IN RE: Bard Implanted Port Catheter Products Liability Litigation

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WO
IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF ARIZONA
IN RE: Bard Implanted Port Catheter
Products Liability Litigation
_________________________________
Kimberly Divelbliss,
Individual Plaintiff,
v.
Becton Dickinson and Company, et al.,
Defendants.
MDL No. 3081
No. CV-23-01627-PHX-DGC
ORDER RE FDA EVIDENCE
Plaintiff’s Motion in Limine 1 asks the Court to exclude all evidence and argument
about the FDA, including § 510(k) clearance of the port catheter at issue in this case.
Doc. 9039. The parties argued this issue at the final pretrial conference. See Doc. 9565.
In the IVC MDL litigation overseen by the undersigned judge, evidence of FDA
clearance of the blood filter at issue was admitted during trial. In re Bard IVC Filters
Prods. Liab. Lit., Sherr-Una Booker, 289 F. Supp. 3d 1045 (D. Ariz. 2018) (“Booker”).
The Court concluded that the relevancy of the evidence was not outweighed by the danger
of unfair prejudice. Id. at 1048-49. Several courts have followed this decision, while
several others have excluded evidence of 510(k) clearance in medical product litigation.
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Three federal courts of appeal have affirmed exclusion of FDA evidence in such cases. See
Kaiser v. Johnson & Johnson, 947 F.3d 996, 1018 (7th Cir. 2020); Eghnayem v. Bos. Sci.
Corp., 873 F.3d 1304, 1318-19 (11th Cir. 2017); In re C.R. Bard, 810 F.3d 913, 922 (4th
Cir. 2016). The Court excluded FDA evidence in the Cook bellwether trial conducted
earlier this year. Doc. 8076.
This is a close evidentiary question, as it was in the IVC litigation and Cook. In this
case, however, the Court finds that evidence of the port catheter’s § 510(k) clearance is
relevant for the same reasons it was relevant in Booker.
Booker was governed by Georgia law, which provided that the jury could consider
“the manufacturer’s compliance with federal regulations” in deciding whether the
manufacturer acted reasonably. 289 F. Supp. 3d at 1047. Given this Georgia law, “the
Court [found] that evidence of Bard’s compliance with the 510(k) process, while certainly
not dispositive, [was] nonetheless relevant to the reasonableness of Bard’s conduct and
whether the company defectively designed the G2 filter.” Id.
This case is governed by New Mexico law. It too makes compliance with applicable
regulations a relevant factor in negligence and strict liability design defect cases. New
Mexico Uniform Jury Instruction (“UJI”) 13-1405 addresses negligence and UJI 13-1408
addresses strict product liability. Both instructions inform the jury that the defendant’s
compliance with regulations is a relevant consideration, but not controlling. In Brooks v.
Beech Aircraft Corp., 902 P.2d 54 (N.M. 1995), the New Mexico Supreme Court cited
these instructions favorably:
The general instruction on ordinary care in products liability actions, UJI 13-1405,
provides in relevant part: “Industry customs [standards] [codes] [rules] are
evidence of ordinary care, but they are not conclusive.” Similarly, the general
instruction on unreasonable risk provides: “Industry customs [standards] [codes]
[rules] are evidence of the acceptability of the risk, but they are not conclusive.”
UJI 13-1408. These instructions should be given in cases involving a claimed
defect in design.
Id. at 64.
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Other New Mexico cases reach the same conclusion. See, e.g., Hauck v. Wabash
Nat’l Corp., No. CV 18-471 KG/LF, 2021 WL 949740, at *3 (D.N.M. Mar. 12,
2021) (finding that “industry regulations and standards are probative of what a reasonably
prudent manufacturer would do”) (cleaned up); Rivera v. Volvo Cars of N. Am., No. 13-
00397 KG/KBM, 2016 WL 7383321, at *5 (D.N.M. 2016) (“In New Mexico, evidence the
jury may consider to determine whether a risk of injury is acceptable to a reasonably
prudent person includes . . . [c]ompliance with industry customs, standards, rules, or
governmental rules or standards.”) (citing UJI 13-1408); Pac. Indem. Co. v. Therm-O-Disc,
Inc., 476 F. Supp. 2d 1216, 1226-27 (D.N.M. 2006) (“The fact that Square D may have
complied with all industry standards and regulations is certainly evidence of the
acceptability of the risk of injury to a reasonably prudent person; however, it is not
conclusive as to the acceptability of the risk for a product liability claim.”).
Citing Brooks, Plaintiff argues that this New Mexico case law applies only to
substantive design and safety standards, not to standards such as FDA’s section § 510(k)
clearance procedures. The trial court in Brooks granted summary judgment for the
defendant because the plaintiff could not show the defendant violated industry standards
or regulations. 902 P.2d at 55. On appeal, the New Mexico Supreme Court held that such
proof was not necessary to establish negligence or strict liability. It explained that industry
regulations are relevant to a consideration of such claims, but not controlling. Id. at 64.
Brooks specifically stated that UJI 13-405 and UJI 13-408 should be given in design defect
cases. Id. While it is true that the regulations at issue in Brooks – which did not exist at
the time of the subject airplane’s design – were substantive design regulations, the New
Mexico Supreme Court did not rely on this fact when it held that regulations are relevant
in design defect cases. Id. Nor do the cases cited above make this distinction.
Compliance with FDA regulations is also relevant, though not dispositive, on the
issue of punitive damages. See Gonzales v. Surgidev Corp., 899 P.2d 576, 591 (N.M.
1995) (“Surgidev’s evidence of compliance with FDA regulations was properly submitted
to the jury for consideration in determining whether Surgidev acted recklessly in failing to
warn of problems with the Style 10 when implanted using the ICCE procedure.”). And
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Defendants intend to present evidence of their post-market surveillance of products and
communications with FDA about that surveillance, in part to rebut Plaintiff’s claim for
punitive damages.1
For these reasons, the Court concludes that FDA evidence, including Defendants’
compliance with section § 510(k), is relevant to Plaintiff’s design defect claims under New
Mexico law.
Plaintiff argues the evidence should nonetheless be precluded under Rule 403
because the risk of unfair prejudice would substantially outweigh its probative value.
Specifically, Plaintiff argues the evidence could lead a jury to treat the FDA evidence as a
stamp of safety, and that dispelling such an incorrect conclusion would consume an
inordinate amount of trial time. Doc. 9039 at 4. The Court disagrees for reasons stated in
Booker. 289 F. Supp. 3d at 1049-50.
Both sides, through appropriate expert testimony or other admissible evidence, will
be permitted to tell the jury about the regulatory clearance process for port catheters, Bard’s
participation in the § 510(k) process, and its compliance (or lack thereof) with that process.
Defendants will not, however, be permitted to present evidence or argument that the FDA
“approved” the subject port for market or that clearance of the device under § 510(k) review
constitutes a finding by the FDA that the filter is safe and effective. As relevant FDA
regulations explain: “Any representation that creates an impression of official approval of
a device because of complying with the [§ 510(k)] premarket notification regulations is
misleading[.]” 21 C.F.R. § 807.97. Plaintiffs will be free to present evidence and argument
that the § 510(k) process is a comparative one that requires only substantial equivalence to
a predicate device. Moreover, any potential confusion can be avoided by a limiting
instruction regarding the nature of the § 510(k) process, as the Court gave in the Cook trial.
1 Defendants may also seek to argue that the lack of FDA market action regarding
the port catheters suggests they are safe and effective. The Court has previously expressed
doubt about this argument, noting that the FDA could have many reasons for not taking
action with respect to a product on the market. If Defendants intend to present such
arguments, they should first raise the issue with the Court outside the hearing of the jury.
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The Court is also convinced that efficient management of the evidence and adherence to
the Court’s time limits will avoid any risk of unnecessary or time-consuming mini-trials.
Defendants have suggested they may argue § 510(k) clearance includes a safety
component, and that clearance means the device is as safe and effective as its predicate
device. The Court has concerns about these arguments.
First, the Supreme Court has made clear that § 510(k) is not a safety review. In
Riegel v. Medtronic, Inc., 552 U.S. 312, 318 (2008), the Court explained that Ҥ 510(k) is
focused on equivalence, not safety, [while] premarket approval is focused on safety, not
equivalence.” Id. at 323 (cleaned up). It noted that “devices that enter the market through
§ 510(k) have never been formally reviewed under the MDA for safety or efficacy[.]” Id.
(cleaned up).
Second, arguing that a device is as safe and effective as a predicate device on the
market means little or nothing if the predicate device was also cleared under § 510(k) and
has never undergone an FDA safety review.
The parties should be prepared to address these concerns at trial if Defendant seeks
to present evidence or argument that § 510(k) clearance includes a safety component and
means the device is as safe and effective as its predicate device.
IT IS ORDERED that Plaintiff’s Motion in Limine 1 (Doc. 9039) is denied.
Dated this 20th day of July, 2026.
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