Nelson v. C. R. Bard, Incorporated

Case: 21-60689 Document: 00516426750 Page: 1 Date Filed: 08/10/2022
United States Court of Appeals
for the Fifth Circuit United States Court of Appeals
Fifth Circuit
FILED
August 10, 2022
No. 21-60689 Lyle W. Cayce
Clerk
Dennis Nelson; Kathy Nelson,
Plaintiffs—Appellants,
versus
C. R. Bard, Incorporated; Bard Peripheral Vascular,
Incorporated,
Defendants—Appellees.
Appeal from the United States District Court
for the Southern District of Mississippi
USDC No. 2:19-CV-135
Before Higginson, Willett, and Ho, Circuit Judges.
Stephen A. Higginson, Circuit Judge:
In this products liability case, plaintiffs, Dennis Nelson and his wife,
Kathy Nelson (“the Nelsons”) sued defendants, C.R. Bard, Inc. and Bard
Peripheral Vascular, Inc. (“Bard”), due to complications Dennis Nelson
experienced after implantation of a filter used as a medical device. The
Nelsons now appeal the district court’s grant of summary judgment to Bard
on their failure to warn and design defect claims. We AFFIRM.
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I.
A.
The Nelsons brought this product liability action after Dennis Nelson
experienced complications following the implantation of an inferior vena
cava filter, called the Recovery IVC Filter (the “Filter”). Generally, such
filters are placed inside the body in an effort to prevent blood clots from
reaching critical organs such as the heart, lungs, or brain. The Filter, a
“venous interruption device[] designed to prevent pulmonary embolism,” is
designed, manufactured, marketed, and sold by Bard. It was approved by the
FDA as an optional retrievable filter in 2003 and could thus be used
permanently or temporarily. 1
Each Filter comes with an Information for Use pamphlet (“IFU”)
that sets forth various pieces of information, including warnings, precautions,
and instructions. Under the bolded “Warnings” heading, the IFU read, in
relevant part:
8. 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.
9. 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,
1
Though the parties appear to dispute whether the Filter was intended to be used
on a permanent or temporary basis when implanted in Dennis Nelson, neither party
provides a record cite directly supporting their position.
2
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deployment into clots and/or dislodgment due to large clot
burdens.
(emphasis added). The IFU also contained a section titled “Potential
Complications,” and this section included the following information (bold at
end in original):
Procedures requiring perculaneous 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. 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.
• 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.
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• Extravasation of contrast material at time of
venacavogram.
• Air embolism.
• Hemaloma or nerve injury at the puncture site or
subsequent retrieval site.
• Hemorrhage.
• Restriction of blood blow.
• 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.
The Filter was restricted to sale “by or on the order of a physician.”
As early as May 2004, Bard internal emails referencing the Filter
began to note that there were complications associated with it. Then, on
December 17, 2004, Bard’s medical director issued an internal document
titled “Health Hazard Evaluation” concerning a consultant’s report on the
Filter. The internal Bard document stated, in part:
An analysis of reporting rates of serious adverse events for all
inferior vena cava filters, as determined by analysis of the
MAUDE and IMS databases by a consultant, revealed that
reporting rates for Recovery are significantly higher than other
filters. However, these databases are subject to known,
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significant biases that make calculation or comparison of
incidence rates among products unreliable and inadvisable . . . .
Nevertheless, the number of reported complaints, and the size
of the differences between Recovery and other filters, warrant
further investigation.
The document continued:
Reports of death, filter migration (movement), IVC
perforation, and filter fracture associated with Recovery filter
were seen in the MAUDE database at reporting rates that
were 4.6, 4.4, 4.1, and 5.3 higher, respectively, than reporting
rates for all other filters. These differences were all statistically
significant. Recovery’s reporting rates for all adverse events,
filter fracture, filter migration, and filter migration deaths were
found to be significantly higher than those for other removable
filters.
On May 16, 2005, Dr. Daniel DeVun implanted Dennis Nelson with a
Filter. Dr. DeVun performed this procedure as a prophylactic measure to
prevent deep venous thrombosis and pulmonary embolism prior to Dennis
Nelson’s temporary cessation of anticoagulation medication in anticipation
of a liver transplant. Medical imaging taken fourteen years later in 2019
revealed that the Filter had fractured. Some of the struts of the Filter had
penetrated through the inferior vena cava wall, and some migrated to other
parts of Nelson’s body. Nelson underwent three surgical procedures to
remove the Filter and its fragments. Though the procedures were partially
successful, one fragment remains in Nelson’s pulmonary artery.
B.
In September of 2017, the Nelsons brought a product liability action
against Bard, as a part of a multidistrict litigation suit. The case was
transferred to the Southern District of Mississippi in September of 2019. In
March of 2021, both the Nelsons and Bard filed motions for summary
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judgment. Thereafter, the district court held a hearing on the dueling
motions.
On August 6, 2021, the district court granted Bard’s motion for
summary judgment. It first addressed the Nelsons’ failure to warn and design
defect claims under the Mississippi Products Liability Act (MPLA). The
court held that the IFU “expressly warned” the treating physician of the
“very complications” that Nelson ultimately suffered; thus, the warnings
were adequate as a matter of law. The district court also addressed Plaintiffs’
theory that the warning was inadequate “because the IFU did not list the
comparative rates of occurrence of complications relative to a predecessor
Bard device and other IVC filters,” and held that it had no merit. The court
reasoned that Mississippi law does not support the conclusion that a failure
to provide comparative-risk information renders a warning inadequate and
that requiring comparative risk information to be included would be a
problematic slippery slope.
On the design defect claim, the district court held that even though
the Nelsons’ expert, Dr. McMeeking, had testified to a design defect, the
Nelsons had nevertheless “failed to adduce sufficient evidence to create [a]
jury question on the issue of causation in fact,” since “[t]here is no testimony
or evidence cited by the Plaintiff that ties the specific design defect identified
by Dr. McMeeking to the damages for which Plaintiffs seek recovery.”
Alternatively, the district court held that the Nelsons had failed to raise a
genuine issue of material fact as to a feasible design alternative under
Mississippi law. 2 The Nelsons appealed.
2
It is notable that the Nelsons originally raised numerous other claims, including,
inter alia, negligent misrepresentation and fraudulent concealment. It appears that the
Nelsons agreed, however, that these claims were “subsumed” in their MPLA failure to
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II.
We review a grant of summary judgment de novo. Doe v. United States,
831 F.3d 309, 317 (5th Cir. 2016). Summary judgment should be granted “if
the movant 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). When weighing the evidence at summary judgment, all factual
inferences are viewed in the light most favorable to the party opposing the
motion. Baker v. Am. Airlines, Inc., 430 F.3d 750, 753 (5th Cir. 2005).
In diversity jurisdiction actions, the substantive law of the state in
which the district court hearing the action sits controls. Erie R.R. v.
Thompkins, 304 U.S. 64, 78 (1938); Capital City Ins. Co. v. Hurst, 632 F.3d
898, 902 (5th Cir. 2011). Both parties agree that Mississippi law controls this
case. Under Mississippi law, the Mississippi Product Liability Act (MPLA)
“applies ‘in any action for damages caused by a product,’” including actions
asserting failure to warn and design defect claims. Elliott v. El Paso Corp., 181
So. 3d 263, 268 (Miss. 2015) (quoting MISS. CODE ANN. § 11-1-63).
III.
A.
“In a failure-to-warn case, a plaintiff must show by the preponderance
of the evidence that the product was defective because it failed to contain
adequate warnings or instructions, the defective condition rendered the
product unreasonably dangerous to the user or consumer, and the defective
and unreasonably dangerous condition of the product proximately caused the
warn and design defect claims; regardless, the Nelsons raise no issue relating to the district
court’s resolution of them.
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damages for which recovery is sought.” Id. at 273 (cleaned up). The MPLA
describes adequate warnings or instructions as follows:
(i) In any action alleging that a product is defective because it
failed to contain adequate warnings or instructions pursuant to
paragraph (a)(i)2 of this section, the manufacturer, designer or
seller shall not be liable if the claimant does not prove by the
preponderance of the evidence that at the time the product left
the control of the manufacturer, designer or seller, the
manufacturer, designer or seller knew or in light of reasonably
available knowledge should have known about the danger that
caused the damage for which recovery is sought and that the
ordinary user or consumer would not realize its dangerous
condition.
(ii) An adequate product warning or instruction is one that a
reasonably prudent person in the same or similar
circumstances would have provided with respect to the danger
and that communicates sufficient information on the dangers
and safe use of the product, taking into account the
characteristics of, and the ordinary knowledge common to an
ordinary consumer who purchases the product; or in the case
of a prescription drug, medical device or other product that is
intended to be used only under the supervision of a physician
or other licensed professional person, taking into account the
characteristics of, and the ordinary knowledge common to, a
physician or other licensed professional who prescribes the
drug, device or other product.
MISS. CODE ANN. § 11-1-63(c). Because the district court granted
summary judgment for Bard on the failure to warn claim, we must decide
whether the Nelsons are able to show a genuine dispute of material fact so
that the claim should have gone to the jury.
We begin by addressing the district court’s holding that the warnings
were adequate as a matter of law. “An adequate warning is one reasonable
under the circumstances.” Janssen Pharmaceutica, Inc. v. Bailey, 878 So. 2d
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31, 55 (Miss. 2004). “To be reasonable, the warning should neither
understate nor overstate the known risks associated with the use of a
particular product.” Id. at 58 (quoting Thomas v. Hoffman-Laroche, Inc., 949
F.2d 806, 815 (5th Cir. 1992)). Ordinarily, the adequacy of a warning is a
factual matter that will be determined by the trier of fact. Union Carbide Corp.
v. Nix, 142 So. 3d 374, 389 (Miss. 2014).
Here, the district court held that the IFU “expressly warned” the
treating physician of the “very complications” that Dennis Nelson
ultimately suffered; thus, the warnings were adequate as a matter of law.
Indeed, the IFU in its bolded “Warnings” explicitly warns of fracture and
migration as “known complication[s],” the very complications that allegedly
caused Nelson’s injuries.
This Court has previously confirmed that “[i]n Mississippi, a warning
may be held adequate as a matter of law where the adverse effect was one that
the manufacturer specifically warned against.” Austin v. Will-Burt Co., 361
F.3d 862, 868 (5th Cir. 2004); see also Williams v. Manitowoc Cranes, L.L.C.,
898 F.3d 607, 616 (5th Cir. 2018) (same). In Austin, a television news van’s
telescoping mast “became entangled with the power lines, sending 8,000
volts through the mast and electrifying the van,” and an employee touched
the van leading to “a fatal electric shock.” 361 F.3d at 864. This Court held
that the “warnings on the mast clearly connected contact with power lines
and risk of death” and, thus, they were adequate. Id. at 868-69. This Court
affirmed the district court’s grant of summary judgment to defendants. Id. at
864.
Instructively, in Williams v. Manitowoc Cranes, the dispute over the
adequacy of the warning “center[ed] on whether Manitowoc needed to warn
operators about the specific hazard that counterweights could fall during a tip-
over.” 898 F.3d at 616. Manitowoc argued that warning about the general
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hazards of tipping over, combined with instructions about how to avoid a tip-
over, constituted adequate warning. Id. This Court disagreed, holding that
the jury had an adequate basis for finding the warning inadequate and finding
that a reasonably prudent person “would have informed crane operators
about the unique danger posed by falling counterweights.” Id. at 617. The
Court explained:
Manitowoc[] . . . failed to warn about the specific “adverse
effect” of a counterweight falling, crushing the operator cab,
and ejecting the operator from the cab. The . . . [manual]
provided no guidance about precautions for avoiding the falling
counterweight hazard. Instead, it discussed only in broad terms
the harms that could result from a tip-over.
We cannot conclude as a matter of law that Manitowoc
adequately warned crane operators about the falling
counterweight danger.
Id. at 617. In between these confirming decisions from our Court, the
Mississippi Supreme Court itself issued the decision Johnson & Johnson v.
Fortenberry, 234 So. 3d 381 (Miss. 2017). The Court explained that the label
at issue “warned physicians that tardive dyskinesia might develop in patients
treated with antipsychotic drugs” and additionally “warned that whether
antipsychotic drug products differ in their potential to cause tardive
dyskinesia was unknown.” Id. at 393. The Court therefore held that the label
warned the treating doctor “specifically of the danger of tardive dyskinesia
in no uncertain terms and was sufficiently adequate as a matter of law.” Id.Taken together, these cases support the district court’s holding that
the IFU warnings were adequate as a matter of law. As in Fortenberry and
Austin, and unlike in Williams, where the defendants failed to specifically
address the hazard of falling counterweights, the IFU warned of the exact
complications that allegedly caused Dennis Nelson’s injuries. Nor did it do
so in uncertain terms: the IFU emphasized that fracture and migration are
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“known complication[s].” The Nelsons do not persuasively argue that there
were any specific complications of the Filter that the IFU failed to warn of. 3
Instead, the Nelsons primarily argue that the warning was inadequate
because Bard failed to disclose comparative rates of risk associated with
other, similar filters. The district court noted the problematic policy
concerns that would follow potential liability for failure to include comparative
device risk information in warnings. We do not address policy considerations,
however perceptive; nor do we conclusively decide as a matter of Mississippi
law whether a warning, using other language and in other circumstances,
might be inadequate for failing to include undisclosed same-device
“dangers” (plural, as in the statute). Cf. Munson v. C.R. Bard, Inc., 561 F.
Supp. 3d 655 (N.D. Miss. 2021) (statutory analysis of MPLA). 4 Instead, we
hold only that the district court correctly entered summary judgment here,
on the Nelsons’ inadequate warning claim because the Nelsons fail to
discuss, in any meaningful way, the warning language itself.
Rather than explaining why the text of the warning was inadequate, the
Nelsons argue to us that Bard concealed and omitted risk data and thereby
provided “insufficient warning of incidence and seriousness” and,
specifically, that Bard failed to warn physicians of high complication rates
3
The Nelsons spend a portion of the failure to warn section of their brief apparently
arguing that the IFU warning was inadequate because it lacked information addressing the
timeline of removal. Bard responds that the Nelsons forfeited this argument by failing to
raise it in the district court. We agree. Though the Nelsons did discuss “permanent” filters
in detail before the district court, it was within the context of comparative risk, not in the
context of language in the IFU. Accordingly, we hold that they have forfeited the
argument. See Rollins v. Home Depot USA, Inc., 8 F.4th 393, 397-98 (5th Cir. 2021) (holding
that a plaintiff forfeits an argument “that a fact dispute precluded summary judgment by
failing to raise it first before the district court”).
4
This case was never raised by the Nelsons, but we have benefitted from its
statutory analysis.
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that it was aware of at the time. They argue that the information that was
concealed was so “egregious” that the “IFU is per se inadequate.” In making
this concealed-information argument, they rely on internal documents. Yet
in Fortenberry, the Mississippi Supreme Court explained that failure to warn
cases must be based upon the warning label itself—its text and language—
rather than internal documents:
Taylor’s attempt to prove her failure to warn claims through
Janssen’s marketing materials and internal documents
expanded the claim beyond the statutory scope of the Products
Liability Act. Based on the terms of the Act, enacted in 1993,
the only pertinent question is whether the prescription drug
label contained adequate warnings or instructions.
...
The Court does not consider Janssen’s marketing materials or
internal documents as support of Taylor’s failure to warn claim
under the Products Liability Act in determining the adequacy
of the Risperdal label. Taylor’s attempt to support her failure
to warn claim with Janssen’s marketing materials and internal
documents improperly expands the statutory scope of her
claim.
234 So. 3d at 393 (citations omitted). 5
Like the plaintiff in Fortenberry, the Nelsons quote from internal Bard
emails and the 2004 Health Hazard Evaluation to assert that “Bard did not
set forth its own internal data or information concerning the failure rates of
5
It is noteworthy that in Fortenberry itself, the label at issue affirmatively stated that
“[w]hether antipsychotic drug product differ in their potential to cause Tardive Dyskinesia
is unknown,” Fortenberry, 234 So. 3d at 389, yet the Court still held, as to the failure to
warn claim, that comparative risks drawn from internal documents were not pertinent to
the label’s adequacy. Id. at 393. By contrast, the Court in Fortenberry explicitly affirmed that
a plaintiff can draw inferences from internal documents when that plaintiff is pursuing a
negligent misrepresentation claim. Id. at 394.
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the Recovery filter in the IFU insert provided in the packaging.” Yet the
Nelsons fail to address the language of the warning itself and how it was
inadequate, as required by Fortenberry. As noted, Bard’s warning label
warned in two different locations that Filter fracture and migration were
“known complication[s].” The Nelsons have thus failed to raise a genuine
issue of material fact as to their failure to warn claim.
B.
“In a design-defect claim under the MPLA, the plaintiff must prove,
by the preponderance of the evidence, that ‘the product was designed in a
defective manner,’ that ‘[t]he defective condition rendered the product
unreasonably dangerous to the user or consumer,’ and that ‘[t]he defective
and unreasonably dangerous condition of the product proximately caused the
damages for which recovery is sought.’” Elliot, 181 So. 3d at 271 (quoting
MISS. CODE ANN. § 11-1-63(a)(i)-(iii)). Additionally:
In any action alleging that a product is defective because of its
design . . . , the manufacturer, designer or product seller shall
not be liable if the claimant does not prove by the
preponderance of the evidence that at the time the product left
the control of the manufacturer, designer or seller:
(i) The manufacturer or seller knew, or in light of reasonably
available knowledge or in the exercise of reasonable care should
have known, about the danger that caused the damage for
which recovery is sought; and
(ii) The product failed to function as expected and there
existed a feasible design alternative that would have to a
reasonable probability prevented the harm. A feasible design
alternative is a design that would have to a reasonable
probability prevented the harm without impairing the utility,
usefulness, practicality or desirability of the product to users or
consumers.
MISS. CODE ANN. § 11-1-63(f).
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The district court granted summary judgment to Bard on the design
defect claim, holding that the Nelsons failed to show how the design defect
they highlighted—“tilting”—caused the fracturing and migration that led to
the complications experienced by Dennis Nelson. The district court also held
that the Nelsons failed to show a genuine issue of material fact as to a feasible
alternative design, because they cited to no testimony explaining that their
proposed alternative design would have “prevented the harm without
impairing the utility, usefulness, practicality, or desirability” of the Filter.
We affirm the district court’s first holding and so do not reach the second.
Bard argues that the Nelsons’ design defect claim must fail because
they had no expert testimony on specific causation, i.e., an expert who could
have testified that a design defect caused the injuries suffered by Dennis
Nelson. Although no requirement exists that an expert must always connect
the dots of specific causation, 6 we agree with the district court that the
Nelsons failed to draw its attention, at the summary judgment stage, to
evidence that the Filter’s allegedly defective design proximately caused the
device to fracture and migrate after it had been implanted in Dennis Nelson.
The district court was explicit about this missing piece:
[R]egardless of whether Mississippi law requires that causation
be addressed in terms of general and specific causation, it is an
6
Bard relies on Vaughn v. Miss. Baptist Medical Center, 20 So. 3d 645 (Miss. 2009).
In that case the Mississippi Supreme Court held that “Vaughn’s argument that lay-witness
testimony can establish the element of proximate cause is without merit” because “[a] lay
witness cannot render an opinion as to whether the symptoms exhibited by Vaughn were
associated with infection.” Id. at 654. But the Court expressly limited its holding,
explaining that although “diagnosing symptoms has been explicitly held by this Court to be
outside of the realm of a lay person and an activity that requires a medical expert,” “a
medical expert is not necessary in instances in which a layman can observe and understand
the negligence as a matter of common sense and practical experience.” Id. at 653-54. Thus,
while Mississippi law requires expert testimony on specific causation in some cases, it does
not require such testimony across the board.
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element under the MPLA that a plaintiff show that the
defective design, which renders the product unreasonably
dangerous, proximately caused the damages for which
recovery is sought. See Miss. Code. Ann. § 11-1-63(a)[](iii).
The Court finds that Plaintiffs have failed to adduce sufficient
evidence to create [a] jury question on the issue of causation in
fact. There is no testimony or evidence cited by the Plaintiff
that ties the specific design defect identified by Dr.
McMeeking to the damages for which Plaintiffs seek recovery.
His testimony addresses how the design can cause the filter to
tilt, but here the issue is fracturing and migration. There is no
evidence submitted to the Court that ties a design defect to
these particular issues.
The Nelsons make broad statements throughout their brief that
presume a design defect must have caused Dennis Nelson’s complications—
e.g., “[h]ow could [Nelson] have a retained fragment in his lung absent
design-induced fracture and migration?”—but actual evidence had to be
identified to the district court in order to advance beyond the summary
judgment stage for a design defect claim. See Elliot, 181 So. 3d at 271; Miss.
Code. Ann. § 11-1-63(a)(iii); Fed. R. Civ. P. 56(a). Although not
quoted to the district court in the summary judgment proceedings, we
discern in one excerpt of Dr. McMeeking’s testimony his opinion pointing in
the direction of causation—where he used a ruler to testify to the “geometric
effect” that tilt brought about, asserting that “the limb will fracture by fatigue
that much sooner because of this geometric effect that is associated with
perforation of the limb through the wall of the IVC.” However, the Nelsons
failed to direct the district court’s attention to this quote, and so we do not
consider it here. See Malacara v. Garber, 353 F.3d 393, 405 (5th Cir. 2003)
(“Rule 56 does not impose upon the district court a duty to sift through the
record in search of evidence to support a party’s opposition to summary
judgment.” (citation omitted)); Ragas v. Tenn. Gas Pipeline Co., 136 F.3d 455,
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458 (5th Cir. 1998) (“The party opposing summary judgment is required to
identify specific evidence in the record and to articulate the precise manner
in which that evidence supports his or her claim.”). 7
IV.
For the reasons set forth above, we AFFIRM the judgment of the
district court. All other pending motions are DENIED.
7
After choosing not to file a reply brief, the Nelsons brought a binder with several
tabs to oral argument and filed a post-argument letter. Bard moved to strike the binder and
letter or allow additional briefing on the matter. The Court has not referenced or examined
the binder, and it was not entered into the record, so striking it is unnecessary.
16