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`20-1208
`Frei, et al. v. Taro Pharmaceutical U.S.A., Inc.
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`UNITED STATES COURT OF APPEALS
`FOR THE SECOND CIRCUIT
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`SUMMARY ORDER
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`RULINGS BY SUMMARY ORDER DO NOT HAVE PRECEDENTIAL EFFECT.
`CITATION TO A SUMMARY ORDER FILED ON OR AFTER JANUARY 1, 2007, IS
`PERMITTED AND IS GOVERNED BY FEDERAL RULE OF APPELLATE
`PROCEDURE 32.1 AND THIS COURT’S LOCAL RULE 32.1.1. WHEN CITING A
`SUMMARY ORDER IN A DOCUMENT FILED WITH THIS COURT, A PARTY MUST
`CITE EITHER THE FEDERAL APPENDIX OR AN ELECTRONIC DATABASE (WITH
`THE NOTATION “SUMMARY ORDER”). A PARTY CITING TO A SUMMARY
`ORDER MUST SERVE A COPY OF IT ON ANY PARTY NOT REPRESENTED BY
`COUNSEL.
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`At a stated term of the United States Court of Appeals for the Second Circuit, held at the
`Thurgood Marshall United States Courthouse, 40 Foley Square, in the City of New York, on the 20th
`day of April, two thousand twenty-one.
`
`PRESENT:
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`
`
`DEBRA ANN LIVINGSTON,
`Chief Judge,
`RICHARD C. WESLEY,
`SUSAN L. CARNEY,
`Circuit Judges.
`
`_________________________________________
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`JUDITH FREI, SANDRA RHODES, CHARLES RHODES, SHIRLEY HART,
`WILLIAM MURPHY, BONNIE MURPHY, JAMES WALTZ, MARY BETH
`WALZ, TRIO CALDWELL, BEVERLY CALDWELL, ALBERT DELSANTRO,
`CHARLOTTE DELSANTRO, ANNA THOMAS, CHARLES DAVID
`SMEDLEY, EDWARD FRISCO, LARRY E. ROBINSON, CECIL BARKLEY,
`NANCY MILLER, LARRY JUNKIN, ARTHUR L. CHURCH, MABLE
`CHURCH, JACQUELINE BOYD, CORTIS BOYD, BRIAN SUKENIK,
`SANDRA WHITE, ROGER WHITE, MARY WATERS, KEVIN HILTON,
`CLINTON HUMPHREY, TENNA HUMPHREY, BONNIE GREENE,
`MICHAEL HESS, SANDRA BONEKEMPER, NANCY HAGERMAN, GARY
`MELTON, CHRISTOPHER FREEMAN, JUDITH FREEMAN, CAROLYN
`SUE BEAN, MARK THOMPSON, ADA DUFFY, JEFFRIE HARRISON,
`CHRISTEN HARRISON, RANIERE CASERTA, COUCHITA CASERTA,
`DON AMBURGEY, JOYCE AMBURGEY, MONA SIMMONS, TRINA
`OWEN, RUBIE HODA, BILLY WEST, MONA WINDHAM, RONNIE
`WINDHAM, JEANNE COLBORNE, TRACIE SHOLLENBARGER, WILLIAM
`SHELTON, PINK JONES, ANNIE JONES, CYNTHIA SKILES, RAYMOND
`SKILES, EARL HINES, DAVID WHITLOCK, JACQUELINE WHITLOCK,
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`Plaintiffs-Appellants,
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`Plaintiffs,
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`v.
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`Defendant-Appellee,
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`No. 20-1208
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`CONNIE LUTE, JANICE SHELTON, JAMES SKINNER, DIXIE MELTON,
`DIANA HINES,
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`RAY HUBLER, MARIE HUBLER, REBECCA FRISCO, DEBRA HINES,
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`TARO PHARMACEUTICAL U.S.A., INC.,
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`ABC CORPORATIONS OR ENTITIES 1-50, JOHN AND JANE DOES 1-50,
`DOES 1-10,
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`Defendants.*
`_________________________________________
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`FOR PLAINTIFFS-APPELLANTS:
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`SAMUEL C. COLE, Cole Legal Services, PLLC,
`Richardson, TX (Joseph P. Guglielmo,
`Scott+Scott Attorneys at Law LLP, New
`York, NY; Alan M. Mansfield, Consumer Law
`Group of California, San Diego, CA; Edward
`K. Wood, Jr., Wood Law Firm LLC,
`Birmingham, AL, on the brief).
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`ARTHUR J. LIEDERMAN (Nicole Battisti, on the
`brief), Morrison Mahoney LLP, New York,
`NY.
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`FOR DEFENDANT-APPELLEE:
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`Appeal from a judgment of the United States District Court for the Southern District of
`New York (Briccetti, J.).
`UPON DUE CONSIDERATION WHEREOF, IT IS HEREBY ORDERED,
`ADJUDGED, AND DECREED that the judgment entered on March 11, 2020, is AFFIRMED.
`Plaintiffs-Appellants appeal from the dismissal of their First Amended Complaint (the
`“Complaint”), alleging that they suffered injuries from taking Amiodarone, a generic drug
`manufactured by Taro Pharmaceutical U.S.A., Inc., for the off-label treatment of atrial fibrillation.
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`* Although Judith Frei was dismissed as a plaintiff, the parties have retained her name in the caption for
`consistency, because she was the “first listed Plaintiff” for much of the litigation. See App’x at 22 n.1.
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`2
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`The Complaint pleads seven claims against Taro: strict liability and negligent failure to warn (Counts
`I-II), negligent marketing and sale (Count III), negligence per se (Count IV), violation of New York
`General Business Law §§ 349 & 350 (Count V), fraud (Count VI), and wrongful death (Count VII).1
`The District Court dismissed the entire Complaint, finding that the failure-to-warn and negligent
`marketing and sale claims were preempted under the Federal Food, Drug, and Cosmetic Act, 21
`U.S.C. § 301 et seq., and that the remaining claims were not plausibly pled. We assume the parties’
`familiarity with the underlying facts, the procedural history of the case, and the issues on appeal, to
`which we refer only as necessary to explain our decision to affirm.
`
`“We review a district court’s grant of a motion to dismiss de novo.” In re Synchrony Fin. Sec.
`Litig., 988 F.3d 157, 166 (2d Cir. 2021).2 This Court is “free to affirm on any ground that finds
`support in the record, even if it was not the ground upon which the trial court relied.” Wells Fargo
`Advisors, LLC v. Sappington, 884 F.3d 392, 396 n.2 (2d Cir. 2018).
`
`We affirm the dismissal of the Complaint under Federal Rule of Civil Procedure 12(b)(6)
`because none of the claims are plausibly pled under Rule 8 and, in the case of the fraud claim, Rule
`9. See Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009) (“To survive a motion to dismiss, a complaint must
`contain sufficient factual matter, accepted as true, to ‘state a claim to relief that is plausible on its
`face.’ A claim has facial plausibility when the plaintiff pleads factual content that allows the court to
`draw the reasonable inference that the defendant is liable for the misconduct alleged.” (quoting Bell
`Atlantic Corp. v. Twombly, 550 U.S. 544, 570 (2007))). Accordingly, we do not reach the questions
`whether, as Taro argues, certain claims are federally preempted or are barred by the state-law learned
`intermediary doctrine.
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`The thrust of the allegations is that Plaintiffs were seriously harmed when they took
`Amiodarone for the “off-label” treatment of atrial fibrillation, a heart condition for which the U.S.
`Food and Drug Administration (the “FDA”) has not officially approved the drug. Manufacturers—
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`1 The parties suggest that the state law of each Plaintiff’s domicile, where the respective injuries
`occurred, may apply to each Plaintiff’s claims. At this stage of the litigation, however, the parties cite
`only to New York law as an exemplar, on the assumption that “Plaintiff’s home states all have
`equivalent common law.” Appellants’ Br. at 15 n.4.
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`2 Unless otherwise noted, in quotations from caselaw, this Order omits all alterations, brackets,
`citations, emphases, and internal quotation marks.
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`3
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`in particular, Wyeth Pharmaceuticals Inc., which produced the original brand-name version of
`Amiodarone—allegedly encouraged this off-label use.
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`The Complaint pleads that Taro, as a subsequent generic manufacturer of Amiodarone, also
`bears responsibility. Underlying all seven claims against Taro are three basic factual theories: (1) Taro
`failed to make available to patients “Medication Guides” on the proper use and risks of Amiodarone
`as mandated in 21 C.F.R. § 208.24; (2) Taro failed to ensure the accuracy of information regarding
`Amiodarone in prescribing reference materials relied on by physicians, like the Physicians’ Desk
`Reference and Epocrates; and (3) Taro concealed information in its exclusive possession regarding
`adverse events that occurred from the use of Amiodarone to treat atrial fibrillation. Each of these
`three theories—and in turn, the seven claims they support—is fatally flawed because the Complaint
`does not plausibly allege Taro’s own involvement in wrongdoing.
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`First, the Complaint conclusorily asserts that Taro failed to make Medication Guides
`available to patients “in the manner required by law.” App’x at 200. But the Complaint offers no
`supporting allegations other than that Plaintiffs did not receive Medication Guides at the point of
`sale for Amiodarone. That this was the end result does not support a plausible inference that Taro
`committed wrongdoing. To the extent the theory is that Taro failed to ensure availability of the
`Medication Guides in accordance with 21 C.F.R. § 208.24, that regulation is minimally satisfied so
`long as Taro maintained “the means to produce Medication Guides.” Id. (b)(2) (emphasis added). It
`does not require that Taro distribute Medication Guides, let alone to patients at the point of sale,
`notwithstanding the Complaint’s suggestion otherwise. The Complaint lacks any allegation that Taro
`violated the minimal requirements of § 208.24. To the extent the theory is that Taro had a duty to
`provide Medication Guides beyond the manner set out in § 208.24, the Complaint does not say so or
`plead how Taro violated this hypothetical enhanced duty. See App’x at 200 (the allegations framing
`Taro’s “failure to provide each patient a Medication Guide” only in terms of a “violation of the
`FDA’s mandate” in § 208.24).
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`Nor is the theory that Taro failed to ensure the accuracy of the prescribing reference
`materials viable. The Complaint alleges that “[i]n connection with Defendants’ unlawful promotion
`and/or sale of Amiodarone . . . they either directly or indirectly provided . . . to the distributor of the
`Physician[s’] Desk Reference (“PDR”) and the developer of Epocrates” “indications and usage
`information regarding Amiodarone” that was misleading. App’x at 171. But the Complaint does not
`allege what that misleading information was or adduce any examples, beyond vaguely asserting that
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`4
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`the effect of the reference materials was to “deceive[] physicians into believing” that Amiodarone
`safely treated atrial fibrillation. App’x at 172. More critically, these allegations are not tailored to
`Taro. The Complaint suggests that the content of the reference materials is “considered ‘labeling’”
`subject to FDA approval, App’x at 173, but Taro, as a generic manufacturer, does not have control
`over this labeling. See PLIVA, Inc. v. Mensing, 564 U.S. 604, 613 (2011) (explaining that only brand-
`name manufacturers are “responsible for the accuracy and adequacy” of drug labeling and a generic
`manufacturer must “ensur[e] that its warning label is the same as the brand name’s”). The Complaint
`does not explain what Taro’s contribution to or authority to correct the reference materials was.
`Indeed, the allegations are not framed in terms of Taro’s misconduct, but rather that of
`“Defendants” generally, presumably referring to the numerous unidentified Doe Defendants not
`parties to this appeal. The only allegation specific to Taro is that images of Amiodarone pills that it
`manufactured appear in Epocrates, but we cannot plausibly infer from this fact that Taro controlled
`the medical content of the reference materials.
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`Finally, the theory that Taro did not report adverse events from the use of Amiodarone is
`not plausibly pled. As Plaintiffs’ counsel conceded at oral argument, this theory is based on a broad
`statistical allegation, and is not specifically tied to Taro’s conduct. The Complaint alleges that:
`There are millions or [sic] persons who are diagnosed with A-fib annually.
`Amiodarone over the years has become the number one prescribed drug for the
`treatment of A-fib. Based on the percentages of persons diagnosed just with
`pulmonary toxicity, there would be tens of thousands or [sic] adverse event reports
`submitted each year. Yet that does not appear to be even close to the number of
`these reports submitted to the FDA in connection with Amiodarone.
`App’x at 191. This allegation merely posits that all entities in the Amiodarone market should have
`collectively reported more adverse events of pulmonary toxicity in light of the frequency of these
`events in the general population. We cannot draw from this allegation an inference that Taro itself
`concealed information in its possession.
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`Because none of the three theories on which all the claims depend is viable, the Complaint
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`fails to state a plausible claim for relief under Rules 12(b)(6), 8, and 9.
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`* * *
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`5
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`For the foregoing reasons, the District Court’s judgment dismissing the Complaint is
`AFFIRMED.
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`FOR THE COURT:
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`Catherine O’Hagan Wolfe, Clerk of Court
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`6
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