A federal judge in the United States District Court for the Southern District of Florida dismissed 32 claims in the case of In Re: Zantac (Ranitidine) Products Liability Litigation. The claims were filed against parties connected with the generic forms of Zantac, the popular heartburn medication. The MDL ruled that the claims against makers, re-packagers, retailers, and distributors of the generic medicine were preempted by federal law.
The defendants’ motion to dismiss centered on the argument that the claims spoke to design defects and failure to warn—problems that the generic manufacturers could not remedy and still be in compliance with federal law. The defense stemmed from Supreme Court decisions in PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011) and Mutual Pharmaceutical Co. v. Bartlett, 570 U.S. 472 (2013).
Plaintiffs in the Zantac MDL, created in February 2020, claim that Zantac’s active ingredient, ranitidine—the same active ingredient in generic forms of the heartburn medication—breaks down into N-nitrosodimethylamine (NDMA). Studies have linked this compound to an increased risk of cancer. Zantac and generic makers and other supply-chain participants were subsequently hit with product liability claims.
Plaintiffs in the generic drug claims challenged the defendants’ motion to dismiss, arguing that preemption did not apply because their claims centered on the claim that the ranitidine drugs were “misbranded when sold.”
The court denied the plaintiffs’ argument, pointing to Mensing and Bartlett’s effect on numerous federal courts’ decisions to preempt claims against generic drug manufacturers, despite plaintiffs’ not basing their claims on design defect or failure to warn. The court further reasoned that by allowing the avoidance of pre-emption based on the products’ defects making them misbranded ““would render the vast body of pre-emption caselaw in the drug context, including binding Supreme Court decisions, meaningless.”
The plaintiffs also brought to light that the defendants could have changed expiration dates on the generic products’ packaging, shortening them to account for the drugs’ increased instability over time and an increase in NDMA levels. Although the court agreed that the expiration date claims would not be preempted, the plaintiffs’ complaints did not include claims based on expiration dates. As such, the court underscored that the expiration date claim was inconsistent with plaintiffs’ arguments that the drugs were dangerous at the point of manufacture.