U.S. District Judge Robin L. Rosenberg ruled that state design defect claims against name-brand Zantac makers such as Pfizer Inc. and Sanofi-Aventis U.S. LLC are preempted by the Federal Food Drug and Cosmetic Act. The judge ruled that it was impossible for the companies to change the drug’s formulation without FDA approval.
Judge Rosenberg rejected consumer and third-party-payer arguments that their claims are not preempted by federal law. They had argued that Zantac was misbranded because its maker failed to disclose that it contained a cancer-causing substance.
The judge said: “As with generic drugs [which are preempted from injury litigation by federal law], 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 ruling follows another set of rulings the judge issued on Jan. 1. He ruled then that state labeling and design defect claims against Zantac generics makers, repackagers, retailers, and distributors are preempted by federal law.
In general, the suits accuse Pfizer Inc., Sanofi SA Inc., GlaxoSmithKline LLC, generic drug makers, distributors, pharmacies, and others in the supply chain, of false advertising, failure to warn, and other claims associated with the discovery of the cancer-causing chemical nitrosodimethylamine (NDMA).
In September 2019, the FDA warned that NDMA trace amounts were found in Zantac and similar generic drugs. On April 1, FDA pulled all prescription and over-the-counter drugs featuring ranitidine (the active ingredient) from the market over concerns that the drug could produce unacceptable levels of the carcinogen when stored above room temperature.
Though FDA has set an allowable daily limit of 96 nanograms of NDMA, researchers have found more than 3 million nanograms in a single dose of Zantac. NDMA can also be found in red meat, tobacco, and beer.
Since February 2020, plaintiffs have filed three separate master complaints against the Zantac defendants. These include a personal injury complaint, a proposed nationwide consumer class action, and a proposed class action on behalf of third-party payers.
For the Plaintiffs’ Side
For the plaintiffs’ side, Judge Rosenberg did say plaintiffs correctly argued that some state laws take the adequacy of a drug’s labeling into consideration as part of a design-defect claim.
The judge said that since a brand-name drug maker can strengthen warnings on drug labels without waiting for the FDA’s approval (as part of the agency’s changes being effected process), a labeling claim against a branded drug maker is not necessarily preempted.
Some Zantac claims remain viable
“Therefore,” the judge said, “the plaintiffs are granted leave to replead design-defect claims against the defendants that are based on the labeling of ranitidine products.”
“This ruling gives us a chance to continue moving forward with Zantac cancer claims,” said Houston attorney David Matthews. “It provides clarity to help us move forward.”
As a result of Judge Rosenberg’s order and orders issued in late December, plaintiffs may re-plead all claims against certain groups of Defendants and other claims against all groups of Defendants.
The rulings could help some 60,000-plaintiffs diagnosed with cancer who have already submitted claims to the MDL registry. Another 1,000 or so Zantac cases have been filed in federal and state courts across the country.
Judge Rosenberg also dismissed state law claims seeking to recoup monetary losses from buying over-the-counter ranitidine. The judge found that Congress did not intend for any state to classify a claim as a product liability claim when the plaintiff was not personally injured.
The case is In re: Zantac (Ranitidine) Products Liability Litigation, case number 9:20-md-02924, in the U.S. District Court for the Southern District of Florida.