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Branded Pharmaceutical Company Liability for Generics: The Zofran Case

Branded Pharmaceutical Company Liability for Generics: The Zofran Case

Despite intense regulation by federal agencies and rigorous testing by the medical and pharmaceutical industries, drugs sometimes cause unexpected side effects. When side effects are severe enough to cause long-term health problems, the affected patients may want to sue the drug manufacturer for compensation. These complex cases involve many moving parts, especially if the drug involved was a generic equivalent of a branded drug. A case last year in Massachusetts highlighted the challenges faced by plaintiffs.

Zofran is allegedly linked to birth defects

Pharmaceuticals manufacturer GlaxoSmithKline (GSK) produces Zofran (generically, Ondansetron), an anti-nausea medication. One of the common uses of Zofran is to treat morning sickness in pregnant women. Although the U.S. Food and Drug Administration has approved Zofran for use treating nausea generally, it has not approved it as a treatment for morning sickness.

Since 2015 a wave of lawsuits has been brought against GSK arguing that Zofran causes birth defects such as heart problems, cleft palates, and skull deformities. Hundreds of plaintiffs have filed suit arguing that GSK knew as early as 1992 that Zofran posed a risk of defects, misrepresented and suppressed that risk, and should be held liable for the resulting injuries. Readers should bear in mind that the science behind this claim is not clear: a 2016 study published by UCLA found no link between Zofran use and birth defects.

Is GSK responsible for generic forms of Zofran?

One of the interesting legal questions raised by the Zofran litigation is whether GSK can be sued for injuries allegedly caused by generic versions of its drugs. Such lawsuits face complex hurdles. Generic drug manufacturers are exempt from state-law tort liability. But the branded manufacturer has no control over the manufacture or sale of generic equivalents of its medicines, which can leave injured plaintiffs without legal recourse, at least under state products liability theories. See PLIVA, Inc. v. Mensing, 564 U.S. 604, 624 (2011).

In the multidistrict litigation case In re Zofran Ondansetron Prods. Liab. Litig., 261 F. Supp. 3d 62 (D. Mass. 2017), numerous plaintiffs argued that GSK is responsible for injuries by the generic equivalent of Zofran because GSK created a market for Zofran as a treatment for morning sickness when the FDA had not approved that use and GSK allegedly knew of the risk of birth defects. A central issue in the case is a federal law requirement that generic drugs carry the same FDA-approved label as their branded equivalent. Therefore, the plaintiffs argued, the generic manufacturer could do nothing to remedy GSK’s failure to include warnings about potential side-effects for pregnant women.

The court in In re Zofran granted GSK’s motion for summary judgment, citing a long string of precedent holding that branded manufacturers cannot be held liable for injuries caused by generic equivalents of their products. (Among the cases cited by the court was a case involving similar issues under Nevada law, Moretti v. Wyeth, Inc., 579 Fed. Appx. 563, 565 (9th Cir. 2014)). The court also refused the plaintiffs’ request to certify a question of law to the plaintiffs’ various home state courts, which would have asked them to opine on whether a brand-name manufacturer was immune from liability under state misrepresentation laws for creating a market for an unapproved use of its drug. The court’s reasoning again highlights the problem plaintiffs face in these cases: because the question assumed facts that were not in evidence (misrepresentations by GSK created a market, resulting in injuries) the court concluded that certification was not appropriate, even where state law permitted it.

GGRM is a Las Vegas personal injury law firm

The Zofran litigation highlights challenges faced by people who are injured by prescription drugs. When a medicine causes a serious problem it’s important to consult with an attorney to understand what may be required to pursue compensation from the drug manufacturer. The law firm of Greenman Goldberg Raby Martinez has represented injured clients in the Las Vegas area for over 45 years. Call us today for a free attorney consultation at 702-388-4476 or send us a request on our contact page.