United States District Court, D. Arizona
G. CAMPBELL SENIOR UNITED STATES DISTRICT JUDGE
case brought by Plaintiffs Lisa and Mark Hyde is set for a
bellwether jury trial on September 18, 2018. During the final
pretrial conference held on September 6, 2018, it became
clear that the parties disagree on whether Plaintiffs'
negligence per se claim is impliedly preempted under 21
U.S.C. § 337(a). The issue was raised and briefed by the
parties in their proposed final pretrial order and jury
instructions. Docs. 12388 at 8-12, 12438 at 54-61. The Court
asked the parties during the pretrial conference whether they
required further briefing and whether they wished to have
this issue resolved before trial. Counsel for both sides
stated that no further briefing was needed and that a ruling
before trial would be helpful.
reasons stated below, the Court finds that the negligence per
se claim is preempted. This conclusion is purely legal - it
is not affected by the evidence that would be presented at
trial. As a result, the Court concludes that it should enter
judgment on this claim before trial under Rule 56 of the
Federal Rules of Civil Procedure. Although decisions under
that rule normally are made in response to a formal motion
for summary judgment, the rule makes clear that the Court may
enter summary judgment sua sponte, provided the
parties are notified of the Court's intention to make a
dispositive decision and have an opportunity to respond.
See Fed. R. Civ. P. 56(f); see also Celotex
Corp. v. Catrett, 477 U.S. 317, 326 (1986)
(“district courts are widely acknowledged to possess
the power to enter summary judgments sua sponte, so
long as the losing party was on notice that she had to come
forward with all of her evidence”). In this instance,
the question is purely one of law, the parties have been
fully heard, and the parties seek a decision before trial.
Such a decision will enable the parties to allocate their
time and evidence to the issues to be considered by the
Lisa Hyde received a Bard IVC filter implant in 2011. In
2014, she learned that the filter had tilted, perforated the
IVC wall, and fractured. The filter and fractured limbs were
removed three months later.
Hyde and her husband assert various claims. Doc. 364; Doc. 1,
Case No. CV-16-00893. Applying Wisconsin law, the Court
granted summary judgment to Defendants on several claims.
Doc. 12007. Plaintiffs continue to assert claims for strict
liability design defect (Count III), negligent design (Count
IV), negligence per se (Count IX), loss of consortium (Count
XV), and punitive damages. Id. at 19.
Wisconsin law, negligence per se is a form of negligence that
results from violation of a statute. See Friederichs v.
Huebner, 329 N.W.2d 890, 917 (Wis. 1983). For the
violation of a safety statute to constitute negligence per
se, the plaintiff “must show: (1) the harm inflicted
was the type the statute was designed to prevent; (2) the
person injured was within the class of persons sought to be
protected; and (3) there is some expression of legislative
intent that the statute become a basis for the imposition of
civil liability.” Tatur v. Solsrud, 498 N.W.2d
232, 235 (D. Wis. 1993) (citing Walker v. Bignell,
301 N.W.2d 447, 454 (Wis. 1981)).
do not allege violation of a Wisconsin statute as part of
their negligence per se claim. Rather, they contend that
Defendants violated various provisions of the Food, Drug, and
Cosmetic Act (“FDCA”), 21 U.S.C. § 301
et seq., and related federal regulations, in
designing the Bard filter. Docs. 12388 at 8-9 (final pretrial
order), 12400 at 4-7 (trial brief), 12438 at 54-59 (proposed
jury instructions). Specifically, Plaintiffs allege
violations of 21 U.S.C. §§ 321, 331, and 352, and
21 C.F.R. §§ 803, 806.1, 820.100, 820.198, and
820.250. Id.; see Doc. 364 ¶ 231.
noted above, the third element of Wisconsin's negligence
per se claim requires “some expression of legislative
intent that the statute become a basis for the imposition of
civil liability.” Tatur, 498 N.W.2d at 235. As
other courts have recognized, however, “[f]ar from
containing an expression that FDA regulations are intended to
form the basis for civil liability, the [FDCA] expresses the
opposite intention.” Cali v. Danek Med., Inc.,
24 F.Supp.2d 941, 954 (W.D. Wis. 1998). Under § 337(a),
“[v]iolations of the FDA are enforceable only by the
United States.” Id. “The FDCA leaves no
doubt that it is the Federal Government rather than private
litigants who are authorized to file suit for noncompliance
with the medical device provisions.” Buckman Co. v.
Plaintiffs' Legal Comm., 531 U.S. 341, 349 n.4
(2001). Thus, “a private litigant cannot bring a
state-law claim against a defendant when the state-law claim
is in substance (even if not in form) a claim for violating
the FDCA - that is, when the state claim would not exist if
the FDCA did not exist.” Leonard v. Medtronic,
Inc., No. 1:10-CV-03787-JEC, 2011 WL 3652311, at *7
(N.D.Ga. Aug. 19, 2011) (citation omitted); see Ellis v.
C. R. Bard, Inc., 311 F.3d 1272, 1284 n.10 (11th Cir.
2002) (noting that under § 337(a) “no private
right of action exists for a violation of the FDCA”).
Buckman, the Supreme Court held that a state law
claim that a defendant made fraudulent statements to the FDA,
in violation of the FDCA, was impliedly preempted by §
337(a) because the claim “exist[ed] solely by
virtue” of FDCA requirements and therefore “would
not be relying on traditional state tort law which had
predated the [FDCA].” 531 U.S. at 353. The same is true
here. Plaintiffs' “claim of negligence per se would
not exist prior to the enactment of the FDCA . . . because
the claim only alleges violation of that law.”
Leonard, 2011 WL 3652311, at *8. As in
Buckman, Plaintiffs' “negligence per se
claim (or, more appropriately characterized, [their]
negligence claim based solely on violations of . . . FDA
regulations) is impliedly preempted by the FDCA.”
Grant v. Corin Grp. PLC, No. 3:15-CV-169-CAB-BLM,
2016 WL 4447523, at *4 (S.D. Cal. Jan. 15, 2016); see
Connelly v. St. Jude Med., Inc., No. 5:17-cv-02005-EJD,
2017 WL 3619612, at *5 (N.D. Cal. Aug. 23, 2017) (negligence
per se claim preempted where it was “based entirely on
violations of the FDCA and its implementing
regulations”); Hafer v. Medtronic, Inc., 99
F.Supp.3d 844, 862 (W.D. Tenn. 2015) (“If Plaintiffs
claim negligence based solely on Defendants' failure to
comply with federal law or solely on illegal off-label
promotion (i.e. negligence per se), Plaintiffs' claims
are impliedly preempted under Buckman.”);
Dunbar v. Medtronic, Inc., No. CV 14-01529-RGK AJWX,
2014 WL 3056026, at *6 (C.D. Cal. June 25, 2014) (“[A]
negligence per se claim alleging violation of the FDCA is
nothing more than a private right of action under the FDCA
for damages. Since the latter is not available as a result of
§ 337(a), the Court finds that the former is preempted
as well.”); McClelland v. Medtronic, Inc., 944
F.Supp.2d 1193, 1200 (M.D. Fla. 2013) (“Plaintiff's
attempt to recast a claim for violation of the FDCA as a
state-law negligence claim is impliedly barred by §
337(a).”); Franklin v. Medtronic, Inc., No.
09-cv-02301-REB-KMT, 2010 WL 2543579, at *8 (D. Colo. May 12,
2010) (“[T]o the extent that Plaintiff seeks to ground
her negligence per se . . . claim on allegations that
Defendant violated the FDCA - namely, by selling a misbranded
and adulterated product - these claims are impliedly
preempted pursuant to 21 U.S.C. § 337(a).”);
Talley v. Danek Med., Inc., 7 F.Supp.2d 725, 731
(E.D. Va. 1998) (“[T]he FDCA expressly prohibits the
bringing of a private cause of action under the Act. To allow
a state negligence per se action based upon alleged
violations of the FDCA would defeat the purpose of that
citation of Garross v. Medtronic, Inc., 77 F.Supp.3d
809, 816 (E.D. Wis. 2015), is not persuasive. Doc. 12388 at
9-10. The plaintiff in that case did not bring a negligence
per se claim, but instead asserted traditional common law
torts such as design defect, failure to warn, and negligence.
Garross, 77 F.Supp.3d at 813. Those claims were not
impliedly preempted under Buckman “because
none of them [arose] solely from a violation of federal law;
rather, each [arose] from an independent, well-recognized
duty owed under state law.” Id. at 816;
see also Hoffmann v. Wis. Elec. Power Co., 664
N.W.2d 55, 62 (Wis. 2003) (noting that “the enactment
of safety statutes . . . does not abolish the duty arising
under common-law negligence”). In this case, Plaintiffs
retain and will assert at trial a common law negligent design
claim; that claim is not affected by this ruling.
cite cases holding that violations of FDCA regulations may
support negligence per se claims in Wisconsin. Doc.
12388 at 9-10 (citing Lukaszewicz v. Ortho Pharm.
Corp., 510 F.Supp. 961, 964 (E.D. Wis. 1981)
(pre-Buckman decision holding that violation of
federal regulation for prescription drug labeling supported
negligence per se claim under Wisconsin law); Marvin v.
Zydus Pharms. (USA) Inc., 203 F.Supp.3d 985, 992 (W.D.
Wis. 2016) (finding that plaintiffs may bring a negligence
per se claim under Wisconsin law based on a violation of
federal medication guide regulations); Doc. 12400 at 13
(citing Kurer v. Parke, Davis & Co., 679 N.W.2d
867, 874 (Wis. Ct. App. 2004) (“In Wisconsin,
violations of the FDA regulations may constitute negligence
per se.”)). But these cases are squarely at odds with
§ 337(a). The plain language of that section and the
Buckman decision indicate that such claims fail.
See Dunbar, 2014 WL 3056026, at *6. Even if state
law recognizes the claims, federal law preempts them. See
Perez v. Nidek Co., 711 F.3d 1109, 1120 (9th Cir. 2013)
(finding state law claim preempted where the plaintiff was
not suing under state law for conduct that happens to violate
the FDCA, but instead is suing solely “because
the conduct violates the FDCA.”) (emphasis in
original). This Court reached the same conclusion in previous
bellwether cases. See Docs. 8874 at 14-18, 10404 at
14-17 (finding negligence per se claims impliedly preempted
in the Booker and Jones bellwether cases).
IS ORDERED that judgment is entered in favor of
Defendants on Plaintiffs' ...