Plivia, Inc., et al., Petitioners v. Gladys Mensing (564 U.S. 604)
U.S. Supreme Court · decided June 23, 2011 · Supreme Court Database (Spaeth)
- Citation
- 564 U.S. 604 · 131 S. Ct. 2567
- Docket
- No. 09-993
- Argued
- March 30, 2011
- Decided
- June 23, 2011
- Term
- October Term 2010
- Vote
- 5–4
- Majority author
- Justice Thomas
- Issue area
- Federalism
- Disposition
- Reversed and remanded
- Outcome
- Petitioning party won
- Ideological direction
- Liberal
How the Justices voted
- Majority
- Chief Justice Roberts, Justice Scalia, Justice Kennedy, Justice Thomas (wrote), Justice Alito
- Dissenting
- Justice Ginsburg, Justice Breyer, Justice Sotomayor (wrote), Justice Kagan
Oral argument transcript and advocates · Opinion on Justia
Opinion excerpt
Justice Thomas delivered the opinion of the Court, except as to Part III-B-2. These consolidated lawsuits involve state tort-law claims based on certain drug manufacturers’ alleged failure to provide adequate warning labels for generic metoelopramide. The question presented is whether federal drug regulations applicable to generic drug manufacturers directly conflict with, and thus pre-empt, these state-law claims. We hold that they do. I Metoelopramide is a drug designed to speed the movement of food through the digestive system. The Food and Drug Administration (FDA) first approved metoelopramide tablets, under the brand name Reglan, in 1980. Five years later, generic manufacturers also began producing meto-clopramide. The drug is commonly used to treat digestive tract problems such as diabetic gastroparesis and gastro-esophageal reflux disorder. Evidence has accumulated that long-term metoelopramide use can cause tardive dyskinesia, a severe neurological disorder. Studies have shown that up to 29% of patients who take metoelopramide for several years develop this condition. McNeil v. Wyeth, 462 F. 3d 364, 370, n. 5 (CA5 2006); see also Shaffer, Butterfield, Pamer, & Mackey, Tardive Dyskinesia Risks and Metoelopramide Use Before and After U. S. Market Withdrawal of Cisapride, 44 J. Am. Pharmacists Assn. 661, 663 (2004) (noting 87 cases of metoclopramide-related tardive…
Excerpt of a 35,372-character opinion. The full text and citation network load in the interactive viewer above.