Latham Bean v. Upsher-Smith Pharmaceuticals

• Court: Court of Appeals for the Fourth Circuit
• Decided: April 8, 2019
• Docket: 17-2263
• Status: Unpublished

Opinion

UNPUBLISHED

UNITED STATES COURT OF APPEALS FOR THE FOURTH CIRCUIT

No. 17-2263

LATHAM SEAN BEAN, individually and as Personal Representative of the Estate of Hubert E. Bean Jr., Deceased,

Plaintiff - Appellant,

v.

UPSHER-SMITH PHARMACEUTICALS, INC.; TARO PHARMACEUTICALS USA, INC.,

Defendants - Appellees.

Appeal from the United States District Court for the District of South Carolina, at Florence. R. Bryan Harwell, Chief District Judge. (4:16-cv-01696-RBH)

Argued: March 21, 2019 Decided: April 8, 2019

Before WILKINSON, KING, and DUNCAN, Circuit Judges.

Affirmed by unpublished per curiam opinion.

ARGUED: Edward Kirksey Wood, Jr., WOOD LAW FIRM, LLC, Birmingham, Alabama; Samuel C. Cole, SAM COLE LEGAL SERVICES, PLLC, Plano, Texas, for Appellant. Mark C. Hegarty, SHOOK HARDY BACON, LLP, Kansas City, Missouri, for Appellees. ON BRIEF: Arthur J. Liederman, Nicole M. Battisiti, MORRISON MAHONEY LLP, New York, New York; Gray T. Culbreath, GALLIVAN, WHITE & BOYD, PA, Columbia, South Carolina, for Appellee Taro Pharmaceuticals USA, Inc. Monteith P. Todd, SOWELL, GREY, STEPP, & LAFFITTE, LLC, Columbia, South Carolina, for Appellee Upsher-Smith Laboratories, LLC.

Unpublished opinions are not binding precedent in this circuit.

2 PER CURIAM:

Appellant here sued Taro Pharmaceuticals and Upsher-Smith Pharmaceuticals,

the manufacturers of amiodarone, under South Carolina law. The suit alleged that the

companies failed to warn Hubert Bean of the risks of amiodarone and, as a result, Bean

took the drug and passed away. The district court dismissed the claim on the grounds that

it was preempted by federal law or, alternatively, that it could not survive application of

South Carolina’s learned intermediary doctrine. We affirm on the second ground and do

not reach the preemption question.

I.

This case was resolved on a motion to dismiss and we therefore take as true the

facts as stated in Bean’s Complaint. Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009). In

October 2013, Hubert Bean was prescribed amiodarone for non-life-threatening atrial

fibrillation. There is no dispute that, at the time of the prescription, Bean’s physician, Dr.

Rajesh Malik, was aware that a course of amiodarone carried with it a risk of pulmonary

toxicity as a side effect. Unfortunately, Mr. Bean experienced that side effect and died on

June 20, 2014, after suffering troubled breathing, coughing, tiredness, weakness,

nervousness, irritability, restlessness, decreased concentration, and depression.

Bean himself was not aware of the risk of pulmonary toxicity. This is because he

never received the FDA-mandated Medication Guide, which, according to the Complaint,

would have made him aware of the risk and convinced him not to take the drug. What is

more, amiodarone is not approved by the FDA as a treatment for non-life-threatening

3 atrial fibrillation; Dr. Malik’s prescription was an “off-label” use of amiodarone. J.A.16-

17.

Latham Bean, Hubert Bean’s son, brought suit against the manufacturers of

amiodarone, Upsher-Smith and Taro, on May 26, 2016. As relevant here, his Complaint

alleged that the manufacturers had violated their duty under South Carolina state law to

warn users of their product’s dangers. The Complaint also alleged that the manufacturers

had unlawfully promoted amiodarone for off-label uses.

The manufacturers moved to dismiss, and the district court granted this motion.

The failure to warn claim, the court ruled, was preempted by federal law or was barred by

South Carolina’s learned intermediary doctrine. The off-label promotion claim was

dismissed as preempted by federal law. Bean appealed only the ruling on the failure to

warn claim, allowing the disposition of the off-label promotion claim to stand

unchallenged. Opening Br. at 3 (“On appeal, Mr. Bean challenges only the dismissal of

his medication guide, failure-to-warn claims against Defendants.”).

II.

We affirm the district court’s application of the learned intermediary doctrine to

dismiss Bean’s failure to warn claim. As this is a sufficient ground on which to resolve

the case, we need not reach the manufacturers’ preemption argument.

In Brooks v. Medtronic, we noted that South Carolina law was silent as to whether

it incorporated the common law doctrine of the learned intermediary. 750 F.2d 1227,

1230 (4th Cir. 1984). However, looking to a “substantial majority of jurisdictions,” we

concluded that the defense would apply in South Carolina. Id. at 1231. Accordingly, we

4 held that the state’s law imposes on manufacturers of drugs like amiodarone a duty to

warn that extends only to “physicians (or other medical personnel permitted by state law

to prescribe drugs).” Id. (quoting Stanback v. Parke, Davis and Co., 657 F.2d 642, 644

(4th Cir. 1981).

Subsequently, South Carolina’s Supreme Court has proven us correct on this

score. In Madison v. American Home Products Corporation, that court held that

pharmacists could not be held strictly liable for the side effects of drugs they supply,

since such liability “is inconsistent with the learned intermediary doctrine.” 595 S.E.2d

493, 496 (S.C. 2004) (quoting David J. Marchitelli, Liability of Pharmacist Who

Accurately Fills Prescription for Harm Resulting to User, 44 A.L.R. 5th 393, 419, §

2(a)(1996)). The district court was therefore correct to apply the doctrine to the present

case, which was decided under South Carolina law.

Comment (b) on §6 of the Restatement (Third) of Torts, describes the

“traditional[]” view that manufacturers of drugs and medical devices can discharge their

common law duty by giving “warnings directed to health-care providers and not to

patients.” Restatement (Third) of Torts, §6, Comment (b). These healthcare providers act

as “learned intermediaries,” using their knowledge, training, and experience to provide

the patient with “such information as is deemed appropriate under the circumstances so

that the patient can make an informed choice as to therapy.” Id. Often, the “learned

intermediary” is the patient’s prescribing physician. See e.g. Salmon v. Parke, Davis &

Co., 520 F.2d 1359, 1362 (4th Cir.1975) (“A manufacturer of an ethical drug must

exercise reasonable care … to warn physicians effectively of the drug's inherent

5 dangers.”); Martin v. Hacker, 628 N.E.2d 1308, 1311 (N.Y.1993) (“The physician acts as

an ‘informed intermediary.’”); Brown v. Superior Court, 751 P.2d 470, 477 (Cal.1988)

(“patient's expectations … are those related to him by his physician, to whom the

manufacturer directs the warnings regarding the drug’s properties”).

In this case, Dr. Malik is the learned intermediary. As Bean’s physician he was

best placed to evaluate Bean’s medical history and circumstances and to decide what

information Bean needed to give informed consent to his treatment. Accordingly, as long

as the manufacturers warned Dr. Malik of the relevant risks, their duty to warn

“devolves” on Dr. Malik himself. Restatement (Third) of Torts, §6, Comment (b).

Appellant concedes that Dr. Malik was aware of the risk of pulmonary toxicity,

the condition which caused Bean’s death. As the district court put it,

Plaintiff does not allege that the prescribing physician did not receive the Medication Guide, was unaware of its contents, or the risk of pulmonary toxicity or lung problems possibly resulting in death. Plaintiff, in fact, alleges that the warnings contained in the Medication Guide were adequate and sufficient to warn Plaintiff of the dangers and risks of taking amiodarone. J.A. 479.

It is uncontested that Dr. Malik received all the warnings required by federal law,

and that these warnings are, on their own, adequate under state law. See Reply Brief of

Appellant at 10. He was aware that amiodarone carries with it a risk of pulmonary

toxicity when he prescribed it to his patient. As plaintiff notes, the risk of pulmonary

toxicity has long been known to apply to any patient taking amiodarone, regardless of the

heart condition being treated. Compl., J.A. 29 at ¶ 83. Although the precise argument

Bean advances on appeal appears to be a moving target, as best we can determine Bean

argues that these warnings were rendered ineffective by the manufacturers’ promotion of

6 amiodarone for off-label uses. The manufacturers, according to Bean, did not lie about

the risks of amiodarone, they lied about its benefits. Id.

Even accepting this allegation as true, it does not defeat application of the learned

intermediary doctrine in this failure to warn case. It is elementary that failure to warn

claims concern misrepresentations of risks. See e.g., Mendenall v. Anderson Hardwood

Floors, LLC, 738 S.E.2d 251, 261 (S.C. 2013) (failure to warn of “dangerous

conditions”); Merchant v. Lorain Division of Koehring, 251 S.E.2d 189, 192 (S.C. 1979)

(failure to warn of “possible hazard”). When companies misrepresent the benefits of a

product, they are subject to liability under different theories, such as negligent

misrepresentation. See e.g. Private Mortg. Inv. Services, Inc. v. Hotel and Club

Associates, Inc., 296 F.3d 308, 315 (4th Cir. 2002). Appellant was aware of this

distinction at the pleading stage, when he brought one set of claims premised on the

manufacturers’ alleged failure to warn and a separate set of claims premised on the

alleged off-label promotion. But Bean declined to appeal the district court’s dismissal of

this second theory of liability; he cannot revive it now, repackaged as a response to the

manufacturers’ invocation of the learned intermediary doctrine.

The Curcio v. Caterpillar case, cited by appellant at oral argument, is not to the

contrary. 585 S.E.2d 272 (S.C. 2003). There, an otherwise adequate warning was

contradicted: one section of a user manual instructed mechanics to disconnect a

machine’s batteries before performing work on it while a different section of the same

manual said the machine “could be started” while work was being performed, which

would be impossible if the batteries were disconnected. Id. at 274. The later contradictory

7 instruction rendered the earlier warning ineffective. But here there is no contradiction.

The manufacturers made Dr. Malik aware of the risk of pulmonary toxicity as they were

required to do by federal law. That warning was never contradicted or diluted: There is

no allegation that the manufacturers ever so much as insinuated that this risk was less

severe that it really was. The only allegation is that the manufacturers misled Dr. Malik

on an unrelated issue—the benefits of amiodarone—which does not come under the

scope of failure to warn liability.

Nor would South Carolina create an exception to the learned intermediary doctrine

for cases where the FDA requires a direct-to-consumer warning. FDA regulations state

that Bean himself, as the ultimate consumer of the amiodarone, should have received a

Medication Guide. See 21 C.F.R. §§ 208.24(a), (b). We take it as true that he did not for

the purpose of this motion to dismiss. But this federal requirement does not create an

exception to South Carolina’s learned intermediary doctrine. Such an exception would fly

in the face of the FDA’s intent that the Medication Guide rule not “alter the duty, or set

the standard of care for manufacturers[.]” 63 Fed. Reg. 66378, 66384 (Dec. 1, 1998). See

also, In re Norplant Contraceptive Prods. Liab. Litig., 165 F.3d 374, 379 (5th Cir. 1999).

The briefing and argument before us focused on the communication of risk. It is

the communication of risk that lies at the heart of a failure to warn claim, not simply in

the field of prescription drugs but with respect to product use in general. South Carolina’s

learned intermediary doctrine, as described in the Restatement (Third) of Torts, therefore

applies with full force. The manufacturers of amiodarone discharged their state-law duty

to warn consumers of their drug’s risks when they indisputably gave Dr. Malik an

8 adequate warning as to the risks of amiodarone use, including pulmonary toxicity. In

making this warning, Taro and Upsher-Smith did what South Carolina law requires of

them.

III.

For the foregoing reasons the judgment of the district court is

AFFIRMED.