Brown v. Janssen Inc., 2015 ONSC 1434

COURT FILE NO.: 06-CV-321585CP

DATE: 20150310

SUPERIOR COURT OF JUSTICE - ONTARIO

RE: NICHOLAS BROWN, MANJIT GAINDA, SABJIT GAINDA, SANDEEP SINGH GAINDA, PAMINDER KAUR GAINDA, KULDEEP CHANDAN GAINDA, and JOANNE VAUTIER, Plaintiffs / Responding Parties

AND:

JANSSEN INC., JANSSEN PHARMACEUTICALS, INC., JANSSEN ORTHO LLC, JOHNSON & JOHNSON and JOHNSON & JOHNSON INC. Defendants / Moving Parties

BEFORE: Justice Edward P. Belobaba

COUNSEL: Gordon McKee and Max Shapiro for the Defendants / Moving Parties

Bryan McPhadden and Idan Erez for the Plaintiffs / Responding Parties

HEARD: February 27, 2015

Proceedings under the Class Proceedings Act, 1992

production of medical records before certification

[1] In this proposed class action, the plaintiffs allege that the defendants’ anti-psychotic drugs, Risperdal and Invega, caused a condition called gynecomastia or male breast growth. The plaintiffs also allege that the defendants failed to warn them about the risks of this possible side-effect. The plaintiffs have filed a certification record that includes five affidavits that describe the experience of the affiant or that of a family member. The certification motion has not yet been scheduled.

[2] The defendant refers to the five affidavits and moves for the production of:

(i) all records of physician(s) who prescribed Risperdal or Invega;

(ii) all records of physician(s) who diagnosed and/or treated for gynecomastia; and

(iii) pharmacy records and other records that indicate whether the five individuals were prescribed brand-name Risperdal or Invega, or a generic version of the drugs.

[3] The case law in the common law provinces relating to the production of 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”;[1] production routinely and generously allowed in order “to ensure a comprehensive record” for the certification motion;[2] and (somewhere in the middle) a focused and limited production of medical records that are shown to be relevant to the issues on certification.[3]

[4] All of the decisions agree that if production is ordered, only the medical records that have some bearing on the issues on certification must be produced. No court has ever required the plaintiff to produce his or her entire medical file. This would obviously be an egregious violation of one’s privacy.

[5] The defendant’s motion for the production of “all records” of the physician(s) who prescribed the Risperdal or Invega, or who diagnosed or treated for gynecosmastia is therefore a non-starter. If, for example, the plaintiff’s family doctor prescribed the impugned medication, the defendant would arguably be entitled to those pages or extracts in the medical file that describe or relate to such prescriptions – but not the patient’s entire medical file.

[6] To his credit, counsel for the defendant was quick to reassure both the court and the plaintiffs at the hearing of the motion that the entire medical file was not being sought. Only the portions that dealt with the actual prescriptions and the diagnoses and treatments or noted any discussions about risks or warnings. However, given the “all records” language in the Notice of Motion, counsel for the plaintiffs understandably devoted much of his factum responding to the literal (and untenable) “all records” request.

[7] In any event, counsel for the plaintiffs made clear during the course of the hearing that he was prepared to produce medical records relating to:

(i) the prescription and ingestion of Risperdal or Invega or any generic equivalent;

(ii) the development of gynecomastia;

(iii) any discussions about related risks or warnings; and

(iv) any related surgeries.[4]

[8] The reason why class counsel are increasingly amenable to the pre-certification production of medical records that help provide some basis in fact for the s. 5(1)(b), (c), (d) or (e) requirements[5] is two-fold: one, 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.

[9] This is not a case like Caputo[6] where the court concluded that the evidentiary record was inadequate. Here, the five affidavits combined with the four categories of medical records proposed by the plaintiff and the inevitable evidence on the upcoming cross-examinations will potentially provide a sufficient foundation for the certification motion. And if the plaintiffs fall short, one could say, that is their risk to take.

[10] The defendant, however, is pressing for additional medical record information – namely, records relating to the diagnosis and treatment of gynecomastia. The production of medical records relating only to “the development of gynecomastia” (as per category (ii) above) is not enough, says the defendant. The defendant submits that the records of the physician(s) who diagnosed and treated the condition “will show if the affiant had pre-existing conditions or other causes of any relevant condition” and are relevant to an assessment of “the relationship between individual and proposed common causation questions” and “whether there are in fact common issues.” The defendant also argues that this evidence “will be particularly relevant to the preferability analysis and will assist in determining whether the resolution of the [proposed common issues] would sufficiently advance the claims of the proposed class to warrant a finding that a class action is preferable to other alternatives.”

[11] Let me consider each of these points in turn. First, the submission about pre-existing conditions or causes. It appears to be beyond dispute that the plaintiff has provided some basis in fact supporting ‘general causation’ – namely, the warnings in the patient-directed portions of the Risperdal and Invega product monographs that refer specifically to male breast enlargement.[7] Therefore, the defendant’s submission about pre-existing conditions or “other causes” of gynecomastia seems be concerned with individual or specific causation, which will be the subject of individual trials after the certified common issues (if indeed this action is certified) are decided. Therefore the first submission does not succeed. Individual causation is not relevant to certification.

[12] The second submission - that this additional evidence may be relevant to an assessment of the relationship between “individual and proposed common issues” or “whether there are in fact common issues” - is valid but much too vague. If the defendant wants this court to order the production of additional medical record evidence because it “may be relevant” to a certification issue, it has to explain how. It cannot simply rely on the bald assertion that the additional evidence “may be relevant.” The same criticism can be levelled at the third submission that the additional evidence would be “relevant to the preferability analysis.” Maybe so. But some measure of explanation is needed.[8]

[13] In Roveredo,[9] Strathy J. considered the defendant’s submissions and was persuaded on the material before him that the additional medical records requested by the defendant:

[m]ay be relevant to the commonality analysis under s. 5(1)(c) of the C.P.A. and may be particularly relevant to the preferability analysis under s. 5(1)(d) – they may assist the court in determining whether, viewed in the entire context of the case, the resolution of the common issues will sufficiently advance the claims of the class to warrant a finding that a class action is preferable to individual actions.[10]

[14] I am not so persuaded on the material before me, for the reasons just stated. Each case, of course, is different. As Strathy J. noted in Roveredo, “… the decision is driven by the circumstances of the particular case and requires a degree of balancing, so as to be fair to both parties.”[11]

Disposition

[15] Therefore, on the facts of this particular case and in fairness to both sides, I confirm the plaintiffs’ offer to produce medical records limited to the four proposed categories and I dismiss the defendant’s request for the additional medical records. But I do so without prejudice to the defendant’s right to pursue these records again on cross-examination. If they are refused and if the defendant can provide some explanation for the request (i.e. more than a bald assertion) and persuade me that the refusal is unjustified, I will be pleased to revisit my decision at that time.

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

Date: March 10,2015 Belobaba J.

[1] See for example, Bartram v. Glaxosmithkline Inc., 2011 BCCA 539 or Jones v. Zimmer GmbH, 2010 BCSC 1504.

[2] See for example, Schroeder v. DJO Canada Inc., 2009 SKQB 169 at para. 58.

[3] See for example, Roveredo v. Bard Canada Inc., 2010 ONSC 5240 or Sweetland v.Glaxosmithkline Inc., 2014 NSSC 216.

[4]The plaintiff has already produced medical record pages or page-extracts dealing with categories (i). (ii) and (iv). The plaintiff is prepared to do the same regarding the “risks and warning” discussions in category (iii).

[5] I am of course referring to the subsections in the Class Proceedings Act, 1992, S.O. 1992, c. 6.

[6] Caputo v. Imperial Tobacco Ltd., [1997] O.J. No. 2567 (Ont. Ct. Gen. Div.)

[7] The defendant did itself no favour and may have lost some credibility when it tried to argue that the product warnings did not provide even “some evidence” of general causation (for certification purposes) because the warnings intended to differentiate between side-effects that “may be caused” by the medication and those that “may be experienced” because of the medication. In my view, the warnings (as set out below, with emphasis added) draw no such distinction:

RISPERDAL® can raise your levels of a hormone called "prolactin" (measured with a blood test). In women, medicines of this type may cause changes in the regularity of their monthly period, breast discomfort, or leakage of milk from the breast even if they are not pregnant. In some men, there may be difficulty in getting or maintaining erections, or other sexual dysfunction and breast enlargement may be experienced.

INVEGA® can raise your levels of a hormone called “prolactin” (measured with a blood test). Women may experience leakage of fluid or milk from the breast even if they are not pregnant, breast discomfort, or missed or irregular periods. Men may experience breast swelling/enlargement or difficulty getting or maintaining an erection or other sexual dysfunction.

[8] The defendant argues in its factum (by simply tracking the language in Roveredo at para. 10) that, “The records sought will be particularly relevant to the preferability analysis and will assist in determining whether the resolution of any [proposed common issues] would sufficiently advance the claims of the proposed class to warrant a finding that a class action is preferable to other alternatives.” This is an assertion that could be made in virtually any case. In my view, both the plaintiffs and the court are entitled to some measure of explanation based on the particular facts of this case.

[9] Supra, note 3.

[10] Ibid., at para. 10

[11] Ibid., at para. 10.