Bowdrie v. Sun Pharmaceutical Industries Ltd.

909 F. Supp. 2d 179, 2012 WL 5465994, 2012 U.S. Dist. LEXIS 161239
CourtDistrict Court, E.D. New York
DecidedNovember 9, 2012
DocketNo. 12-CV-853(WFK)(MDG)
StatusPublished
Cited by5 cases

This text of 909 F. Supp. 2d 179 (Bowdrie v. Sun Pharmaceutical Industries Ltd.) is published on Counsel Stack Legal Research, covering District Court, E.D. New York primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Bowdrie v. Sun Pharmaceutical Industries Ltd., 909 F. Supp. 2d 179, 2012 WL 5465994, 2012 U.S. Dist. LEXIS 161239 (E.D.N.Y. 2012).

Opinion

DECISION AND ORDER

WILLIAM F. KUNTZ, II, District Judge.

Plaintiffs Angela Bowdrie, Sharon Brow, John L. Brown, Leonard Brown, Bonnie Brubaker, Gail Cambell, Ada Cobbs, Michelle Couser, Eva Douglass, Josephine Dyer, Carol Groomes, Latoya Hill, Danielle Hyden, Lonita Jackson, Loretta Johnson, Reginald Kennard, Dorothy Kind, Susie Lekich, Jan Loput, Annie Morrison, Timothy Nelson, Patricia Parsons, Svetlana Polovets, Patricia Rocha, Ashley Smith, Yelonda Swearengin, Monte Tyson, and Dorothy Young (collectively “Plaintiffs”) filed this action in New York State Supreme Court, Kings County on or about October 12, 2011 against Defendants Sun Pharmaceutical Industries, Ltd. (“Sun Ltd”), Caraco Pharmaceutical Laboratories, Ltd. (“Caraco”), Sun Pharmaceutical Industries, Inc. (“Sun Inc.”), Sun Pharma Global, Inc. (“Sun Global”), Taro Pharmaceutical Industries, Ltd. (“Taro Ltd.”), and Taro Pharmaceuticals, U.S.A., Inc. (“Taro Inc”). Plaintiffs filed an Amended Complaint on January 20, 2012. On February 21, 2012, Sun Inc. and Caraco removed this action to the Eastern District of New York. See Docket Entry 1 (the “Notice of Removal”). Neither Sun Global nor Taro Ltd.- has appeared in this action. The remaining Defendants (collectively “Defendants”) now move to dismiss the Amended Complaint pursuant to Rules 8(a) and 12(b) of the Federal Rules of Civil Procedure. Plaintiffs oppose and move to remand this action to New York State Supreme Court.

.This Court denies the motion to remand by Plaintiffs, and grants the motion to dismiss by Defendants in its entirety.

BACKGROUND

Pursuant to the Federal Food, Drug, and Cosmetics Act, 21 U.S.C. § 301 et seq. (the “FDCA”), to secure the approval of the Food and Drug Administration (“FDA”), a manufacturer of a new drug must file an application demonstrating the drug is safe, effective, and adequately labeled. 21 U.S.C. § 355(b), (d); 21 C.F.R. § 314.1 et seq. The Drug Price Competition and Patent Term Restoration Act, 98 Stat. 1585, (the “Hatch-Waxman Amendments”) amended the FDCA to permit generic drug manufacturers to bypass the approval practice by submitting an “abbreviated new drug application” (f‘ANDA”)— an application showing the proposed generic drug to be the same as a reference [182]*182listed drug (“RLD”) that has already-gained FDA approval. 21 U.S.C. § 355(j)(2); 21 C.F.R. § 314.94. The generic must be bioequivalent to and have the same labeling as the RLD. 21 U.S.C. § 355(j)(2)(A)(iv), (v); 21 C.F.R. § 314.94(a)(7), (8).

Plaintiffs are all individuals or their decedents who allege they were injured after ingesting generic Phenytoin Sodium (“Phenytoin”), an antiepileptic manufactured by Defendants. Am. Compl., ¶¶ 9-38. Plaintiffs allege the Phenytoin they ingested differed from the RLD — Dilantin—in terms of labeling and bioequivalence. Id. at ¶¶ 4, 5, 8, 91-106, 126-50, 159, 177-226. Plaintiffs allege it is recognized widely in the medical community that the side effects of Phenytoin- include what are collectively referred to as “severe cutaneous adverse reactions,” or SCAR events, which may result in “painful and debilitating tissue injury and loss, epidermal blistering, necrosis, and sloughing.” Id. at ¶ 18. Plaintiffs allege the makers of Dilantin enhanced the warnings regarding SCAR events on their labeling and in a medication guide in July 2009. Id. at ¶ 128. Plaintiffs allege Defendants failed to update their labeling to mirror Dilantin’s July 2009 revision and failed to implement the Dilantin medication guide. Id. at ¶¶ 130-49. Plaintiffs allege the makers of Dilantin implemented changes in the manufacturing process for that drug in 2007, after the FDA had granted Defendants’ ANDAs for Phenytoin. Id. at ¶¶ 91, 95, 100-05. Plaintiffs allege Defendants failed to assure bioequivalence to Dilantin following the changes in Dilantin’s manufacturing process. Id. Plaintiffs allege they experienced SCAR events as a result of the differences between the Phenytoin they consumed and Dilantin, and plead the following causes- of action under New York state law: (1) strict product liability; (2) negligence; (3) fraud; (4) breach of implied warranties; (5) negligence per se; and (6) wrongful death.

ANALYSIS

I. Wyeth v. Levine and Pliva, Inc. v. Mensing

Two decisions of the United States Supreme Court, Wyeth v. Levine, 555 U.S. 555, 129 S.Ct. 1187, 173 L.Ed.2d 51 (2009) and PLIVA, Inc. v. Mensing, — • U.S. -, 131 S.Ct. 2567, 180 L.Ed.2d 580 (2011) are at the forefront of all recent products liability actions alleging inadequate warnings by drug manufacturers, including this one.

The plaintiff in Levine was injured when the intravenous form of Phenergan, an antihistamine used to treat nausea, caused gangrene that ultimately required the amputation of her right forearm. The plaintiff filed a products liability action in Vermont state court, alleging the drug’s labeling was defective because, although it warned of the danger of gangrene following intra-arterial injection, it failed to instruct physicians to use the safer of two methods of intra-arterial injection. The trial judge instructed the jury that evidence of Wyeth’s compliance with FDA requirements did not establish the adequacy of the existing warnings, and the jury found Wyeth liable for negligence and Phenergan defective as a result of inadequate warnings. The Vermont Appellate and Supreme Courts affirmed.

The United States Supreme Court granted Wyeth’s petition for certiorari to address, inter alia, the issue of impossibility preemption. Wyeth argued it would have been impossible to comply with its state law duty to warn without violating the FDCA and FDA regulations. The Supreme Court rejected Wyeth’s argument, finding Wyeth could have could have unilaterally strengthened its warnings without [183]*183prior FDA approval through the “changes being effected” (“CBE”) process, 21 C.F.R. § 314.70(c)(6)(iii), which enables certain labeling changes to be implemented simultaneous to submitting the changes to the FDA for review.

Two years later in Mensing, the Supreme Court decided two consolidated cases alleging injuries based on manufacturers’ failure to provide adequate labeling for generic metoclopramide, used to treat digestive tract problems. The RLD for generic metoclopramide is Reglan, first approved for use by the FDA in 1980. Evidence shows that a percentage of long-term users of metoclopramide develop tar-dive dyskinesia, a neurological disorder.

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Bluebook (online)
909 F. Supp. 2d 179, 2012 WL 5465994, 2012 U.S. Dist. LEXIS 161239, Counsel Stack Legal Research, https://law.counselstack.com/opinion/bowdrie-v-sun-pharmaceutical-industries-ltd-nyed-2012.