United States District Court, D. Arizona
IN RE: Bard IVC Filters Products Liability Litigation,
G. Campbell United States District Judge
multidistrict litigation (“MDL”) involves more
than 3, 000 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. Each Plaintiff received a Bard
IVC filter implant and claims that the filter is defective
and has caused Plaintiff to suffer serious injury or death.
Plaintiffs assert various state law claims and seek both
compensatory and punitive damages.
motion, Bard seeks summary judgment on the ground that
Plaintiffs' state claims are expressly preempted by the
Medical Device Amendments of 1976 (“MDA”), 21
U.S.C. § 360 et seq., and impliedly preempted by the MDA
under the Supreme Court's conflict preemption principles.
Doc. 5396. The motion is fully briefed, and the Court heard
oral arguments on November 17, 2017. The Court will deny
Court will begin by describing IVC filters and their uses,
the history of the MDA, the relevant regulatory process, and
the claims asserted by Plaintiffs.
is a large vein that carries de-oxygenated blood from the
lower body to the heart. IVC filters are small metal devices
implanted in the upper portion of the IVC to stop blood clots
from travelling to the heart and lungs. Blood clots often
develop in the legs from a condition called deep vein
thrombosis or “DVT.” Once blood clots reach the
lungs, they are deemed pulmonary emboli or “PE.”
Pulmonary emboli and other thromboembolic events, such as
strokes, can cause serious injury or death.
at risk for DVT and PE may be prescribed blood thinners such
as Heparin or Warfarin to help prevent blood clots. But these
medications do not prevent blood clotting for certain people
at high risk for DVT or PE, and blood thinners may not be an
option for bariatric and trauma patients who could experience
thromboembolic events during surgery. In those situations,
physicians may recommend implanting an IVC filter to catch
any blood clots before they reach a vital organ.
filters originally were designed to be implanted permanently.
Because some patients need only temporary filters, however,
medical device manufacturers such as Bard developed
retrievable filters. Bard first obtained Food and Drug
Administration (“FDA”) clearance to market a
retrievable IVC filter in 2003. Seven different versions of
Bard filters are at issue in this MDL - the Recovery, G2, G2
Express, G2X, Eclipse, Meridian, and Denali. They are
spider-shaped devices with multiple struts fanning out from a
cone-shaped head. The struts consist of legs with hooks that
attach to the IVC wall, and shorter curved arms that serve to
catch or break up blood clots. Each of these filters is a
variation of its predecessor. The last-generation Denali
filter received FDA clearance in May 2013. The filters are
designed to be retrievable using Bard's Recovery Cone
History of the MDA.
our history, states have exercised police powers to protect
the health and safety of their residents. The federal
government first entered this field more than a century ago
with passage of the Food and Drug Act of 1906, 34 Stat. 768,
which prohibited the manufacture of adulterated or misbranded
food and drugs. Congress broadened the coverage of the
statute to include misbranded or adulterated cosmetics and
medical devices in the Food, Drug, and Cosmetic Act of 1938
(“FDCA”), 52 Stat. 1040, as amended, 21 U.S.C.
§ 301 et seq.
FDCA required premarket approval for new drugs, but not new
medical devices. As technology advanced and reliance on
medical devices grew, policymakers and the public became
concerned about the increasing number of injuries resulting
from device failures. Notable in this regard were injuries
women suffered from the Dalkon Shield contraceptive device in
the 1960s and early 1970s. Other devices, including
catheters, artificial heart valves, and pacemakers, also
created possible health risks. Several states responded with
regulatory measures, such as California's 1970 law
requiring premarket approval of medical devices. 1970 Cal.
Stats. ch. 1573, §§ 26670-26693.
1976, Congress passed the MDA “to provide for the
safety and effectiveness of medical device[s] intended for
human use[.]” Pub. L. No. 94-295, 90 Stat. 539 (1976).
The MDA extends coverage of the FDCA to medical devices
through federal oversight measures implemented by the FDA. It
also curtails state regulation of medical devices through a
provision that preempts state requirements that differ from
or add to federal requirements. 21 U.S.C. § 360k.
FDA Regulatory Process.
gives the FDA broad powers to classify and regulate medical
devices. The FDA assigns medical devices to Class I, Class
II, or Class III based on their risk levels. Class I devices,
which include products such as bandages and tongue
depressors, are low-risk and subject to oversight only
through “general controls” such as labeling
requirements. 21 U.S.C. § 360c(a)(1)(A). Class II
devices pose moderate health risks. The original MDA
definition of a Class II device identified performance
standards as the means by which the FDA could reasonably
ensure safety and effectiveness. The Safe Medical Devices Act
of 1990 (“SMDA”), Pub. L. 101-629, added various
“special controls” for this purpose. The special
controls may include FDA guidance documents, premarket data
requirements, performance standards, postmarket surveillance
measures, and patient registries. 21 U.S.C. §
360c(a)(1)(B). Class III includes devices used to support
human life, such as pacemakers and hearts valves, and devices
that pose a high risk of injury. 21 U.S.C. §
360c(a)(1)(C). They receive the highest level of regulatory
control. IVC filters originally were designated as
Class III devices, but were moved to Class II, along with
many other pre-MDA devices, in 2000. See 65 Fed.
Reg. 17138, 17144 (Mar. 31, 2000); 21 C.F.R. § 870.3375.
applies different levels of scrutiny to medical devices
before approving or clearing them for market, and the level
of scrutiny can affect whether state laws are preempted. The
most rigorous level of scrutiny is known as “premarket
approval, ” often referred to as the “PMA
process.” 21 U.S.C. § 360e(a). To comply, a
manufacturer must file an application that provides a wide
range of detailed information to the FDA in order to
demonstrate that the device is safe and effective.
See 21 U.S.C. § 360e(c). If the FDA finds the
device safe and effective, it approves the device for
medical devices can be cleared for market through a less
rigorous process known as section “510(k)” review
after the original statutory provision describing the review.
A manufacture can satisfy this level of review, and be exempt
from the PMA process, by providing premarket notice to the
FDA that its device is “substantially equivalent”
to a predicate device already on the market. §
360c(f)(1)(A). This 510(k) review is more streamlined than
the PMA process and focuses primarily on equivalence rather
than safety and effectiveness. If a 510(k) notice results in
an FDA finding of substantial equivalence, the device is
cleared for marketing.
maintains a bright line between devices
“approved” through the PMA process and devices
“cleared” through 510(k) review. PMA approval
results in a finding of safety and effectiveness, while
510(k) clearance results only in a finding of substantial
equivalence. FDA regulations require manufacturers to
maintain this distinction:
Submission of a [510(k) notice] in accordance with this
subpart, and a subsequent determination by the Commissioner
that the device intended for introduction into commercial
distribution is substantially equivalent to a device in
commercial distribution . . . does not in any way denote
official approval of the device. Any representation that
creates an impression of official approval of a device
because of complying with [510(k) notification] is misleading
and constitutes misbranding.
21 C.F.R § 807.97.
Bard IVC filters at issue in this case, like most medical
devices on the market today, received FDA clearance through
510(k) review. Each Bard filter was deemed to be
substantially equivalent to a predicate filter already on the
market. No Bard filter has received FDA approval through the
allege that Bard IVC filters are defective. Plaintiffs
contend that the filters tilt, perforate the IVC, and
fracture and migrate to neighboring organs such as the heart
and lungs. Plaintiffs claim that Bard filters are more
dangerous than other kinds of IVC filters, and that Bard
concealed adverse information and otherwise failed to warn
the medical community and the public about the risks posed by
its filters. Bard vigorously disputes Plaintiffs'
allegations of high risk levels, contending that overall
complication rates associated with Bard filters are low and
comparable to those of other IVC filters.
master complaint asserts 17 causes of action under various
state laws: strict product liability claims for
manufacturing, information, and design defects (Counts
I-III); negligence claims for design, manufacturing, failure
to recall or retrofit, failure to warn, misrepresentation,
and per se negligence (Counts IV-IX); breach of warranties
(Counts X-XI); fraudulent misrepresentation and concealment
(Counts XII-XIII); consumer fraud and unfair trade practices
(Count XIV); loss of consortium (Count XV); wrongful death
(Count XVI); and survival claims (Count XVII). Doc.
seeks summary judgment on each cause of action, arguing that
the MDA preempts them all. Doc. 5396 at 14-34. For reasons
explained below, the Court finds that Bard has not met its
burden of establishing preemption and therefore will deny
Summary Judgment Standard.
seeking summary judgment “bears the initial
responsibility of informing the district 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 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 is to be believed, and all
reasonable inferences are to be drawn in that party's
favor, because the weighing of evidence and drawing of
inferences are jury functions. Id. at 255.
Basic Preemption Principles.
a transferee court receives a case from the MDL Panel, the
transferee court applies the law of the circuit in which it
is located to issues of federal law.” In re Gen.
Am. Life Ins. Co. Sales Practices Litig., 391 F.3d 907,
911 (8th Cir. 2004). In this case, that would be the law of
the Ninth Circuit. Thus, in performing its federal preemption
analysis, the Court will look primarily to Supreme Court and
Ninth Circuit cases.
Supremacy Clause provides a clear rule that federal law
‘shall be the supreme Law of the Land; and the Judges
in every State shall be bound thereby, anything in the
Constitution or Laws of any State to the Contrary
notwithstanding.'” Arizona v. United
States, 567 U.S. 387, 399 (2012) (quoting U.S. Const.
art. VI, cl. 2). Under this clause, “Congress has the
power to preempt state law.” Crosby v. Nat'l
Foreign Trade Council, 530 U.S. 363, 372, (2000).
purpose of Congress is the ultimate touchstone'” in
determining whether Congress has preempted a state law.
Cipollone v. Liggett Grp., Inc., 505 U.S. 504, 516
(1992) (quoting Malone v. White Motor Corp., 435
U.S. 497, 504 (1978)). Federal preemption may be either
express or implied. Attay v. Cty. of Maui, 842 F.3d
688, 699 (9th Cir. 2016). Where there is no express
congressional command, a state law is impliedly preempted if
“it actually conflicts with federal law[.]”
Id. (citing Cipollone, 505 U.S. at 516).
Conflict preemption occurs “where compliance with both
federal and state regulations is a physical
impossibility[.]” Arizona, 567 U.S. at 399
(internal citations and quotation marks omitted).
the intent of a statutory provision that speaks expressly to
the question of preemption is at issue, ‘[courts] do
not invoke any presumption against pre-emption but instead
focus on the plain wording of the clause, which necessarily
contains the best evidence of Congress' pre-emptive
intent.'” Attay, 842 F.3d at 699 (quoting
Puerto Rico v. Franklin Cal. Tax-Free Trust, __ U.S.
__, 136 S.Ct. 1938, 1946 (2016)). Where there is no express
preemption and a federal statute regulates in an area
“traditionally occupied by states, such as health,
safety, and land use, a ‘presumption against
preemption' adheres.” Gobeille v. Liberty Mut.
Ins. Co., __ U.S. __, 136 S.Ct. 936, 946 (2016) (quoting
Wyeth v. Levine, 555 U.S. 555, 565 n.3 (2009)).
Court first will discuss express preemption under § 360k
of the MDA, and then turn to implied preemption.
Section 360k of the MDA includes this express preemption
Except as provided in subsection (b) of this section, no
State or political subdivision of a State may establish or
continue in effect with respect to a device ...