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HRT punitive damages before Pennsylvania Supreme Court

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The FDA approved Wyeth's hormone replacement therapy drug Prempro after its standard overrequired testing, but an expert witness testified in a Pennsylvania state court that Wyeth's failure to do "more" testing entitled a plaintiff to punitive damages, and a jury awarded a $10.1 million jackpot to plaintiff Mary Daniel, who implausibly blamed her breast cancer on 18 months of Prempro use. (Courts in places that aren't judicial hellholes throw cases like that out, since there's no competent scientific evidence that short-term Prempro use causes breast cancer.)

The trial judge did throw out $8.6 million of punitive damages on the grounds that Wyeth can't be blamed for making the same mistake the FDA supposedly did; but an appellate court reversed that decision and reinstated the jury verdict, and it's now in front of the Pennsylvania Supreme Court on a third level of review. Can courts apply a certain level of plausible common sense to the punitive damages inquiry, or is it sufficient for the testimony of a single expert gun for hire to expose a defendant to random punitive damages? Note that punitive damages here cannot affect pharma manufacturer behavior other than deterring new drugs in the aggregate: if punitive damages can be imposed because an expert says that the defendant should have done "more" testing, then plaintiffs will always find an expert willing to say another test should have been run in hindsight. [Legal Intelligencer via Bashman, who, alas, is arguing on the wrong side; Drug & Device Blog]

Drug & Device Blog notes further hellhole-ish shenanigans:

The basis for punitive damages was apparently failure to test - which doesn't even rate as an independent cause of action in Pennsylvania. Not only that, the plaintiff in Daniel got away with playing "hide the expert," resulting in the jury hearing the recorded opinion of an expert that the expert later testified he had recanted. Beneath all this was a moot footnote (choice of law not being disputed) that the law of the defendant's principal place of business (Pennsylvania has no tort reform whatever concerning punitive damages) should control for punitive damages purposes over the law of the plaintiff's state of residence, a distinct minority position.

The Pennsylvania Supreme Court is only reviewing the FDA defense, however.

On the other hand, if Pennsylvania courts are going to insist upon holding defendants to unreasonable standards at the same time that they're applying unreasonable choice-of-law standards, one wonders why pharmaceutical companies tolerate having their principal place of business in Pennsylvania when states like Texas or Michigan would be willing to accommodate them. Perhaps some companies find that the occasional arbitrary $10.1 million liability (combined with the expense of defense costs and multiplied over millions of potential plaintiffs who will forum shop for Philadelphia juries) is all worth it for the convenience of having offices in King of Prussia, Pennsylvania, and just views it as an odd local tax that largely benefits wealthy trial lawyers at the expense of the citizenry.

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Haven't the Pennsylvania Courts ever heard of Daubert criteria? Testimony by a pathologist that Prempro "coulda, shoulda, mighta" caused breast cancer hardly establishes proximate cause.

Furthermore, what kind of test does Dr. Layfield, or the Appellate Court suggest be devised? How can you determine a drug proximately causes cancer in humans without giving the drug to humans and seeing what happens? So the whole thing fails the "falsifiable test." But that gets us back to Daubert.

Who is sitting on the bench in those Pennsylvania courts, anyway?

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Rafael Mangual
Project Manager,
Legal Policy

Manhattan Institute


Published by the Manhattan Institute

The Manhattan Insitute's Center for Legal Policy.