United States District Court, D. Arizona
G. Campbell Senior United States District Judge.
multidistrict litigation proceeding (“MDL”)
involves thousands of personal injury cases brought against
Defendants C. R. Bard, Inc. and Bard Peripheral Vascular,
Inc. (collectively, “Bard”). Bard manufactures
and markets medical devices, including inferior vena cava
(“IVC”) filters. The MDL Plaintiffs received
implants of Bard IVC filters and claim they are defective and
have caused serious injury or death.
the MDL cases is brought by Plaintiff Debra Tinlin. She
received a Bard filter fourteen years ago. Her case has been
chosen as one of several bellwether cases and is set for
trial in May 2019. Defendants have filed a motion for summary
judgment. Doc. 15071. The motion is fully briefed. Docs.
15696, 16011. The parties request oral argument, but it will
not aid the Court's decision. See Fed. R. Civ.
P. 78(b); LRCiv 7.2(f). For reasons stated below, the Court
will grant the motion in part and deny it in part.
is a large vein that returns blood to the heart from the
lower body. An IVC filter is a device implanted in the IVC to
catch blood clots before they reach the heart and lungs. This
MDL involves multiple versions of Bard IVC filters - the
Recovery, G2, G2X, Eclipse, Meridian, and Denali. They are
spider-shaped devices that have multiple limbs fanning out
from a cone-shaped head. The limbs consist of legs with
elastic hooks that attach to the IVC wall, and bent arms to
catch or break up blood clots.
Plaintiffs allege that Bard filters are more dangerous than
other IVC filters because they have higher risks of tilting,
perforating the IVC, or fracturing and migrating to vital
organs. Plaintiffs further allege that Bard failed to warn
patients and physicians about these higher risks. Defendants
dispute these allegations, contending that Bard filters are
safe and effective, that their complication rates are low and
comparable to those of other IVC filters, and that the
medical community is aware of the risks associated with IVC
The Tinlin Plaintiffs.
Debra Tinlin has a history of deep vein thrombosis and
pulmonary emboli. She received a Bard Recovery filter on May
7, 2005. Dr. Joshua Riebe implanted the filter.
10, 2013, Ms. Tinlin experienced cardiac tamponade after the
filter fractured and two struts embolized in the right
ventricle of her heart. She had emergency surgery to drain a
pericardial effusion. No fractured strut was found during the
procedure. She was discharged ten days later.
31, 2013, a fractured strut was removed through open heart
surgery. A chest scan showed several other struts perforating
the IVC wall. Subsequent scans revealed multiple fractured
struts in the pulmonary arteries. These struts and the filter
have not been removed.
Tinlin and her husband assert various claims against Bard
under Wisconsin law, some of which have been
withdrawn. The following claims remain: failure to
warn (Counts II and VII), design defect (Counts III and IV),
misrepresentation (Counts VIII and XII), concealment (Count
XIII), deceptive trade practices (Count XIV), and loss of
consortium (Count XV). See Doc. 364 (master
complaint); Doc. 1, Case No. CV-16-00263 (short-form
seek summary judgment on the remaining claims and future
damages, but not on Plaintiff's request for punitive
damages. Doc. 15071 at 2-4. The Court will grant summary
judgment on the misrepresentation and deceptive trade
practices claims, deny summary judgment on the claims for
failure to warn, design defect, concealment, and loss of
consortium, and grant summary judgment in part with respect
to future damages.
Summary Judgment Standard.
seeking summary judgment “bears the initial
responsibility of informing the court of the basis for its
motion and identifying those portions of [the record] which
it believes demonstrate the absence of a genuine issue of
material fact.” Celotex Corp. v. Catrett, 477
U.S. 317, 323 (1986). Summary judgment is warranted where the
moving party “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). Summary
judgment is also 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.
disputes over facts that might affect the outcome of the suit
will preclude summary judgment, and the disputed evidence
must be “such that a reasonable jury could return a
verdict for the nonmoving party.” Anderson v.
Liberty Lobby, Inc., 477 U.S. 242, 248 (1986). The
evidence must be viewed in the light most favorable to the
nonmoving party, and all justifiable inferences are drawn in
that party's favor because “[c]redibility
determinations, the weighing of evidence, and the drawing of
inferences from the facts are jury functions[.]”
Id. at 255; see Matsushita Elec. Indus. Co. v.
Zenith Radio Corp., 475 U.S. 574, 587 (1986)
Failure to Warn Claims (Counts II and VII).
assert strict liability and negligent failure to warn claims.
See Doc. 364 ¶¶ 171-81, 210-17; Doc. 1 at
3, Case No. CV-16-00263. To establish each claim, Plaintiffs
must show, among other things, that the lack of an adequate
warning was a cause of their injuries. See Wis.
Stat. § 895.047(1)(e) (a plaintiff asserting a strict
liability claim must prove that “the defective
condition was a cause” of her injuries); Kessel v.
Stansfield Vending, Inc., 714 N.W.2d 206, 211 (Wis. Ct.
App. 2006) (a plaintiff claiming negligent failure to warn
must prove a “causal connection between the
defendant's breach of the duty of care and the
plaintiff's injury”). “Under Wisconsin law,
negligence or defect ‘caused' an injury if it was a
substantial factor in producing the injury.” Burton
v. Am. Cyanamid, No. 07-CV-0303, 2019 WL 325318, at *2
(E.D. Wis. Jan. 25, 2019); see Sumnicht v. Toyota Motor
Sales, U.S.A., 360 N.W.2d 2, 11 (Wis. 1984) (“The
long-standing test for cause in Wisconsin is whether the
defect was a substantial factor in producing the
injury.”); Morgan v. Pa. Gen. Ins., 275 N.W.2d
660, 666 (Wis. 1979) (“The test of cause-in-fact is
whether the negligence was a ‘substantial factor'
in producing the injury.”); Fandrey v. Am. Family
Mut. Ins., 680 N.W.2d 345, 353 (Wis. 2004) (“When
Wisconsin courts currently speak of ‘cause,' they
do so in the context of the substantial factor test for
cause-in-fact.”); see also Wis JI-Civil 1500
(general causation standard).
contend that the failure to warn claims fail because
Plaintiffs cannot show that an adequate warning would have
changed Dr. Riebe's decision to use a Recovery filter for
Ms. Tinlin. Doc. 15071 at 3, 7-9. The Court does not
note that Dr. Riebe does not recall seeing the Recovery's
instructions for use (“IFU”) and does not
routinely read IFUs or “dear doctor” letters.
Doc. 15071 at 8-9. But “it does not follow that he
would have ignored any warnings provided by
[D]efendants.” Stevens v. Stryker Corp., No.
12-CV-63-BBC, 2013 WL 12109101, at *6 (W.D. Wis. May 9,
2013). Defendants do not contend that IFUs and “dear
doctor” letters are the only avenues by which Bard can
provide warnings to physicians. See Doc. 15071 at 9.
Dr. Riebe testified that sales representatives for IVC filter
manufacturers, including Bard, visited the hospital where he
performed surgery and called on him as a customer throughout
his practice. Doc. 15702 ¶ 10; see Doc. 15702-1
at 3, 10. Because Bard sales representatives could have
personally provided warnings about the Recovery to Dr. Riebe,
the fact that he did not read IFUs or “dear
doctor” letters does not establish a lack of causation.
Riebe testified that he needed complete and accurate
information from medical device manufacturers to help him
conduct a proper risk-benefit analysis. Doc. 15702-1 at 5. He
stated that he would have wanted to know about the
Recovery's alleged higher risks of failure, and that Bard
did not understand the root causes, did not have a good
understanding of the long-term performance of its retrievable
filters or the dynamics of the IVC, had placed the Recovery
on hold due to migration problems, and internally found the
Recovery to have unacceptable risks. Id. at 6-8, 14.
This information would have been important for understanding
the Recovery's safety and conducting a proper
risk-benefit analysis. Id. at 8-9, 19; see
Doc. 15701 ¶¶ 17-22. Bard's knowledge that
overweight patients tend to have large expansions of their
IVCs, if shared with Dr. Riebe, would have helped him select
a filter that would have remained in place in Ms. Tinlin.
Doc. 15702-1 at 22; see Doc. 15702 ¶ 5.
reasonably could infer from this evidence that Bard's
failure to warn Dr. Riebe about the Recovery's higher
risks of failure, Bard's lack of knowledge about the root
causes, and the Recovery's known migration problems in
overweight patients was a substantial factor in Dr.
Riebe's decision to choose a Recovery for Ms. Tinlin.
See Burton v. Am. Cyanamid, 334 F.Supp.3d 949, 967
(E.D. Wis. 2018) (denying summary judgment where the jury
could draw “the permissible inference . . . that the
persons responsible for selecting [the product] would have
heeded warnings regarding the risk . . . if such warnings had
been issued”); Stevens, 2013 WL 12109101, at
*6 (finding a triable issue with respect to causation even
though the physician generally did not rely on information he
received from the defendants when he decided to use their
medical device); Forst, 602 F.Supp.2d at 969 (a jury
could rely on the prescribing physician's testimony that
the lack of warning about the drug's increased risk for
suicide prevented him from doing a proper risk-benefit
analysis in concluding that his decision to prescribe would
have changed); Michaels v. Mr. Heater, Inc., 411
F.Supp. 992, 1007 (W.D. Wis. 2006) (denying summary judgment
where the jury reasonably could find that the failure to
provide adequate warnings was a substantial factor in causing
the plaintiff's injuries).
contend that because Dr. Riebe had no involvement in
selecting the IVC filters used at his hospital, and never
suggested that any filter other than a Recovery could have
been used for Ms. Tinlin, no reasonable inference can be
drawn that he would have selected a different filter
regardless of what warning Bard provided. Doc. 15071 at 9.
But Dr. Riebe testified that he often would switch to a Cook
Bird's Nest filter for patients with large IVCs. Doc.
15702-1 at 25; see Doc. 15702 ¶ 5.
have not shown, as a matter of undisputed fact, that their
alleged failure to warn was not a cause of Plaintiffs'
injuries. The Court will deny ...