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HATCH-WAXMAN ACT

Mutual Pharmaceutical Co. v. Bartlett

in
Oral argument: 
March 19, 2013
Court below: 
United States Court of Appeals for the First Circuit

After receiving a prescription for sulindac, the generic version of Clinoril, Karen Bartlett developed Stevens-Johnson Syndrome and toxic epidermal necrolysis, rare skin disorders that causes the sufferer’s skin to deteriorate by either being burned off or by turning into an open wound. Bartlett subsequently suffered painful, permanent injuries, including near-blindness, esophageal burns, and lung damage. A New Hampshire federal jury awarded Bartlett $21.06 million for her injuries based on a New Hampshire products liability claim for defective design. Mutual Pharmaceutical Company, a sulindac manufacturer, now challenges that decision by arguing that federal law regulating generic drugs preempts New Hampshire's design-defect law. The United States Court of Appeals for the First Circuit upheld the lower court design, finding no preemption, despite Supreme Court precedent finding preemption in similar contexts. Mutual Pharmaceutical argues that the Food, Drug, and Cosmetic Act preempts the state design-defect law because the Act requires generic drug manufacturers to produce generic medications that are bioequivalent to the corresponding name brand version of the drug. Bartlett responds that the state law does not conflict with federal law because the state law imposes no duty for sellers to change their product from the name brand version. 

Questions Presented: 

Whether the First Circuit erred when it created a circuit split and held-in clear conflict with this Court's decisions in PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011); Riegel v. Medtronic, Inc., 552 U.S. 312 (2008); and Cipollone v. Liggett Group, Inc., 505 U.S. 504 (1992)-that federal law does not preempt state law design-defect claims targeting generic pharmaceutical products because the conceded conflict between such claims and the federal laws governing generic pharmaceutical design allegedly can be avoided if the makers of generic pharmaceuticals simply stop making their products. 

Issue

Does federal law governing claims against generic pharmaceutical products preempt state law design-defect claims against the makers of those products?

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Written by: 
Nathan Taylor
Cristina Quinones-Betancourt
Edited by: 
Charlotte Davis
Additional Resources: 

Caraco Pharmaceutical Laboratories, Ltd. v. Novo Nordisk A/S (10-844)

in

Oral argument: Dec. 5, 2011

Appealed from: United States Court of Appeals for the Federal Circuit (April 14, 2010)

Petitioner Caraco Pharmaceutical Laboratories, a generic drug manufacturer, sought FDA approval to market the diabetes drug repaglinide. Pursuant to the Hatch-Waxman Act's expedited FDA application process for generic drugs, Caraco certified that its drug label would not conflict with Respondent Novo Nordisk’s patented repaglinide-metformin use combination. Relying on Novo’s description of its patent, the FDA denied the certification. Caraco invoked the Act’s counterclaim provision to compel Novo to revert to a narrower patent description. The United States Court of Appeals for the Federal Circuit found that Caraco could not assert the counterclaim. Caraco argues that the Federal Circuit’s reading of the counterclaim provision is incorrect and that the purpose of the counterclaim provision—to “correct” misleading patent descriptions—supports reversal. Novo asserts that the statute plainly permits a counterclaim only if Novo’s patent does not claim any approved method of use. The Supreme Court’s reading of the counterclaim provision may affect healthcare costs and the generic drug manufacturing industry.

Pliva, Inc. v. Mensing (09-993); Actavis Elizabeth, LLC v. Mensing (09-1039); Actavis, Inc. v. Demahy (09-1501) (consolidated)

in

Oral argument: Mar. 30, 2011

Appealed from: United States Court of Appeals for the Eighth Circuit (Nov. 27, 2009); United States Court of Appeals for the Fifth Circuit (Jan. 8, 2010)

DRUGS, FAILURE-TO-WARN, FOOD, DRUG, AND COSMETIC ACT, FEDERAL PREEMPTION, HATCH-WAXMAN ACT

Doctors prescribed both Gladys Mensing and Julie Demahy the drug Reglan. They each had their prescriptions filled with the generic equivalent of the name brand drug. After long-term use of this generic drug, Mensing and Demahy developed severe neurologic disorders. The women separately sued Pliva and Actavis, the generic drug manufacturers, making state law failure-to-warn claims, alleging that the drug’s warning label failed to adequately warn them of the risks. Pliva and Actavis argue that the federal Food, Drug, and Cosmetic Act, along with Food and Drug Administration regulations that govern the entire drug approval and labeling process, preempt Mensing and Demahy’s state law claims because it was impossible for Pliva and Actavis to comply with both federal and state law. The companies argue that they could not provide additional warnings beyond what the brand manufacturer provided on its label. In deciding this case, the Supreme Court will ultimately have to weigh the costs born by generic drug manufacturers and the public against the benefits of incentivizing manufacturers to create safer drugs with more complete warnings.

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