Academic journal article Defense Counsel Journal

Taking the "Product" out of Product Liability: Litigation Risks and Business Implications of Innovator and Co-Promoter Liability

Academic journal article Defense Counsel Journal

Taking the "Product" out of Product Liability: Litigation Risks and Business Implications of Innovator and Co-Promoter Liability

Article excerpt

PLAINTIFF files a lawsuit claiming that her use of a prescription medication caused her to sustain injuries. Brand Pharmaceuticals did not manufacture the drug and therefore cannot be liable to Plaintiff, right? Not necessarily. Two emerging theories of liability, so-called "innovator liability" and "co-promoter liability," aim to hold a non-manufacturer responsible for injuries caused by another company's pharmaceutical product. Under innovator liability, a pharmaceutical manufacturer may be liable for injuries caused by a competitor's generic version of its brand drug based on its supposed responsibility for the drug's prescribing information. Under co-promoter liability, a company that contracts to market another manufacturer's pharmaceutical product may be liable based solely on its marketing activities. This article explores the theories underlying these novel sources of liability and proposes business strategies to consider that could help mitigate these emerging risks.

I. Traditional Tort Doctrine Limits Product Liability to the Manufacturer of the Product.

By asserting innovator and co-promoter liability, plaintiffs are attempting to circumvent well-established tort law principles. It is axiomatic that "[a] fundamental principle of traditional products liability law is that the plaintiff must prove that the defendant supplied the product which caused the injury." (1) A plaintiff suing for alleged injuries from a pharmaceutical product (or medical device) must identify the actual defendant that manufactured the product she alleges injured her. (2)

When advancing theories of innovator and co-promoter liability, plaintiffs target defendants they acknowledge played no role in manufacturing or supplying the drug that allegedly caused their injury. These theories require courts to suspend traditional tort law doctrines of causation and duty and have, for that reason, largely been rejected. However, as discussed below, a handful of jurisdictions have viewed these theories more favorably.

II. Innovator Liability Against Brand Manufacturers for Generic Drugs

A. Background: Hatch-Waxman Act, Wyeth v. Levine, and PLIVA v. Mensing

The roots of innovator liability can be found in the Drug Price Competition and Patent Term Restoration Act of 1984, commonly referred to as the "Hatch-Waxman Act." (3) Designed to facilitate the entrance of generic drugs into the pharmaceuticals market, the Hatch-Waxman Act relaxed the requirements for U.S. Food and Drug Administration (FDA) approval for those drugs. Instead of having to leap the same clinical hurdles as the original drug sponsor, generic manufacturers need only demonstrate that their product is "the same as" an existing brand drug, meaning that it is bioequivalent to its brand counterpart and has the same active ingredient(s), route of administration, dosage form, and strength. (4) Other than routine information reflecting the different manufacturer or distributor, the generic drug also must have "the same" prescribing information, i.e. label, as the brand drug (i.e., the reference listed drug) on which its approval was based. (5)

This requirement of "sameness" is key to two recent U.S. Supreme Court decisions addressing federal preemption that appear to have reinvigorated innovator liability arguments. In Wyeth v. Levine, the Court held that FDA's approval of a brand drug's prescribing information did not preempt state-law failure-to-warn claims because the brand manufacturer had discretion under FDA's "changes being effected" (CBE) regulation to unilaterally strengthen a drug warning. (6) Two years later, however, the Court held in PLIVA, Inc. v. Mensing, that failure to warn claims against generic manufacturers were preempted because--due to the Hatch-Waxman Act's sameness requirement generic manufacturers cannot use the CBE process to unilaterally change their labels. (7)

In the post-Hatch-Waxman age, approximately 80% of prescriptions are filled with generic pharmaceuticals. …

Search by... Author
Show... All Results Primary Sources Peer-reviewed


An unknown error has occurred. Please click the button below to reload the page. If the problem persists, please try again in a little while.