Court Opinion

ID: 7827890
Source: CourtListenerOpinion
Date Created: 2022-09-07 20:00:28.041128+00
Date Added: 2024-06-11T16:30:55.308949
License: Public Domain

NOT PRECEDENTIAL

                    UNITED STATES COURT OF APPEALS
                         FOR THE THIRD CIRCUIT
                              _____________

                            Nos. 21-1642 & 21-2304
                                _____________

                    UNITED STATES COURT OF APPEALS
                         FOR THE THIRD CIRCUIT
                              _____________

                            Nos. 21-1642 & 21-2304
                                _____________

PHYLLIS BENNETT, Executor of the Estate of Harvey Bennett; ARTHUR J. OLSTAD;
   KATHLEEN OLSTAD; ROBERT PERKINS; ELIZABETH CLARK; WILLIAM
 MURPHY; BONNIE MURPHY; RITA WEAVER; MARVIN BAUMAN; ROWENA
       BAUMAN; HENRY ACKERMAN; GENIEVE ACKERMAN; DONALD
 HACKERSON; CAROLYN HACKERSON; JAMES WALZ; MARY BETH WALZ;
   JUDITH COTE; THEODORE ALMOND; EDWARD J. MILLER, JR.; THOMAS
   HEPLER; BARBARA KING; SAMUEL KING; RICKEY THOMAS; CAROLYN
    THOMAS; JOHN ACKERMAN; KIM ACKERMAN; ALBERT DELSANTRO;
            CHARLOTTE DELSANTRO; RICHARD BRESETTE; RALPH
 BOOTH; HANS OMASTA; WINONA OMASTA; EDDIE BATES; LINDA BATES;
CHARLES DAVID SMEDLEY; MARCHETTE COOK, Personal Representative of the
       Estate of Alice Southerland; TY BEARD; VERNON DEBOARD, Personal
 Representative of the Estate of Katherine DeBoard; JOHN A. DAVIS, JR.; DEBORAH
  DAVIS; KENNETH COLLINS; KIM COLLINS; CAROLYN HARRISON, Personal
  Representative of the Estate of Gerald Harrison; KAY ANN RICE; ROBERT RICE;
 LOIS RONCAL; DARLENE HERONEMA; KATHERINE WOLLASTON; DANIEL
  WOLLASTON; GEORGE CHOSICH; ELIZABETH CHOSICH; PEGGY BROWN;
     MARY ANN MINASIAN; LEE ALVIN SMITH; MARY PARKER; BRIAN
SUKENIK; LINDA BRUNNER; DENNIS WORKMAN; MARY WATERS; GEORGE
 SCHMIDT; SHARON SCHMIDT; CLINTON HUMPHREY; TENNA HUMPHREY;
    BETTY BOSTIC; JIMMY BOSTIC; GEORGIA SUTTON; BRAHA JACKSON;
      ROBERT MASON; NOEL CLECKLER; FRANCES CLECKLER; MARK
  LAGANELLI, Personal Representative of the Estate of Lawrence Laganelli; NEILS
     DAVIS; DON AMBURGEY; JOYCE AMBURGEY; ELBERT CROWDER;
      TIMOTHY LEROSE; MARGARET LEROSE; DOYLE TURNER, Personal
    Representative of the Estate of Carolyn Turner; MELVIN KINNEY; ISABELLA
 KINNEY; BALDEMAR MARTINEZ; ANNA MARTINEZ; ALBERT SHEPHERD,
 Personal Representative of the Estate of Emily Shepherd; DORIS JOHNSON; FRED
   BURROUGH; MONA WINDHAM; RONNIE WINDHAM; WILLIAM HUNT;
PHYLLIS HUNT; PINK JONES; ANNIE JONES; MARY DAVIS; JAMES MASON;
 CATHY MASON; CECIL THOMAS; DEBBIE THOMAS; MARTHA SUE DIXON;
BELVA WARD; DONALD BARD; JUDY BARD; JOHN SPAULDING, JR.; LINDA
  SPAULDING; SHIRLEY MILLER; RONALD MILLER; JACQUELINE FABBRI,
 Personal Representative of the Estate of Frank Fabbri; INGA REYNOLDS, Personal
Representative of the Estate of Gerwin Hermenau; CARLETTA WILLIAMS, Personal
Representative of the Estate of James C. Williams, III; TRIO CALDWELL; BEVERLY
CALDWELL; EDWIN STREED; MARGARET STREED; DIANNE CRUCE; DOUG
HYAK; DAMEON ALBRITTON; JI YONG AHN ALBRITTON; LAUREL TURLEY;
ROGER TURLEY; DIANE MANCINELLI; CONNIE LUYE, Personal Representative
    of the Estate of Evelyn Moss; ROBERT E. SMITH; DORLIS LYLE, Personal
 Representative of the Estate of James Lyle; GEORGE L. BUSH; EDWIN MARTIN;
 CHARLES HERSHISER; MARY FRANCES HERSHISER; SHELBY CAMPBELL;
 PENNY WATSON, Personal Representative of the Estate of Darwin Watson; JOHN
                              HENDRIX; LINDA PERRY,

                                               Appellants in No. 21-1642

     JAMES JORDAN; SHARON JORDAN; BOBBY HUGHES, PERSONAL
  REPRESENTATIVE OF THE ESTATE OF MIRIAM HUGHES; BILLY KARR;
 SHANNON DAY; CINDY DAY; PATRICIA ALBRECHT RHODES, PERSONAL
  REPRESENTATIVE OF THE ESTATE OF REX RHODES; BRUCE WEHLING,
PERSONAL REPRESENTATIVE OF THE ESTATE OF LEONARD WEHLING, JR.,

                                               Appellants in No.21-2304

                                      v.

                    TEVA PHARMACEUTICALS USA INC
                            _____________

         ON APPEAL FROM THE UNITED STATES DISTRICT COURT
                    FOR THE DISTRICT OF DELAWARE
              (D.C. Civil Nos. 1-19-cv-02126 and 1-20-cv-01209)
                 District Judge: Honorable Colm F. Connolly
                                _____________

                              Argued May 4, 2022
                                _____________

                                       2
    Before: CHAGARES, Chief Judge, GREENAWAY, JR. and PORTER, Circuit Judges

                           (Opinion Filed: September 7, 2022)

Samuel C. Cole    [ARGUED]
4421 Kelly Drive
Richardson, TX 75082

Edward K. Wood, Jr.
Wood Law Firm
P.O. Box 382434
Birmingham, AL 35238

        Counsel for Appellants

Jaime A. Santos     [ARGUED]
Goodwin Procter
1900 N Street, N.W.
Washington, DC 20036

Carla R. Karp
Greenberg Traurig
500 Campus Drive
Suite 400
Florham Park, NJ 07932

Glenn S. Kerner
Greenberg Traurig
One Vanderbilt Avenue
New York, NY 10017

        Counsel for Appellee

                                      _____________

                                        OPINION
                                     ______________


 This disposition is not an opinion of the full Court and, pursuant to I.O.P. 5.7, does not
constitute binding precedent.

                                             3
GREENAWAY, JR., Circuit Judge.

       Prescription drugs are generally a boon to the health of our populace. Their ability

to address maladies is something we have accepted and embraced societally. But

unfortunately, prescription drugs often carry a risk of side effects. That risk—and a

pharmaceutical company’s obligation to warn of the risk of side effects—gives rise to

this litigation.

       Amiodarone, which is manufactured by Teva Pharmaceuticals USA Inc. (“Teva”

or “Appellee”), is a generic version of a prescription drug named Cordarone (produced by

Wyeth Pharmaceuticals). Appellants are patients, spouses, heirs, and the estates of

decedents who used the drug for its off-label use to treat atrial fibrillation (“a-fib”). They

commenced two actions against Teva relating to Teva’s manufacture and distribution of

Amiodarone.

       Appellants allege Teva violated its state law duties, as a generic manufacturer, to

warn users regarding Amiodarone’s off-label use. Specifically, Teva did not provide

federally mandated Medication Guides, and it failed to report all adverse events to the

FDA. Also, according to Appellants, Teva either directly or through omission

misrepresented that Amiodarone was safe and effective as a treatment for a-fib.

       In this consolidated appeal, we will affirm the District Court’s dismissal of

Appellants’ claims because Appellants fail to adhere to the requirements of Rules 8 and 9

of the Federal Rules of Civil Procedure.

                                              4
       BACKGROUND

       A.        Statutory and Regulatory Framework

       The Food, Drug, and Cosmetic Act (“FDCA”), Ch. 675, 52 Stat. 1040 (codified as

amended at 21 U.S.C. § 301 et seq.), provides the regulatory framework for prescription

drugs in the United States. Under the FDCA, drug manufacturers must seek approval

from the United States Food and Drug Administration (“FDA”) to bring a new drug to

market. The approval processes for brand-name drugs and generic drugs differ

significantly.

       Brand-name drug manufacturers must first file a New Drug Application. 21

U.S.C. § 355(b)(1), (d). Thereafter, they must prove the drug’s safety and efficacy and

propose accurate and adequate labeling. Id. “As the Supreme Court has recognized,

‘[m]eeting those requirements involves costly and lengthy clinical testing.’” In re

Fosamax (Alendronate Sodium) Prod. Liab. Litig. (No. II), 751 F.3d 150, 153 (3d Cir.

2014) (quoting PLIVA, Inc. v. Mensing, 564 U.S. 604, 612 (2011)).

       By contrast, pursuant to the Drug Price Competition and Patent Term Restoration

Act of 1984 (the “Hatch-Waxman Act”), codified at 21 U.S.C. §§ 355, 360cc and

35 U.S.C. §§ 156, 271, 282, generic drugs can “gain FDA approval simply by showing

equivalence to a . . . drug that has already been approved by the FDA.” In re Fosamax,

751 F.3d at 153 (quoting Mensing, 564 U.S. at 612); see also 21 U.S.C. § 355(j)(2)(A)).

To do so, generic drug manufacturers must file an Abbreviated New Drug Application.

The FDA will provide its approval if the generic drug manufacturer sufficiently

demonstrates that “the generic drug and the FDA-approved brand-name drug are

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bioequivalent[, and] . . . hav[e] the same active ingredients, . . . route of administration,

dosage form, dosage form, dosage strength, and labeling.” In re Fosamax, 751 F.3d at

153 (citing 21 U.S.C. § 355(j)(2)(A)(ii)-(v)). The purpose of the Hatch-Waxman Act is

to “allow[ ] manufacturers to develop generic drugs inexpensively, without duplicating

the clinical trials already performed on the equivalent brand-name drug.” Id. (quoting

Mensing, 564 U.S. at 612.).

       For drugs with serious side effects, the FDA also requires patient labeling.

21 C.F.R. § 208.1(c) (“Patient labeling will be required if the FDA determines that . . .

[t]he drug product is one for which patient labeling could help prevent serious adverse

effects.”). For those drugs, the manufacturer must provide Medication Guides or the

means to produce them to distributors, packers, or authorized dispensers. 21 C.F.R.

§ 208.24(b).1 In turn, distributors or packers must provide those guides or the means to

produce them to authorized dispensers. 21 C.F.R. § 208.24(c). At the time that a drug is

dispensed, these dispensers must then provide the Medication Guide to patients or their

agents. 21 C.F.R. § 208.24(e). The FDA approves Medication Guides “to ensure [they

1
  Specifically, § 208.24(b) provides: “[e]ach manufacturer who ships a container of drug
product for which a Medication Guide . . . is responsible for ensuring that Medication
Guides are available for distribution to patients by either: (1) [p]roviding Medication
Guides in sufficient numbers to distributors, packers, or authorized dispensers to permit
the authorized dispenser to provide a Medication Guide to each patient receiving a
prescription for the drug product; or (2) [p]roviding the means to produce Medication
Guides in sufficient numbers to distributors, packers, or authorized dispensers to permit
the authorized dispenser to provide a Medication Guide to each patient receiving a
prescription for the drug product.”

                                               6
are] consistent with [the information contained] in the package insert.” 63 Fed. Reg. at

66386.

         Beyond drug approval and labeling, the FDCA and FDA impose other

requirements. As relevant here, the FDCA “generally prohibits manufacturers from

marketing, advertising, or otherwise promoting drugs for . . . unapproved or ‘off-label’

uses” (i.e., “therapeutic uses other than their FDA-approved indications”). In re Schering

Plough Corp. Intron/Temodar Consumer Class Action, 678 F.3d 235, 239–40 (3d Cir.

2012) (citing 21 U.S.C. § 331(a) and (d)). However, because “the FDCA does not

regulate the practice of medicine, physicians may lawfully prescribe drugs for [such] off-

label uses.” Id. (citation omitted). Drug manufacturers must also report adverse drug

experiences to the agency.2 21 C.F.R. § 314.80(c). Pursuant to Section 314.80, adverse

drug experiences are defined as “[a]ny adverse event associated with the use of a drug in

humans, whether or not considered drug related.” Id.

         B.    Factual and Procedural History

         Appellants either are patients who were injured by the drug Amiodarone or sue on

behalf of their relatives who were injured by the drug Amiodarone. Although the facts

differ slightly among them, the general allegations are the same. Each patient suffered

from a-fib and was prescribed Amiodarone. Appellants allege that the patients suffered

2
  Examples of adverse drug experiences include: “[a]n adverse event occurring in the
course of the use of a drug product in professional practice; an adverse event occurring
from drug overdose whether accidental or intentional; an adverse event occurring from
drug abuse; an adverse event occurring from drug withdrawal; and any failure of
expected pharmacological action.” 21 C.F.R. § 314.80(a).

                                             7
significant side effects (such as pulmonary fibrosis, pulmonary toxicity, and respiratory

failure) as a result of using Amiodarone, including, in some cases, death.

       Amiodarone is the generic form of the brand-name drug Cordarone. Teva is a

manufacturer of generic Amiodarone. Amiodarone is a drug of “last resort” for patients

suffering from ventricular fibrillation and tachycardia. Appendix (“App.”) 322. The

FDA has not approved Amiodarone for the treatment of a-fib, but physicians prescribe it

for this “off-label” purpose. App. 58.

       The plaintiffs bring seven claims under Delaware state law: strict liability and

negligent failure to warn (Counts 1–2); negligent marketing and sale (Count 3);

negligence per se (Count 4); strict liability for defective manufacturing under Del. Code

§ 3302 (Count 5); fraud (Count 6); and a derivative claim for wrongful death (Count 7).

Appellants’ claims broadly fall into three theories of liability. First, Appellants allege

that they did not receive Medication Guides when their Amiodarone prescriptions were

dispensed, as required by federal regulations, because Teva failed to make them available

to pharmacists in sufficient numbers. Second, Appellants allege that Teva failed to report

known adverse events to the FDA. Third, Appellants allege that Teva negligently and

fraudulently promoted Amiodarone as approved for the treatment of a-fib or benefitted

from others’ fraudulent promotion of the off-label use of the drug.

       Teva moved to dismiss both cases pursuant to Federal Rule of Civil Procedure

12(b)(6). The District Court granted both motions, holding that the plaintiffs’ claims

were impliedly preempted by the FDCA. In opposing the motions to dismiss, Appellants

concluded by briefly requesting leave to amend their complaints should the District Court

                                              8
be inclined to grant the motions. However, because the District Court held that the

claims were preempted as a matter of law, the court dismissed both complaints with

prejudice. Appellants timely appealed. This Court consolidated the appeals on July 21,

2021. Appellants in Jordan v. Teva Pharmaceuticals USA Inc, No. 21-2304, adopted the

brief filed by Appellants in Bennett v. Teva Pharmaceuticals USA, Inc., No. 21-1642, on

October 19, 2021.

       After observing a potential issue regarding the District Court’s subject matter

jurisdiction over these cases, we remanded the orders of the District Court. Specifically,

we instructed the District Court to consider whether the Doe defendants were merely

nominal defendants that may be dismissed without prejudice or whether to permit the

Appellants to amend the Bennett complaint to assert jurisdiction under CAFA.

Subsequently, the parties filed a joint motion to dismiss the Doe defendants and a petition

for rehearing. We granted both requests on August 26, 2022, and now reach the merits.

       STANDARD OF REVIEW

       We review “a district court’s decision granting a party’s motion to dismiss de

novo.” Buck v. Hampton Twp. Sch. Dist., 452 F.3d 256, 260 (3d Cir. 2006). “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.” Zuber v. Boscov’s, 871 F.3d 255,

258 (3d Cir. 2017) (quoting Santiago v. Warminster Twp., 629 F.3d 121, 128 (3d Cir.

2010)). “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.” Id. (quoting Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009)).

                                              9
       Pursuant to Rule 8 of the Federal Rules of Civil Procedure, a plaintiff is required

to provide “a short and plain statement of the claim showing that the pleader is entitled to

relief.” Fed. R. Civ. P. 8(a)(2). In addition, under Rule 9, fraud claims are subject to a

heightened pleading standard. Fed. R. Civ. P. 9(b); see also In re Burlington Coat

Factory Sec. Litig., 114 F.3d 1410, 1418 (3d Cir. 1997) (citation omitted) (“boilerplate

and conclusory allegations will not suffice” and “[p]laintiffs must accompany their legal

theory with factual allegations that make their theoretically viable claim plausible.”).

       DISCUSSION

       As a preliminary matter, we shall address whether Appellants’ claims are

sufficiently pled pursuant to Rules 8 and 9. “[A]lthough the District Court did not

address [the sufficiency of the pleadings], we can affirm based on any grounds supported

by the record.” Ridley Sch. Dist. v. M.R., 680 F.3d 260, 282 (3d Cir. 2012) (citing

Chambers ex rel. Chambers v. Sch. Dist. Of Philadelphia Bd Of Educ., 587 F.3d 176,

183–34 (3d Cir. 2009)).

       A.     Medication Guide Claim

       Appellants allege that “Defendants failed to ensure the Medication Guide was

provided to all consumers, including Plaintiffs, in the manner required by law.” App. 352

¶ 188. Not only is this allegation conclusory insofar as it fails to articulate how Teva’s

provision of the Medication Guide was purportedly deficient, see Iqbal, 556 U.S. at 678,

but also 21 C.F.R. § 208.24(b)(2) does not impose a requirement that drug manufacturers

deliver Medication Guides directly to patients. Rather, § 208.24 permits manufacturers

to “[p]rovid[e] the means to produce Medication Guides in sufficient numbers to

                                             10
distributors, packers, or authorized dispensers.” 21 C.F.R. § 208.24(b). Appellants make

no factual allegations that support the inference that Appellee failed to do so. Thus, their

Medication Guide claim is not plausibly alleged.

       B.     Failure to Report Claim

       Appellants allege “Defendants also failed to report thousands of serious adverse

medical events in their exclusive possession to the FDA, health care professionals, and

consumers, including Plaintiffs.” App. 352. These pleadings are conclusory. Appellants

cannot rely on the assumption that because millions of patients are diagnosed with a-fib

and Amiodarone is prescribed off-label to treat it, Appellee failed to report or otherwise

concealed adverse events. At the very least, Appellants would need to provide examples

of countless adverse events that Appellee knew or should have reasonably known about

but failed to report to the FDA. Appellants’ failure to sufficiently plead such claims

necessarily means that their pleadings, to the extent they allege fraud, likewise fail to

satisfy the heighted pleading standard of Rule 9.

       C.     Off-Label Promotion Claim

       Appellants allege “Teva ‘provided or failed to correct false and misleading

information about the indications and uses of Amiodarone provided to physicians via

reference materials like the PDR and Epocrates, that are used by physicians in prescribing

situations and which the prescribing physicians read and rely on in prescribing

Amiodarone to Plaintiffs.’” Appellants’ Br. at 49 (citing App. 363). Such allegations are

similarly insufficient under Rule 9’s heightened pleading standard. Appellants do not

identify any specific misrepresentations and instead, generally assert that the information

                                             11
provided in the reference materials, which Appellants characterize as labeling, was false

and misleading.

       In addition, Appellants do not plead sufficient factual allegations to support the

inference that Teva is responsible for or otherwise contributed to these reference

materials. Teva, as a generic drug manufacturer, does not have any control over

labeling—that was solely Wyeth’s responsibility. See Mensing, 564 U.S. at 613 (citation

omitted) (explaining that a generic drug manufacturer must “ensur[e] that its warning

label is the same as the brand name’s”).

       D.     Leave to Amend

       Although Rule 15 provides that leave to amend should be “freely give[n] when

justice so requires,” we will not grant Appellants leave in this case. Fed. R. Civ. P.

15(a)(2). Where, as here, a plaintiff includes a “single sentence, lacking a statement for

the grounds for amendment and dangling at the end of her memorandum” in opposition to

a motion to dismiss, “a motion for leave to amend was never properly before [the District

Court].” Ramsgate Ct. Townhome Ass’n v. W. Chester Borough, 313 F.3d 157, 161 (3d

Cir. 2002). Thus, the District Court did not abuse its discretion when it dismissed

Appellants’ claims with prejudice.

       CONCLUSION

       For the foregoing reasons, we will affirm the District Court’s dismissal of

Appellants’ complaints.

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