Case: 18-50380      Document: 00514701725         Page: 1    Date Filed: 10/29/2018




           IN THE UNITED STATES COURT OF APPEALS
                    FOR THE FIFTH CIRCUIT
                                                                          United States Court of Appeals
                                                                                   Fifth Circuit


                                    No. 18-50380                                 FILED
                                  Summary Calendar                         October 29, 2018
                                                                            Lyle W. Cayce
                                                                                 Clerk
PETER B. CASEY,

              Plaintiff - Appellant

v.

BRISTOL-MYERS SQUIBB COMPANY; OTSUKA AMERICA
PHARMACEUTICAL, INCORPORATED,

              Defendants - Appellees




                   Appeal from the United States District Court
                        for the Western District of Texas
                             USDC No. 5:17-CV-1175


Before JOLLY, COSTA, and HO, Circuit Judges.
PER CURIAM:*
       Peter Casey alleges that he began taking Abilify in 2011, after it was
prescribed to him by his psychologist. In June 2016, he stopped taking Abilify
following a three week “tapering off” period.            He alleges that withdrawal
symptoms manifested two weeks later. These allegedly included headaches,
weight loss, insomnia, impotence, and, most importantly, Tardive Dyskensia,


       * Pursuant to 5TH CIR. R. 47.5, the court has determined that this opinion should not
be published and is not precedent except under the limited circumstances set forth in 5TH
CIR. R. 47.5.4.
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                                      No. 18-50380
a neurological disorder that causes repetitive, unintentional movements.
Casey filed suit against defendants, manufacturers and marketers of Abilify,
in Texas state court asserting a state law failure-to-warn claim.                       The
defendants removed the case to federal district court. The district court then
dismissed the case, finding that the defendants were entitled to a judgment on
the pleadings because, under Texas law, there is a presumption that warnings
approved by the United States Food and Drug Administration (FDA) are
“adequate.” See Tex. Civ. Prac. & Rem. Code § 82.007.
       Casey makes two arguments on appeal. First, he suggests that the
defendants misled or withheld from the FDA material information causally
related to the side effects that he suffered, thus rebutting the state law
presumption and plausibly stating a cognizable claim. Fraud on the FDA is
one of the exceptions set forth in the Texas statute as capable of rebutting the
presumption against liability. Tex. Civ. Prac. & Rem. Code § 82.007(b)(1). We
have previously held, however, that federal law requires a plaintiff suing under
a state law failure-to-warn cause of action to show that the FDA itself has
found that defendants behaved fraudulently. Loften v. McNeil Consumer &
Specialty Pharms., 

(5th Cir. 2012).                     Despite conclusory
statements in his brief, Casey’s complaint does not allege this, let alone contain
any specific factual matter to support it.        Therefore, the district court did not
err in its ruling concerning fraud on the FDA. 1




       1The district court presumed that Casey was required to plead facts to rebut the Texas
law presumption in his complaint. We have not previously decided in a published opinion
whether Tex. Civ. Prac. & Rem. Code § 82.007 establishes an additional element of a failure-
to-warn claim that must be adequately pled by the plaintiff, or an affirmative defense, which
does not. We have presumed the former, however, in at least one unpublished opinion.
Thurston v. Merck & Co., 415 F. App’x 585 (5th Cir. 2011). Because Casey does not raise this
issue on appeal, we need not address it.
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                                No. 18-50380
      Second, Casey argues that the district court erred because, by labeling
his symptoms “side effects” rather than “withdrawal” symptoms, the
defendants gave per se inadequate warnings.        We see no merit to this
argument. Leaving aside whether there is a meaningful difference between
labeling the symptoms generally as “side effects” or explicitly attaching the
“withdrawal” label to them, this is not a decision for us to make. The FDA has
approved the warning provided by the defendants, and Texas law has made
this approval sufficient to forestall any products liability claim absent the
existence of a specified exception. Since Casey has not adequately pled any of
these exceptions, we have no basis for finding that the defendants may be held
liable.
      Therefore, we AFFIRM the judgment of the district court.




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