Is a warning that a drug may cause cancer in dogs adequate notice that it may cause cancer in humans?

The Drug Recall Lawyer Blog is reporting today on an interesting case in which the title of this post is the key issue. Go here for the full story.

In this case, the plaintiff was on hormone therapy, including a drug called Provera for ten years, through three different physicians. Part of this time, she took Provera (a progestin) in combination therapy with Premarin (an estrogen). The label for Provera, inserted in the Physicians’ Desk Reference by Pfizer, included the following: Beagle dogs treated with medroxyprogesterone acetate [the active ingredient in Provera] developed mammary nodules some of which were malignant. Although nodules occasionally appeared in control animals, they were intermittent in nature, whereas the nodules in the drug-treated animals were larger, more numerous, persistent, and there were some breast malignancies with metastases. Their significance with respect to humans has not been established.

Based on this warning, Pfizer tried to claim that Plaintiff was on notice that the drug could have caused her breast cancer more than two years before she filed the lawsuit (and, more than two years before a study showed the cancer risks with respect to humans).

The jury decided for the plaintiff, but the court entered a judgment notwithstanding the verdict. However, on December 31, the Superior Court of Pennsylvania (Pennsylvania’s first level appellate court) decided in Simon v. Wyeth Pharmaceuticals, et al. that the trial judge's grant of judgment notwithstanding the verdict was erroneous stating that "It defies logic, contrary to the trial court’s suggestion, that Appellant should have been aware of the risk of taking HRT through her own due diligence. It is entirely unreasonable that a lay person, completely lacking in medical training, would make the logical connection between HRT and breast cancer prior to the release of the WHI study, when three trained medical doctors believed that there was no such connection."

In the alternative, the trial court also justified the JNOV by concluding Pfizer’s failure to warn was not a proximate cause of the plaintiff's injury. This conclusion was apparently based on Pfizer's argument that a different warning would have made no difference. If that was the argument, by the way, the issue was not about proximate cause but about cause in fact. But in any case, the appellate court rejected the argument, noting that the doctors behaved much differently with their patients after the release of the study related to possible side effects in humans. One doctor noted in a deposition that, after the study, he “took every single patient off of the pill” There was sufficient evidence to support an inference that a different warning would have made a difference. There are about 1,000 other hormone therapy cases pending in courts around the country.