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Pennsylvania Appellate Court Overturns JNOV In Hormone Therapy Case

On the last day of December, Plaintiff Merle Simon received a stunning present. The Superior Court of Pennsylvania (Pennsylvania’s first level appellate court) decided in Simon v. Wyeth Pharmaceuticals, et al. that the trial judges grant of judgment notwithstanding the verdict in 2007 was erroneous. The trial judge’s opinion was based on statute of limitations grounds and, alternatively, proximate causation. Here are the important dates:

  • 1992 to 2002: Plaintiff took hormone therapy
  • May 2002: Plaintiff diagnosed with invasive lobular breast cancer
  • July 9, 2002: Massive WHI study finding a correlation between hormone therapy and breast cancer
  • July 1, 2004: Plaintiff filed a lawsuit

The opinion called Pfizer out for a ridiculous argument advanced in the trial court (though it was accepted by the trial court). Plaintiff was on hormone therapy, including Provera (manufactured by Pharmacia & Upjohn, owned by Pfizer) 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.

That warning tells me that Pfizer is not worried about Provera causing breast cancer in humans. Because, as we all know, humans are not beagles. Regardless, in their statute of limitations argument, Pfizer tried to claim that Plaintiff was on notice that their drug could have caused her breast cancer more than two years before she filed the lawsuit (and more than two years before the WHI study). Instead, they argued that the lawsuit should have been filed within two years of the date she was diagnosed with breast cancer.

The law in Pennsylvania on the statute of limitations for situations like this is basically two years per 42 Pa.C.S. § 554(2). The discovery rule is a judicially-created exception, and it provides that the statute is tolled (the clock stops ticking) when an injury or its cause is not known or reasonably knowable. See Wilson v. El-Daief, 964 A.2d 354 (Pa. 2009). The inquiry is factual as to whether the party was unaware of his injury and unable to determine its cause in the exercise of reasonable diligence. Therefore, it is proper for the jury to decide.

Plaintiff’s three trained doctors, who kept her on hormone therapy, continued to prescribe it to her and their other patients up until the point of the release of the WHI study when their warnings to patients changed. Pfizer argues that Plaintiff should have been a better physician (or a better prognosticator?) than her physicians, and should have known that there was a possible link between her breast cancer and the Provera, despite the fact that the drug’s warnings are intended for doctors in the learned intermediary state, and despite the fact that the warnings give no indication whatsoever that breast cancer was a possibility for non-beagles. The language used by the appellate court is decisive:

  • The Appellant had no reason even to suspect that there was a link between her use of HRT and breast cancer until the WHI report was released (p.19).
  • It defies logic, contrary to the trial court’s suggestion, that the Appellant should have been aware of the risk of taking HRT through her own due diligence. It is entirely unreasonable that a layperson, 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 (p.19).

The trial court ruled that JNOV was appropriate, in the alternative, because Pfizer’s failure to warn was not a proximate cause of breast cancer. The appellate court made swift work of that argument, noting that the doctors were not aware of a possible connection between the drugs and the breast cancer at any time before the WHI study and that they behaved much differently with their patients after the release of the study—the warnings to patients were more significant. Pfizer argued that a different warning would have made no difference, but the factual record indicates that it clearly would have made a difference. One doctor noted in a deposition that, after the study, he “took every single patient off of the pill” (p.34).

This victory will ripple across the sea of other hormone therapy plaintiffs who have been patiently waiting for their day in court—about 1,000 other cases were pending, awaiting this result, and they should be started on a trial schedule. In the meantime, the trial court has two months to rule on Pfizer’s motion for a new trial, which was moot when JNOV was granted.