INC.

Defendants/Applicants

J.G. McKee and J. Lawrie, for the Defendants/Applicants

J.M. Newland, G. MacKenzie and R.M. Raikes for the Plaintiffs/Respondents

HEARD at Toronto: April 21, 2004

O’DRISCOLL J.:

i. Nature of Proceedings

1The Applicants/Defendants have brought two (2) applications seeking leave to appeal to the Divisional Court:

(a) an application (191/04), dated September 23, 2003, as amended on March 10, 2004, seeking leave to appeal the certification ruling of Cullity J., dated September 16, 2004, made under s. 5 of the Class Proceedings Act, 1992, S.O. 1992, c. 6 (the CPA);

(b) an application (192/04), dated October 16, 2003, as amended on April 1, 2004, seeking leave to appeal the evidence admissibility ruling of Cullity J., dated October 9, 2003

2Section 30(2) of the CPA provides that a party may appeal to the Divisional Court from an order certifying a proceeding as a class proceeding, with leave of the Superior Court of Justice as provided in the rules of court. This engages rule 62.02(4) of the Rules of Civil Procedure which states:

(4) Leave to appeal shall not be granted unless,

(a) there is a conflicting decision by another judge or court in Ontario or elsewhere on the matter involved in the proposed appeal and it is, in the opinion of the judge hearing the motion, desirable that leave to appeal be granted; or

(b) there appears to the judge hearing the motion good reason to doubt the correctness of the order in question and the proposed appeal involves matters of such importance that, in his or her opinion, leave to appeal should be granted. (emphasis added)

3Although the Defendants/Applicants have brought two (2) applications for leave to appeal, there can be only one application for leave to appeal, namely, the application for leave to appeal the decision of Cullity J., dated September 23, 2003, certifying the action pursuant to s. 5 of the CPA (191/04). The impugned evidentiary ruling is subsumed in that application and has no free standing status.

4For the reasons that follow, both applications for leave to appeal are dismissed.

II. Proceedings to Date

5On September 17, 18, 19 and 20, 2002, Cullity J. heard a motion brought by the Defendants for an order striking portions of affidavits filed by the Plaintiffs in support of their motion for certification. The affidavits were those of Dr. Gregory John Wilson, Dr. Frank O. Tyers and Dr. Julio Arboleda-Flórez.

6On October 29, 2002, Cullity J. released a six (6) page endorsement and adjourned the motion to the date of the hearing of the motion seeking certification.

7On June 16, 17, 19 and 20, 2003, Cullity J. heard submissions regarding the affidavit evidence and the motion to certify. On September 16, 2003, Cullity J. released twenty-four (24) pages of reasons certifying the action under the CPA because he found that the Plaintiffs had established and satisfied each of the conditions in the five (5) paragraphs of s. 5(1) of the CPA.

8On October 9, 2003, Cullity J. released a twelve (12) page endorsement and ordered that:

(i) the first nine (9) words of paragraph 60 of the affidavit of Dr. G. Frank O. Tyers, dated February 22, 2002, be struck out, and

(ii) paragraphs 9 to 13, 15, 16 and 24 to 34, the second and fourth sentences in paragraph 18 and the second sentence in paragraph 20 of the affidavit of Dr. Julio Arboleda-Flórez, sworn June 10, 2002, be struck out, and

(iii) the balance of the Defendants’ motion regarding the affidavits be dismissed.

9On January 14, 2004, counsel made further submissions as to the “class” and other matters.

10On January 16, 2004, Cullity J. released five (5) pages of additional reasons. The formal order of January 16, 2004 states, in part:

1. THIS COURT ORDERS that this action be and is hereby certified as a class proceeding, subject to the provisions of this Order.

2. THIS COURT ORDERS that the Class is described as

(a) Canadian residents – other than residents of British Columbia or Quebec – who were implanted with one or more mechanical heart valves, or annuloplasty rings, coated with Silzone® that were designed, manufactured, marketed, distributed or sold by the defendants (“the Patients’ Class”) and

(b) Persons who, by reason of their relationship with members of the Patients’ Class would have standing in this action pursuant to Section 61(1) of the Family Law Act, R.S.O. 1990, c. F 3, as amended, if that section was otherwise applicable to the claims asserted on their behalf (the “Family Class”).

3. THIS COURT ORDERS that the common issues for the Class are:

4. Did the defendants breach a duty of care owed to Patients’ class members by reason of the design, pre-market testing, regulatory compliance, manufacture, sale, marketing, distribution and recall of Silzone-coated mechanical heart valves and annuloplasty rings implanted in such members?

5. What effect, if any, does such Silzone coating have on tissue healing?

6. Does a Silzone coating on heart valves, or annuloplasty rings, materially increase the risk of various medical complications including, but not limited to, paravalvular leakage, thrombosis, thromboembolism, stroke, heart attacks, endocarditis or death?

7. Do Silzone-implanted patients need additional or different medical monitoring than that for conventional mechanical heart valve patients?

8. Should the defendants be required to implement a medical monitoring regime and, if so, what should the regime comprise and how should it be established?

9. Is the burden of proof of causation or negligence affected by spoliation of evidence by the defendants?

10. Does the defendants’ conduct merit an award of punitive damages, and if so, in what amount?

11. THIS COURT ORDERS that Erik Andersen and Sharon Frost are the representative parties of the Patients’ Class and APPOINTS them as the representative parties for the Patients’ Class.

12. THIS COURT ORDERS that Yvonne Andersen is the representative party of the Family Class and APPOINTS her as the representative party for the Family Class.

III. Background and Chronology

11The Defendants’ “Aid for Oral Argument” at Tab 7 provides a glossary which includes the following words and phrases:

Annulus – the ring shaped opening at the base of a heart valve. In valve replacement surgery, the ring shaped opening left after the native valve is removed from the surrounding heart tissue.

Annular Tissue – the tissue comprising the ring that forms the base of a heart valve.

Annuloplasty – reconstruction of the annulus of an incompetent heart valve.

AVERT – Artificial Valve Endocarditis Reduction Trial.

Endocarditis – an infection of the tissue lining the interior of the heart, including the tissue surrounding heart valves. Endocarditis is also often referred to as infective endocarditis, or when in association with a prosthetic heart valve, prosthetic valve endocarditis (PVE). Though infective, it can be culture negative (i.e., no micro-organism revealed by culture testing).

Endocardium – the innermost lining of the heart.

Mitral Valve – the valve between the left atrium (the upper chamber) and the left ventricle (the lower chamber) of the heart.

Paravalvular leak (PVL) – in association with a prosthetic valve, a leak around the outside of the valve where there is a lack of permanent and continuous anchoring of the prosthetic valve to the tissue in the patient’s heart.

Sewing Cuff – ring of fabric around a mechanical heart valve that allows the valve to be sewn to the patient’s own heart tissue at the annulus.

Thromboembolism (TE) or Thromboembolic Event – the process by which thrombus or embolism obstructs a vessel. Includes a stroke.

12The Defendants manufacture and distribute mechanical heart valves and other heart – repair products and devices, including annuloplasty rings, which are devices implanted in a patient to reconstruct a diseased opening at the base of the heart valve. Between late 1997 and January 22, 2000, the Defendants also manufactured and distributed mechanical heart valves coated with an elemental silver with the registered name “Silzone”. The only difference between the Defendants’ mechanical heart valve and the Silzone valve was the silver coating on the sewing cuff.

13The Plaintiffs, Erik Andersen and Sharon Frost, reside in Ontario and had Silzone heart valves implanted in 1998. They claim that they have seriously suffered as a result of the implantation of those Silzone valves. They seek damages alleging negligence by the Defendants in selling and distributing Silzone heart valves without proper research and testing. Yvonne Andersen is Erik Andersen’s spouse and claims damages under Part V of the Family Law Act, R.S.O. 1990, c. F. 3.

14During 1999, hospitals in Denmark and Ireland stopped implanting Silzone valves because of numerous cases of paravalvular leaks, thromboembolic events and deaths associated with poor tissue healing of patients who had a Silzone implanted. Toronto General Hospital stopped in January 1999, Sunnybrook in March 1999, Laval Hospital in May 1999 and Vancouver General Hospital in November 1999.

15In November 1999, the British Medical Devices Agency issued a “Device Alert Bulletin” warning of the propensity of the Silzone valve to thromboembolic events, particularly in the mitral position.

16In November 1999, the Governments of Australia and New Zealand ordered the Defendants to remove the Silzone valve from their markets.

17From the time of obtaining a Supplementary Notice of Compliance (SNOC) from Canadian Health Protection Branch of Health Canada (HPB) in July 1997, until January 2000, the Defendants sold Silzone-coated mechanical heart valves and annuloplasty rings throughout Canada for implantation in Canadian patients.

18Commencing in July 1998, some ten (10) months after the Silzone valve had commenced being implanted in patients in Canada, the Defendants sponsored a five (5) year multi-central randomized clinical trial known as AVERT (Artificial Valve Endocarditis Reduction Trial). The study was to have an enrolment of 4,400 patients at seventeen (17) different centres. The conventional St. Jude Masters Series Valves and the St. Jude Silzone valves were to be implanted in equal numbers. Patients were to be monitored and the results of the study published on an interim basis.

19In early January 2000, enrolment in AVERT was suspended, with only 807 of the anticipated 4,400 patients enrolled, because results showed a statistically and significantly greater number of explants of the Silzone-coated mechanical heart valves due to paravalvular leaks and a clinically significant increase in thromboembolic events.

20On January 22, 2000, the Defendants announced a world wide recall of the Silzone-coated mechanical heart valves and annuloplasty rings. World wide, prior to the recall, more than 36,000 Silzone-coated mechanical heart valves and annuloplasty rings were implanted in patients.

21In Canada, the Defendants advised, during the period from September 1997 to January 2000, a total of 2268 Silzone-coated mechanical heart valves were implanted in patients:

(a) Ontario – 1015

(b) Quebec – 656

(c) British Columbia – 286

(d) Manitoba – 180

(e) New Brunswick – 52

(f) Alberta – 48

(g) Newfoundland – 28

(h) Nova Scotia – 3

22There are 1199 patients included in the class certified by Cullity J., which includes all Canadian patients in Canada other than those in British Columbia and the Province of Quebec where parallel class proceedings are pending. The Quebec action was certified on September 3, 2004. In the U.S.A., on January 5, 2004, the U.S. District Court, District of Minnesota, certified a parallel U.S. class proceeding – leave to appeal was granted on September 2, 2004.

23Each of the 1199 Canadian patients in the class has had one or more Silzone-coated valves implanted in his or her heart.

24The factum of counsel for the Plaintiffs/Respondents states:

6. The plaintiffs allege that the defendants manufactured, distributed, and sold a defective, highly dangerous product that they released onto the market based on woefully inadequate pre-market testing in circumstances in which adequate pre-market clinical trials would have demonstrated the dangers of the product. Indeed, the limited pre-market in vitro studies done showed equivocal results regarding anti-bacterial efficacy, and the two short-term sheep studies showed that the silver coating damaged the tissue healing process, causing paravalvular leak thromboembolism and, for one of the sheep, death. ……

7. Kevin E. Healy, Ph.D., an Associate Professor in the Departments of Bioengineering and Material Science and Engineering at the University of California at Berkeley, has opined that by 1997, ample scientific literature existed dealing with silver-coated surgical devices indicating that serious complications could result in patients with Silzone heart valves.

8. If the tissue surrounding the valve does not heal properly, resulting in poor tissue ingrowth, the valve will not anchor properly into the tissue and will remain loose. As a result, the risk of paravalvular leak will increase. Even in the absence of paravalvular leak, the impaired tissue healing and resulting poor quality tissue would lead to thrombogenic conditions which increase the risk of thrombus formation and the occurrence of thromboembolic events.

9. In Dr. Healy’s opinion, each and every Silzone patient will experience, to a greater or lesser extent, damage to the tissue healing process. The risks associated with silver concentrations in cells adjacent to the Silzone valve put each and every patient who received a Silzone valve at risk for potentially serious complications. These increased risks exist independent of any individual factors in Silzone patients.

10. It is the plaintiffs’ position in this action that the defendants knew or should have known much earlier than January, 2000 that there were significant medical risks to patients implanted with these devices. One of the issues raised by this litigation is the appropriateness of the defendants’ delay in issuing its recall notice. This is the classic “what did they know and when did they know it” issue, which does not depend upon the conduct of individual patients for its determination.

11. The certification stage is decidedly not meant to be a test of the merits of the action. Rather, the certification stage focuses on the form of the action. The question at the certification stage is not whether the claim is likely to succeed, but whether the suit is appropriately prosecuted as a class action.

25Cullity J. stated in his reasons, dated September 16, 2003:

[34] …the questions at this stage are whether there is an issue that is relevant to the causes of action pleaded, whether there is some evidential basis for it and whether it is common to all members of the class.

[40] I am persuaded that the first requirement mentioned by the Chief Justice [Western Canadian Shopping Centres Inc. v. Dutton (2001), 2001 SCC 46, 201 D.L.R. (4th) 385, (S.C.C)] – that resolution of the proposed common issues must be necessary to each member’s claim – has been satisfied. I do not accept the submission that commonality is absent because the issues directed at a breach of the standard of care, and at the risk of adverse complications, can be broken down into a series of issues relating to particular medical conditions that may not have been experienced by every member of the class. As far as the standard of care is concerned, the focus at a trial of the common issues will be on the adequacy of the measures taken by the defendants to prevent adverse consequences. One of the questions will relate to the consequences to which testing and research should be directed. The claims of each member of the class will be affected by the answer and I do not believe that the possibility that different members of the class may have suffered from different adverse consequences to their health detracts significantly from the commonality of the issue.

[54] …Apart from the possibility of surgeons’ errors, the alternative causes to which the experts refer would, to a large extent, be attributable to a patient’s pre-existing medical condition, medical and surgical history, susceptibility to a particular health problem or medical and surgical history that the defendants allege was not caused, or contributed to, by a Silzone device. Unlike the condition, and history, of each plumbing system in Gariepy, the medical condition and history of the members of the class should be well-documented and, of course, the Silzone valves and other devices would have been implanted by individuals whose profession it was to identify and treat problems of the kind that the patient had experienced. Both the evidence available and the nature of the inquiry should, I believe, be far more narrowly focused, manageable and controllable than an inquiry into the cause of leaking plumbing appliances that were manufactured by numerous different third parties, installed by many others – of, possibly, various degrees of competence – and used and, possibly, misused, by homeowners across the province.

[55] In Gariepy, Nordheimer J. adverted to one distinction between the facts before him and those of cases such as this when he stated:

“The situation here is also not like a medical products liability case, such as Nantais v. Telectronics Proprietary (Canada) Ltd. (1995), 1995 7113 (ON SC), 25 O.R. (3d) 331 (Ont. Gen. Div.) or Endean v. Canadian Red Cross Society (1997), 1997 2079 (BC SC), 148 D.L.R. (4th) 158 (B.C.S.C.), where proof of defectiveness will likely give rise to either a need to remove the product or otherwise provide treatment or, at the very least, a need to monitor the performance of the product such that, again, immediate damage is occasioned to all members of the class.”

[56] Similarly, here, if the common issues relating to causation are answered in accordance with the plaintiff’s submissions, there would be immediate “damage” to all members of the class in the sense in which the learned judge used the term. In Gariepy, one of the plaintiffs’ experts had acknowledged that not all plumbing systems with the pipes and fittings would ultimately fail. There was no monitoring issue.

[58] In contrast with these cases, I am here dealing with a putative class of known individuals each of whom received a heart implant, or other device, coated with the same allegedly hazardous substance. For those who are asymptomatic, a trial of common issues will determine the question of liability and remedies. For those who seek damages for injuries suffered by reason of a breach of the standard of care, the specific issues of causation that would have to be determined on an individual basis would, in my judgment, be far more narrowly focused than those that were held to detract from commonality in Gariepy, and from preferability in Pearson.

[59] The evidence of the defendants is that there are 1199 patients included in the putative class and that reports of complications experienced by 31 of these had been received as of March 12, 2003. The specific questions of causation may be difficult in some cases and conflict in the evidence of expert witnesses can be anticipated. Neither of these factors is, in any way, unusual and, subject to the comments I will make with respect to the proposed litigation plan, I see no reason to conclude that a resolution of the individual issues of causation and damages will be unmanageable.

[78] …Much of the evidence on which each side relied was relevant to the merits of the claims. However, virtually all of the evidence that was relevant to the questions of commonality, the nature of the individual issues and their significance relative to the individual issues was relevant in varying degrees – and, very often, directly relevant – to the merits.

[81] The three witnesses, Dr. Wilson, Dr. Tyers and Dr. Arboleda-Flórez – whose evidence was challenged in the earlier motion – were, in my opinion, qualified to give the expert evidence on which plaintiffs’ counsel relied at the hearing and in their factum. At a trial of the common issues the relative weight to be given to those opinions would no doubt be explored. However, on this motion, when their opinions clashed with those of the defendants’ experts on, for example, the likely toxic effects of silver, the increased risk of complications caused by the Silzone implants, or the appropriate standards applicable to research and testing, I have not found it necessary, appropriate or relevant to attempt to resolve the conflict. To the extent that the evidence was relevant to the issues on the motion, I have considered it. To the extent that I considered it to be irrelevant, I ignored it.

IV. Requirements for Leave to Appeal

26Rule 62.02(4)(a) and (b) stipulate that “leave to appeal shall not be granted unless, (a) there is a conflicting decision by another judge or court in Ontario or elsewhere on the matter involved in the proposed appeal and, it is, in the opinion of the judge hearing the motion, desirable that leave to appeal be granted”. The word “and” makes the two clauses conjunctive and, therefore, both parts must be satisfied.

27In my view, the Defendants/Applicants have not referred me to any “conflicting decision by another judge or court either in Ontario or elsewhere on the matter involved in the proposed appeal”.

28In my view, the governing decision is that of the Court of Appeal for Ontario in Anderson v. Wilson (1999), 44 O.R. (3d) 675, 682. In my view, the September 16, 2003 order of Cullity J. does not conflict with Anderson v. Wilson, where it was said:

p. 682

Implants, motor vehicle malfunctions, improper interest charges and such all lend themselves to resolution as to liability without involvement of the injured parties. (Footnotes omitted)

p. 683

In my view, it seems sensible with this number of potential plaintiffs and the similarities that are evident in their claims, that any potential efficiency in advancement of their claims through the flexibility provided by the CPA should, where reasonable, be utilized.

In my view, this argument is far too broad. Unlike typical medical negligence cases this action concerns allegations of a general practice over a number of years falling below acceptable standards. Those general allegations can be pulled out and tried separately, to the benefit of all parties.

I agree with the British Columbia Court of Appeal’s observation, as did Campbell J., that the common issues need only involve a matter, that if determined, would move the litigation forward. In Campbell v. Flexwatt Corp. (1998), 1997 4111 (BC CA), 15 C.P.C. (4th) 1, 44 B.C.L.R. (3d) 343 (C.A.), leave to appeal to the Supreme Court of Canada denied, Cumming J.A., speaking for the court at pp. 17-18 reasoned:

The Class Proceedings Act requires that the claims of the class members raise common issues which, for reasons of fairness and efficiency, ought to be determined within one proceeding. Common issues can be issues of fact or law and do not have to be identical for every member of the class.

When examining the existence of common issues it is important to understand that the common issues do not have to be issues which are determinative of liability; they need only be issues of fact or law that move the litigation forward. The resolution of a common issue does not have to be, in and of itself, sufficient to support relief. To require every common issue to be determinative of liability for every plaintiff and every defendant would make class proceedings with more than one defendant virtually impossible. (Emphasis added)

In this case, the common issue as to the standard of conduct expected from the clinics from time to time, and whether they fell below the standard, can fairly be tried as a common issue.

29In Anderson v. Wilson, the motions court judge defined the common issue as “liability and punitive and exemplary damages” (p. 676). As to damages, the Divisional Court phrased it: “Is this a case for punitive and exemplary damages” (p. 677).

30Because rule 62.02(4)(a) is conjunctive and the Applicant has failed to persuade me that there is a conflicting decision, I need not decide whether it is desirable that leave to appeal should be granted with regard to the second branch of subsection (a). If that issue were before me, I would answer it in the negative. It is true that litigation is always important to those particular parties to it. However, in my view, this case is fact specific and its purview, for the most part, is confined to the parties.

31Rule 62.02(4)(b) states, “or” “leave to appeal shall not be granted unless there appears to the judge hearing the motion good reason to doubt the correctness of the order in question and the proposed appeal involves matters of such importance that, in his or her opinion, leave to appeal should be granted”.

32In my view, with respect, there is no reason to doubt the correctness of Cullity J.’s decision to order that this action be certified as a class proceeding under s. 5(1) of the CPA. His decision is consistent with cases certified as class proceedings involving what are alleged to be medical devices or products. In my view, this case does not come within Ash v. Lloyds’ Corp. (1990), 1992 7652 (ON SC), 8 O.R. (3d) 282 (Ont. Ct. Gen. Div.).

33I agree that this case is fundamentally different from: Pearson v. Inco, [2002] O.J. No. 2764: appeal to the Divisional Court dismissed: 2004 34446 (ON SCDC), [2004] O.J. No. 317.

34I am aware of the words of the Court of Appeal for Ontario in Anderson v. Wilson (supra) at p. 677: “…I am mindful of the deference which is due to the Superior Court judges who have developed expertise in this very sophisticated area of practice. The Act provides for flexibility and adjustment at all stages of the proceeding and any intervention by this court [Ont. C.A.] at the certification level should be restricted to matters of general principle”.

35Counsel for the Defendants/Applicants have not persuaded me on the first branch of rule 62.02(4)(b) and, it, too, being conjunctive, it is unnecessary for me to address the second branch of the subrule. However, the words of Catzman J. in Rankin v. McLeod, Young, Weir Ltd. (1986), 1986 2749 (ON SC), 57 O.R. (2d) 569, 575 are applicable:

…in my view, the “importance” comprehended by the rule transcends the interests of the immediate parties to the litigation and contemplates issues of broad significance or general application that are felt to warrant resolution by a higher level of judicial authority. I have earlier indicated my assessment that the issues raised in respect of the orders in question are not of broad importance extending beyond the interests of the parties. It follows that, even on the assumption that there appears good reason to doubt the correctness of the orders in question, the proposed appeal does not involve matters of such importance, within the contemplation of the rule, that leave to appeal should be granted.

V. Result

36The applications for leave to appeal (191/04 and 192/04) under s. 30 of CPA and rule 62.02(4)(a) and (b) are dismissed.

VI. Costs

37If counsel are unable to agree as to costs, counsel for the Plaintiffs/Respondents shall file written submissions within ten (10) days of the date of these reasons. Counsel for the Defendants/Applicants shall have ten (10) days to respond and counsel for the Plaintiffs/Respondents shall have a further five (5) days to reply. Thereafter, costs will be fixed.

O’Driscoll J.