Brand Name Preemption: The New Frontier in Pharmaceutical Product Liability Litigation

72 Food & Drug L.J., 2017

24 Pages Posted: 20 Jun 2017 Last revised: 8 Nov 2017

See all articles by Eric Lindenfeld

Eric Lindenfeld

University of Minnesota - Minneapolis

Date Written: June 19, 2017


Over the past half-decade, the Supreme Court has issued a succession of opinions that have preempted all product liability claims made against the manufacturers of generic pharmaceuticals. While plaintiffs have attempted to evade these rulings through innovative legal theories, to date, they have been largely unsuccessful. As a result, lawsuits against brand name manufacturers have increased dramatically. Despite these developments, the implementation of clear preemption principles with regards to brand name products has lagged. While the Supreme Court has, on one occasion, attempted to clarify brand name preemption, the guidance was vague, cryptic and has led to a hodgepodge of conflicting judicial decisions. This confusion has led legal experts, academics and practitioners to call upon the Court to revisit the field of brand name preemption.

This Article is an attempt to assemble, centralize and clarify the most misunderstood areas of brand name preemption. It is also an attempt to forecast the future of some of the most uncertain areas underlying the field. It is cautioned that this Article does not attempt to offer a solution to the growing judicial inconsistencies concerning brand name preemption. Nor should this Article be read to endorse either side of the preemption debate. Rather, it is the hope of the author that the Article generate greater interest in the field of pharmaceutical product liability litigation and stimulate a deeper discussion into its ultimate fate. At the very least, the investigation conducted herein should function as a useful starting point for the academic, judge or practitioner who has found themselves in the marsh that is brand name preemption.

Suggested Citation

Lindenfeld, Eric, Brand Name Preemption: The New Frontier in Pharmaceutical Product Liability Litigation (June 19, 2017). 72 Food & Drug L.J., 2017, Available at SSRN:

Eric Lindenfeld (Contact Author)

University of Minnesota - Minneapolis ( email )

110 Wulling Hall, 86 Pleasant St, S.E.
308 Harvard Street SE
Minneapolis, MN 55455
United States

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