Legal Opinion
Bristol-Myers Squibb Company v. Donna E. Shalala, Secretary of Health and Human Services, and David A. Kessler, M.D.
Court of Appeals for the D.C. Circuit
Decided August 16, 1996No. 95-5399PublishedCited by 50 opinions
1Opinion of the Court
Opinion for the Court filed by Circuit Judge GINSBURG.
GINSBURG, Circuit Judge:
Bristol-Meyers Squibb brought an action in the district court to challenge the regulations of the Food and Drug Administration that govern approval of a new generic drug based upon research paid for by the manufacturer of the “innovator” or “pioneer” drug with which the generic product is therapeutically interchangeable. The district court dis missed the company’s complaint on the ground that the allegations therein did not satisfy the constitutional requirements for standing to sue in federal court, as explicated…
2Cases cited8 opinions
- Lujan v. Defenders of WildlifeSupreme Court of the United States · 1992
- Chevron U. S. A. Inc. v. Natural Resources Defense Council, Inc.Supreme Court of the United States · 1984
- Babbitt v. United Farm Workers National UnionSupreme Court of the United States · 1979
- Hardin v. Kentucky Utilities Co.Supreme Court of the United States · 1968
- United States v. Generix Drug Corp.Supreme Court of the United States · 1983
3 more not listed; retrieve them via the Exa API.
3Cited by50 opinions
- Serono Labs Inc v. Ferring Pharm. Inc.Court of Appeals for the D.C. Circuit · 1998
- Tozzi v. U.S. Department of Health & Human ServicesCourt of Appeals for the D.C. Circuit · 2001
- Shays v. Federal Election CommissionCourt of Appeals for the D.C. Circuit · 2005
- Animal Legal Defense Fund, Inc. v. GlickmanCourt of Appeals for the D.C. Circuit · 1998
- MD Pharmaceutical, Inc. v. Drug Enforcement AdministrationCourt of Appeals for the D.C. Circuit · 1998
45 more not listed; retrieve them via the Exa API.