Sellers v. Boehringer Ingelheim Pharms., Inc.

• Decision Date: 25 July 2012
• Docket Number: No. 3:12–cv–00615–DRH–SCW.,3:12–cv–00615–DRH–SCW.
• Citation: 881 F.Supp.2d 992
• Parties: Vera Lee SELLERS, Plaintiff, v. BOEHRINGER INGELHEIM PHARMACEUTICALS, INC., Defendant.
• Court: U.S. District Court — Southern District of Illinois

881 F.Supp.2d 992

Vera Lee SELLERS, Plaintiff,
v.
BOEHRINGER INGELHEIM PHARMACEUTICALS, INC., Defendant.

No. 3:12–cv–00615–DRH–SCW.

United States District Court,
S.D. Illinois.

July 25, 2012.

[881 F.Supp.2d 997]

Peter J. Flowers, Foote, Meyers, Mielke & Flowers, LLC, St. Charles, IL, Ryan L. Thompson, San Antonio, TX, for Plaintiff.

Dan H. Ball, Molly M. Jones, Bryan Cave, St. Louis, MO, Orlando Rodriquez Richmond, Sr., Butler, Snow, et al., Ridgeland, MS, Eric E. Hudson, Butler Snow, et al., Memphis, TN, Kari L. Sutherland, Butler, Snow, et al, Oxford, MS, for Defendant.

ORDER DENYING MOTION TO DISMISS
HERNDON, Chief Judge.
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.¹

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

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heart rhythm (atrial fibrillation). The plaintiff, Vera Lee Sellers, alleges that, as a result of ingesting Pradaxa she suffered a severe gastrointestinal bleed causing her to be hospitalized at St. Mary's Hospital for a period of 5 days. Doc. 2 ¶ 41. 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. SeeMDL No. 2385,In re Pradaxa Prod. Liab. Litig. (Doc. 54).² 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. ³

On May 31, 2012, plaintiff Vera Sellers 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. SeeMDL No. 2385,In re Pradaxa Prod. Liab. Litig. 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 Panel on Multidistrict Litigation

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(“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.

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. SeeFed.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, 682 F.3d 687, 690 (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.⁴

B. Relevant Facts1. Overview

In May 2011, the plaintiff's physician prescribed the prescription drug Pradaxa for treatment of the plaintiff's medically necessary blood thinning needs. Doc. 2 at ¶ 41. 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 ¶ 11. Shortly after being prescribed Pradaxa, on or about July 7, 2011, the plaintiff suffered a severe gastrointestinal bleed causing her to be hospitalized for 5 days in St. Mary's

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Hospital. Id. at ¶ 41. During this time, the plaintiff allegedly suffered from uncontrollable bleeding which was caused and/or worsened by her use of Pradaxa. Id. The Pradaxa prescribed to and ingested by the plaintiff was allegedly “designed, manufactured, marketed, advertised, distributed, promoted, labeled, tested and sold” by BIPI. Id. at ¶ 10.

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. ⁵See e.g., Id. at ¶¶ 18–22, 26(a-m), 27. 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 ¶¶ 18, 20–22, 26(a-m), 39. 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 ¶¶ 14, 18, 20, 21. 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 ¶ 26(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 ¶¶ 14–26. Both plaintiff 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. See e.g., Id. at ¶¶ 19, 20, 40, 44, 79. As to the plaintiff'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 ¶¶ 20, 79. ⁶ Neither the plaintiff nor her

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prescribing physician knew or could have known that ingesting Pradaxa would expose the plaintiff 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. See e.g., Id. at ¶ 40, 44. If the plaintiff or her prescribing physician had known the truth about Pradaxa and if Pradaxa had contained adequate warnings, the plaintiff would not have used Pradaxa. See e.g., ¶ 45.

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 on October 19, 2010. Id. ¶ 12. 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 ¶ 16. It also included direct to consumer advertisements. Id. at 17. The Pradaxa Marketing...