Court Opinion

ID: 147639
Source: CourtListenerOpinion
Date Created: 2010-06-02 16:13:35+00
Date Added: 2024-06-11T15:02:44.634967
License: Public Domain

FILED
                                                            United States Court of Appeals
                                                                    Tenth Circuit

                                                                    June 2, 2010
                       UNITED STATES COURT OF APPEALS
                                                    Elisabeth A. Shumaker
                                                                    Clerk of Court
                                  TENTH CIRCUIT

 CANDACE MILLER and
 GEORGE MILLER,

           Plaintiff-Appellant/
           Cross-Appellees,

           v.                                   Nos. 08-5042 and 08-5050
                                                    (N. D. Oklahoma)
 SMITHKLINE BEECHAM                             (D.C. No. 4:03-CV-00393)
 CORPORATION d/b/a
 GLAXOSMITHKLINE,

           Defendant-Appellee/
           Cross-Appellant,

 and

 PHARMACEUTICAL RESEARCH
 AND MANUFACTURERS OF
 AMERICA; PRODUCT
 LIABILITY ADVISORY
 COUNCIL, INC.; CHAMBER OF
 COMMERCE OF THE UNITED
 STATES OF AMERICA,

           Amici Curiae.

                              ORDER AND JUDGMENT *

       *
         This order and judgment is not binding precedent except under the
doctrines of law of the case, res judicata, and collateral estoppel. It may be cited,
however, for its persuasive value consistent with Fed. R. App. P. 32.1 and 10th
Cir. R. 32.1.
Before BRISCOE, Chief Judge, and HENRY and HARTZ, Circuit Judges.

      This case requires that we vacate and remand to the district court for

application of the “clear error” test for federal preemption recently set forth in

Wyeth v. Levine, 129 S. Ct. 1187 (2009). See Dobbs v. Wyeth Pharmaceuticals,

no. 08-6018, __ F.3d ___ (10th Cir. 2010) (also remanding for application of

Levine).

                                I. BACKGROUND

      Candace and George Miller separately sued Glaxosmithkline (GSK) for

failing to adequately label its antidepressant Paxil to warn of suicide risk, alleging

that this failure to warn caused Ms. Miller’s 1998 suicide attempt in which she

seriously injured herself. GSK moved for summary judgment, arguing (1) that

there was federal preemption of both of the Millers’ state law failure to warn

claims; (2) that both of the Millers’ claims were barred by statute of limitations;

and (3) that the learned intermediary doctrine prevented either of the Millers from

proving that the alleged failure to warn proximately caused their injuries.

      On the preemption issue, GSK argued that under federal labeling

regulations it would have been impossible to have added a suicide warning label

to protect itself against state law failure to warn claims. GSK argued that the

Food and Drug Administration required scientific evidence for such warnings, and

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that if it had placed a suicide warning label on Paxil then it would have been

prosecuted under federal law for unlawfully misbranding the drug with a

scientifically unsubstantiated warning label. On the statute of limitations issue,

GSK argued that both of the Millers had received notice of a claim against GSK

more than two years before they filed their suits. On the learned intermediary

doctrine issue, GSK argued that neither of the Millers could prove proximate

causation, because under Oklahoma law the duty to warn runs to the physician not

to the patient, and because Ms. Miller’s physicians would not have changed their

treatment decisions even with a stronger suicide warning label on Paxil.

      In a one-page order without an accompanying opinion, the district court

granted summary judgment in favor of GSK on federal preemption grounds for

both Millers’ claims, as well as on statute of limitations grounds for Mr. Miller’s

claim. The district court denied GSK’s motion for summary judgment on statute

of limitations grounds for Ms. Miller’s claim, as well as on learned intermediary

grounds for both Millers’ claims.

                                 II. DISCUSSION

      The Millers appeal, arguing that the district court erred (1) in finding each

of their failure to warn claims preempted, and (2) in finding Mr. Miller’s claim to

be time-barred. On the preemption issue, the Millers maintain that no conflict

existed between state and federal law, because FDA regulations permit

pharmaceutical companies to simultaneously change their labels while also

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submitting the change for review by the FDA. According to the Millers, at the

time of Ms. Miller’s suicide attempt in 1998, GSK could have unilaterally added a

Paxil suicide warning label using a “Changes Being Effected” (CBE) supplement,

which allows a pharmaceutical company to unilaterally “add or strengthen a

contraindication, warning, precaution, or adverse reaction,” and use that

strengthened label while simultaneously filing the CBE application for FDA

approval. 21 C.F.R. § 314.70(c)(6)(iii). On the statute of limitations issue, the

Millers argue that there is a factual dispute about when Mr. Miller received notice

that he had a claim against GSK, and about whether he received notice more than

the statutory two years before he filed his suit. The Millers request that we

reverse the district court’s grant of summary judgment and remand the case to the

district court for a trial to determine whether GSK failed its state law duty to

properly label its products.

      GSK cross-appealed, arguing that (1) Ms. Miller’s claim is time-barred for

the same reason that the district court found her husband’s claim to be time-

barred, and (2) both suits should be dismissed under Oklahoma’s learned

intermediary doctrine because neither plaintiff can prove proximate causation.

      After the district court’s decision, the Supreme Court in Levine changed the

legal standard for a successful federal preemption defense against a state law

failure to warn claim, holding that “absent clear evidence that the FDA would not

have approved a change to [the drug’s] label, we will not conclude that it was

                                         -4-
impossible for [the pharmaceutical company] to comply with both federal and

state requirements.” 129 S. Ct. at 1198 (emphasis added). After Levine, GSK

must demonstrate that federal labeling requirements made it impossible to meet

its state law duty to warn by proving that there was “clear evidence” that the FDA

would have rejected GSK’s labeling change had it unilaterally strengthened

Paxil’s warning label using the CBE supplement. Id.

      In light of Levine’s newly-established “clear evidence” test, we must

VACATE the district court’s grant of summary judgment to GSK, and REMAND

to give the court the opportunity to make evidentiary findings and analyze the

record in light of Levine’s new “clear evidence” standard. 1

                                Entered for the Court,

                                Robert H. Henry
                                United States Circuit Judge

      1
       In the disposition of this appeal we do not address the statute of limitations
and learned intermediary doctrine arguments. The parties are not foreclosed from
raising those issues in a subsequent appeal, if appropriate.

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