Barbara R. Tutwiler v. Sandoz, Inc.

• Court: Court of Appeals for the Eleventh Circuit
• Decided: April 9, 2018
• Docket: 17-13985
• Status: Unpublished

Opinion

Case: 17-13985 Date Filed: 04/09/2018 Page: 1 of 10

[DO NOT PUBLISH]

IN THE UNITED STATES COURT OF APPEALS

FOR THE ELEVENTH CIRCUIT ________________________

No. 17-13985 Non-Argument Calendar ________________________

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: Case: 17-13985 Date Filed: 04/09/2018 Page: 2 of 10

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-life-

threatening 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.

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.

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. 10