Knight et al v. Boehringer Ingelheim Pharmaceuticals, Inc.

Filing 118

MEMORANDUM OPINION AND ORDER granting Defendant's 42 Motion for Summary Judgment only with regard to Plaintiffs' claims for defective design and breach of implied warranty of fitness, and denying the remainder of Defendant's Motion f or Summary Judgment; denying Plaintiffs' 44 Motion for Partial Summary Judgment; denying Defendant's 45 Motion to Exclude Case-Specific Testimony of Dr. Hazem Ashhab; denying Defendant's 68 Motion in Limine No. 6 to Exclude Evide nce and Argument Regarding Plasma Concentration Levels; denying Defendant's 65 Motion in Limine No. 3 to Exclude Evidence, Testimony, or Argument Related to Foreign Regulatory Actions, Foreign Labeling Materials and Company Core Data Sheet; an d denying Defendant's 66 Motion in Limine No. 4 to Exclude Evidence and Argument Regarding Lack of Reversal Agent to the extent that Plaintiffs' warnings claims allege that BI inadequately warned that no reversal agent existed, and denying as moot the remainder of the motion. Signed by Judge Robert C. Chambers on 5/31/2018. (cc: counsel of record; any unrepresented parties) (jsa)

IN THE UNITED STATES DISTRICT COURT FOR
THE SOUTHERN DISTRICT OF WEST VIRGINIA
HUNTINGTON DIVISION

CLAUDE R. KNIGHT and
CLAUDIA STEVENS, individually
and as Personal Representatives of
the Estate of Betty Erelene Knight, deceased,
Plaintiffs,
v.

CIVIL ACTION NO. 3:15-6424

BOEHRINGER INGELHEIM
PHARMACEUTICALS, INC.
Defendant.

MEMORANDUM OPINION AND ORDER
Pending before the Court are a litany of motions, including Defendant’s Motion for
Summary Judgment (ECF No. 42) and Plaintiffs’ Motion for Partial Summary Judgment (ECF No.
44). Importantly, four of Defendant’s other still-pending motions are relevant to its summary
judgment motion: Motion to Exclude Case-Specific Testimony of Dr. Hazem Ashhab (ECF No.
45) (“Motion to Exclude Dr. Ashhab”); Motion in Limine No. 3 to Exclude Evidence, Testimony,
or Argument Related to Foreign Regulatory Actions, Foreign Labeling Materials and Company
Core Data Sheet (ECF No. 65) (“Foreign Label Motion”); Motion in Limine No. 4 to Exclude
Evidence and Argument Regarding Lack of a Reversal Agent (ECF No. 66) (“Reversal Agent
Motion”); Motion in Limine No. 6 to Exclude Evidence and Argument Regarding Plasma
Concentration Levels (ECF No. 68) (“Plasma Levels Motion”). In addition to fully briefing the
motions, the parties provided oral argument before the Court at the Pretrial Motions Hearing on
May 15, 2017. As explained below, the Court GRANTS, IN PART, AND DENIES, IN PART

Defendant’s Motion for Summary Judgment (ECF No. 42), DENIES Plaintiffs’ Motion for Partial
Summary Judgment, DENIES Defendant’s Motion to Exclude Dr. Ashhab (ECF No. 45),
DENIES Defendant’s Foreign Label Motion (ECF No. 65), DENIES Defendant’s Reversal Agent
Motion (ECF No. 66), and DENIES Defendant’s Plasma Levels Motion (ECF No. 68).
I. BACKGROUND
This case is one in a series of product liability suits brought around the country, in which
plaintiffs have claimed that they were harmed due to allegedly defective aspects of Pradaxa, a drug
created and sold by Defendant Boehringer Ingelheim Pharamaceuticals, Inc. (“BI”). See generally
Chambers v. Boehringer Ingelheim Pharmaceuticals, Inc., No. 4:15-CV-00068 (CDL), 2018 WL
849081 (M.D. Ga. Jan. 2, 2018); Warren v. Boehringer Ingleheim Pharmaceuticals Inc., No. 1:16cv-01326-SEB-DML, 2017 WL 3970666 (S.D. Ind. Sept. 8, 2017). In this variation of the nationwide cases, Ms. Betty Knight had been taking Pradaxa for roughly 18 months before she suffered
a serious gastrointestinal bleed in May 2013. Ex. 1 to Pls.’ Resp. to Summ. J., ECF No. 51-1, at 23. Although doctors eventually stopped the bleed, Ms. Knight remained largely debilitated, being
moved in and out of in-patient care facilities, hospitals, and her home. Id. A few months later, in
September 2013, Ms. Knight passed away at the age of 84. Id. at 4; Ex. 3 to Def.’s Mot. for Summ.
J., ECF No 41-3, at 2.
A. Ms. Knight’s Medical Condition and Events Leading to her Passing
Among other conditions1, Ms. Betty Knight suffered from atrial fibrillation (“A-Fib”), a
condition in which the heart beats irregularly. Ex. 1 to Def.’s Mot. for Summ. J., ECF No. 42-1, at
3-4; Ex. 3 to Def.’s Mot. for Summ. J., at 2. This irregular heart beat can cause a pooling of blood

1

Ms. Knight also had other health conditions, including coronary artery disease, peripheral
vascular disease, diabetes, and renal disease. Ex. 1 to Def.’s Mot. for Summ. J., at 4.
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in areas of the heart, and can lead to the development of blood clots. Ex. 1 to Def.’s Mot. for Summ.
J., at 3-4. Significantly, if these clots break away and travel to the brain, the suffering patient can
have a stroke. Id.
Ms. Knight’s A-Fib, in addition to her being over 75 years-old, increased her stroke risk.
Ex. 1 to Def.’s Mot. for Summ. J., at 4. In fact, largely because of these two factors, Ms. Knight’s
primary care physician, Dr. Dawn MacFarland, characterized Ms. Knight has having a high risk
of stroke. Id.
As early as 2005, doctors had prescribed medicine to Ms. Knight in order to lessen her
atrial fibrillation-related stroke risk. Ex. 1 to Pls.’ Resp. to Summ. J., at 2. The first drug Ms. Knight
received was warfarin, which is marketed under the brand name Coumadin. Like Pradaxa, warfarin
works as an anticoagulant that helps to prevent the development of blood clots, thereby reducing
the risk of stroke. Ex. 4 to Pls.’s Resp. to Summ. J., ECF No. 51-4, at 22-23. And as with the use
of any anticoagulant drug, warfarin increases the risk of a patient experiencing bleeding. Id. at 20.
In order to address and mitigate the bleed risk associated with warfarin use, patients must
submit to stringent dietary restrictions and a regular and frequent monitoring regime. Id. at 22-24;
Ex. 8 to Pls.’ Resp. to Summ. J., ECF No. 51-8, at 6-8; Ex. 1 to Def.’s Mot. to Summ. J., at 5-6; Ex.
9 to Pls.’ Resp. to Summ. J., ECF No. 51-9, at 3. Warfarin has a narrow therapeutic range, which
is a range of anticoagulant effect that decreases the risk of stroke without unnecessarily increasing
the risk of a bleed. Ex 4 to Pls.’ Resp. to Summ. J., at 22-23. Based upon the measurement levels
reflected during the monitoring tests, doctors adjust a patient’s warfarin dose in an effort to keep
the patient in the therapeutic range. Id.
During her time on warfarin, Ms. Knight regularly submitted to this monitoring. Despite
the inconvenience it posed to Ms. Knight, the regular testing was critical to her warfarin treatment.

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According to her doctors, they had a difficult time managing Ms. Knight’s warfarin levels. Ex. 1
to Def.’s Mot. for Summ. J., at 6. In fact, Ms. Knight’s warfarin levels regularly fell outside of the
therapeutic range. Id. Indeed, even while on warfarin, Ms. Knight’s monitoring reflected that at
times she was over-anticoagulated. Id. at 7. Despite this intermittent over-anticoagulation on
warfarin, Ms. Knight did not experience a major bleed while on the medicine.
With the numerous restrictions of warfarin, Ms. Knight and her family were interested in
getting her on a different anticoagulant that would intrude less upon Ms. Knight’s everyday
activities. Ex. 1 to Def.’s Mot. for Summ. J., at 7-8. And, prompted by a commercial they saw
which touted the benefits of Pradaxa, Ms. Knight and her children made an appointment to speak
with Dr. MacFarland about switching Ms. Knight to Pradaxa. Id.; Ex. 9 to Pls.’ Resp. to Summ. J.,
at 2; Ex. 1 to Pls.’ Resp. to Summ. J., at 2.
Ms. Knight and her children visited Dr. MacFarland’s office on October 17, 2011, at which
point Ms. Knight first received a prescription for Pradaxa. Ex. 1 to Def.’s Mot. for Summ. J., at 1213; Ex. 1 to Pls.’ Resp. to Summ. J., at 2. Freed from the warfarin related constraints, Ms. Knight
enjoyed not having to regularly submit to the monitoring and testing of her anticoagulant levels.
Ex. 9 to Pls.’ Resp. to Summ. J., at 9. Instead of the frequent dose adjustment involved with
warfarin, Dr. MacFarland’s office prescribed a set dose for Ms. Knight’s Pradaxa, 75 mg B.I.D.
Ex. 1 to Pls.’ Resp. to Summ. J., at 2. For sales in the United States, Pradaxa’s package insert, often
referred to as the “label,” recommended that doctors prescribe either a dose of 75 mg or 150 mg,
dependent upon the patient’s renal function. Id.; Ex. 2 to Pls.’ Resp. to Summ. J., ECF No. 51-2,
at 2. Based upon Ms. Knight’s severe kidney impairment, the Pradaxa label recommended the 75
mg dose, twice a day. Id. Dr. MacFarland’s prescription followed the label’s dosing
recommendation. Id.; Ex. 8 to Pls.’ Resp. to Summ. J., at 8-9. At the time of her initial prescription,

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Ms. Knight was 82 years old, and took two P-gp inhibitor drugs, as well as Iburprofen three times
a day. Ex. 1 to Pls.’ Resp. to Summ. J., at 2.
In April 2013, Ms. Knight went to the hospital after suffering from a heart attack. Ex. 3 to
Def.’s Mot. for Summ. J., at 3. At the hospital, Ms. Knight underwent a left heart catheterization,
with stint placement. Id. After the procedure, doctors continued to give Ms. Knight her Pradaxa,
and required her to take two other drugs: Plavix and aspirin. Id.; Ex. 1 to Pls.’ Resp. to Summ. J.,
at 2. Plavix is an anti-platelet drug that affects the blood’s clotting, and was prescribed to Ms.
Knight to address her cardiac risk after the placement of two stints. Id. So too, taking aspirin also
helps to prevent heart attacks. Doctors refer to the prescription of Pradaxa, Plavix, and aspirin
together as “triple therapy.” Ex. 3 to Def.’s Mot. for Summ. J., at 2; Ex. 4 to Def.’s Mot. for Summ.
J., ECF No. 42-4, 8-10. Like Pradaxa, both Plavix and aspirin increase the risk of bleeding. Ex. 3
to Def.’s Mot. for Summ. J., at 2; Ex. 4 to Def.’s Mot. for Summ. J., at 9; Ex. 5 to Def.’s Mot. for
Summ. J., ECF No 42-5, at 5; Ex. 7 to Pls.’ Resp. to Summ. J., ECF No. 51-7, at 2.
On May 20, 2013, almost a month after she had started the triple therapy, Ms. Knight
reported to her doctors that she was experiencing symptoms indicative of gastrointestinal bleeding.
Ex. 4 to Def.’s Mot. for Summ. J., at 10-11; Ex. 1 to Pls.’ Resp. to Summ. J., at 3. According to her
medical records, Ms. Knight had been experiencing those symptoms for roughly a week by the
time she visited her doctor. Ex. 1 to Pls.’ Resp. to Summ. J., at 3. The bleed symptoms had
continued to worsen over that time, and Ms. Knight was admitted to the hospital. Id.
Dr. Ahmed Abdelgaber, the doctor treating Ms. Knight at the hospital, directed that she not
receive her Pradaxa, Plavix, or aspirin, due to the active, serious bleed. Id.; Ex. 3 to Def.’s Mot. for
Summ. J., at 4. The next day, May 21, 2013, despite having not received the “triple therapy”
medicines for over twenty-four hours, a coagulation test performed on Ms. Knight indicated that

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she was over-anticoagulated. Id. Ms. Knight’s aPTT, a test that measures the level of
anticoagulation, registered 47 seconds, an elevated score that reflected over-anticoagulation. Id.
Dr. Charles Huh, a gastroenterologist, performed a endoscopy and a colonoscopy. Id.; Ex.
3 to Def.’s Mot. for Summ. J., at 4. Dr. Huh found an active bleed in Ms. Knight’s colon; he
believed the bleed was due to an arteriovenous malformation. Dr. Huh stopped the active bleed by
applying two endoscopic clips. Four days after her procedures, Ms. Knight was released from inpatient care, and transferred to the skilled nursing unit of St. Mary’s Medical Center. Id. At some
point shortly after her procedure, Ms. Knight resumed taking her Pradaxa. Id.
Despite stopping the bleed, and resuming her Pradaxa, Ms. Knight’s health still struggled.
According to doctors who saw her in June and July of 2013, she was “not bouncing back” and she
had “been weak since [her admission to the hospital].” Id. Additionally, during an appointment
with a cardiologist that summer, and while still taking her Pradaxa, Ms. Knight had an another
aPTT test showing that she was over-anticoagulated. Id. This time, her aPTT resulted in 67
seconds, indicating even greater over-anticoagulation. Id.
Throughout that summer, Ms. Knight was admitted to the hospital various times, and
generally did not demonstrate any improvement. Id. at 3-4. In one of her last admissions to the
hospital, from August 17, 2013 until August 22, 2013, Ms. Knight received treatment at St. Mary’s
Medical Center after suffering a heart attack. Id. at 4; Ex. 3 to Def.’s Mot. for Summ. J., at 5.
Finally, just a few days after being released, on September 1, 2013, she was admitted again to St.
Mary’s Medical Center, but for the last time. Id. With an aPTT of 54 seconds at the time of her
final hospitalization, Ms. Knight continued to demonstrate over-anticoagulation. Id. However, at
no point during the multiple hospitalizations after May 2013 did Ms. Knight suffer another major

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bleed. The next day, on September 2, 2013, Ms. Knight passed away. Id.; Ex. 3 to Def.’s Mot. for
Summ. J., at 5.
B. Pradaxa and its Label
Approved by the FDA in October of 2010, Pradaxa belongs to a relatively new class of
drugs developed to provide an alternative to warfarin for stoke prevention in patients with atrial
fibrillation. Ex. 4 to Pls.’ Resp to Summ. J., at 24. In seeking FDA approval of Pradaxa, BI
conducted a clinical trial called RE-LY, in which it tested dosages of 110 mg and 150 mg. Id. at
26. During the RE-LY trial, which involved thousands of participants, researchers measured the
blood plasma concentration of dabigatran, the substance created by taking Pradaxa. Id. The
concentrations varied widely. For people taking 150 mg of Pradaxa, their tough level of
dabigatran—the level right before patients were supposed to take their next dose—ranged from
1.4 ng/ml to 809 ng/ml. Id. at 26. Even the 10th and 90th percentiles of Pradaxa plasma
concentration demonstrated wide variability, going from 39.8 ng/ml to 215 ng/mL, respectively.
Id. at 27. However, BI found that the potential “sweet spot” for diagatran plasma concentrations—
the level at which the potential benefit of stroke prevention outweighed, or at least matched, the
increased risk of bleeding—was between approximately 50 ng/ml and 150 ng/ml. Id. at 29-30.
Although at least twenty percent of trial patients fell outside that range, the risks associated with
falling outside that range were potentially dire. Id. at 26-36.
BI’s RE-LY trial showed that in patients with plasma concentrations of roughly 210
ng/mL or greater, the risk of stoke did not really change, but the risk of experiencing a major bleed
doubled. Id. at 31. In a different, later trial, BI again confirmed this doubling of the major bleed
risk when patients’ plasma concentration met or exceeded a certain level. Id. Largely consistent
with the earlier findings, in the later trial BI found that at 215 ng/ml patients’ risk of a major bleed

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doubled. Id. Even BI’s internal emails between its medical staff demonstrate the understanding
that the blood plasma concentration of diagatran should not exceed roughly 200 ng/mL. In one
email, the principle investigator for the RE-LY study told his colleagues that
the obvious implication of these data [is] that they point to a trough plasma
concentration range for optimization of efficacy and safety in a range from
40-200 ng/ml. We need to say this more direct[ly]. Of course there is some
uncertainty but the data are fairly clear. There is very good reason to never
go above 200 ng/ml.
Id. at 33 (emphasis original to report).
Despite the observation of BI and its employees that certain blood plasma concentrations
of Pradaxa increased the risk of a major bleed without contributing any additional stroke
prevention benefit, BI did not place this information in either Pradaxa’s label or the Medication
Guide that went to patients. Ex. 4 to Pls.’ Resp. to Summ. J., at 16-17; see generally Ex. 2 to Pls.’
Resp. to Summ. J. Furthermore, BI did not include in those publications that the potentially
dangerous concentrations appeared in patients who took the medication as recommended. Id.
However, this was not the only pertinent information lacking from Pradaxa’s label and
Medication Guide, according to Plaintiffs. Although it apparently had information demonstrating
that certain patients, who both suffer from severe renal impairment and take medications called Pgp inhibitors, should not take Pradaxa, BI did not include that information in the original label or
Medication Guide. Ex. 3 to Pls.’ Resp. to Summ. J., ECF No. 51-3, at 7-11; see generally Ex. 2 to
Pls.’ Resp. to Summ. J. Later, BI did add information regarding the risk associated with those
patients who both have renal impairment and take P-gp inhibitors. But BI did not take any
additional steps to notify doctors or patients of this change. Instead, it merely changed the text of
the label without bringing further attention to the alteration.

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Indeed, when Ms. Knight first received her prescription for Pradaxa, the label did not
contain a specific warning about either the doubling risk at a certain level of plasma concentration
or the risk associated with concomitant use of P-gp inhibitors. Ex. 3 to Pls.’ Resp. to Summ. J., at
7-11; see generally Ex. 2 to Pls.’ Resp. to Summ. J. The amendment adding this warning came
shortly after Ms. Knight was first prescribed Pradaxa. In that amendment, BI included at least some
information regarding the increased bleed risk associated with simultaneous use of P-gp inhibitors
in patients with renal impairment. Id. But at no point, other than having a general warning
regarding a risk of bleeding, did BI detail the possibility of dangerous concentrations of Pradaxa
that doubled the bleed risk without adding any meaningful stroke prevention. Ex. 1 to Pls.’ Resp.
to Summ. J., at 4-5.
In other markets, however, BI inserted this information into the package warnings for
Pradaxa. For example, the Pradaxa label for the medication sold in Europe included warnings both
about the increased risk of bleeding in patients whose plasma concentration exceed 200 ng/ml, and
about the increased bleed risk in older individuals with renal impairment who are also on a P-gp
inhibitor. Ex. 4 to Pls.’ Resp. to Summ. J., 49-52; Ex. 14 to Pls.’ Resp. to Summ. J., ECF No. 5114, at 4-6. Consistent with this warning, BI recommended that European physicians should test
the dabigatran exposure in patients with a high bleed risk. Id. BI also provided the same warning
and instruction to doctors and patients in Canada. Id. at 49. In fact, in the U.K. label, BI went as
far as instructing prescribing doctors and patients that “the exposure [ ] to dabigatran [(Pradaxa)]
was approximately 6 times higher [in patients with severe renal insufficiency, like Ms. Knight,] .
. . than that observed in [patients] without renal insufficiency.” Ex. 14 to Pls.’ Resp. to Summ. J.,
at 25.

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Not only did BI not alert patients and doctors in the United States about some of the
quantified, increased risks of bleeding in patients with certain characteristics, but it also appears
that BI did not notify the FDA of at least some of the relevant risk information. Seemingly, despite
having information regarding the doubled risk associated with Pradaxa concentrations of over
roughly 200 ng/mL, BI never informed the FDA of this “cut-off value.” Ex. 33 to Pls.’ Resp. to
Summ. J., ECF No. 51-33, at 103.
C. Development of Praxbind, the Antidote to Pradaxa
When Pradaxa first hit the market, there was no way to reverse its effects if a patient was
suffering a bleed due to over-anticoagulation. For those suffering from such a bleed, treating
medical teams could only attempt to manage the bleed. Ex. 26 to Pls.’ Resp. to Summ. J., ECF No.
51-26. BI’s own medical developers noted that there was “an unmet medical need for reversal
agents . . . to reverse the anticoagulant effects of [drugs like Pradaxa].” Ex. 25 to Pls.’ Resp. to
Summ. J., ECF No. 51-25, at 7-8. However, by 2015, BI had discovered, produced, and received
approval for an antidote for Pradaxa called Praxbind. See generally Ex. 23 to Pls.’ Resp. to Summ.
J., ECF No. 51-23.
In 2002, during the early stages of Pradaxa’s formulation, BI first discovered the antibody
that would catalyze the development of Praxbind. Ex. 24 to Pls.’ Resp. to Summ. J., ECF No. 5124, at 2-3; Ex. 19 to Pls.’ Resp. to Summ. J., ECF No. 51-19, at 2. However, it was not until 2008
that the BI team realized that this antibody might provide a base from which to build an antidote
to the anticoagulant effects of Pradaxa. Ex. 19 to Pls.’ Resp. to Summ. J., at 1. After that antibody
was “humanized,” BI doctors produced the antidote for testing and trials. Ex. B Def.’s Reply in
Supp. of Def.’s Reversal Agent Motion, ECF No. 98-2, at 8-9. Reflecting its urgency to get
Praxbind on the market, BI requested accelerated approval from the FDA. Ex. 26 to Pls.’ Resp. to

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Summ. J., at 1. Citing the need of Praxbind, the FDA granted the accelerated approval. Ex. 23 to
Pls.’ Resp. to Summ. J., at 1. In all, the Praxbind development process and FDA approval took six
years, a relatively short time for medications. Ex. B Def.’s Reply in Supp. of Def.’s Reversal Agent
Motion, at 6-7.
Studies demonstrated that Praxbind quickly and effectively reversed the effects of Pradaxa.
This made it an antidote in cases where patients’ anticoagulation resulted in a dangerous bleed.
Ex. 27 to Pls.’ Resp. to Summ. J., ECF No. 51-27, at 6-7. The drug works by binding to dabigatran,
the substance produced by Pradaxa that leads to anticoagulation, thus making dabigatran
unavailable for use in the body. Ex. 26 to Pls.’ Resp. to Summ. J., at 1. Based upon these results,
BI presented Praxbind as an “enhance[ment to] the safety profile of [Pradaxa],” which would
increase the value of Pradaxa. Ex. 25 to Pls.’ Resp. to Summ. J., at 8-9; see Ex. 31 to Pls.’ Resp. to
Summ. J., ECF No. 51-31.
D. Plaintiffs’ Claims
Upon these facts, Plaintiffs advance a list of claims, all generally alleging that BI is liable
for Ms. Knight’s death due to the defective nature of, and inadequate warnings for, Pradaxa.
Plaintiff’s first claim, Strict Products Liability (Count I), encompasses two theories: (1) that
Pradaxa was defectively designed, and (2) that BI failed to adequately warn Ms. Knight about the
dangers of taking Pradaxa. See Pls. Resp. to Summ. J., ECF No. 51, at 2-3. Specifically, Plaintiffs
claim that Pradaxa was defectively designed at the time that Ms. Knight took it because there was
no way to reverse Pradaxa’s anticoagulant effect.
Regarding the warnings, Plaintiffs claim that BI failed to provide sufficiently specific
information, and that the Pradaxa label and Medication Guide lacked important information, which
rendered them misleading and inadequate. Id. at 2. Plaintiffs’ warnings claims break down roughly

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into three independent components. First, according to Plaintiffs, BI failed to include information
regarding the higher risk of major bleeding events for patients who both suffer from severe renal
impairment and take P-gp inhibitors. Id. at 3. Once BI did change the label to include a portion of
the warning information for those with renal impairment who take P-gp inhibitors, Plaintiffs claim
BI failed to properly bring that change to the attention of patients or prescribing doctors through a
“Dear Doctor Letter.” Id. Second, BI never warned patients or doctors that there was a
concentration level of Pradaxa which patients should not exceed due to the exponential increase
in bleed risk. And, Plaintiffs contend that BI should have, but did not, instruct physicians to take
measurements of the Pradaxa concentration to avoid a heightened bleed risk. Coupled with that
recommendation to monitor, Plaintiffs assert that BI should have identified a test for doctors to
accurately measure Pradaxa concentration levels. Third and finally, Plaintiffs contend that BI
knew, but failed to make clear, the specific multipliers of risk increase associated with patient
characteristics such as age, concomitant medications, and renal impairment. All of which, had they
been in place, would have prevented Ms. Knight from suffering the alleged fatal bleed.
Additionally, Plaintiffs assert a variety of common law and statutory claims including:
negligence (Count II), negligent misrepresentation/fraud (Count III), breach of express warranty
(Count IV), breach of implied warranty (Count V), negligence per se (Count VI), fraudulent
concealment (Count VIII), and a claim for punitive damages (Count IX). Generally, Plaintiffs
supports these claims based upon the same arguments and evidence as their defective design and
failure to claims.

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II. STANDARD OF REVIEW
A. Summary Judgment Standard
To obtain summary judgment, the moving party must show that no genuine issue as to any
material fact remains and that the moving party is entitled to judgment as a matter of law. Fed. R.
Civ. P. 56(a). “Material facts” are those that might affect the outcome of a case, and a “genuine
issue” exists when a reasonable jury could find for the nonmoving party upon the evidence
presented. The News & Observer Publ’g Co. v. Raleigh-Durham Airport Auth., 597 F.3d 570, 576
(4th Cir. 2010) (citing Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248 (1986)). In considering
a motion for summary judgment, the Court will not “weigh the evidence and determine the truth
of the matter[.]” Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 249 (1986). So too, it is not the
province of the Court to make determinations of credibility. Gray v. Spillman, 925 F.2d 90, 95 (4th
Cir. 1991). Instead, the Court will draw any permissible inference from the underlying facts in the
light most favorable to the nonmoving party. Matsushita Elec. Indus. Co. v. Zenith Radio Corp.,
475 U.S. 574, 587-88 (1986). Any inference, however, “must fall within the range of reasonable
probability and not be so tenuous as to amount to speculation or conjecture.” JKC Holding Co. v.
Wash. Sports Ventures, Inc., 264 F.3d 459, 465 (4th Cir. 2001) (citation omitted).
Although the Court views all underlying facts and inferences in the light most favorable to
the nonmoving party, in order to survive summary judgment, the nonmoving party must offer some
“concrete evidence from which a reasonable juror could return a verdict in his [or her] favor[.]”
Anderson, 477 U.S. at 256. Summary judgment is appropriate when the nonmoving party has the
burden of proof on an essential element of his or her case and, after adequate time for discovery,
does not make a showing sufficient to establish that element. See Celotex Corp. v. Catrett, 477
U.S. 317, 322-23 (1986). The nonmoving party must satisfy this burden of proof by offering more

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than a mere “scintilla of evidence” in support of his or her position. Anderson, 477 U.S. at 252.
“Mere speculation by the non-movant cannot create a genuine issue of material fact” to avoid
summary judgment. JKC Holding Co., 264 F.3d at 465.
B. Daubert Standard
Rule 702 of the Federal Rules of Evidence governs the admissibility of expert witness
testimony. A qualified expert's testimony is admissible if it “rests on a reliable foundation and is
relevant[.]” Daubert v. Merrell Dow Pharm. Inc., 509 U.S. 579, 597 (1993). There is no
mechanistic test for determining if an expert's proffered relevant testimony also is reliable. Rather,
“‘the test of reliability is flexible’ and ‘the law grants a district court the same broad latitude when
it decides how to determine reliability as it enjoys in respect to its ultimate reliability
determination.’” United States v. Wilson, 484 F.3d 267, 274 (4th Cir. 2007) (quoting Kumho Tire
Co. v. Carmichael, 526 U.S. 137, 141-42 (1999) (italics original in Kumho)).
To fulfill its gatekeeping responsibility, the court must determine whether: (1) “the expert's
scientific, technical, or other specialized knowledge will help the trier of fact to understand the
evidence or to determine a fact in issue;” (2) “the testimony is based on sufficient facts or data;”
(3) “the testimony is the product of reliable principles and methods;” and (4) “the expert has
reliably applied the principles and methods to the facts of the case.” Fed. R. Evid. 702(a)–(d).
“This entails a preliminary assessment of whether the reasoning or methodology underlying the
testimony is scientifically valid and of whether that reasoning or methodology properly can be
applied to the facts in issue.” Daubert, 509 U.S. at 592-93.
In considering reliability, the Court must ensure that the expert opinions are “‘based on
scientific, technical, or other specialized knowledge and not on belief or speculation, and
inferences must be derived using scientific or other valid methods.’” Nease v. Ford Motor Co.,

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848 F.3d 219, 229 (4th Cir. 2017) (quoting Oglesby v. Gen. Motors Corp., 190 F.3d 244, 250
(4th Cir. 1999) (italics original)). “[E]xpert witnesses have the potential to be both powerful and
quite misleading[.]” PBM Prods., LLC v. Mead Johnson & Co., 639 F.3d 111, 123 (4th Cir.
2011) (internal quotation marks and citations omitted). Therefore, the Court’s gatekeeping role
with respect to experts is critical. When experts formulate opinions from existing data, “nothing
in either Daubert or the Federal Rules of Evidence requires a district court to admit opinion
evidence that is connected to existing data only by the ipse dixit[—translation: “he himself said
it”—]of the expert.” Gen. Elec. Co. v. Joiner, 522 U.S. 136, 146 (1997). When an expert's
opinion is based upon mere ispe dixit, “[a] court may conclude that there is simply too great an
analytical gap between the data and the opinion proffered.” Id. (citation omitted).
III. DISCUSSION
Because Defendant’s four preliminary motions affect the consideration of its Motion for
Summary Judgment, the Court will first address those preliminary motions. After reaching a
conclusion as to the Motion to Exclude Dr. Ashhab, the Plasma Levels Motion, the Foreign Label
Motion, and the Reversal Agent Motion, the Court will analyze Defendant’s Motion for Summary
Judgment and Plaintiffs’ Motion for Partial Summary Judgment.
A. Preliminary Motions
a. Motion to Exclude Dr. Ashhab
In probably the most consequential preliminary motion, Defendant moves this Court to
exclude the testimony and opinions of Plaintiffs’ only case-specific expert, Dr. Hazem Ashhab.
Defendant contends that Dr. Ashhab’s opinions are both speculative and unsupported. Def.’s Mem.
in Supp. of Mot. to Exclude Dr. Ashhab, ECF No. 46, at 1. As such, Defendant argues that his

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opinions fail to meet the reliability requirement announced in Daubert v. Merrell Dow Pharm.,
509 U.S. 579 (1993). Id. at 5-16.
Dr. Ashhab is a board-certified gastroenterologist with a lengthy history of experience. Ex.
17 to Pls.’ Resp. to Def. Mot. to Exclude Dr. Ashhab, ECF No. 53-18, at 1. His report summarizes
Ms. Knight’s course of treatment following diagnoses of atrial fibrillation and other significant
medical conditions. See generally id. In preparation for his report, Dr. Ashhab reviewed treatment
records and deposition transcripts from the principal physicians who cared for Ms. Knight during
the relevant period. Id. at 1. In his report, he offers four main opinions, summarized below:
1) Pradaxa caused or contributed to Ms. Knight’s gastrointestinal bleed in May 2013;
2) she was over-anticoagulated with Pradaxa at the time of her bleed but Praxbind would
have lessened or stopped the bleed;
3) she continued to be over-anticoagulated up to the time of her death, at least in part due
to Pradaxa, as evidenced by her elevated aPTT levels, and Defendant failed to inform
and instruct her physicians how to monitor Pradaxa concentration, in order to reduce
the Pradaxa dose or switch to another anticoagulant; and
4) the May 2013 bleed contributed to her death.
Id. 2-5; Def.’s Mem. in Supp. of Mot. to Exclude Dr. Ashhab, at 4 n.1.
Assailing Dr. Ashhab’s opinion that Ms. Knight was over-anticoagulated as a result of
Pradaxa when she was hospitalized in May 2013, Defendant contends Dr. Ashhab’s deposition
testimony reveals inconsistencies that render his opinions unreliable. Def. Mem. in Supp. of Mot.
to Exclude Dr. Ashhab, at 6-9. In that deposition and in his report, Dr. Ashhab referred to her
elevated aPTT score, 47, measured at least 24 hours, and likely 36 hours, after the Pradaxa was
suspended due to the bleed. Ex. 3 to Def.’s Mot. to Exclude Dr. Ashhab, ECF No. 45-3, at 30-35;

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Ex. 17 to Pls.’ Resp. to Def. Mot. to Exclude Dr. Ashhab, at 3-5. Defendant cites to one of Plaintiffs’
other experts who opined that an aPTT test result “cannot discriminate between above median
therapeutic range and supra-therapeutic dabigatran levels.” Def. Mem. in Supp. of Mot. to Exclude
Dr. Ashhab, at 8; Ex. 3b to Pls.’ Resp to Mot. to Exclude Dr. Ashhab, ECF No. 53-4, at 54.
Defendant argues that this inconsistency between the Plaintiffs’ experts establishes the
unreliability of Dr. Ashhab’s opinion that the aPTT result indicated Pradaxa-related overanticoagulation. Def. Mem. in Supp. of Mot. to Exclude Dr. Ashhab, at 8-9.
Having read the full deposition transcript and considered the exhibits and argument offered
by the parties, the Court disagrees with Defendant. Dr. Ashhab relied upon his extensive
experience in concluding Ms. Knight was likely over-anticoagulated at the time of her bleed. See
generally Ex. 17 to Pls.’ Resp. to Def. Mot. to Exclude Dr. Ashhab. In his deposition, Dr. Ashhab
explained that he considered the May 21 aPTT result, noting that it was measured after two or
three doses had been skipped. Ex. 3 to Def.’s Mot. to Exclude Dr. Ashhab, at 34-35. But he
explained that Ms. Knight’s aPTT readings must have been considerably higher when she received
her regular doses both during the time that the bleed began, and while she continued to take her
regular dose until she was treated for the bleed. Id.
However, Dr. Ashhab did not merely assert, unsupported, the relationship between aPTT
results and Pradaxa-related over-coagulation. Instead, BI, itself, told doctors via Pradaxa’s label
that “the aPTT test provides an approximation of PRADAXA’s anticoagulant activity.” Ex. 2 to
Pls.’ Resp. to Def.’s Mot. to Exclude Dr. Ashhab, ECF No. 53-2, at 2. In order to draw a conclusion
regarding Ms. Knight’s Pradaxa-related over-anticoagulation, Dr. Ashhab used a test that BI told
doctors to use to approximate Pradaxa’s anticoagulant activity. Ex. 3 to Def.’s Mot. for Summ. J.,
at 32-34 (“Q. So is it your position that any conclusion that you draw from [an aPTT] as to Ms.

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Knight’s over-anticoagulation is a guess? A. It’s a guesstimate based on the best available
information provided to me from the lab because I did not have any other way of measuring that
according to the drug manufacturer’s recommendation. They don’t give me anything else. So I use
what I have.” (emphasis added)); Ex. 2 to Pls.’ Resp. to Summ. J., at 2 (“Bleeding risk can be
assessed by the ecarin clotting time (ECT) . . . If ECT is not available, the aPTT test provides an
approximation of PRADAXA’s anticoagulant activity.”). Where BI told doctors that the aPTT
approximates the anticoagulant activity of Pradaxa, it cannot now argue that a doctor’s opinion
regarding too much anticoagulant activity is unreliable where it was based, in part, upon that test.
The aPTT results, however, are not Dr. Ashhab’s only basis for opining that Ms. Knight was overanticoagulated.
Dr. Ashhab also noted that Ms. Knight’s medical history and other medical conditions are
known to substantially increase the risk of bleeding. Ex. 17 to Pls.’ Resp. to Def. Mot. to Exclude
Dr. Ashhab, at 4-5. And because those conditions increase the risk of bleeding, they are also
recognized as affecting whether, or how much, Pradaxa should be prescribed. Id. In other words,
Dr. Ashhab reviewed and considered Ms. Knight’s complete medical record and the implications
that record had on her bleed risk.
Upon his review, his medical experience and knowledge, and the results of an anticoagulant
test that was recommended by BI in Pradaxa’s label, Dr. Ashhab opined that Pradaxa contributed
to Ms. Knight’s over-anticoagulation. Id.; Ex. 3 to Def.’s Mot. for Summ. J., at 32-34; Ex. 2 to Pls.’
Resp. to Summ. J., at 2. Indeed, even one of Defendant’s experts agreed that Pradaxa contributed
to Ms. Knight’s bleed. Ex. 4 to Pls.’ Resp. to Def.’s Resp. to Summ. J., ECF No 53-5, at 2. In light
of his considerations, Dr. Ashhab’s opinion that the bleed in May 2013 – which indisputably

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occurred – was causally connected to over-anticoagulation due to Pradaxa has an adequate medical
foundation.
The record in this case further confirms Dr. Ashhab’s conclusions. In response to
Defendant’s related motion to exclude evidence of plasma concentration levels, Plaintiffs supply
considerable medical research, some from sources connected to Defendant, supporting the basis
for Dr. Ashhab’s conclusions. See generally Exs. 4, 5, 7-9, 17-21 to Pls.’ Resp. to Def.’s Plasma
Levels Mot., ECF Nos. 81-4, 81-5, 81-7–81-9, 81-17–81-22. That literature, most of which was
generated or published prior to Ms. Knight’s death, reflects a growing consensus that age, renal
function, and concomitant use of other specific drugs greatly increases the risk of bleeding. Id.
Further, high plasma concentration levels of Pradaxa are associated with an increased risk of
bleeding, while not adding significantly to the prevention of stroke. Ex. 4 to Pls.’ Resp. to Def.’s
Plasma Levels Mot., at 6. The literature also recognizes that aPTT levels are a useful tool in
determining plasma concentration levels in order to monitor and regulate Pradaxa use. Ex. 7 to
Pls.’ Resp. to Def.’s Plasma Levels Mot., at 1; Ex. 8 to Pls.’ Resp. to Def.’s Plasma Levels Mot.,
at 3-5; see Ex. 17 to Pls.’ Resp. to Def.’s Plasma Levels Mot. With the medical literature confirming
the appropriateness of Dr. Ashhab’s approach and conclusions, Defendant’s attacks fall short.
Additionally, Defendant attempts to criticize Dr. Ashhab’s opinions based upon his
“guesstimate” of Ms. Knight’s aPTT level at the time she reported the bleeding. See Def.’s Mem.
in Supp. of Mot. to Exclude Dr. Ashhab, at 8-9. However, Defendant’s argument simply
mischaracterizes Dr. Ashhab’s deposition testimony. In his report, Dr. Ashhab did not specify a
particular aPTT estimate for Ms. Knight at the time of her bleed. See generally Ex. 17 to Pls.’
Resp. to Def. Mot. to Exclude Dr. Ashhab. And in his deposition, Dr. Ashhab only “guessed” at
specific numbers in response to defense counsel’s questions. Id. at 32-36. It is clear from reading

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Dr. Ashhab’s deposition testimony that this “guess” was merely an illustrative example given to
aid the clarity of his answers in response to defense counsel.
Relevantly, instead of merely opining upon “guesses,” Dr. Ashhab criticizes the Pradaxa
label precisely because BI neither recommended patient monitoring for possible overanticoagulation, nor identified means to monitor anticoagulation through a Pradaxa concentration
level test. Ex. 3 to Def.’s Mot. to Exclude Dr. Ashhab, at 32-33, 36. Indeed, a review of Pradaxa’s
label does not reveal any meaningful guidance given to doctors for the monitoring of
anticoagulation through plasma concentration levels. See Ex. 2 to Pls.’ Resp. to Def.’s Mot. to
Exclude Dr. Ashhab. Therefore, Dr. Ashhab’s opinion is admissible.
Dr. Ashhab provides an admissible causation opinion that attributes Ms. Knight’s bleeding
to Pradaxa, with regard to occurrence, severity, and persistence. Consistent with that opinion, Dr.
Ashhab is also permitted to testify that had the additional warnings and instructions accompanied
Pradaxa, Ms. Knight’s treatment would have been different, diminishing the risk of bleeding and
avoiding the role this medication played in her demise. Therefore, the Court DENIES Defendant’s
Motion to Exclude Dr. Ashhab.
Additionally, as explained below, because the Court separately rejects Plaintiffs’ design
defect claim related to the lack of a reversal agent, like Praxbind, Dr. Ashahb’s opinions as to what
would have occurred if a reversal were available are inadmissible.
b. Plasma Levels Motion
Defendant also seeks the exclusion of any evidence and argument related to “(1) the risk
of bleeding posed by Pradaxa blood plasma concentrations above a specific level and (2) the
alleged need to warn physicians to monitor patients’ Pradaxa plasma concentrations.” Def.’s
Plasma Levels Motion, ECF No. 68, at 1. Generally, Defendant argues that evidence and argument

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regarding the plasma concentrations should be excluded both because there is no evidence of Ms.
Knight’s blood plasma concentration at the time of her bleed, and because “there is no scientific
support for Plaintiffs’ proposals regarding the benefit of plasma concentration monitoring for
Pradaxa patients.” Id. However, Defendant’s argument largely rehashes many of the same
contentions that it made in its Motion to Exclude Dr. Ashhab. Id. at 4-5. Similar to the Court’s
decision regarding the Motion to Exclude Dr. Ashhab, the Court rejects Defendant’s arguments
for the exclusion of plasma concentration evidence and argument.
Contrary to the Defendant’s argument, the record reflects ample support for Plaintiffs’
proposals concerning plasma concentration monitoring. See e.g. Ex. 4 to Pls.’ Resp. to Def.’s
Plasma Level Mot., at 6. Indeed, even BI’s own documents and internal communications
recognized a potentially dangerous “cutoff value” of plasma concentration. Ex. 6 to Pls.’ Resp. to
Def.’s Plasma Level Mot., ECF No. 81-6, at 2; Ex. 9 to Pls.’ Resp. to Def.’s Plasma Level Mot., at
1-7; Ex. 34 to Pls.’ Resp. to Summ. J., ECF No. 51-34, at 1-2; Ex. 35 to Pls.’ Resp. to Summ. J.,
ECF No. 51-35, at 1. Where Defendant has previously recognized both the dangerous implication
of some plasma concentrations of Pradaxa, and the potential need for monitoring to ensure patient
safety, it is incongruous for it to now contend that there is no science to support these positions.
Likewise, the Court dismisses Defendant’s argument that evidence regarding plasma
concentration should be excluded because no measurements of Ms. Knight’s plasma concentration
were taken at the time of her bleed. If anything, Defendant’s argument illustrates one of Plaintiffs’
central claims: that Defendant never provided doctors with guidance as to how to measure Pradaxa
blood plasma concentration levels. Plaintiffs recognize that at the time of her major bleed, doctors
did not take Ms. Knight’s plasma concentration levels. Pls.’ Resp. to Def.’s Plasma Levels Mot.,
ECF No. 81, at 9-10. Indeed, Plaintiffs argue that had BI instructed doctors on how to test for the

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blood plasma concentrations of Pradaxa, doctors would likely have been able to abate Ms. Knight’s
bleeding earlier, and prevent her rapid deterioration and eventual demise. Id. The Court will not
allow Defendant to exclude evidence of a test when Defendant is potentially responsible for that
test not being administered in this case.
Further, the aPTT testing performed around the time of Ms. Knight’s bleed supports
Plaintiffs’ contention that she was likely over-anticoagulated. In addition to Dr. Ashhab’s expert
opinion on that point, Plaintiffs have also produced scientific literature showing the relationship
between aPTT scores and over-anticoagulation, as measured by blood plasma concentration of
dabigatran. Ex. 17 to Pls.’ Resp. to Def.’s Plasma Levels Mot., at 5-6. Given the relationship
between the aPTT results and the blood plasma concentration levels, the Court finds that the
existing medical record provides a sufficient basis for blood plasma concentrations to be relevant,
admissible evidence. The Court DENIES Defendant’s Plasma Levels Motion.
c.

Foreign Label Motion

In its Foreign Label Motion, Defendant requests that the Court exclude any evidence,
testimony, or argument concerning foreign regulatory actions regarding Pradaxa, foreign labels,
or the Company Core Data Sheet (“Data Sheet”) for Pradaxa. Def.’s Foreign Label Mot., ECF No.
65, at 1. The foreign labels contain information and warnings about Pradaxa that BI gave to doctors
and patients in different countries. The Data Sheet “summarizes the safety and efficacy statements
[of Pradaxa], and it also represents the basis for the local labels on a worldwide basis.” Ex. E to
Def.’s Foreign Label Mot., ECF No. 65-5, at 3. Defendant argues both that this line of evidence is
irrelevant and that it is disproportionally prejudicial. Def.’s Foreign Label Mot., at 1.
With regard to relevance, Defendant contends the foreign labels and the Data Sheet apply
to dosages not at issue in this case. Thus, Defendant argues that the labels and Data Sheet are

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inapplicable to Ms. Knight’s Pradaxa usage. Def.’s Foreign Label Mot., at 5-6. Specifically,
Defendant asserts that the European label concerns only doses of 110 mg or 150 mg of Pradaxa
for A-Fib patients. Id. at 5. The only 75 mg dose of Pradaxa addressed by the European label is
for prevention of embolism in patients who have orthopedic surgery. Id. Defendant contends that
the risks associated with either dissimilar doses, or doses for different purposes, are not relevant
to Ms. Knight’s 75 mg Pradaxa dose for stroke prevention related to her A-Fib. Although true that
the foreign labels do not recommend a 75 mg dose for A-Fib patients, the value of this evidence
does not come from the exact dosing information.
The foreign labels and Data Sheet demonstrate Defendant’s knowledge and beliefs
regarding the bleed risks of Pradaxa. Importantly, the foreign labels and Data Sheet demonstrate
that BI understood that a certain plasma concentration of Pradaxa posed a much greater danger of
bleeding to patients. Ex. 6 to Pls.’ Resp. to Def.’s Foreign Label Mot., ECF No. 82-6, at 5-7, 6376; Ex. 8 to Pls.’ Resp. to Def.’s Foreign Label Mot., ECF No. 82-8, at 35-37; Ex. 14 to Pls.’ Resp.
to Summ. J., at 4-7. The foreign labels and Data Sheet also demonstrate that BI knew that certain
risk factors exponentially increased dabigatran absorption—thus increasing both the plasma
concentration and the risk of major bleeding—and that BI knew the multiplier by which these risk
factors affected Pradaxa absorption in those taking the medicine as recommended. Id. Furthermore,
those documents show that that BI believed it necessary to not only provide a threshold plasma
concentration level of dabigatran that patients should not exceed, but also that BI believed it
necessary to recommend testing in patients with certain risk factors to ensure that dabigatran levels
did not exceed the threshold. Id. The Court finds that this evidence is relevant, establishing what
BI knew and believed regarding the bleed risks with certain patients on Pradaxa.

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In its second argument for exclusion of the foreign labels and Data Sheet, Defendant warns
that this evidence would confuse the jury. Def.’s Foreign Label Mot., at 7. Introducing evidence
of foreign labels and the Data Sheet would “invite[] the jury to disregard the FDA’s conclusions,”
and to instead depend upon foreign regulatory bodies. Id. at 9-10. As a result, so says Defendant,
a “mini-trial” would ensue. Defendant asserts that if Plaintiffs were permitted to introduce
evidence of foreign labeling, Defendant would “need to explain the differing regulatory histories
and standards and show that the company complied with the requirements of foreign regulators.”
Def.’s Reply in Supp. of Foreign Label Mot., ECF No. 97, at 6-7. Defendant says that it would also
have to explain “why information in the [Data Sheet] and on Pradaxa’s product labeling around
the world began to diverge . . . .” Id. Defendant submits that “[t]he Court should avoid these minitrials.” Id. The Court agrees that it should avoid these mini-trials, however, the Court disagrees
that Plaintiffs’ introduction of foreign labels or the Data Sheet will necessitate such mini-trials.
In the context of this litigation, where Plaintiffs contend that BI knew about enhanced
risks, but failed to inform doctors and patients in West Virginia, the foreign labels and Data Sheet
offer probative and valuable evidence of BI’s knowledge and beliefs. And, where Plaintiffs’
evidence suggests that BI may have never informed the FDA about some of the information
regarding the heightened risk of bleeding, see Ex. 33 to Pls.’ Resp. to Summ. J., at 103, BI’s
knowledge and its conduct regarding that knowledge becomes even more pertinent.
The Court recognizes that an argument that BI must meet foreign labeling standards when
warning patients and doctors in the United States may be impermissible. However, Plaintiffs have
made clear that they seek to introduce this evidence to demonstrate what BI knew and believed.
See Pls.’ Resp. to Def.’s Foreign Label Mot., ECF No. 82, at 1-2. Due to Plaintiffs’ allegation
about a lack of specific information in the U.S. label and Medication Guide regarding multiple

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aspects of the increased bleed risk associated with Pradaxa, the foreign label and Data Sheet have
a high probative value for BI’s knowledge and beliefs.
Simply, the danger of confusion, unfair prejudice, or misleading the jury does not
substantially outweigh the probative weight of the evidence regarding foreign labels and the Data
Sheet. See Fed. R. Evid. 403. Therefore, the Court DENIES Defendant’s Foreign Label Motion
(ECF No. 65). However, the Court will not permit the parties to devolve the trial into “mini-trials”
over the foreign labeling standards. The parties should keep the argument regarding the foreign
labels and the Data Sheet confined to BI’s knowledge and beliefs. To the extent that the parties
believe additional measures are necessary to address any likelihood of confusion or prejudice
concerning the applicability of foreign labeling standards, those measures may be addressed by
the instructions to the jury.
d.

Reversal Agent Motion

Finally, Defendant requests that this Court preclude Plaintiffs from offering evidence of,
or argument about, Pradaxa’s lack of a reversal agent during the time that Ms. Knight took Pradaxa.
Def.’s Reversal Agent Mot., ECF No. 66, at 1. Defendant argues both that evidence regarding the
lack of a reversal agent is irrelevant to Plaintiffs’ claims and that that evidence is unduly
prejudicial. Id. at 5-9.
As explained later in this Memorandum Opinion and Order, the Court grants summary
judgment in favor of Defendant on Plaintiffs’ defective design claim that is based upon the
contention that Pradaxa should have had a reversal agent when Ms. Knight took the medication.
However, Plaintiffs’ claims regarding the failure to warn remain viable. To the extent that
Plaintiffs’ warnings claims involve an allegation that BI’s warning that no reversal agent existed
was inadequate, Plaintiff may elicit testimony and introduce evidence. But, because Plaintiffs’

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defective design claim does not survive, evidence of either the lack of the reversal agent or the
later development of the reversal agent, used to demonstrate the defective design of Pradaxa, will
not be permitted. Therefore, the Court DENIES, IN PART, and DENIES, AS MOOT, the
remainder of Defendant’s Reversal Agent Motion (ECF No. 66).
B. Dispositive Motions
Turning to the dispositive motions, there are two pending: Defendant’s Motion for
Summary Judgment (ECF No. 42) and Plaintiffs’ Motion for Partial Summary Judgment (ECF No.
44). As explained below, the Court finds that a majority of Plaintiffs’ claims, with the exception
of Plaintiffs’ defective design claim premised upon the lack of a reversal agent and Plaintiffs’
claim for breach of implied warranty of fitness, are better suited for a determination by a jury.
a. Defendant’s Motion for Summary Judgment
Defendant vies for summary judgment in its favor on all of Plaintiffs’ claims. Essentially,
Defendant contends that the record fails to support any of Plaintiffs’ claims.
As an initial matter, West Virginia law provides that strict liability defective product claims
“fall into three broad, and not mutually exclusive, categories: [(1)] design defectiveness; [(2)]
structural defectiveness; and [(3)] use defectiveness arising out of the lack of, or the adequacy of,
warnings, instructions, and labels.” Ilosky v. Michelin Tire Corp., 307 S.E.2d 603, 609 (W. Va.
1983) (quoting Morningstar v. Black & Decker Mfg. Co., 253 S.E.2d 666, 682 (W. Va. 1979)).
These claims do not encompass the totality of product liability claims in West Virginia. A plaintiff
may premise a product liability action “on three independent theories—strict liability, negligence,
and warranty.” Id. at 613. Because each theory has different elements to establish liability, “[n]o
rational reason exists to require plaintiffs in product liability actions to elect which theory to submit

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to the jury . . . .” Id. Consistent with the product liability claims permitted under West Virginia
law, Plaintiffs have stated claims upon each of the three independent theories for liability.
In the interests of clarity, the Court will examine each category of claims, and the parties’
respective arguments, in turn.
i. Failure to warn claims
As the Court detailed above, Plaintiffs’ failure to warn claims fall into roughly three
categories: (1) BI failed to include information regarding the higher risk of major bleeding events
for patients who suffer from severe renal impairment and who take P-gp inhibitors, and BI’s
subsequent change to the label was inadequate because BI failed to bring that change to the
attention of physicians and patients; (2) BI never warned patients or doctors that at a certain blood
plasma concentration of Pradaxa, patients have an exponentially higher risk of bleeding, without
any significant decrease in stroke risk, and BI should have instructed doctors to monitor, and how
to monitor, patients’ dabigatran concentration levels in their blood plasma; and (3) BI failed to
provide specific information regarding the multiple increase in bleed risk associated with certain
patient factors such as age, concomitant medications, and renal impairment. See supra pp. 11-12.
Further, Plaintiffs contend that different, adequate warnings would have avoided Ms. Knight’s
injury. Pls.’ Resp. to Summ. J., ECF No. 51, at 5-11.
Defendant argues that summary judgment is appropriate on Plaintiffs’ failure to warn
claims2 because (1) the Pradaxa labeling was adequate with regard to Ms. Knight, and (2) because

2

As an aspect of its summary judgment motion, Defendant argues that the Court should
dismiss “[a]ny claim that the Pradaxa label should have instructed physicians to prescribe a dose
lower than what was approved by the FDA [because it] is preempted by federal law.” Def.’s Mem.
in Supp. of Mot. for Summ. J., at 6-7. Plaintiffs, however, have not advanced any such claim.
Therefore, without needing to engage in the substance of that argument, the Court DENIES, AS
MOOT, that aspect of Defendant’s Motion for Summary Judgment.
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“Plaintiffs’ have no evidence that a different Pradaxa warning would have avoided Ms. Knight’s
injury.” Def.’s Mem. in Supp. of Mot. for Summ. J., ECF No. 43, at 7-14; Def.’s Mot. for Summ.
J., ECF No. 42, at 1. The Court disagrees with both of Defendant’s contentions. Accordingly,
Plaintiffs’ failure to warn claims should be determined by a jury.
In general, a “manufacturer is strictly liable for injuries caused by its products ‘if the
involved product is defective in the sense that it is not reasonably safe for its intended use.’” Waters
v. Electrolux Home Prods., Inc., 154 F.Supp.3d 340, 351-52 (N.D.W. Va. 2015) (quoting Ilosky,
307 S.E.2d at 609). The touchstone for reasonable safeness is what standards a reasonably prudent
manufacture should have abided by at the time the product was made. Ilosky, 307 S.E.2d at 609.
Additionally, the plaintiff must demonstrate that the defect was the proximate cause of the alleged
injury. Id.
In order to maintain a failure to warn claim under West Virginia law, also referred to as
use defectiveness, a plaintiff must establish that the defendant breached a duty to warn. See Waters,
154 F.Supp.3d at 352. The plaintiff’s use of the product must be foreseeable in order to give rise
to a manufacturer’s duty to warn. See Ilosky, 307 S.E.2d at 609. A determination that a product is
unsafe arising from a failure to adequately warn depends upon “what the reasonably prudent
manufacturer would accomplish in regard to the safety of the product, having in mind the general
state of the art of the manufacturing process, including design, labels and warnings, as it relates to
the economic costs, at the time the product was made.” Id. at 611 (quoting Morningstar, 253 S.E.2d
at 682-83) (internal quotation marks omitted). Given a showing that a plaintiff used the product
consistent with its intended use, “the determination of whether a defendant’s efforts to warn of a
product’s dangers are adequate is a jury question.” Id. at 611.

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In the discussing the preliminary motions above, the Court noted much of Plaintiffs’
evidence regarding the potential insufficiency of Defendant’s warnings for Pradaxa. Not only has
Plaintiffs’ expert, Dr. Ashhab, opined that Ms. Knight’s May 2013 gastrointestinal bleed “was
caused or contributed to by her use of Pradaxa,” Ex. 1 to Pls.’ Resp. to Summ. J., at 4, but even
one of Defendant’s experts concurred that Pradaxa contributed to Ms. Knight’s bleed. Ex. 4 to
Pls.’ Resp. to Def.’s Resp. to Summ. J., at 2. Dr. Ashhab also concluded that had BI “instructed
Ms. Knight’s physicians to measure dabigatran levels, and provided guidance on how to measure
and interpret her dabigatran plasma concentration,” the doctors would likely have found her levels
to be elevated, and would have taken corrective action to lessen Ms. Knight’s bleed risk. Ex. 1 to
Pls.’ Resp. to Summ. J., at 5. Indeed, Dr. MacFarland’s testimony confirms Dr. Ashhab’s opinion
that additional or different warnings would have affected the medical management of Ms. Knight.
Dr. MacFarland testified that had BI recommended monitoring or identified additional testing, she
would have used it in her treatment of Ms. Knight. Ex. 8 to Pls.’ Resp. to Summ. J., at 9-12.
Dr. Ashhab’s opinions, coupled with Dr. MacFarland’s testimony, at the very least
demonstrate that had BI provided additional, different, or more detailed information in its Pradaxa
label, Ms. Knight would have likely not been over-anticoagulated because both she and her doctors
would have known that she had a high risk of developing a dangerous concentration of dabigatran.
Ex. 1 to Pls.’ Resp. to Summ. J., at 4-5. With this knowledge, doctors could have monitored Ms.
Knight’s blood plasma, and thus substantially reduced the chance that she would have suffered a
major bleed. Id. Finally, Dr. Ashhab concluded that the May 2013 bleed contributed to Ms.
Knight’s eventual death due to her inability to fully recover, and continued debility. Id. at 5.
Despite Dr. Ashhab’s admissible expert opinion, Defendant contends that Pradaxa’s label
adequately warned Ms. Knight and her physicians of Pradaxa’s risk and met the “reasonably

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prudent manufacturer” standard. Defendant points out that the label noted that “Pradaxa can cause
serious and, sometimes, fatal bleeding.” Def.’s Mem. in Supp. of Mot. for Summ. J., at 8 (emphasis
original to memorandum). Additionally, Defendant asserts that the label contained “detailed
information provided about the bleed rates seen in the 18,000-person RE-LY study,” including
warnings that elderly patients had a higher bleed risk, and that there was no reversal agent. Id. at
8-9. Defendant then cites the Medication Guide, which tells patients that there is a higher risk of
bleeding in patients over 75, and that other medications may increase the bleed risk. Id. at 9.
Finally, in contending that it provided adequate warnings, Defendant argues that its amended
Pradaxa label is an adequate warning, at least with respect to one of Plaintiffs’ warnings claims.
Def.’s Reply in Supp. of Mot. for Summ. J., at 2. Specifically, Defendant asserts that its addition of
warning for people who both take P-gp inhibitors and have poor renal function, which it added
roughly two months after Ms. Knight started taking Pradaxa, satisfies its duty to warn with respect
to those issues. Id.
Citing both Dr. Ashhab’s opinions, as well as BI’s internal communications, scientific
literature, and BI’s foreign labeling information, Plaintiffs contend that Defendant’s warnings were
inadequate. Although BI provided a generalized warning regarding bleeding, Plaintiffs argued that
due to the detailed risk-multipliers known by BI, it had a duty to warn patients like Ms. Knight
who were not only elderly, but who also took concomitant medications, and had severe renal
insufficiency. Additionally, Plaintiffs argue that BI’s post-prescription amendment of Pradaxa’s
label also failed to meet BI’s duty to warn Ms. Knight about the increased bleed risk for patients
who both take P-gp inhibitors and have severe renal impairment. Plaintiffs have produced volumes
of evidence supporting their positions, including Dr. Ashhab’s report, scientific literature, BI’s
internal communications, and BI’s foreign labeling information, most of which the Court has noted

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in this opinion. Based upon this evidentiary showing—which because the evidence on the record
has been discussed and cited throughout this opinion, the Court will not extensively detail again
here—the Court finds that Plaintiffs’ have viable warnings claims upon their multi-faceted
allegations of inadequate warnings.
However, the Court will not make a decision regarding whether or not the Pradaxa
warnings were adequate as a matter of law. Both parties have submitted evidence to support their
respective positions, as the Court has discussed. Further, the Supreme Court of Appeals of West
Virginia (“West Virginia Supreme Court”) has instructed that “[t]he determination of whether a
defendant’s efforts to warn of a product’s dangers are adequate is a jury question.” Ilosky, 307
S.E.2d at 611. Mindful of the West Virginia Supreme Court’s direction, and in light of sufficient
evidentiary productions by both parties, the Court finds that the adequacy of Defendant’s efforts
to warn must be determined by a jury. See Johnson v. Fankell, 520 U.S. 911, 916 (1997) (“[T]he
interpretation of [state law] by the [States’ Supreme Court] would be binding on federal courts.
Neither this Court nor any other federal tribunal has any authority to place a construction on [state
law] different from the one rendered by the highest court of the State.” (citations omitted)).
In addition to challenging the adequacy of the warnings, Defendant also argues that
Plaintiffs have adduced no evidence that establishes that different warnings would have avoided
Ms. Knight’s injuries. Def.’s Mem. in Supp. of Mot. for Summ. J., at 9-11. Defendant contends that
Plaintiffs fail on the causation element of their warnings claims both because they have not shown
that Ms. Knight ever read any Pradaxa warnings or labels, and because they cannot establish that
additional information would have altered doctors’ medical treatment of Ms. Knight. Id. Therefore,
Defendant argues, Plaintiffs cannot show that that “a [different] warning would have made a
difference.” Id. at 10 (quoting Tracy v. Cottrell ex. rel. Cottrell, 524 S.E.2d 879, 891 n.9 (W. Va.

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1999)). Furthermore, Defendant maintains that the difference must reflect a change “in a manner
which would have avoided [the plaintiff’s [sic] injury].” Id. at 11 (alterations original to
memorandum) (quoting Mead v. Parsley, No. 2:09-cv-00388, 2010 WL 4909435, at *10 (S.D.W.
Va. Nov. 24, 2010) (Copenhaver, J.)). But, the Court disagrees Defendant’s arguments on
causation.
First, the evidentiary record rebuts Defendant’s argument that Ms. Knight did not read the
Pradaxa warnings. Ms. Claudia Stevens, Ms. Knight’s daughter, testified that Ms. Knight had a
three-drawer plastic storage container in which she kept her medications and the information that
came with them. Ex. 10 to Def.’s Mot. for Summ. J., ECF No. 42-10, at 3-4. Although Ms. Stevens
could not confirm whether or not Ms. Knight read the Pradaxa label, Ms. Steven’s brother, Claude
Knight, did provide insightful testimony on this issue. Mr. Knight confirmed that Ms. Knight read
drug labels. Ex. 11 to Def.’s Mot. for Summ. J., ECF No. 42-11, at 4-5. Mr. Knight testified that
his mother, Ms. Knight, “pointed things [from the labels] out” to him. Id. In fact, on at least one
occasion, Mr. Knight recalled his mother pointing out a side effect of a drug that she took. Id. at
5. That Ms. Knight kept medication labels, and that she was known to have read drug labels, meets
the evidentiary burden for that question to survive summary judgment. Although the evidence is
not clear cut, the record demonstrates more than a scintilla of evidence. That is all that is necessary
for the question to go to the jury. See Anderson, 477 U.S. at 252.
Secondly, Plaintiffs adduced evidence showing that had BI provided additional
information and warnings, Ms. Knight’s doctors would have taken additional precautions and
performed different testing. Dr. MacFarland not only testified that she would have liked to have
known about the additional bleed risk information, such as characteristic-based increases in
Pradaxa absorption, but she also testified that BI neither told her to perform Pradaxa concentration

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testing, nor how to conduct such a test if she wanted to. Ex. 8 to Pls.’ Resp. to Summ. J., at 9-12.
Further, Dr. MacFarland asserted that information about the exponential increase in bleed risk due
to certain characteristics, such as age and renal function, would have affected her treatment
decisions with regard to Ms. Knight’s Pradaxa. Id. Finally, Dr. MacFarland agreed that had BI told
her about this risk information and given her a measurement protocol regarding the blood plasma
concentration of Pradaxa, she would have altered her medical management of Ms. Knight. Id. at
11-12.
Seeking to sow doubt upon the hypothetical effect of different warnings, Defendant focuses
upon the testimony of two of Ms. Knight’s other treating physicians. Defendant notes that Dr.
Skuli Gunnalaugsson, a cardiologist who treated Ms. Knight, recorded in Ms. Knight’s medical
chart that she was well-managed from a bleeding and stroke-prevention perspective on August 29,
2013. Def.’s Mem. in Supp. of Mot. for Summ. J., at 12. So too, Defendant cites to the testimony
of Dr. Abdelgaber, another of Ms. Knight’s treating physicians, who believed that “it was
appropriate for [Ms. Knight] to be taking Pradaxa,” in light of her medical history. See id. at 13;
see also Ex. 6 to Def.’s Mot. for Summ. J., ECF No. 42-6, at 3. However, Dr. Abdelgaber also
testified that if BI had recommended a test to measure the anticoagulant effect of Pradaxa, he
would have used it. Ex. 6 to Def.’s Mot. for Summ. J., at 11-12. Defendant argues that although
Dr. Abdelgaber’s testimony, in addition to the testimony of the other treating physicians, indicates
that the doctors may have used a recommended concentration-monitoring test, it does not establish
that a different warning “would have avoided Ms. Knight’s use of Pradaxa or her gastrointestinal
bleed.” Def.’s Mem. in Supp. of Mot. for Summ. J., at 13.
Likewise, Defendant cites to Meade v. Parsley, a case out of this District, in support of its
contention that Plaintiffs have failed to show that the additional or different warnings would have

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altered behavior and avoided Ms. Knight’s injury. See Def.’s Mem. in Supp. of Mot. for Summ. J.,
10-13. In that case, the plaintiff and her treating physician both testified that neither of them ever
read the label for the medication in question. Meade v. Parsely, No. 2:09-cv-00388, 2010 WL
4909435, at *2 (S.D.W. Va. Nov. 24, 2010) (Copenhaver, J.). Additionally, the plaintiff did not
retain an expert to establish general causation for her claims. Id. at *5. The Court found, citing to
the lack of an expert on general causation, that the plaintiff had failed to establish causation. Id. at
*7-8. Then the Court continued, explaining that even if the plaintiff had a causation expert, her
claims would still fail because the record clearly demonstrated, by way of both her and her doctor’s
testimony, that no one read the labels. Id. at *9-10. Therefore, differing warnings would not have
changed the circumstances because no one would have read them. Id. Meade, however, differs
greatly from this case. Thus, Defendant’s reliance upon Meade does not convince this Court that
it should reach the same result.
Simply, the evidence establishes questions of fact as to both whether Ms. Knight read the
label, and whether her doctors would have altered her treatment, thereby avoiding her injuries. The
situation in Meade was clear. The plaintiff and her doctor both testified unambiguously that they
did not read the medication’s label. Id. at *5. In this case, the facts lack that definitive element.
Additionally, Plaintiffs here have escaped the elementary mistake committed by the Meade
plaintiff. In addition to Dr. Ashhab’s expert report, Plaintiffs have produced extensive reports and
scientific literature to support their causative argument. See generally Exs. 1, 4, 12, 21, 25, & 33
to Pls.’ Resp. to Summ. J. The Court believes that Plaintiffs’ case avoids the critical shortcomings
of the plaintiff’s case in Meade. Therefore, the Court will not impose Meade’s outcome upon
Plaintiffs.

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This leaves the Court with disputed evidence that could reasonably lead to differing
conclusions. The Court cannot, as a matter of law, determine that additional or different warnings
would have had no impact upon Ms. Knight’s medical treatment, or that they would not have
avoided her injuries. Indeed, based upon Dr. MacFarland’s and Dr. Abdelgaber’s testimony that
they would have used a test recommended by BI to more accurately measure the anticoagulant
activity caused by Pradaxa, a reasonable fact finder could conclude that the warnings would have
affected Ms. Knight’s treatment and prevented her severe bleed. The Court finds that Plaintiffs
have met their burden to establish a question of fact regarding the casual element of their use
defectiveness claims.
In sum, having found that Plaintiffs have sufficiently demonstrated evidence to survive
summary judgment on each element of their failure to warn claims, the Court DENIES
Defendant’s Motion for Summary Judgment regarding those failure to warn, or use defectiveness
claims.3
ii. Defective design claim
Defendant also argues that Plaintiffs’ defective design claim should be dismissed. In order
to demonstrate that Defendant’s design of Pradaxa was defective, Plaintiffs rely upon the absence
of Praxbind, the antidote to Pradaxa, at the time of Pradaxa’s FDA approval and Ms. Knight’s use
of the drug. Defendant contends that Plaintiffs’ theory inappropriately seeks to prove the
defectiveness of one drug by citing the development of an entirely different drug. The Court agrees
with Defendant, and as such GRANTS Defendant’s Motion for Summary Judgment in its favor
on Plaintiffs defective design claim.

Because at least some of Plaintiffs’ claims continue, the Court also DENIES Defendant’s
Motion for Summary Judgment with regard to Plaintiffs’ wrongful death claim. See Def.’s Mem.
in Supp. of Mot. for Summ. J., at 19.
3

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Design defects, under West Virginia, exist when a “product is not reasonably safe for its
intended use due to a specific design flaw.” Tyree v. Bos. Sci. Corp., No. 2:12-cv-08633, 2014 WL
5320518, at *3 (S.D.W. Va. Oct. 17, 2014) (Goodwin, J.) (citing Philip Combs, Andrew Cooke,
Modern Products Lability Law in West Virginia, 113 W. Va. L.Rev. 417, 425 (2011)). Breaking
this assertion into elements, a “plaintiff must establish that (1) the product was not reasonably safe;
(2) for its intended use; (3) due to a defective design feature; (4) which proximately caused the
plaintiff’s injury.” Id. (citing Morningstar, 253 S.E.2d at 682-83).
Putting the other elements aside, Plaintiffs’ argument concerning the defective design rests
upon “the lack of any adequate methods to reverse the anticoagulant effect of Pradaxa.” Pls.’ Resp.
to Summ. J., at 11. In an attempt to demonstrate this inadequacy, Plaintiffs “point[] to two issues:
Praxbind’s sole function, and how [BI] itself describes Praxbind.” Id. at 14. Nearly all of Plaintiffs’
defective design argument rests upon the development of Praxbind, or the lack thereof. See id. at
17. The Court, however, will not permit Plaintiff to maintain a design defect claim by relying upon
the development of a separate biologic.
About five months ago, a District Court in the Middle District of Georgia dealt with this
same issue. In Chambers v. Boehringer Ingelheim Pharm., Inc., the plaintiffs, who were
represented by the same counsel as Plaintiffs in this case, argued that BI “failed to timely develop
Praxbind, despite it being feasible for the company to do so well before Mr. Chambers suffered
his fatal bleed in May 2014.” No. 4:15-CV-00068 (CDL), 2018 WL 849081, at *13 (M.D. Ga. Jan.
2, 2018) (quoting plaintiffs’ response). The court rejected the plaintiffs’ argument. It concluded
that the plaintiffs “may not establish a design defect of Pradaxa by pointing to the failure to
develop Praxbind.” Id. (italics orginial). Emphasizing that Praxbind required separate FDA
approval from Pradaxa, the court clarified that “Praxbind is not part of Pradaxa’s design.” Id.

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Additionally, the court noted that although Praxbind may have stopped Mr. Chamber’s bleeding,
“its absence certainly did not cause the bleed in the first instance.” Id.
This Court agrees with both the reasoning and conclusion of the Chambers court. Aside
from the potential preemption issues involved with Plaintiffs’ argument, see Def.’s Mem. in Supp.
of Mot. for Summ. J., at 17, this Court finds that the failure to develop a separate FDA-approved
medication prior to the sale of a different FDA-approved medication does not constitute
permissible evidence of a design defect. See Chambers, 2018 WL 849081, at *12-14. Accordingly,
Plaintiffs’ design defect claim fails.
iii. Remaining common law and statutory claims
In addition to the defective product claims, Defendant requests that this Court dismiss
Plaintiffs’ remaining claims alleging negligence, fraud, and warranty breaches. Defendant argues
for summary judgment on the negligence and fraud claims “for the same reasons Plaintiffs cannot
establish a strict liability claim.” Def.’s Reply in Supp. of Mot. for Summ. J., at 7-8; see also Def.’s
Mem. in Supp. of Mot. for Summ. J., at 17-19. However, as this Court has explained, Plaintiffs’
warnings claims will continue. Defendant has only argued for the dismissal of the fraud and
negligence claims based upon the same rationale it used to attack the strict liability claims.
Therefore, the Court rejects Defendant’s argument, and DENIES Defendant’s Motion for
Summary Judgment regarding Plaintiffs’ negligence and fraud claims.4

4

Additionally, Defendant argues for the dismissal of Plaintiffs’ negligence per se claim
based upon federal preemption. Defendant notes that “any tort claim premised solely on an alleged
violation of the Federal Food, Drug, and Cosmetic Act is preempted by federal law.” Def.’s Mem.
in Supp. of Mot. for Summ. J., at 18-19 (citing Perdue v. Wyeth Pharm., Inc., 209 F.Supp.3d 847,
851 (E.D.N.C. 2016)). Consistent with Defendant’s legal contention, Plaintiffs submitted that they
“agree not to pursue recovery solely for violations of the FDCA, but believe evidence of such
violations is proper and may be considered by the jury in support of Plaintiffs[’] other claims.”
Pls.’ Resp. to Summ. J., at 16 n.70 (underlining original). Plaintiffs’ stipulation moots Defendant’s
argument for dismissal. Because “a plaintiff may bring a state law claim for conduct also in
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Regarding Plaintiffs’ warranty claims, Defendant argues that Plaintiffs’ claims fail to meet
the statutory requirements under West Virginia law. Plaintiffs have stated three warranty claims,
one express warranty claim and two implied warranty claims. The two implied warranty claims
are based upon the implied warranty of merchantability and the implied warranty of fitness.
Encapsulated within a total of two paragraphs of briefing, Defendant summarily contends that the
implied warranty claim—Defendant did not differentiate between Plaintiffs’ two implied warranty
claims, and instead apparently condensed them into a single claim—fails because it is inconsistent
with the statutory definition of the claim.
Citing Keffer v. Wyeth, a case from this District, Defendant argues that the implied warranty
claim—failing to differentiate between the two implied warranty claims—fails because “W. Va.
Code § 46-2-315 ‘requires a particular purpose that differs from the ordinary purpose for which
the goods are generally used.’” Def.’s Mem. in Supp. of Mot. for Summ. J., at 18 (citing Keffer v.
Wyeth, 791 F.Supp.2d 539, 547 (S.D.W. Va. 2011) (Copenhaver, J.)). As the court in Keffer made
clear, that requirement applied only to a claim for breach of the implied warranty of fitness. See
Keffer v. Wyeth, 791 F.Supp.2d 539, 546-47 (S.D.W. Va. 2011) (Copenhaver, J.). Judge
Copenhaver found that the plaintiff in Keffer had failed to state a claim for breach of the implied
warranty of fitness because the plaintiff had used the drug for “the ordinary, rather than particular,
purpose.” Id. at 547. Similarly, in this case, the record reflects that Ms. Knight took Pradaxa for
its ordinary, intended use, and not for some peculiar or particular purpose. See id. at 546-47;
Mullins v. Ethicon, Inc., No. 2:12-cv-02952, 2017 WL 319590, at *2 (S.D.W. Va. Jan. 20, 2017)

violation of the FDCA,” the Court also DENIES Defendant’s Motion for Summary Judgment to
the extent that Plaintiffs keep to the confines of their stated use of the actions that are also violations
of the FDCA. See Perdue v. Wyeth Pharms., Inc., 209 F.Supp. 847, 851 (E.D.N.C. 2016).
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(Goodwin, J.) (citing W. Va. Code § 46-2-315). Therefore, the Court GRANTS Defendant’s
Motion for Summary Judgment on Plaintiffs’ claim for breach of implied warranty of fitness.
However, the requirement cited by Defendant does not apply to a claim for breach of the
implied warranty of merchantability. Section 46-2-314 of the West Virginia Code provides that “a
warranty that the goods shall be merchantable is implied in a contract for their sale if the seller is
a merchant with respect to goods of that kind.” W. Va. Code § 46-2-314(1). Consistent with this
statutory instruction, “merchantable” goods must be “fit for the ordinary purposes for which such
goods are used . . . and adequately contained, packaged, and labeled as the agreement may require.”
Keffer, 791 F.Supp.2d at 542 (internal quotations and citations omitted) (citing W. Va. Code § 462-314(2)). Indeed, Judge Copenhaver noted, in Keffer, that “courts have recognized that claims for
strict liability and breach of the implied warranty of merchantability are essentially coextensive in
products liability actions.” Id. at 545. Because the Court has already found that Plaintiffs have
sufficiently supported their failure to warn claims, the Court similarly finds that Plaintiffs have
produced enough evidence to continue with their claim for breach of the implied warranty of
merchantability. See id. at 544-46; Raab v. Smith, 150 F.Supp.3d 671, 700 (S.D.W. Va. 2015)
(Johnston, J.) (“The Court . . . determines that, for the same reasons Plaintiffs have sufficiently
stated a claim for strict products liability based on the alleged defective [medical] devices, they
have also stated a claim for breach of the implied warranty of merchantability.”). The Court
DENIES Defendant’s Motion for Summary Judgment regarding Plaintiffs’ claim for breach of
implied warranty of merchantability.
Turning to Plaintiffs’ express warranty claim, Defendant vies for its dismissal based upon
Plaintiffs’ failure to “identif[y] any warranty relied on.” Def.’s Mem. in Supp. of Summ. J., at 18.
As with the implied warranty claims, express warranty claims are a statutory creation. West

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Virginia Code instructs that “[a]ny affirmation of fact or promise made by the seller to the buyer
which relates to the goods and becomes part of the basis of the bargain creates an express warranty
that the goods shall conform to the affirmation or promise.” W. Va. Code § 46-2-313(1)(a). To
maintain an express warranty claim, “no particular reliance on such statements need be shown in
order to weave them into the fabric of the agreement.” Tyree v. Bos. Sci. Corp., No. 2:13-cv-08633,
2014 WL 5359008, at *5 (S.D.W. Va. Oct. 20, 2014) (Goodwin, J.) (citing W. Va. Code § 46-2313 (ed. note 3)).
Contrary to Defendant’s concise argument, the Court finds that Plaintiffs have adduced
enough evidence to proceed with their express warranty claim. As noted above, not only did Ms.
Knight and her children seek out Pradaxa based upon BI’s marketing and commercials, but the
evidence also creates a genuine issue of fact as to whether Ms. Knight read the materials given to
her regarding Pradaxa. The record sufficiently presents a genuine issue of fact as to whether an
express warranty existed, and whether the breach of that warranty caused Ms. Knight’s injuries.
See Tyree, 2018 WL 5359008, at *5. Thus, the Court DENIES Defendant’s Motion for Summary
Judgment concerning Plaintiffs’ express warranty claim.
iv. Punitive Damages
In West Virginia, in order to establish entitlement to punitive damages, a plaintiff must
show that the “wrongful act [was] done maliciously, wantonly, mischievously, or with criminal
indifference to civil obligations.” Peters. v. Rivers Edge Mining, Inc., 680 S.E.2d 791, 821 (W.
Va. 2009). Within the context of a products liability suit, the plaintiff demonstrates the
appropriateness of punitive damages “by showing that the manufacturer, having actual or
constructive knowledge of the product defect, continued to manufacture and distribute it.”
Eskridge v. Pacific Cycle, Inc., 556 Fed. Appx. 182, 192 (4th Cir. Jan. 17, 2014) (unpub.) (citing

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Davis v. Celotex Corp., 420 S.E.2d 557, 559-61 (W. Va. 1992)). Specifically, for warnings claims,
the plaintiff must produce evidence that shows that the defendant “had actual or constructive
knowledge that [its] warnings were not sufficient.” Id. (citing Ilosky, 307 S.E.2d at 619). Defendant
claims that because Plaintiffs have shown no defect, and because it “provided clear and explicit
warnings about the risk of bleeding,” Plaintiffs’ punitive damages claim fails.
The Court, however, believes that the record sufficiently presents evidence that raises a
genuine issue of fact as to whether Defendant had actual or constructive knowledge of the
insufficiency of Pradaxa’s warnings. Rebutting Defendant’s argument, Plaintiffs rehash the litany
of scientific literature, BI internal communications, and Pradaxa’s foreign labels to show that
Defendant had the requisite knowledge of Pradaxa’s insufficient warnings. Pls.’ Resp. to Summ.
J., at 19-21. The Court, having cited those portions of the record throughout this opinion, finds
that the evidence suggests that Defendant may have had knowledge about the inadequacy of the
warnings. Not only did the internal communications indicate recognition of the potential need for
monitoring, but also Pradaxa’s foreign labels reflected a clear understanding of the extent of the
bleed risk. Further, because the Court has found that a genuine issue of material fact exists as to
the adequacy of the warnings, the Court similarly finds a genuine issue of material fact concerning
Defendant’s knowledge of the warnings’ adequacy. Therefore, the Court DENIES Defendant’s
Motion for Summary Judgment on Plaintiffs’ punitive damages claim.
b. Plaintiffs’ Motion for Partial Summary Judgment
In addition to Defendant’s summary judgment motion, Plaintiffs also moved for partial
summary judgment. Plaintiffs’ motion, however, only concerned their defective design and failure
to warn strict liability claims. Pls.’ Mot. for Partial Summ. J., ECF No. 44, at 2.

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Without the need for extensive discussion, the Court rejects Plaintiffs’ motion. As
explained above, this Court granted summary judgment on the defective design claim in
Defendant’s favor. And this Court found that genuine issues of material fact existed as to Plaintiffs’
failure to warn claims. Therefore, summary judgment upon these claims would be inappropriate.
The Court DENIES Plaintiffs’ Motion for Partial Summary Judgment (ECF No. 44).
IV. CONCLUSION
Based upon the forgoing, the Court:
1. GRANTS Defendant’s Motion for Summary Judgment (ECF No. 42) only with
regard to Plaintiffs’ claims for defective design and breach of implied warranty
of fitness, and DENIES the remainder of Defendant’s Motion for Summary
Judgment;
2. DENIES Plaintiffs’ Motion for Partial Summary Judgment (ECF No. 44);
3. DENIES Defendant’s Motion to Exclude Case-Specific Testimony of Dr.
Hazem Ashhab (ECF No. 45);
4. DENIES Defendant’s Motion in Limine No. 6 to Exclude Evidence and
Argument Regarding Plasma Concentration Levels (ECF No. 68);
5. DENIES Defendant’s Motion in Limine No. 3 to Exclude Evidence,
Testimony, or Argument Related to Foreign Regulatory Actions, Foreign
Labeling Materials and Company Core Data Sheet (ECF No. 65); and
6. DENIES Defendant’s Motion in Limine No. 4 to Exclude Evidence and
Argument Regarding Lack of Reversal Agent (ECF No. 66) to the extent that
Plaintiffs’ warnings claims allege that BI inadequately warned that no reversal
agent existed, and DENIES, AS MOOT, the remainder of the motion.

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The Court DIRECTS the Clerk to send a copy of this Memorandum Opinion and Order to
counsel of record and any unrepresented parties.

ENTER:

May 31, 2018

ROBERT C. CHAMBERS
UNITED STATES DISTRICT JUDGE

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