Roncal v. Aurobindo Pharma U.S.
| Decision Date | 28 April 2022 |
| Docket Number | Civil Action 3:20-cv-02643 |
| Parties | LOIS RONCAL; JOHN NATHAN TIMM; BOBBIE ROBERTS; TROY ROBERTS; JENNIFER GRANBERRY, Personal Representative of the Estate of LINDALE GRANBERRY; CYNTHIA SKILES; RAYMOND SKILES; FRANK TRICOMI, JR; MARILYN TRICOMI; JOHN POTOSNAK, III; VAILE POTOSNAK; ROBERT GHISELIN; GERI GHISELIN; CONNIE LUYE, Personal Representative of the Estate of EVELYN MOSS; FERNANDO CASTELLANOS; MICAELA CASTELLANOS; JIMMY TOLBERT; IMOGENE BERRY; FRANCIS DODD; CONSTANCE JAMES, Personal Representative of the Estate of GEORGE NOBLIN, Plaintiffs, v. AUROBINDO PHARMA USA, INC.; and DOES 1-50, Inclusive, Defendants. |
| Court | U.S. District Court — District of New Jersey |
Plaintiffs allege that they, their spouses, or the decedents they represent were injured or died as a result of having taken Amiodarone to treat non-life-threatening atrial fibrillation (“a-fib”), at least some of which was manufactured by Defendant Aurobindo USA, Inc. Plaintiffs bring seven claims: (1) Strict Products Liability - Failure to Warn, (2) Negligence - Failure to Warn, (3) Negligence - Marketing and Sale, (4) Negligence Per Se, (5) Strict Liability - Manufacturing Defect, (6) Fraud and Deceit, and (7) Wrongful Death. See ECF No. 26 (“SAC”) ¶¶ 112-75. The Court has jurisdiction over these claims pursuant to 28 U.S.C. § 1332.
Aurobindo moves to dismiss Plaintiff's Second Amended Complaint (“SAC”) pursuant to Rule 12(b)(6) of the Federal Rules of Civil Procedure. ECF No. 27. For the reasons set forth below, Aurobindo's motion will be granted.
I [1]
In 1985, non-party Wyeth obtained Food and Drug Administration (“FDA”) approval to market and sell Cordarone “as a drug of last resort for patients suffering from documented, recurrent, life-threatening, ventricular fibrillation and ventricular tachycardia when the[] conditions would not respond to other available anti-arrhythmic drugs and therapies.” SAC ¶ 31; see also SAC ¶¶ 57, 100, 105. Cordarone “was never approved . . . for the treatment of [a-fib] that Plaintiffs suffered from.” SAC ¶ 31. Aurobindo manufactures Amiodarone, a generic version of Cordarone. SAC ¶¶ 28, 30.
Wyeth “and others” marketed Cordarone as a “first line anti-arrhythmic therapy, ” including for treatment of a-fib. SAC ¶ 32. The FDA warned Wyeth that it is “unlawful for a manufacturer to promote any drug for a use not described in the approved labeling of the drug.” SAC ¶ 32; see also SAC ¶¶ 58 (), 59, 61 63-69, 71-74.
Plaintiffs allege that Aurobindo benefitted from Wyeth's off-label promotional efforts by “focusing primarily on pricing in their marketing and promotional efforts to increase market share.” SAC ¶¶ 32, 85, 94, 135-37, 161.
Plaintiffs also allege that Aurobindo misled doctors and the public. To that end, Plaintiffs assert that Aurobindo and others “directly or indirectly provided the indications and usage information regarding Amiodarone to the distributor of the Physician's Desk Reference . . . and the developer of Epocrates, the two most widely used reference materials used by physicians in prescribing situations.” SAC ¶ 33. The information about Amiodarone in reference material such as Epocrates allegedly “deceives physicians into believing” Amiodarone is approved for treatment of a-fib, is not a drug of last resort to be used in limited situations, has benefits that outweigh its safety risks with respect to a-fib, and “underwent appropriate FDA-approved randomized, clinical trials.” SAC ¶¶ 36, 39; see also SAC ¶¶ 37-39. Aurobindo licensed pictures of its Amiodarone pills to Epocrates. SAC ¶¶ 40, 140.
Plaintiffs' allegations are predicated on Aurobindo's alleged failure to provide warnings and information about its product. Plaintiffs allege that Aurobindo failed to fulfill its obligations regarding Medication Guides. See SAC ¶¶ 44-45. Medication Guides are “FDA-approved patient labeling, ” 21 C.F.R. § 208.3(h), that must be written “in nontechnical, understandable language, ” describe “the particular serious and significant public health concern that has created the need for the Medication Guide, ” 21 C.F.R. § 208.20(a)(1), (b)(2), and be provided to patients or their agents barring an applicable exception, see 21 C.F.R. § 208.24. Like other manufacturers, Aurobindo is required to ensure that Medication Guides are available for distribution to patients prescribed Amiodarone. See SAC ¶¶ 1-16 (subparagraph b), 44, 51; 21 C.F.R. §§ 208.1, 208.24. Plaintiffs allege that Aurobindo failed to: (1) provide Medication Guides to Plaintiffs, see, e.g., SAC ¶¶ 1-16 (subparagraph f), 21, 44, 88, 111, 114, 145, 147; (2) provide sufficient numbers of Medication Guides or provide them “in proper form, ” see SAC ¶¶ 1-16 (subparagraph e), 20, 44, 48-49, 104, 110-11; and (3) ensure Plaintiffs received the Guides, see SAC ¶¶ 1-16 (subparagraph f), 44, 51, 104, 110-11. Plaintiffs contend that Aurobindo's failures in this regard also render Amiodarone a mislabeled drug under New Jersey law. SAC ¶¶ 44-45, 51.
Plaintiffs additionally claim that Aurobindo knew of adverse events and risks related to Amiodarone but failed to report them. SAC ¶¶ 47, 56, 76, 90-94. For example, Plaintiffs allege that “Amiodarone . . . has become the number one prescribed drug for the treatment of” a-fib, and that “there would be tens of thousands o[f] adverse event reports submitted [to the FDA] each year” given “the percentages of persons diagnosed with just pulmonary toxicity, ” yet there “appear” to be far fewer adverse event reports submitted to the FDA. SAC ¶ 79; see also SAC ¶¶ 81-84, 118-21.
Aurobindo has moved to dismiss the SAC. ECF No. 27. Plaintiffs oppose the motion. ECF No. 30. This matter was assigned to the undersigned for the limited purpose of resolving the motion to dismiss. ECF No. 35.
II[2]
At the outset, the Court addresses the governing law. Although Plaintiffs argue that they plead violations of New Jersey law “in the alternative, ” their argument is belied by their allegations. ECF No. 30 (“Pls' Op.”) at 2. Plaintiffs repeatedly allege that Defendants' conduct violated New Jersey (and federal) law. See SAC ¶¶ 1-16 (subparagraph e), 44-45, 51, 96, 128 147-48, 157. The SAC mentions the law of no other state, and the SAC's allegations do not suggest New Jersey law was plead alternatively. See id.
“A federal court sitting in diversity applies the choice-of-law rules of the forum state-here, New Jersey-to determine the controlling law.” Maniscalco v. Brother Int'l (USA) Corp., 709 F.3d 202, 206 (3d Cir. 2013). New Jersey has adopted “the Second Restatement's most-significant-relationship test . . . for deciding the choice of substantive law in tort cases involving more than one state.” McCarrell v. Hoffmann-La Roche, Inc., 153 A.3d 207, 219 (N.J. 2017) (emphasis omitted). This test requires a court to examine, among other things, “whether or not an actual conflict exists between the laws of the potential forums.” Maniscalco, 709 F.3d at 207. A party seeking to apply the law of a foreign jurisdiction has the burden to show such law applies. See Chernus v. Logitech, Inc., No. 17-CV-00673, 2018 WL 1981481, at *10 (D.N.J. Apr. 27, 2018) (); see also Guy Mitchell & Betty J. Mitchell Fam. Tr. ex rel. Stanzak v. Artists Rts. Enf't Corp., No. 11-CV-0024, 2014 WL 202099, at *2 (E.D. Wash. Jan. 17, 2014) (), afFd sub nom. Mitchell v. Artists Rts. Enf't Corp., 653 Fed.Appx. 522 (9th Cir. 2016); Triple Int., Inc. v. Motel 6, Inc., 414 F.Supp. 589, 594 (W.D. Wis. 1976) ().
To the extent Plaintiffs argue that the Court should apply the law of their states of residence, they have not identified whether those laws conflict with the forum's law. See Pls.' Br. at 8-9 ().[3] Given Plaintiffs' failure to identify a conflict, the law of the forum governs. See, e.g., Gelis v. Bayerische Motoren Werke Aktiengesellschaft, No. 17-CV-07386, 2018 WL 6804506, at *4 (D.N.J. Oct. 30, 2018) .[4]Accordingly, New Jersey law applies.
Having determined that New Jersey law applies, the Court next addresses which New Jersey law applies. Plaintiffs have alleged seven common law claims. Aurobindo argues that the New Jersey Products Liability Act (“PLA”) N.J.S.A. § 2A:58C-1, et seq., subsumes those common law claims and thus all of Plaintiffs' common law claims must be dismissed. In response, Plaintiffs now contend that their “claims should be fairly read as alleging violations of the” PLA “[t]o the extent . . . New Jersey law controls, ” Pls.' Br. at 12, and offer to replead if needed. As discussed below, the PLA does control, but repleading is not needed because the Court will construe Plaintiffs' allegations as if lodged under the PLA.
“[T]he PLA codified certain issues relating to the common law governing product liability actions.”[5] Sun Chem Corp. v. Fike...
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