Federal Judge Rids Labeling Claims in Zantac MDL

A Florida federal judge presiding over sprawling multidistrict litigation involving the carcinogens found in the heartburn medication Zantac cut more claims from the litigation, holding that design defect claims are barred by federal law.

The judge rejected arguments by consumers and third-party payers that their claims are not preempted because the heartburn drug was misbranded, as the presence of a cancer-causing substance in the drug was not disclosed.

“As with generic drugs, a claim based on an allegation that a brand-name drug’s FDA-approved formulation renders the drug misbranded is a pre-empted claim because the drug’s manufacturer cannot independently and lawfully change a drug formulation that the FDA has approved,” the judge said.

The FDA issued a warning in September 2019 that trace amounts of NDMA were found in Zantac and similar generic drugs. On April 1, they pulled all prescription and over-the-counter drugs featuring ranitidine – the active ingredient in heartburn medications – from the market over concerns that the drug, when stored above room temperature, could produce unacceptable levels of carcinogen.

Since a brand-name manufacturer can strengthen warnings on drug labels without waiting for the FDA’s sign-off – as part of the agency’s changes being effected process – a labeling claim against a branded drug manufacturer isn’t necessarily preempted, the judge said.

“Therefore, the plaintiffs are granted leave to replead design-defect claims against the defendants that are based on the labeling of ranitidine products,” the judge said.

The judge also dismissed state law claims seeking to recoup monetary losses from buying over-the-counter ranitidine, finding the Congress didn’t intend for any state to classify a claim as a product liability claim when the plaintiff was not personally injured.