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KNIGHT v. BOEHRINGER INGELHEIM PHARMACEUTICALS

No. 19-1636.

984 F.3d 329 (2021)

Claude R. KNIGHT; Claudia Stevens, individually and as Personal Representative of the Estate of Betty Erelene Knight; Betty Erelene Knight, Deceased, Plaintiffs-Appellees, v. BOEHRINGER INGELHEIM PHARMACEUTICALS, INC., Defendant-Appellant.

United States Court of Appeals, Fourth Circuit.

Decided: January 6, 2021.

Attorney(s) appearing for the Case

ARGUED: Paul Schmidt , COVINGTON & BURLING LLP, Washington, D.C., for Appellant. James Darren Summerville , SUMMERVILLE FIRM, LLC, Atlanta, Georgia, for Appellees. ON BRIEF: Phyllis A. Jones , COVINGTON & BURLING LLP, Washington, D.C.; Adam H. Charnes , Thurston H. Webb , KILPATRICK TOWNSEND & STOCKTON LLP, Winston-Salem, North Carolina, for Appellant. C. Andrew Childers , Emily T. Acosta , CHILDERS SCHLUETER & SMITH, Atlanta, Georgia; Neal L. Moskow , URY & MOSKOW, LLC, Fairfield, Connecticut, for Appellees.

Reversed by published opinion. Judge Quattlebaum wrote the opinion, in which Judge Niemeyer and Judge Diaz joined.

Under the preemption doctrine, a state-law challenge to federally approved pharmaceutical warning labels may only proceed when the pharmaceutical company has the unilateral ability to change that labeling. The Food and Drug Administration's changes-being-effected ("CBE") regulation...

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