United States District Court, D. Arizona
G. Campbell United States District Judge
multidistrict litigation proceeding involves thousands of
personal injury cases related to inferior vena cava
(“IVC”) filters manufactured and marketed by
Defendants C. R. Bard, Inc. and Bard Peripheral Vascular,
Inc. (collectively, “Bard”). The case brought by
Plaintiff Sherr-Una Booker was selected for one of several
bellwether trials. A jury trial was held in March 2018. The
jury found in favor of Plaintiff Booker on one of four claims
and awarded her $3.6 million in damages.
have filed a renewed motion for judgment as a matter of law
and a motion for a new trial. Docs. 10879, 10880. The
requests for oral argument are denied because the issues have
been fully briefed and oral argument will not aid in the
Court's decision. For reasons stated below, the motions
will be denied.
surgery in June 2007, Plaintiff was implanted with a Bard G2
IVC filter given her history of blood clots and the risk of
experiencing a pulmonary embolism during or after surgery.
Seven years later, it was discovered that the G2 filter had
tilted, penetrated the IVC wall, and fractured, and that one
strut of the filter had migrated to the right atrium of
Plaintiff's heart. Subsequent x-rays revealed two other
fractured struts and multiple legs perforating the IVC.
Plaintiff underwent surgery in July 2014, and the G2 filter
and one of the fractured struts in the IVC were removed.
During attempts to remove the strut from the heart, however,
Plaintiff's tricuspid valve was damaged. Plaintiff had
open heart surgery to repair the tricuspid valve and remove
the strut from the right atrium. One fractured strut remains
embedded in Plaintiff's IVC wall.
filed suit against Defendants in February 2016, alleging that
Bard filters are more dangerous than other IVC filters
because they have higher risks of complications, and that
Bard failed to warn physicians and patients about these
higher risks. Doc. 364; Doc. 1, CV-16-00474-PHX-DGC. She
asserted various claims under Georgia law. Id. Four
claims were presented to the jury at trial: strict liability
design defect, negligent design, strict liability failure to
warn, and negligent failure to warn. Id. The jury
found Defendants liable on the negligent failure to warn
claim and awarded Plaintiff $1.6 million in compensatory
damages and $2 million in punitive damages. Docs. 10595,
seek judgment as a matter of law under Federal Rule of Civil
Procedure 50, contending that the evidence was insufficient
to support the verdict. Doc. 10879. Defendants alternatively
seek a new trial pursuant to Rule 59 on the ground that the
verdicts on the strict liability and negligent failure to
warn claims are inconsistent. Doc. 10880. Plaintiff argues
that substantial evidence supports the verdict in her favor.
Doc. 11014. She further argues that the verdicts are not
inconsistent, that Defendants have waived their challenge to
the alleged inconsistency, and that the Court is without
authority to order a new trial even if the verdicts are
inconsistent. Doc. 1107.
Motion for Judgment as a Matter of Law.
provides that a court may grant judgment as a matter of law
if a party has been fully heard on an issue and the court
finds that “a reasonable jury would not have a legally
sufficient evidentiary basis to find for the party on that
issue[.]” Fed.R.Civ.P. 50(a)(1). The Rule 50 standard
mirrors the standard for granting summary judgment under Rule
56 - “the inquiry under each is the same.”
Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 250
(1986). In deciding whether to grant a Rule 50 motion,
“the court ‘may not make credibility
determinations or weigh the evidence.'”
E.E.O.C. v. Go Daddy Software, Inc., 581 F.3d 951,
961 (9th Cir. 2009) (quoting Reeves v. Sanderson Plumbing
Prods., Inc., 530 U.S. 133, 149-50 (2000)). Rather, the
court “must view the evidence in the light most
favorable to the nonmoving party . . . and draw all
reasonable inferences in that party's favor.”
Reeves, 530 U.S. at 150. The test is “whether
the evidence permits only one reasonable conclusion, and that
conclusion is contrary to the jury's verdict.”
Go Daddy, 581 F.3d at 961 (citation omitted).
argue that the evidence presented at trial is insufficient to
support the jury's verdict on the negligent failure to
warn claim and punitive damages. Doc. 10879 at 2. The Court
denied Defendants' initial request for judgment as a
matter of law during trial, and denied their earlier motion
for summary judgment. Docs. 8874, 10580. The Court continues
to conclude that there is sufficient evidence to support a
finding in favor of Plaintiff.
Negligent Failure to Warn Claim.
establish a negligent failure to warn under Georgia law,
“the plaintiff must show the defendant had a duty to
warn, the defendant breached that duty and the breach was the
proximate cause of the plaintiff's injury.”
Wheat v. Sofamor, S. N.C. , 46 F.Supp.2d 1351, 1362
(N.D.Ga. 1999). The duty to warn arises “whenever the
manufacturer knows or reasonably should know of the danger
arising from the use of its product.” Chrysler
Corp. v. Batten, 450 S.E.2d 208, 211 (Ga. 1994). The
duty generally is “breached by (1) failing to
adequately communicate the warning to the ultimate user or
(2) failing to provide an adequate warning of the
product's potential risks.” Wilson Foods Corp.
v. Turner, 460 S.E.2d 532, 534 (Ga.Ct.App. 1995)
contend that the negligent failure to warn claim fails as a
matter of law for three reasons. First, Plaintiff presented
no evidence to support the fundamental premise of the claim -
that the G2 filter had higher risks of complications than
other IVC filters. Doc. 10879 at 3-6. Second, she proposed no
alternative warning. Id. at 5. Third, there is
insufficient evidence of causation. Id. at 6-8.
Plaintiff counters that the evidence presented at trial, when
taken as a whole and construed in her favor, is more than
sufficient to support the jury's finding that Bard failed
to provide an adequate warning to her treating physicians and
that this failure was a proximate cause of her injuries. Doc.
11014 at 2-12.
Evidence of an Inadequate Warning.
presented sufficient evidence for the jury reasonably to find
that the G2 filter failed at higher rates than other filters,
including Bard's own Simon Nitinol Filter
(“SNF”), and that Bard failed to warn
Plaintiff's treating physicians about these higher rates.
As early as February 2006, less than two months after the
G2's launch, Bard had received ten reports of G2 filter
migration. Bard performed a health hazard evaluation and
concluded that “unlike the literature reports, the
migration events with the G2 filter have been associated with
a high percentage of caudal migrations accompanied by
significant filter tilting and limb displacement.” Doc.
11014-1 at 348 (Trial Ex. 8355). Bard further concluded that
the G2's actual failure rate was probably higher than the
rate suggested by ten migrations “due to the
asymptomatic nature of some of the migration events and
because the actual number of G2 filters implanted is very
probably less than the number distributed.”
Id. at 349. Bard's internal analysis showed that
the G2 experienced caudal migration at rates higher than
those for the SNF and the G2 filter's predicate device,
the Recovery, and that Bard found the risks associated with
caudal migration to be “unacceptable.”
Id. at 93-119 (Trial Ex. 2248). Further analysis
showed that the G2 filter tilted, perforated the IVC, and
fractured more often than the Recovery. Id. at 327
(Trial Ex. 2052). The Everest clinical trial, which limited
patient follow-up to only six months, showed a G2 filter
migration rate of 12%, a tilt rate of 18%, and a penetration
rate of 22%. Id. at 192 (Trial Ex. 5290). Bard's
review of the Everest study and its internal complaint
database showed that 80% of caudal migrations were associated
with tilt and penetration, and 43% of fractures were
associated with tilt. Id. at 132, 138 (Trial Ex.
1517). One of Bard's leading design engineers testified
that the design features of the G2 made it less resistant to
caudal migration and this complication could lead to tilting,
perforation, and fracture. Id. at 5, 10-12. The jury
reasonably could have concluded from this evidence that Bard
knew the G2 filter experienced caudal migration at rates
higher than other filters and that this type of failure could
lead to other complications.
was also evidence that Bard failed to warn physicians about
the G2 filter's higher complication rates, and that
physicians generally would want to know this information when
making treatment decisions. The G2 filter's instructions
for use (“IFU”) and promotional materials did not
warn about higher risk rates or that caudal migration was
often associated with other complications. Doc. 11012-1 at
95-98 (Trial Ex. 5283); Doc. 11014-1 at 34 (testimony that
the IFU set forth a “laundry list of
complications” that did not disclose risk rates and
diluted the warnings about the most common and severe
complications). Nor did Bard provide this information to its
sales force or to physicians directly through “dear
doctor” letters. Doc. 11012-1 at 31-32. Two of
Plaintiff's experts, Drs. Hurst and Muehrcke, testified
that information about higher risks rates and the potential
for a cascade of complications is information interventional
radiologists generally would want to know when deciding to
treat a patient with an IVC filter. Doc. 11014-1 at 22-23,
assert that they presented the unrebutted testimony of Dr.
Grassi that establishes “the norm” for what the
medical community knew about adverse events of IVC filters
generally. Doc. 10879 at 6. But the jury was free to give
little or no weight to Dr. Grassi's testimony (Doc. 10589
at 7), and the Court may not “substitute its judgment
concerning the weight of the evidence for the
jury's.” Reeves, 530 U.S. at 153.
Moreover, when construed in Plaintiff's favor, Dr.
Grassi's testimony about adverse event rates in the
literature does not contradict the evidence that the G2
filter failed at rates higher than other filters and that
Plaintiff's treating physicians were not warned about the
to Defendants' assertion, sufficient evidence supports
the jury's finding that Bard failed to provide an
adequate warning about the G2 filter's complications and
contend that Plaintiff proposed no alternative warnings for
the jury to consider when deciding whether the warnings Bard
provided about the G2 filter were adequate. Doc. 10879 at 5.
Throughout trial, however, Plaintiff made clear that Bard
should have warned physicians that the G2 filter failed at
rates higher than other filters, and that its propensity to
migrate caudally could lead to other complications such as
tilt, perforation, and fracture. Both Dr. Hurst and Dr.
Muehrcke testified that this information should have been
included in the G2 filter's IFU or otherwise provided to
physicians. Doc. 11014-1 at 22-23, 35-40.
reliance on Nolley v. Greenlee Textron, Inc., No.
1:06-CV-228-MHS, 2007 WL 5369405, at *7 (N.D.Ga. Dec. 6,
2007), is misplaced. Doc. 11078 at 2-3. The district court in
that case concluded that, without expert testimony as to what
alternative warnings should have been given, the jury would
“have no means by which to adjudge whether the existing
warnings were adequate.” Id. at 6 (citing
Pineda v. Ford Motor Co., No. 04-3359, 2006 WL
3762015, at *2 (E.D. Pa. Dec.19, 2006)). That is not the
situation in this ...