We’ve blogged before, occasionally, about drug/device developments north of the border. Most of these developments have involved class action practice, where Canadian law is considerably more liberal than the corresponding rules here in the USA.
But there’s a point at which class actions fail even under Canadian law. That point was recently reached in the parallel Seroquel litigation pending in Ontario. We’re pleased to report that, in Martin v. AstraZeneca Pharmaceuticals PLC, No. 06-CV-314632CP, slip op. (Ont. Super. May 7, 2012), the court flatly rejected class certification.
Unlike the Canadian judiciary (the opinion is 78 pages long, single spaced), we’ll try to keep this report brief.
The class was huge and undifferentiated – “all persons” in Canada who “ever used Seroquel.” Slip op. at ¶5. Likewise, the alleged injuries were everything under the sun. Id. ¶¶7-9. The claims are the same that we typically see in the USA, a hodgepodge of inadequate warning, off-label promotion, and fraud on regulatory agency allegations. Id. ¶¶11-13. Their experts were also eye-rollingly familiar to US litigators, Laura Plunkett and William Wirsching. Id. ¶¶26-28. As often happens in the US, Plunkett was ruled incompetent to offer any medical opinions. Id. ¶¶50. More interestingly, since it’s part of her schtick, Plunket was also held incompetent to testify about Canadian regulations, since her only background involved the American FDA. Id. ¶¶65-66. Contrary to the plaintiffs’ apparent position, Canada is not simply an appendage of the US.
Despite having sophisticated class action counsel, plaintiffs were really lousy pleaders. “It is plain and obvious that the causes of action as pleaded will fail.” Id. ¶108. Among other things, they “lump” differently situated defendants “together as a group” and allege that everybody’s liable for everything. Id. ¶109. Maybe we should call these pleading rulings “Canadian TwIqbal” or “CwIqbal” for short. Whatever it’s called, the plaintiffs couldn’t meet the standard and the entire complaint was pitched.
How can counsel who can’t or won’t satisfy the most basic pleading requirements possibly be considered “adequate” for class action purposes?
Just a thought.
Another interesting holding in Martin – at least to us, since we don’t know much Canadian substantive law – is that it’s essential in design defect cases to plead “a safer and economical alternative design.” Id. ¶¶136-37. That’s also the law in many US jurisdictions. Of course plaintiffs can’t plead an actual alternative design in most drug cases, so they just plead that somehow some other drug is safer. That didn’t cut it in Martin. Id. ¶136.
Also, apparently off-label use is regarded in Canada in the same fashion as it is in the USA, something we had always assumed, but never knew for certain:
[T]he negligent distributing, marketing and sale cause of action has a further defect as it relates to off-label uses. It is deficient and will fail because the defendants did not have the duty to “ensure” that [the drug] was not distributed, marketed or sold for off-label uses. This is because doctors have the legal right to prescribe [a drug] for off-label uses, regardless of the defendants’ conduct.
Martin, slip op. ¶155.
In sum, the plaintiffs’ abject failure to plead viable claims was the first and foremost ground for rejecting the class action. Id. ¶¶191-92. It was hardly the only ground, however. The court went on to determine that the class failed to satisfy the prerequisites of Canadian class certification.
- There was no identifiable class. Martin, slip op. ¶¶198-206.
- The class definition was ridiculously overbroad, including many people who were helped, not harmed by the drug. Id. ¶¶207-09.
- There were no common issues because the plaintiffs failed to describe the claimed injury with any clarity. Id. ¶¶221-28.
- Weight gain and diabetes could not be common issues because both conditions are “ubiquitous” and can be caused by a great many things. Id. ¶¶232-54.
- Allegations of off-label promotion were not logically connected to any claim because no promotion was established that involved any of the plaintiffs’ physicians. Id. ¶¶255-57.
- Off-label use could not be a common issue because it’s legal, widespread and not tortious. Id. ¶¶258-62. The plaintiffs’ own medical expert admitted that he personally prescribed the drug off label on a regular basis. Id. ¶287.
- Plaintiffs failed to establish any evidence of off-label promotion in Canada. Evidence concerning the USA was not evidence concerning Canada. Id. ¶¶263-76.
- Off-label use was not a common issue because there are lots of such uses with nothing in common. Id. ¶¶277-80.
- Since plaintiffs conceded that the drug was effective, its “defectiveness” could not be a common issue. Id. ¶283.
- Duty could not be common “because the issue lumps all defendants and different types of negligence together and draws no distinction” between on and off-label use. Id. ¶285.
- When a duty to warn arose could not be common because the warnings were changed numerous times since the drug was on the market, and thus were not the same throughout the class. Id. ¶290. The weight gain warning in particular changed seven separate times, and the diabetes warnings even more. Id. ¶¶293, 298-301.
- Plaintiffs’ expert’s opinions about warnings in the USA were not relevant to Canada, and the Canadian warnings weren’t criticized. Id. ¶¶303-15.
- Other supposedly common issues were stated with such extreme generality that their resolution would not advance the progress of the litigation. Id. ¶¶322-28.
- The litigation was in Canada. It didn’t matter whether the defendants violated regulations imposed by the American FDA. Id. 329-44.
- Since the plaintiffs failed to establish any common issues on liability, there was no need to decide whether there were common issues concerning remedy. Id. ¶¶345-53.
- The representative plaintiffs were woefully ignorant, having never even read the drug’s warnings. They didn’t exhibit sufficient “interest and commitment” to the litigation. Id. ¶¶362-68.
- Plaintiff’s litigation plan was “a work of fiction.” Id. ¶¶369-74.
In reading through the lengthy Martin opinion one thing jumped over and over. The plaintiffs’ treatment of the entire country of Canada bordered on contempt – arguing that whatever might support a claim in the USA should simply be assumed to apply to Canada as well. Class action (and other) litigants would do well to remember that Canada is an sovereign country with its own independent system for the regulation of drugs. As for litigants such as these plaintiffs and their experts, who treated the forum country as little more than an annoying afterthought, we recommend: