Frei v. Taro Pharm. United Statesa., Inc.

443 F.Supp.3d 456

Judith FREI; Sandra Rhodes ; Charles Rhodes ; Shirley Hart; William Murphy; Bonnie Murphy; James Walz ; 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 Green ; Michael Hess; Sandra Bonekemper; Nancy Hagerman; Gary Melton ; Dixie Melton; Christopher Freeman; Judith Freeman; Carolyn Sue Bean; Mark Thompson; Ada Duffy; Jefferie 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; Janice Shelton ; Pink Jones; Annie Jones ; Cynthia Skiles; Raymond Skiles; James Skinner; David Whitlock; Jacqueline Whitlock; Connie Luye; Earl Hines; and Diana Hines, Plaintiffs,

v.TARO PHARMACEUTICALS U.S.A., INC., and Does 1-10, inclusive, Defendants.

19 CV 2939 (VB)

United States District Court, S.D. New York.

Signed March 9, 2020

Filed March 10, 2020

Alan M. Mansfield, San Diego, CA, Edward K. Wood, Jr., Wood Law Firm LLC, Birmingham, AL, Joseph Peter Guglielmo, Scott + Scott, L.L.P., New York, NY, Melanie Haberman Muhlstock, Parker Waichman & Alonso, LLP, Port Washington, NY, for Plaintiffs.

Arthur J. Liederman, Nicole Marie Battisti, Morrison Mahoney, LLP, New York, NY, for Defendants.

OPINION AND ORDER

Briccetti, United States District Judge:

Plaintiffs Judith Frei, Sandra Rhodes, Charles Rhodes, Shirley Hart, William Murphy, Bonnie Murphy, James Walz, 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 Green, Michael Hess, Sandra Bonekemper, Nancy Hagerman, Gary Melton, Dixie Melton, Christopher Freeman, Judith Freeman, Carolyn Sue Bean, Mark Thompson, Ada Duffy, Jefferie 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, Janice Shelton, Pink Jones, Annie Jones, Cynthia Skiles, Raymond Skiles, James Skinner, David Whitlock, Jacqueline Whitlock, Connie Luye, Earl Hines, and Diana Hines, bring claims against defendants Taro Pharmaceuticals U.S.A., Inc., and Does 1-10 (collectively, "Taro"), relating to Taro's manufacture, sale, and promotion of the generic prescription drug amiodarone hydrochloride ("amiodarone"), an anti-arrhythmic heart medication.

Now pending is Taro's motion to dismiss plaintiffs' first amended complaint (the "amended complaint") under Rule 12(b)(6). (Doc. #27).

For the following reasons, the motion is GRANTED.

The Court has subject matter jurisdiction pursuant to 28 U.S.C. §§ 1331 and 1367.

BACKGROUND

For the purpose of ruling on the motion to dismiss, the Court accepts as true all well-pleaded allegations in the amended complaint and draws all reasonable inferences in plaintiffs' favor, as summarized below.

Taro manufactures and sells amiodarone, which is the generic form of Cordarone, a brand-name drug manufactured by Wyeth Pharmaceuticals, Inc. ("Wyeth").

In 1985, Wyeth received approval from the Food and Drug Administration ("FDA") to market and sell Cordarone. The FDA approved the use of Cordarone /amiodarone for the treatment of "ventricular fibrillation and ventricular tachycardia"—life-threating heartbeat irregularities. (Doc. #21 ("Am. Compl.") ¶ 60). However, the FDA approved the use of amiodarone only when other treatment options have been unsuccessful or were otherwise not appropriate for a particular patient. (Id.). In other words, the FDA approved amiodarone as a "drug of last resort." (Id. ¶ 61).

Under federal law, generic pharmaceutical manufacturers are not required to repeat the FDA approval process undertaken by brand-name manufacturers, often called "innovators." Rather, pursuant to the Hatch-Waxman Act of 1984, which amended the Food, Drug, and Cosmetic Act ("FDCA"), a generic manufacturer must submit to the FDA an Abbreviated New Drug Application ("ANDA") to obtain approval to manufacture a generic pharmaceutical following the FDA's approval of its brand-name equivalent. In 2001, the FDA approved Taro's ANDA, permitting Taro to manufacture and sell amiodarone.¹

According to the amended complaint, Wyeth aggressively and successfully marketed Cordarone for inappropriate "off label" use as a first-line anti-arrhythmic therapy, even though it was approved for use only as a drug of last resort. "Off-label" use of a pharmaceutical occurs when the medication is used in a manner that has not been approved by the FDA. According to plaintiffs, the FDA repeatedly warned Wyeth to stop marketing Cordarone in a manner which downplayed safety risks and promoted off-label use. Further, the FDA promulgated a regulation requiring manufacturers of amiodarone to make available to distributors a medication guide—a handout explaining drug safety information, which distributors must then provide to patients when dispensing prescriptions—setting forth in plain terms the drug's medical uses and health risks. See 21 C.F.R. § 208.24.

Plaintiffs allege that as a result of Wyeth's pervasive marketing activities, which benefitted generic manufactures such as Taro, physicians—not appreciating the safety risks associated with amiodarone—began to prescribe the drug as a first-line therapy for atrial fibrillation.

Plaintiffs are sixty-seven individuals across twenty-one states, who allege that they, or their spouses, or their related decedents, were injured as a result of being prescribed, and ingesting amiodarone manufactured by Taro, to treat atrial fibrillation. According to plaintiffs, Taro failed to provide, or make available for distribution, medication guides to both distributors and patients. Plaintiffs further allege Taro took advantage of Wyeth's promotional marketing of the drug for off-label use, and failed to inform physicians, distributors, or patients of the many potential dangers of amiodarone, including that it was not intended for use as a first-line therapy for atrial fibrillation.

Plaintiffs assert claims for strict products liability, negligence in promoting amiodarone for off-label use and failing to inform of the dangers thereof, negligence per se, failing to provide a medication guide to distributors and patients, misrepresentation and deception, fraud, and wrongful death.

DISCUSSION

I. Standard of Review

In deciding a Rule 12(b)(6) motion, the Court evaluates the sufficiency of the operative complaint under the "two-pronged approach" articulated by the Supreme Court in Ashcroft v. Iqbal, 556 U.S. 662, 679, 129 S.Ct. 1937, 173 L.Ed.2d 868 (2009).² First, a plaintiff's legal conclusions and "[t]hreadbare recitals of the elements of a cause of action, supported by mere conclusory statements," are not entitled to the assumption of truth and are thus not sufficient to withstand a motion to dismiss. Id. at 678, 129 S.Ct. 1937 ; Hayden v. Paterson, 594 F.3d 150, 161 (2d Cir. 2010). Second, "[w]hen there are well-pleaded factual allegations, a court should assume their veracity and then determine whether they plausibly give rise to an entitlement to relief." Ashcroft v. Iqbal, 556 U.S. at 679, 129 S.Ct. 1937.

To survive a Rule 12(b)(6) motion, the complaint's allegations must meet a standard of "plausibility." Ashcroft v. Iqbal, 556 U.S. at 678, 129 S.Ct. 1937 ; Bell Atl. Corp. v. Twombly, 550 U.S. 544, 564, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007). A claim is facially plausible "when the plaintiff pleads factual content that allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged." Ashcroft v. Iqbal, 556 U.S. at 678, 129 S.Ct. 1937. "The plausibility standard is not akin to a ‘probability requirement,’ but it asks for more than a sheer possibility that a defendant has acted unlawfully." Id. (quoting Bell Atl. Corp. v. Twombly, 550 U.S. at 556, 127 S.Ct. 1955 ).

In considering a motion to dismiss pursuant to Rule 12(b)(6), courts "may consider the facts alleged in the complaint, documents attached to the complaint as exhibits, and documents incorporated by reference in the complaint." DiFolco v. MSNBC Cable L.L.C., 622 F.3d 104, 111 (2d Cir. 2010). Courts may also consider matter of which judicial notice may be taken, including public documents and records. Chambers v. Time Warner, Inc., 282 F.3d 147, 153 (2d Cir. 2002).

II. Warning and Labeling

Plaintiffs plead two separate failure to warn claims, one for strict liability, and the other for negligence. Under New York law, failure to warn claims "are identical under strict liability and negligence theories of recovery." DiBartolo v. Abbott Labs., 914 F. Supp. 2d 601, 611 (S.D.N.Y. 2012).

"[A] pharmaceutical manufacturer has a duty to warn of all potential dangers in its prescription drugs that it knew, or, in the exercise of reasonable care, should have known to exist." DiBartolo v. Abbott Labs., 914 F. Supp. 2d at 611 (citing Martin v. Hacker, 83 N.Y.2d 1, 8, 607 N.Y.S.2d 598, 628 N.E.2d 1308 (1993) ). To state a prima facie claim for failure to warn under New York law, a plaintiff "must demonstrate (1) that the warning was inadequate and (2) that the failure to adequately warn of the dangers of the drug was a proximate cause of his or her injuries." Id. at 611–12.

Taro argues that plaintiffs' strict liability and negligence causes of action for failure to warn are preempted by federal law. Taro contends federal...