Egad.

We did those two basic posts on Friday explaining for lay readers the litigation process and the importance of the preemption, Daubert, and learned intermediary defenses. And now we hit you with that title: “HRT JNOV Explained.”

Are we schizophrenic around here, or what?

With all due apologies to new readers who thought we were abandoning lawyer-speak, we’re reverting to form.

Anyway, Wyeth had won all of its Pennsylvania hormone replacement therapy trials — either at trial or in later proceedings. And Pfizer has now seen its trial loss erased by entry of judgment notwithstanding the verdict. On December 26 — right smack in the middle of the holidays, which explains why we’re just posting about this now — the judge entered a 29-page order justifying the decision to grant JNOV. Simon v. Wyeth, No. 4229, slip op. (Phila. Cty. C.P. Dec. 26, 2007). Here’s a link.

The facts were typical: Plaintiff-wife took HRT, developed breast cancer, and sued the manufacturers for negligence, breach of express warranty, and breach of corporate responsibilities. (That last claim is a little cryptic for us, but we’re just reporting what the opinion says.) Plaintiff-husband pleaded a consortium claim.

The jury found in favor of one of the manufacturers, Wyeth, and against the other, Upjohn (which is now Pfizer). The jury awarded the plaintiff-wife $1.5 million; the trial judge granted judgment n.o.v.

The j.n.o.v. rests on two grounds. First, the wife was diagnosed with breast cancer on May 21, 2002, but didn’t file suit until July 1, 2004, which appears to miss the two-year statute of limitations. The trial court held that studies suggesting a possible link between HRT and breast cancer had been published as early as 1989, so the plaintiff should have discovered her claim promptly upon being diagnosed with cancer. Slip op. at 13. (How ironic to see a plaintiff hoist on the petard of early studies. As defense counsel, we’re always wondering how we can simultaneously argue that the plaintiff should have known of his or her possible claim even though the drug didn’t cause the plaintiff’s injury.)

The court also found that the package insert for Prempro sufficiently disclosed the possible risk of breast cancer to put the plaintiff on notice of her claim as soon as she was diagnosed. Id. at 14. And, last but not least, the court noted that the treating physician ordered the plaintiff to discontinue her HRT regimen once she was diagnosed with breast cancer. “A reasonable person would have at least inquired at the time of the diagnosis why the HRT regimen was being discontinued or what, if any, was the relationship between the HRT regimen and the breast cancer diagnosis.” Id. at 16.

That holding alone would of course suffice to justify granting judgment notwithstanding the verdict.

But wait! There’s more!

The court went on to find the plaintiff failed to carry her burden of proving causation in light of the learned intermediary doctrine. The court first found that Pennsylvania law does not apply a “heeding presumption” in the learned intermediary context. Id. at 21. That conclusion is absolutely correct, as we’ve explained elsewhere.

The court also held that both of plaintiff’s treating physicians were aware of a possible link between HRT and breast cancer when they prescribed the drugs to plaintiff. Id. at 23. Since the physicians prescribed HRT despite knowledge of the very risk that materialized, a changed warning would not have altered the physicians’ prescription decision. The learned intermediary doctrine barred plaintiff’s claim. (It’s worth noting that at least one physician testified that he now tells his patients about the possible HRT-cancer link, and the plaintiff said that, if warned of the risk, she would not have ingested the drug. The trial court thus adopted the strong form of the learned intermediary doctrine by holding that only the physician’s prescribing decision, and not the patient’s reaction to information the physician might have conveyed, is relevant to the calculus.)

Finally, the trial court brushes aside the plaintiff’s objections to a collection of evidentiary rulings. The only one that caught our eye was the motion in limine to exclude versions of the package insert that post-dated the plaintiff”s prescription. The court held (properly, if you ask us) that the later package insert was not admissible.

This is only a trial court decision, and it does no more than provide the rationale for a previously granted j.n.o.v. But, with the defense wins mounting, plaintiffs will increasingly realize that they have a tough row to hoe in the Pennsylvania HRT proceedings.