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
case brought by Doris and Alfred Jones has been selected as
one of several bellwether cases and is set for trial in May
2018. Defendants have filed a motion for partial summary
judgment. Doc. 7351. The motion is fully briefed, and the
parties agree that oral argument is not necessary. For
reasons set forth 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 small metal device implanted
in the IVC to catch blood clots before they reach the heart
and lungs. This MDL involves seven different versions of Bard
IVC filters - the Recovery, G2, G2 Express, G2X, Eclipse,
Meridian, and Denali. They are spider-like 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 curved arms that serve to catch or break up blood
clots. Each of these filters is a variation of its
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
physicians and patients about these higher risks. Plaintiffs
assert a host of state law claims and seek both compensatory
and punitive damages. Defendants dispute Plaintiffs'
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
Plaintiffs Doris and Alfred Jones.
August 2010, before gastrointestinal surgery, Doris Jones was
implanted with an Eclipse filter due to recurrent deep vein
thrombosis. Dr. Anthony Avino implanted the filter without
incident. In April 2015, Mrs. Jones went to the emergency
room with complaints of lightheadedness and arm pain. A chest
scan revealed a fractured filter limb that had embolized in
the right pulmonary artery. The filter was removed but the
fractured limb remains in place.
Jones and her husband assert various claims under Georgia
law, some of which have been withdrawn. The following claims
remain: failure to warn (Counts II and VII), design defects
(Counts III and IV), misrepresentation (Counts VIII and XII),
negligence per se (Count IX), fraudulent concealment (Count
XIII), consumer fraud and unfair trade practices (Count XIV),
loss of consortium (Count XV), and punitive damages.
See Doc. 364 (master complaint); Doc. 1,
CV-16-00782-PHX-DGC (short-form complaint).
seek summary judgment on the failure to warn,
misrepresentation, negligence per se, consumer fraud and
unfair trade practices, and punitive damages claims. Doc.
7351 at 3. Plaintiffs concede that summary judgment is proper
on the consumer fraud and unfair trade practices claim. Doc.
7943 at 2 n.1. The Court will grant summary judgment on that
claim and the misrepresentation and negligence per se claims.
The Court will deny summary judgment on the failure to warn
and punitive damages claims.
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 must be
viewed in the light most favorable to the nonmoving party,
Matsushita Elec. Indus. Co. v. Zenith Radio Corp.,
475 U.S. 574, 587 (1986), 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, ”
Anderson, 477 U.S. at 255.
Failure to Warn (Counts II and VII).
law applies in this case because the alleged injuries
occurred in Georgia and Plaintiffs lived there when their
complaint was filed. Doc. 7351 at 5; Doc. 1 ¶¶ 4-6,
CV-16-00782-PHX-DGC. To establish a failure to warn claim
under Georgia law, “the plaintiff must show that 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). 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 may be breached in two ways:
“(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 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, Plaintiffs allege that Bard failed to adequately warn
physicians about the known defects and higher complication
rates associated with Bard filters. Doc. 364 ¶¶
174-78, 211-16. Plaintiffs claim that this failure
constitutes a breach of Bard's duty to warn and
proximately caused their injuries. Id. ¶¶
177-81, 215-17. Plaintiffs assert strict liability and
negligence claims for the alleged failure to warn.
Id. ¶¶ 171-81, 202-09; see Doc. 1
at 3, CV-16-00782-PHX-DGC.
contend that proximate cause is lacking because Dr. Avino did
not read the Eclipse filter's instructions for use
(“IFU”) and had actual knowledge of the risk of
fracture. Doc. 7351 at 6-7. Defendants further contend that
the warnings provided with the Eclipse filter were adequate
because they included the complication experienced by Mrs.
Jones. Id. at 8-11. The Court will address each
Failure to Read the Eclipse IFU.
rely on Wilson Foods Corp. v. Turner, 460 S.E.2d
532, 534 (Ga.Ct.App. 1995), for the proposition that
“failure to read product instructions . . . will
prevent a plaintiff from recovering on a claim grounded on
failure to provide adequate warning of the products'
potential risk.” Doc. 7351 at 6. Defendants contend
that Dr. Avino did not read the Eclipse IFU before implanting
the device in Mrs. Jones, and Plaintiffs therefore cannot
show that any warning inadequacy proximately caused their
duty to warn is breached not only by having a deficient
warning, but also by “failing to adequately communicate
the warning to the ultimate user.” Thornton,
22 F.3d at 289. Indeed, Wilson makes clear that
failure to read instructions “‘does not bar
recovery where the plaintiff is challenging the adequacy of
the efforts of the manufacturer or seller to communicate the
dangers of the product to the buyer or user.'” 460
S.E.2d at 534 (quoting Thornton, 22 F.3d at 290).
Plaintiffs bring such a challenge in this case.
claim that the instructions contained in the IFU were
inadequate, and that Bard otherwise failed to communicate
sufficient warnings to physicians. Specifically, Plaintiffs
allege that Bard breached its duty to warn by not
“providing instructions for safe use” or
“communicating the information and dangers” about
Bard filters to physicians. Doc. 364 ¶¶ 181, 216.
Plaintiffs note that medical device warnings are provided in
various ways, including “dear doctor” letters,
product pamphlets, and statements by the company sales
representatives. Doc. 7943 at 14 (citing Allen v.
Belinfante, 458 S.E.2d 867, 869 (Ga.Ct.App. 1995)
(assessing doctor's awareness of “dear
doctor” letters and other sources of information about
potential risks in determining liability for failure to warn
claim)); see PLIVA, Inc. v. Mensing, 564 U.S. 604,
615 (2011) (noting that manufacturers provide warnings
through dear doctor letters).
Plaintiffs' claim that Bard breached its duty to warn by
failing to adequately communicate warnings to physicians
through means other than IFUs, the fact that Dr. Avino may
not have read the Eclipse IFU is not dispositive on
causation. See Jones v. Amazing Prods., Inc., 231
F.Supp.2d 1228, 1247 (N.D.Ga. 2002) (“A plaintiff's
failure to read a warning will not . . . bar recovery as to
the first prong of the test: namely, where the plaintiff is
challenging the adequacy of the defendant's
efforts to communicate the dangers of the product to the
user[.]” (citing Wilson, 460 S.E.2d at 534));
In re Stand ‘n Seal Prods. Liab. Litig., No.
1:07MD1804-TWT, 2009 WL 2145911, at *6 (N.D.Ga. July 15,
2009) (denying summary judgment where the plaintiffs did not
read the warning label but claimed that the
manufacturer's efforts to communicate the dangers were
inadequate (citing Wilson)); Mizell v.
Pilgrim's Pride Corp., No. CV 509-064, 2012 WL
130056600, at *5 (S.D. Ga. Mar. 14, 2012) (finding the
failure to read a warning not dispositive where the plaintiff
challenged the manufacturer's communication of the
warning (citing Wilson)); In re Seroquel Prods.
Liab. Litig., No. 6:06-md-1769-Orl-22DAB, 2007 WL
4117201, at *2 (M.D. Fla. Nov. 6, 2007) (denying summary
judgment where the plaintiffs alleged that the ...