Generic Zantac Suit Falls to Preemption

A Florida federal court has ruled that state labeling and design defect claims in a multidistrict suit against the makers, repackagers, retailers, and distributors of generic forms of Sanofi’s Zantac are preempted by federal law. Attorney Kaitlyn Stone (Faegre Drinker) says the court dismissed claims against 32 generic manufacturers and distributors.

The plaintiffs allege that the Zantac and generics active ingredient ranitidine breaks down into N-nitrosodimethylamine, part of a group of compounds that have been shown to increase the risk of cancer. FDA asked Sanofi and generic manufacturers to recall prescription and over-the-counter ranitidine products 4/2020.

The plaintiffs said their claims should not be preempted because they were based on an allegation that the products were misbranded when sold.

However, the court said that no court has adopted the plaintiffs’ theory that impossibility preemption can be avoided by pleading that a drug is misbranded.