United States District Court, S.D. West Virginia, Huntington Division
CLAUDE R. KNIGHT and CLAUDIA STEVENS, individually and as Personal Representatives of the Estate of Betty Erelene Knight, deceased, Plaintiffs,
BOEHRINGER INGELHEIM PHARMACEUTICALS, INC. Defendant.
MEMORANDUM OPINION AND ORDER
C. CHAMBERS, UNITED STATES DISTRICT JUDGE.
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).
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. 1:16-cv-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 2-3. 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.
Ms. Knight's Medical Condition and Events Leading to her
other conditions, 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 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.
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.
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.
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.
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.
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.
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.
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 12-13; 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, 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.
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.
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.
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 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.
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 in-patient 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.
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.
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 bleed. The next day, on
September 2, 2013, Ms. Knight passed away. Id.;
Ex. 3 to Def.'s Mot. for Summ. J., at 5.
Pradaxa and its Label
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.
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 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).
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.
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.
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.
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. 51-14, 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.
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
Development of Praxbind, the Antidote to Pradaxa
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.
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. 51-24, 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 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.
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.
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
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 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.
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.
STANDARD OF REVIEW
Summary Judgment Standard
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)
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 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.