Dine v. Biomet, 2015 ONSC 1911

CITATION: Dine v. Biomet, 2015 ONSC 1911

COURT FILE NO.: CV-13-490112-CP

DATE: 20150415

SUPERIOR COURT OF JUSTICE - ONTARIO

RE: Steven Dalton Dine, Plaintiff / Responding Party

AND:

Biomet Inc., Biomet Orthopedics LLC, Biomet Manufacturing Corp., Biomet US Reconstruction LLC and Biomet Canada Inc., Defendants / Moving Parties

BEFORE: Justice Edward P. Belobaba

COUNSEL: Kent Thomson, Derek Ricci and Kristin Jeffery for the Defendants

Jonathan Ptak, Doug Lennox and Garth Myers for the Plaintiff

HEARD: March 20, 2015

Proceedings under the Class Proceedings Act, 1992

production of Medical records before certification

[1] This is the second time in less than a month that I have been asked to decide the extent to which medical records in a class action product liability case should be produced before certification.

[2] The first was Brown v Janssen,[^1] a pharmaceutical case. I concluded that the plaintiff was required to produce only those records that were shown to be relevant to the issues on the certification motion. In this case, involving metal-on-metal hip implants, I have (not surprisingly) come to the same conclusion. But in doing so, I have had to review again the same parade of cross-country case law that seems to be presented by counsel on every motion for the pre-certification production of medical records.

[3] I am not blaming the lawyers - the jurisprudence in this area, at least in the common law provinces, remains uneven and the judicial language is wide-ranging. Lawyers continue to pick and choose whichever case excerpt seems appropriate. And judges continue to review these cases and make their rulings, each time it seems, from scratch – a practice that only Sisyphus would appreciate.

[4] It is time to formulate a clear rule. Or, putting it less ambitiously, to restate what most Ontario judges already accept as the current rule, but in words that are plain and to the point and without unnecessary dicta.

Towards a clear rule

[5] I begin with the context. I am only concerned with the production motion that requests medical records before certification and before any cross-examination of the proposed representative plaintiff. As I noted in Brown v. Janssen, class counsel are becoming increasingly amenable to a limited pre-certification production of medical records that provide some basis in fact for the s. 5(1)(b), (c), (d) or (e) requirements[^2] - for two reasons:

[O]ne, they know that undocumented medical assertions contained in an affidavit will probably not clear the “some evidence” hurdle; and two, they know their affiants will be asked about and will be required to produce these records on cross-examination. Better and more efficient to produce them now, provided of course that the productions are properly limited to the certification requirements and do not stray unduly into the merits of the claims.[^3]

[6] Thus, in many cases, the plaintiff will attach supporting medical documentation in the affidavit to help clear the “some basis in fact” hurdle – for example, medical record evidence that the impugned drug or medical device was prescribed, ingested or installed, or expert opinion evidence about the product’s “defects” to help establish general causation and commonality. The dispute in most class action/medical record motions is no longer about the complete absence of any medical documentation (as was the case in Caputo v. Imperial Tobacco[^4]) but about the plaintiff’s obligation to produce additional medical documentation.

[7] As I noted in Brown v Janssen,[^5] the case law in the common law provinces relating to the production of (additional) medical records prior to certification is, to say the least, uneven. The decisions appear to fall into three broad categories: production rarely allowed and only in “exceptional circumstances”;[^6] production routinely and generously allowed in order “to ensure a comprehensive record” for the certification motion;[^7] and (somewhere in the middle) a focused and limited production of medical records that are shown to be relevant to the issues on certification.[^8]

[8] In my view, Ontario judges have taken the “middle” path: a focused and limited production of medical records that are shown to be relevant to the issues on certification. When one reviews the Ontario decisions directly on point - Anderson,[^9] Roveredo,[^10] and Brown[^11] - one finds that the primary concern of the motions judge in each case was whether the requested medical records were relevant to the issues on the certification motion.[^12] In Roveredo, the judge was satisfied that a level of relevance had been established;[^13] in Anderson and Brown, the judge found otherwise and denied the request for any medical records (Anderson) or for any additional records (Brown).

[9] There is no doubt, as Strathy J. noted in Roveredo, that each decision “is driven by the circumstances of the particular case and requires a degree of balancing, so as to be fair to both parties.”[^14] But there is also no doubt that the primary determinant of the court’s decision whether the additional medical records should be produced is whether the defendant has shown to the court’s satisfaction that these additional productions are in some way relevant to the issues on certification, i.e. to one or more of ss. 5(1)(b), (c), (d) or (e) of the CPA. It is not enough, as I noted in Brown, for the defendant to simply assert, for example, that the medical records “may be relevant” to certification. The defendant has to explain how - “some measure of explanation is needed.”[^15] Something more than bald assertions.

[10] The current Ontario rule is that the production of medical records (or indeed any documentary production) will only be ordered pre-certification if the defendant can show that the documentation is relevant to one or more of the issues on certification. In my view, the Ontario rule reflects the Rules of Civil Procedure that make clear that “relevance” is the “key determinant”[^16] in the production of documents both at the cross-examination and discovery stages.[^17] It also reinforces two essential themes in class action legislation and case law.

[11] First, that the certification motion is a procedural motion that has nothing to do with the merits of the proceeding.[^18] There is therefore little room for individualized evidence, which in excess may result in unnecessary confusion and misdirection. This point has been noted repeatedly in the context of medical records by courts from Newfoundland to British Columbia:

The medical records of the plaintiffs are clearly relevant to the merits of their individual claims but, as noted above, the certification stage is not meant to determine the merits of the action. Indeed the Court must be vigilant to ensure that the certification application does not become mired down in the merits of an individual claim.[^19]

[T]he introduction of individual medical records at this stage would be more likely to improperly confuse the issues on the certification action with a premature consideration of the merits of an individual claim.[^20]

[12] Secondly, that the class action is designed to proceed in stages - certification; the common issues trial; the individual assessments[^21] - and the nature and focus of permitted discovery at each stage should vary accordingly. If, as a general rule, discovery before the common issues trial is limited to the common issues, and discovery of individual class members is only allowed once the common issues are resolved,[^22] then it must follow that “pre-discovery discovery” before certification must be limited to the issues on certification. Otherwise, the intended legislative design is turned on its head.

[13] The judicial discretion to control the discovery process[^23] is particularly important in a class proceeding “where the size of unrestricted discovery and production may have the effect of extending the action for years and increasing the costs astronomically.”[^24] If the class action is to remain viable as a vehicle for improved access to justice, it cannot be front end-loaded at the certification stage with evidence that is unnecessary and irrelevant.

[14] Thus the Ontario rule – that the defendant must satisfy the court that the additional medical records are relevant to the issues on the certification motion – coupled with the court’s inherent discretion to control discovery and its wide-ranging power under s. 12 of the CPA (to make any order it considers appropriate to ensure that the class action proceeds fairly and expeditiously) provides the court with all that it needs to ensure both relevance and fairness. Of course, in the vast majority of pre-certification production motions, requiring the moving party to demonstrate relevance will hardly ever be unfair, to either side.

[15] In my view, the Ontario rule that allows pre-certification production of medical records only if they are shown to be relevant to the issues on certification best achieves the objectives of the Class Proceedings Act as interpreted in the established jurisprudence.[^25]

[16] Turning now to the defendant’s motion and why its request for additional medical records, except in one instance, must be dismissed.

Background

[17] The plaintiff, Stephen Dine, had three hip replacements, the first two using the defendants’ metal-on-metal hip implants. For ease of reference, I will refer to the defendant companies as “the defendant” or “Biomet.” Mr. Dine says that these metal-on-metal implants were defectively designed and manufactured and that Biomet failed to provide adequate warning. Mr. Dine has commenced this multi-million dollar class action on behalf of all persons who were implanted in Canada with Biomet metal-on-metal hip products.

[18] Biomet, a multinational medical device company that manufactures and distributes the impugned hip implants, has delivered a statement of defence denying all of the allegations. Biomet says that unlike previous metal-on-metal hip implant class actions against other manufacturers, the Biomet hip implants at issue in this proceeding have been scrutinized by Health Canada and have never been the subject of a recall in Canada, voluntary or otherwise. Moreover, says Biomet, the worldwide clinical data that was available in respect of these devices at the time Dine commenced this proceeding made clear that the devices in question were reasonably safe and effective for their intended uses.

[19] The plaintiff has filed six affidavits, including his personal affidavit describing his experiences with the defendant’s metal-on-metal hip implants. Attached to this personal affidavit are six pages of medical records that were generated at the time of his third surgery that also include a brief synopsis of the first two surgeries and the plaintiff’s experience with the implants that were installed.

[20] The plaintiff has also filed an affidavit from Dr. Stephen Graves, an expert on metal-on-metal hip implants and the Director of the Australian Orthopaedic Association National Joint Registry. In his 85-page report, Dr. Graves concludes that there are “safety concerns” with the defendant’s metal on metal hip implant devices that relate to the “higher than anticipated rate of revision,” that this higher rate of revision surgery is “unacceptable” and that “there are better alternatives.”

[21] Recently, in response to a request from the defendant, the plaintiff has provided some additional medical information, specifically the product code labels for the Biomet hip implant components that were allegedly used in the plaintiff’s first and second hip surgeries. The product labels show the lot numbers and the references numbers of the Biomet implants and refer to “Recap resurfacing” and a “Magnum Modular Head” which are acknowledged to be Biomet brand names.

[22] This is obviously not a case like Caputo.[^26] Some medical records and related evidence have been provided. The defendant, however, requests further production. The actual four-part request is set out in the Appendix. Put simply, the defendant asks for all of the plaintiff’s medical records that relate in any way to the condition of his hips before the surgeries; the three hip implant surgeries, including all operative and post operative notes; any blood or urine tests for cobalt and chromium; and any medical notes about pain, lack of mobility or other injuries allegedly caused by the implants.

[23] The certification motion is scheduled to proceed in September of this year. The defendant has filed a motion for summary judgment asking that the (individual) action be dismissed in its entirety. The defendant submits that the proposed motion for summary judgment on its own justifies the production of all of the requested additional medical records. I do not agree. At this point all that is before the court is a putative class action. If certification is denied, it will be up to the plaintiff to ask that the action be continued as an individual action under s. 7 of the CPA. This may or may not happen. At this point, there is no individual action to which the motion for summary judgment can attach. The submission that the plaintiff is obliged to produce medical records with regard to an individual action that does not yet exist is wrong-headed and, at the very least, premature. In short, the fact that the defendant intends to bring a motion for summary judgment shortly after the certification motion has no bearing on the analysis herein.

Analysis

[24] Has the defendant shown that the additional medical documentation, namely all of the plaintiff’s medical records relating to his hips, his hip surgeries, and their outcomes and consequences, are relevant to the issues on certification? There are five issues on certification as set out in s. 5(1)(a) to (e) of the CPA. The first, cause of action, does not require or invite any evidence. The remaining four – an identifiable class of two or more persons; common issues; preferable procedure; and a suitable representative plaintiff – require “some basis in fact,”[^27] that is, some evidentiary basis.

[25] In my view, bald assertions aside, the defendant has not shown how or why these additional medical records will assist the court or are in any way relevant to the first three of the four issues just noted. The defendant’s request for the production of medical records as set out in the Appendix is too broad and is impermissibly directed towards the merits of Mr. Dine’s individual claim.

[26] However, the defendant has explained how some of the additional medical record evidence may be relevant to the fourth issue, the suitability of Mr. Dine as the representative plaintiff. I will discuss each of these points in turn.

[27] Section 5(1)(b). There is no dispute about the fact that this proposed class action has an identifiable class of two or more persons. It is clear from the material before me, including the analysis of Dr. Graves and the defendant’s reference to “world-wide data” that the defendant sold dozens if not hundreds of the impugned hip implants in Canada and there is not suggestion to the contrary. In any event, Mr. Dine’s medical records and his individualized experience would add nothing to the discussion about “identifiable class” and here again there is no suggestion to the contrary. The adequacy or suitability of Mr. Dine as a representative plaintiff is more properly considered under s. 5(1)(e). In short, the additional medical records have not been shown to be in any way relevant to the s. 5(1)(b) issue.

[28] Section 5(1)(c). The plaintiff asks that seven issues be certified as common issues: whether the defendant owed and breached a duty of care; the availability of aggregate damages; the class member’s entitlement to monitoring costs; the defendant’s obligation to implement and fund a medical monitoring regime; and the availability of punitive damages.

[29] The case law is clear that the plaintiff must provide some evidence of the existence of the common issue and that the common issue will advance the litigation.[^28] The defendant has not indicated how or why the plaintiff’s individualized medical records will assist the court or be otherwise relevant in the adjudication of any of the seven proposed common issues. The plaintiff will no doubt rely on Dr. Graves’ expert report to provide some evidence for the existence and commonality of the duty of care issues. The plaintiff’s medical experience as an individual recipient of the impugned products – beyond the evidence that is already before the court - will not add anything to this discussion. There is also no suggestion that the court’s determination of the remaining common issues (aggregate damages, monitoring costs, monitoring regime or the availability of punitive damages - all of which have a class-wide basis) will be assisted in any way by the production and review of Mr. Dine’s personal medical file.

[30] In short, the additional medical records have not been shown to be relevant to the s. 5(1)(c) issue.

[31] Section 5(1)(d). In Roveredo, Strathy J. ordered that additional medical records be produced because he was persuaded that the records may be “particularly relevant to the preferability analysis” in that “they may assist the court in determining whether … a class action is preferable to individual actions.” Here, however, the defendant has not explained how the additional medical records would help the defendant show that individual lawsuits would be preferable to a class proceeding.

[32] The proposition advanced by the defendant, that causation and damages will require individual trials or assessments (after the common issues trial) is not disputed by the plaintiff. And the proposition that common issues such as breach of a duty of care will advance the litigation has not been challenged by the defendant. In any event, the defendant has not explained how the latter proposition could even be challenged simply by gaining access to one individual’s additional medical records. This is not a case like Crisante v DePuy[^29] where there was a known number of class members that had revision surgeries (about 30 to 40 individuals) and the defendant could therefore plausibly argue that case-managed individual trials were preferable to a class proceeding. Here there is no such information. And it certainly will not be found in Mr. Dine’s personal medical records. In short, the additional medical records being sought herein have not been shown to be in any way relevant to the s. 5(1)(d) issue.

[33] Section 5(1)(e). This is the only issue where the defendant has provided more than just bald assertions. The defendant questions whether Mr. Dine is even a member of the class that he purports to represent, i.e. that he himself was implanted with Biomet products. The defendant’s request for the entire hip-related medical file is much too broad. But a more focused request for additional information identifying the actual hip implants would certainly be relevant to the s. 5(1)(e) issue.

[34] Even though the plaintiff recently provided some product code labels, the defendant submits that it is still unable to confirm that these product code labels relate to Mr. Dine's actual surgeries. At the hearing of this motion, counsel for the plaintiff offered to produce the front pages of the operating notes that in his view would provide the necessary correlation.

[35] I am satisfied that with respect to s. 5(1)(e) and the suitable representative issue, the defendant has shown why additional medical information about the products actually implanted during the plaintiff’s hip surgeries is relevant to this issue. I therefore direct the plaintiff to provide additional medical information (if it has not yet been provided) that describes the specific products that were actually implanted during the plaintiff’s hip surgeries. If there are any disputes in this regard, the parties may advise me by e-mail and arrange an attendance before me at their convenience.

Disposition

[36] The defendant’s motion for the production of the additional medical records as described in the Appendix is dismissed as too broad and not justified. But this dismissal is without prejudice to the defendant’s right to pursue these records again on cross-examination. If they are refused and if the defendant can show they are indeed relevant to certification, I will be pleased to revisit the matter on a proper refusals motion. At this point, however, the defendant has not shown that the medical records as broadly described in Appendix are in any way relevant to the issues on certification.

[37] However, the defendant has shown that some additional medical information that is focused solely on identifying or describing the Biomet products that were implanted during the three hip surgeries is relevant to the s. 5(1)(e) issue. These additional documents shall be produced as described above in para. 35.

[38] If costs cannot be resolved, the plaintiff should forward a brief costs submission within 10 days and the defendant within 10 days thereafter.

Belobaba J.

Date: April 15, 2015

[Appendix attached.]

Appendix: The Medical Records Request

“Biomet seeks production of the records and reports set out below, or the execution by Dine of an appropriate consent and authorization that will permit Biomet to obtain the records and reports set out below:

• All records and reports from any physician, surgeon or other healthcare provider relevant to the diagnosis, prognosis, treatment, care or management of Dine's complaints, symptoms, conditions, defects or injuries to or affecting his hips;
• All records and reports from any physician, surgeon or other healthcare provider relevant to surgeries performed on Dine's hip or hips, including without limitation the hip surgeries performed on or about May 31, 2006, March 3, 2008 and March 15, 2013. The records and reports should include, among others: (i) complete copies of pre-operative, operative and post-operative records and reports; (ii) records and reports pertaining to the reasons for such surgeries; (iii) radiographic images of Dine's hips or hip implants; (iv) post-operative analysis of Dine's hips, hip implants or hip explants; and (iv) records and reports pertaining to any post-operative instructions or treatment provided to Dine;
• All records and reports from any physician, surgeon or other healthcare provider relevant to the levels of cobalt or chromium in Dine's blood or urine, including all records and reports relevant to any complaint, symptom, condition, defect or injury, or any treatment therefor, affecting the level of cobalt or chromium in Dine's blood or urine; and
• All records and reports from any physician, surgeon or other healthcare provider relevant to Dine's pain, lack of mobility and other injuries or harm allegedly caused by his Biomet implants, including records and reports of any treatment therefor such as records and reports relevant to medications taken, given or used by Dine.

For the sake of clarity, "the records and reports" referred to above include any "documents", as defined in Rule 30.01 of the Rules of Civil Procedure.”

[^1]: Brown v. Janssen, 2015 ONSC 1434. [^2]: I am of course referring to the subsections in the Class Proceedings Act, 1992, S.O. 1992, c. 6 (“CPA”). [^3]: Supra, note 1, at para. 8. [^4]: Caputo v. Imperial Tobacco Ltd., 1997 12162 (ON SC), [1997] O.J. No. 2576 (Gen.Div.) [^5]: Supra, note 1, at para. 3. [^6]: See, for example, Bartram v. Glaxosmithkline Inc., 2011 BCCA 539 or Jones v. Zimmer GmbH, 2010 BCSC 1504. [^7]: See, for example, Schroeder v. DJO Canada Inc., 2009 SKQB 169 at para. 58. [^8]: See, for example, Roveredo v. Bard Canada Inc., 2010 ONSC 5240 or Sweetland v. Glaxosmithkline Inc., 2014 NSSC 216. [^9]: Anderson v. Wilson, [1996] O.J. No. 4827 (Gen. Div.) [^10]: Supra, note 8. [^11]: Supra, note 1. [^12]: Anderson, supra, note 9, at para. 8; Roveredo, supra, note 8, at para. 10; and Brown, supra, note 1, at paras. 3-4. This court’s decisions in Pearson v Inco Ltd., [2002] O.J. No. 1842 (S.C.J.) and Parker v Pfizer Canada, 2012 ONSC 1652 deal with refusals at the cross-examination to produce any additional medical information and thus, strictly speaking, are not like the cases just listed (which deal with requests to produce medical records well before any such cross-examinations.) The rule relating to the refusal to answer questions or produce any further documentation at the actual cross-examination is not in dispute: the information must be relevant and proportionate to the needs of the certification motion – see Parker v. Pfizer, at paras. 23, 24 and 30. One would think, therefore, that the rule relating to the production of medical record information before the actual cross-examination takes place should be the same. [^13]: Supra, note 8, at para. 10. [^14]: Ibid., at para. 10. [^15]: Brown, supra, note 1, at para. 12. Also see Perell J. in Mask v. Silvercorp Metals Inc., 2014 ONSC 4647 (Div.Ct) at para. 16 regarding the need to file evidence “to explain the relevance of, or necessity of” the requested documents. [^16]: Perell and Morden, The Law of Civil Procedure in Ontario, (2010) at 474. [^17]: See, for example, Rules 30.02 and 30.03 and their discussion in Perell and Morden, supra, note 16, at 471 to 478. [^18]: Hollick v Toronto (City), 2001 SCC 68, [2001] 3 S.C.R. 158, at para. 16: “The certification stage is decidedly not meant to be a test of the merits of the action …Any inquiry into the merits of the action will not be relevant on a motion for certification.” [^19]: Pardy v. Bayer Inc., [2003] N.J. No. 210 (T.D.) at para 48. [^20]: Bartram (Guardian ad litem of) v. Glaxosmithkline Inc., 2011 BSCC 1174 at para. 21; leave to appeal denied, 2011 BCCA 539. [^21]: See, for example, s.11 of the CPA. [^22]: Winkler, Perell, Kalajdzic and Warner, The Law of Class Actions in Canada, (2014) at 192. Also see the discussion in Trillium v. General Motors of Canada, 2012 ONSC 5960, at paras. 15-18. [^23]: Ibid., at 193. [^24]: Ibid., at 193. [^25]: In its reply factum, the defendant tried to argue that given the law of cross-examination as summarized in Ontario v. Rothmans, 2011 ONSC 2504 at para. 143, it is entitled to cross-examine on any matter put in issue by the plaintiff in his affidavit, "even if it is irrelevant and immaterial to the motion before the Court.” Because the plaintiff described his hip surgeries and related problems in his affidavit, the defendant says he put his medical condition in issue and therefore it has the right to obtain production of his medical records even if they are irrelevant to the issues on the certification motion. This submission, in my view, is a non-starter. If accepted, it would completely undermine the so-called Ontario rule discussed herein and subvert both the design of the CPA and years of jurisprudence about the scope and content of the certification motion.

Fortunately, in the context of class proceedings and certification motions, no case has gone this far. Ontario v Rothmans was not a class proceeding and the refusals motion that prompted the court’s survey and summary of the law of cross-examination was not concerned with an upcoming certification motion. In Parker v. Pfizer Canada Inc., [2012 ONSC 1652](https://www.minicounsel.ca/scj/2012/1652), Perell J. suggested that Ontario v Rothmans could apply to certification motions (at para. 23) but went on to accept “the general rule” that documentary production should be restricted “to what is necessary to inform the certification process” (at para. 24) and confined “to those issues on the motion for certification on which the plaintiffs may have relevant evidence to assist the court” (at para. 26). In short, in Parker, Justice Perell applied the Ontario rule discussed herein.

The decision of Master MacLeod in Caputo v. Imperial Oil, [2002] O.J. No. 3767, a refusals motion relating to a pending certification, also does not assist the defendant. The Master did say that “If you put it [into the affidavit] you admit its relevance and can be cross-examined on it” but then added “at least within the four corners of the affidavit” (at para. 14). Nothing about compelling the production of additional documentation.

In sum, in the context of a certification motion, no court has ever decided that ‘if you put it into the affidavit, you can not only be cross-examined on it, you can also be compelled to produce additional documentation even if the requested documentation is irrelevant to certification.” It bears repeating that any such decision would completely undermine the design of the CPA and years of jurisprudence about the scope and content of the certification motion. The defendant’s submission does not succeed.

[^26]: Supra, note 4. [^27]: Hollick v. Toronto, 2001 SCC 68, [2001] 3 S.C.R. 158, at para. 25. [^28]: Baroch v Canada Cartage, 2015 ONSC 40 and the case law discussed at paras. 22-23. [^29]: Crisante v DePuy Orthopaedics, 2013 ONSC 5186.