Source: https://www.druganddevicelawblog.com/2010/08/pennsylvania-fen-phen-appeals-third.html
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Pennsylvania Fen-Phen Appeals - The Third Shoe Drops | Drug & Device Law
Home » Pennsylvania Fen-Phen Appeals – The Third Shoe Drops
Pennsylvania Fen-Phen Appeals – The Third Shoe Drops
By Bexis on August 3, 2010
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.
We would counter (whether the defendant in Lance did, or not, we don’t know) with:
We begin our analysis by observing that the [plaintiff’s] argument rests on a misperception of the nature of the applicable law. Even where this Court has “adopted” a section of the Restatement as the law of Pennsylvania, the language is not to be considered controlling in the manner of a statute. Such precepts, though they may govern large numbers of cases, are nothing other than common law pronouncements by the courts; their validity depends solely on the reasoning that supports them. Where the facts of a case demonstrate that the rule outruns the reason, the court has the power, indeed the obligation, to refuse to apply the rule.
Coyle v. Richardson-Merrell, Inc., 584 A.2d 1383, 1385 (Pa. 1991). Just because it’s in the Restatement, doesn’t make it the law. If the “inherent risks” of drugs are such that the law precludes strict liability, how are those risks different when the label is changed to negligence? The Lance court doesn’t say. We’d say that the rule outran the reason.
And here, we think there’s a good reason why negligent design of a drug shouldn’t be the law. How does one change the “design” of a drug? Perhaps one could change ingredients where the drug is made up of more than one thing, but the plaintiff in Lance wasn’t arguing that fen-phen should be all fen or all phen. So what’s the “standard of care” that was violated? We don’t know that either. If it amounts to arguing that the drug was too dangerous to be sold at all – well, then we’d say that Levine or no Levine, that’s a preempted claim. See Longs v. Wyeth, 536 F. Supp.2d 843 (N.D. Ohio 2008) (another fen-phen case). We don’t think state law can tell a manufacturer that it can’t sell a drug that’s been FDA approved. We don’t think that’s what the court thought it was doing in Lance because elsewhere in the opinion it explicitly “defer[red] to the federal regulatory scheme and the FDA’s decision as to whether a drug should lawfully remain on the market.” Slip op. at 13 ¶24. See also (although Lance inexplicably doesn’t cite it) White v. Weiner, 562 A.2d 378, 383 (Pa. Super. 1989) (adopting a policy of “deference” to the FDA), aff’d mem. 583 A.2d 789 (Pa. 1991).
The problem is that design claims (whether “negligence” or “strict liability”) are made for products that have alternative designs. When such claims are asserted against products that can’t be redesigned – in the analysis of Coyle, the rule outruns the reason.
So now we have a cause of action for “negligent design” that nobody knows what it is. But at least there’s not more than one. That’s because the Lance court returned to its senses and rejected some other non-warning causes of action. It joined every other court in the country in holding that there’s no common-law duty to recall a drug (or any product):
[T]his Court is persuaded by the majority of modern jurisdictions that have decided not to impose a common law duty to recall on a manufacturer. . . . [P]ublic policy considerations weigh heavily against imposing a duty to recall on a manufacturer.
Slip op. at 12 ¶22.
Then there’s the court’s total dictum applying a “post-sale duty to warn” in drug cases. Id. at 14 ¶25. The plaintiff in Lance made no warning claim at all, and such a duty has never been allowed in Pennsylvania, where such duties have been limited to products that are defective at the time of sale – because that’s been considered a strict liability claim. And under Hahn there’s no strict liability warning claim. That’s one of the perils of dictum – reaching out for something that’s not before the court (and probably hasn’t been briefed) risks the court not understanding how the law fits together.
Still, the court did kill one claim right and proper in Lance – this idea of some sort of free-standing duty to test. Bexis mentioned in his book (§3.07 n.2) the antediluvian case that the plaintiffs latched onto, Hoffman v. Sterling Drug, Inc., 485 F.2d 132 (3d. Cir. 1973), but the court simply said no:
Regardless of the Hoffman decision, which is not binding upon this Court, Pennsylvania law has not recognized an independent tort for negligent failure to test. In fact, we have held that “the claim for ‘negligent failure to test’ is not a viable cause of action recognized by our courts[.]”
Slip op. at 16 ¶28 (citation omitted).
Finally, the court refused to consider whether there should be a claim under Restatement Third §6(c) – leaving it to the Supreme Court whether to adopt the Third Restatement. Slip op. at 16-17 ¶31. The plaintiff was asking for such a claim. We find that sort of strange because we’ve spent a fair amount of time as defense lawyers arguing for the adoption of §6(c) in design defect cases involving medical devices. We don’t exactly know the state of play that put the (third) shoe on the other foot this time around, but it’s got us thinking “please don’t throw us into that briar patch.”
Tags: Comment K, Duty To Test, Pennsylvania, Recall