What Constitutes a Plaintiff’s “Relevant” Medical Records at the Pre-Authorization Stage of a Class Action Instituted Against Pharmaceutical Companies?

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Authors: Margo R. Siminovitch and Betlehem L. Endale

Publication ǀ March 26, 2021

On February 16, 2021, in the context of a class action proceeding brought by the firms Fishman Flanz Meland Paquin and Trudel Johnston & Lespérance on behalf of a plaintiff, the Honourable Gary D.D. Morrison, J.S.C. rendered a decision limiting the extent to which a plaintiff must disclose their medical records at the pre-authorization stage in cases involving pharmaceutical companies.[1]

BACKGROUND

The opioid crisis in Canada has been caused in part by the use of prescription opioids.[2]

In 2019, an application for authorization of a class action was brought in the Superior Court of Quebec against 34 pharmaceutical companies that are alleged to have manufactured, marketed, distributed and/or sold opioids to Quebec residents. It is alleged, inter alia, that these companies misrepresented to healthcare professionals and the public the safety and efficacy of their opioid products and failed to provide adequate warnings of the serious harms associated with opioid use.

The class that the plaintiff seeks to represent includes all residents of Quebec who were prescribed and consumed opioids during the period from 1996 to the present and who suffered from, or are suffering from, opioid use disorder (“OUD”).

No exhibits were filed in support of plaintiff’s allegations with respect to his personal history relating to the use of prescription opioids but the plaintiff’s RAMQ record and his medical records for the days he spent at an in-hospital treatment program were communicated to the defendants. By joint application to the Court, the defendants sought to obtain additional medical records arguing that: (1) the plaintiff’s opioid use is the foundation of the class action he is seeking to have authorized; (2) the plaintiff’s allegations were “bald, vague and imprecise”; (3) the defendants needed to know the specific opioids used by the plaintiff and when such drugs were used; (4) contradictions between the plaintiff’s allegations and the information in his medical records might be revealed; and (5) the information was required to satisfy the defendants’ right to a full answer and defence.

THE LEGAL PRINCIPLES

Pursuant to article 574 para. 3 of the Code of Civil Procedure (the “CCP”), the evidence that may be filed at the pre-authorization of a class action is limited to that which is “relevant” (the word “appropriée” is employed in the French text). As stated by the Court of Appeal in Agostino,[3] in applying this provision, the judge must follow a “narrow corridor” (couloir étroit) between rigidity and permissiveness in deciding whether to allow additional evidence to be filed at the pre-authorization stage of a class action – exercising a caution that is consistent with the summary nature of the authorization stage of class actions. Recently, in Asselin, the Court of Appeal reaffirmed that only additional evidence that is necessary and indispensable to the authorization stage should be allowed.[4] At this pre-authorization stage, “the judge’s role is to filter out frivolous claims, and nothing more.[5]

In considering whether additional evidence should be filed at the authorization stage, the court must assess whether the plaintiff’s allegations are sufficient to demonstrate an arguable case. Justice Brown of the Supreme Court of Canada explained what is meant by the sufficiency of factual allegations at the authorization stage, stating that it is possible for the evidence submitted in support of the application to contain “concrete”, “specific” or “tangible” facts that could be used to establish an arguable case even though the allegations seem to be “vague, general or imprecise”.[6]

Despite the guidance from the appellate courts[7] militating against an expansive approach to the introduction of additional evidence, and despite the fact that at the pre-authorization stage of a class action the facts alleged are deemed to be true,[8] there has been a certain propensity for authorizing judges to order the communication of medical records in cases involving drugs or medical devices[9], perhaps because of the complexity of these cases. However, the appellate courts have not exempted pharmaceutical cases from the principles espoused in other cases and have overturned lower court decisions allowing the filing of medical records beyond what is necessary and indispensable.[10]

THE JUDGMENT

Justice Morrison dismissed defendants’ joint application for the communication of plaintiff’s additional medical records, the whole with judicial costs.

The decision confirms that, at the early stage of a class action, defendants are not entitled to evidence on the basis that it is required to protect their right to make a full answer and defence. As noted by the Court, this right remains to be exercised at the hearing on the merits.

The judge held that it is not sufficient that the evidence sought may eventually be relevant for the merits of the case; rather, the relevancy of such evidence at this stage must be assessed specifically for the authorization analysis to be conducted in accordance with article 575 CCP.

The judge rejected defendants’ argument that the additional medical records should be provided to allow them to identify which specific opioids were consumed by the plaintiff, stating that it is settled law that a plaintiff need not prove a direct cause of action against, or legal relationship with, each defendant in a class action involving multiple defendants.

The judge found that the underlying purpose of the defendants’ request for additional documents was simply an attempt to improperly “fish” for contradictions from the facts alleged by the plaintiff in the hope of finding something useful to defeat the claim. Most significantly, the judge noted that what the defendants were hoping to find in the additional medical records was evidence that the plaintiff had been warned by a health care professional about the dangers of chronic opioid use, most particularly with respect to addiction. Justice Morrison, referencing the appellate decision in Barratto,[11] confirmed that the issue of the learned intermediary defence was a matter for the hearing on the merits and, moreover, even if such warnings by the health care professionals were found to exist in the plaintiff’s medical records, that evidence would not lead to an indisputable conclusion, but would give rise to a new factual debate that would have to be dealt with on the merits. As Justice Morrison noted, there is a very limited purpose for a judge to allow contradictory evidence to be adduced at the authorization stage, as that would give rise to an analysis of the proof as if the Court were hearing the case on the merits, which is a slippery slope that must be avoided at this stage.

Justice Morrison recognized that, in many pharmaceutical cases, access to medical and pharmaceutical records has been permitted because of the lack of clarity and precision in the allegations regarding the use of certain drugs; however, he concluded that this was not the situation in the case before him. In support of this conclusion, Justice Morrison remarked on the fact that the medical records already communicated to the defendants include references to the plaintiff’s diagnosis of, and treatment for, OUD as a result of his long-term use of prescription opioids.

TAKE AWAY

Although at the pre-authorization stage of a class action the alleged facts are deemed to be true, the decision rendered by Justice Morrison suggests that it is prudent for a plaintiff to provide a limited amount of evidence to support a plaintiff’s allegations regarding the use of pharmaceutical products and the harm sustained. Such support could be in the form of exhibits to the proceedings or information provided subsequent to the filing of the proceedings.

The medical records communicated to the defendants supported the factual allegations with respect to the plaintiff’s long-term use of prescription opioids and his diagnosis of, and treatment for, OUD. Given the nature of the information that was disclosed, which supported the causal relationship between the drugs used and the harm suffered, the communication of additional medical records was not necessary or indispensable.

[1] Riccardo Camarda v. Abbott Laboratories Ltd. et als. (16 February 2021), Montreal 500-06-001004-197 (QC SC).

[2] https://www.canada.ca/en/health-canada/services/publications/healthy-living/canada-opioid-crisis-fact-sheet.html.

[3] Allstate du Canada, compagnies d’assurances c. Agostino, 2012 QCCA 678, para. 35.

[4] Asselin c. Desjardins Cabinet de services financiers inc., 2017 QCCA 1673, paras. 37-38.

[5] Desjardins Financial Services Firm Inc. v. Asselin, 2020 SCC 30, paras. 27 and 55.

[6] L’Oratoire Saint-Joseph du MontRoyal v. J.J., 2019 SCC 35, para. 60 [L’Oratoire].

[7] Infineon Technologies AG v. Option consommateurs, 2013 SCC 59 [Infineon]; Vivendi Canada Inc. v. Dell’Aniello, 2014 SCC 1; L’Oratoire, Id.

[8] Article 575(2) CCP; Infineon, Id., para. 67.

[9] Saurette c. Astrazeneca Canada inc., 2019 QCCS 3323; Letarte c. Bayer inc., 2018 QCCS 873; Scalabrini c. Merck Canada inc., 2016 QCCS 2353.

[10] Baratto c. Merck Canada Inc., 2018 QCCA 1240 [Baratto].

[11] Baratto, Id., paras. 64-65.