Utts v. Bristol-Myers Squibb Co.

• Decision Date: 23 December 2016
• Docket Number: 16cv5668(DLC)
• Citation: 226 F.Supp.3d 166
• Parties: Charlie UTTS and Ciara Utts, Plaintiffs, v. BRISTOL–MYERS SQUIBB COMPANY and Pfizer Inc., Defendants.
• Court: U.S. District Court — Southern District of New York

226 F.Supp.3d 166

Charlie UTTS and Ciara Utts, Plaintiffs,

v.BRISTOL–MYERS SQUIBB COMPANY and Pfizer Inc., Defendants.

16cv5668(DLC)

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

Signed December 23, 2016

For Charlie Utts and Ciara Utts: Nicholas Farnolo, Napoli Shkolnik PLLC, 400 Broadhollow Road, Melville, New York 11747.

For Bristol–Myers Squibb Company and Pfizer Inc.: Loren H. Brown, Cara D. Edwards, DLA Piper LLP (US), 1251 Avenue of the Americas, New York, New York 10020.

OPINION AND ORDER

DENISE COTE, District Judge:

Plaintiffs Charlie and Ciara Utts bring this product liability lawsuit against defendants Bristol–Myers Squibb Company ("BMS") and Pfizer Inc. ("Pfizer"), alleging that Mr. Utts suffered severe internal bleeding caused by taking Eliquis, a prescription drug manufactured, marketed, and distributed by the defendants. The defendants have moved to dismiss the complaint pursuant to Federal Rules of Civil Procedure 12(b)(6) and 9(b). For the following reasons, the defendants' motion is largely granted, with leave to amend most of the dismissed claims.

BACKGROUND

The following facts are drawn from the complaint and documents integral to it, including the Eliquis label approved by the Federal Drug Administration ("FDA"). The facts are construed in favor of the plaintiffs. See Keiler v. Harlequin Enters. Ltd. , 751 F.3d 64, 68 (2d Cir. 2014).

Plaintiffs Charlie and Ciara Utts are both residents of California. Mr. Utts was diagnosed with atrial fibrillation¹

some time before July 2014 and prescribed Eliquis by his doctor. Mr. Utts suffered severe internal bleeding after taking Eliquis.

Eliquis—the brand name of the prescription medicine apixaban—is an anticoagulant, blood-thinning medication used to reduce the risk of stroke

and systemic embolism in patients with nonvalvular atrial fibrillation. Unlike other anticoagulant medications such as warfarin, Eliquis does not have a known antidote or reversal agent. It does, however, have certain marked advantages over other anticoagulant medications. For example, Eliquis does not require periodic blood testing, nor does it impose dietary restrictions on its users.

I. FDA Approval of Eliquis

The FDA approved Eliquis for sale and marketing in the United States in 2012. Pursuant to federal law, all applications for FDA approval of new drugs must include a description of the clinical investigations of the drug, including an analysis of each clinical pharmacology study of the drug and each controlled clinical study pertinent to a proposed use of the drug. See 21 C.F.R. § 314.50(d)(5). In accordance with this requirement, the defendants submitted the results of the international clinical trials known as ARISTOTLE. The plaintiffs allege several deficiencies with the ARISTOTLE study, including the defendants' use of "incompetent and untrustworthy agents in China to conduct the ARISTOTLE study." The plaintiffs further contend that the defendants concealed several side effects experienced by study participants.²

While the defendants' application was pending before the FDA, Dr. Thomas Marcinak, an FDA employee appointed to review the Eliquis application, recommended that the proposed Eliquis label discuss the quality control problems associated with the ARISTOTLE study. In response to concerns about the rigor of the ARISTOTLE study, the defendants stated that they were submitting additional data to the FDA for its consideration.

II. The Eliquis Label

At the time Mr. Utts was prescribed Eliquis, the label contained several warnings about the risk of bleeding. For example, the "Warnings and Precautions" section of the label provides, under a subheading entitled "Bleeding," that:

ELIQUIS increases the risk of bleeding and can cause serious, potentially fatal, bleeding.... There is no established way to reverse the anticoagulant effect of apixaban, which can be expected to persist for about 24 hours after the last dose, i.e., for about two half-lives. A specific antidote for ELIQUIS is not available.

The "Adverse Reactions" section further provides that "[t]he most serious adverse reactions reported with ELIQUIS were related to bleeding," while the "Overdosage" section noted that "[t]here is no antidote to ELIQUIS. Overdose of ELIQUIS increases the risk of bleeding." Finally, the "Patient Counseling Information" section instructs physicians to inform their patients that "it might take longer than usual for bleeding to stop," and that "they may bruise or bleed more easily when treated with ELIQUIS." The label also instructs physicians to "[a]dvise patients about how to recognize bleeding or symptoms of hypovolemia

and of the urgent need to report any unusual bleeding to their physician."

The Eliquis label specifically references the ARISTOTLE study. It provides that "[t]he safety of ELIQUIS was evaluated in the ARISTOTLE and AVERROES studies," and that the "most common reason for treatment discontinuation in both studies was for bleeding-related adverse reactions." It notes that "in ARISTOTLE this occurred in 1.7% and 2.5% of patients treated with ELIQUIS and warfarin

, respectively, and in AVERROES, in 1.5% and 1.3% on ELIQUIS and aspirin, respectively."

Finally, the Eliquis Medication Guide—a paper insert in all prescription medicine packages—instructs patients that "ELIQUIS can cause bleeding which can be serious and rarely may lead to death. This is because ELIQUIS is a blood thinner medicine that reduces blood clotting." (Emphasis in original.)

III. Procedural History

The plaintiffs filed their complaint on July 15, 2016. The complaint asserts twelve causes of action against the defendants: (1) product liability—design defect; (2) product liability—manufacturing defect; (3) product liability—failure to warn; (4) product liability—strict liability; (5) negligence; (6) breach of express warranty; (7) breach of implied warranties; (8) fraudulent concealment; (9) negligent misrepresentation; (10) fraud; (11) violation of consumer protection laws; and (12) loss of consortium on behalf of Mrs. Utts.

On October 5, the defendants filed a motion to dismiss under Rules 12(b)(6) and 9(b). On October 13, the defendants moved the Judicial Panel on Multidistrict Litigation ("JPML") to transfer and coordinate 34 actions pending in 13 different district courts, including the instant action, pursuant to 28 U.S.C. § 1407. On October 21, the parties in the instant action filed a letter requesting that the Honorable Lewis A. Kaplan stay all proceedings pending resolution of the JPML petition. The request to enter a stay was denied on October 28.

On November 21, the case was reassigned to this Court as related to 16 other product liability cases concerning the medication Eliquis that have been filed in this district.³ That same day, this Court issued an Order instructing the parties in this case and all related actions to confer and identify one motion that is appropriate for early resolution. The November 21 Order also explained that the initiation of discovery would turn on whether or not the Court denies the selected motion to dismiss. On December 2, the parties identified the present motion to dismiss as the one motion appropriate for early resolution. The motion to dismiss became fully submitted on December 5.

DISCUSSION

When deciding a motion to dismiss, a court must "accept all allegations in the complaint as true and draw all inferences in the non-moving party's favor." LaFaro v. New York Cardiothoracic Grp., PLLC , 570 F.3d 471, 475 (2d Cir. 2009) (citation omitted). "To survive a motion to dismiss under Rule 12(b)(6), a complaint must allege sufficient facts which, taken as true, state a plausible claim for relief." Keiler , 751 F.3d at 68 ; Ashcroft v. Iqbal , 556 U.S. 662, 678, 129 S.Ct. 1937, 173 L.Ed.2d 868 (2009) ("[A] complaint must contain sufficient factual matter, accepted as true, to state a claim to relief that is plausible on its face." (citation omitted)). A claim has facial plausibility when "the factual content" of the complaint "allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged." Tongue v. Sanofi , 816 F.3d 199, 209 (2d Cir. 2016) (citation omitted). "Where a complaint pleads facts that are merely consistent with a defendant's liability, it stops short of the line between possibility and plausibility of entitlement to relief." Iqbal , 556 U.S. at 678, 129 S.Ct. 1937 (citation omitted). In sum, "a plaintiff's obligation to provide the grounds of his entitlement to relief requires more than labels and conclusions, and a formulaic recitation of the elements of a cause of action will not do." Bell Atl. Corp. v. Twombly , 550 U.S. 544, 555, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007) (citation omitted).

To satisfy the requirements of Rule 9(b), the complaint must: (1) detail the events giving rise to the fraud, such as the statement/omission that is alleged to be fraudulent, the identity of the speaker, the location of the fraud, and the reason the statement is fraudulent; and (2) allege facts "that give rise to a strong inference of fraudulent intent." Loreley Fin. (Jersey) No. 3 Ltd. v. Wells Fargo Sec., LLC , 797 F.3d 160, 171 (2d Cir. 2015) (citation omitted).

In deciding a motion to dismiss, the court considers "any written instrument attached to the complaint as an exhibit or any statements or documents incorporated in it by reference," Stratte–McClure v. Morgan Stanley , 776 F.3d 94, 100 (2d Cir. 2015) (citation omitted), as well as "documents upon which the complaint relies and which are integral to the complaint." Subaru Distribs. Corp. v. Subaru of Am., Inc. , 425 F.3d 119, 122 (2d Cir. 2005). The Eliquis label and package insert are integral to the complaint.

I. Choice of Law

A district court, sitting in diversity, applies the choice of law rules of the forum state—in this case, New York law. Alphonse Hotel Corp. v. Tran , 828 F.3d 146, 152 (2d Cir. 2016). Under New York choice of law rules, "the first step in any case presenting...