Thompson v. Allergan: Further Eroding "Alternative Feasible Design" in Drug Cases?

As we previously wrote, the Supreme Court’s recent decision in Mutual Pharmaceutical Co. Inc. v. Bartlett raised the intriguing possibility that federal courts might be receptive to arguments by name brand pharmaceutical manufacturers that “feasible safer alternative design” arguments are preempted in product liability cases, due to the comprehensive nature of the FDA’s oversight of prescription medications.

Bartlett is expressly limited to the generic drug context, but in that opinion the Court found two reasons that redesign of the generic drug was not possible. The first was that the generic must be equivalent to the branded drug. The second, and far more interesting analysis, noted that any alteration to the chemical composition of the drug (the alternate design that is proposed to be “feasible” and “safer”) results in an entirely different drug that would require new FDA approval.

The U.S. District Court for the Eastern District of Missouri has recently issued an opinion, relying on Bartlett, that arguably takes us a step closer to this result for branded drugs. The case is Thompson v. Allergan USA, Inc., 2014 U.S. Dist. LEXIS 10081, 2014 WL 308794 (E.D. Mo. Jan. 28, 2014).

Thompson was a putative class action brought by consumers who challenged the dosage regimen of the eye drop Restasis®. Plaintiff contended that the single-use vials of Restasis® contain more than the prescribed dosage of a single drop of the medication per eye, but that prescribing information required them to discard the excess medication after administering a single dose. Plaintiff claimed that she and other Missouri consumers suffered economic damages as a result of the waste created by the packaging of Restasis®, which she argued resulted in an unnecessarily high price for the medication. Plaintiff brought claims on behalf of herself and a purported class of Missouri consumers for violations of the Missouri Merchandising Practices Act (“MMPA”), unjust enrichment, and money had and received.

Thompson is not a product liability case, and plaintiff did not advance a theory of a “feasible safer alternative design.” Plaintiff did, however, argue that Allergan should have made use of an alternative design for its product that eliminated the waste occasioned by the dosing regimen and the requirement that the vials be discarded after a single use. Plaintiff argued that each single-use vial should have contained less medication.

Allergan argued (1) that plaintiff failed to state a claim, and (2) that federal law preempted plaintiff’s claims because Allergan was unable to reduce the amount of medicine in each vial without prior FDA approval. The court’s disposition of the failure to state a claim argument is consistent with the existing body of law with respect to “unfair practices” acts like the MMPA, finding that the plaintiff received the “benefit of the bargain” and that Allergan did not misrepresent what it was selling.

The district court explicitly relied upon Bartlett for its analysis of the preemption argument. The Thompson court found that plaintiff’s claim was preempted because Allergan was not permitted, under FDA regulations, to lower the volume in each vial of Restasis® on its own initiative without FDA approval. 2014 U.S. Dist. LEXIS 10081, *15-16. The court also, notably, rejected plaintiff’s argument that Allergan bore the burden of proving that the FDA would have denied a request to make the volume change, another pet theory that plaintiffs advance in “feasible alternative design” product liability cases, and did so by relying upon PLIVA, Inc. v. Mensing, 131 S. Ct. 2567, 2579 (2011) (a generic labeling case).

Thompson, while not a product liability case, is notable both for its holding that “alternative design” arguments with respect to FDA-approved medications were preempted, and for drawing upon Bartlett and PLIVA in a “brand name” drug case. We have long argued that drug design defect claims, whether they are directed at generic or braded drugs, should be barred as a matter of law, because any “alternative design” of a drug is an entirely different drug from the one approved by the FDA. Any finding that a drug is “defectively designed” is simply an opinion that the FDA should never have approved the drug, which is preempted. We think the district court reached the correct result, and will monitor this case for any appellate developments.