By Nadine E. Roddy, J.D.
Claims based on a failure to make changes to the FDA-approved design that the pharmaceutical companies could not lawfully have made were dismissed with prejudice.
Product liability claims in a multi-district litigation brought against pharmaceutical companies that produced and sold Zantac® and its generic forms containing ranitidine were preempted by federal law, a federal district court sitting in Florida has held. Claims based on failure to make changes to the Food and Drug Administration (FDA)-approved design that the companies could not lawfully have made independently were dismissed with prejudice, while design claims based on labeling defects were dismissed with leave to re-plead. The court also granted leave to plead pre-FDA-approval design defect claims in the first instance (In re: Zantac (Ranitidine)Products Liability Litigation, January 8, 2021, Rosenberg, R.).
Background. Consumers of the pharmaceutical product Zantac and its generic forms, which are sold as heartburn and gastric treatments, brought product liability suits under federal and state law after it was discovered that the active ingredient ranitidine can transform into a cancer-causing agent. The FDA, the Environmental Protection Agency (EPA), and an international agency consider the agent to be a probable human carcinogen, and the FDA has set the acceptable daily intake level of the agent at 96 nanograms. On April 1, 2020, the FDA requested the voluntary withdrawal of all ranitidine products from the market.
A multi-district litigation was created for all pretrial purposes, and hundreds of consumers filed lawsuits in, or transferred their lawsuits to, the designated federal district court. The court created a Census Registry in which thousands of claimants who had not filed lawsuits registered their claims. In three Master Complaints, the consumers asserted federal claims as well as state claims under the laws of all 50 states, Puerto Rico, and the District of Columbia. The named defendants allegedly designed, manufactured, tested, marketed, distributed, labeled, packaged, handled, stored, and/or sold ranitidine products. Various groups of defendants filed a Rule 12 partial motion to dismiss the Master Complaints as preempted by the federal Food, Drug, and Cosmetic Act (FDCA) and other federal laws.
Master Personal Injury Complaint (MPIC). The MPIC plaintiffs alleged that they had developed cancers from taking ranitidine products. Each plaintiff individually sought compensatory damages, punitive damages, restitution, and all other available remedies. The complaint asserted 15 counts based on theories of strict product liability, negligence, breach of warranty, violation of consumer protection and deceptive trade practices laws, and others. The defendants contended that the design defect claims were preempted because the pharmaceutical companies could not have changed the design of ranitidine products without FDA approval while remaining in compliance with federal law.
Consolidated Consumer Class Action Complaint (CCCAC). One hundred eighty-three named individuals brought the CCCAC on behalf of themselves and all others similarly situated pursuant to Rule 23. They asserted 314 counts against various groups of defendants, including RICO violations, unjust enrichment, Magnuson-Moss Warranty Act violations, fraud, and negligence.
Grant of motion to dismiss. After an extensive analysis of the law of federal preemption and its application to state law claims involving pharmaceutical products, the court dismissed with prejudice all claims in all three Master Complaints that were based on failure to make changes to the FDA-approved design that the pharmaceutical companies could not lawfully have made independently. The court dismissed with leave to re-plead the design defect claims based on labeling defects, and it also granted leave to plead pre-approval design defect claims in the first instance. The claims seeking reimbursement for purchases of over-the-counter ranitidine products also were dismissed with prejudice, as they were not premised upon injury to a plaintiff’s person or property. Thus, they were not saved from express preemption under 21 U.S.C. section 379r(e).
The case is No. 9:20-md-02924-RLR.
Attorneys: J. Kyle Bachus (Bachus & Schanker, LLC) for Zantac (Ranitidine) Products Liability Litigation. Alex Cameron Walker (Modrall, Sperling, Roehl, Harris & Sisk, P.A.) for Glenmark Pharmaceuticals, Inc. USA. Ann Querns (Blank Rome LLP) for Apotex Corp.
Companies: Glenmark Pharmaceuticals, Inc. USA; Apotex Corp.
MainStory: TopStory PreemptionNews DrugsNews DesignManufacturingNews WarningsNews FloridaNews
Interested in submitting an article?
Submit your information to us today!Learn More
Product Liability Law Daily: Breaking legal news at your fingertips
Sign up today for your free trial to this daily reporting service created by attorneys, for attorneys. Stay up to date on product liability legal matters with same-day coverage of breaking news, court decisions, legislation, and regulatory activity with easy access through email or mobile app.