Federal Judge Rules Several Zantac Claims As Preempted

Federal Judge Rules Several Zantac Claims As Preempted

Introduction

Last week, a separate order was issued concerning the growing Zantac multidistrict litigation in which Judge Robin L. Rosenberg of the U.S. District Court for the Southern District of Florida dismissed a majority of the state product liability claims, stating that they are preempted by federal law.

Zantac (ranitidine hydrochloride) is an antacid and an H2 (histamine-2) receptor blocker used for treating and preventing ulcers in the duodenum, stomach, and intestines. It is also used for treating erosive esophagitis, heartburn, gastroesophageal reflux disease-GERD, Zollinger-Ellison syndrome. In 1983, Glaxo Holdings Ltd, a company which is a part of GlaxoSmithKline PLC, received approval from the FDA to sell Zantac in the U.S. However, owing to patent expiry in 1987 in the United States, Glaxo had to face stiff competition by the generic alternatives launched immediately by competitors. Since 2017, the OTC version of Zantac was marketed by Sanofi in the United States and Canada. In 2004, Pfizer gained FDA approval to sell the Zantac OTC in the United States.

According to the December 31 order, Judge Rosenberg contended that state labeling and design defect claims against 32 Zantac generics makers, retailers, and distributors are preempted as the companies cannot alter brand-name drug labels or designs independently and comply with labels approved by the U.S. Food and Drug Administration (FDA).

The plaintiff had filed three separate master complaints against the defendants, which included a personal injury complaint, a proposed nationwide consumer class action, and a proposed class action on behalf of third-party payers. The defendants argued to toss the state claims stating that they are preempted by federal law as they would have had to seek permission or assistance from the federal government to make changes to the drug to adjust with state law requirements.

The judge dismissed the claims on preemption ground but gave the plaintiffs 30 days to replead their allegations based on the drugs' expiration dates, testing, storage and transportation conditions, FDA warnings, manufacturing defects, and warranty breaches.

In September 2019, the FDA issued a warning stating that it found traces of NDMA in Zantac and similar generic drugs. Earlier this year, the federal agency requested manufacturers to discontinue all versions of Zantac from the market. Several studies were also published last month that strengthened the problems associated with Zantac.

The litigation, which comprises approximately 1,000 lawsuits and is presided by Judge Rosenberg, alleges Pfizer Inc., Sanofi SA, Boehringer Ingelheim Pharmaceuticals Inc., and GlaxoSmithKline LLC, along with generics makers, distributors, pharmacies, and others in the supply chain, of misleading advertising, failure to warn, and other claims associated with the presence of cancer-causing chemical N-Nitrosodimethylamine (NDMA) in popular heartburn drug.

According to a study published in the medical journal Organic Process Research & Development, U.K researchers who are working with GlaxoSmithKline (GSK), the Zantac manufacturer have suggested that Zantac degrades the active pharmaceutical ingredient ranitidine which results in the formation of the cancer-causing chemical N-nitrosodimethylamine (NDMA).