McClarty et al v. C.R. Bard, Inc. et al
Filing
37
ORDER granting in part and denying in part 27 Defendants' Motion for Summary Judgment. Signed by District Judge Terrence G. Berg. (AChu)
Case 4:14-cv-13627-TGB-RSW ECF No. 37 filed 10/15/20
PageID.3927
Page 1 of 32
UNITED STATES DISTRICT COURT
EASTERN DISTRICT OF MICHIGAN
SOUTHERN DIVISION
HOMER W. McCLARTY,
VICKI RIVERA,
and
4:14-CV-13627-TGB-RSW
Plaintiff,
ORDER DENYING IN PART
AND GRANTING IN PART
DEFENDANTS’ MOTION FOR
SUMMARY JUDGMENT
vs.
C.R. BARD INC., and BARD
PERIPHERAL VASCULAR, INC.,
Defendant.
This is a products liability action regarding a medical device
designed to prevent blood clots from traveling to the heart and lungs.
Plaintiff Vicki Rivera1 underwent surgery in 2006 to have an inferior
The other named Plaintiff in this case is Homer W. McClarty (the
“Trustee”), who is the appointed and acting Chapter 7 Trustee of Vicki
Rivera’s bankruptcy estate. Pl.’s Compl., ECF No. 1, PageID.2. Under
the Bankruptcy Code, the bankruptcy estate includes “all legal or
equitable interests of the debtor in property as of the commencement of
the [bankruptcy] case.” 11 U.S.C. § 541(a)(1). This includes “causes of
action.” Bauer v. Com. Union Bank, Clarksville, Tenn., 859 F.2d 438,
441 (6th Cir. 1988) (quoting Gochenour v. Cleveland Terminals Bldg.
Co., 118 F.2d 89, 93 (6th Cir. 1941)). Further, because the “trustee in
bankruptcy acts as a representative of the estate,” the trustee is the one
who has the “capacity to sue and be sued.” Bauer, 859 F.2d at 441
(quoting 11 U.S.C. § 323(b)). The Trustee is included in the caption of
this case as a Plaintiff because the injury at the center of this complaint
occurred prior to the commencement of the bankruptcy case. ECF No. 1,
1
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vena cava filter (“IVC filter”) implanted. In 2011, medical professionals
discovered that the IVC filter had fractured and migrated to her left lung.
Plaintiff claims that the manufacturer and seller of the filter, C.R. Bard,
Inc. and its affiliated company Bard Peripheral Vascular, Inc., violated
products liability law. Plaintiff’s complaint alleges claims of defective
design, defective manufacture, failure to warn of the device’s harm,
breach of implied warranty, and negligent misrepresentation.
Defendants have moved for summary judgment. ECF No. 27. The
motions have been fully briefed and the Court heard oral argument on
August 26, 2020. For the reasons stated below, Defendant’s motion for
summary judgment is DENIED with respect to Plaintiff’s defective
design and breach of implied warranty claim, and GRANTED with
regard to Plaintiff’s negligent misrepresentation claim.
I.
Background
C.R. Bard, Inc. (“Bard”) is a developer, manufacturer, and
distributor of medical technologies and devices. Bard is one of many
manufacturers that creates and sells inferior vena cava filters (“IVC
filters”), which are medical devices that are surgically implanted in the
inferior vena cava to prevent blood clots from traveling into the lungs and
heart. Def.’s Mot. Summ. J., ECF No. 27, PageID.3134. The inferior vena
cava is the central vein that returns blood to the heart from the lower
PageID.2. Therefore, the cause of action is part of the bankruptcy estate
which the Trustee may pursue.
2
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portions of the body. Id. at PageID.3135. In certain individuals, blood
clots (“thrombi”) can develop in the deep leg veins, known as deep venous
thrombi (“DVT”). If these blood clots travel from the legs up into the heart
or lungs, they can cause blockage in the smaller vessels. This is known
as a pulmonary embolism. Pulmonary embolisms may cause a variety of
health problems, the symptoms of which can be chest pain, shortness of
breath, and brain damage which can result in death. Id. A doctor may
recommend an IVC filter for individuals who have experienced, or are at
increased risk for developing, DVT and pulmonary embolisms.
In 1992, Bard began distributing the Simon Nitinol Filter (“SNF”),
an IVC filter, under a distribution agreement with Nitinol Medical
Technologies (“NMT”). Ex. P, ECF No. 33-2, PageID.3434. After
distributing the SNF for several years, Defendant developed a modified
design which would allow the filter to be removed called the Recovery
Filter. Id. In November of 2002, Bard obtained clearance to market the
Recovery Filter by submitting a 510(k) application to the Food and Drug
Administration (“FDA”). A 510(k) application is an FDA approval process
based on the “substantial equivalence” of a device with a “legally
marketed predicate device.” Ex. E, ECF No. 32-5, PageID.3322. The FDA
approved the application based on representations by Bard that the
Recovery Filter was “substantially equivalent” to the predecessor SNF
device. Id. at PageID.3324. The FDA also approved the Recovery Filter
for optional removal in 2003. Ex. F, ECF No. 32-6, PageID.3329.
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Beginning in 2005, Bard manufactured and sold an IVC filter
design called the G2 Filter System (“G2 Filter”). Pl.’s Resp. Mot. Summ.
J., ECF No. 32, PageID.3284. Like other IVC filters, the G2 Filter is
designed to prevent blood clots from traveling from the lower portion of
the body to the heart and lungs. The G2 Filter is constructed out of nickeltitanium alloy (“Nitinol”) and “consists of two tiers of struts that make
up its ‘arms’ and ‘legs.’” ECF No. 27, PageID.3135. Using a catheter, the
collapsed filter is inserted into a patient through the jugular vein or
femoral vein. When the filter, a photo of which is below, is properly in
place within the inferior vena cava, the arms and legs of the filter open
up and anchor onto the walls of the vein. Id.
2
Once in place, the filter’s struts will catch, or break up, blood clots that
are traveling up from the legs and prevent them from traveling through
the inferior vena cava to the heart and lungs.
As it had done previously with the Recovery Filter, Defendant
obtained clearance to market the G2 Filter by submitting a 510(k)
2
Illustration of the Bard G2 Filter. ECF No. 27, PageID.3135.
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application to the Food and Drug Administration (“FDA”). Ex. G, ECF
No. 32-7, PageID.3336. Here, the application was based on the assertion
by Bard that the G2 Filter was identical in its description and indications
for use to a predicate device that had been manufactured by Bard and
approved by the FDA, the Recovery Filter System. Id. The primary
modifications were dimensional. Id. at PageID.3335. The FDA approved
Bard’s 510(k) application in 2005 for the G2 Filter as a permanent
placement IVC filter. In 2008, the FDA also approved the G2 Filter as a
retrievable option IVC filter. ECF No. 33-2, PageID.3525.
Plaintiff, Vicki Rivera, is a resident of Michigan. ECF No. 27,
PageID.3135. Prior to undergoing surgery for weight loss on March 17,
2006, due to her history of DVT, Plaintiff underwent a surgical procedure
to implant a Bard G2 Filter. Five years later, during a CT scan to
evaluate gastrointestinal issues on September 19, 2011, medical
professionals discovered a fractured filter strut from the Bard G2 Filter
in her abdomen. Id. A second fractured strut was discovered in Plaintiff’s
right lung in December of 2014 during an x-ray to evaluate broken ribs.
Id. at PageID.3136. The G2 Filter, and its associated fractured parts,
remain inside Plaintiff’s body. ECF No. 32, PageID.3183.
Plaintiff alleges Bard was aware that both the G2 Filter and its
predicate device, the Recovery Filter, had higher reported failure rates
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than the SNF or other IVC filters on the market.3 ECF No. 32,
PageID.3284. To support these allegations Plaintiff relies upon a report
conducted by an independent consultant hired by Bard which
states,“[r]eports of death, filter migration (movement), IVC perforation,
and filter fracture associated with Recovery filter were seen in the
MAUDE database at reporting rates that were 4.6, 4.4, 4.1, and 5.3
higher, respectively, than reporting rates for all other filters.” Ex. K, ECF
No. 32-11, PageID.3350. Plaintiff also highlights various internal Bard
communications suggesting that Bard was aware and attempted to
conceal the disproportionate failure rates of the G2 Filter and Recovery
Filter. See Ex. J, ECF No.32-10, PageID.3347 (“Comparison with other
filters is problematic in many ways, and we should avoid/downplay this
as much as possible.”).
In addition to internal Bard documents, the record includes several
reports by Plaintiff’s experts. The expert reports primarily describe two
design defects present in both the G2 Filter and Recovery Filter. First,
the reports allege that both filters lacked an appropriately rounded
Plaintiff asserts that the G2 Filter and its predicate device, the
Recovery Filter, are similar in a multitude of ways: the devices look
alike, share the same filtration design, are made of the same material,
and are inserted the same way. ECF No. 1, PageID.8-9. Most critically,
Plaintiff alleges that the G2 Filter also shares some of the same defects
as the Recovery Filter. Id. at PageID.9. For this reason, while the device
implanted in Plaintiff was a G2 Filter device, the Recovery Filter and
its properties are also discussed.
3
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“chamfer,” that is, a sloped or angled corner to prevent sharp edges, on
the rim of the filter from which the arms and legs of the device deploy.
Ex. R, ECF No. 33-4, PageID.3737. As the arms emerge from the top of
the cap, they may come into contact with the rough, unpolished edge as
they try to deploy out. The reports opine that this contact and stress can
cause fatigue, cracks, and bends in the arms. Id. at PageID.3742. Next,
the experts point out that Bard did not polish away rough grinding marks
on the bottom of the wires called the “feet.” Id. at PageID.3746. The rough
surface condition on the bottom of these struts can increase the stress on
the wires and result in fracture. A fracture in the arm or leg of the filter
may result in tilting or migration of the device, or pieces of it, as the feet
help hold the device in position. Id. at PageID.3758.
To remedy the fracturing caused by the sharp rim, the expert
reports recommend adding a rounded chamfer where the wires emerge
from the device during deployment. ECF No. 33-4, PageID.3745. The
experts also recommend smoothing the surface of the bottom of the wires
through electropolishing to prevent abnormal strain on the arms and legs
of the device. Id. at PageID.3748. Additionally, Plaintiff’s experts refer to
internal Bard communications to support the view that the SNF is an
alternative permanent filter because it did not receive the same
complaints regarding fracture and migration. Ex. M, ECF No. 32-13,
PageID.3362. Specifically, the expert reports note that the SNF
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possessed an adequate chamfer to prevent premature failure of the filter
arms. ECF No. 33-4, PageID.3744-45.
Plaintiff brings this suit against Bard alleging design defect,
manufacturing defect, failure to warn, breach of implied warranty, and
negligent misrepresentation. Bard moves for summary judgment on all
of Plaintiff’s claims. ECF No. 27.
II.
Standard of Review
Summary judgment is appropriate “if the movant shows that there
is no genuine dispute as to any material fact and the movant is entitled
to judgment as a matter of law.” Fed. R. Civ. P. 56(a). A fact is material
only if it might affect the outcome of the case under the governing law.
Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 249 (1986).
On a motion for summary judgment, the Court must view the
evidence and any reasonable inferences drawn from the evidence in the
light most favorable to the non-moving party. Matsushita Elec. Indus. Co.
v. Zenith Radio Corp., 475 U.S. 574, 587 (1986); Redding v. St. Edward,
241 F.3d 530, 531 (6th Cir. 2001).
The moving party has the initial burden of demonstrating an
absence of a genuine issue of material fact. Celotex Corp. v. Catrett, 477
U.S. 317, 325 (1986). If the moving party carries this burden, the party
opposing the motion “must come forward with specific facts showing that
there is a genuine issue for trial.” Matsushita, 475 U.S. at 587. “[A] mere
scintilla of evidence in support of the nonmovant’s position is not
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sufficient to create a genuine issue of material fact.” Towner v. Grand
Trunk Western R. Co., 57 Fed.App’x. 232, 235 (2003) (citing Anderson,
477 U.S. at 251-52). Rather, the non-moving party must present
sufficient evidence as to each element of the case such that a trier of fact
could reasonably find for the plaintiff. Davis v. McCourt, 226 F.3d 506,
511 (6th Cir. 2000).
Summary judgment is appropriate “against a party who fails to
make a showing sufficient to establish the existence of an element
essential to that party's case, and on which that party will bear the
burden of proof at trial.” Celotex, 477 U.S. at 322.
III. Discussion
In the original complaint, Plaintiff brought claims for (1) design
defect, (2) manufacturing defect, (3) failure to warn, (4) breach of implied
warranty, and (5) negligent misrepresentation. ECF No. 1, PageID.2734. In their response brief, Plaintiff voluntarily withdrew the second and
third claims for manufacturing defect and failure to warn. ECF No. 32,
PageID.3295. The Court therefore evaluates the remaining claims of
design
defect,
breach
of
implied
warranty,
and
negligent
misrepresentation.
Based on the evidentiary record presented, material issues of fact
preclude summary judgment on Plaintiff’s claims for design defect and
breach of implied warranty. However, Defendant C.R. Bard is entitled to
summary judgment on Plaintiff’s claim for negligent misrepresentation
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as Plaintiff is unable to present evidence demonstrating reliance. The
reasoning in support of these conclusions is discussed below.
a.
Design Defect
According to Defendant, Plaintiff’s claim of design defect is
insufficient because it failed to (1) demonstrate that a safer alternative
design was feasible, (2) show causation, or (3) overcome the rebuttable
presumption of nonliability. ECF No. 27, PageID.3132. Michigan has
adopted a risk-utility test to evaluate products liability claims based on
an alleged design defect. Peck v. Bridgeport Mach., Inc., 237 F.3d 614,
617 (6th Cir. 2001). The test requires a plaintiff to show that (1) the
product was not “reasonably safe” at the time it left the control of the
manufacturer or seller, and (2) a “practical and technically feasible
alternative production practice” exists. M.C.L. § 600.2946(2); Croskey v.
BMW of N. Am., Inc., 532 F.3d 511, 515-16 (6th Cir. 2008). To survive a
motion for summary judgment, a plaintiff must provide evidence showing
that:
(1)
the
severity
of
the
injury
was
foreseeable
by
the
manufacturer;
(2)
the likelihood of occurrence of the injury was foreseeable by
the manufacturer at the time of distribution of the product;
(3)
there was a reasonable alternative design available;
(4)
the available alternative design was practicable;
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(5)
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the available and practicable reasonable alternative design
would have reduced the foreseeable risk of harm posed by
defendant's product; and
(6)
the defendant’s omission of the available and practicable
reasonable alternative design rendered its product not reasonably
safe.
Peck, 237 F.3d at 617. These elements may be supported by direct or
circumstantial evidence, including expert testimony or evidence of
similar incidents. Croskey, 532 F.3d at 516. The Court should grant
summary judgment when the plaintiff fails to make out a prima facie
design defect claim based on the six elements in the risk-utility test
outlined above.
i.
Risk-Utility Test
Defendant does not dispute that Plaintiff has provided evidence of
the first and second prongs of the risk-utility test, which demonstrate the
“magnitude of risks involved.” Peck, 237 F.3d at 618 (quoting Owens v.
Allis-Chalmers Corp., 326 N.W.2d 372, 378 (Mich. 1982)). As there is no
dispute that Plaintiff satisfies the first two prongs of the risk-utility
analysis, the Court need only address whether Plaintiff satisfied the
remaining prongs, all of which focus on the issue of an alternative design.
The second part of the risk-utility test requires Plaintiff to present
a reasonable alternative design. Peck, 237 F.3d at 618. To survive
summary judgment, a plaintiff must present evidence of a “practical and
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feasible” alternative that would have reduced the risk of particular injury
at issue without impairing the product’s usefulness or desirability.
M.C.L. § 600.2946(2). See Dow v. Rheem Mfg. Co., 2011 WL 4484001, at
*17 (E.D. Mich. Sept. 26, 2011); Zettle v. Handy Mfg. Co., 998 F.2d 358,
362 (6th Cir. 1993).
As to the factors requiring plaintiff to show there was a reasonable
alternative design that was available, practicable, and would have
reduced the risk, Defendant asserts that Plaintiff has failed to satisfy
these elements because it says the proposed alternative, the company’s
predecessor SNF Filter,4 is a different product and not sufficiently
similar to the alleged defective G2 Filter to serve as a reasonable
substitute. Def.’s Reply to Resp. Mot. Summ. J., ECF No. 34,
PageID.3892. Further, Defendant argues that Plaintiff has not provided
sufficient evidence of a practicable and feasible alternative design
because there is no evidence that the designs would improve fracture
rates without impairing the usefulness of the product. Id. at
PageID.3893; M.C.L. § 600.2946(2).
As discussed in the Background section, the Recovery Filter was the
predicate device to the G2 Filter. Prior to that, the SNF was the
predicate device to the Recovery Filter. Bard obtained clearance to
market the Recovery Filter based on representations by Bard that the
Recovery Filter was “substantially equivalent” to the SNF device. ECF
No. 33-2, PageID.3434.
4
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Defendant’s argument fails to address the multitude of design
alternatives presented by Plaintiff’s experts. In addition to discussing the
SNF Filter, Plaintiff’s experts propose two design alternatives to prevent
fracturing and migration: (1) electropolishing the rough grinding marks
on the bottom of the wires, and (2) adding a rounded chamfer onto the
rim of the filter from which the arms and legs of the device deploy. ECF
No. 33-4, PageID.3745. See Davis v. C.R. Bard, Inc., 2012 WL 6082933,
at *4 (E.D. Mich. Dec. 6, 2012) (denying summary judgment as to the
design defect claim where experts propose smoothing edges of device to
reduce chance of fracture). The Plaintiff’s expert opines that there are
grinding marks on the bottom of the wires, or “feet,” of the device because
Defendant failed to polish the struts of the G2 Filter. ECF No. 33-4,
PageID.3746. According to the report, rough surfaces lead to local stress
concentrations, which can result in fatigue fractures in the arms and legs
of the filter. Id. at PageID.3778. Local stress concentrations in the “ankle”
region of the wire, which leads to anchoring hooks that keep the filter in
place, can result in tilting or migration of the device. Id. at PageID.3789.
Tilting and migration increase the likelihood of perforation or
penetration of the filter limbs and may result in strut fractures and
possible fragment migration. According to the expert report, to remedy
these rough surfaces, the wires could be electropolished to remove any
scratches, slip markings, or gouging. Id. at PageID.3778.
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The expert reports also recommend the addition of an appropriately
rounded “chamfer.” ECF No. 33-4, PageID.3737. When the G2 Filter is
initially implanted, the arms and legs are collapsed. Once the device is in
place, the arms and legs deploy from the cap of the device. Experts opine
that the cap, or rim, from which the arms and legs deploy had sharp,
rough edges. Id. When the arms and legs tried to deploy, they could come
into contact with these unpolished edges, Id. at PageID.3742, potentially
causing fatigue, cracks, and bends in the arms and legs. Plaintiff’s expert
proposes adding an appropriately rounded “chamfer” to this rim. Id. at
PageID.3737. A chamfer is a sloped or angled corner that can reduce the
sharpness of an edge. The expert claims that an appropriately rounded
chamfer on the inner surface of the rim would reduce, or eliminate, the
contact between the rim and arms and legs as they deploy. Id. at
PageID.3787. This reduction, or elimination, of contact would decrease
stress and potential failure of the struts of the device.
As evidence of the feasibility of these alternatives, Plaintiff’s expert
notes that subsequent IVC filters designed by Bard did in fact polish
down the sharp edges of the rim to create an appropriately rounded
chamfer. ECF No. 33-4, PageID.3746. Plaintiff also points to internal
communications where Bard employees discuss the feasibility and
advantages of utilizing the SNF Filter as an alternative permanent filter
because it had not received the same complaints as the G2 Filter. ECF
No. 32-13, PageID.3362. These communications support Plaintiff’s
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argument that Bard employees themselves believed there to be feasible
alternatives to the G2 Filter that were available, practicable and indeed,
already in use. Both the expert recommendations for specific design
improvements and the internal communications regarding use of the
SNF Filter are sufficient to raise a question of fact that the third and
fourth elements of the risk-utility test are satisfied because they point
with specificity to practical and available alternative designs.
In addition to presenting alternative designs, the remaining
elements of the risk utility test require a plaintiff to articulate how the
proposed alternative design would have reduced harm without sacrificing
utility. See Zettle, 998 F.2d at 362. For evidence that the proposed
alternative designs would reduce the risk of harm posed by the G2 Filter,
Plaintiff compares fracture rates for the G2 against other filters and
argues that the lower fracture rates for the SNF Filter demonstrate that
the alternative design it offered would decrease the risk of a fracture. In
one report, Plaintiff’s expert asserts that a Bard employee had
recommended the SNF Filter specifically to address complications in
patients who were undergoing bariatric surgery, the same medical
procedure Plaintiff was set to undergo. ECF No.33-2, PageID.3491.
Another expert report compares the rims and sleeves of the G2 Filter
with other IVC filters and concludes that the polishing down of the sharp
edges would reduce the stress that could lead to fracture. ECF No. 33-4,
PageID.3745. Cf. Dow, 2011 WL 4484001, at *13 (finding alternative
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designs insufficient where expert failed to conduct comparative testing
or analysis). Having reviewed this record, the Court concludes that
Plaintiff has presented sufficient evidence to raise a question of fact
regarding the fifth and sixth elements of the risk-utility test by
presenting evidence of comparative evaluation that demonstrate safer
alternative filters and designs which Plaintiff’s experts claim could
reduce the risk of fracture without impeding utility.
Because Plaintiff has presented evidence to demonstrate all six
elements of the risk-utility test, Plaintiff has successfully made out a
prima facie case of design defect that is sufficient to avoid summary
judgment.
ii.
Causation
Defendant also contends that Plaintiff has not demonstrated
causation because she has failed to present evidence from a treating
physician or expert witness expressing the opinion that the fracturing of
the G2 Filter is the cause of Plaintiff’s specific medical conditions. ECF
No. 27, PageID.3142. Defendant argues that the medical symptoms
Plaintiff identifies were not caused by the fractured parts of the device
being present in her body, but rather because of certain pre-existing
medical conditions from which she suffered. Id. However, during oral
argument, Defendant conceded that the migration of a strut within a
patient to a place where it is not supposed to be is in fact a form of injury.
While such an admission suggests that Defendant’s arguments about the
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connection between Plaintiff’s specific conditions and the fractured struts
relates more to the issue of whether the damages arising from her
medical conditions can be connected to the injury—rather than whether
the defect in the device caused an injury—the Court will nevertheless
examine Defendant’s arguments on causation below.
Under Michigan’s products liability law, Plaintiff must show a
causal connection between the defect and injury to prevail. Skinner v.
Square D Co., 516 N.W.2d 475, 478 (Mich. 1994); Glaser v. Thompson
Med. Co., Inc., 32 F.3d 969, 971 (6th Cir. 1994). Plaintiff must provide
sufficient evidence that would allow a jury to determine that it was “more
likely than not that the defendant’s conduct in fact caused the injury.”
Glaser, 32 F.3d at 971. It is not enough to present evidence that shows a
“mere possibility” of causation. Id. (quoting Mulholland v. DEC Int’l
Corp., 443 N.W.2d 340, 350 n.18 (Mich. 1989)). However, the plaintiff
does not have to present evidence that “positively eliminates every other
potential cause” to meet the burden. Skinner, 516 N.W.2d at 478.
Evidence of causation is adequate if it “establishes a logical sequence of
cause and effect, notwithstanding the existence of other plausible
theories, although other plausible theories may also have evidentiary
support.” Id. (quoting Mulholland, 443 N.W.2d at 415).
The Court is not persuaded by Bard’s argument that Plaintiff has
failed to present any evidence to demonstrate that the fractured medical
device is the proximate cause of her alleged medical problems. It is
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undisputed that the G2 Filter implanted in Plaintiff fractured and the
two struts that failed are still inside Plaintiff’s body. ECF No. 32,
PageID.3282-83. Cf. Skinner, 516 N.W.2d at 484 (finding experts’
theories deficient because experts were asked to assume without
explanation critical facts in the chain of causation). The fractured filter
was discovered by medical imaging. Ex. B, ECF No. 33, PageID.3391.
Plaintiff has provided materials which show the range of health
consequences that can result from an IVC fracture and notes that by
Bard’s own criteria the migration of a filter in and of itself is considered
a serious injury. Ex. C, ECF No. 27-4, PageID.3210. While not a treating
physician, Plaintiff’s expert finds that her medical records are consistent
with the experience of a fractured G2 Filter. Ex. S, ECF No. 33-5,
PageID.3865. Plaintiff offers her medical records as circumstantial
evidence of her physical and emotional injury. In addition to complaints
of abdominal pain, the medical records state that Plaintiff attributes her
anxiety and mental anguish to knowledge that a fractured piece of the
filter had migrated to her lung. Ex. T, ECF No. 33-6, PageID.3869, 3878.
Finally, Plaintiff claims she will have to undergo continuous medical care
including imaging studies, clinical visits, and physical examinations in
order to monitor the effects of the fractured G2 Filter. ECF No. 1,
PageID.13.
While Defendant contends that Plaintiff’s health problems could
have been caused by her pre-existing conditions, this attack is not
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sufficient to support summary judgment. Plaintiff does not have to
produce evidence which eliminates every potential cause of injury.
Skinner, 516 N.W.2d at 480. Plaintiff’s medical records certainly provide
some evidence that her pre-existing conditions could have caused the
abdominal pain she has suffered. But that reasonable inference must be
balanced against the evidence of Plaintiff’s undeniable experience of the
fractures, the migration of the fragments to her abdomen and lung, as
well as injuries such as continued costs of monitoring and mental and
emotional stress. Given this conflict in the proof, Defendant’s arguments
regarding causation are not sufficient to prevail at the summary
judgment stage. See Swartz v. Proctor and Gamble Mfg. Co., 2018 WL
2239558, at *4 (E.D. Mich. May 16, 2018) (denying summary judgment
even when the defendant offered a study to rebut causation).
Upon review of the medical records, Plaintiff’s testimony, and the
expert reports, the Court concludes that Plaintiff has presented enough
evidence for a reasonable jury to determine that the allegedly defective
G2 Filter caused Plaintiff’s injuries. Defendant may of course seek to
persuade the jury that a preponderance of the evidence shows Plaintiff’s
pre-existing conditions caused her injuries at trial, but the Court is not
persuaded that Plaintiff’s medical history entitles Bard to summary
judgment.
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For these reasons, the Court denies Defendant’s summary
judgment claim on Plaintiff’s design defect claim on the basis that
Plaintiff failed to present sufficient evidence of causation.
iii.
Rebuttable Presumption of Non-Liability
Under Michigan’s products liability law, there is a rebuttable
presumption of nonliability for manufacturers who develop products that
comply with safety regulations or standards. M.C.L. § 600.2946(4). The
statute states:
In a product liability action brought against a manufacturer
or seller for harm allegedly caused by a product, there is a
rebuttable presumption that the manufacturer or seller is not
liable if, at the time the specific unit of the product was sold
or delivered to the initial purchaser or user, the aspect of the
product that allegedly caused the harm was in compliance
with standards relevant to the event causing the death or
injury set forth in a federal or state statute or was approved
by, or was in compliance with regulations or standards
relevant to the event causing the death or injury promulgated
by, a federal or state agency responsible for reviewing the
safety of the product.
Id. The presumption applies to the four theories of products liability,
which includes design defect and breach of implied warranty claims.
Peter v. Stryker Orthopaedics, Inc., 2009 WL 235639, at *3 (E.D. Mich.
Jan. 29, 2009).
However, the presumption is not absolute and to survive summary
judgment the plaintiff must bring forth evidence that rebuts the
presumption of nonliability. See Makki v. OSI Sealants, Inc., 2009 WL
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4644688, at *2 (E.D. Mich. Dec. 2, 2009) (“The jury's conclusion meant
one of two things, either (a) Defendant did not convince the jury that its
product was in compliance with applicable standards, or (b) even if the
jury was persuaded that the product was in compliance with applicable
standards, the jury also concluded that Makki rebutted the presumption
of non-liability.”); Wendorf v. JLG Indus., Inc., 683 F.Supp.2d 537, 546
(E.D. Mich. 2010); Peter, 2009 WL 235639, at *3 (E.D. Mich. Jan. 29,
2009) (finding summary judgment appropriate where the plaintiff failed
to submit any evidence to rebut the presumption of no liability).
According to Defendant, because the G2 Filter was in compliance
with FDA standards of design and manufacturing, the burden must shift
to Plaintiff to rebut a presumption of non-liability. ECF No. 27,
PageID.3138. Plaintiff contends that it meets this burden with evidence
that the G2 Filter suffered a high failure rate compared to other filters,
and that such evidence successfully rebuts the presumption. ECF No. 32,
PageID.3289.
Defendant directs the Court to Peter v. Stryker Orthopaedics, Inc.,
to support their argument that Plaintiff has failed to meet the burden in
providing evidence to rebut the presumption of nonliability. 2009 WL
235639, at *3 (E.D. Mich. Jan. 29, 2009). However, in that case, Plaintiff
failed to submit “any” evidence of defect and did not respond at all to the
motion for summary judgment. Id. Here, in addition to responding to the
motion, Plaintiff has provided expert reports and studies that provide
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evidence of disproportionate fracture rates in the G2 Filter. Plaintiff
identifies a report from an independent consultant hired by Bard that
reports the rates of death, filter migration, perforation, and fracture with
the Recovery Filter to be “4.6, 4.4, 4.1, and 5.3 higher” than reporting
rates for all other filters. ECF No. 32-11, PageID.3350. Plaintiff further
points to an expert report which states that animal studies of the G2
Filter were stopped early as they showed risk for filter migration,
perforation, hemorrhage, and more. ECF No. 33-2, PageID.3508. Even
during oral argument, Defendant did not dispute that evidence of
disproportionate fracture rate is the type of evidence that can allow a
plaintiff to overcome the presumption of nonliability. The facts here are
more closely aligned with Davis v. C.R. Bard, where the plaintiff, like
Rivera, produced expert opinion that the product was defective and
studies which “appear[ed] to allow the inference that the [product] is
unsafe compared to its competitors and is unreasonably likely to fracture
and cause major health issues.” 2012 WL 6082933, at *5-6 (E.D. Mich.
Dec. 6, 2012).
At summary judgment, the Court does not have to determine
whether the presumption has been fully rebutted. Davis, 2012 WL
6082933 at *6. The Court needs only determine whether a reasonable
jury could so conclude. Id. Here, Plaintiff has presented enough evidence
to allow such a conclusion. Accordingly, Defendants are not entitled to
summary judgment based on a presumption of nonliability.
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In summary, Plaintiff has presented sufficient evidence to create a
genuine issue of material fact as to the six elements of the risk-utility
test, to support causation, and to rebut the presumption of nonliability,
thereby presenting a question for the jury to resolve. Having met their
evidentiary burden, the Court finds that Defendant is not entitled to
summary judgment as to Plaintiff’s design defect claim.
b.
Breach of Implied Warranty
Defendant contends that Plaintiff is unable to establish a breach of
implied warranty claim because the learned intermediary doctrine bars
the claim. ECF No. 27, PageID.3133. Defendant also argues that Plaintiff
has not shown proximate cause. Id. In particular, Defendant asserts that
in withdrawing her failure to warn claim, Plaintiff concedes that she
could not prove causation. ECF. No. 34, PageID.3896. Because the failure
to warn and breach of implied warranty claims are based on the same
questions, Defendant argues the implied warranty claim should also fail
as Plaintiff is unable to demonstrate causation.
Michigan law recognizes breach of implied warranty as a distinct
cause of action for product failure. Prentis v. Yale Mfg. Co., 365 N.W.2d
176, 186 (Mich. 1984). To succeed on a breach of warranty claim, the
plaintiff must show that the product was defective. Kaminiski v. Libman
Co., 748 Fed.App’x. 1, 4 (6th Cir. 2018). “To that end, the plaintiff must
prove either defective manufacture or defective design, which may
include a failure to warn.” Id.
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When the defendant is both the seller and manufacturer, the
elements of proof for a breach of implied warranty claim are the same as
those required in a negligence claim. Prentis, 365 N.W.2d at 186 (“[I]n an
action against the manufacturer of a product based upon an alleged
defect in its design, ‘breach of implied warranty and negligence involve
identical evidence and require proof of exactly the same elements.’”
(quoting Squibb v. E.R. Squibb & Sons, Inc., 273 N.W.2d 476, 479 (Mich.
1979))). See Kaminiski, 748 Fed.App’x. at 5 n.3; Peak v. Kubota Tractor
Corp., 559 Fed.App’x. 517, 523-24 (6th Cir. 2014). The Sixth Circuit has
explained the logic behind the appropriate legal standard:
The reason for this confluence is that a plaintiff alleging
breach of implied warranty on the part of a seller must show
that the purchased product was defective. That showing, in
turn, requires proof that the product's manufacturer acted
negligently, typically by omitting a safety feature or in failing
to give warning of a latent danger. A suit for breach of implied
warranty against a seller who is also the manufacturer will
therefore require the same showing of negligence on the
defendant's part as an ordinary products liability suit against
a manufacturer.
Hollister v. Dayton Hudson Corp., 201 F.3d 731, 737 (6th Cir. 2000).
Defendant argues that because Plaintiff has conceded there is
insufficient evidence of causation for a failure to warn claim, Plaintiff’s
breach of implied warranty claim must also fail due to the fact that the
claims are based on the same underlying assertion. ECF No. 34.
PageID.3896. Plaintiff concedes that breach of implied warranty claims
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are similar to failure to warn claims, and fails to explain why, without
the testimony of her implanting physician, her implied warranty claim
should succeed. ECF No. 32, PageID.3297. Unlike in Davis, Plaintiff has
not presented evidence that Bard’s failure to update its disclosure
material provided to surgeons caused her injury. If Plaintiff’s only means
for proving the G2 Filter was defective, as required for an implied
warranty claim, was her failure to warn claim, Defendant would succeed.
However, Plaintiff also attempts to show the G2 Filter was
defective through a design defect claim, which Defendant fails to address.
To prevail on a breach of implied warranty claim, Plaintiff may
demonstrate that a product was defective by proving “either defective
manufacture or defective design, which may include a failure to warn.”
Kaminski, 748 Fed.App’x at 5 (emphasis added). As discussed in the
preceding section, Plaintiff has successfully made out a prima facie case
of design defect under the risk-utility test. As Defendant C.R. Bard is
both the manufacturer and seller of the G2 Filter, “it is inconceivable that
a jury could determine that the manufacturer had not breached its duty
of reasonable care and at the same time find that the product was not
reasonably safe for its reasonably foreseeable uses.” Prentis, 365 N.W.2d
at 187. Plaintiff has presented a prima facie case of design defect and in
so doing has created a genuine issue of fact as to whether Bard breached
its duty of reasonable care.
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Accordingly, Defendant is not entitled to summary judgment on
Plaintiff’s breach of implied warranty claim.
c.
Negligent Misrepresentation
Defendant contends that Plaintiff’s negligent misrepresentation
claim must fail because there is no evidence of any misrepresentations
that Bard made to Plaintiff’s implanting physician with regard to the G2
Filter. ECF No. 27, PageID.3147. Defendant further asserts that Plaintiff
has not, and in fact cannot, offer any evidence that Plaintiff’s implanting
physician detrimentally relied on any misrepresentation by Bard with
regard to the G2 Filter when treating Plaintiff. ECF No. 27, PageID.3147.
In response, Plaintiff contends that Bard had knowledge that the G2
Filter had higher rates of fracture than other filters, but failed to include
this information in its warnings to users. ECF No. 32, PageID.3298-3299.
“Michigan law recognizes the tort of negligent misrepresentation.”
Gillett v. Sofamor, S.N.C., 2001 WL 1135304, at *6 (E.D. Mich. Sept. 13,
2001). To support a claim for this cause of action, a plaintiff must present
“proof that a party justifiably relied to his detriment on information
provided without reasonable care by one who owed the relying party a
duty of care.” Law Offices of Lawrence J. Stockler P.C. v. Rose Stockler,
436 N.W.2d 70, 79 (Mich. Ct. App. 1989). In addition to reliance, under
Michigan law, the elements of negligent misrepresentation are:
(1)
the defendant made a material misrepresentation;
(2)
the representation was false;
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(3)
the
defendant
was
negligent
PageID.3953
in
Page 27 of 32
making
the
misrepresentation; and
(4)
the plaintiff suffered damages as a result.
Cleveland Indians Baseball Co., L.P. v. New Hampshire Ins. Co., 727 F.3d
633, 641 (6th Cir. 2013) (referencing Stockler, 436 N.W.2d at 81).
A plaintiff may show a misrepresentation of fact where “the
defendant had a duty to disclose facts but suppressed them instead.”
Boumelhem v. Bic Corp., 535 N.W.2d 574, 579 (Mich. Ct. App. 1995)
(referencing In re People v. Jory, 505 N.W.2d 228 (Mich. 1993)). The
question of whether a manufacturer has a duty is one for the Court.
Avendt v. Covidien, Inc., 262 F.Supp.3d 493, 520 (E.D. Mich. 2017).
“Michigan has adopted and follows the learned intermediary doctrine,
which holds that a manufacturer has no duty to warn the ultimate
consumer if the product is provided for use by a sophisticated consumer.”
Id. (referencing Brown v. Drake-Willock, Intern., Ltd., 530 N.W.2d 510
(Mich. Ct. App. 1995)). Under the learned intermediary doctrine, a
manufacturer is exempt from its duty to warn ultimate users of
prescription drugs and medical devices of inherent dangers because
patients rely on the expertise of a doctor when utilizing a medical device
or prescribed drug and may not appreciate warnings provided by the
manufacturer. Knight v. St. Jude Med., 2011 WL 1230819, at *10 (W.D.
Mich. Jan. 11, 2011).
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In considering whether Plaintiff has presented sufficient evidence
on this claim, the Court must first determine whether Bard owes a duty
to Plaintiff, as well as her health care providers. Avendt, 262 F.Supp.3d
at 520; ECF No. 1, PageID 33. Because Michigan has adopted the learned
intermediary doctrine and the G2 Filter is a prescription medical device,
Bard’s duty to warn runs only to Plaintiff’s physicians—not Plaintiff as
the patient. See Knight, 2011 WL 1230819 at *11 (dismissing claim that
the defendant withheld relevant information about a medical device
because the defendant owed no duty to the patient—only their health
care providers).
During oral argument, Plaintiff also asserted that Defendant owed
a duty to her as a patient because she was a member of the class of
persons to which Bard had a public duty to provide information. Plaintiff
contends that Michigan has adopted Section 552 of the Restatement
(Second) of Torts, which extends liability for negligence to “anyone under
a public duty to provide information to any class of persons that benefits
from the public duty.” Stockler, 436 N.W.2d at 36. Plaintiff argues that
Bard owed her a duty because the Restatement provides protection to
injured third parties who were recipients of the misrepresentation.
Plaintiff’s reliance on Stockler fails to take account of the context of
that case. The Court in Stockler adopted the Restatement in “reviewing
the scope of an accountant’s potential third-party liability for negligent
misrepresentation.” 436 N.W.2d at 36 (emphasis added). Subsequent
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cases have recognized the holding of Stockler as limited to particular
professions and their associated duty of care. See City of Birmingham
Employees’ Retirement Sys. v. Comerica, Inc., 2012 WL 13002132, at *3
(E.D. Mich. Aug. 28, 2012) (finding that Michigan only adopted Section
552 of the Restatement (Second) of Torts with respect to accountant’s
duties of care). As Stockler is inapplicable here, the scope of Bard’s
potential liability does not extend to Plaintiff as part of a class of persons.
Due to the learned intermediary doctrine and the inapplicability of
Stockler to the current facts, Defendant did not owe a duty directly to
Plaintiff to avoid making a negligent misrepresentation. As such, to the
extent any negligent misrepresentation claim relies on the assertion that
Bard failed to warn or withheld information from Plaintiff, Bard would
be entitled to summary judgment on such claims.
But Plaintiff also alleges that Defendant withheld relevant warning
information from Plaintiff’s health care providers. ECF No. 1, PageID.33.
Here, the learned intermediary doctrine does not bar Plaintiff’s negligent
misrepresentation claims as to Plaintiff’s health care provider because
the treating doctor is the proper recipient of any warnings and
information about the G2 Filter. See Avendt, 262 F.Supp.3d at 521
(discussing Brown, 530 N.W.2d at 516). Defendant had a duty to provide
adequate warnings to Plaintiff’s implanting physician.
Accepting then that Bard owed a duty to Plaintiff’s health care
provider, Defendant contends that Plaintiff has not provided any
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evidence that Bard misrepresented any information about the G2 Filter
to her implanting physician. ECF No. 27, PageID.3133. As support for
this argument, Defendant points to Tice v. Zimmer Holdings, Inc., where
the Court granted a motion to dismiss because the plaintiffs’ claims did
not “put Defendants on notice of any specific statements that were
fraudulent, let alone explain why they were fraudulent, or indicate where
and when they were made.” 2015 WL 4392985, at *8 (W.D. Mich. July 15,
2015). But unlike Tice, Plaintiff specifically asserts that the information
packet misrepresented the risks of the G2 Filter because it failed to
convey the magnitude of risk for fracture, perforation, and migration
compared to other filters on the market. Ex. H, ECF No. 32-8; 2012 WL
6082933, at *10-11. Where Plaintiff has provided the information packet
as evidence of specific statements that omitted necessary information,
the facts here are more closely aligned with Davis v. C.R. Bard. 2012 WL
6082933, at *10-11. In Davis, as here, Plaintiff presented a variety of
expert reports showing that Bard was aware of the disproportionate rates
of fracture, migration, and perforation, but Bard failed to update its
materials to appropriately reflect the risks of the G2 Filter. Ex. Q, ECF
No.33-3, PageID.3714. The Court views Davis as instructive in finding
that evidence of disproportionate rates of failure and the lack of
comparative information in the information materials to disclose this risk
raises factual issues regarding negligent misrepresentations. As such,
Plaintiff has submitted sufficient evidence to show there is a genuine
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issue of material fact as to whether the higher rates of failure for the G2
Filter compared to other filters was made known to the implanting doctor
or Plaintiff.
However, Plaintiff must also provide some evidence of reliance.
Petfreedom.com, L.L.C. v. Net Generation, Inc., 2009 WL 2382430, at *3
(Mich. Ct. App. Aug. 4, 2009). On this point, the Court is unable to find
any evidence in the record to demonstrate that Plaintiff’s health care
provider relied to his detriment on information provided by Bard that
failed to adequately reflect the risks posed by the G2 Filter. See Knight,
2011 WL 1230819 at *13 (holding that negligent misrepresentation
requires evidence of reliance). Further, the surgeon who implanted the
G2 Filter, Dr. Talbert, is now deceased and therefore unable to provide
testimony to support the element of reliance. Ex. K, ECF No. 27-12. In
Davis, the plaintiff presented the implanting doctor’s deposition to
demonstrate reliance on the inadequate warnings in the information
packet. 2012 WL 6082933 at *10 (denying summary judgment with
regard to the plaintiff’s negligent misrepresentation claim). Here
Plaintiff has no such evidence.
Plaintiff has not provided any evidence to create a genuine issue of
material fact as to whether Dr. Talbert, or any other medical
professional, relied on the alleged misrepresentation in treating Plaintiff
with the G2 Filter. Because there is no evidence to support the element
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of reliance, Defendant is entitled to summary judgment on Plaintiff’s
negligent misrepresentation claim.
IV.
Conclusion
For the foregoing reasons, Defendant C.R. Bard’s motion for
summary judgment is DENIED with respect to Plaintiff Vicki Rivera’s
claims for design defect and breach of implied warranty, and GRANTED
as to Plaintiff’s claim for negligent misrepresentation.
SO ORDERED.
Dated: October 15, 2020
s/Terrence G. Berg
TERRENCE G. BERG
UNITED STATES DISTRICT JUDGE
32
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