Brief Fact Summary.
Mensing and Demahy were prescribed Reglan, a brand name for metoclopramide. The drug was known to be associated with very serious side effects. Thereafter, Mensing and Demahy developed tardive dyskinesia, one of the side effects, and brought suit against the drugs manufactures on the grounds that they failed to adequately warn about the drugs dangerous effects. The manufactures asserted an affirmative defense of preemption. The Courts of Appeals for the Fifth and Eighth Circuits denied Manufacturers’ defense, and Manufacturers petitioned the Supreme Court for certiorari.
Synopsis of Rule of Law.
Federal law preempts a state law that imposes liability on a generic-drug manufacture for failing to place a warning label.
Thus, there must be a showing of implicit preemption of the whole field strong enough to overcome the presumption that state and local regulation of health and safety matters can constitutionally coexist with federal regulation.View Full Point of Law
In 2001 and 2002, Gladys Mensing and Julie Demahy were each prescribed Reglan, the brand name for metoclopramide. Metoclopramide was released in 1980 and began to become associated with the development of tardive dyskinesia, a serious neurological disorder. As this associated gained attention and evidence, the drug’s warning label was continuously being altered altered in 1985, 2004, and 2009. The 2009 label warned that the use of the drug for more than 12 weeks should be avoided in all rare cases. Mensing and Demahy’s prescriptions were not for Reglan, but instead, for the generic metoclopramide. After Mensing and Demahy used the drug for several years, they both developed tardive dyskinesia. Mensing and Demahy (collectively, Plaintiffs) brought suit against the manufacturers of the generic drugs they had taken (collectively, Manufacturers). Plaintiffs contend that Manufacturers are liable under state tort law because they failed to provide sufficient warning for the drugs dangers. Manufacturers asserted an affirmative defense of preemption on the grounds that federal law mandated them to use the same label as Reglan. Thus, it was impossible for Manufacture to comply with a state-law duty that mandated a different label. The Courts of Appeals for the Fifth and Eighth Circuits denied Manufacturers’ defense, and Manufacturers petitioned the Supreme Court for certiorari.
Whether federal law preempts a state law that imposes liability on a generic-drug manufacture for failing to place a warning label.
Yes, federal law preempts a state law that imposes liability on a generic-drug manufacture for failing to place a warning label.
The majority’s decision is inconsistent with the preemption doctrine because previous cases required a more stringent standard for proving impossibility of conforming with state and federal law, not a unilateral action as a qualification for evaluating compliance with both state and federal law.
Because federal law mandates different requirements upon brand-name and generic-drug manufacturers, the federal law preempts the state law requirements.Under federal law, A brand-name manufacturers is required to provide accurate and adequate labels while generic manufacturers is only required match their labels to those of the corresponding brand-name drug. Therefore, Plaintiff’s state-law claims are preempted, and the lower court’s decision is reversed.