Canada: B.C. Court Dismisses Proposed Class Action Against Generic Manufacturers Of Fentanyl Patch

On June 20, 2014, Justice Bracken of the British Columbia Supreme Court dismissed a proposed class action against two generic manufacturers of transdermal fentanyl patches following a summary trial, prior to the certification hearing (Player v. Janssen-Ortho Inc., 2014 BCSC 1122). In doing so, he considered the following issues:

  • Whether the matter was appropriate for summary trial;
  • The appropriate scope of evidence that may be considered in a pre-certification summary trial; and
  • The merits of the plaintiff's claim, including the extensive expert evidence filed by the parties.

He concluded that the evidence did not support any of the plaintiffs' claims, which purported to be founded on a range of legal principles, including negligent design, failure to warn, misrepresentation, breach of fiduciary duty and strict liability, as well as on alleged breaches of the Competition Act, the Food and Drugs Act, the Business Practices and Consumer Protecting Act, and the Sale of Goods Act.

Background

The proposed class proceeding targeted several manufacturers of a form of painkiller, of which the active ingredient, fentanyl, is delivered by a patch applied directly to the patient's skin. The plaintiffs, who were suing on their own behalf and on behalf of the estates of their deceased spouses who were alleged to have overdosed on fentanyl, alleged that, due to design defects, the fentanyl patches can cause serious harm in ordinary use.

The plaintiff commenced the proposed class proceeding in September 2010 on behalf of all persons in British Columbia including their estates, who used fentanyl patches after December 20, 1991. The claim was subsequently expanded to cover all of Canada. The plaintiff moved for certification, while two of the defendants who manufacture generic versions of the fentanyl patch, Teva Canada Limited and Sandoz Canada Incorporated (the applicant defendants), applied for an order directing a summary trial of the claims against them. Following a sequencing hearing, Justice Bracken ordered that the summary trial could proceed prior to the certification hearing.

The basis for the applicant defendants' summary trial application was that they manufacture a different product from the other defendants. The evidence showed that fentanyl patches come in two types: (i) "matrix" drug-in-adhesive patches, where the drug is suspended in a semi-solid state within the adhesive patch, and (ii) "reservoir" style patches, which have a reservoir of liquid/gel fentanyl that is released into the patient's bloodstream through a rate-controlling membrane. The applicant defendants took the position that the claim is over-inclusive insofar as it fails to support allegations of harm with respect to the matrix-style patches manufactured by the applicant defendants, as opposed to the reservoir style used by the other defendants.

Scope of Inquiry in a Pre-Certification Summary Trial

As a preliminary matter, Justice Bracken considered whether the court should consider only those facts that relate to the representative plaintiffs or whether it should also consider facts relating to the class as a whole. He began by noting a significant difference between B.C. class actions law and that of other provinces: in most Canadian provinces a proposed class proceeding is treated as an individual action, but this is not so in British Columbia. Under B.C. law, a pre-certification proceeding cannot be dismissed solely on the basis that the representative plaintiff does not have a claim against any particular defendant. In Justice Bracken's view, it followed from this that, in a summary trial, the court can properly consider admissible evidence relating to the claims of the potential class members, including evidence from proposed class members and expert evidence that the products are defective in design and thus in breach of the duty of care to all class members.

Justice Bracken noted, however, that this is complicated in the context of the summary trial rule which allows the court to grant judgment in favour of any party, regardless of which party has brought the application. The court noted that while it could consider the evidence of proposed class members, it could not use this evidence to issue judgment in favour of the representative plaintiffs as the proposed class members were not parties to the action. Accordingly, the evidence relating to the proposed class was considered by Justice Bracken only in determining whether it would be unjust to decide the issues on the application. His Honour noted that if the representative plaintiffs failed to prove their claims, but there was evidence that the applicant defendants breached a duty of care to Canadian consumers, he would not issue judgment on the summary trial and would allow the claims to continue.

As it turned out, the plaintiffs did not adduce any direct evidence from the proposed class members (though they could have). Instead, they tried these alternative tactics:

  • Submitting affidavits from members of the plaintiffs' law firm who had spoken with proposed class members; and
  • Presenting evidence of adverse event reports submitted by consumers, health professionals, manufacturers and distributors to Health Canada and made available in an online database by Health Canada.

Neither of these approaches went down very well with the court. The affidavit evidence, being hearsay, was given minimal weight. The evidence from the Health Canada website was, as Justice Bracken noted, double hearsay. Not only that, it was unreliable and could not be used either as evidence of injuries caused by fentanyl patches or as evidence of risks associated with those products.

Suitability for Summary Trial

The British Columbia Supreme Court Civil Rules permit any party to apply to the court for judgment by way of summary trial, which involves evidence via affidavits and written materials rather than by viva voce testimony. A court may not grant judgment in a summary trial if the judge is unable to find the facts necessary to determine the issues or is of the opinion that it would be unjust to decide the issues summarily. The factors considered by the court in making this determination include the complexity of the matter and whether credibility is a critical factor in the determination of the dispute. Justice Bracken noted that in a summary trial all parties must come to the hearing "prepared to prove their claim, or defence" and as such the plaintiff cannot argue that the matter is unsuitable for summary disposition on the basis that they have not put forward sufficient evidence.

Appropriateness of Summary Trials in Class Proceedings

The plaintiffs argued that in the context of a proposed class proceeding, a summary trial was prima facie inappropriate for determining issues in the proceeding, raising a number of objections.

The plaintiffs argued that as a pre-certification decision would only bind the representative plaintiffs (and not members of the proposed class), a summary trial was not efficient given that another member of the proposed class would simply step forward to pursue the claim on behalf of the class. Justice Bracken held that this concern, in itself, was not sufficient to find that a summary trial was inappropriate because the application concerned issues common to all class members (i.e., whether the applicant defendants were in breach of any duty in law to users of their product) and not just the representative plaintiffs. He further held that if the evidence is insufficient to support the action, then "the consequences associated with involvement in an extensive and expensive class action are very serious":

As stated in Kowch at para. 14, "[i]t is not a principle of class action law that weeds should be allowed to ripen and grow, instead of being nipped in the bud."

Further, if the matter has no merit, allowing it to continue to certification will undoubtedly cause prejudice to Teva and Sandoz. Where the court can find the necessary facts through the summary process, it promotes efficiency to issue judgment at the pre-certification stage.

Two Key Issues

Justice Bracken next considered whether the complexity of the case or evidence made it unsuitable for summary trial. Justice Bracken held that while the evidentiary record was extensive, the two key issues were relatively straightforward:

  • Whether there was evidence to connect the applicant defendants' product to the deaths of the plaintiffs, and
  • Whether there was sufficient evidence to establish the product was defectively designed.

On the first issue, there was no evidence to connect the applicant defendants' products to the death of one plaintiff as it was admitted that he did not use their products. Regarding the other plaintiff, there was insufficient evidence to prove that he used a fentanyl patch manufactured by the applicant defendants. In addition, Justice Bracken found the plaintiffs did not put forward any admissible evidence establishing fentanyl as a cause of his death.

On the second issue (defective design), Justice Bracken found that he could not give sufficient weight to the evidence of the plaintiffs' expert as she was not qualified to give an opinion on some aspects of the case, she chose to ignore evidence that contradicted her opinion and had taken the role of an advocate contrary to the rules on the admissibility of expert opinion evidence. In any event, at best, her evidence on defective design was that there is another design or designs that might be safer. Accordingly, there was no credible evidence to support the plaintiffs' claim nor was the case too complex to be decided on summary trial.

Justice Bracken noted that there had been examinations for discovery and cross-examinations and therefore the plaintiffs had a full opportunity to present evidence to support their claims. The evidence that had been presented allowed for a full appreciation of the facts essential to the determination of the plaintiffs' action:

Class actions are a powerful tool. They allow an action to proceed where an individual plaintiff would find the cost of an action prohibitive as well as in actions where the research and investigation is not within the ability of a single plaintiff. However, it is not a tool where simply making an allegation against a defendant or group of defendants is sufficient. There must be evidence to warrant the expense of a full trial.

Findings on the Merits

After an extensive review of the evidence, Justice Bracken found that the evidence did not support any of the plaintiffs' claims.

Negligence

The onus is on a plaintiff to show that a product as designed was not reasonably safe as there was a substantial likelihood of harm and it was feasible to design the product in a safer manner. Justice Bracken found that the applicant defendants complied with appropriate regulatory standards and accepted the evidence of the defendants' experts on the utility and usefulness of their products as well as on the lack of availability of a suitable alternative. His Honour concluded that there was no satisfactory evidence to show that there was a safer alternative design or that an alternate design of the fentanyl patches was available and could have been used but for the negligence of the applicant defendants.

Failure to Warn

The plaintiffs alleged that the applicant defendants failed to provide adequate warning to consumers of the dangers associated with the use of fentanyl. Based on his review of the product monograph (which was identical to the product monograph approved by Health Canada for the innovator drug) and the expert evidence, Justice Bracken concluded that the product monograph contained clear, accurate and understandable warnings such that the applicant defendants were not liable for failure to warn.

Additional Grounds of Liability

Having found no negligence or failure to warn, Justice Bracken dealt summarily with the additional claims advanced by the plaintiffs finding: there was no misrepresentation of facts in the product monograph; there was no evidence of unlawful, unfair or deceptive trade practices in contravention of the Competition Act nor was there any evidence of a causal connection between the applicants' fentanyl patches and any loss or damage to the plaintiffs; there was no evidence to support breach of consumer protection legislation or any express or implied warranty under the Sale of Goods Act; there was no evidence to support a fiduciary relationship and a breach of fiduciary duty by the applicant defendants; and there was no claim for strict liability as courts in Canada have rejected the doctrine of strict liability in products liability cases.

The Ruling

Accordingly, the action was dismissed as against the applicant defendants.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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