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Last week we reported on two recent decisions by the Pennsylvania Superior Court (an intermediate appellate court) in fen-phen litigation.  Well, there was a third shoe out there, and yesterday it dropped.  In Lance v. Wyeth, No. 2905 EDA 2008, slip op. (Pa. Super Aug. 2, 2010), affirmed – for the first time in a reported appellate decision in Pennsylvania – that the restrictions on strict liability recognized by the Pennsylvania Supreme Court in Hahn v. Richter, 673 A.2d 888 (Pa. 1996), precluded any claim for strict liability design defect in product liability litigation involving prescription drugs (and, we presume, medical devices as well.

Although Appellant labels her claim as “negligent and unreasonable marketing,” her proposed cause of action duplicates a design defect claim, seeking to impose strict liability on [defendant] because [its drug] was unreasonably dangerous.  With our Supreme Court’s adoption of comment k, a design defect claim for strict liability is not cognizable under Pennsylvania law when it is asserted against a manufacturer of prescription drugs.  For purposes of strict liability and §402A, a drug cannot be deemed unreasonably dangerous, even if it is defectively designed, so long as the drug is manufactured properly and contains adequate warnings.

Slip op. at 7-8 ¶15.  We’ve made the argument, of course, that Hahn precluded strict liability of any sort (other that manufacturing defects, which are pretty rare), but now we’ve got an appellate court for the proposition.
But then the court goes and recognizes a negligent design claim for a prescription drug.  That’s better than strict liability, given Pennsylvania’s weird evidentiary restrictions, but not by all that much.   The court bases it on two things:  (1) that Restatement of Torts §395 “contains no exemption or special protection for prescription drugs” and (2) the statement in Restatement of Torts §402A that strict liability “is not exclusive, and does not preclude liability based upon the alternative ground of negligence.”  Slip op. at 10-11 ¶¶18-19.Continue Reading Pennsylvania Fen-Phen Appeals – The Third Shoe Drops

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This week the Superior Court of Pennsylvania (the intermediate appellate court) issued two new opinions on warning causation in the context of the learned intermediary rule.  Cochran v. Wyeth, Inc., ___ A.2d ___, No. 2838 EDA 2008, slip op. (Pa. Super. July 27, 2010), and Owens v. Wyeth, No. 185 EDA 2009, slip op. (Pa. Super. July 26, 2010) (memorandum).
Both of these cases arise from the few remaining fen-phen cases in Philadelphia County, which involve primary pulmonary hypertension as the claimed injury.  Obviously, Cochran is the more important of the two, because it will be published, and is precedential.
Cochran involved a peculiar warning claim.  The plaintiff conceded that the warnings regarding primary pulmonary hypertension were adequate.  Instead she claimed that the warnings about valvular heart disease (VHD) – a condition she admittedly never contracted – were inadequate, and that had the prescribing physician been warned of that risk (as opposed to PPH), he would not have prescribed the drug.  Obviously, opening up the entire warning to inadequacy attacks, regardless of the injury actually suffered, would have been a major increase in the scope of liability.  Fortunately the Superior Court didn’t buy the theory:

Here, [defendant] allegedly breached its duty in failing to disclose the risk of VHD, and Appellant’s injury was PPH.  The risk of VHD did not develop into the actual injury of VHD. Although [the prescriber] testified in his deposition that he would not have prescribed [the drug] to Appellant had he known of the risk of VHD, this does not alter the fact that [defendant] failed to disclose the risk of VHD and Appellant suffered from PPH.  In these circumstances, the relationship between the legal wrong (the failure to disclose the risk of VHD) and the injury (PPH) is not directly correlative and is too remote for proximate causation.  Therefore, as a matter of law, there is no proximate, causal connection between [defendant’s] failure to disclose the risk of VHD and Appellant’s specific injury.

Cochran, slip op. at 14-15.Continue Reading New Defense Learned Intermediary Wins In Pennsylvania

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The two of us have been practicing law now for a little over 25 years. Bexis graduated law school in 1982 and Herrmann a year later (see our bios – links at the top – for the gory details). At big firms it takes a few years – five at least – before we could…

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A year ago, on March 31, 2007, we published a post titled “We Like Sykes” about the Pennsylvania federal decision in Sykes v. Glaxo-SmithKline, et al., 484 F. Supp.2d 289 (E.D. Pa. Mar. 28, 2007). In that decision, Judge Stengel granted summary judgment in favor of the vaccine manufacturers (as preempted by the…

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Even with the rise (and fall) of new and unusual theories of liability, the bulk of what we defend against still consists of inadequate warning claims. We’ve been down this road so often that we know in our sleep when we’ve got a slam dunk defense to one of these. We’re ready to file our…

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FDA-regulated products now account for an estimated one-fifth of overall economic activity in the U.S. They have also been the focus of a litigation explosion. This timely guide covers all aspects of litigation involving drugs, medical devices, vaccines and other FDA-regulated prescription products.
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