ONTARIO
SUPERIOR COURT OF JUSTICE
COURT FILE NO.: CV-13-475701CP
DATE: 20151215
BETWEEN:
ALBERT C. BATTEN and THE ESTATE OF MARGARET JANE HAMILTON, on behalf of her Estate Representative Wendy Nelson, and WENDY NELSON, personally
Plaintiffs
– and –
BOEHRINGER INGELHEIM (CANADA) LTD., BOEHRINGER INGELHEIM PHARMACEUTICALS, INC., BOEHRINGER INGELHEIM PHARMA GMBH & CO KG, and BOEHRINGER INGELHEIM INTERNATIONAL GMBH
Defendants
Bryan C. McPhadden and Daniel Bach, for the Plaintiffs
Scott Maidment, Calie Adamson, and Anna Tombs, for the Defendants
HEARD: December 2, 2015
Proceedings under the Class Proceedings Act, 1992
PERELL, J.
REASONS FOR DECISION
A. INTRODUCTION
[1] The Plaintiffs, Albert C. Batten, the Estate of Margaret Jane Hamilton, and Wendy Nelson in her personal capacity and as estate representative of the late Mrs. Hamilton, bring a proposed class action under the Class Proceedings Act, 1992, S.O. 1992, c. 6 against Boehringer Ingelheim (Canada) Ltd., Boehringer Ingelheim Pharmaceuticals, Inc., Boehringer Ingelheim Pharma GMBH & Co. KG and Boehringer Ingelheim International GMBH (collectively “Boehringer”). The Plaintiffs claim damages of $100 million, aggravated damages of $25 million, punitive damages of $25,000 and a to-be-determined amount of special damages for medical and other expenses.
[2] The Plaintiffs have delivered their evidentiary material for the certification motion which is scheduled for July 25-27, 2016.
[3] Boehringer, before delivering its responding material, which is due by January 22, 2016, seeks the production of the medical records of Mr. Batten and of the late Mrs. Hamilton. The Plaintiffs, who have produced some redacted medical records of Mr. Batten and of Mrs. Hamilton, refuse to produce any more medical information. The Plaintiffs submit that additional medical records are irrelevant to the pending certification because it is a purely procedural motion. In the alternative, they submit that the request for medical records is too broad and that Boehringer’s request is premature and should have been made following cross-examinations where the medical records were shown to be relevant.
[4] For the reasons that follow, I grant Boehringer’s motion.
B. FACTUAL AND PROCEDURAL BACKGROUND
[5] Boehringer manufactures an anticoagulant; i.e. a blood-thinner drug known as Pradaxa®. Pradaxa® is indicated for: (a) the prevention of venous thromboembolism in patients who have undergone hip or knee replacements; (b) the treatment of deep vein thrombosis and pulmonary embolism; and (c) the prevention of stroke and systemic embolism in patients with atrial fibrillation. Pradaxa® is contraindicated in patients with, among other things, severe renal impairment, clinically significant active bleeding, lesions at risk of clinically significant bleeding, and prosthetic heart valves.
[6] In this proposed class, it is alleged that Pradaxa® causes irreversible and sometimes fatal bleeding and that it is a uniquely dangerous drug because unlike other blood-thinners, during the time that Pradaxa® is present in the body, there exists no reversal agent or antidote to slow down or reverse its blood-thinning effect.
[7] The Plaintiffs propose the following class definition:
(a) All persons throughout Canada who purchased and/or ingested the drug Pradaxa® and their estates, administrators or other legal representatives ("the Class"); and
(b) All persons who have a derivative claim on account of a family relationship with a person in (a.) ("the Family Class").
[8] The Plaintiffs propose the following common issues:
(1) Can ingesting Pradaxa® cause an increased risk of excessive and irreversible bleeding?
(2) Were any of the defendants negligent in the research, development, and testing of Pradaxa®? If so, which of them?
(3) Were any of the defendants negligent in the marketing, packaging, labeling, and promotion of Pradaxa®? If so, which of them?
(4) Can patients taking Pradaxa® benefit from regular monitoring of the strength of the anti-coagulant effect being exerted on them by Pradaxa®?
(5) If so, did any of the Defendants have a duty to warn the class members of the need to monitor the effect of Pradaxa®? If so, did any of them fail to warn in an adequate manner? If so, who, when and how?
(6) Did any of the Defendants have a duty to warn the class members about the lack of an antidote for bleeding caused by Pradaxa®? If so, did any of them fail to warn in an adequate manner? If so, who, when and how?
(7)(a) Are the Defendants liable for damages resulting from the purchase and ingestion of Pradaxa®?
(a) If yes, which Defendants are liable for such damages?
(b) Is each Defendant responsible in law for the acts or omissions of the other Defendant in respect of the design sale and marketing of Pradaxa® in Canada?
(8) Are the Defendants liable for the subrogated health care costs of class members incurred in the treatment of conditions related to taking Pradaxa®?
(9) If the Defendants, or any of them, breached a duty of care would any such Defendant’s conduct justify an award of punitive damages?
[9] In his affidavit in support of the certification motion, Mr. Batten deposed about his use of Pradaxa® as follows:
In 2009, I was diagnosed with a condition known as atrial fibrillation. As it was explained to me, atrial fibrillation is a condition in which the heart's rhythm is abnormal.
I was prescribed warfarin to treat that condition, and I began taking warfarin in January 2009.
I experienced no side effects while taking warfarin-for three years, and it appeared to be working in regulating my atrial fibrillation; however, it was quite inconvenient to be taking warfarin because its effects had to be constantly monitored - I would have to visit the hospital regularly to make sure that my blood was not being thinned too much or too little.
In 2012, my doctor told me about a new blood thinner/anti-coagulant by the name Pradax (now known as “Pradaxa®,” and advised that I would not need to attend for monitoring as I did with warfarin.
I took warfarin continuously until May 2012. On or about May 25, 2012, I stopped taking warfarin. I started taking Pradaxa® on or about May 28, 2012.
I continued taking Pradaxa® until July 2012. During the time when I was taking Pradaxa®, I was no longer being monitored.
On or about July 7, 2012, I suffered from blood in the stool.
From July 16 to July 19, I was hospitalized as a consequence of having blood in the stool.
I was taken off Pradaxa® and have been taking warfarin ever since.
For the three years during which I was taking warfarin, I had not experienced any of similar problems with Pradaxa®, and certainly no blood in the stool.
[10] In her affidavit in support of the certification motion, Miss Nelson, who is the daughter of the late Mrs. Hamilton deposed about her mother’s use of Pradaxa® as follows:
I am the daughter of the late Margaret Jane Hamilton ("Mrs. Hamilton"). Mrs. Hamilton was a healthy and vibrant elderly woman who was prescribed Pradaxa® by her healthcare provider, in or about April, 2012, following a hospital visit for atrial fibrillation. Prior to being prescribed Pradaxa®, Mrs. Hamilton had not suffered a stroke, was not suffering from hypertension, had not been diagnosed as being diabetic and had not previously suffered heart failure. She had good kidney function at the time she was prescribed Pradaxa®. In or about December, 2012, Mrs. Hamilton was briefly taken off Pradaxa®, to enable her to undergo a lumpectomy. The surgery was successful, and she resumed the usage of Pradaxa®.
On May 16, 2013, Mrs. Hamilton collapsed in her home and suffered cerebral hemorrhage. She died shortly thereafter. Mrs. Hamilton was still taking Pradaxa® at the time of the hemorrhage and had been prescription compliant throughout the time she was prescribed Pradaxa®. Also at the time of the hemorrhage, Mrs. Hamilton was not taking any other anti-coagulants, such as aspirin, Plavix or Motrin.
[11] In the summer of 2015, Boehringer’s counsel requested the Plaintiffs’ counsel to produce the medical records of Mr. Batten and of the late Mrs. Hamilton, and on September 18, 2015, the Plaintiff’s provided five pages of redacted medical records of Mr. Batten and two pages of redacted medical records for Ms. Hamilton. The Plaintiffs submit that these records were produced for the limited purpose of establishing that Mr. Batten and Mrs. Hamilton were Class Members; i.e., that they had ingested Pradaxa®.
[12] Mr. Batten’s records contain: (a) his prescription history from his pharmacy, but all prescriptions other than Pradaxa® have been redacted; (b) clinical notes, but all entries other than those referencing Pradaxa® have been redacted. The medical records provide no information about prior medical history, other medications, or co-morbidities. There is no indication as to why Pradaxa® was prescribed for Mr. Batten.
[13] Mrs. Hamilton’s records contain her pharmacy prescription records referencing only Pradaxa®, as well as a list of tests performed at her hospitalization without any reference to results. There are no records relating to her initial prescription of Pradaxa® or ongoing experiences while taking the drug. There is no information about prior medical history, other medications, or co-morbidities.
[14] In its Notice of Motion, Boehringer seeks production of:
(a) All medical records of Mr. Batten and Ms. Hamilton related to treatment for the injuries alleged in the Statement of Claim including consultation notes, discharge summaries, test results (including laboratory and imaging results), and medications lists from the hospitalization of Mr. Batten and Mrs. Hamilton described in the amended statement of claim;
(b) The complete patient profile of Mr. Batten and Mrs. Hamilton, including their past medical history and medication lists, from their respective primary care physicians; and
(c) All medical records of Mr. Batten and Mrs. Hamilton related to any discussions by or with any health care provider related to any risks associated with Pradaxa® or any warnings or precautions related to any such risks (collectively, the “Medical Records”).
[15] A request for “all medical records” is a very broad request, but as explained at the hearing of the motion, Boehringer’s request is constrained by the qualifications that the records are related to the injuries alleged in the Statement of Claim and to discussions related to the risk associated with Pradaxa® and by the request’s reference to what is known as a “patient profile,” which is not a comprehensive medical history but rather a summary of a person’s medical history that is a composite record well known to medical practitioners. This is a much narrower request.
[16] Notwithstanding the narrowing of the request, it was still resisted by the Plaintiffs, who submitted that they have already submitted all that is necessary for the purposes of the certification motion. The Plaintiffs submitted that they have produced evidence that Mr. Batten and Mrs. Hamilton were prescribed Pradaxa®; that they experienced bleeding; and that expert evidence demonstrates that Boehringer failed to adequately warn about the risk of bleeding associated with Pradaxa®. Given this “basis in fact,” the Plaintiffs submit that no further amount of medical documents will assist this Court one way or another.
[17] The Plaintiffs submit that given the high personal privacy of medical records, they should only be compelled in litigation when legitimately necessary to the matters at issue at that stage of the litigation, and the Plaintiffs submit that in the context of a class action, there is no legitimate reason for compelling production of highly private and confidential medical records at the pre-certification stage. Further, as noted above, the Plaintiffs submit that certification is a purely procedural step in the action and that Mr. Batten’s and Ms. Hamilton’s medical records, which would be relevant to their individual issue’s trial and, perhaps, the common issues trial are not relevant to the purely procedural matters of the test for certification. Further, the Plaintiffs submit that the onus is on Boehringer to show that the medical records are relevant to the certification issue and it has failed to present any evidence to substantiate its assertion of relevancy.
C. DISCUSSION AND ANALYSIS
[18] Recently, in Brown v. Janssen Inc., 2015 ONSC 1434 and Dine v. Biomet Inc. 2015 ONSC 1911, Justice Belobaba addressed the issue of the extent to which medical records in a proposed products liability class action should be produced before the certification motion, and he reviewed the authorities from across the country; i.e.: Anderson v. Wilson, [1996] O.J. No. 4827 (Gen. Div.); Caputo v. Imperial Tobacco Ltd., 1997 12162 (ON SC), [1997] O.J. No. 2576 (Gen. Div.); Pardy v. Bayer Inc., [2003] N.J. No. 210 (T.D.); Schroeder v. DJO Canada Inc. 2009 SKQB 169, 2009 SKQB169; Roveredo v. Bard Canada Inc., 2010 ONSC 5240; Jones v. Zimmer Gmbh, 2010 BCSC 1504; Bartram (Guardian ad litem of) v. Glaxosmith Inc., 2011 BCSC 1174, leave to appeal denied, 2011 BCCA 539 (B.C.C.A.); Sweetland v. Glaxosmithkline Inc., 2014 NSSC 216; and Baroch v. Canada Cartage Diversified GP Inc., 2015 ONSC 40.
[19] To this list of cases about the production of medical records, the following may be added: Pearson v. Inco Ltd. (2002), 22 C.P.C. (5th) 167 (Ont. S.C.J.); Kimpton v. Canada (Attorney General), 2002 BCSC 67; Pro-Sys Consultants Ltd. v. Microsoft Corporation, 2007 BCSC 1663; Stanway v. Wyeth Canada Inc., 2010 BCSC 1497; Miller v. Merck Frost Canada, 2011 BCSC 1759, leave to appeal ref’d 2012 BCCA 137; Parker v. Pfizer Canada Inc., 2012 ONSC 1652; Charlton v. Abbott Laboratories, Ltd., 2013 BCSC 21.
[20] In Brown v. Janssen Inc., supra, and Dine v. Biomet Inc., supra, after reviewing the authorities from class action litigation across the country, Justice Belobaba made four legally substantive observations: (1) across the country, the jurisprudence on the issue of pre-certification motion disclosure of medical evidence is uneven ranging from production of medical records only in exceptional circumstances to comprehensive disclosure; (2) the scope of production is driven by the circumstances of the particular case and determining the scope of disclosure requires a degree of balancing so as to be fair to both parties; (3) Ontario courts employ the middle path of “a focused and limited production of medical records that are shown to be relevant to the issues on certification;” and, (4) the defendant has to explain why the medical records are relevant to the issues on certification for which some basis in fact is the evidentiary standard for class definition, commonality, preferable procedure, and qualification of the representative plaintiff.
[21] Justice Belobaba also made a legally non-substantive observation, which is that as a matter of practice, plaintiffs now frequently provide disclosure of some medical records, conceding their relevancy to the certification criterion, and, thus, typically, the issue to be determined on the defendant’s motion for production is whether additional disclosure should be made.
[22] I support Justice Belobaba’s initiative to bring some stability to this area of class action jurisprudence, and subject to one substantive qualification and one non-substantive observation, I agree with his legally substantive observations. My substantive observation, however, has the effect of qualifying the onus on the defendant to explain why additional medical records are relevant to the issues on certification.
[23] My additional substantive observation, which appears trite, but which is actually quite profound, is that although there is only one test for certification, set out in s. 5 of the Class Proceedings Act, 1992 and developed by the case law, class actions are not monolithic.
[24] It is obvious that a products liability class action about a pharmaceutical that has serious adverse side effects is not the same as a negligence class action about a train derailment and explosion that destroys the downtown of a municipality. It is perhaps not so obvious, but class actions within a genre of actions; for example, the product’s liability genre, are not monolithic. This trite-to-profound observation qualifies the onus on the defendant to provide an explanation; the qualification sometimes increases the obligation on the defendant to demonstrate the relevancy of medical records to the certification motion and sometimes it decreases the obligation.
[25] To use an example that I suggested during oral argument, in my opinion, if there had been a class action about thalidomide, then, in my opinion, in that action, the pleading that a drug designed to treat morning sickness had caused birth defects, would make the production of the plaintiff’s personal medical records unnecessary for the certification motion because the plaintiff’s evidence that his or her mother took the drug and that he or she was born with a birth defect would be sufficient to establish some basis in fact for the certification criterion. Similarly, in an infected food class action, causing healthy class members to become sick and unhealthy class members to become sicker, I cannot fathom what relevance the Plaintiffs’ medical records might have to the issues to be decided on certification. Conversely, to use the example of a class action now before the court about eighteen different surgical mesh devices designed for transvaginal surgeries to treat Pelvic Organ Prolapse and Stress Urinary Incontinence, in my opinion, it would be apparent from the pleadings that quite a bit of medical evidence from the plaintiff would be expected and it would not take much, if anything, from the defendant to explain why comprehensive medical records should be produced. See O’Brien v. Bard Canada Inc., 2015 ONSC 2470.
[26] I agree with my colleague that a certification motion is not the time for a determination of the merits of the plaintiff’s claim and that the evidentiary record for the certification motion should be focused on what is necessary for the certification motion, but to require in every case, the defendant to explain why the medical records are required could produce the unsalutary consequence of encouraging defendants to deliver expert evidence on the motion for production of additional medical records, which would exacerbate and not ameliorate the problem that Justice Belobaba is addressing in Brown v. Janssen Inc., supra, and Dine v. Biomet Inc., supra.
[27] I emphasize that class actions are not monolithic, because the relevance of the proposed representative plaintiff’s medical records on a certification motion will depend on the nature of the particular case being certified. For some class actions, medical records will obviously not be relevant at all or only relevant for individual issue’s trials. In other class actions, it will be readily apparent how much medical disclosure is required. In yet other cases, it will be unclear whether or not the defendant’s request for additional disclosure will be productive of anything. In this context, it is worth repeating what Justice Strathy, as he then was, said in Roveredo v. Bard Canada Inc., supra, at para. 9:
- It is not always easy to separate, prior to the certification hearing, where an examination of the “basis in fact” ends and an impermissible excursion into the merits begins. Nor is it always easy to say whether a particular piece of evidence, viewed in isolation, will assist the court in addressing the certification test. It is undesirable that representative plaintiffs be subjected to burdensome production motions and extensive cross-examinations on what is meant to be a procedural motion. On the other hand, the process must be fair and the defendant must be given a reasonable opportunity to respond to the plaintiff’s evidence. As well, the court cannot address certification in a vacuum. The apparent commonality of the issues and preferability of the procedure may appear obvious when looking at the pleadings or a limited record, but may become less obvious when a full and balanced record is available.
[28] Generally speaking, for products liability claims, there are four established categories and the need to produce or not produce medical records will be more or less obvious in the context of the particular case. First, manufacturers have a duty of care to consumers to see that there are no defects in manufacture that are likely to give rise to injury in the ordinary course of use: Donoghue v. Stevenson, 1932 (FOREP), [1932] A.C. 562 (H.L.). Second, manufacturers have a duty of care to warn consumers of dangers inherent in the use of the product of which the manufacturer has knowledge or ought to have knowledge: Hollis v. Dow Corning Corp., 1995 (SCC), [1995] 4 S.C.R. 634 at para. 20; Lambert v. Lastoplex Chemicals Co., 1971 (SCC), [1972] S.C.R. 569 at p. 574; Bow Valley Husky (Bermuda) Ltd. v. Saint John Shipbuilding Ltd., 1997 (SCC), [1997] 3 S.C.R. 1210. Third, manufacturers have a duty of care in designing the product to avoid safety risks and to make the product reasonably safe for its intended purposes: Ragoonanan v. Imperial Tobacco Canada Ltd. (2000), 2000 (ON SC), 51 O.R. (3d) 603 (S.C.J.); Rentway Canada Ltd. v. Laidlaw Transport Ltd., [1989] O.J. No. 786 (H.C.J.), aff'd [1994] O.J. No. 50 (C.A.). Fourth, there is a pure economic loss claim in negligence because manufacturers have a duty of care to compensate consumers for the cost of repairing a dangerous product that presents a real and substantial danger to the public: Winnipeg Condominium Corporation No. 36 v. Bird Construction Co. Ltd., 1995 (SCC), [1995] 1 S.C.R. 85.
[29] A plaintiff’s complete medical records would arguably not be necessary for the certification motion in a products liability case about an defectively packaged contraceptive, or about a meat product tainted by listeria, or about a medical device that was not properly sterilized or about a medical device like a blood sugar reader that did not work at all, although the medical records might be relevant at the individual issues stage of the class proceeding to determine whether individual harm had occurred. In contrast, the plaintiff’s complete medical records would arguably be necessary in a case about a design defect in a medical device like transvaginal mess or a case about the off label use of a drug.
[30] This brings me to my non-substantive observation, which is that the class action bar seems to already know what level of disclosure of medical evidence is required for the particularities of the class action before the court. My own experience in case managing class actions cases involving medical evidence is that the matter of what should be disclosed is rarely litigated and my role is limited to making sealing orders to preserve the privacy of the representative plaintiff’s medical history, which is a possible order in many but not all cases.
[31] In the case at bar, it appears to me that it is obvious just based on the pleadings that more medical evidence than evidence just to substantiate that Mr. Batten and Mrs. Hamilton had ingested Praxada was required and more extensive medical records are relevant to the certification criteria.
[32] As noted above, the Plaintiffs submit, however, that no further production should be ordered because Boehringer did not produce any evidence on this motion to explain why more than the minimal medical evidence already provided was inadequate. The Plaintiffs argue that the Defendant’s should not be allowed to explain relevancy at this stage and the production of further medical evidence should await the establishment of relevancy at the pre-certification motion cross-examinations.
[33] I disagree. To my mind, this prematurity argument just exacerbates the delay associated with the run up to a certification motion. In my opinion, if I were to dismiss Boehringer’s motion for further production for want of evidence of an explanation of relevancy, I would just be encouraging a procedural cottage industry where the motion for production would see defendants delivering expert’s opinions about why further production is necessary.
[34] To use the case at bar as an example, the Plaintiffs would have it that the current motion is premature with the result that I should dismiss the motion. Were I to agree, then what would inevitably follow is that Boehringer will deliver broad ranging unfocused expert evidence in its certification material, to be followed by pre-certification cross-examinations, to be followed by a request for medical evidence at those cross-examinations, to be followed by refusals at the cross-examinations, to be followed by a refusals motion, to be followed by the prospect of success on the refusals motion, to be followed by more cross-examinations, to be followed by the delivery of more focused expert reports by both parties, to be followed by a further round of cross-examinations on the more focused expert’s reports, to be followed by more refusals motions, to be followed by the procedural nausea known in the trade as motion sickness, which sometimes has the nasty morbidity of leave motions and appeals to the Divisional Court and the Court of Appeal, which just further delay the glacially slow march to the certification hearing.
[35] In my opinion, to repeat my conclusion above, it is obvious from argument based on the pleadings that more than medical evidence to confirm that Mr. Mr. Batten and Mrs. Hamilton had ingested Praxada is required in the case at bar and more extensive medical records are relevant to the certification criteria.
D. CONCLUSION
[36] For the above reasons, I grant Boehringer’s motion and I order that the medical records be produced within 60 days. If Mr. Batten’s and the late Mrs. Hamilton’s medical practitioners are not co-operative, I will entertain a motion under rule 30.10 (Production from Non-Parties with Leave) and I will in any event entertain a motion for a sealing order. A case conference is necessary to reschedule the timetable for the certification motion.
[37] If the parties cannot agree about the matter of costs, they may make submissions in writing beginning with Boehringer’s submissions within 20 days of the release of these Reasons for Decision, followed by the Plaintiffs’ submissions within a further 20 days. As it may assist the parties, my current inclination is to award costs to Boehringer payable in any event of the cause but not forthwith.
Perell, J.
Released: December 15, 2015
COURT FILE NO.: CV-13-475701CP
DATE: 20151215
ONTARIO
SUPERIOR COURT OF JUSTICE
BETWEEN:
ALBERT C. BATTEN and THE ESTATE OF MARGARET JANE HAMILTON, on behalf of her Estate Representative Wendy Nelson, and WENDY NELSON, personally
Plaintiffs
– and –
BOEHRINGER INGELHEIM (CANADA) LTD., BOEHRINGER INGELHEIM PHARMACEUTICALS, INC., BOEHRINGER INGELHEIM PHARMA GMBH & CO KG, and BOEHRINGER INGELHEIM INTERNATIONAL GMBH
Defendants
REASONS FOR DECISION
PERELL J.
Released: December 15, 2015