FILED United States Court of Appeals PUBLISH Tenth Circuit
UNITED STATES COURT OF APPEALS January 26, 2021 Christopher M. Wolpert FOR THE TENTH CIRCUIT Clerk of Court _________________________________
AMBER BROOKS; JAMIE GALE,
Plaintiffs - Appellants,
v. No. 19-3240
MENTOR WORLDWIDE LLC,
Defendant - Appellee. _________________________________
Appeal from the United States District Court for the District of Kansas (D.C. No. 2:19-CV-02088-KHV-TJJ) _________________________________
Anthony A.B. Dogali (Barbara U. Uberoi with him on the briefs), Dogali Law Group, P.A., Tampa, Florida, for Plaintiffs-Appellants.
Dustin B. Rawlin (Jeffrey C. Sindelar, Jr. with him on the brief), Tucker Ellis LLP, Cleveland, Ohio, for Defendant-Appellee. _________________________________
Before HARTZ, PHILLIPS, and CARSON, Circuit Judges. _________________________________
CARSON, Circuit Judge. _________________________________
As is its prerogative, Congress heavily regulates the production and use of
medical devices. In doing so, Congress has introduced federal law to an area state
law, alone, once governed. That introduction of federal law has left, by both express
and implied preemption, only a narrow gap within which a plaintiff can plead a tort claim arising from the failure of a medical device. Successful pleading requires
navigating a legal quagmire that has consumed unwary legal professionals for more
than forty years. Today we again wade into that quagmire.
Plaintiffs Amber Brooks and Jamie Gale brought tort claims based on injuries
they sustained when their breast implants began deteriorating. The district court
found that they failed to state a claim upon which relief could be granted and
dismissed their Complaint with prejudice. Plaintiffs ask us to reverse the district
court’s dismissal. We agree with the district court that federal law preempts some of
Plaintiffs’ claims and that Plaintiffs insufficiently pleaded the rest. Therefore,
exercising jurisdiction under 28 U.S.C. § 1291, we affirm.
I.
In 1976, Congress passed the Medical Device Amendments (MDA) to the
Federal Food, Drug, and Cosmetics Act (FDCA). Riegel v. Medtronic, Inc., 552 U.S.
312, 316 (2008). Through that legislation, Congress standardized and regulated the
safety and effectiveness of medical devices. Id. at 315–16. Class III devices—those
subject to the strictest controls—must go through a premarket approval (PMA)
process, administered by the Food and Drug Administration (FDA). Id. at 317. The
PMA process begins with a rigorous application, involving extensive research and
testing and usually requiring a multi-volume submission. Id. The approval process
may last years, consuming over 1,200 hours of agency review time on average, and
often requires that the manufacturer continue to study and report information about
the device during and after approval. Id. at 317–18. The FDA may refer the
2 application to a panel of experts or require further data from the manufacturer. Id.
Only upon “reasonable assurance” of the device’s safety and effectiveness, weighing
any probable benefit to health against any probable risk of injury or illness, may the
FDA approve a Class III device. Id. at 318. Part of every PMA review involves
warnings and labeling. Id. And the FDA may only approve labels and warnings if it
determines they are not false or misleading. Id. The FDA may condition premarket
approval on adherence to performance standards, restrictions on sale or distribution,
or further research. See id. at 319. After approval, a manufacturer may not change
“design specifications, manufacturing processes, labeling, or any other attribute, that
would affect safety or effectiveness.” Id. Furthermore, the FDA may subject
approved devices to ongoing reporting obligations and can revoke approval based on
new or existing data and must do so when “it determines that a device is unsafe or
ineffective.” Id. at 319–20.
Because this case comes to us at the motion-to-dismiss phase, we take the facts
from the Complaint. In 2003, Defendant Mentor Worldwide LLC submitted its
application for premarket approval of the “MemoryGel” silicone breast implant.
Almost three years later, the FDA granted approval subject to Defendant conducting
a range of post-approval studies. Defendant failed to properly conduct these studies
and to report their results in a variety of ways. These failures included low follow-up
rates and high drop-out rates for the studies, failure to collect data, failure to report
data, reporting inconsistent data, lack of adequate sample sizes in studies, inadequate
summarization of findings and results, failure to update labeling in accordance with
3 findings, and omitting information about study methodology. Defendant also failed
to fulfill reporting obligations that were not tied to specific post-approval studies and,
while the PMA application was pending, whistleblowers alleged that Defendant had
been fraudulent in its reporting.
In the years before the PMA process, Defendant manufactured and used
MemoryGel implants for clinical testing, under an “investigational device
exemption,” granted by the FDA. During this period, whistleblower complaints led
to a federal investigation of Defendant’s Texas manufacturing facility. The
investigation resulted in a consent decree under which Defendant agreed to remedy
specific deficiencies and conduct future operations in accordance with federal law
and the FDA’s “quality system regulation” for manufacturing standards.
After Defendant completed the PMA process, Plaintiffs received MemoryGel
implants. Both soon felt negative effects. Gale developed various symptoms and
health problems. Brooks experienced even more symptoms and problems.
Physicians eventually removed both Plaintiffs’ implants. Gale’s implants had both
leaked. Brooks’s implants apparently leaked as well. Upon removal of the implants,
some of Plaintiffs’ symptoms went away, some diminished in severity, and others
remained.
Plaintiffs filed their Complaint in the United States District Court for the
District of Kansas. Defendant moved to dismiss the Complaint for failure to state a
claim. The district court dismissed the case with prejudice. See Fed. R. Civ. P.
41(b). The district court found that federal law preempted all of Plaintiffs’ claims
4 and, in any event, Plaintiffs failed to sufficiently plead their claims. The district
court also determined that Missouri law, rather than Kansas law, applied to Brooks’s
claims and denied Plaintiffs’ request for leave to amend their Complaint.
II.
This case presents two discrete issues. First, whether the district court erred in
granting Defendant’s motion to dismiss for failure to state a claim. We review this
decision de novo, Wasatch Equality v. Alta Ski Lifts Co., 820 F.3d 381, 386 (10th
Cir. 2016), including the district court’s rulings on preemption, Cerveny v. Aventis,
Inc., 855 F.3d 1091, 1096 (10th Cir. 2017). And second, whether the district court
erred in declining to grant Plaintiffs leave to amend their Complaint. We review this
decision for an abuse of discretion. Warnick v. Cooley, 895 F.3d 746, 754 (10th Cir.
2018).
III.
In their Complaint, Plaintiffs sought to plead claims for failure to warn and
manufacturing defect, sounding in ordinary negligence, negligence per se, and strict
liability. For the reasons below, we conclude that federal law preempts their
negligence per se claims and their failure-to-warn claims that sound in ordinary
negligence and strict liability. We further hold Plaintiffs insufficiently pleaded their
ordinary negligence and strict liability claims for manufacturing defect.
5 A.
The FDCA and MDA contain two preemption provisions relevant here. 1 The
first provides for express preemption of certain state laws:
(a) Except as provided in subsection (b), 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.
21 U.S.C. § 360k. The Supreme Court established a two-part test to evaluate a claim
for express preemption. Riegel v. Medtronic, Inc., 552 U.S. 312, 321–22 (2008).
First, we must ask “whether the federal government has established requirements
1 Plaintiffs assert that the district court erred in finding that Missouri law, rather than Kansas law, governs Brooks’s tort claims. When a federal court exercises subject-matter jurisdiction based on 28 U.S.C. § 1332, it applies the substantive law of the state in which it sits, including that state’s choice-of-law principles. Pepsi- Cola Bottling Co. of Pittsburg, Inc., v. PepsiCo, Inc., 431 F.3d 1241, 1255 (10th Cir. 2005). Thus, the United States District Court for the District of Kansas applies Kansas’s choice-of-law principles. Where an act or omission in one state leads to an injury in another state, Kansas applies the law of the state where the injury occurred. Ling v. Jan’s Liquors, 703 P.2d 731, 735 (Kan. 1985) (rejecting the “most- significant-relationship” test and holding that Kansas law controlled where an event in Missouri led to injury in Kansas). The district court determined that, although Brooks’s operation occurred in Kansas, she alleged that the resulting injuries arose in Missouri. Therefore, the district court said, under Kansas’s choice-of-law rules Missouri law applies to Brooks’s claims. Although Plaintiffs urge this as a potential error, we need not decide which state’s law applies because either would reach the same result below regardless. We do not couch the discussion in this section of our opinion in terms of either state’s law, and our analysis does not depend on which state’s law applies. Rather, we look to Plaintiffs’ Complaint and conclude that federal law preempts their claims as stated. 6 applicable to” the implants. Id. at 321. The parties do not dispute that the MDA
applies to the implants. 2 Second, we must determine whether the state-law claims
impose a requirement that relates to the safety or effectiveness of the implant and
differs from or adds to the federal requirements. Id. at 321–22. Federal law
preempts a tort claim “unless the federal requirements impose duties that are at least
as broad as those” imposed by the state law. Caplinger v. Medtronic, Inc., 784 F.3d
1335, 1340 (10th Cir. 2015).
The second preemption statute provides that
Except as provided in subsection (b), all such proceedings for the enforcement, or to restrain violations, of this chapter shall be by and in the name of the United States. . . .
21 U.S.C. § 337. Interpreting and applying this requirement is easier than the first.
“Congress intended that the MDA be enforced exclusively by the Federal
Government.” Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341, 352 (2001).
Thus, the FDCA preempts “any state tort claim that exists ‘solely by virtue’ of an
FDCA violation.” Caplinger, 784 F.3d at 1339 (quoting Buckman, 531 U.S. at 353).
Along with express preemption, this implied preemption provision leaves only a
narrow gap of possible state tort claims. Any such claim must be predicated on
conduct that violates the FDCA but may not be brought solely because that conduct
violates the FDCA—the conduct must also violate a parallel state-law requirement.
2 In any event, these implants have endured the premarket approval process, which subjects them to federal requirements. See Caplinger v. Medtronic, Inc., 784 F.3d 1335, 1340 (10th Cir. 2015). 7 Put differently, to survive preemption, a plaintiff must plead conduct that
(1) violates the FDCA (because state law may not impose additional or different
duties) and (2) would be actionable under state law independently of the FDCA
(because a plaintiff may not seek to enforce the FDCA). See In re Medtronic, Inc.,
Sprint Fidelis Leads Prods. Liab. Litig., 623 F.3d 1200, 1204 (8th Cir. 2010) (internal
citation omitted). And when the pleader misses the gap—that is, when federal law
preempts a claim—the court should dismiss that claim. See Caplinger, 784 F.3d at
1337, 1347.
1.
We first address Plaintiffs’ negligence per se theory. Insofar as the Complaint
alleged failure-to-warn or manufacturing-defect claims based on negligence per se,
federal law preempts those claims. Congress and the courts have clearly defined the
narrow gap: a plaintiff may sue under a state-law cause of action for conduct that
violates the MDA but not because that conduct violates the MDA. When we ask
whether liability under negligence per se exists independently under state law,
regardless of the FDCA or MDA, we must answer “no.” See Buckman, 531 U.S. at
353. Plaintiffs’ negligence per se theory relies on a federal requirement to supply the
duty of care and looks to a violation of the requirement as the breach of that duty.
See id. Any negligence per se action premised on an MDA violation necessarily
seeks to enforce the MDA rather than a parallel state-law duty. And only the United
States may enforce the MDA. 21 U.S.C. § 337(a); id. at 349 n.4.
8 Furthermore, negligence per se premised on a violation of the MDA lacks
viability under the laws of either Kansas or Missouri. Kansas law limits negligence
per se to violations of a statute for which the legislature intended to create a private
cause of action. Cullip ex rel. Pitts v. Domann ex rel. Domann, 972 P.2d 776, 782
(Kan. 1999); Rhoten v. Dickson, 223 P.3d 786, 803 (Kan. 2010). Similarly, Missouri
law limits negligence per se to violations of a statute where the legislature intended
to replace the ordinary negligence standard of care. Lowdermilk v. Vescovo Bldg. &
Realty Co., Inc., 91 S.W.3d 617, 629 (Mo. Ct. App. 2002); J.J.’s Bar & Grill, Inc. v.
Time Warner Cable Midwest, LLC, 539 S.W.3d 849, 869 (Mo. Ct. App. 2017). The
MDA’s text tells us that Congress created no private cause of action in the MDA, and
Buckman tells us that Congress did not intend the MDA to supplant state-law duties
of care. 21 U.S.C. § 337(a); 531 U.S. at 352–53. For these reasons, we conclude that
the district court properly dismissed Plaintiffs’ negligence per se theory.
2.
This leaves ordinary negligence and strict liability for failure to warn. The
district court found, and we agree, that Plaintiffs sought to allege that Defendant
breached a duty to warn (1) patients, (2) physicians, and (3) the FDA about the
implants’ health risks. Like the district court, we conclude that federal law preempts
these claims.
First, Plaintiffs identify no federal requirement that a Class III-device
manufacturer provide a warning directly to a patient. Plaintiffs’ briefing addresses
preemption in vague, general, and largely historical terms but never nails down a
9 specific argument about any of their claims. We are under no obligation to “search[]
out theories and authorities [Plaintiffs] have not presented for [themselves].”
Caplinger, 784 F.3d at 1342. And we have expressed particular hesitation to do so in
this area of law where “there exists so much risk of going astray.” Id. Because
Plaintiffs have not offered—and we will not seek out—a federal requirement to warn
patients, any state-law duty to do so adds to the federal scheme as it is before us. Id.
at 1341. Federal law expressly preempts any such addition. Id.
Next, Plaintiffs alleged that Defendant had a duty to warn physicians directly
by updating its warning labels. But just as above, Plaintiffs fail to identify a federal
requirement that Defendant do so. In fact, a Class III device manufacturer ordinarily
may not change or update its warning labels and package inserts without prior FDA
approval. 21 U.S.C. § 360e(d); Caplinger, 784 F.3d at 1341. Defendant could have
changed its labeling without FDA approval by a permissive mechanism, but that
mechanism is not mandatory. 21 C.F.R. § 814.39. It allows, but does not require, a
change. McMullen v. Medtronic, Inc., 421 F.3d 482, 489 (7th Cir. 2005). And
absent a federal requirement that they do so, federal law expressly preempts any
state-law duty requiring a manufacturer to update its labeling. In re Medtronic, 623
F.3d at 1205; Caplinger, 784 F.3d at 1341.
Finally, Plaintiffs alleged that Defendant violated its duty to warn the FDA.
They claim that Defendant did not properly conduct post-approval, FDA-mandated
testing and report negative results. Plaintiffs also theorize that this reporting would
have indirectly warned physicians of the implants’ dangers. But Plaintiffs have not
10 identified a state-law duty to comply with FDA-imposed post-approval requirements
such as testing and reporting. Buckman made clear that only the federal government
may enforce reporting requirements and investigate and respond to suspected fraud.
531 F.3d at 348–49. Similarly, the government retains the exclusive right to enforce
post-approval requirements for continued testing, including the right to revoke
approval for noncompliance. See id.; 21 C.F.R. § 814.82(c). Federal law thus
impliedly preempts Plaintiffs’ claims based on alleged failures to properly conduct
post-approval testing and reporting as attempts to enforce the MDA. 21 U.S.C.
§ 337(a); Buckman, 531 U.S. at 348–49; Caplinger, 784 F.3d at 1339. As a result,
the district court properly dismissed Plaintiffs’ failure-to-warn claims.
B.
We turn now to the remaining manufacturing-defect claims. We use the
Iqbal/Twombly standard to determine whether Plaintiffs have stated a plausible
claim. Brown v. Montoya, 662 F.3d 1152, 1162–63 (10th Cir. 2011). In applying
this standard, we take Plaintiffs’ well-pleaded facts as true, view them in the light
most favorable to Plaintiffs, and draw all reasonable inferences from the facts in
favor of Plaintiffs. Id. at 1162. A plausible claim includes facts from which we may
reasonably infer Defendant’s liability. Id. at 1163. Plaintiffs must nudge the claim
across the line from conceivable or speculative to plausible. Id. Allegations that are
“‘merely consistent with’ a defendant’s liability” stop short of that line. Ashcroft v.
Iqbal, 556 U.S. 662, 678 (2009) (quoting Bell Atl. Corp. v. Twombly, 550 U.S. 544,
557 (2007)). Labels, conclusions, formulaic recitations of elements, and naked
11 assertions will not suffice. Id. An allegation is conclusory where it states an
inference without stating underlying facts or is devoid of any factual enhancement.
Kellum v. Mares, 657 Fed. App’x 763, 770 (10th Cir. 2016) (unpublished) (citing
Black’s Law Dictionary (10th ed. 2014)). 3 Conclusory allegations are “not entitled to
the assumption of truth.” Khalik v. United Air Lines, 671 F.3d 1188, 1193 (10th Cir.
2012). In fact, we disregard conclusory statements and look to the remaining factual
allegations to see whether Plaintiffs have stated a plausible claim. Waller v. City &
Cnty. of Denver, 932 F.3d 1277, 1282 (10th Cir. 2019). We must draw on our
experience and common sense in evaluating the plausibility of a claim. Iqbal, 556
U.S. at 679. The degree of specificity needed to establish plausibility and provide
fair notice depends on the context and the type of case. Id.; Robbins v. Oklahoma,
519 F.3d 1242, 1248 (10th Cir. 2008).
Plaintiffs fail to allege facts reflecting any negligence in the manufacturing of
the implant or that the implant was, in fact, defective. Although the Complaint spins
a wide-reaching story of noncompliance with FDA regulations and requirements, bad
conduct, whistle-blower complaints, misrepresented data, and other horrors, it does
little to support this highly conclusory story with specific facts. Bald accusations
such as “defendant violated the law,” “defendant failed to exercise reasonable care,”
and the like will not support a claim for relief. Iqbal, 556 U.S. at 679 (“While legal
3 See also Camasta v. Jos. A. Bank Clothiers, Inc., 761 F.3d 732, 740 (7th Cir. 2014); McCauley v. City of Chicago, 671 F.3d 611, 622–23 (7th Cir. 2011) (Hamilton, J., dissenting in part). 12 conclusions can provide the framework of a complaint, they must be supported by
factual allegations.”). Plaintiffs do allege largely historical facts that almost entirely
deal with indiscretions in conducting studies and reporting results. But these factual
allegations do not touch on any specific flaw in the manufacturing process relevant to
Plaintiffs’ own implants. Nor does Plaintiffs’ 38-page, 201-paragraph Complaint
describe a particular flaw in the specific implants they received.
In the Complaint, Plaintiffs conclude that the implants “differed from the
specifications agreed to by the FDA” and “used materials and components which
differed from those approved by the FDA,” without alleging any supporting facts.
They also conclude that Defendant (1) “fail[ed] to follow good manufacturing
practices,” (2) had “not complied with applicable federal regulations” and “fail[ed] to
adhere to manufacturing protocols approved by the FDA,” (3) “carelessly and
negligently s[old] and distribut[ed]” the implants “in violation of” federal law,
(4) “negligently incorporate[ed] components and/or materials” that were not
“commercially reasonable” and “could not stand up to normal usage,” and
(5) “fail[ed] to exercise reasonable care in inspecting and testing . . . manufacturing,
quality control and quality assurance processes.” Plaintiffs did not plead factual
allegations to support these or any of their other conclusions, and thus they cannot
sustain a claim for relief.
Given the lack of factual allegations relevant to their manufacturing-defect
claims and the conclusory nature of the Complaint regarding those claims, we agree
13 with the district court that Plaintiffs have not adequately pleaded these claims. The
district court, therefore, properly dismissed the manufacturing-defect claims.
IV.
Finally, Plaintiffs argue that the district court erred in denying their request
“that the dismissal be entered without prejudice to provide them with an opportunity
to amend.” Plaintiffs included this one-sentence request at the end of their response
to Defendant’s motion to dismiss. But Plaintiffs did not comply with District of
Kansas Local Rule 15.1 (requiring that the proposed pleading be attached to a motion
for leave to amend) and did not explain how any amendment would relate to the
preemption issue. So the district court declined to grant leave to amend and granted
Defendant’s motion to dismiss with prejudice. To find an abuse of discretion, we
must conclude that this decision was “arbitrary, capricious, whimsical, or manifestly
unreasonable.” Bylin v. Billings, 568 F.3d 1224, 1229 (10th Cir. 2009) (quoting Orr
v. City of Albuquerque, 417 F.3d 1144, 1153 (10th Cir. 2005)).
Federal Rule of Civil Procedure 15(a)(1) provides that a plaintiff may amend
its complaint as a matter of right within 21 days after a defendant serves a Rule 12(b)
motion. By this mechanism, a plaintiff can seek to cure any defect identified in the
motion. But Plaintiffs declined to take this course. After expiration of the time to
amend as a matter of right, Plaintiffs could have formally moved for leave to amend
in compliance with the applicable Federal Rules and Local Rule 15.1. But they did
not. They chose, instead, to make a one-sentence request in their response to the
motion to dismiss. Plaintiffs argue that such bare requests “serve an important
14 function, in that a party is able to make a general request without being placed in a
difficult situation of diluting their primary position.” Opening Br. 37. Here,
Plaintiffs apparently took the “primary position” that their original Complaint could
survive the motion to dismiss.
We have long held that bare requests for leave to amend do not rise to the
status of a motion and do not put the issue before the district court. Glenn v. First
Nat. Bank in Grand Junction, 868 F.2d 368, 370–71 (10th Cir. 1989) (“A naked
request for leave to amend asked for as alternative relief when a party has the
unexercised right to amend is not sufficient.”). Such “shot[s] in the dark” do not
request “an order contemplated under the rules,” do not state any particular grounds
for the request, and lack basis. Id. at 370. “A court need not grant leave to amend
when a party fails to file a formal motion.” Calderon v. Kan. Dep’t of Soc. & Rehab.
Servs., 181 F.3d 1180, 1186 (10th Cir. 1999) (also recognizing the importance of
compliance with local rules). Furthermore, any request for a court order, such as a
request for leave to amend, must state with particularity the grounds for the order.
Id. (citing Fed. R. Civ. P. 7(b)(1)). Because we do not recognize Plaintiffs’ single
sentence as a cognizable motion, the district court did not abuse its discretion in
denying that request. See Glenn, 868 F.2d at 371; Calderon, 181 F.3d at 1186–87 (“a
request for leave to amend must give adequate notice to the district court and to the
opposing party of the basis of the proposed amendment before the court is required to
recognize that a motion for leave to amend is before it”); see also Warnick, 895 F.3d
15 at 755 (finding no abuse of discretion where a plaintiff merely suggested she should
be allowed to amend and violated D. Kan. Local Rule 15.1).
Our precedent also requires that to amend a pleading after the dismissal of a
case, a party must first move to reopen the case under Federal Rule of Civil
Procedure 59(e) or 60(b) and then move for leave to amend under Rule 15 in
accordance with the Rule 7 standard. Calderon, 181 F.3d at 1185. But Plaintiffs did
not take this route either. They argue that this “process places [a] significant burden
on the plaintiffs” and “creates a due process issue.” Opening Br. 37. This
underdeveloped argument constitutes a perfunctory invitation to explore a possible
constitutional issue embedded in the Federal Rules of Civil Procedure. Because
Plaintiffs did not raise it before the district court and did not adequately develop it on
appeal, we will not accept that invitation. See Bronson v. Swensen, 500 F.3d 1099,
1104 (10th Cir. 2007). Plaintiffs made a strategic choice to stand by their “primary
position” and took none of the available avenues to amend their Complaint. We will
not protect them from their own inaction. See Glenn, 868 F.2d at 371. The district
court did not abuse its discretion in denying Plaintiffs’ request.
AFFIRMED.