Sellers v. Boehringer Ingelheim Pharmaceuticals, Inc. et al

Filing 36

ORDER denying 12 Motion to Dismiss for Failure to State a Claim. Signed by Chief Judge David R. Herndon on 7/25/2012. (dsw)

UNITED STATES DISTRICT COURT
SOUTHERN DISTRICT OF ILLINOIS
VERA LEE SELLERS

)
)
)
)
)
)
)
)
)

Plaintiff,
v.
BOEHRINGER INGELHEIM
PHARMACEUTICALS, INC.

No., 3:12-cv-00615-DRH-SCW

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

1

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.
1

II.
A.

PROCEDURAL BACKGROUND

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, 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.

See MDL No. 2385, In re Pradaxa Prod. Liab. Litig.

(Doc.54).2 Of the 36 Pradaxa Product Liability Cases pending in federal court, 17

2

On June 21, 2012, various Boehringer entities filed their response to the MDL
Motion. As of the date of that response, at least 30 Pradaxa Product Liability
Cases were pending in 14 different federal judicial districts. At that time, 11 of
the 30 cases were pending in the Southern District of Illinois. See MDL No. 2385,
In re Pradaxa Prod. Liab. Litig. (Doc. 54). Since the filing of that response, 6
additional Pradaxa Product Liability Case have been filed with this Court See Witt
v. Boehringer Ingelheim Pharmaceuticals, Inc. et al., No. 3:12-cv-781; McCoy et
al v. Boehringer Ingelheim Pharmaceuticals, Inc. et al, No. 3:12-cv-806; Bishop
et al v. Boehringer Ingelheim Pharmaceuticals, Inc. et al, No. 3:12-cv-810;
Elahee et al v. Boehringer Ingelheim Pharmaceuticals, Inc. et al No. 3:12-cv811; Martin v. Boehringer Ingelheim Pharmaceuticals, Inc. et al; No. 3:12-cv812; Schofield v. Boehringer Ingelheim Pharmaceuticals, Inc. et al; No. 3:12-cv813. Accordingly, there are now at least 36 Pradaxa Product Liability Cases
pending in federal district courts across the country and 17 of those cases are
pending in this judicial district.
2

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. See
MDL 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
3

The following 17 cases, filed in the Southern District of Illinois, involve Pradaxa
and include substantially similar product liability claims:
(1) Boston v.
Boehringer Ingelheim Pharmaceuticals, Inc. et al., No. 3:12-cv-610; (2)
Richardson v. Boehringer Ingelheim Pharmaceuticals, Inc. et al., No. 3:12-cv611; (3) Garner v. Boehringer Ingelheim Pharmaceuticals, Inc. et al., No. 3:12cv-612; (4) Herbeck v. Boehringer Ingelheim Pharmaceuticals, Inc. et al., No.,
3:12-cv-613; (5) Fitzgibbons v. Boehringer Ingelheim Pharmaceuticals, Inc. et
al., No., 3:12-cv-614; (6) Sellers v. Boehringer Ingelheim Pharmaceuticals, Inc.
et al., No., 3:12-cv-615; (7) Smith v. Boehringer Ingelheim Pharmaceuticals, Inc.
et al., 3:12-cv-616; (8) Stout v. Boehringer Ingelheim Pharmaceuticals, Inc. et
al., No. 3:12-cv-617; (9) Kekich v. Boehringer Ingelheim Pharmaceuticals Inc. et
al., No. 3:12-cv-709; (10) Crosby v. Boehringer Ingelheim Pharmaceuticals, Inc.
et al., No. 3:12-cv-710; (11) Williams v. Boehringer Ingelheim Pharmaceuticals,
Inc. et al., No. 3:12-cv-711; (12) Witt v. Boehringer Ingelheim Pharmaceuticals,
Inc. et al., No. 3:12-cv-781; (13) McCoy et al v. Boehringer Ingelheim
Pharmaceuticals, Inc. et al, No. 3:12-cv-806; (14) Bishop et al v. Boehringer
Ingelheim Pharmaceuticals, Inc. et al, No. 3:12-cv-810; (15) Elahee et al v.
Boehringer Ingelheim Pharmaceuticals, Inc. et al No. 3:12-cv-811; (16) Martin
v. Boehringer Ingelheim Pharmaceuticals, Inc. et al; No. 3:12-cv-812; and (17)
Schofield v. Boehringer Ingelheim Pharmaceuticals, Inc. et al; No. 3:12-cv-813.
3

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.
III.
A.

RELEVANT FACTUAL BACKGROUND

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).
4

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. 4
B.

Relevant Facts
1.

Overview

4

The text of the subject warning is the basis for one of the arguments raised by
BIPI in its motion to dismiss. Specifically, BIPI asserts that the plaintiff’s claims
are subject to dismissal because the Pradaxa label explicitly warned about the
risk of “serious and, sometimes, fatal bleeding.” Accordingly, for purposes of
addressing this argument, the Court considers the text of the subject warning.
5

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
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.5 See

5

The plaintiff’s complaint includes a number of allegations regarding specific
events relating to Pradaxa’s risk and safety profile that allegedly provided BIPI
with notice of deficiencies in Pradaxa. The following events allegedly took place
after Pradaxa was approved for use in the U.S (October 19, 2010) but before or
on or about the period when the plaintiff was prescribed and injured by Pradaxa:
(May/June 2011): (1) 932 Pradaxa-associated “Serious Adverse Event” Medwatch
reports were filed with the FDA, including reports of death and severe life
threatening bleeding; Doc. 2 ¶¶ 23-24 and (2) New Zealand imposed lower dosage
requirements for patients over 80 years of age and for patients with renal
impairment. Id. at ¶ 28. The additional events occurred after the plaintiff was
prescribed and injured by Pradaxa, including the following: (1) Officials in Japan
6

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
imposed certain requirements for patients taking Pradaxa, including a “BOXED
WARNING” regarding the risk of severe hemorrhages, id. at ¶ 31; and (2) two
letters from physicians were published in the New England Journal of Medicine
stating that the serious risks of Pradaxa, such as the lack of an effective reversal
agent or protocol, are not fully appreciated by the medical community. Id. at ¶
32.
7

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 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.

6

The plaintiff’s prescribing physician allegedly received marketing materials and
information from BIPI sales representatives that promoted Pradaxa as being more
effective and convenient than Warfarin. Purportedly, the marketing information
the prescribing physician received failed to disclose that there was no effective
reversal agent or protocol for controlling bleeding in patients taking Pradaxa. Id.
at ¶ 20.
8

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 ¶¶ 1719.

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 Campaign allegedly overstated
the effectiveness and benefits of Pradaxa. Id. at ¶¶ 18, 20-22. Specifically, the
plaintiff alleges, the marketing campaign overstated the efficacy of Pradaxa with
respect to preventing stroke and systemic embolism. See e.g., Id. at ¶ 18. The
plaintiff also contends the Pradaxa marketing campaign improperly promoted
Pradaxa

as

being

more

effective

and

convenient

than

the

prescription

anticoagulant Warfarin.7 See e.g., Id. at ¶ 20.
Like Pradaxa, Warfarin is a prescription anticoagulant indicated for
reducing the risk of stroke and systemic embolism in patients with atrial
fibrillation. Id. at ¶ 13. 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.
7

Prior to Pradaxa, Warfarin was the only oral anticoagulant available in the
United States for reducing the risk of stroke and systemic embolism in patients
with atrial fibrillation. Id. at ¶ 13.
9

An additional difference between Pradaxa and Warfarin is the availability of
a reversal agent or protocol for the drugs’ anticoagulation effects. Id. at ¶ 21.
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 ¶¶ 18, 20, 21.
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. Id.
3.

Pradaxa’s Labeling and Prescribing Information

The “Warnings Section” in Pradaxa’s labeling and prescribing information
has always included the following warning:

10

WARNINGS AND PRECAUTIONS
Risk of bleeding: PRADAXA can cause serious and, sometimes, fatal
bleeding.

Promptly evaluate signs and symptoms of blood loss.

(5.1).8
The

plaintiff asserts Pradaxa’s

“original”9

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 ¶¶ 22, 26(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 ¶ 26(m).

In addition to failing to disclose the

information described above, the plaintiff alleges that the original labeling and
prescribing information contained the following inadequacies:

8

The FDA-approved Pradaxa labels are available on the FDA’s public website as
follows:
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Sear
ch.DrugDetails
(last accessed July 20, 2012).
9
The plaintiff makes assertions regarding Pradaxa’s “original” labeling and
prescribing information but does not expressly define the term “original.” Other
factual allegations in the complaint, however, allow for the Court to reasonably
infer (as is required at this stage of the litigation) that the term “original” refers to
the labeling and prescribing information that was effective between October 2010
(when Pradaxa was approved by the FDA) and March 2011 (Pradaxa’s first
labeling modification). As noted above, however, the March 2011 modification
did not alter Pradaxa’s Warnings Section and allegedly contained the same
inadequacies as the original labeling and prescribing information.
11

failed to provide adequate warnings or information about the “true safety
risks” associated with Pradaxa use;
failed to provide adequate warnings or information about the problems
associated with assessing the degree and/or extent of anticoagulation in
patients taking Pradaxa;
failed to provide adequate warnings or information about the protocol for
intervening or stabilizing patients who suffer from bleeding while taking
Pradaxa;
failed to provide adequate warnings or information about the need to assess
renal functioning prior to starting a patient on Pradaxa and the need to
continue assessing renal functioning while a patient is taking Pradaxa;
failed to provide adequate warnings or information about the increased risk
of bleeding events associated with aging patient populations;
failed to provide adequate warnings or information about the increased risk
of gastrointestinal bleeds in patients taking Pradaxa and specifically in
patients with a history of gastrointestinal issues.
failed to “investigate, research, study and consider, fully and adequately
patient weight as a variable factor in establishing recommended dosages of
Pradaxa;
failed to investigate, research, study and define, fully and adequately, the
safety profile of Pradaxa;

12

failed to include a “Boxed Warning” or a “Bolded Warning” about serious
bleeding events associated with Pradaxa use.
Id. at ¶ 26.
In March 2011, BIPI modified Pradaxa’s labeling and prescribing
information. Id. at ¶ 27.

The next modification to Pradaxa’s labeling and

prescribing information occurred in November 2011 (after the plaintiff was
prescribed Pradaxa and after the plaintiff’s alleged injury).10 Thus, in the instant
case, the relevant information is the information included in the “original” labeling
and prescribing material and/or in the March 2011 labeling and prescribing
material.
The March 2011 modification provided additional information regarding
the use of Pradaxa in patients taking certain medications.
Warnings Section (provided above) remained the same.

The text of the

Further, the plaintiff

contends Pradaxa’s March 2011 labeling and prescribing information suffered
from the same deficiencies as Pradaxa’s original labeling and prescribing
information. Id. at ¶ 27.

10

Pursuant to the plaintiff’s complaint, the Pradaxa labeling and prescribing
information was modified in March 2011 (additional information for patients
taking certain medications); November 2011 (additional information regarding the
use of Pradaxa in patients with kidney disease); January 2012 (nature of revision
not specified); and April 2012 (nature of revision not specified). None of the
modifications altered the text of the warnings section. The plaintiff alleges that all
of the modified labeling and prescribing information suffered from the same
deficiencies as the original labeling and prescribing information.
13

IV.

RELEVANT LEGAL PRINCIPLES

A 12(b)(6) motion challenges the sufficiency of the complaint to state a
claim upon which relief can be granted. Hallinan v. Fraternal Order of Police
Chicago Lodge 7, 570 F.3d 811, 820 (7th Cir.), cert. denied, ––– U.S. ––––, 130
S.Ct. 749, 175 L.Ed.2d 517 (2009). The United States Supreme Court explained
in Bell Atlantic Corp. v. Twombly, 550 U.S. 544, 570, 127 S.Ct. 1955, 167
L.Ed.2d 929 (2007), that Rule 12(b)(6) dismissal is warranted if the complaint
fails to set forth “enough facts to state a claim to relief that is plausible on its
face.”
In making this assessment, the district 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).
Even though Twombly (and Ashcroft v. Iqbal, 556 U.S. 662, 129 S.Ct.
1937, 173 L.Ed.2d 868 (2009)) retooled federal pleading standards, notice
pleading remains all that is required in a complaint. “A plaintiff still must provide
only ‘enough detail to give the defendant fair notice of what the claim is and the
grounds upon which it rests and, through his allegations, show that it is plausible,
rather than merely speculative, that he is entitled to relief.’ “ Tamayo v.
Blagojevich, 526 F.3d 1074, 1083 (7th Cir. 2008). The level of detail the

14

complaint must furnish can differ depending on the type of case before the Court.
So for instance, a complaint involving complex litigation (antitrust or RICO
claims) may need a “fuller set of factual allegations ... to show that relief is
plausible.” Tamayo, 526 F.3d at 1083, citing Limestone Dev. Corp. v. Village of
Lemont, Illinois, 520 F.3d 797, 803–04 (7th Cir. 2008).
The Seventh Circuit Court of Appeals has offered further direction on what
(post- Twombly & Iqbal ) a complaint must do to withstand dismissal for failure
to state a claim. In Pugh v. Tribune Co., 521 F.3d 686, 699 (7th Cir. 2008), the
Court reiterated: “surviving a Rule 12(b)(6) motion requires more than labels and
conclusions;” the allegations must “raise a right to relief above the speculative
level.” Similarly, the Court remarked in Swanson v. Citibank, N.A., 614 F.3d
400, 403 (7th Cir. 2010): “It is by now well established that a plaintiff must do
better than putting a few words on paper that, in the hands of an imaginative
reader, might suggest that something has happened to her that might be
redressed by the law.” In Atkins v. City of Chicago, 631 F.3d 823, 831-832 (7th
Cir. 2011), Judge Posner explained that Twombly and Iqbal:
require that a complaint be dismissed if the allegations do not state a
plausible claim. The Court explained in Iqbal that “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. at 1949. This is a little unclear because plausibility, probability,
and possibility overlap....
But one sees more or less what the Court was driving at: the fact that
the allegations undergirding a plaintiffs claim could be true is no
longer enough to save it. .... [T]he complaint taken as a whole must
15

establish a nonnegligible probability that the claim is valid, though it
need not be so great a probability as such terms as “preponderance
of the evidence” connote.... After Twombly and Iqbal a plaintiff to
survive dismissal “must plead some facts that suggest a right to relief
that is beyond the ‘speculative level.’ ” In re marchFIRST Inc., 589
F.3d 901, 905 (7th Cir. 2009).

V.
A.

ANALYSIS

The Plaintiff’s Claims
The plaintiff asserts the following claims: (1) Strict Liability-Failure to

Warn,

(2)

Strict

Liability-Design

Defect,

(3)

Negligence,

(4)

Negligent

Misrepresentation and/or Fraud, (5) Breach of Express Warranty, (6) Breach of
Implied Warranty of Merchantability, (7) Negligence Per Se, (8) Fraudulent
Concealment, and (9) an action under the Illinois Consumer Fraud and Deceptive
Practices Act. The plaintiff also requests (10) Punitive Damages and Prejudgment
Interest. Doc. 2, Counts I-X, ¶¶46-140.
B.

Overview of BIPI’s Arguments
BIPI contends that all of the plaintiff’s claims and requests for damages,

viewed in the context of applicable Illinois law, fail to satisfy the Iqbal/Twombly
pleading standard and, where applicable, the heightened pleading standard under
Federal Rule of Civil Procedure 9. Additionally, BIPI contends that any claims
premised on the alleged failure to adequately warn of the risk of irreversible
bleeding cannot proceed because Pradaxa has always included a warning
regarding the risk of “serious and, sometimes, fatal bleeding.” BIPI also raises
16

arguments with respect to venue, the learned intermediary doctrine, and
Comment K to the Restatement (Second) of Torts. Finally, BIPI raises various
arguments that are specific to the plaintiff’s claims for relief and for punitive
damages/prejudgment interest.
The Court addresses the relevant issues accordingly below.
C.

BIPI warned about “serious and sometimes fatal bleeding”
Pradaxa has always included a statement warning consumers and

physicians about the risk of “serious and sometimes fatal bleeding.” According to
BIPI, the plaintiff’s claims cannot stand because Pradaxa carried an explicit
warning about the risk of potentially fatal bleeding. This argument presumes that
the inadequacies or deficiencies being alleged by the plaintiff are premised on
failure to warn about the risk of serious or fatal bleeding and nothing more. The
plaintiff, however, is not merely alleging that BIPI is liable because it failed to
warn that Pradaxa is associated with the risk of serious and sometimes fatal
bleeding. Instead, the plaintiff contends (among other things), BIPI failed to warn
that, if a serious bleeding event occurs, there is no effective means for reversing
the anticoagulation effects of Pradaxa. In addition, the plaintiff alleges (among
other things) that BIPI failed to adequately warn about the increased risk of
excessive or uncontrollable bleeding in patient’s taking Pradaxa. Accordingly, the
fact that Pradaxa included a warning about the risk of serious or fatal bleeding
does not justify dismissal of the plaintiff’s claims.

17

D.

Comment K to the Restatement (Second) of Torts § 402A
The mere fact that a product causes injury does not mean, in and of itself,

that it was defective. Rather, Illinois has adopted comment k to the Restatement
(Second) of Torts § 402A, which provides, in pertinent part, as follows:
there are some products which, in the present state of human
knowledge, are quite incapable of being made safe for their intended
and ordinary use. These are especially common in the field of drugs.
An outstanding example is the vaccine for the Pasteur treatment of
rabies, which not uncommonly leads to very serious and damaging
consequences when it is injected. Since the disease itself invariably
leads to a dreadful death, both the marketing and the use of the
vaccine are fully justified notwithstanding the unavoidable high
degree of risk which they involve.
Restatement (Second) of Torts, § 402A, comment k at 353–54 (1965). Although
comment k specifically mentions drugs, not all drugs fall within the purview of
comment k; rather, the application of comment k must be decided on a case-bycase basis. Glassman v. Wyeth Laboratories, Inc., 606 N.E.2d 338, 342 (Ill. App.
Ct. 1992).

To come within the purview of comment k, a drug must be

unavoidably unsafe, be properly prepared and have adequate warnings. Id.
The facts alleged in the complaint, taken as true at this point in the
litigation, do not establish that Pradaxa was properly prepared or had adequate
warnings.

On the contrary, as discussed in the facts above, the plaintiff has

alleged that Pradaxa’s warnings were inadequate and that Pradaxa was
improperly designed. Further, nothing in the complaint establishes that Pradaxa
is an unavoidably unsafe product. Accordingly, at this point in the litigation, the
Court cannot conclude that BIPI is entitled to Comment K immunity.
18

E.

Learned Intermediary Doctrine
Illinois law does not require a prescription drug manufacturer to provide

warnings to the ultimate user or consumer.

Instead, under the “learned

intermediary” doctrine, prescription drug manufacturers have a duty to warn
physicians of any known dangers of their drug and the physicians, in turn, have a
duty to convey warnings to patients. Kirk v. Michael Reese Hosp. and Medical
Center, 513 N.E.2d 387, 393 (Ill. 1987).

If the warning provided by the

manufacturer adequately explains the risks and side effects of the drug, the
product is not unreasonably dangerous or defective as a matter of law. Id.
Consequently, an adequate warning shields the manufacturer from liability if the
patient suffers from those effects while taking the drug. Id.
If, on the other hand, a warning is inadequate and the risk is not widelyknown within the medical community, the learned intermediary doctrine does not
shield the manufacturer from liability. See, e.g., Hansen v. Baxter Healthcare
Corp., 764 N.E.2d 35, 43 (Ill. 2002); Procter v. Davis, N.E.2d 1203, 1213 (Ill.
App. Ct. 1997); Tongate v. Wyeth Labs., 580 N.E.2d 1220, 1228 (Ill. App. Ct.
1991). In the instant case, the plaintiff has alleged that BIPI failed to adequately
warn physicians regarding the risks of Pradaxa and that BIPI concealed material
risk information from physicians.

Accordingly, assuming the plaintiff’s

allegations are true, the learned intermediary doctrine does not shield BIPI from
liability. See Walton v. Bayer Corp., 643 F.3d 994, 1001 (a manufacturer that

19

conceals a drug’s adverse side effects from physicians is not protected under the
learned intermediary doctrine).
F.

Fraud Based Claims and Preemption - Fraud on the FDA
BIPI claims the plaintiff’s fraud based claims are actually “fraud-on-the-

FDA” claims and are therefore preempted by the Federal Food, Drug, and
Cosmetic Act (“FDCA”) under Buckman Co. v. Plaintiffs' Legal Committee, 531
U.S. 341, 121 S.Ct. 1012, 148 L.Ed.2d 854 (2000). In Buckman, the Supreme
Court held that the FDCA preempts state law claims alleging that the defendant
made fraudulent representations to the FDA to obtain approval for a drug or
medical device and that, had the defendant not made those misrepresentations,
the FDA would not have approved the drug or device and the plaintiff would not
have been injured. 531 U.S. at 343–45.
mention of such a claim.

The plaintiff’s complaint makes no

Instead, the plaintiff alleges that BIPI made

misrepresentations and omissions of material fact to the plaintiff, the plaintiff’s
physicians, the healthcare industry, and the consuming public. Accordingly, the
Court is not persuaded that the plaintiff’s fraud based claims are preempted
based on law pertaining to fraud on the FDA.
G.

Uncontrollable Bleeding and “Connecting the Dots”
The plaintiff alleges that as a result of taking Pradaxa she suffered from a

severe gastrointestinal bleed which required hospitalization.

Doc. 2 ¶ 41.

Pursuant to the complaint, the plaintiff suffered uncontrollable bleeding which
20

was caused and/or worsened by Pradaxa. Id. BIPI contends that the plaintiff has
not sufficiently pled factual allegations to allege a plausible claim for relief under
Illinois law and has not “connected the dots” between the complaint’s allegations
and the alleged injury. Doc. 12 p. 9. As an example, BIPI argues that the alleged
injury of “uncontrollable” bleeding cannot support any claim for relief because the
plaintiff is not still bleeding. Id. In other words, because the plaintiff’s treating
physicians were eventually able to control her gastrointestinal bleed, she did not
suffer from “uncontrollable” bleeding. BIPI’s overly literal interpretation of the
term “uncontrollable” is not well taken.

A reasonable fact finder would not

interpret "uncontrollable" in this context as without control until death ensues.
Rather it is clear plaintiff has alleged sufficient inability to manage bleeding so as
to cause injury. The Court finds that the alleged injury is sufficiently pled.
With regard to “connecting the dots,” BIPI contends that the plaintiff’s
alleged injury is not sufficiently connected to Pradaxa’s alleged defective
conditions. Id. pp. 9-11. For instance, BIPI states that because the plaintiff does
not expressly allege that she suffered any injury from anticoagulation or lack of a
reversal agent, the plaintiff’s alleged injury is not sufficiently connected to the
claim that Pradaxa was unreasonably dangerous because it lacked a reversal
agent or protocol and/or failed to warn about the lack of a reversal agent or
protocol. Id. p. 10.
The Court disagrees.

The plaintiff alleges that she suffered from a

gastrointestinal bleed and a subdural hematoma causing her to be hospitalized
21

and treated in the intensive care unit. The plaintiff expressly alleges that had the
plaintiff and/or the plaintiff’s prescribing physician known about the defects
alleged in the complaint, the plaintiff would not have used Pradaxa. Further, the
plaintiff alleges that her injury was caused and/or worsened by Pradaxa’s allegedly
defective conditions and/or BIPI’s failure to warn about Pradaxa’s alleged dangers.
These allegations plead a right to relief that is beyond the “speculative level” and is
sufficient at this stage in the litigation.
H.

Sufficiency of the Plaintiff’s Allegations
1.

Strict Liability – Failure to Warn or Design Defect

To prevail under a theory of strict product liability under Illinois law, a
plaintiff must prove: “[1] the injury resulted from a condition of the product, [2]
that the condition was unreasonably dangerous, and [3] that the condition existed
at the time the product left the manufacturer's control.” Faucett v. Ingersoll–Rand
Min. & Machinery Co., 960 F.2d 653, 655 (7th Cir. 1992) (citation omitted). In a
strict liability case based on a failure to warn in Illinois, the plaintiff must allege
and prove that the defendant knew or should have known of the danger. Giles v.
Wyeth, Inc., 556 F.3d 596, 600 (7th Cir. 2009) (quoting Smith v. Eli Lilly & Co.,
137 Ill.2d 222, 148 Ill. Dec. 22, 560 N.E.2d 324, 344 (Ill.1990)).
A plaintiff may proceed under two separate theories to prove that a product
is “unreasonably dangerous”: (1) existence of a design or manufacturing defect or
(2) failure of the manufacturer to adequately warn consumers of the product's
22

dangers. Lamkin v. Tower, 563 N.E.2d 449 (Ill. 1990). In the instant case, the
plaintiff is claiming that Pradaxa was unreasonably dangerous both because of a
design defect and because of a failure to adequately warn of particular dangers.
Under a design defect theory, a plaintiff can either “(1) ... introduc[e]
evidence that the product failed to perform as safely as an ordinary consumer
would expect when used in an intended or reasonably foreseeable manner (known
as the “consumer expectation” test) or (2) ... introduc[e] evidence that the
product's design proximately caused his injury and the defendant fails to prove
that on balance the benefits of the challenged design outweigh the risk of danger
inherent in such designs.” (known as the “risk-utility” test) Lamkin, 563 N.E.2d
449.
Under a failure to warn theory, a product that requires a warning can be
considered defective at the time it left the seller if the warning is not adequate.
Restatement (Second) of Torts, § 402A. If a product is considered unreasonably
dangerous and that dangerousness is not generally known, then the seller “is
required to give warning against it, if he has knowledge, or by the application of
reasonable, developed human skill and foresight should have knowledge, of the
presence of the ingredient and the danger.” (Id. cmt. J.)
In the instant case, the plaintiff has alleged enough facts to state a plausible
strict liability claim based on either a theory of design defect or failure to warn.
For instance, the plaintiff does not merely contend that Pradaxa was in a defective

23

condition at the time it left the manufacturer’s control.

Rather, the plaintiff

provides specific allegations regarding Pradaxa’s alleged defects, including the
following:

(1) Pradaxa has an increased risk of serious or fatal bleeding; (2)

Pradaxa does not have an effective reversal agent or protocol; (3) Pradaxa is less
safe than the equally efficacious prescription anticoagulant Warfarin; (4) Pradaxa
places certain patient populations at an increased risk for serious or fatal
bleeding; and (5) it is difficult or impossible to assess the degree and/or extent of
anticoagulation in patients taking Pradaxa.

Thus, the plaintiff has sufficiently

alleged the existence of an unreasonably dangerous condition under the theory of
design defect. With regard failure to warn, the plaintiff contends that Pradaxa was
unreasonably dangerous because it failed to warn about the defective conditions
alleged in the complaint. This also states a plausible claim for relief.
2.

Fraud Based Claims

The complaint states claims for fraud, fraudulent concealment, and
statutory consumer fraud (under the Illinois Consumer Fraud Act or ICFA). The
Court finds that the plaintiff’s complaint states a plausible claim for relief under
each of the above referenced theories of recovery.
BIPI contends that the allegations of fraud are not sufficiently particular
under Rule 9(b) and that as a result the fraud claims fail to state plausible claims
for relief under Rule 8. Specifically, BIPI contends that the complaint contains no

24

allegations demonstrating “when, where, to whom, or how” the alleged
misrepresentations were made. The Court disagrees.
The complaint pleads the “who,” that is, Defendant Boehringer Ingelheim
Pharmaceuticals, Inc.

Doc. 2 ¶¶ 2, 10.

The complaint pleads the when –

specifically, between October 19, 2010 (when the FDA approved Pradaxa for use
in the United States) through August 2011 (when the plaintiff was prescribed
Pradaxa and when the plaintiff’s alleged injury occurred) and possibly until April
2012 (to the extent that the alleged facts establish knowledge of the alleged defects
between October 19, 2010 and September 27, 2011).

Id. at ¶¶ 12-45.

The

complaint also pleads the where - throughout the United States. Id. at ¶¶ 16, 27,
33, 36, 38. The complaint pleads “to whom” the representations and omissions
were made.

See e.g., Id. at ¶ 19 (the plaintiff); Id. at ¶ 20 (the plaintiff’s

prescribing physician); and Id. at ¶ 16 (U.S. primary care physicians, internists,
group practitioners, cardiologists, and practice nurses). The complaint pleads
how the representations were made. See e.g., Id. at ¶ 16 (detailing sessions); Id.
at ¶¶ 17-18 (direct to consumer advertising); and Id. at ¶¶ 26-27 (labeling and
prescribing information).
The Court further notes, as to the content of the alleged misrepresentations,
the plaintiff alleges the Pradaxa Marketing Campaign, as well as Pradaxa’s labeling
and prescribing information, contained knowing misrepresentations or omissions
regarding the safety and efficacy of Pradaxa, including the following: (1) Pradaxa’s
efficacy and safety in relation to the prescription anticoagulant Warfarin; (2)
25

Pradaxa’s additional benefits; (3) Pradaxa’s allegedly higher risk of serious
bleeding; (4) the lack of an effective reversal agent or protocol in the event of a
serious bleeding event; (5) the difficulty or impossibility of assessing the level or
extent of anticoagulation in patients using Pradaxa; and (6) the safety risks in
certain patient populations. The plaintiff also alleges intent to deceive on the part
of BIPI and that both the plaintiff and her prescribing physician were exposed to
and deceived by the allegedly deceptive information. Finally, the plaintiff alleges
actual damages (damages associated with the plaintiff’s gastrointestinal bleed and
hospitalization) caused by the alleged deception (the plaintiff alleges that had the
plaintiff or her prescribing physician not been deceived she would not have taken
Pradaxa).
Considering the above allegations, the Court finds that the plaintiff has
pled, with sufficient particularity, claims for fraud, fraudulent concealment, and
statutory consumer fraud.
3.

Negligence

In Illinois, product liability cases asserting negligence fall under the
standard of common law negligence. Calles v. Scripto–Tokai Corp., 864 N.E.2d
249, 263 (Ill. 2007). The Plaintiff in this case must therefore allege “the existence
of a duty of care owed by the defendant, a breach of that duty, an injury that was
proximately caused by that breach, and damages.” Id.

26

BIPI argues that the plaintiff’s negligence claim is premised on failure to
warn and fails to state a claim upon which relief may be granted because the
plaintiff attempts to place a duty on BIPI to directly warn the plaintiff and the
“general public,” when its only duty was to warn the prescribing physician. Doc.
12 pp. 13-14. The Court agrees that under the learned intermediary doctrine a
prescription drug manufacturer does not have a duty to directly warn consumers
about a drug’s adverse risks. Thus, to the extent that the plaintiff’s negligence
claim asserts BIPI owed the plaintiff or the general public a duty to warn, it must
fail.

No such duty exists (this is so regardless of whether the learned

intermediary doctrine will ultimately shield BIPI from liability for claims premised
on a failure to warn in the instant case).
The learned intermediary doctrine, however, does not establish that BIPI,
as a prescription drug manufacturer, owes no duty to users of Pradaxa. Under
Illinois law, a manufacturer has a duty of due care to design and manufacture a
product that will be reasonably safe for its intended use.
Scripto-Tokai

Corp.,

864

N.E.2d

249,

270

(Ill.

See e.g., Calles v.

2007)

(manufacturer’s

nondelegable duty to design reasonably safe products); Salerno v. Innovative
Surveilance Technology, Inc., 932 N.E.2d 101, 111 (Ill. App. Ct. 2010)
(manufacturer has a nondelegable duty to design reasonably safe products);
Cornstubble v. Ford Motor Co., 532 N.E.2d 884, 886 (Ill. App. Ct. 1988) (duty to
design and manufacture a product that is reasonably safe for its intended use).

27

Although, for claims premised on failure to warn, the learned intermediary
doctrine limits the class of persons to whom the warning is required to be given, it
does not abolish a prescription drug manufacturer’s duty to design and
manufacture a reasonably safe product.

In other words, a prescription drug

manufacturer owes a duty to design and manufacture a product that is reasonably
safe for its intended use. This duty can be breached in a number of ways, some of
which have nothing to do with failure to warn. To the extent that failure to warn
is in issue, the manufacturer has a duty to warn only the prescribing physicians.
In the instant case, the plaintiff has adequately alleged the existence of a
duty. See Doc. 2 ¶ 64 (alleging BIPI owed “a duty to the general public and
specifically to [the plaintiff] to exercise reasonable care in the design, study,
development, manufacture, promotion, sale, labeling, marketing and distribution
of Pradaxa”). The plaintiff has also asserted that BIPI violated this duty. See e.g.
Id. at ¶ 95 (BIPI failed to “exercise reasonable care in the developing, testing,
designing and manufacturing of Pradaxa”); Id. at ¶ 68(c) (alleging BIPI failed to
“design and/or manufacture a product that could be used safely due to the lack of
a known reversal agent”); Id. at ¶ 20 (alleging BIPI failed to adequately warn
plaintiff’s prescribing physician about the risks associated with Pradaxa)
(incorporated by reference in the plaintiff’s negligence claim in ¶ 63).
For the reasons stated above, The Court concludes that the plaintiff has
sufficiently stated a claim for common law negligence.

28

4.

Negligence Per Se

The plaintiff asserts claims for negligence per se. These claims reference
alleged violations of the Food, Drug and Cosmetic Act (FDCA). BIPI contends that
these claims are based on the FDCA and are barred because there is no private
cause of action under the FDCA. The plaintiff responds arguing that the plaintiff’s
per se negligence claims are based on Illinois common law and that reference to
the FDCA is merely the basis for the applicable standard of care.
Under Illinois law, “if a statute defines what is due care in some activity,
the violation of the statute either conclusively or (in Illinois) presumptively
establishes that the violator failed to exercise due care.” Cuyler v. United States,
362 F.3d 949, 952 (7th Cir. 2004). The statutory definition of due care, however,
only comes into play if the defendant owes a duty of care to the injured party – in
this case the plaintiff. Id. In the instant case, the plaintiff has alleged that, under
Illinois common law, BIPI owed a duty of care to the plaintiff and that the FDCA
provides the definition for the standard of care owed to the plaintiff. Accordingly,
the fact that there is no private right of action under the FDCA does not warrant
dismissal of the plaintiff’s negligence per se claims. See e.g., Id.; Wigod v. Wells
Fargo Bank, N.A., 673 F.3d 547, 582 (7th Cir. 2012).
Further, for reasons already discussed, the Court also finds that the
plaintiff has asserted facts sufficient to support a plausible claim for relief under
the theory of negligence per se.

29

5.

Breach of Express Warranty

With regard to the plaintiff’s breach of express warranty claim, BIPI
contends the plaintiff has failed to plead facts that could be construed as an
express warranty or as reliance on an express warranty.

The Court notes the

following allegations in the plaintiff’s complaint:
Existence of a Warranty
“Defendant[] expressly warranted that Pradaxa was a safe and effective
prescription blood thinner,” Doc. 2 ¶ 83;
Defendant overstated the efficacy of Pradaxa. Id. ¶ 21 (incorporated into
the express warranty count in ¶ 82);
Defendant disseminated to the plaintiff and her physicians inaccurate,
misleading, and false information. Id. at ¶ 68(a), 106(a) (incorporated into
the express warranty count in ¶ 82); and
Pradaxa was as safe or safer, and as effective or more effective, than other
anticoagulation alternatives. Id. ¶ 74 (incorporated into the express
warranty count in ¶ 82).
Reliance
The

plaintiff

and/or

her

physicians

justifiably

relied

on

BIPI’s

representations id. ¶ 79 (incorporated into the express warranty count in ¶
82)

30

Had the plaintiff and her physicians known of the risks of Pradaxa and the
lack of additional benefits, the plaintiff would not have ingested Pradaxa.
id. at ¶ 44 (incorporated into the express warranty count in ¶ 82).
In light of these allegations, the Court finds that the plaintiff has sufficiently
alleged a claim for breach of express warranty.
6.

Breach of Implied Warranty of Merchantability

“To succeed on a breach of implied warranty of merchantability claim “a
plaintiff must establish (1) a sale of goods, (2) that the seller of the goods is a
merchant with respect to those goods, and (3) that the goods were not of
merchantable quality.” Maldonado v. Creative Woodworking Concepts, Inc., 796
N.E.2d 662, 666 (Ill. App. Ct. 2003).

A product that is not of merchantable

quality is one that is unfit for the ordinary purposes for which the goods are used.
Maldonado, 796 N.E.2d at 666.
In addition to arguing that the breach of warranty claims are barred by the
learned intermediary doctrine and comment K to the Restatement (Second) of
Torts 402A (issues the Court has already addressed), BIPI contends that “there
can be no claim” that Pradaxa “did not function in an otherwise merchantable
manner.” The Court disagrees. The plaintiff has alleged numerous deficiencies
related to Pradaxa. In addition, the plaintiff has alleged that she was hospitalized
due to excessive bleeding as a result of ingesting Pradaxa. These allegations go to

31

the issue of merchantability and are sufficient for surviving BIPI’s motion to
dismiss.
I.

Punitive Damages and Prejudgment Interest
BIPI asks the Court to strike the plaintiffs requests for punitive damages

and prejudgment interest. The Court finds that a more fully developed record is
necessary for determining whether these claims are appropriate in the instant
case and denies the request to strike as premature.
J.

Venue
BIPI seeks dismissal based on improper venue.

Where, as here,

jurisdiction is based solely on diversity, venue is determined in accordance with
the requirements of 28 U.S.C. § 1391(a).

Pursuant to this provision, such an

action may be brought:
only in (1) a judicial district where any defendant resides, if all
defendants reside in the same State, (2) a judicial district in which a
substantial part of the events or omissions giving rise to the claim
occurred, or a substantial part of property that is the subject of the
action is situated, or (3) a judicial district in which any defendant is
subject to personal jurisdiction at the time the action is commenced,
if there is no district in which the action may otherwise be brought.
Id. In the instant case, the plaintiff has made the following allegations: (1) the
events giving rise to the plaintiff’s claims occurred in the Southern District of
Illinois (Doc. 2 ¶ 9); (2) BIPI resides in this judicial district, id. ¶ 8; (3) at all
relevant times the plaintiff was a resident and citizen of Salem Illinois located in
Marion County, id. ¶ 1; and (4) shortly after being prescribed Pradaxa, the
32

plaintiff suffered a severe gastrointestinal bleed, her excessive bleeding was
worsened by Pradaxa, and her bleeding caused her to be hospitalized at St. Mary’s
Hospital. Id. ¶ 41.
Assuming that the above allegations are true, venue is proper and BIPI is
not entitled to dismissal based on improper venue.
VI.

CONCLUSION

For the reasons set forth above, BIPI’s Motion to Dismiss is DENIED.
IT IS SO ORDERED.

David R. Herndon
2012.07.25
10:40:38 -05'00'
Chief Judge
United States District Court

Date: July 25, 2012

33