Ontario Court finds that Innovator Drug Companies Have No Duty of Care Towards Consumers of Generic Drugs

On February 18, the Ontario Superior Court considered whether an innovator company has a duty of care towards consumers of the generic version of their product. A class action concerning gabapentin, marketed as Neurontin, was commenced against Pfizer. The Plaintiffs made a number of allegations, including that the Defendants wrongfully promoted the drug for off-label uses, that the Defendants were negligent in distributing a drug that had a harmful side effect (a propensity for suicidal behaviour) and that the Defendants were liable for the harm caused by the generic gabapentin distributed by their competitors. In response, the Defendants made a motion to strike portions of the Plaintiff’s claim. On considering whether a cause of action sufficient for certification of the class action was disclosed, the Court looked at whether Pfizer could be liable for the harm caused by the generic drug. The Plaintiffs argued that it was reasonably foreseeable that Neurontin would be copied by generic companies who would rely on the Defendant’s research and regulatory approval. Justice Perell applied the duty of care analysis and found that although the harm was foreseeable, the nature of the relationship between Pfizer and consumers of the generic drug was insufficiently proximate. More importantly, however, Justice Perell found that it would not be fair to find the Defendant liable for releasing an idea that is subsequently copied, for failing to control the actions of the generic companies, or for failing to stop physicians from prescribing generics. Pfizer was therefore found not to have a duty of care to consumers of the generic version of the drug. The Plaintiffs’ claim that Pfizer wrongfully promoted the drug for off-label uses was similarly rejected. Though physicians may prescribe a drug for other than its authorized use, manufacturers are prohibited from promoting such off-label uses. In the US, the Defendant was shown to be participating in such wrongful promotional activities. Justice Perell found, however, that there was no evidence that such wrongful marketing took place in Canada – the fact that the U.S. marketing material was available to Canadian doctors did not amount to promotion. This claim was therefore similarly struck. Otherwise, on accepting that material facts pleaded as true, the claim regarding possible side effects of the drug easily met the first criterion of certification, and the Court went on to certify the action. For a copy of the decision see, 2010 ONSC 1095, February 18, 2010, P.M. Perell J., see: Goodridge v. Pfizer Canada Inc Summary by: Lea Epstein