Zantac, and its generic name, ranitidine, have been on the market since 1983 for the treatment of heartburn and acid reflux. By 1988, it was one of the world’s top-selling drugs, earning $1 billion in annual sales. By 2004, over-the-counter versions became available, and physicians were writing more than 25 million prescriptions annually by 2018.
In September 2019, Valisure and Valisure RX, a pharmacy and testing lab, filed a citizen petition requesting a recall of all ranitidine products. The petition cites high levels of N-nitrosodimethylamine (NDMA), a known carcinogen. Valisure claimed it found over 3,000,000 nanograms of NDMA in tested ranitidine samples. These results were over 31,000 times more than the acceptable daily limit of 96 nanograms. The U.S. Food & Drug Administration (FDA) issued a warning concerning this finding. One ranitidine manufacturer, Sanofi, voluntarily recalled some of its prescriptions. Some pharmacies and retailers also suspended sales.
By November 2019, the FDA released test results stating that levels of NDMA found in samples were similar to those in common foods. The results concluded that the ranitidine would not form NDMA in the intestines. However, the FDA also found that some of its samples contained high levels of NDMA. The FDA then requested companies issue voluntary recalls. Later, new testing determined that NDMA concentration in the drug could increase over time, particularly when stored in high temperatures. By April 2020, the FDA requested manufacturers withdraw all ranitidine products from the market.
The Lawsuits in the Zantac MDL
In September 2019, plaintiffs filed the first class action against Zantac manufacturers, Sanofi and Boehringer Ingelheim, in California federal court. The lawsuit alleged negligence, design defects, and failure to warn claims concerning the amounts of NDMA present in its products. A second lawsuit was filed in New Jersey federal court a week after, alleging similar claims. By February 2020, plaintiffs filed over 100 similar lawsuits across various districts. This warranted the creation of a multidistrict litigation consolidating proceedings in the Southern District of Florida. The plaintiffs are pursuing both federal and state claims.
The allegations against the defendant manufacturers were consolidated into master complaints. One complaint was on behalf of consumers who suffered personal injuries, such as the development of cancer. Another complaint was filed on behalf of all Zantac purchasers for economic losses and for those who will need medical monitoring. The other complaint was on behalf of third-party payors of the product. Since the time of consolidation, over 1,400 plaintiffs have filed lawsuits in the Southern District of Florida. Furthermore, tens of thousands of potential plaintiffs registered with the Court’s Census Registry.
Defendants’ Motion to Dismiss
Last August, the generic and store-brand manufacturer defendants moved to dismiss the claims against them. The defendants alleged that the Food, Drug, and Cosmetic Act (FDCA) preempted claims alleging economic injuries and design defects. Judge Robin Rosenberg of the U.S. District Court for the Southern District of Florida, found the U.S. Supreme Court precedent did establish a number of categories of claims against generic drug manufacturers that the FDCA preempted. In terms of generic labels and designs, it would be impossible for generic drugs to comply with individual state requirements without the FDA first taking action.
Arguments in the Zantac MDL
The plaintiffs argued the defendants misbranded their products (a provision to the FDCA that provides a preemption exception). However, the court found that such an interpretation of the FDCA would permit a plaintiff to avoid preemption “simply by asserting” that a drug’s labeling is “false or misleading…” and “would render preemption case law meaningless.” The court sided with the defendants but gave plaintiffs leave to amend their complaints with more narrowly defined design defect claims.
Plaintiffs’ subsequent pleadings, however, did not pass the court’s muster. For claims that manufacturers didn’t warn the FDA of the product’s dangers, the defendants argued that the claims were preempted. The relevant state-law is the duty to warn consumers. Manufacturers could not have satisfied that duty while complying with federal law. In addition, only the United States could enforce FDCA requirements on drug manufacturers. The court agreed.
Plaintiffs also alleged that the manufacturers failed to warn as to proper expiration dates. NDMA increases in the products over time, especially when stored in high humidity. According to the plaintiffs, manufacturers breached their duty to warn by failing to shorten expiration dates. Moreover, the plaintiffs claimed the defendants breached their duty in the products’ transportation and storing. The plaintiffs asserted that the FDCA did not preempt these claims. The court held that these alleged “sub-duties” are not separate torts. Rather, they are different theories of breach under ordinary negligence, and thus, preempted under the FDCA.
Possible Future Litigation
The court dismissed all claims against the generic and store-brand manufacturers without leave to amend in light of the plaintiffs’ failure to remedy the deficiencies of its past pleadings. However, 1,400 lawsuits are still pending, and plaintiffs have filed 70,000 potential new claims with the court concerning other defendants. There is a pending briefing schedule for the first bellwether trials, which are tentatively scheduled to begin in 2023.