It is not always sunny in Philadelphia for product liability lawyers – especially defense lawyers like us. Faithful readers have heard us gripe about the state of Pennsylvania product liability law – see, for example, this and this – and with good reason. Pennsylvania strict liability law has been a confusing mess for years. The Pennsylvania Supreme Court raised our hopes that it would clean it all up when it granted review in Bugosh v. I.U. North America, Inc., but the Court dashed our hopes last year by inexplicably changing its mind and dumping the case, as we discussed here. The mess will linger far longer than the two feet of snow that landed on the Commonwealth this weekend and the additional 12 to 18 inches that are starting to fall today.

But the law is at least as slushy.

In the area of the law nearest to our hearts, however, Pennsylvania gets some things exactly right, as the Philadelphia Court of Common Pleas showed recently in Lance v. Wyeth, Inc., 2010 Phila. Ct. Com. Pl. LEXIS 11 (Jan. 7, 2010). Lance is a Phen-Fen case, but a weird one. The plaintiff’s daughter took the diet drug Redux for a few months in 1997 and was diagnosed in 2004 with primary pulmonary hypertension. Plaintiff blamed diet drugs and sued. Plaintiff must have known she couldn’t win a normal failure-to-warn claim, so she tried a novel approach: she asserted a negligence claim based on the “Unreasonable Marketing of a Dangerous Drug and Unreasonable Failure to Remove the Drug from the Market before January 1997.” In other words, she claimed that Redux should not have been sold at all. Talk about a conflict with the drug’s FDA approval! That’s why other courts have held this sort of claim preempted, even after Wyeth v. Levine, 129 S. Ct. 1187 (2009).

To make her point even clearer, the plaintiff in Lance explicitly said in her complaint that she was not making a failure-to-warn claim. That’s bizarre – not only in our experience do plaintiffs almost never explicitly give up possible claims, but warning claims are usually what prescription drug product liability litigation is all about. It must have been a seriously poor case in some way (learned intermediary, probably) for that plaintiff to do that. Plaintiffs act this way only when they are really, really trying to pick a fight on a specific ground. She got the fight she was looking for, but she lost. And here in the land of cheesesteaks and soft pretzels, the court didn’t have to resort to anything so highfaluting as preemption to decide the case.

Wyeth moved for summary judgment, which the court granted. Under Pennsylvania’s peculiar system that is reminiscent of Alice in Wonderland (“Sentence first — verdict afterward”), the court explained its ruling only after Lance appealed (still, that’s better than it used to be, when Pennsylvania trial judges didn’t have to write opinions at all). The court reiterated that Pennsylvania courts do not impose strict liability on manufacturers of prescription drugs – and so drug makers, unlike our other clients, are spared the current muddle in Pennsylvania product liability law. A plaintiff can sue a prescription drug maker in Pennsylvania only if the manufacturer was negligent, either by a manufacturing defect or an improper warning – that is, no “design” claims. The court said it would look at a drug maker’s marketing and promotional practices only when the plaintiff had a failure to warn claim, and the plaintiff does not have a separate, standalone cause of action for negligent marketing.

Lance argued that Wyeth was negligent both for putting Redux on the market and for failing to withdraw it. But the Philadelphia court wasn’t buying the argument plaintiff was putting on the legal market. The court concluded that “so long as a prescription drug has the appropriate FDA approved labeling found to sufficiently warn prescribing physicians of the risks of such a drug, the drug cannot be found unreasonably dangerous.” 2010 Phila. Ct. Com. Pl. LEXIS 11, at *16.

That sort of sounds something like preemption, but it isn’t. Pennsylvania common-law courts have given a degree of deference to the FDA, completely apart from preemption for a long time.

[C]ompliance with federal labeling requirements normally is sufficient to preclude criminal prosecution by the Commonwealth for misbranding. Certainly the foregoing provisions do not control our disposition of appellant’s claim in this civil action; they, nevertheless, do embody a legislative intent that we cannot ignore. Our legislature unequivocally has expressed a policy of deference to the federal scheme in the area of drug labeling, and we can ascertain no reason not to extend that policy to civil cases raising misbranding claims.

White v. Weiner, 562 A.2d 378, 383 (Pa. Super. 1989) (citations omitted), aff’d mem., 583 A.2d 789 (Pa. 1991).
We wrote last year about a similar argument rejected by a federal court in another Fen-Phen case named Longs v. Wyeth. The federal court rejected a plaintiff’s claims that a drug should not have been sold because those claims were a direct attack on the drug’s FDA approval and therefore were preempted by federal law. The federal court said that was still the law even after Wyeth v. Levine, 129 S. Ct. 1187 (2009).
Although we are quite partial to preemption arguments, preemption can be a fickle defense these days, as it is subject to the shifting political winds. We prefer the Philadelphia court’s reasoning in rejecting the novel “this drug is unreasonably dangerous and never should have been sold” argument because the reasoning won’t blow away when the political winds shift. Under Pennsylvania law, an FDA-approved drug with adequate labeling is not unreasonably dangerous. Period. You don’t need to look at Congressional reports, legislative history, Preemption Preambles, or the Federalist Papers to reach that conclusion, and even the U.S. Supreme Court can’t change it, because the highest court in the land has no authority over Pennsylvania law. And that is why, despite the dirty snow on the ground and the gathering storm, it is looking sunny in Philadelphia today.