[PUBLISH]
IN THE UNITED STATES COURT OF APPEALS
FOR THE ELEVENTH CIRCUIT FILED
________________________ U.S. COURT OF APPEALS
ELEVENTH CIRCUIT
No. 09-10167 MAR 5, 2010
________________________ JOHN LEY
CLERK
D. C. Docket No. 07-00077-CV-RLV4
DONNA LADEAN DIETZ,
individually, and as Surviving Spouse
of Garrison David Dietz,
deceased, and as Temporary
Administratrix of the Estate of
Garrison David Dietz, Deceased,
Plaintiff-Appellant,
versus
SMITHKLINE BEECHAM CORP.
d.b.a. Glaxo SmithKline,
Defendant-Appellee.
________________________
Appeal from the United States District Court
for the Northern District of Georgia
_________________________
(March 5, 2010)
Before TJOFLAT and BARKETT, Circuit Judges, and BARZILAY,* Judge.
BARZILAY, Judge:
Plaintiff-Appellant Donna Dietz (“Appellant”) appeals the district court’s
grant of summary judgment for Defendant-Appellee Smithkline Beecham Corp.
(“SBC”) in her wrongful death suit, which arose out of her husband’s suicide
while taking Paxil, a drug manufactured by SBC. For the reasons stated below,
the district court’s decision is affirmed.
I. Background & Procedural History
On April 3, 2002, the 33 year-old Garrison David Dietz (“Dietz”),
Appellant’s late husband, met with his family practitioner, James Zuppa, M.D.
Dietz presented with anxiety, depression, insomnia, and stress, but expressed that
he had no suicidal ideation and disclosed no history of psychological illness. R.E.
Doc. 43 Ex. B at 56:5-19, 61:14-23. Dr. Zuppa diagnosed Dietz with major
depression and offered him hospitalization for psychiatric treatment, which Dietz
declined. R.E. Doc. 43 at 62:2-5, 66:3-4. Consequently, Dr. Zuppa prescribed
him Paxil, a selective serotonin reuptake inhibitor (“SSRI”) antidepressant
manufactured by SBC, and Ambien, a sleep aid. R.E. Doc. 43 at 62:11. He then
*
Honorable Judith M. Barzilay, Judge, United States Court of International Trade, sitting
by designation.
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instructed Dietz to schedule a follow-up visit in three weeks and to contact him in
the event of an “acute crisis.” R.E. Doc. 43 at 65:19-22, 66:4-5. He also referred
him to a nearby psychologist. R.E. Doc. 43 at 62:25-63:2. Eight days after having
filled and begun his Paxil prescription, Dietz committed suicide by throwing
himself in front of a train.
Appellant filed a diversity suit in the Northern District of Georgia on April
24, 2007, alleging that under Georgia law SBC was (1) strictly liable as “a
manufacturer of a defective and unreasonably dangerous product, and for
marketing defects and misrepresentations, which proximately caused Gary Dietz’s
injuries and death,” (2) “unreasonable, or negligent, and was a proximate cause of
Garry Deitz’s injuries and death,” and (3) “liable under a breach of warranty.”
R.E. Doc. 1 at ¶¶ 10-12. SBC filed two motions for summary judgment, the first
of which raised Georgia’s learned intermediary doctrine as an affirmative defense
and is at issue in the present opinion.1
During discovery, the parties deposed Dietz’s physician, Dr. Zuppa. He
testified that he considered the potential risks and benefits of prescribing Paxil to
Dietz when he wrote the prescription in 2002. R.E. Doc. 75 (Dietz v. Smithkline
1
The second motion claimed that Appellant’s claims are preempted by federal law.
Because the district court did not reach this issue, this Court need not discuss it.
3
Beecham Corp., No. 4:07-CV-0077 (N.D. Ga. Dec. 9, 2008) (order granting
summary judgment)) at 2. He also acknowledged that subsequent studies have
pointed to a “slight[ly] increase[d]” risk of suicide among children and adolescents
taking SSRIs, but stated that he still does not usually explain the increased risks to
adult patients whom he considers stable. R.E. Doc. 75 at 3 (brackets in original).
Moreover, Dr. Zuppa testified that, even in retrospect, he agreed with his decision
to treat Dietz with Paxil and would do so again today under the same
circumstances:
Q. And you testified that you still agree with your decision to prescribe Paxil for
Mr. Dietz, right?
A [Dr. Zuppa]. Yes.
R.E. Doc. 43 Ex. B at 80:15-18; accord R.E. Doc. 43 Ex. B at 42:14-23.
Q. (By Mr. Norden) The current prescribing information for Paxil. I
want to give you an opportunity to read exactly what the black box
says. . . .
A [Dr. Zuppa]. Okay.
....
Q. . . . . Based after having read this [new, updated] 2008 prescribing
information for Paxil, is there anything in that that makes you believe
that if you had read that same information in April of 2002 you would
have decided not to prescribe Paxil for Gary Dietz?
A. No.
Q. So sitting here today, . . . knowing Gary Dietz ultimately took his
own life, do you still consider your decision to prescribe Paxil for him
on April 3rd, 2002, to be an appropriate decision?
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A. I felt the risk of not treating him was worse. So I would have to
make a decision, and I felt like I needed to prescribe him Paxil.
R.E. Doc. 43 Ex. B at 112:4-113:7; see also R.E. Doc. 55 Exs. 9, 12 (letters from
SBC to doctors informing them of increased risk of suicide for adults under age of
25 taking SSRIs).
II. Jurisdiction & Standard of Review
The Court has jurisdiction over this appeal pursuant to 28 U.S.C. § 1291.
The court reviews a district court’s grant of summary judgment de novo. Int’l
Stamp Art, Inc. v. USPS, 456 F.3d 1270, 1273 (11th Cir. 2006) (citation omitted).
The court will deem summary judgment appropriate “if the pleadings, the
discovery and disclosure materials on file, and any affidavits show that there is no
genuine issue as to any material fact and that the movant is entitled to a judgment
as a matter of law.” Fed. R. Civ. P. 56(c)(2). Once the movant adequately
supports its motion, the burden shifts to the nonmoving party to show that specific
facts exist that raise a genuine issue for trial. Int’l Stamp Art, Inc., 456 F.3d at
1274.
III. The Learned Intermediary Doctrine
In standard products liability cases premised on a failure to warn, Georgia
law insists that a plaintiff show that the defendant had a duty to warn, that the
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defendant breached that duty, and that the breach proximately caused the
plaintiff’s injury. Wheat v. Sofamor, S.N.C., 46 F. Supp. 2d 1351, 1362 (N.D. Ga.
1999) (holding that proximate cause is necessary element of plaintiff’s case
whether proceeding under strict liability or negligence theory). Within the context
of prescription drugs, however, Georgia employs the learned intermediary
doctrine, which alters the general rule that imposes liability on a manufacturer for
failing to warn an end user of the known risks or hazards of its products. Id. at
1363. According to the doctrine, the manufacturer of
a prescription drug [manufacturer] . . . does not have a duty to warn
the patient of the dangers involved with the product, but instead has a
duty to warn the patient’s doctor, who acts as a learned intermediary
between the patient and the manufacturer. The rationale for the
doctrine is that the treating physician is in a better position to warn
the patient than the manufacturer, in that the decision to employ
prescription medication . . . involves professional assessment of
medical risks in light of the physician’s knowledge of a patient’s
particular need and susceptibilities.
McCombs v. Synthes (U.S.A.), 587 S.E.2d 594, 594 (Ga. 2003) (footnotes &
quotation marks omitted); accord Ellis v. C.R. Bard, Inc., 311 F.3d 1272, 1279-81
(11th Cir. 2002) (per curiam); see Wheat, 46 F. Supp. 2d at 1363; Bryant v.
Hoffmann-La Roche, Inc., 585 S.E.2d 723, 730 (Ga. Ct. App. 2003). In most
cases, a court begins its inquiry under this doctrine by determining whether the
manufacturer provided the learned intermediary with an adequate warning. Wheat,
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46 F. Supp. 2d at 1363 (citation omitted). If the warning was adequate, the inquiry
ends, and the plaintiff cannot recover. See Singleton v. Airco, Inc., 314 S.E.2d
680, 682 (Ga. Ct. App. 1984). If the warning is inadequate, or merely presumed to
be, the plaintiff must demonstrate that the deficient warning proximately caused
the alleged injury to prevail. See Wheat, 46 F. Supp. 2d at 1363. Therefore, in
cases where “a learned intermediary has actual knowledge of the substance of the
alleged warning and would have taken the same course of action even with the
information the plaintiff contends should have been provided, courts typically
conclude that . . . the causal link is broken and the plaintiff cannot recover.” Ellis,
311 F.3d at 1283 n.8 (quoting Wheat, 46 F. Supp. 2d at 1363) (quotation marks
omitted).2
IV. Discussion
Appellant cannot demonstrate that SBC’s alleged failure to warn Dr. Zuppa
about increased suicide risks associated with Paxil proximately caused Dietz to
commit suicide. The doctor provided explicit, uncontroverted testimony that, even
when provided with the most current research and FDA mandated warnings, he
2
Georgia’s long-recognized, unwavering use of the learned intermediary doctrine has cast
no “substantial doubt” on the doctrine’s continued validity under Georgia law. The court
therefore denies Appellant’s request to certify to the Georgia Supreme Court the question on
whether Georgia law required SBC to warn Dietz directly about the risks associated with taking
Paxil. See Jackson-Shaw Co. v. Jacksonville Aviation Auth., 508 F.3d 653, 654 n.2 (11th Cir.
2007) (quotation marks omitted).
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still would have prescribed Paxil for Dietz’s depression. Pursuant to Georgia’s
learned intermediary doctrine, this assertion severs any potential chain of
causation through which Appellant could seek relief, and Appellant’s claims thus
fail.3
VI. Conclusion
The district court’s grant of summary judgment for SBC is affirmed.
AFFIRMED
3
At oral argument, Appellant’s attorney asked the court to consider whether a stronger
warning from SBC would have affected Dr. Zuppa’s prescribing practice, not simply whether he
would have prescribed Dietz the drug, the assumption being that had Dietz or his family
members received the current information on Paxil’s side effects, they would have taken actions
to prevent his suicide. As a thorough examination of the record reveals no evidence to support
this argument, Appellant’s claim cannot survive summary judgment. See Int’l Stamp Art, Inc.,
456 F.3d at 1274.
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