United States District Court, D. Arizona
Maria E. Barraza, et al., Plaintiffs,
C. R. Bard Inc., and Bard Peripheral Vascular Inc., Defendants.
G. Campbell United States District Judge.
Maria E. Barraza and others bring this case against
Defendants C.R. Bard, Inc. and Bard Peripheral Vascular Inc.
(collectively, “Bard”) seeking medical
monitoring. Plaintiffs sue on behalf of themselves and
classes of individuals who have been implanted with a Bard
inferior vena cava filter, have not had that filter removed,
and have not filed a claim or lawsuit for personal injury
related to the filter. Doc. 57-2 at 36-41, ¶ 206.
Plaintiffs have filed a motion for class certification. Doc.
54. The motion is fully briefed, and the Court heard oral
arguments on August 21, 2017. Docs. 54, 72, 78,
For reasons that follow, the Court will deny Plaintiffs'
inferior vena cava (“IVC”) is a large vein that
carries de-oxygenated blood from the lower body to the heart.
This case concerns seven of Defendants' IVC blood filters
that were manufactured and marketed starting in 2003 for
either permanent or temporary use. Doc. 54-1 at
IVC filters are small devices placed in the IVC to stop blood
clots from travelling to the lungs. The Bard IVC filters at
issue in this case are the Recovery®, G2®, G2®
Express, G2®X, Eclipse®, Meridian®, and
Denali® filters. Doc. 72 at 9.
allege that these filters have defects that put users at an
unacceptable risk of serious injury or death. Id. at
5-6. Plaintiffs contend that the Bard filters tilt, perforate
the IVC, and fracture and migrate to neighboring organs such
as the heart and lungs. Id. Fractures can occur
without notice or symptoms until serious physical injury or
death occurs. Id. Plaintiffs cite a wide range of
medical sources and Bard documents to support their claim
that Bard IVC filters are more dangerous than other kinds of
IVC filters. Doc. 54-1 at 5-20.
dispute Plaintiffs' allegation of high risk levels,
contending that the overall complication rates associated
with Bard IVC filters are low. Doc. 72 at 11. Defendants note
that there are many IVC blood filters on the market, that all
of these products involve risks that physicians and patients
must consider when deciding whether the patient's medical
condition warrants the implant of a blood filter, and that
failure rates for Bard filters are comparable to those of
other IVC filters. Defendants contend that the various
warnings cited by Plaintiffs - issued by the FDA and other
professional groups - apply to all blood filters, not just
Bard filters. Id. at 9-11.
the FDA and various medical organizations have recommended
monitoring of all patients with IVC filters, physicians
follow-up with such patients at relatively low rates. Doc.
54-1 at 16-19; Doc. 72 at 10. Removals of IVC filters, even
those intended to be temporary, also occur at low rates.
Id. Each of the Plaintiffs and proposed class
members currently have Bard filters implanted in their
IVC's, and bring this action to obtain medical monitoring
to reduce the risk presented by such filters. This Court
currently is presiding over a multidistrict litigation
proceeding (MDL) involving more than 2, 500 personal injury
cases arising out of Bard filters. This class action involves
many of the same attorneys and has been following a
coordinated litigation track with the MDL, but is otherwise
filed their motion for class certification on June 5, 2017,
after almost a year of class-related discovery and expert
disclosures. Docs. 22, 54. The motion recognized that only 16
states permit claims for medical monitoring, and sought
certification of a single class that includes filter
recipients who reside in those states:
Plaintiffs move to certify a class covering each of the
states that allow medical monitoring as a cause of action or
remedy. The proposed class is defined to include all
individuals in the sixteen jurisdictions that allow medical
monitoring without manifest physical injury, who have been
implanted with a Bard retrievable filter since July 25, 2003
(the date Bard received clearance to market the first of its
filters as retrievable) to the present, who have not had
their filters removed (and are at least ninety days
post-implant), and who have not filed a personal injury
lawsuit concerning their Bard filter.
Doc. 54-1 at 21.
motion recognizes that this case includes only 11 named
Plaintiffs from 11 of the 16 states, but asserted that these
individuals could represent persons from the five states that
have no named Plaintiff. Id. at 23 n.20. To
demonstrate the feasibility of this class and a trial that
encompasses all 16 states, Plaintiffs presented a trial plan
which asserts that the elements of medical monitoring claims
are the same in all 16 states. Id. at 37-69.
Plaintiffs identify these common elements: (1) exposure, (2)
to a toxic substance or hazard, (3) which exposure was caused
by Defendants' negligence or tortious conduct, (4)
resulting in an increased risk of a serious illness or
injury, (5) for which a medical test for early detection
exists, (6) is reasonably necessary, and (7) is beyond that
which is offered in the ordinary course. Id. at 27.
responded to this proposed class, noting significant
differences among the laws of the 16 states to be included in
the proposed class. Doc. 72-8. Defendants made other
arguments regarding the suitability of the proposed class
under Rule 23.
changed significantly at the class certification hearing.
Plaintiffs' counsel stated that they were not seeking
certification of a single class for all 16 states, but
instead were seeking certification of 16 separate classes,
one for each state that allows medical monitoring claims.
Doc. 94 at 50-51. Plaintiffs stated that they had provided
the Court with a single trial plan because they seek a
consolidated trial of all 16 classes, and they believe the
Court could give a single set of jury instructions that
blended the laws of the 16 states. When it was noted that 5 of
the 16 states have no class representative, Plaintiffs'
counsel argued that the Court could certify the classes for
these 5 states without a class representative. Id.
at 74. When this proposition was challenged - the Court noted
that Rule 23(a) cannot be satisfied without a class
representative - Plaintiffs' counsel changed tack again,
stating that “[w]e are only asking that you certify the
states at this time where we have identified a rep. If the
Court does certify those states, we would ask for leave to
add additional reps in the states that don't have reps at
the moment.” Id. at 74-75. This was
Plaintiff's final position, and the one the Court will
address in this order.
Plaintiffs seek certification of classes consisting of
persons with Bard filters in the following 11 states:
Arizona, California, Colorado, Florida, Illinois, Maryland,
Massachusetts, Missouri, Ohio, Pennsylvania, and West
Virginia. Each of these classes is represented by a single
Rule 23(a), a district court may certify a class only if (1)
it is so numerous that joinder of all members is impractical,
(2) there are questions of law or fact common to the class,
(3) the claims of the representative parties are typical of
the claims of the class, and (4) the representatives will
fairly and adequately protect the interests of the class.
Fed.R.Civ.P. 23(a)(1)-(4). For reasons explained later in
this order, the Court finds that the named Plaintiffs are not
typical of the class members. The other requirements of Rule
23(a) are satisfied.
Court must also find that one of the requirements of Rule
23(b) has been met. Plaintiffs seek class certification under
both Rule 23(b)(2) and 23(b)(3). Doc. 54. Rule 23(b)(2)
permits certification if “the party opposing the class
has acted or refused to act on grounds generally applicable
to the class, thereby making appropriate final injunctive
relief or corresponding declaratory relief with respect to
the class as a whole.” Fed. R. Civ. P 23(b)(2). Rule
23(b)(3) provides that class certification is appropriate if
questions of law or fact common to the class predominate over
questions affecting only individual class members, and if a
class action would be superior to other available methods for
resolving the controversy. Fed.R.Civ.P. 23(b)(3).
Court must rigorously analyze the proposed classes to ensure
they comport with Rule 23. See Wal-Mart Stores, Inc. v.
Dukes, 564 U.S. 338, 351 (2011).
Rule 23(b)(3) predominance inquiry tests whether proposed
classes are sufficiently cohesive to warrant adjudication by
representation.” Amchem Prods., Inc. v.
Windsor, 521 U.S. 591, 623 (1997); accord In re
Wells Fargo Home Mortg. Overtime Pay Litig., 571 F.3d
953, 957 (9th Cir. 2009). “This calls upon courts to
give careful scrutiny to the relation between common and
individual questions in a case.” Tyson Foods, Inc.
v. Bouaphakeo, 136 S.Ct. 1036, 1045 (2016).
whether ‘questions of law or fact common to class
members predominate' begins, of course, with the elements
of the underlying cause of action.” Erica P. John
Fund, Inc. v. Halliburton Co., 563 U.S. 804, 809 (2011).
Plaintiffs argue that medical monitoring claims in all the
relevant jurisdictions have the following elements: (1)
exposure, (2) to a toxic substance or hazard, (3) which
exposure was caused by the defendant's negligence or
tortious conduct, (4) resulting in an increased risk of a
serious illness or injury, (5) for which a medical test for
early detection exists, (6) is reasonably necessary, and (7)
is beyond that which is offered in the ordinary course. Doc.
54-1 at 27. The Court will focus on these elements in
deciding whether common or individual issues predominate in
the proposed classes.
Elements One & Two: Exposure to a Toxicity or
first two elements of the medical monitoring claim - exposure
to a toxic substance or hazard - will not produce significant
individual issues. Defendants do not dispute that the named
Plaintiffs each have been implanted with Bard IVC filters,
nor that thousands of additional individuals currently carry
such filters. Thus, unlike a case where exposure to toxic
substances might require individualized proof, exposure to
Bard filters exists for each person who has received such a
filter. Although proof that class members received Bard
filters would be required during the claim phase if the
classes were certified and successful, that fact could be
established with relative ease in an administrative process.
respect to the alleged hazards of Bard filters, Plaintiffs
intend to make their case through generalized evidence of
failure rates, FDA warnings, expert testimony, and other
common evidence. Defendants will respond with similar general
evidence. Defendants do not contend that individual issues
will predominate on this element.
Element Three: Negligence and Causation.
satisfy the third element, Plaintiffs must show that they
face an increased risk of injury and require monitoring
because of Defendants' negligence in designing the
filters and failing to warn of their risks. Doc. 54-1 at
Plaintiffs argue that they can establish this element with
class-wide law and evidence - whether Defendants owed a duty
to Plaintiffs is a question of law that will not vary among
class members, and whether Defendants were negligent in
designing and marketing the filters will be decided on the
basis of Defendants' actions, not individual issues.
disagree. They assert that Plaintiffs' proof of
negligence will raise a wide range of issues. The classes
include seven different Bard filters manufactured and
marketed at different times over the course of more than 15
years. Doc. 72 at 20-21. Defendants contend that the design
processes and warnings for these filters varied across kinds
of filters and over time, as did Defendants' knowledge
concerning the risks associated with the filters.
Id. (citing Doc. 74-4, Exhibit 11).
Design and Testing Issues.
Plaintiffs' proposed state classes includes all seven of
the Bard filters at issue in this case. Plaintiffs allege
that each of the filters was negligently designed. Trial of
each of the classes will therefore include the design history
and risks of each of these seven filters. And these facts
must be evaluated in the context of what was reasonable at
the time each filter was designed and marketed. See,
e.g., Muller v. Synthes Corp., No. 99 C 1492,
2002 WL 460827, at *7 (N.D. Ill. Mar. 26, 2002) (to prove
negligent design under Illinois law, the plaintiff must show
that the defendant deviated from the standard of care that
other manufactures of similar products followed at the time
the relevant product was designed). In at least some of the
states, proof of negligent design requires consideration of
safer alternatives or the state of the art at the time the
filter was designed or first sold. See, e.g.,
A.R.S. 12-683(1) (a defendant shall not be liable in a
product liability case if “[t]he defect in the product
is alleged to result from inadequate design or fabrication,
and if the plans or designs for the product or the methods
and techniques of manufacturing, inspecting, testing and
labeling the product conformed with the state of the art at
the time the product was first sold by the
defendant.”). Thus, the Court and the jury will need to
consider the design of each filter.
seven Bard IVC filters were introduced to the market in the
following years: Recovery® in 2002 for permanent use and
2003 for retrievable use; G2® in 2005 for permanent use
and 2008 for retrievable use; G2® Express and G2®X in
2008; Eclipse® in 2010; Meridian® in 2011; and
Denali® in 2013. Doc. 74-4. Each of these filters was a
variation of earlier generations, but with several changes.
Id. For example, the G2® filter had the
following changes from the Recovery® filter: (1)
increased hook wire diameter of approximately 24%; (2)
increased nominal leg span of 25%; (3) increased nominal arm
length of approximately 50%; (4) curved instead of straight
arm tips; and (5) increased radius of curvature on arms at
the sleeve. Doc. 74-4 at 8.
G2® Express and G2®X filters had the following
changes from earlier versions: (1) modification of the filter
tip to include a snare tip to allow retrievability with
commercially available snares; (2) the snarable tip was
electropolished instead of having a machine polished straight
tip with no snare; and (3) the filter height was greater with
the addition of a snarable tip. Id. at 13.
Eclipse® filter was introduced with these changes over
prior versions: the nitinol wire used to form the arms and
legs was electropolished prior to filter assembly and
annealing. Id. at 14. The Meridian® filter added
to alternating filter arms (1) a “shoulder
anchor” made out of titanium alloy tube with an in-line
anchor tip to improve caudal movement/migration resistance,
and (2) a “wrist anchor” made out of titanium
alloy tube with an offset anchor tip to improve caudal
movement/migration resistance. Id. at 15.
Denali® filter included these modifications: (1)
fabricated differently; (2) different leg spans; (3)
different arm spans; (4) different unconstrained height; (5)
staggered leg lengths; (6) four instead of six legs with
cranial anchors; (7) addition of caudal anchors to two filter
legs; (8) addition of penetration limiter on each filter leg;
and (9) electropolished following filter assembly.
Id. at 17.
various generations of Bard filters also underwent separate
testing. For example, the Recovery® filter underwent
bench testing of clot trapping efficiency, migration
resistance, hook strength, radial strength, weld integrity,
creep study of filter hooks, EnduraTEC fatigue testing,
simulated use, rotating-beam corrosion fatigue testing,
optimum welding parameters, wire tensile test, and finite
element analyses. Id. at 4. The Recovery® filter
also underwent the following animal studies: in-vivo
evaluation for permanent indication and early removal, and
in-vivo evaluation for long-term removal indication.
Id. at 5. A clinical study was conducted by Dr.
Murray Asch, who investigated the safety and effectiveness of
the Recovery® filter in approximately 60 patients.
Id. Other tests were performed for other generations
of filters. See Doc. 74-4.
allege that structural and manufacturing differences between
the filters are insignificant and that tests on the various
filters were deficient. They note that the filters were
approved by the FDA through the § 510(k) clearance
process, not the FDA's more onerous pre-market approval
process for new devices. See 21 C.F.R. §
807.87, 807.92, 807.93 (2012). But even in the face of these
arguments, there are still design, manufacturing, and testing
differences between the various generations of Bard filters
that would need to be addressed at trial. Whether the
manufacturing changes and product tests were sufficient to
ensure the safety of the filters is hotly contested and would
be decided by the trier of fact, but only in the context of
seven generations of filters with differing specifications
and testing histories. And for states that require a
comparison to the state of the art, the design and
manufacturing standards for blood filters generally would
also have to be considered for each year.
Failure to Warn Issues.
Recovery® filter was approved by the FDA for permanent
use in November 2002 and for retrievable use in July 2003.
Doc. 74-4 at 5. Bard's “instructions for use”
included the following warnings:
Migration of the filter. This may be caused by placement in
oversized vena cava diameters exceeding 28 mm or if proper
anchoring techniques are not utilized.
Perforation of the vena cava wall. This may occur if improper
insertion technique is not utilized.
Caval occlusion. The probability of this occurring should be
weighed against the inherent risk/benefit ratio for a patient
who is experiencing pulmonary embolism, or who is likely to
do so without intervention.
October 2003, the warnings were revised to include this
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
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 been reported in association with improper
deployment, deployment into clots and/or dislodgment due to
large clot burdens.
Procedures requiring percutaneous interventional techniques
should not be attempted by physicians unfamiliar with the
possible complications. Complications may occur at any time
during or after the procedure. Possible complications
include, but are not limited to, the following: Movement or
migration of the filter is a known complication of vena cava
filters. . . . Filter fracture is a known complication of
vena cava filters. . . . Perforation or other acute or
chronic damage of the IVCwall; Acute or recurrent pulmonary
embolism. This has been reported despite filter usage. It is
not known if thrombi passed through the filter, or originated
from superior or collateral vessels; Caval
thrombosis/occlusion; Extravasation of contrast material at
time of venacavogram; Air embolism; Hematoma or nerve injury
at the puncture site or subsequent retrieval site;
Hemorrhage; Restriction of blood flow; Occlusion of small
vessels; Distal embolization; Infection; Intimal tear;
Stenosis at implant site. All these above complications have
been associated with serious adverse events such as medical
intervention and/or death. 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.
Id. at 6-8. Bard also sent letters to doctors in
December 2004 or January 2005 alerting them to these revised
instructions for use. Id. at 8.
G2® filter was approved by the FDA for retrievable use in
2008. The instructions for use included these warnings:
There have been reports of complications, including death,
associated with the use of vena cava filters in morbidly
* * *
NOTE: It is possible that complications such as those
described in the ‘Warnings, Precautions, and Potential
Complications' section of this Instructions for Use may
affect the recoverability of the device and result in the