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Thanks to Terry Henry at Blank Rome for sending along today’s preemption decision in In re Fosamax (Alendronate Sodium) Products Liability Litigation (No. II), No. 12-2250, slip op. (3d Cir. April 30, 2014), affirming the dismissal of so-called “design defect” claims against generic drug manufacturers under the laws of 28 states.  Essentially, the Third Circuit did what the Pennsylvania Superior Court should have done in its metoclopramide appeals, but didn’t.  The Third Circuit held each and every “design defect” claim preempted under multiple state laws because the plaintiffs could articulate no theory of liability that didn’t depend on one of three preempted things:  (1) changing warnings; (2) changing design; or (3) stop selling the product altogether:

When we pressed [plaintiffs] at oral argument to give an example of a strict-liability design-defect claim under any relevant state regime that would not ultimately result in some combination of the same three options for the Generic Defendants – i.e., changing the labeling . . ., changing the design of the drug, or pulling the drug from the market – they were unable to identify such a claim . . . .  Therefore, it is unnecessary for us to embark on a 28-state tour of strict-liability design-defect law.

In sum, Mensing and Bartlett recognize that manufacturers have no control over the design or labeling of generic drugs.  Short of exiting the market – which Bartlett rejects – [plaintiffs] have failed to identify anything the Generic Defendants can do to reconcile their conflicting duties under state and federal law.  Therefore, [plaintiffs’] strict-liability design-defect claims are pre-empted.

Fosamax, slip op.
at 33-34 (citations and footnotes omitted). The Third Circuit thus joins every court to have analyzed the practical question:  take away warnings, design, and removal from the market, and there’s nothing left upon which to base liability, short of a true manufacturing defect claim, which are downright rare in our neck of the woods.

Fosamax also held that the Restatement sections argued by the plaintiffs, Restatement (Second) of Torts §402A, comment k (1965) and Restatement (Third) of Torts, Products Liability §6(c) (1998) did not avoid preemption.  Comment k would necessarily require a change of a drug’s warnings or design.  Fosamax, slip op. at 29-30 n.26.  Section 6 (c) involved “a risk/utility theory” of the sort addressed by BartlettSlip op. at 18 n.16 (lots of footnotes in Fosamax).

In Fosamax “the bottom line is that [plaintiffs] placed their bets on the First Circuit’s Bartlett decision. and they lost.”  Slip op. at 17 n.15 (citation and quotation marks omitted).  The Third Circuit did not allow plaintiffs to “shape shift” their claims on appeal after the Supreme Court reversed Bartlett. Slip op. at 15.  That’s good for defendants, but not so good for us bloggers, since we’d love to report that the Third Circuit also blew out the other side’s post-Bartlett salami slicing.  Fosamax does take pains to point out that, by not addressing waived arguments, it should not be seen as endorsing them (something we wish the Supreme Court in Riegel had done with respect to parallel claims):

Our lack of comment is not a tacit endorsement of the Appellants’ negligence theory.  We have yet to hear how the Generic Defendants’ duties under negligence-based design-defect claims would be any different from their duties, discussed below, under strict-liability design-defect claims, i.e., changing the labeling, changing the composition, or removing the product from the market.

Fosamax, slip op. at 19 n.17.  We think that’s right.  As we pointed out at the time, the negligence-based stop selling theory in Lance v. Wyeth, 85 A.3d 434 (Pa. 2014), should likewise be preempted under Bartlett as the action required by state law is the same as for any strict liability design defect theory. Once a drug is approved, its design cannot be changed in any way that affects safety or effectiveness without prior FDA approval.

For the same reasons the Third Circuit refused to allow the Fosamax plaintiffs to shift their arguments towards an “absolute liability” theory after Bartlett – not that any state in the country recognizes such liability.  Fosamax, slip op. at 31-32 n.28.

Now that the Third Circuit has spoken on generic preemption, the Pennsylvania Superior Court’s unartful dodging of the same issues in the Reglan/Metoclopramide litigation is looking every bit as shaky as we thought it would.  In preemption cases,

When the Third Circuit has spoken on a federal issue . . . it is appropriate for this Court to follow Third Circuit precedent in preference to that of other jurisdictions.  Whenever possible, Pennsylvania state courts follow the Third Circuit so that litigants do not improperly “walk across the street” to achieve a different result in federal court than would be obtained in state court.

Werner v. Plater-Zyberk, 799 A.2d 776, 782 (Pa. Super. 2002); (citing Cellucci v. General Motors Corp., 676 A.2d 253, 255 n.1 (Pa. Super. 1996), aff’d, 550 Pa. 407, 706 A.2d 806 (1998)) (both addressing federal preemption issues).