We’re feeling uncharacteristically magnanimous after last night’s USA Olympic hockey victory, so we’ll cheerfully report on a recent pharma innovator-liability case from the True North. In Goodridge v Pfizer Canada Inc., 2010 ONSC 1095 (Feb. 18, 2010), the plaintiffs claimed injuries from off-label use of Neurontin and its generic version. We tip the cyber hat to Nick Mizell at Shook Hardy for bringing the case to our attention.
Most of the Canadian opinion is as tasty as a maple glazed donut from Tim Horton’s. The court believed it was writing the first Canadian opinion on innovator liability for generic products, and as far as we can tell that’s true. One of the first things the court decided was that American precedents were interesting but useless. (Perhaps that’s how Canadian hockey fans felt about Rafalski and Miller — until last night. But we digress.) At first we thought that’s too bad, because, as the court observes, most American decisions “favoured the Defendants’ arguments.” (We admit it – we love the “ou” in “favour” and “colour.” Why not “doctour”?) But the Canadian court goes on to reach the right result, holding that Pfizer Canada owes no duty to consumers of generic gabapentin.
Applying the first part of the duty test, the court acknowledged it was foreseeable to an innovator that people might be injured by the generic. But the rest of the test goes against the plaintiffs. The connection between the innovator — which simply “releas[ed] an idea that is copied” — is remote from the consumer of the generic. More important, the court thought it simply unfair to impose liability on an innovator that “cannot control, qualify, or stop” the conduct in question — off-label use of the generic.
Further, the Canadian court identified two policy reasons for not imposing a duty on the innovator: (1) such a duty would essentially impose strict liability for defective products, which would be “a radical change in Canadian law” (the court quotes from an earlier Canadian’s court’s observation that while many American courts imposed strict liability, it wasn’t necessary “in the Canadian context, where there is much greater social assistance available for those who are hurt” — ouch!); and (2) innovator liability would stifle — you guessed it — innovation. We uttered similar comments about innovator liability cases in the United States here. Interesting and useful — at least we think so.
The court addressed other issues, mostly in a sensible way. For example, the court refused to certify an off-label promotion class action. The plaintiffs tried to exploit the allegations of off-label promotion of Neurontin in the US, but the court saw no “basis in fact for the allegations about wrongful marketing activities in Canada.” The court also declined to accept the plaintiffs’ argument that Canadian doctors were necessarily “influenced by any promotional activities emanating from the United States.” The court did certify some common issues for class treatment, but ordered individual trials for individual issues (specific causation and injury, anyone?). It also deleted the question of punitive damages as a common issue.
We’re not yet ready to issue a gold medal, but the judge did a better than average job — certainly better than what we’ve seen in the figure-skating competition.