Products Liability Law Daily Manufacturer of Zofran® not liable for generic version injuries
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Wednesday, May 23, 2018

Manufacturer of Zofran® not liable for generic version injuries

By Jeffrey H. Brochin, J.D.

GlaxoSmithKline LLC, the manufacturer of Zofran® (Ondansetron), was not liable for injuries sustained by pregnant women who ingested generic versions of the drug, a federal district court in Massachusetts ruled. Accordingly, the complaints of patients from Connecticut, New Jersey, and Oklahoma who filed multi-district litigation pleadings were dismissed (In re Zofran (Ondansetron) Products Liability Litigation, May 21, 2018, Saylor, F.).

The MDL proceeding arose out of claims that the use of the drug Zofran by pregnant women caused birth defects, and that the manufacturer negligently and fraudulently promoted Zofran to treat pregnancy-related nausea and vomiting despite its knowledge of risks associated with taking the drug during pregnancy. Certain patients also alleged that the brand manufacturer should be liable for injuries caused by the ingestion of the generic formulation due to the widespread off-label promotion of Zofran by GlaxoSmithKline (GSK)—by which it created a market for the drug’s use to treat pregnancy-related nausea that led to the use of generic alternatives—and therefore should be liable for all injuries created by those products.

Previous dismissal of generic-only claims. In August 2017, the court granted GSK’s motion to dismiss the claims of six patients who alleged that they ingested only the generic formulation of the drug. The court found that the relevant states would not impose liability on a brand-name manufacturer for injuries caused by ingestion of generic drugs. It also denied the request for certification. In October 2017, GSK moved for judgment on the pleadings on the claims of seven additional patients who alleged that they ingested the generic version of the drug. As a result of voluntary dismissals, only three cases subject to the motion remained to be decided.

Case law in relevant states. The court surveyed recent holdings in the three states of the patients for whom motions to dismiss were pending, and determined that under Oklahoma, Connecticut, and New Jersey law, GSK could not be held liable for injuries sustained by patients who ingested the generic versions of Zofran. The majority view is that patients injured by generic products cannot recover against brand-name manufacturers, although a minority view permits recovery, at least under some circumstances. Although the minority view has gained ground in the last year in California and Massachusetts opinions, the court found that this was not sufficient under the circumstances to tip the balance.

For the foregoing reasons, GSK’s motion for judgment on the pleadings as to the three remaining patient claims was granted.

The case is No. 1:17-cv-10062-FDS.

Attorneys: Joseph M. Barnes (The Reardon Law Firm, PC) for Casey Buker. Christopher T. Hellums (Pittman Dutton & Hellums, PC) and Kimberly Barone Baden (Motley Rice LLC) for Zofran [Ondansetron]. Amber Davis-Tanner (Quattlebaum, Grooms & Tull PLLC) and Bryan A. Coleman (Maynard Cooper & Gale PC) for GlazoSmithKline LLC. Jennifer M. Stevenson (Shook, Hardy & Bacon LLP) for GlaxoSmithKline, LLC. Erin McCalmon Bosman (Morrison & Foerster LLP) for McKesson Corp.

Companies: Zofran [Ondansetron]; GlazoSmithKline LLC; GlaxoSmithKline LLC; McKesson Corp.

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