United States District Court, D. Arizona
G. Campbell 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 have received
implants of Bard IVC filters and claim that they are
defective and have caused Plaintiffs to suffer serious injury
or death. Plaintiffs assert numerous state law claims and
seek both compensatory and punitive damages.
the MDL cases is brought by Plaintiff Sherr-Una Booker, who
had a Bard filter implanted ten years ago. Plaintiff's
case has been selected as one of several bellwether cases and
is set for trial in March 2018. Defendants have filed a
motion for partial summary judgment on Plaintiff's
claims. Doc. 7456. The motion is fully briefed, and the Court
heard oral arguments on November 17, 2017. For reasons set
forth below, the Court will grant the motion in part and deny
it in part.
factual background section of this order has been redacted
because it sets forth Plaintiff's personal medical
information protected from public disclosure under the
provisions of HIPPA and orders sealing documents in this
case. See Doc. 7787. An unredacted version of this order has
been filed under seal. See Doc. 8873.]
Court was assigned this MDL in August 2015. Doc. 1. Three
months later, the MDL Plaintiffs filed a long-form master
complaint that asserts seventeen causes of action. Doc.
303-1. The master complaint alleges that Bard filters,
including the G2, were negligently designed and manufactured
and are more dangerous than other IVC filters. The complaint
further alleges that Defendants concealed adverse information
and otherwise failed to warn about increased risks posed by
Bard filters. Defendants dispute the allegations of
concealment and high risk levels, contending that
complication rates associated with Bard filters are low and
comparable to those of other IVC filters.
short-form individual complaint filed on February 22, 2016,
Plaintiff asserts the following claims under Georgia law:
manufacturing defects (Master Complaint Counts I and V),
failure to warn (Counts II and VII), design defects (Counts
III and IV), failure to recall or retrofit (Count VI),
misrepresentation (Counts VIII and XII), negligence per se
(Count IX), breach of warranties (Counts X and XI), and
punitive damages. Doc. 1, CV-16-00474-PHX-DGC. Plaintiff
agreed not to pursue the breach of warranty claims before the
present motion was filed. Doc. 7460 at 2 n.1.
seek summary judgment on all claims other than design
defects. Id. at 1. In her response to
Defendants' motion, Plaintiff concedes the insufficiency
of her manufacturing defect and failure to recall or retrofit
claims. Doc. 8167 at 2 n.1. The Court will grant summary
judgment on these claims and the breach of warranty claims.
remaining claims on which Defendants seek summary judgment
are failure to warn, misrepresentation, negligence per se,
and punitive damages. The Court will deny summary judgment on
the failure to warn and punitive damages claims and grant
summary judgment on the claims for misrepresentation and
negligence per se.
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 appropriate if 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). Only disputes over facts
that might affect the outcome of the suit will preclude the
entry of 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 of the
nonmoving party, however, is to be believed, and all
justifiable inferences 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.
Failure to Warn (Counts II and VII).
parties agree that Georgia law applies because the alleged
injuries occurred in Georgia and Plaintiff lived there when
the complaint was filed. Doc. 7460 at 6. To establish a
failure to warn claim 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).
“[A] manufacturer has a duty to warn of nonobvious
foreseeable dangers from the normal use of its
product.” Thornton v. E.I Du Pont de Nemours &
Co., 22 F.3d 284, 289 (11th Cir. 1994) (citations
omitted). 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.” Thornton, 22
F.3d at 289.
cases involving prescription drugs and medical devices,
Georgia applies the “learned intermediary”
doctrine. Under this doctrine, the manufacturer has no
“duty to warn the patient of the dangers involved with
the product, but instead has a duty to warn the patient's
doctor, who acts as a learned intermediary between the
patient and manufacturer.” McCombs v. Synthes
(U.S.A.), 587 S.E.2d 594, 595 (Ga. 2003) (citing
Ellis v. C. R. Bard, Inc., 311 F.3d 1272, 1279-80
(11th Cir. 2002)). The manufacturer's warnings to the
physician, however, “must be adequate or reasonable
under the circumstances of the case.” Id.
case, the G2 filter's Instructions for Use
(“IFU”) were available to Dr. D'Ayala when he
decided to implant the filter in Plaintiff, but he did not
have information about any increased risks associated with
Bard filters. Doc. 7462-2 at 5-6. Plaintiff alleges that the
instructions Bard provided failed to adequately warn about
the device's known defects and high complication rates,
including the filter's propensity to tilt, fracture, and
perforate the IVC. See Doc. 303-1 ¶¶
174-78, 211-16. Plaintiff claims that this failure to warn
constitutes a breach of Bard's duty to adequately warn of
the dangers presented by its IVC filters, and proximately
caused her injuries. Id. ¶¶ 177-81,
215-17. Plaintiff asserts strict liability and negligence
claims for the alleged failure to warn. Id.
¶¶ 171-81, 202-09; see Doc. 1 at 3,
contend that the warnings contained in the IFU were adequate
as a matter of law because they included the risks of filter
movement, fracture, and perforation - the very complications
Plaintiff experienced. Doc. 7460 at 9-11. Defendants further
contend that proximate cause is lacking because Dr.
D'Ayala implanted the G2 filter with knowledge of its
potential risks, and there is no evidence that additional
warnings would have made him choose a different filter or
treatment. Id. at 11-12. For purposes of summary
judgment, Defendants do not dispute that Plaintiff has
presented evidence that Bard knew its IVC filters had
complication rates higher than other filters at the time
Plaintiff was implanted with the G2 filter. See Doc. 8167 at
Adequacy of the Warnings.
for the G2 filter included the following warnings under the
bold heading of “Potential Complications”:
. Movement or migration of the filter is a
known complication of vena cava filters. This may be caused
by placement in IVCs with diameters exceeding the appropriate
labeled dimensions specified in the IFU. Migration of filters
to the heart or lungs have also been reported in association
with improper deployment, deployment into clots and/or
dislodgment due to large clot burdens.
. Filter fracture is a known complication of
vena cava filters. There have been reports of embolization of
vena cava filter fragments resulting in retrieval of the
fragment using endovascular and/or surgical techniques. Most
cases of filter fracture, however, have been reported without
any adverse clinical sequelae.
. Perforation or other acute or chronic
damage of the IVC wall.
. All of the above complications have been
associated with serious adverse events such as medical
intervention and/or death. There have been reports of
complications, including death, associated with the use of
vena cava filters in morbidly obese patients. The
risk/benefit ratio of any of these complications should be
weighed against the inherent risk/benefit ratio for a patient
who is at risk of pulmonary embolism without intervention.
Doc. 7457-1 at 2.
concedes that the IFU warned about G2 filters tilting,
fracturing, and perforating the IVC, but notes that these
complications exist for all IVC filters. Doc. 8167 at 13.
Plaintiff argues that the warnings were inadequate because
they did not include risk rates or disclose that the risks
associated with the G2 filter were higher than those ...