Current Edition

Florida judge rules for generic, over-the-counter manufacturers of Zantac knockoffs, backing preemption claim

In dismissing claims against manufacturers of generic and over-the-counter versions of heartburn medicine Zantac, a U.S. District court judge in Florida has upheld the preemption argument, a long-standing legal position that the pharma industry is using with increasing effectiveness.

At issue is whether FDA labeling decisions should protect drugmakers from claims made in state court.

Judge Robin Rosenberg’s decision in the multidistrict litigation (MDL) case affirms the position and is likely to have sweeping consequences, influencing more than 1,400 other related claims that have been referred to the Southern District of Florida.

The recent decision in Florida surrounded ranitidine, the active ingredient of GlaxoSmithKline’s Zantac, which has been shown to transform over time into a cancer-causing agent, N-nitrosodimethylamine (NDMA). Over the last few years, Zantac, which was approved in 1983, and other OTC and generic drugs containing ranitidine have been pulled from shelves.

In September 2019, the FDA originally established an acceptable daily intake of NDMA at 96 nanograms. But in April of last year, the agency requested manufacturers to pull all drugs containing ranitidine off the market.

Plaintiffs around the country had already initiated lawsuits against the manufacturers of the heartburn drugs, and in February 2020, the MDL was established. Additionally, “tens of thousands,” according to court documents, have registered claims without filing lawsuits.

Plaintiffs sued the manufacturers for multiple counts including failure to warn and negligence. But Judge Robin Rosenberg dismissed the claims, citing preemption.

“State law would require them to redesign or re-label ranitidine products, which they could not do under their federal duty of sameness,” Rosenberg wrote. “They were not required to stop selling the products in order to comply with both federal and state law. Thus, the failure-to-warn and negligence claims are preempted.”

This was the second round of claims that the court rejected. In the first round, the plaintiffs’ claims of design defect and failure to provide warning also were preempted.

The court gave the plaintiffs a chance to replead based on matters including expiration dates and storage and transportation conditions of the drugs. But giving them another opportunity “would be futile,” Rosenberg wrote.

“At some point the pleadings must begin to close and that time has come,” read the court document. “The court’s dismissal of the plaintiffs’ claims against the generic manufacturer and store-brand defendants is without leave to amend.”

Two years ago, in a decision involving Merck and its osteoporosis medication Fosamax, the Supreme Court ruled unanimously that failure to warn claims made at the state level are a question of law to be decided in court and not a question of fact to be decided by a jury. The decision overturned an appeals court ruling that the preemption question should be decided by a jury trial.