Health Law Daily Defective design, failure to warn claims against generic drug manufacturer preempted
Wednesday, October 30, 2019

Defective design, failure to warn claims against generic drug manufacturer preempted

By Kathleen Kennedy-Luczak, J.D.

It would be impossible for a generic drug maker to comply with any duty under state law to redesign a product or its label given the federal prohibition against alterations.

State law claims of defective design and failure to warn against a generic drug manufacturer and seller were dismissed by an Illinois federal court based on the conflict preemption doctrine. Noting that federal law imposes a "duty of sameness" on generic drug manufacturers, the court explained that generic drugs and their labels must be identical to those approved for the corresponding brand-name equivalent (Greager v. McNeil-PPC, Inc., October 28, 2019, Alonso, J.).

Ibuprofen reaction. Suffering from a fever, the patient ingested Motrin IB and a generic equivalent sold by Walmart under the store-brand name Equate. The active ingredient in both products is ibuprofen, a nonsteroidal anti-inflammatory drug available over the counter to reduce swelling, pain, or fever. The patient alleged that, as a result of ingesting the ibuprofen products, she developed a severe skin disorder that caused permanent damage and will require lifelong medical care.

Lawsuit filed. The patient sued Perrigo, the manufacturer of the Equate-branded ibuprofen product, and Walmart. She asserted claims of defective design, failure to warn, negligence, consumer fraud, breach of implied warranty of merchantability, and willful and wanton misconduct. Perrigo and Walmart moved to dismiss, arguing that the patient’s claims were preempted by the federal Food, Drug and Cosmetic Act (FDC Act) and its regulations.

Duty of sameness. As a generic drug manufacturer, Perrigo submitted an abbreviated new drug application (ANDA) to obtain FDA approval for its ibuprofen drug. Perrigo argued that federal law imposes a "duty of sameness" on generic drug makers. Specifically, their products and labeling must be identical to those approved for a corresponding brand-name equivalent. Consequently, Perrigo contended, it was impossible for them to comply with any state law duty to redesign its ibuprofen product or to amend or add to the warnings on its label. The court agreed, citing Supreme Court precedent in PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011), as controlling. It would be impossible for Perrigo to comply with state tort law as well as the FDC Act and its regulations, which prohibited them from altering the product or its label in any way.

Conflict preemption. The patient argued that the "duty of sameness" does not apply to over-the-counter drugs such as Perrigo’s Equate-branded ibuprofen product. According to the patient, over-the-counter drugs are governed by a different set of federal laws and regulations. However, the court reasoned that the statutory clause relied upon by the patient to show Congress’ intent to preserve product liability claims from preemption, 21 U.S.C. §379r(e), merely saves such claims from express preemption, not from preemption generally. Indeed, Perrigo and Walmart did not rely on any express preemption provision. Rather, their position was based on the conflict preemption doctrine, when state law conflicts with federal law to the extent that compliance with both is impossible. As an ANDA holder, it was impossible for Perrigo to comply with the FDCA simultaneously with the state tort duties that the patient accused it of violating.

Key distinction. Noting the patient’s lack of authority in support of her argument, the court found an important distinction in the regulatory structure and case law. The key distinction was not between prescription and non-prescriptions drugs but between new drug application (NDA) holders and ANDA holders. The difference was critical because of the changes-being-effected regulation, which permits NDA holders, but not ANDA holders, to "add or strengthen" a warning on the product’s label. Therefore, state-law product liability claims for inadequate labeling against ANDA holders are preempted, but similar claims against NDA holders may not be. It was an impossibility under federal law for Perrigo to do what the patient claimed they failed to do. They were not permitted to alter the label or the composition of the product to better reflect or reduce the product’s health risks. The court concluded that because all the patient’s claims involved the same failure to warn or improve the product, they were all preempted. Perrigo’s motion to dismiss and Walmart’s motion to dismiss were both granted.

The case is No. 19 C 918.

Attorneys: Dennis Allen Vanderginst (VanDerGinst Law P.C.) for Allison Greager. William Victor Essig (Drinker Biddle & Reath LLP) for McNeil-PPC, Inc., McNeil Consumer Healthcare., McNeil Consumer Pharmaceuticals Co., Johnson & Johnson Consumer Inc., Ortho-McNeil-Janssen Pharmaceuticals, Inc., Janssen Pharmaceuticals, Inc. and Johnson & Johnson.

Companies: McNeil-PPC, Inc.; McNeil Consumer Healthcare; McNeil Consumer Pharmaceuticals Co.; Johnson & Johnson Consumer Inc.; Ortho-McNeil-Janssen Pharmaceuticals, Inc.; Janssen Pharmaceuticals, Inc.; Johnson & Johnson

MainStory: TopStory CaseDecisions FDCActNews DrugBiologicNews PreemptionNews PrescriptionDrugNews PLDrugNews IllinoisNews

Back to Top

Interested in submitting an article?

Submit your information to us today!

Learn More

Health 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 health legal matters with same-day coverage of breaking news, court decisions, legislation, and regulatory activity with easy access through email or mobile app.