Hughes v. Boston Scientific Corp.

Case: 09-60925 Document: 00511358338 Page: 1 Date Filed: 01/21/2011

IN THE UNITED STATES COURT OF APPEALS
FOR THE FIFTH CIRCUIT United States Court of Appeals
Fifth Circuit

FILED
January 21, 2011

No. 09-60925 Lyle W. Cayce
Clerk

JAN HUGHES,

Plaintiff-Appellant
v.

BOSTON SCIENTIFIC CORPORATION,

Defendant-Appellee

Appeal from the United States District Court
for the Southern District of Mississippi

Before KING, GARWOOD, and DAVIS, Circuit Judges.
W. EUGENE DAVIS, Circuit Judge.
This appeal requires us to determine the extent to which Appellant Jan
Hughes’s state tort claims seeking recovery for injuries allegedly caused by a
medical device manufactured by Appellee Boston Scientific Corporation (“Boston
Scientific”) are preempted by the Medical Device Amendments of 1976 (“MDA”),
21 U.S.C. § 301 et seq., to the Federal Food, Drug, and Cosmetics Act of 1938
(“FDCA”), 52 Stat. 1040. The district court granted Boston Scientific’s motion
for summary judgment, holding that all of Hughes’s claims are preempted.
Hughes now appeals that ruling, focusing primarily on her claim that Boston
Scientific failed to provide adequate warnings of dangers or risks associated with
the HTA. For the following reasons, we affirm the district court’s ruling with
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No. 09-60925

regard to all of Hughes’s claims except for her failure to warn claim to the extent
that this claim is predicated on Boston Scientific’s failure to comply with the
applicable federal statutes and regulations. Because we conclude that this claim
is not preempted, we remand that claim to the district court for further
proceedings, consistent with this opinion.
I.
A.
Boston Scientific is the designer, manufacturer, marketer, and seller of the
HydroThermAblator (“HTA”), a medical device designed for the treatment of
menorrhagia, or excess uterine bleeding. The device works by circulating hot
saline solution (194° F) through a closed cycle into and then flushing it from the
uterus, causing the lining of the uterus to slough off and discharge.
The HTA was approved for entry into the market by the Food and Drug
Administration (“FDA”) under its rigorous premarketing approval (“PMA”)
process in 2001. Boston Scientific sold the HTA device on the market from 2002
to 2009.1 The HTA was classified as a Class III medical device under the MDA,
thus receiving the highest degree of FDA oversight.
Class III devices are those that either “presen[t] a potential unreasonable
risk of illness or injury” or are “for a use in supporting or sustaining human life
or for a use which is of substantial importance in preventing impairment of
human health.” 21 U.S.C. § 360c(a)(1)(C). As part of the PMA approval process,
manufacturers of Class III devices must provide the FDA with a “reasonable
assurance” that the device is both safe and effective. Id. § 360e(d)(2). The
applicant must submit detailed information including full reports of all relevant
information that is known by the applicant, samples of both labeling and the
device itself, and a full description of the methods and facilities used for

1
Boston Scientific acquired the HTA from another company in 2002 and voluntarily
recalled the device on July 31, 2009.

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manufacturing and installation of the device. Id. § 360e(c)(1). In its review, the
agency must “weig[h] any probable benefit to health from the use of the device
against any probable risk of injury or illness from such use.” Id. § 360c(a)(2)(C).
Once a device has received PMA approval, the manufacturer cannot make
changes to any feature of the device without obtaining FDA permission. Id. §
360e(d)(6).
After PMA approval, manufacturers of Class III devices must comply with
Medical Device Reporting (“MDR”) requirements. Id. § 360i(a)(1); 21 C.F.R. §
803.50(a). The FDA may approve marketing of the Class III device subject to
additional postapproval conditions, which the FDA may include in its PMA
approval order. See 21 U.S.C. §§ 360c-360j; 21 C.F.R. §§814.80, 814.82. If a
manufacturer fails to comply with the FDA regulations or postapproval
conditions, the FDA has the power to withdraw PMA approval, as well as the
power to impose other remedies such as additional warnings or corrective
labeling. See 21 U.S.C. §§ 351, 352, 360(h), 374.
B.
Hughes filed a complaint against Boston Scientific in the Circuit Court of
Jones County, Mississippi, on March 26, 2008, seeking recovery for injuries she
allegedly sustained from the HTA device. Hughes alleges that on October 25,
2006, her treating physician, Dr. Weber, performed the ablation procedure on
her using the HTA device. During the procedure, hot liquid leaked from the
device, at which point the device’s alarm sounded and shut down, as it is
designed to do. The leak caused a three-inch by two-inch burn on Hughes’s outer
perineal body and an area of similar size inside the vaginal introitus, which Dr.
Weber characterized as second-degree burns. Hughes returned for treatment of
her burns every other day for two weeks, and thereafter once a week for six to
eight weeks.

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Hughes asserted claims in her initial complaint under the Mississippi tort
law theories of products liability, breach of warranty, negligence, breach of
implied warranty of merchantability, and of fitness for a particular purpose.
Following Boston Scientific’s removal of the action to federal district court,
Hughes filed an amended complaint against Boston Scientific. In the amended
complaint, Count I for “Products Liability” includes the assertions that “[t]he
product failed to contain adequate warnings of dangers or risks which were
known or in the light of reasonably available knowledge should have been known
to Boston Scientific” and that “the product failed to contain adequate
instructions to communicate sufficient information on the dangers associated
with, and the safe use of the product.” Count II of the amended complaint for
“Negligence” includes similar claims that “Boston Scientific failed to provide
adequate warnings of dangers or risks which were known or in the light of
reasonably available knowledge should have been known to Boston Scientific”;
that “Boston Scientific failed to provide adequate instructions to sufficiently
communicate information on the dangers associated with the product and its
safe use”; and that “Boston Scientific failed to notify the users and consumers of
the product of similar problems with, or malfunctions of other units when used
for their intended purpose.” Count II also charges that Boston Scientific
“manufactured and distributed” the product inconsistently with its FDA PMA
approval by failing to report serious injuries and malfunctions of the device as
defined in the MDR regulations. Hughes also included a separate Count IV for
“Negligence Per Se,” charging that Boston Scientific violated the FDA
regulations governing the safety, effectiveness, and reliability of the HTA.
In the district court, Hughes proceeded on the theory that Boston
Scientific failed to comply with the FDA’s MDR regulations requiring a
manufacturer of a Class III device to report incidents in which the device may
have caused or contributed to a death or “serious injury,” or malfunctioned in

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No. 09-60925

such a way that would likely cause or contribute to death or serious injury if the
malfunction recurred. 21 U.S.C. § 360i(a)(1); 21 C.F.R. § 803.50(a).2 The term
“serious injury” is defined in the MDR regulations as “an injury or illness that
is life-threatening, results in permanent impairment of a body function or
permanent damage to a body structure or necessitates medical or surgical
intervention to preclude permanent impairment of a body function or permanent
damage to a body structure.” 21 U.S.C. § 360i(a)(2); 21 C.F.R. § 803.3. The term
“malfunction” is defined to mean “the failure of a device to meet its performance
specifications or otherwise perform as intended,” with performance specification
defined to “include all claims made in the labeling for the device,” and intended
performance defined as “the intended use for which the device is labeled or
marketed . . . .” 21 § C.F.R. 803.3.
Hughes supports her argument that Boston Scientific failed to abide by
these reporting regulations with evidence obtained during discovery that Boston
Scientific developed an “algorithm” regarding reportable events caused by the
HTA according to which Boston Scientific reported some, but not all, burns, as
follows:
(1) First degree burns were not reportable.
(2) Second degree burns were reportable depending on the
extensiveness and intervention required to treat the injury. A
second degree burn was MDR reportable if any of the following
criteria were met: (a) the burn was classified as extensive by the
physician; (b) the burn involved both internal anatomy such as the
vagina and cervix and external anatomy such as the vulva,
perineum and buttocks; (c) the burn required intervention involving

2
Hughes has also argued that Boston Scientific did not comply with the additional
reporting conditions the FDA included in its PMA approval order for the HTA, pursuant to 21
C.F.R. § 814.81(a)(9), requiring the filing of “Adverse Reaction Reports” concerning “[a]ny
adverse reaction, side effect, injury, toxicity, or sensitivity reaction that is attributable to the
device and (a) has not been addressed by the device’s labeling or (b) has been addressed by the
device’s labeling, but is occurring with unexpected severity or frequency.” The PMA approval
order notes that these reporting conditions were largely duplicative of the MDR regulations.

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a medical or surgical procedure that cannot be administered by the
patient (such as: systemic antibiotics, debridement, skin grafting,
etc.).
(3) Other second degree burns that can be effectively managed by
application of cream or ointment were not considered to be MDR
reportable.
(4) Third degree burns were reportable.

Boston Scientific included this algorithm in its annual reports for the HTA
from 2002 to 2008, required by FDA regulation to be filed with the FDA’s Center
for Devices and Radiological Health (“CDRH”). In response to a 2003 letter from
the CDRH inquiring about Boston Scientific’s criteria for reportable burns,
Boston Scientific included the algorithm in a 2004 letter to the CDRH.
Hughes relies on the expert report of Charles Kyper, a former FDA official.
Kyper has given his opinion that Boston Scientific’s failure to report certain first
and second-degree burns caused by leakage from the HTA device, pursuant to
the algorithm, violated the MDR regulations. Hughes further asserts that the
FDA itself disapproved of Boston Scientific’s reporting practices, relying on the
deposition of a Boston Scientific representative, Charles Montgomery, who
testified that in 2008 an FDA official “directed” Boston Scientific by letter to
abandon the algorithm and to begin reporting more burns caused by the HTA.
After this “direction” from the FDA in 2008, Boston Scientific began
reporting more burns caused by the HTA device. Hughes produced evidence that
this change in reporting resulted in a sharp increase in the number of reports to
the FDA in 2008 and 2009. According to Hughes, evidence from the FDA’s
MAUDE internet database, which tracks device reports, shows that from 2002
until the time of Hughes’s injury in 2006, Boston Scientific submitted 62 reports
regarding the HTA, 53 of which involved leaks or burn-related injuries; but
following the change in Boston Scientific’s reporting criteria at the FDA’s

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direction in 2008 through July 2009, Boston Scientific filed 495 reports,
including 247 of which involved leaks or burn-related injuries.
C.
The district court granted summary judgment to Boston Scientific based
on its conclusion that all of Hughes’s claims are expressly preempted by § 360k
of the MDA as construed by the Supreme Court in Riegel v. Medtronic, Inc., 552
U.S. 312 (2008). The district court also rested its decision that Hughes’s
negligence claim is preempted on Buckman v. Plaintiffs’ Legal Comm., 531 U.S.
341 (2001), in which the Supreme Court held that certain claims are impliedly
preempted by § 337a of the MDA. Hughes now appeals the district court’s
ruling.
II.
This court reviews a district court’s award of summary judgment de novo,
applying the same standards as the district court. Gomez v. St. Jude Med. Daig
Div., Inc., 442 F.3d 919, 927 (5th Cir. 2006). 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.” F ED. R. C IV.
P ROC. 56(a) (2010). The court must view the record in the light most favorable
to the non-moving party in determining whether there is a genuine issue of
material fact. Am Int’l Specialty Lines Ins. Co. v. Canal Indem. Co., 352 F.3d
254, 260 (5th Cir. 2003).
III.
We first consider Hughes’s argument that her claims are not expressly
preempted under § 360k of the MDA. The Supreme Court has twice addressed
the preemption of state-law claims regarding medical-device liability pursuant
to § 360k, most recently in Riegel, 552 U.S. at 312. Riegel, like the Court’s
earlier decision in Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), makes clear that
a medical device manufacturer is protected from liability under state-law tort

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claims related to a defective or dangerous device to the extent that the
manufacturer has complied with federal statutes and regulations. However,
Riegel and Lohr also make clear that a manufacturer is not protected from state
tort liability when the claim is based on the manufacturer’s violation of
applicable federal requirements.
In Riegel, the Court established a two-prong test for determining if a state-
law tort claim is preempted by § 360k.3 First, we ask if the FDA has established
requirements applicable to the particular device at issue. 552 U.S. at 322.
Second, we ask whether the state law at issue creates a requirement that is
related to the device’s safety or effectiveness and is “different from or in addition
to” the federal requirement.” Id. In setting up this two-prong test, the Court
confirmed that state common-law causes of action are considered “requirements”
under this test that cannot vary from federal requirements pursuant to § 360k.
Specifically, the Court held that New York common-law tort claims of
negligence, strict liability, and breach of warranty imposed requirements that
were preempted by federal requirements pertaining to medical devices to the
extent that these state tort claims required the device “to be safer, but hence less
effective, than the model the FDA has approved. . . .” 552 U.S. at 325.
But the plaintiff’s claims that the manufacturer had breached an express
warranty and was negligent in manufacturing the device “because it did not
comply with federal standards” were not before the Court, as the district court
had allowed those two claims to proceed without finding them to be preempted

3

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 intended for human use any requirement – (1) which is different from,
or in addition to, any requirement applicable under this chapter to the device,
and (2) which relates to the safety or effectiveness of the device or to any other
matter included in a requirement applicable to the device under this chapter.

552 U.S. at 316 (quoting 21 U.S.C. § 360k(a)).

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and had later dismissed them on summary judgment. Id. at 321 n. 2. In fact,
the Court clearly noted that its holding only applied to claims that a “device
violated state tort law notwithstanding compliance with the relevant federal
requirements.” Id. at 330 (emphasis added).
Applying Riegel’s two-prong test for express preemption to Hughes’s
claims, we first ask whether the FDA has established requirements applicable
to the particular device at issue. Id. at 322. Riegel established that any Class
III device receiving PMA approval by the FDA will satisfy this first prong of the
test, see id., and Hughes does not dispute this. Thus, we easily conclude that the
first prong of Riegel’s test is satisfied. Moving to the second prong of the test, we
must ask whether the state law at issue creates a requirement that is related to
the device’s safety or effectiveness and is “different from or in addition to” a
federal requirement. Id. This is the key legal issue disputed by the parties.
Thus, we consider below the elements of Hughes’s state-law claims to determine
whether these claims impose requirements that differ from or are in addition to
federal requirements.
A.
It is clear that all of Hughes’s state products liability claims that purport
to impose liability on Boston Scientific despite Boston Scientific’s compliance
with the applicable FDA design and manufacturing specifications, as approved
by the FDA during the PMA process, seek to impose different or additional state
duties and are expressly preempted. Id. at 325. We held such traditional state
products liability claims to be expressly preempted even prior to Riegel’s
confirmation that these types of claims may not be maintained under § 360k.
Gomez v. St. Jude Medical Daig. Div., Inc., 442 F.3d 919, 930-31 (5th Cir. 2006);
Martin v. Medtronic, Inc., 254 F.3d 573, 575 (5th Cir. 2001).
This includes Hughes’s products liability claim for failure to provide
adequate warnings or instructions communicating dangers associated with the

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HTA to the extent that this Mississippi strict liability claim would question the
sufficiency of the FDA-approved labeling, warnings, and instructions for the
HTA device or require Boston Scientific to have included different warnings,
labels, or instructions with the device. Gomez, 442 F.3d at 931 (“To permit a
jury to decide [plaintiff’s] claims that the information, warnings, and training
material the FDA required and approved through PMA process were inadequate
under state law would displace the FDA’s exclusive role and expertise in this
area and risk imposing inconsistent obligations on [the defendant].”). We
therefore affirm the district court’s judgment with respect to these product
liability claims.
B.
We reach a different conclusion, however, with regard to Hughes’s claim
that Boston Scientific failed to provide adequate warnings or sufficiently
communicate information about the risks associated with the HTA device to the
extent that this claim is predicated on Boston Scientific’s failure to report
“serious injuries” and “malfunctions” of the device as required by the applicable
FDA regulations. Hughes submits that the Mississippi duty to provide
“adequate warnings or instructions,” which is imposed on manufacturers
pursuant to the products liability code, Miss. Code. Ann. §§ 11-1-63(a)(i)(2), (c)(i),
has been construed by Mississippi courts as a duty to provide “reasonable
warnings” of risks. Thomas v. Hoffman-LaRoche, Inc., 949 F.2d 806, 811 (5th
Cir. 1992) (citing Wyeth Labs., Inc. v. Fortenberry, 530 So. 2d 688, 691 (Miss.
1988)). Hughes further argues that such a failure to warn claim may be pursued
not only under a strict products liability theory, but also under a negligence
theory, citing Bennett v. Madakasira, 821 So. 2d 794, 804 (Miss. 2002) (stating
in a drug liability case that the failure to warn inquiry, whether under a strict
liability or negligence theory, turns on “the adequacy of the defendant’s
warnings”).

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Assuming that a failure to warn claim may be pursued under Mississippi
law as Hughes argues, it is clear that such a claim is preempted only to the
extent that it purports to impose liability despite Boston Scientific’s compliance
with FDA regulations. Riegel, 522 U.S. at 325; Gomez, 442 F.3d at 933. To the
extent that Hughes asserts a failure to warn claim based only on Boston
Scientific’s failure to comply with FDA regulations, however, such a claim is not
expressly preempted.
Rather, a failure to warn claim limited to an assertion that the defendant
violated a relevant federal statute or regulation is “parallel” to federal
requirements as defined in Riegel, in which the Court stated that Ҥ 360k does
not prevent a State from providing a damages remedy for claims premised on
violation of FDA regulations; the state duties in such a case ‘parallel,’ rather
than add to, federal requirements.” 552 U.S. at 330 (quoting Medtronic, 518 U.S.
at 495, 513 (O’Connor, J., concurring in part and dissenting in part)).
The discussion of parallel claims originated in the Court’s earlier Lohr
opinion, in which the majority held that “[n]othing in § 360k denies Florida the
right to provide a traditional damages remedy for violations of common-law
duties when those duties parallel federal requirements.” Lohr, 518 U.S. at 495,
501. Like Hughes, the Lohr plaintiffs asserted a state negligence claim based
on the manufacturer’s violation of the state duty to warn about dangers of a
medical device. Lohr, 518 U.S. at 481. The Court held that this claim was
parallel, and not preempted. Id. at 501.
In our Gomez case, a suit seeking recovery for personal injuries caused by
a Class III medical device, we relied on Lohr’s understanding of parallel claims.
Gomez, 442 F.3d at 932 (“[A] lawsuit that simply parallels or enforces the federal
regulatory requirements without “threatening” or interfering with them is not

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preempted.”) (citing Lohr, 518 U.S. at 495).4 We held that the plaintiff’s
products liability and negligence claims were preempted to the extent they
purported to impose liability notwithstanding the manufacturer’s compliance
with FDA requirements. Id. at 931. We also affirmed the district court’s order
permitting trial on the plaintiff’s negligence claim alleging that the defendant
had defectively manufactured the device “because it did not comply with the
FDA-approved specifications.” Id. at 933 (“The district judge properly limited
Gomez’s negligence claims to a claim that the Angio-Seal used in her surgery
was defectively manufactured because it did not comply with the FDA-approved
specifications.”).
Riegel, Lohr, and Gomez are consistent in holding that claims for negligent
failure to warn or negligent manufacturing of a device are not preempted,
provided that such claims are premised entirely on violation of the applicable
federal requirements. Moreover, this reading of Riegel is in accord with post-
Riegel opinions from other circuits. For instance, the Sixth Circuit held that the
plaintiff’s negligent manufacturing claim based on a Class III medical device
manufacturer’s alleged violation of the FDA’s Good Manufacturing Practices
(“GMP”), which had been incorporated into the PMA regulations, was not
preempted. Howard v. Sulzer Orthopedics, Inc., 382 F. App’x 437, 440-42 (6th
Cir. June 16, 2010) (unpublished). The Seventh Circuit also recently held in a
well-reasoned opinion that state negligence claims premised on a defendant
manufacturer’s failure to abide by the FDA’s approved manufacturing

4
In Gomez, we repeated and endorsed some statements about the meaning of parallel
claims from our earlier Martin case, another suit seeking recovery for personal injuries caused
by a Class III medical device. Gomez, 442 F.3d at 931 n. 2. In Martin, the court stated that
“tort suits based on a manufacturer’s failure to follow the FDA’s regulations and procedures
are not preempted,” and further that “common law duties that incorporate the PMA process,
such as the general duty to take due care to comply with the PMA process in labeling or
manufacturing . . . are not preempted.” Martin, 254 F.3d at 583, n. 8.

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specifications survive express preemption. Bausch v. Stryker Corp., No. 09-3434,
__ F.3d __, 2010 U.S. App. LEXIS 26094 (7th Cir. Dec. 23, 2010).
Thus, Riegel is no bar to this claim. Hughes’s failure to warn claim is
comparable to the negligent failure to warn claim in Lohr and the negligent
manufacturing claims in Gomez, Howard, and Bausch. These authorities make
clear that Hughes’s claim is not expressly preempted to the extent she asserts
that Boston Scientific violated the state duty to warn by failing to accurately
report serious injuries and malfunctions of the HTA device as required by the
FDA’s MDR regulations. The MDR regulations are related to the
manufacturer’s duty to provide the FDA with information regarding a device’s
safety and effectiveness, and this information is disseminated to the public.5 A
factfinder could infer that a manufacturer’s failure to provide this information
as required by FDA regulations is a parallel violation of the state duty to provide
reasonable and adequate information about a device’s risks.
Thus, we are satisfied that Hughes’s failure to warn claim is not expressly
preempted to the extent that it is based on Boston Scientific’s violation of
applicable FDA regulations requiring accurate reporting of serious injuries and
malfunctions of the HTA device. This claim does not impose additional or
different requirements to the federal regulations, but is parallel to the federal
requirements.
C.
Hughes next argues that the district court erred in holding that her
“negligence per se claim” is preempted. Negligence per se is a legal theory that
assists a party to prove that his adversary was negligent. Gray v. Beverly

5
The summary judgment evidence indicates that manufacturers provide these reports
to the FDA, the FDA then disseminates the reports to the public, and the reports are then
relied upon by physicians and authors of medical journals in comparing the relative safety of
medical devices. See discussion of causation supra Section V.

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Enterprises-Miss., Inc., 390 F.3d 400, 407 (5th Cir. 2004) (“Negligence per se . .
. is a theory by which statutes are used to establish the appropriate standard of
care.”) (Mississippi tort action); see also Fowler V. Harper, et al., H ARPER, J AMES,
AND G RAY ON T ORTS, § 17.6, 709, n. 16 (3d ed. 2007) (“In a substantial number
of jurisdictions such a [statutory] violation is held to be evidence of negligence
to be weighed by the jury.”) (citing state cases including Simpson v. Boyd, 880
So. 2d 1047, 1053 (Miss. 2004)).6
As we have explained, the doctrine of preemption is designed to foreclose
a state cause of action that imposes different or additional requirements on a
defendant when compared to federal requirements. The only issue presented to
us on this appeal is whether the district court correctly determined that
Hughes’s suit is preempted. Thus, Boston Scientific’s preemption defense only
requires us to decide which of Hughes’s state law causes of action are foreclosed
under § 360k. Because negligence per se is a theory or “doctrine” that assists a
party in proving negligence rather than an independent state tort action,
whether that doctrine will apply at trial does not affect Hughes’s ability to assert
her negligent failure to warn cause of action under § 360k. We need not decide,
therefore, whether Hughes will be able to invoke the doctrine of negligence per
se as a matter of Mississippi law to establish that Boston Scientific breached the
state duty to warn by failing to report serious injuries and malfunctions of the
HTA device as required by the MDR regulations. In other words, because
Hughes’s claim is not foreclosed by § 360k, Hughes is not foreclosed by §360k

6
The parties agree that the Mississippi law or “doctrine” of negligence per se generally
operates so that when a defendant has violated a particular statute or regulation, the injured
party is entitled “to an instruction that the party violating it is guilty of negligence.” Thomas
v. McDonald, 667 So. 2d 594, 596 (Miss. 1995); Simpson, 880 So. 2d at 1053. To recover, the
plaintiff must also show “he is a member of the class that the statute was designed to protect
and that the harm suffered was the type of harm which the statute was intended to prevent”
and that the violation “proximately caused” the injury. Thomas, 667 So. 2d at 596; Simpson,
880 So. 2d at 1053.

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from arguing at trial that the doctrine of negligence per se is available to assist
her in proving her claim. See Gomez, 442 F.3d at 933 (referring to the plaintiff’s
negligent manufacturing claim surviving preemption as one for possible
“negligence per se” under Louisiana law); Bausch, No. 09-3434, __ F.3d __, 2010
U.S. App. LEXIS 26094 at *13 (noting with regard to the non-preempted
negligent manufacturing claim that “Illinois treats a violation of a statute or
ordinance designed to protect human life or property as prima facie evidence of
negligence . . .”); Sulzer, 382 F. App’x at 442 (Plaintiff’s “negligence per se claim
for GMP violations is not preempted.”).
Boston Scientific makes a related argument, with which the district court
agreed, that §360k should prevent Hughes from invoking the doctrine of
negligence per se because a defendant is permitted by Mississippi law to argue
the reasonableness of its actions as a rebuttal to the presumption of negligence
that arises from violation of a statute or regulation. See, e.g., Alabama Great S.
R.R. Co. v. Lee, 826 So. 2d 1232, 1236 (Miss. 2002). Boston Scientific contends
that this reasonableness defense constitutes an “additional” or “different” duty
under § 360k. We disagree because reasonableness is an optional defense to
rebut the presumption of negligence that arises from the defendant’s violation
of a statute or regulation in Mississippi (and in most states) that a defendant
may present to narrow the scope of liability. See id. It is strictly up to the
defendant whether “reasonableness” is injected in the case. Our reaction to
Boston Scientific’s argument is consistent with the Supreme Court’s statement
in Lohr that “[w]hile such a narrower requirement might be ‘different from’ the
federal rules in a literal sense, such a difference would surely provide a strange
reason for finding preemption of a state rule insofar as it duplicates the federal

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rule.” Lohr, 518 U.S. at 495.7 There is nothing in Riegel suggesting that the
Supreme Court’s view on this issue has changed. Therefore, guided by the
Court’s comments, we conclude that invoking the negligence per se doctrine to
support a negligence claim that is otherwise parallel to federal requirements is
not expressly preempted.8
D.
Boston Scientific argues next that permitting the jury to determine
whether Boston Scientific violated the FDA’s reporting requirements would lead
to the possible imposition of different or additional state requirements. Boston
Scientific contends that the FDA never made a “formal” finding that Boston
Scientific failed to comply with the MDR regulations or initiated an enforcement
action against Boston Scientific and that such a “formal” action by the FDA must
be considered an “implicit precondition” to a parallel suit because a jury should
not be permitted, in the first instance, to make such a finding.
We are persuaded that any additional “formal” finding or enforcement
action by the FDA is not an “implicit precondition” to suit under the facts of this
case. No controlling authority holds or implies that any particular type of formal
action by the FDA is a prerequisite to a parallel state suit. To the contrary, in
Gomez, this court permitted the plaintiff to prove non-compliance with the

7
The Court repeated this “strange reason” comment in Bates v. Dow-Agro Sciences,
LLC, 544 U.S. 431, 448 n.23 (2005) (regarding preemption under the Federal Insecticide,
Fungicide, and Rodenticide Act).
8
One of the reasons given by the district court for holding Hughes’s negligence per se
“claim” to be preempted is that the FDA regulations are “administrative,” and the district
court further suggested that allowing such a claim is “contrary to Congressional intent.”
Hughes v. Boston Sci. Corp., 669 F. Supp. 2d 701, 712-13 (S.D. Miss. 2009). For the reasons
stated above, § 360k does not preempt use of the negligence per se doctrine. Therefore, the
district court erred in finding that principles of preemption applied to affect the use of this
doctrine. Implied preemption is also inapplicable to bar use of negligence per se for the same
reasons. However, we express no opinion on whether Hughes may utilize the doctrine of
negligence per se based on violation of the FDA regulations at issue in this case as a matter
of Mississippi tort law because this question is not before us.

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No. 09-60925

applicable FDA manufacturing specifications without requiring her to show that
the FDA made a formal finding or undertook an enforcement. Gomez, 442 F.3d
at 933. The Sixth Circuit also permitted state negligence claims based on
violations of FDA manufacturing specifications without a formal FDA finding of
non-compliance. Howard, 382 F. App’x at 440-42.
At best, the miscellaneous district court opinions cited by Boston Scientific
suggest that conclusory allegations of an FDA regulatory violation are
impermissible. But Hughes’s allegations are not conclusory. She has presented
evidence that supports the view that Boston Scientific violated the plain text of
the MDR regulations. The regulations required Boston Scientific to report any
time the device “may have caused or contributed to death or serious injury,” or
malfunctioned in a manner that would “would be likely to cause or contribute to
a death or serious injury in the malfunction were to recur.” 21 U.S.C. §
360i(a)(1)(A)-(B); 21 C.F.R. § 803.50(a). The term “serious injury” is defined as
“an injury or illness that is life-threatening, results in permanent impairment
of a body function or permanent damage to a body structure or necessitates
medical or surgical intervention to preclude permanent impairment of a body
function or permanent damage to a body structure.” 21 C.F.R. § 803.3. This
definition is mandated by statute. 21 U.S.C. § 360i(a)(2). Hughes has offered
expert testimony that some of the burns Boston Scientific failed to report
necessitated medical or surgical intervention to preclude permanent injuries.
Boston Scientific’s failure to report such burns would support a finding of
violation of the plain text of the regulation. Id.; 21 C.F.R. § 803.3.
Similarly, the word “malfunction” is defined to mean “the failure of a
device to meet its performance specifications or otherwise perform as intended,”
with performance specification defined to “include all claims made in the
labeling for the device,” and intended performance defined as “the intended use
for which the device is labeled or marketed . . . .” 21 § C.F.R. 803.3. Hughes’s

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No. 09-60925

expert has stated his opinion that Boston Scientific’s failure to report burns
caused by leakage from the HTA violated this regulation because the risk of such
burns was not reflected on the HTA’s labeling. The summary judgment evidence
supports this plain interpretation of the term “malfunction,” because the HTA’s
labeling available to Hughes in 2006 apparently warned only about burns caused
by user error, not burns caused by leakage from the device in the absence of user
error. According to Hughes’s summary judgment evidence, her burn was caused
by leakage from the HTA device not arising from user error, and some of the
other unreported burns may have been due to similar leaks not implicating user
error.
We therefore conclude that the evidence is sufficient to allow the jury to
determine that Boston Scientific failed to report serious injuries and
malfunctions caused by the HTA as required by the MDR regulations.
Furthermore, any danger that the jury in this case may apply the plain terms
of the MDR regulations in a different or more stringent manner than the FDA
intended is considerably mitigated by the summary judgment evidence
indicating that the FDA disapproved of Boston Scientific’s reporting practices.
Charles Montgomery, Boston Scientific’s representative, testified during
deposition that an FDA official “directed” Boston Scientific via letter in 2008 to
abandon the algorithm and to begin reporting all burns caused by the HTA. 9
Montgomery testified that the FDA told Boston Scientific that when information
regarding a burn is “ambiguous” as to whether the burn requires medical
treatment or intervention, the burn must be reported. Accordingly, once Boston
Scientific changed its reporting practices consistent with the FDA’s direction in
2008, Boston Scientific began reporting significantly more burns caused by the
HTA.

9
This letter was discussed at length in the deposition but we have been unable to locate
it in the record.

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No. 09-60925

This evidence strongly suggests that the FDA concluded that Boston
Scientific’s algorithm failed to satisfy the MDR regulations requiring reports of
“serious injuries.” The FDA’s 2008 letter appears to be consistent with how the
FDA usually addresses noncompliance with MDR obligations. Kyper asserts in
his expert report that the FDA often relies on voluntary measures to remedy
reporting violations rather than initiate expensive and time-consuming
enforcement actions or PMA withdrawals. Boston Scientific has not directed the
court to any regulation or statutory provision requiring the FDA to respond to
a violation in any particular manner. Rather, the regulations support Hughes’s
contention that the FDA has the discretion to undertake any enforcement
method it chooses to remedy violations of the MDR regulations, including
voluntary measures. Thus, permitting the jury in this action to find that Boston
Scientific violated these regulations, consistent with the FDA’s 2008 letter to
Boston Scientific, is supported by Riegel, Lohr, and Gomez, all of which make
clear that a state may impose “additional remedies” for violations of FDA
regulations beyond those which the FDA imposes. See, e.g., Riegel, 552 U.S. at
330.
Moreover, permitting the jury to make this finding would not conflict with
any contrary FDA decision. Based upon its inclusion of the reporting algorithm
in its annual reports to the FDA, Boston Scientific argues that the FDA actually
did approve the algorithm before challenging it in 2008. But Boston Scientific
cannot point to any decision or communication by the FDA expressly or
impliedly approving the algorithm. Nor can Boston Scientific cite any authority
establishing that the FDA’s silence should be treated as approval of the
algorithm. To the contrary, some courts have rejected similar arguments. See,
e.g., In re Bextra & Celebrex Mktg. Sales Practice & Prod. Liab. Litig., No. M:05-
1699 CRB, 2006 U.S. Dist. LEXIS 95500, *70-71 (N.D. Cal. Aug. 16, 2006)
(defendant drug manufacturer “cite[d] no authority for its assertion that the

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No. 09-60925

FDA’s silence as to a particular advertisement means that the FDA ‘necessarily
determined’ that the advertisement was not deceptive . . . .”); accord In re Bayer
Corp. Combination Aspirin Prods. Mktg. & Sales Practices Litig., 701 F. Supp.
2d 356, 375 (E.D.N.Y. 2010). Based on consideration of this evidence in the light
most favorable to Hughes, we cannot conclude that the FDA approved Boston
Scientific’s algorithm before disapproving of it in 2008. For all these reasons, we
reject Boston Scientific’s assertion that any additional “formal” finding or action
by the FDA is a prerequisite to this parallel suit.
IV.
We next consider Hughes’s argument that the district court erred in
holding that her negligence claim 10 was preempted under § 337a of the MDA, as
construed in Buckman, 531 U.S. at 341. The suit in Buckman was for personal
injuries suffered from orthopedic bone screws in patients’ spines. Id. The
plaintiffs alleged that the manufacturer made fraudulent representations to the
FDA about the screws’ potential use in the spine in order to receive FDA
approval. Id. The plaintiffs argued that but for this fraud, the FDA would not
have approved the screws and the plaintiffs would not have been injured. Id. at
347. The Court held that allowing the plaintiff to pursue a suit based on a
“fraud-on-the-FDA” theory conflicted with the federal regulatory scheme by
disrupting the “delicate balance of statutory objectives,” and was therefore
impliedly preempted under 21 U.S.C. § 337(a).11 Id. at 347-53. The majority
made clear, however, that some parallel state claims survive preemption by the
MDA, stating “it is clear that the [Lohr] claims arose from the manufacturer’s

10
The district court repeatedly referred to the implied preemption of Hughes’s
“negligence per se claim.”
11
§ 337(a) states that “[e]xcept as provided in subsection (b), all such proceedings for
the enforcement, or to restrain violations, of this Act shall be by and in the name of the United
States.”

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No. 09-60925

alleged failure to use reasonable care in the production of the product, not solely
from the violation of FDCA requirements,” whereas “[i]n the present case,
however, the fraud claims exist solely by virtue of the FDCA disclosure
requirements.” Id. at 352-53 (citing Lohr, 518 U.S. at 481). The majority also
distinguished the “fraud-on-the-FDA” theory from the “traditional state tort law”
claims that were not preempted in Silkwood v. Kerr-McGee Corp., 464 U.S. 238
(1984). Id. at 351-52.
Hughes’s claim is not analogous to the “fraud-on-the-FDA” theory in
Buckman. The plaintiffs in Buckman were attempting to assert a freestanding
federal cause of action based on violation of the FDA’s regulations; the plaintiffs
did not assert violation of a state tort duty. In contrast, Hughes is asserting a
Mississippi tort claim based on the underlying state duty to warn about the
dangers or risks of product. She seeks to prove Boston Scientific’s breach of the
state duty by showing that Boston Scientific violated the FDA’s MDR
regulations. Because Hughes is asserting a recognized state tort claim, her
claim is comparable to the tort claims in Silkwood and Lohr that Buckman
recognized as surviving implied preemption. The Seventh Circuit reached a
similar conclusion, holding that the plaintiff’s negligence claims based on the
manufacturer’s violation of the FDA’s specifications were not impliedly
preempted under Buckman because the plaintiffs were asserting breach of a
“recognized state-law duty” rather than “an implied right of action under federal
law.” See Bausch, No. 09-3434, __ F.3d __, 2010 U.S. App. LEXIS 26094 at *28.
Notably, Hughes’s claim does not depend on speculation that the FDA
would have taken any particular regulatory action in response to violation of the
regulations at issue, as in Buckman. Moreover, Boston Scientific’s
interpretation of Buckman barring this otherwise parallel state claim is
inconsistent with the Supreme Court’s reasoning in Riegel, decided long after
Buckman. Riegel unequivocally held that parallel state claims survive a

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No. 09-60925

defendant’s preemption defense under the MDA because states may impose an
additional “damages remedy for claims premised on violation of FDA
regulations.” Riegel, 522 U.S. at 330. Our conclusion in this respect is also
supported by our decision in Gomez, decided years after Buckman, in which we
permitted a negligence claim for defective manufacturing to proceed. Gomez,
442 F.3d at 933. Thus, we hold that Hughes’s failure to warn claim is not
impliedly preempted.
V.
Finally, Boston Scientific argues that Hughes failed to present enough
evidence to create a genuine issue of material fact regarding causation. A
Mississippi negligence claim, including one relying on the rule of negligence per
se, can only succeed if the plaintiff can prove that the defendant’s violation of a
statute or regulation caused the plaintiff’s injury. See, e.g., Thomas, 667 So. 2d
at 596. Because the district court held that all of Hughes’s claims are
preempted, the district court did not address causation.
Hughes’s primary causation theory is that if Boston Scientific had reported
the true number of injuries and malfunctions related to burns caused by the
HTA, this information would have appeared on the FDA’s MAUDE internet
database and in medical journals, and with this information Dr. Weber would
not have recommended the HTA to Hughes for treatment, nor would Hughes
have chosen the HTA as a treatment option.12 However, we decline Boston

12
Hughes has asserted other causation theories which are untenable. She asserts that
had Boston Scientific properly reported all burns (1) the FDA would have taken some
regulatory action against the HTA, including but not limited to removing the HTA from the
market; and (2) the HTA labels or user manual would have warned of the risk of burns
associated with use of the HTA. The first theory is entirely speculative, Rod v. Home Depot
USA, Inc., 931 So. 2d 692, 695 (Miss. Ct. App. 2006) (holding that causation cannot be proved
based on speculation), and could impermissibly allow the jury to question the FDA’s decision
to approve the device for the market. Buckman, 531 U.S. at 347-53. The second theory is
unacceptable because Hughes cannot ask the jury to second-guess the HTA’s label or user
manuals, which were specifically approved by the FDA. Gomez, 442 F.3d at 931.

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No. 09-60925

Scientific’s invitation to consider whether it is entitled to summary judgment on
this issue in this appeal. We are persuaded that we should permit the district
court to consider this argument in the first instance on remand.
VI.
For the above reasons, we affirm that part of the district court’s judgment
dismissing Hughes’s state-law claims as preempted except for Hughes’s failure
to warn claim. We conclude that Hughes’s failure to warn claim is neither
expressly nor impliedly preempted by the MDA to the extent that this claim is
premised on Boston Scientific’s violation of FDA regulations with respect to
reporting burns caused by the HTA.
Accordingly, we affirm the district court’s dismissal on summary judgment
of all claims Hughes asserted except for Hughes’s failure to warn claim. We
vacate the order insofar as it dismisses this claim and remand this claim to the
district court for further proceedings consistent with this opinion.
AFFIRMED in part, VACATED in part, and REMANDED.

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