UNITED STATES COURT OF APPEALS FOR THE FOURTH CIRCUIT

No. 19-1636

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.

Appeal from the United States District Court for the Southern District of West Virginia, at Huntington. Robert C. Chambers, District Judge. (3:15-cv-06424)

Argued: October 29, 2020 Decided: January 6, 2021

Before NIEMEYER, DIAZ, and QUATTLEBAUM, Circuit Judges.

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

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. QUATTLEBAUM, Circuit Judge:

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 permits pharmaceutical companies to unilaterally modify their physician labels only to “add or strengthen a . . . warning” based upon “newly acquired information” about “evidence of a causal association” between the drug and a risk of harm. 21 C.F.R. § 314.70(c)(6)(iii). Here we must determine some goalposts of “newly acquired information.”

Boehringer Ingelheim Pharmaceuticals, Inc. developed a drug called Pradaxa to help reduce the risk of stroke. The FDA approved the drug and its label. After taking this drug for over a year, Betty Knight suffered a gastrointestinal bleed. She then developed other complications and eventually died. Her children, Claude Knight and Claudia Stevens, 1 sued Boehringer asserting a variety of state-law claims alleging Boehringer failed to adequately warn about the risks associated with taking Pradaxa.

Boehringer argued that federal law preempted the claims. The Knights disagreed, claiming the risks were “newly acquired information” discovered after Pradaxa’s FDA approval. If true, then Boehringer could have added warnings to its physician label without FDA approval, and federal law would not preempt the state-law claims.

1 For clarity, we will refer to Betty Knight as “Knight” and her children as the “Knights.” 2 The district court agreed with the Knights and allowed the case to go to the jury. The jury returned a mixed verdict, finding for Boehringer on the Knights’ failure to warn and breach of express and implied warranty claims, but for the Knights on their fraud claim. Boehringer filed a renewed motion for judgment as a matter of law, and, in the alternative, a new trial. After the district court denied its post-trial motions, Boehringer appealed on several grounds. Most relevant here, it argues it did not discover “newly acquired information” that would have permitted a unilateral change of Pradaxa’s physician label. Thus, according to Boehringer, the Knights’ fraud claim based on the physician label was preempted. Because we agree with Boehringer, we reverse the district court’s order denying Boehringer’s post-trial motion for judgment as a matter of law.

I.

Before addressing the preempt