In early January 2021, U.S. District Court Judge Robin Rosenberg moved to dismiss economic damages and design defect claims against major drugmakers in the ongoing Zantac multidistrict litigation. Judge Rosenburg ruled that these claims against Sanofi, GlaxoSmithKline, Pfizer, and Boehringer Ingelheim were preempted by the Federal Food, Drug, and Cosmetic Act.
In Re: Zantac
In 2019, the U.S. Food and Drug Administration (FDA) launched an investigation into whether ranitidine—the active ingredient of Zantac—increases levels of N-nitrosodimethylamine (NDMA) in users. NDMA is a probably human carcinogen, meaning it is potentially cancer-causing. In April 2020, the FDA requested that all ranitidine medication manufacturers remove their products from the market.
The plaintiffs in the cases making up this MDL filed lawsuits alleging that they developed cancer after using ranitidine. The cases involve a number of various claims, including negligence, violation of state consumer protection laws, and design defect claims, among others. The design defect allegations also include arguments that the defendant drugmakers should have changed the design of the ranitidine in response to the initial FDA investigation.
These cases were consolidated by the U.S. Judicial Panel on Multidistrict Litigation (MDL) in February 2020. The panel assigned the cases—now totaling more than 500—to Judge Rosenberg in the U.S. District Court for the Southern District of Florida.
The cases have been filed under three master complaints. One of the master complaints alleges personal injury to consumers. One is a consolidated class action complaint on behalf of a proposed class including all Zantac purchasers. Finally, the third case is by third-party payors.
The Preempted Claims
In August 2020, the defendants moved to dismiss the portions of the complaints that dealt with state law economic injury, and with design defects. The defendant drugmakers argued that both types of claims were preempted by the Food, Drug, and Cosmetic Act (FDCA).
Specifically, the defendants argued that the FDCA explicitly preempts state law claims that seek to recover the purchase price of over-the-counter medications, such as ranitidine medications like Zantac. They argued that the design defect claims were preempted because there was no way to change the design of the ranitidine medication without violating FDA requirements.
The plaintiffs argued that their state law and design defect claims were not preempted by the FDCA because the claims were based on the fact that the ranitidine products were “misbranded when sold.”
Despite the plaintiffs’ arguments, Judge Rosenberg agreed with the defendants, dismissing the design defect claims with prejudice. However, the judge did give the plaintiffs permission to re-file narrower design defect claims, as long as those claims focus on changes that the defendants could have made without violating FDA requirements.
Predictions for the Zantac MDL
In making its ruling, the court relied on two Supreme Court decisions, PLIVA, Inc. v. Mensing and Mutual Pharmaceutical Co. v. Bartlett. The court noted that Mensing and Bartlett have established the precedent that many different categories of claims against generic drug manufacturers are preempted by the FDCA. Further, this preemption has occurred even in the absence of explicit allegations of design defects or failure to warn.
Courts have also found claims of failure to conduct testing, violation of consumer protection laws, and breach of warranty to be preempted in previous cases. The courts have also found that misrepresentation, similar to the “misbranding” claim made in this case, is preempted by the FDCA.
Judge Rosenberg followed this line of reasoning, holding that “finding that Plaintiffs can avoid pre-emption by alleging that defects in ranitidine products made the products misbranded would render the vast body of pre-emption caselaw in the drug context, including binding Supreme Court decisions, meaningless.” The state labeling and design defect claims had the potential to affect not only the makers of ranitidine, but also re-packagers, retailers, and distributors. By dismissing these claims, the court affected the claims facing 32 makers and distributors of ranitidine.
The court’s willingness to consider narrower design defect claims, meanwhile, could result in at least one new area of argument: claims that the defendants should have changed the expiration dates on the ranitidine they manufactured, packaged, or sold. Since some evidence indicates that NDMA levels increased in the medication over time, plaintiffs may attempt to argue that the defendants should have changed the expiration dates in order to help protect patients from exposure to excessive levels of NDMA.
Whether such an argument will succeed, however, will depend in part on the experts asked to opine on whether and how NDMA levels increase in aging ranitidine, as well as how that NDMA might have affected plaintiffs who now blame it for their cancer. Experts in pharmacology, toxicology, oncology, and related fields will likely be called upon to opine.