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Frank Fitzgibbons, Individually v. Boehringer Ingelheim Pharmaceuticals

July 24, 2012

FRANK FITZGIBBONS, INDIVIDUALLY AND AS SPECIAL ADMINISTRATOR FOR THE ESTATE OF BONNIE FITZGIBBONS PLAINTIFF,
v.
BOEHRINGER INGELHEIM PHARMACEUTICALS, INC. ET AL., DEFENDANTS.



The opinion of the court was delivered by: David R. Herndon Chief Judge United States District Court

ORDER DENYING MOTION TO DISMISS

I. INTRODUCTION

The above referenced diversity case is before the Court on the defendant's, Boehringer Ingelheim Pharmaceuticals, Inc. ("BIPI'), motion to dismiss the plaintiff's claims for failure to state a claim pursuant to Federal Rule of Civil Procedure 12(b)(6). For the reasons set forth below, the motion is DENIED.

II. PROCEDURAL BACKGROUND

A. Overview of Related Pradaxa Product Liability Litigation

The above referenced case involves PRADAXA ("Pradaxa"), a prescription pharmaceutical indicated for the prevention of stroke and systemic embolism (blood clots) in patients with abnormal heart rhythm (atrial fibrillation). The plaintiff in the above referenced case alleges that, as a result of ingesting Pradaxa, the plaintiff's decedent, Bonnie Fitzgibbons, suffered a serious bleeding event leading to hospitalization and death. Presently, there are at least 36 cases involving Pradaxa with substantially similar fact patterns and allegations ("Pradaxa Product Liability Cases") pending in fourteen different judicial districts in the United States. See MDL No. 2385, In re Pradaxa Prod. Liab. Litig. (Doc. 54).*fn1 Of the 36 Pradaxa Product Liability Cases pending in federal court, 17 are on file in this judicial district and have been assigned to the undersigned judge.*fn2

On May 31, 2012, plaintiff Vera Sellers (Sellers v. Boehringer Ingelheim Pharmaceuticals, Inc. et al., No. 3:12-615) filed a motion for transfer of actions pursuant to 28 U.S.C. § 1407 ("MDL Motion"). See Id. The MDL Motion requests centralization and consolidation of the Pradaxa Product Liability Cases before a single federal district court. Id. Plaintiff Sellers' proposed forum is the Southern District of Illinois. Id. On May 30, 2012, five of the entities named as defendants in the Pradaxa Product Liability Cases filed a response to the MDL Motion. See MDL No. 2385, In re Pradaxa Prod. Liab. Litig. (Doc. 54). The responsive pleading states that these defendants are not opposed to consolidation but are opposed plaintiff Sellers' proposed forum. Id. These defendants propose consolidation in the District of Connecticut or, alternatively, the Eastern District of Tennessee or Eastern District of Kentucky. Id. The Judicial Penal on Multidistrict Litigation ("JPML") will hear the MDL Motion on July 26, 2012.

B. Effect of Pending MDL Motion

The pendency of a motion for consolidation "does not affect or suspend orders and pretrial proceedings in any pending federal district court action and does not limit the pretrial jurisdiction of that court." J.P.M.L. Rule 2.1(d). Further, this Court recently concluded that a stay of pretrial proceedings is not warranted in the Pradaxa Product Liability Cases pending in this Court. Accordingly, the Court proceeds with the subject motion to dismiss.

C. This Order Addresses BIPI's Motion to Dismiss the Plaintiff's Claims Pursuant to Rule 12(b)(6)

In addition to suing BIPI, the U.S. distributor of Pradaxa, the plaintiff also sued three other entities, Boehringer Ingelheim USA Corporation ("BI USA"), Boehringer Ingelheim Corporation ("BIC"), and Boehringer Ingelheim Vetmedica, Inc. ("BIVI"). BI USA, BIC, and BIVI filed separate motions to dismiss (or in the alternative for summary judgment) arguing that they have no involvement with the design, manufacture, marketing, sale, labeling, promotion, or any other aspect of Pradaxa. Shortly thereafter, on July 20, 2012, the Court granted voluntary dismissal without prejudice as to BI USA, BIC, and BIVI. Accordingly, the claims against these entities are no longer in issue. In light of these dismissals, the Court reviews the allegations in the plaintiff's complaint directed at "defendants" generally to refer only to BIPI.

III. RELEVANT FACTUAL BACKGROUND

A. Legal Standard

When the court acts on a defendant's motion to dismiss pursuant to Rule 12(b)(6), the court accepts as true all well-pled factual allegations and draws all reasonable inferences in the plaintiff's favor. See Rujawitz v. Martin, 561 F.3d 685, 688 (7th Cir. 2009); St. John's United Church of Christ v. City of Chicago, 502 F.3d 616, 625 (7th Cir. 2007), cert. denied, 553 U.S. 1032, 128 S.Ct. 2431, 171 L.Ed.2d 230 (2008). Generally, the Court's analysis is limited to factual allegations contained in the complaint and the complaint's exhibits. See Fed. R. Civ. P. 12(d) (documents outside the complaint may not be considered without converting the motion to dismiss into a motion for summary judgment).

There are, however, two exceptions to this general rule: First, a district court may "take judicial notice of matters of public record without converting a motion for failure to state a claim into a motion for summary judgment." Gen. Elec. Capital Corp. v. Lease Resolution Corp., 128 F.3d 1074, 1080 (7th Cir. 1997). Second, a court may consider documents attached to a motion to dismiss * * * if they are referred to in the plaintiff's complaint and are central to his claim." Brownmark Films, LLC v. Comedy Partners, ------ F.3d --------, 2012 WL 2044806, at *2 (7th Cir.2012) (internal quotation omitted).

With the exception of the text of the warning that has always accompanied Pradaxa, the facts below are taken from the plaintiff's complaint, which at this point in the litigation the Court presumes to be true. Additionally, the Court considers the text of the warning that has always been included in Pradaxa's labeling and prescribing information. Although the exact language of the subject warning is not included in the plaintiff's complaint, it may be considered by the Court without converting BIPI's motion to dismiss into a motion for summary judgment pursuant to either of the exceptions described above.*fn3

B. Relevant Facts

1. Overview

On or about August 2011, the decedent's physician prescribed the prescription drug Pradaxa for treatment of the decedent's non-valvular atrial fibrillation. Id. at ¶ 43. Pradaxa is a member of a class of anticoagulants known as direct thrombin inhibitors and is indicated to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation (patients with atrial fibrillation have an increased risk of stroke). Id. at ¶¶ 14-15. Shortly after being prescribed Pradaxa, on or about September 11, 2011, the decedent suffered a severe gastrointestinal bleed causing her to be hospitalized until she died on October 7, 2011. Id. During this time, the decedent allegedly experienced excessive and/or uncontrollable bleeding. Id. The Pradaxa prescribed to and ingested by the decedent was allegedly "designed, manufactured, marketed, advertised, distributed, promoted, labeled, tested and sold" by BIPI. Id. at ¶ 13.

The plaintiff contends, inter alia, that despite being aware of certain safety risks associated with use of Pradaxa, BIPI failed to adequately warn or disclose information about such risks to the medical community and consumers.*fn4 See e.g., Id. at ¶ 29(n). Specifically, the plaintiff contends that (1) BIPI failed to adequately warn or disclose information regarding the risk of serious and sometimes fatal irreversible bleeding events associated with the use of Pradaxa;

(2) failed to warn or disclose information regarding the protocol, or lack thereof, for reducing the anticoagulation effects of Pradaxa in patients who experience a severe bleeding incident; (3) failed to provide adequate warnings and information regarding the increased risks of bleeding in certain patient populations; (4) failed to provide adequate warnings and information regarding the ability or need to assess certain factors in patients taking Pradaxa; and (5) failed to warn that patients taking Pradaxa are at an increased risk for excessive and/or uncontrollable bleeding. See e.g., Id. at ¶¶ 21, 23, 24, 25, 29, 54. The plaintiff also contends that BIPI made affirmative misrepresentations regarding the efficacy, safety risk profile, and additional benefits of Pradaxa. See e.g., Id. at ¶¶ 21, 23, 24, 29. Finally, the plaintiff contends that BIPI failed to adequately research or investigate the safety profile of Pradaxa and failed to adequately research or investigate patient weight as a variable factor in establishing recommended dosages of Pradaxa. Id. at ¶ 29(c),(d).

The alleged inadequacies and affirmative misrepresentations were reportedly included in the Pradaxa Marketing Campaign and in Pradaxa's labeling and prescribing information. See Id. at ¶¶ 17-29. Both decedent and her prescribing physician allegedly relied on information disseminated by BIPI via the Pradaxa Marketing Campaign and/or the information published in Pradaxa's labeling and prescribing information. Id. at ¶¶ 22, 42, As to the decedent's prescribing physician, the decision to prescribe Pradaxa was based on information published in Pradaxa's labeling and prescribing materials, information published in Pradaxa's marketing materials, and information provided by BIPI sales representatives. Id. at ¶¶ 23, 42, 46.*fn5 Neither the decedent nor her prescribing physician knew or could have known that ingesting Pradaxa would expose the decedent to the risk of an irreversible bleeding event (and other safety risks that BIPI allegedly failed to adequately disclose) or that the purported additional benefits of Pradaxa had been misrepresented. Id. at ¶ 42, 46. If the decedent or her prescribing physician had known the truth about Pradaxa and if Pradaxa had contained adequate warnings, the decedent would not have used Pradaxa.

A more detailed review of the plaintiff's assertions regarding the Pradaxa Marketing Campaign and Pradaxa's labeling and prescribing information is included below.

2. The Pradaxa Marketing Campaign

The U.S. Food and Drug Administration ("FDA") approved Pradaxa for use in the United States in October 2010. Id. ¶ 15. In 2010 and 2011 BIPI marketed and promoted Pradaxa ("Pradaxa Marketing Campaign"). Id. at ¶¶ 17-19. BIPI's marketing efforts included, inter alia, "detailing sessions" (marketing/sales visits by BIPI representatives) with primary care physicians and other healthcare professionals. Id. at ¶ 19. It also included direct to consumer advertisements. Id. at 20. The Pradaxa Marketing Campaign allegedly overstated the effectiveness and benefits of Pradaxa. Specifically, the plaintiff alleges, the marketing campaign overstated the efficacy of Pradaxa with respect to preventing stroke and systemic embolism. Id. at ¶¶ 21, 23. The plaintiff also contends the Pradaxa marketing campaign improperly promoted Pradaxa as being more effective and convenient than the prescription anticoagulant Warfarin.*fn6 Id. at ¶ 17.

Like Pradaxa, Warfarin is a prescription anticoagulant indicated for reducing the risk of stroke and systemic embolism in patients with atrial fibrillation. Id. at ¶ 16. Patients taking Warfarin must follow dietary restrictions and regularly monitor their blood levels to determine whether their dosage should be adjusted. Id. Patients taking Pradaxa, on the other hand, are not under any dietary restrictions and do not have to undergo regular blood testing. Id.

An additional difference between Pradaxa and Warfarin is the availability of a reversal agent or protocol for the drugs' anticoagulation effects. Id. at ¶ 24. With regard to Warfarin, there is an established protocol for treating and stabilizing patients who experience a serious bleeding event while taking the drug. As to Pradaxa, there is no effective means for reversing the anticoagulation effects of the drug in patients who experience a serious bleeding event. Id. at ¶¶ 21, 23, 24. Therefore, there is no effective means to treat and stabilize patients who experience a serious bleeding event while taking Pradaxa. Id. at ¶¶ 21, 23, 24.

The plaintiff alleges that the Pradaxa Marketing Campaign failed to disclose information regarding the lack of a reversal agent or protocol for reversing the anticoagulation effects of Pradaxa. Id. The plaintiff also alleges that the Pradaxa Marketing Campaign failed to adequately disclose other risks and safety information associated with the use of Pradaxa.

3. Pradaxa's Labeling and Prescribing Information

The "Warnings Section" in Pradaxa's labeling and prescribing information has always included the following warning:

WARNINGS AND PRECAUTIONS

Risk of bleeding: PRADAXA can cause serious and, sometimes, fatal bleeding. Promptly evaluate signs and symptoms of blood loss. (5.1).*fn7

Plaintiff asserts that Pradaxa's "original"*fn8 labeling and prescribing information did not include information regarding the protocol, or lack thereof, for reversing the anticoagulation effects of Pradaxa in patients who experience a severe bleeding event. Id. at ¶¶ 25, 29(a),(b),(m). Further, the plaintiff contends, it did not disclose that, if serious bleeding were to occur, the lack of an effective reversal agent or protocol could have "permanently disabling, life-threatening or fatal consequences." Id. at ¶ 29(m). In addition to failing to disclose ...


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