RESPONDENT: Gladys Mensing
LOCATION: Actavis Elizabeth LLC
DOCKET NO.: 09-993
DECIDED BY: Roberts Court (2010-2016)
LOWER COURT: United States Court of Appeals for the Eighth Circuit
CITATION: 564 US (2011)
GRANTED: Dec 10, 2010
ARGUED: Mar 30, 2011
DECIDED: Jun 23, 2011
Edwin S. Kneedler - Deputy Solicitor General, Department of Justice, for the United States as amicus curiae, supporting the respondents
Jay P. Lefkowitz - for the petitioners
Louis M. Bograd - for the respondents
Facts of the case
Gladys Mensing took the drug metoclopramide for four years to help fight diabetic gastroparesis. She filed a lawsuit against the generic drug's manufacturers and distributors, contending that the drug gave her a severe neurological movpent disorder, tardive dyskinesia, but none of the generic drug's manufacturers and distributors made any effort to include warnings on the label.
Metoclopramide manufacturers Pliva Inc. and Actavis Elizabeth LLC asked for the lawsuit to be thrown out, arguing that government regulations require thp to have the same label on metoclopramide as is on its brand-name equivalent, Reglan. Reglan did not have a warning about tardive dyskinesia while Mensing was taking metoclopramide.
A federal judge on the U.S. District Court for the District of Minnesota agreed, saying the lawsuit was pre-ppted by the federal regulations requiring the two labels to match. But the U.S. Court of Appeals for the 8th Circuit overturned that ruling, holding that more should have been done to warn consumers about possible risks.
Can generic drug makers be sued for not warning about potentially dangerous side effects on their drug labels even when they follow federal rules that only require their labels to match those of their brand-name equivalents?
Media for PLIVA, Inc. v. MensingAudio Transcription for Oral Argument - March 30, 2011 in PLIVA, Inc. v. Mensing
Audio Transcription for Opinion Announcement - June 23, 2011 in PLIVA, Inc. v. Mensing
This case has come to us on a -- on writs of certiorari to United States Court of Appeals -- Courts of Appeals for the Fifth Circuit and the Eighth Circuit.
Respondents were prescribed the drug Reglan to treat digestive tract problems.
Each received generic Reglan from her pharmacist.
After taking the drug for several years, each developed a serious neurological disorder.
Respondents then sued the manufacturers of the generic drugs in a state court alleging that the manufacturers failed to provide an adequate warning label.
The question presented here is whether Federal Drug Statutes and Regulations conflict with and thus pre-empt these state tort lawsuits.
The Fifth and Eighth Circuits found no pre-emption and allowed the lawsuits to proceed.
In an opinion filed with the clerk today, we reversed the judgments of the Courts of Appeals.
The generic manufacturers have demonstrated a conflict between state and federal law.
State law requires the manufacturers to change their warning labels but the Federal Drug Regulations prevent them from independently doing so.
The manufacturers could potentially have complied with state law but only with the help of the brand name Reglan manufacturer and the special permission and assistance of the Food and Drug Administration, a federal agency.
We find that federal law pre-empts the state law, state tort lawsuits here.
The Supremacy Clause of the Constitution instructs the federal law -- that federal law is the supreme law of the land, in a state law to the contrary notwithstanding.
It would distort the plain text of the Supremacy Clause to find no pre-emption simply because a federal agency has the discretion to resolve an existing conflict between federal and state law on a case by case basis.
Justice Kennedy joins all but Part III–B–2 of the opinion.
Justice Sotomayor has filed a dissenting opinion in which Justices Ginsburg, Breyer and Kagan joined.