Utts v. Bristol-Myers Squibb Co., 16cv5668(DLC).

• Decision Date: 08 May 2017
• Docket Number: 16cv5668(DLC).
• 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

251 F.Supp.3d 644

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 May 8, 2017

For Charlie Utts and Ciara Utts: Hunter J. Shkolnik, 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, Lucas P. Przymusinski, DLA Piper LLP (US), 1251 Avenue of the Americas, 45^th Floor, 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 gastrointestinal bleeding

from taking Eliquis, a prescription drug manufactured, marketed, and distributed by the defendants. They assert that the label did not adequately warn of the risk of excessive bleeding.

The defendants have moved to dismiss the Second Amended Complaint ("SAC") pursuant to Federal Rules of Civil Procedure 12(b)(6) and 9(b). The primary issues in this motion to dismiss are whether the plaintiffs' state law failure to warn claims are preempted by federal law and whether the label is adequate as a matter of law. For the following reasons, the defendants' motion is granted in its entirety.

Before describing each of the SAC's claims and addressing the legal challenges to them brought through this motion to dismiss, it is useful to provide an overview of the analysis that follows. Although the focus of the SAC is on an alleged failure by the defendants to warn that use of Eliquis, which belongs to a new class of blood thinners, runs the risk of causing excessive bleeding and has no known antidote, those allegations are largely abandoned in opposition to the motion to dismiss. The reason for this choice is not hard to discern. The risk of excessive bleeding from this blood thinner and the lack of an antidote were clearly disclosed to the Food & Drug Administration ("FDA") when it approved the drug, and are prominently disclosed to medical practitioners and patients on the FDA-approved labeling for the drug.

In opposition to this motion, therefore, the plaintiffs emphasize two other, albeit related, issues with the drug. The plaintiffs emphasize in their brief that, despite the fact that there is a risk of excessive bleeding and no known antidote for the drug, the dosage recommendations for the drug are not individually tailored and the defendants do not recommend constant monitoring of patients using the drug. These claims fare no better.

When the SAC's allegations about dosage and monitoring are examined, those allegations fail as well. For instance, the SAC does not identify any specific warnings or guidance that should have been included on the label regarding either dosage or monitoring but were not. The plaintiffs have not identified any research or other clinical work that recommends another dosage strategy than that currently described on the label, or explains what specialized monitoring of a patient would accomplish. These two complaints concern features of the design of the drug that were well known to the FDA when it approved the drug.¹

Faced with the fact that, as of today, there is no research or clinical experience to suggest that any changes to the Eliquis label's disclosures related to a risk of excessive bleeding are warranted, the plaintiffs argue vehemently that the motion to dismiss should be denied and that they should be permitted to conduct discovery to try to locate evidence in the defendants' files that might support their failure to warn claims. They emphasize that there is substantial ongoing litigation over the earlier drugs in the class of drugs to which Eliquis belongs. But, the ability of other plaintiffs in other litigation over other drugs to survive a motion to dismiss does not relieve the plaintiffs of the requirements imposed by Rule 12(b). Accordingly, the claims in the SAC, which reduced to their essence are attacks on the design of this drug, will be dismissed.

BACKGROUND

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 fibrillation²

and prescribed Eliquis by his doctor. After taking Eliquis, Mr. Utts suffered severe gastrointestinal bleeding and was hospitalized in July 2014 for approximately three weeks to undergo blood transfusions and several rounds of dialysis.

Eliquis—the brand name of the prescription medicine apixaban³ —is a blood-thinning medication used to reduce the risk of stroke

and systemic embolism in patients with nonvalvular atrial fibrillation. Eliquis belongs to a class of drugs known as novel oral anticoagulants ("NOACs"). It does not have a known antidote or reversal agent. Unlike anticoagulant medications such as warfarin,⁴ NOACs, including Eliquis, do not require periodic blood testing or impose dietary restrictions on users.

I. FDA Approval of Eliquis

The FDA approved Eliquis for sale and marketing in the United States in 2012.⁵ 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 that the defendants' agents "committed fraud in their conduct of the ARISTOTLE study," by, amongst other things, "concealing side effects which occurred in test users of Eliquis."⁶

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 label⁷ contained several warnings about the risk of bleeding and the lack of an effective antidote. The label also offered specific dosing recommendations and discussed the results of the controversial ARISTOTLE study. The warnings that are pertinent to the present motion to dismiss are described here.⁸

A. Warnings about Bleeding Risks

The Eliquis label warns about the risk of serious bleeding no less than five times. First, in the "Highlights of Prescribing Information" section, under the "Warnings and Precautions" heading, the label states that "ELIQUIS can cause serious, potentially fatal bleeding." In the "Full Prescribing Information" section of the label, there is a heading entitled "Warnings and Precautions" with a subheading entitled "Bleeding." This subheading provides: "ELIQUIS increases the risk of bleeding and can cause serious, potentially fatal, bleeding." Under the "Adverse Reactions" heading, the label states: "The most serious adverse reactions reported with ELIQUIS were related to bleeding." Also under the "Adverse Reactions" heading, the "Clinical Trials Experience" subheading explains that the "most common reason for treatment discontinuation in both [clinical] studies was for bleeding-related adverse reactions." Under the "Overdosage" heading, the label states that "[o]verdose of ELIQUIS increases the risk of bleeding." Finally, under the "Patient Counseling Information" heading, the label advises physicians to inform their patients that "it might take longer than usual for bleeding to stop, and they may bruise or bleed more easily when treated with ELIQUIS." It 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."

B. Warnings about Concomitant Therapy

In addition to warning generally about the risk of bleeding, the Eliquis label also specifically warns about the risk of bleeding when Eliquis is used in conjunction with antiplatelet agents, such as aspirin

. The "Bleeding" subheading provides that:

Concomitant use of drugs affecting hemostasis increases the risk of bleeding. These include aspirin

and other antiplatelet agents, other anticoagulants, heparin, thrombolytic agents, selective serotonin reuptake inhibitors, serotonin norepinephrine reuptake inhibitor, and nonsteroidal anti-inflammatory drugs (NSAIDs).

Furthermore, the "Anticoagulants and Antiplatelet Agents" subheading asserts that "[c]oadministration of antiplatelet agents, fibrinolytics, heparin

, aspirin, and chronic NSAID use increases the risk of bleeding," and that in the ARISTOTLE study, for example, "concomitant use of aspirin increased the bleeding risk on ELIQUIS from 1.8% per year to 3.4% per year."

C. Warnings about the Lack of an Effective Antidote

The Eliquis label twice warns about the fact that there is no specific antidote to Eliquis. First, under the "Bleeding" subheading, the label unambiguously states: "A specific antidote for ELIQUIS is not available," and "[t]here 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 ...." Second, under the "Overdosage" heading, the label states: "There is no antidote to ELIQUIS."

In addition to warning about the lack of a specific antidote, the label also discusses potential reversal strategies and to what extent these strategies are supported by clinical research:

Because of high plasma protein binding, apixaban is not expected to be dialyzable .... Protamine sulfate and vitamin K would not be expected to affect the

...