Barbara Tutwiler v. Sandoz, Inc.

Filing

Opinion issued by court as to Appellant Barbara R. Tutwiler. Decision: Affirmed. Opinion type: Non-Published. Opinion method: Per Curiam. The opinion is also available through the Court's Opinions page at this link http://www.ca11.uscourts.gov/opinions.

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Date Filed: 04/09/2018

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[DO NOT PUBLISH]

IN THE UNITED STATES COURT OF APPEALS
FOR THE ELEVENTH CIRCUIT
________________________
No. 17-13985
Non-Argument Calendar
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D.C. Docket No. 2:16-cv-01246-LSC

BARBARA R. TUTWILER,
Plaintiff - Appellant,
versus
SANDOZ, INC.,
Defendant - Appellee.
________________________
Appeal from the United States District Court
for the Northern District of Alabama
________________________
(April 9, 2018)
Before MARTIN, JORDAN, and JILL PRYOR, Circuit Judges.
PER CURIAM:

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Barbara Tutwiler appeals the district court’s dismissal of her failure-to-warn
claim against Sandoz, Inc., a generic drug manufacturer.

The district court

concluded that Ms. Tutwiler’s claim was impliedly preempted by federal law and
barred by the learned intermediary doctrine under Alabama law. After a thorough
review of the parties’ briefs, as well as the record, we affirm.
I
The following factual background summarizes the allegations made in Ms.
Tutwiler’s amended complaint, which we accept as true at the motion to dismiss
stage. See Hill v. White, 321 F.3d 1334, 1335 (11th Cir. 2003) (per curiam).
A
In October of 2012, Ms. Tutwiler’s physician, Dr. Vance Plumb, prescribed
her a drug named amiodarone in order to treat her non-life-threatening atrial
fibrillation.

Ms. Tutwiler followed the course of amiodarone treatment as

prescribed by Dr. Plumb. At some time between the spring and summer of 2014,
Ms. Tutwiler began experiencing shortness of breath, wheezing, trouble breathing,
coughing, tiredness, weakness, nervousness, irritability, restlessness, decreased
concentration, and depression. In July of 2014, Ms. Tutwiler was diagnosed by a
second physician with interstitial lung disease and pulmonary fibrosis.
The generic version of amiodarone supplied to Ms. Tutwiler by her
pharmacist was produced by Sandoz, Inc. According to the amended complaint,
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amiodarone is “a drug of last resort for patients suffering from documented
recurrent life-threatening ventricular fibrillation and ventricular tachycardia . . . .”
Amiodarone is not approved by the federal Food and Drug Administration for the
treatment of non-life-threatening atrial fibrillation but is heavily marketed for this
“off-label” use by both the brand-name manufacturer and Sandoz.
Sandoz is subject to the same advertising, marketing, and promotional
requirements and restrictions set forth by the FDA for the brand-name
manufacturer. This includes producing and making available to distributors a
Medication Guide that contains appropriate and current warning labels and that is
ultimately disseminated to the patient by the distributor. Ms. Tutwiler did not
receive a Medication Guide from her pharmacist as required by the FDA. As a
result, Ms. Tutwiler alleges, she was not aware that she was being prescribed
amiodarone for an “off-label” use and not as a last resort for her non-lifethreatening atrial fibrillation.
B
Ms. Tutwiler’s initial complaint asserted eight causes of action: (1) strict
products liability (failure to warn); (2) negligence (failure to warn); (3) negligence
(marketing and sale); (4) negligence per se; (5) fraud and deceit; (6) personal
injury; (7) unjust enrichment; and (8) injunctive and declaratory relief. Sandoz
filed a motion to dismiss, which the district court granted without prejudice for
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certain of Ms. Tutwiler’s claims on federal preemption grounds and due to the
complaint being insufficiently pled.
Ms. Tutwiler amended her complaint, re-pleading three causes of action: (1)
strict products liability (failure to warn); (2) negligence (failure to warn); and (3)
negligence (marketing and sale). Sandoz again filed a motion to dismiss, which
the district court granted with prejudice, ruling that Ms. Tutwiler’s amended
complaint contained substantially similar theories or failed to describe the claims
with sufficient particularity. Ms. Tutwiler now appeals only the dismissal of her
failure to warn claims.
II
We review de novo the district court’s dismissal of Ms. Tutwiler’s amended
complaint for failure to state a claim under Federal Rule of Civil Procedure
12(b)(6). See Hill, 321 F.3d at 1335. A complaint “that states a plausible claim for
relief survives a motion to dismiss.” Ashcroft v. Iqbal, 556 U.S. 662, 679 (2009).
But a complaint based on legal conclusions and “[t]hreadbare recitals of the
elements of a cause of action, supported by mere conclusory statements” will not.
Id. at 678 (citing Bell Atlantic Corp. v. Twombly, 550 U.S. 544, 555 (2007)).
We also review de novo the district court’s interpretation of state law. See
Tampa Bay Water v. HDR Eng’g, Inc., 731 F.3d 1171, 1177 (11th Cir. 2013).

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III
Ms. Tutwiler argues that dismissal was improper because (1) her state-based
failure-to-warn claim is not preempted by federal law and (2) the Alabama learned
intermediary doctrine is inapplicable.
A
Preemption is derived from the Supremacy Clause of the United States
Constitution. See U.S. Const. art. VI, cl. 2; Mink v. Smith & Nephew, Inc., 860
F.3d 1319, 1328 (11th Cir. 2017). We first determine whether the Ms. Tutwiler’s
claim stands under Alabama state law, and only if necessary will we consider the
question of preemption.

See Slack v. McDaniel, 529 U.S. 473, 485 (2000)

(articulating that courts should “not pass upon a constitutional question . . . , if
there is also present some other ground upon which the case may be disposed of”);
Mink, 860 F.3d at 1328 (stating that we “only [ ] decide the preemption questions
where necessary”). As explained below, Alabama’s learned intermediary doctrine
bars Ms. Tutwiler’s claims. We therefore do not address the issue of preemption.
See Mink, 860 F.3d at 1328.
B
We apply Alabama law to Ms. Tutwiler’s claims. See, e.g., Guaranty Trust
Co. of N.Y. v. York, 326 U.S. 99, 112 (1945) (“The source of substantive rights
enforced by a federal court under diversity jurisdiction . . . is the law of the
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States.”). The Alabama Supreme Court adopted the learned intermediary doctrine
in Stone v. Smith, Kline & French Laboratories, 447 So. 2d 1301 (Ala. 1984), a
case that addressed whether a manufacturer’s duty to warn extended to both the
physician and the patient to whom the drug would be prescribed. Stone held that
pharmaceutical companies, “who must warn ultimate purchasers of dangers
inherent in patent drugs sold over the counter, in selling prescription drugs are
required to warn only the prescribing physician, who acts as a ‘learned
intermediary’ between manufacturer and consumer.” Id. at 1305 (quoting Reyes v.
Wyeth Laboratories, 498 F.2d 1264, 1276 (5th Cir. 1974)).
The doctrine in Alabama acknowledges “the role of the physician as a
learned intermediary between a drug manufacturer and a patient.” Wyeth, Inc. v.
Weeks, 159 So. 3d 649, 673 (Ala. 2014).

The underlying principle is that

“prescribing physicians act as learned intermediaries between a manufacturer of a
drug and the consumer/patient and, therefore, the physician stands in the best
position to evaluate a patient’s needs and to assess the risks and benefits of a
particular course of treatment for the patient.” Id. at 672–73. See also Springhill
Hosps., Inc. v. Larrimore, 5 So. 3d 513, 518 (Ala. 2008) (“The relationship
between physician-patient-manufacturer applies equally to the relationship
between the physician-patient and pharmacist. In both circumstances the patient
must look to the physician, for it is only the physician who can relate the
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propensities of the drug to the physical idiosyncrasies of the patient.”) (internal
quotation marks and citation omitted).
Thus, in Alabama, the “manufacturer’s duty to warn is limited to an
obligation to advise the prescribing physician of any potential dangers that may
result from the use of its product.” Weeks, 159 So. 3d at 673 (citing Toole v.
Baxter Healthcare Corp., 235 F.3d 1307, 1313–14 (11th Cir. 2000)); Walls v.
Alpharma USPD, Inc., 887 So. 2d 881, 883 (Ala. 2004) (same). The adequacy of
the manufacturer’s warning is “measured by its effect on the physician, [ ] to
whom it owed a duty to warn, and not by its effect on the consumer.” Weeks, 159
So. 3d at 673 (alteration adopted); Walls, 887 So. 2d at 883 (same).
Once the manufacturer has met its duty to warn, the manufacturer holds no
further duty to warn the patient directly. See Weeks, 159 So. 3d at 673. If,
however, the warning to the learned intermediary is insufficient or is a
misrepresentation of risks, “the manufacturer remains liable for the injuries
sustained by the patient.” Id. In such a situation, the patient must show that:
[T]he manufacturer failed to warn the physician of a risk not
otherwise known to the physician and that the failure to warn was the
actual and proximate cause of the patient’s injury. In short, the patient
must show that, but for the false representation made in the warning,
the prescribing physician would not have prescribed the medication to
his patient.

Id. at 673–74.
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C
We cannot accept Ms. Tutwiler’s conclusory allegation that Dr. Plumb is not
a learned intermediary without “well-pleaded factual allegations” to support it. See
Iqbal, 556 U.S. at 679.

Ms. Tutwiler contends that the Alabama learned

intermediary doctrine is inapplicable because Dr. Plumb—along with all
physicians in the United States—was inadequately warned of the dangers of
amiodarone by Sandoz.

The district court ruled that these allegations were

insufficient because Ms. Tutwiler failed to allege that “if her physician had been
aware of the risks of prescribing amiodarone . . . he would not have prescribed the
drug to her.” D.E. 26 at 5. We agree. Assuming Ms. Tutwiler pled sufficient facts
to support that Sandoz inadequately warned Dr. Plumb, she has still failed to plead
“that the failure to warn was the actual and proximate cause of [her] injury,” as
required by Alabama law. Weeks, 159 So. 3d at 673.
On appeal Ms. Tutwiler again argues that the learned intermediary doctrine
does not apply because she alleged that Sandoz did not adequately warn Dr.
Plumb. This argument, however, does not address Alabama’s separate requirement
that she also plead proximate causation—that Dr. Plumb would not have
prescribed her amiodarone had he known of its dangers. See Weeks, 159 So. 3d at
673–74.

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Ms. Tutwiler failed to do this. Instead, she claims that she would not have
taken amiodarone had she known of its dangerous effects. Regardless of what Ms.
Tutwiler would or would not have done with the information, Alabama law
requires a showing of what Dr. Plumb would have done with it. See Weeks, 159
So. 3d at 673–74 (requiring a showing that “but for the false representation made
in the warning, the prescribing physician would not have prescribed the medication
to his patient”). See also Toole, 235 F.3d at 1313–14 (noting that adequacy of
warnings is measured by the “effect on the physician”).

Without more, Ms.

Tutwiler fails to allege what “effect on the physician” the allegedly-omitted
information would have had on Dr. Plumb’s decision to prescribe amiodarone. See
Weeks, 159 So. 3d at 673–74; Toole, 235 F.3d at 1313–14. This failure leaves Ms.
Tutwiler short of meeting her burden to plead proximate causation. See Weeks,
159 So. 3d at 673–74. Ms. Tutwiler’s failure-to-warn claim is therefore barred by
the Alabama learned intermediary doctrine.1

1

Ms. Tutwiler requests that we certify a question regarding the application of the learned
intermediary doctrine in this case to the Alabama Supreme Court. We decline to do so because
the learned intermediary doctrine is well-settled in Alabama and we do not have substantial
doubt as to its application here. See Dietz v. Smithkline Beecham Corp., 598 F.3d 812, 816 n.2
(11th Cir. 2010) (denying request for certification because “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.”).
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IV
Alabama’s learned intermediary doctrine bars Ms. Tutwiler’s failure to warn
claim. We therefore affirm. 2
AFFIRMED.

2

Given our ruling, we need not address preemption.
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