Court of Appeals of Missouri, Western District, Fourth Division
FROM THE CIRCUIT COURT OF BOONE COUNTY, MISSOURI THE
HONORABLE CHRISTINE CARPENTER, JUDGE
Mark D. Pfeiffer, Chief Judge, Gary D. Witt, Judge and Edward
R. Ardini, Jr., Judge.
R. ARDINI, JR., JUDGE.
Williams (Williams) brought this cause of action in the
Circuit Court of Boone County alleging fourteen separate
claims against Bayer Corp. (Bayer) related to its Essure
contraceptive device along with a variety of counts against
her treating physicians. Bayer filed a Motion to Dismiss on
the basis that the claims directed against it were preempted
under federal law which was granted by the trial court.
Williams now appeals arguing that the trial court erred in
dismissing those claims on preemption grounds and in not
granting her leave to file an amended petition. We affirm in
part and reverse and remand in part.
and Procedural Background
became pregnant with her fifth child sometime in late 2012.
After consulting with her physicians, she made the
determination to undergo a tubal ligation in conjunction with
the delivery. However, in late April of 2013,
Williams's physicians determined the umbilical cord had
prolapsed around her fetus and she required an immediate
caesarian section. Due to the emergency nature of the
caesarian section, the tubal ligation was not performed.
Following the birth, her physicians recommended Williams
consider using Essure as an alternative to tubal ligation.
Essure is a medical device manufactured and sold by Bayer
that is implanted in a woman's fallopian tube for the
purpose of causing inflammation and promoting the growth of
scar tissue. This scar tissue blocks the fallopian tube,
thereby achieving sterilization. After considering the
recommendations of her physicians and reviewing the
information provided on the Essure website, Williams agreed
to undergo the Essure procedure.
the procedure to place the Essure device, Williams began to
experience severe abdominal pain and requested her physicians
stop. As a result, the procedure was abandoned after only one
of the two devices was inserted. Williams continued to
experience significant pain following the procedure and,
after several months, requested her physicians remove the
Essure device. An x-ray performed during the attempt to
remove the Essure device revealed that it had broken apart
and perforated Williams's uterine wall. Consequently,
pieces of the Essure device were left in Williams's body.
Williams continued to experience pain and underwent further
surgery to remove one of her fallopian tubes along with a
29, 2015, Williams filed a petition alleging multiple claims
against Bayer as well as additional claims directed at
several of her physicians. One month after filing her initial
petition, Williams filed an amended petition that included
the same causes of action against Bayer. Bayer thereafter
filed a Motion to Dismiss arguing, among other things, that
all of Williams's claims were expressly or impliedly
preempted by federal law. After extensive briefing, the trial
court heard oral argument before taking the matter under
advisement. On March 17, 2016, the trial court issued an
order granting Bayer's Motion to Dismiss finding all of
the claims asserted against Bayer were preempted under
federal law. Williams subsequently filed
Plaintiff's Motion to Amend Judgment that included a
request for leave to amend her petition along with a proposed
Second Amended Petition, which the trial court did not grant.
First Amended Petition included fourteen counts directed
against Bayer: (Count 1) violation of the Missouri
Merchandising Practices Act (MMPA), (Count 2) fraudulent
misrepresentation, (Count 3) negligent misrepresentation,
(Count 4) breach of express warranties, (Count 5) breach of
implied warranty of merchantability, (Count 6) negligence
per se, (Count 7) strict product liability -
defective manufacturing, (Count 8) negligent manufacturing,
(Count 9) strict products liability for failure to warn -
off-label use, (Count 10) failure to warn - post premarket
approval risks, (Count 11) negligent training, (Count 12)
negligently supplying a product for use, (Count 16) civil
conspiracy, and (Count 17) res ipsa loquitur. The
trial court found that each of these claims were expressly or
impliedly preempted by the federal Medical Device Amendment
of 1976, 21 U.S.C. §360c, et seq., and
dismissed each with prejudice. Williams's first point on
appeal argues that the trial court erred in reaching this
review the granting of a motion to dismiss de novo.
Armstrong-Trotwood, LLC v. State Tax Commission, 516
S.W.3d 830, 835 (Mo. banc 2017). We assume all facts alleged
in the petition are true and liberally construe all
reasonable inferences in favor of the plaintiff. Smith v.
Humane Soc'y of United States, 519 S.W.3d 789, 798
(Mo. banc 2017). "[T]he petition is reviewed in an
almost academic manner, to determine if the facts alleged
meet the elements of a recognized cause of action, or of a
cause that might be adopted in that case." Id.
(quoting Nazeri v. Mo. Valley C., 860 S.W.2d 303,
306 (Mo. banc 1993)).
regarding the Medical Device Amendment of 1976
Federal Food, Drug, and Cosmetic Act (FDCA) has long required
FDA approval for the introduction of new drugs into the
market." Riegel v. Medtronic, Inc., 552 U.S.
312, 315 (2008) (internal citations omitted). The same cannot
be said of medical devices, however, which the act initially
"did not authorize any control over."
Medtronic, Inc. v. Lohr, 518 U.S. 470, 475 (1996).
Instead, "the introduction of new medical devices was
left largely for the States to supervise as they saw
fit." Riegel, 552 U.S. at 315. However, this
changed following the highly publicized failure of several
medical devices in the 1970's, the most notable being the
Dalkon Shield intrauterine contraceptive device. See
Riegel, 552 U.S. at 315; Lohr, 518 U.S. at 476.
In response to these failures, Congress passed the Medical
Devices Amendment of 1976, 21 U.S.C. §360c, et
seq., (MDA), which established a comprehensive scheme of
federal oversight regarding the introduction of new medical
devices. Riegel, 552 U.S. at 316.
the MDA, medical devices are divided into one of three
classes. "Devices that present no unreasonable risk of
illness or injury are designated Class I and are subject only
to minimal regulation by 'general controls.'"
Lohr, 518 U.S. at 476-77 (citing 21 U.S.C. §
360c(a)(1)(A)). These devices include such things as elastic
bandages and examination gloves. Riegel, 552 U.S. at
316. "Devices that are potentially more harmful are
designated Class II" and may "still be marketed
without advance approval, " but "must comply with
federal performance regulations known as 'special
controls.'" Lohr, 518 U.S. at 477 (citing
21 U.S.C. § 360c(a)(1)(B)). This class includes such
devices as powered wheelchairs and surgical drapes.
Riegel, 552 U.S. at 316. "Finally, devices that
either 'presen[t] a potential unreasonable risk of
illness or injury, ' or which are 'purported or
represented to be for a use in supporting or sustaining human
life or for a use which is of substantial importance in
preventing impairment of human health, ' are designated
Class III." Lohr, 518 U.S. at 477 (citing 21
U.S.C. § 360c(a)(1)(C)). Class III medical devices
include replacement heart valves, implanted cerebella
stimulators, and pacemaker pulse generators. Riegel,
552 U.S. at 317. Essure is a Class III device.
III devices are subject to the highest level of scrutiny
under the MDA. Id. "Before a new Class III
device may be introduced to the market, the manufacturer must
provide the FDA with a 'reasonable assurance' that
the device is both safe and effective." Lohr,
518 U.S. at 477. The method of providing this
"reasonable assurance" is known as "premarket
approval" or PMA. Id. "Once a device has
received premarket approval, the MDA forbids the manufacturer
to make, without FDA permission, changes in design
specifications, manufacturing processes, labeling, or any
other attribute, that would affect safety or
effectiveness." Riegel, 552 U.S. at 319.
(citing 21 U.S.C. § 360e(d)(6)(A)(i)). "If the
applicant wishes to make such a change, it must submit, and
the FDA must approve, an application for supplemental
premarket approval, to be evaluated under largely the same
criteria as an initial application." Id.
(citing 21 U.S.C. § 360e(d)(6); 21 CFR §
includes an express preemption provision that provides:
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(a); Id. at 316. The United
States Supreme Court discussed this provision at length in
Riegel v. Medtronic, Inc. and set forth a two-step
analysis for determining whether a state law claim is
expressly preempted under it. Riegel, 552 U.S. at
321-22. First, the court must determine whether the federal
government established requirements applicable to the medical
device. Id. at 321. Second, the court must determine
whether the state law claim would impose requirements
"different from, or in addition to, " the federal
requirements. Id. at 321-22. If both of these
questions are answered in the affirmative, then the state law
claim is expressly preempted. Id. at 321-25; see
also Zaccarello v. Medtronic, Inc., 38 F.Supp.3d 1061,
1066 (W.D. Mo. 2014) (stating same).
the Supreme Court's Riegel decision also
specifically found that not all state law claims would be
preempted under the MDA. Riegel, 552 U.S. at 321-22.
Rather, the Supreme Court noted that the MDA's express
preemption provision "does not prevent a State from
providing a damages remedy for claims premised on a violation
of FDA regulations." Id. at 330. In such cases,
the Supreme Court concluded the state claims
"'parallel, ' rather than add to, federal
addition to expressly preempting certain state law claims,
the United States Supreme Court has also found that the MDA
implicitly preempts some claims. The MDA states that all
actions to enforce FDA requirements "shall be by and in
the name of the United States." 21 U.S.C. §337(a).
The Supreme Court has held that this language means that
state law based fraud-on-the-FDA claims were implicitly
barred under the MDA. Buckman Co. v. Plaintiffs'
Legal Committee, 531 U.S. 341, 348 (2001). In other
words, "a claim that 'exist[s] solely by virtue'
of federal requirements (such as a claim for fraud in
submissions to the FDA during the premarket approval process)
is impliedly preempted by the MDA, while claims that rely on
'traditional state tort law' may proceed (to the
extent they can overcome express preemption)." De La
Paz v. Bayer Healthcare LLC, 159 F.Supp.3d 1085, 1091-92
(N.D. Cal. 2016) (quoting Buckman, 531 U.S. at 349).
the Supreme Court's decisions of Riegel and
Buckman are read together, they "create a
narrow gap through which a plaintiff's state-law claim
must fit" in order to fully avoid preemption. In re
Medtronic, Inc., Sprint Fidelis Leads Products Liability
Litigation, 623 F.3d 1200, 1204 (8th Cir. 2010) (quoting
Riley v. Cordis Corp., 625 F.Supp.2d 769, 777 (D.
Minn. 2009). "The plaintiff must be suing for conduct
that violates the FDCA (or else his claim is
expressly preempted by § 360k(a)), but the plaintiff
must not be suing because the conduct violates the
FDCA (such a claim would be impliedly preempted under
Buckman)." Id. (quoting
Riley, 625 F.Supp.2d at 777). At least one court has
gone as far as comparing the difficulty of this task to
navigating the treacherous passage between the mythical
monsters Scylla and Charybdis. Caplinger v. Medtronic,
Inc., 784 F.3d 1335, 1340 (10th Cir. 2015).
Nevertheless, Williams asserts that her claims against Bayer
securely fit within this gap. We proceed to consider the
merits of her arguments.
1 - Missouri Merchandising Practices Act
first count, Williams alleges that Bayer violated the MMPA by
making several representations on its website concerning the
Essure device that she argues were false or
deceptive. In order to determine if this claim is
expressly preempted, we must first look to see if the FDA has
established requirements applicable to Essure. In
Riegel, the Supreme Court recognized that
specifications listed in a premarket approval of a Class III
medical device constituted federal requirements applicable to
that device. Riegel, 552 U.S. at 322-23. There is no
dispute in the present case that Essure is a Class III
medical device that has been subject to premarket approval.
Therefore, we conclude that the first step of the preemption
analysis is ...