Knoth v. Keith et al
Filing
67
ORDER granting in part and denying in part 46 Motion to Dismiss Signed by District Judge David C. Bramlette, III on 11/08/2019 (sl)
IN THE UNITED STATES DISTRICT COURT
FOR THE SOUTHERN DISTRICT OF MISSISSPPI
WESTERN DIVISION
STEPHANIE S. KNOTH
PLAINTIFF
V.
CIVIL ACTION NO. 5:18-CV-49 DCB-MTP
APOLLO ENDOSURGERY US, INC., ET AL.
DEFENDANT
MEMORANDUM OPINION AND ORDER
This matter is before the Court upon Defendant Apollo
Endosurgery US., Inc, (“Apollo”)’s Motion to Dismiss (Doc. 46);
Plaintiff Stephanie S. Knoth (“Knoth”)’s Response (Doc. 51) and
Defendant Apollo’s Reply (Doc. 55). Having considered the
motion, the responses, and applicable statutory and case law,
and being otherwise fully informed in the premises, the Court
GRANTS in part and DENIES in part Apollo’s Motion to Dismiss
(Doc. 46).
Background
This is a medical malpractice and products liability dispute,
arising from the implant of the Orbera gastric balloon. The Court
incorporates
in
this
Order
the
lengthy
description
of
the
background and underlying facts in this action, discussed in its
previous Order (Doc. 29).
1
On May 4, 2018, Knoth, representing herself pro se, filed
this lawsuit against Apollo and other defendants. Doc. 1. As to
Apollo, the Complaint makes standard product liability allegations
about Knoth’s implant, specifically, that the Orbera balloon was
unsafe and defective. Id. at ¶ 31-32. Apollo moved to dismiss the
case on the basis that Knoth’s claims were preempted under 21
U.S.C. § 360k(a), the Medical Device Amendments Act of 1976. “As
provided by § 360k(a), Congress expressly preempted any state tort
law ‘requirement’ for a device that differs from its federal
requirements.” Doc. 47, p. 3.
Express preemption is an indication of Congress’s intention
to supersede state law. As such, if Apollo’s state law claims are
preempted by §360k, this court must dismiss the state law claims
as being superseded by the Medical Device Amendments Act (“MDA”)
which establishes a system to regulate medical devices. Preemption
in this field is especially onerous, as “there is no private right
of action to recover damages or other relief under the MDA.” See
Blanchard v. Collagen Corp., 909 F.Supp 427, 431 (E.D. La. 1995).
Therefore, the only remedy available to plaintiffs is through
“traditional state powers, namely, tort compensation and health
and safety.” Id.
Apollo also relies on the United States Supreme Court’s
decision in Riegel v. Medtronic, Inc., 552 U.S. 312 (2008)(holding
2
that
the
FDA
pre-market
approval
process
established
federal
requirements and the patient’s New York common-law claims of
negligence,
strict
liability,
and
implied
warranty
against
manufacturer were preempted). Apollo cites Riegel as controlling
authority because the FDA approved the Orbera balloon as a Class
III medical device after the product went through the pre-market
approval process. Doc. 47, p. 3.
In October 2018, Knoth retained counsel and sought leave to
amend her Complaint to plead state-law claims that “parallel”
federal law, agreeing that her original state-law claims were
preempted. See Docs. 11, 23. This Court granted her leave to amend
the Complaint, and she did so. See Docs. 29, 30. Now, Apollo moves
to dismiss Knoth’s claims against it, pursuant to FED. R. CIV. P.
12(b)(6). Doc. 46, p. 1.
Standard
Rule 12(b)(6) affords a defendant the opportunity to test
the legal sufficiency of the complaint, i.e., whether the
plaintiff pleads a legal claim for which relief can be sought.
See Electrostim Medical Services, Inc. v. Health Care Service
Corp., 614 Fed.Appx. 731, 736 (5th Cir. 2015). To survive a
motion to dismiss, the plaintiff’s claim for relief must be
plausible on its face. See Ashcroft v. Iqbal, 556 U.S. 662, 678
(2009)(quoting Bell Atl. Corp. v. Twombly, 550, U.S. 544, 570
3
(2007)). The plausibility standard requires that the complaint’s
factual allegations “be enough to raise a right to relief above
the speculative level.” Twombly, 550 U.S. at 555. If there is
“any evidence in the record from any source from which a
reasonable inference in the [nonmoving party’s] favor may be
drawn, the moving party simply cannot obtain a summary
judgment…”. Celotex Corp. v. Catrett, 477 U.S. 317, n.2
(1986)(citing In re Japanese Electronic Products Antitrust
Litigation, 723 F.2d 238, 258 (3rd Cir. 1983)).
Discussion
1. Pre-Market Approval & Post-Approval Conditions for Class III
Devices
The federal Medical Device Amendments of 1976 (“MDA”)
imposed a “regime of detailed federal oversight,” over the
market for medical devices. See Riegel v. Medtronic, Inc., 522
U.S. 312, 316 (2008). Congress entered the field of medical
device regulation in order to intentionally sweep back state
obligations in favor of uniform federal regulation. See id. To
do so, the MDA utilized a two-pronged approach: (1) imposing an
“intricate regulatory scheme to increase oversight and promote
uniformity at the federal level,” and (2) eliminating
interference by state enforcement agencies through an express
4
preemption clause, 21 U.S.C. §360k. See Raab v. Smith & Nephew,
Inc., 150 F.Supp.3d 671, 682 (S.D. W.Va. 2015).
The degree to which the FDA regulates a medical device
depends on the level of classification of the device. The higher
the classification the more stringent the regulations. Class III
devices are the most highly regulated because the devices are
used in supporting or sustaining human life, are substantially
important in preventing the impairment of human health, or the
devices present an unreasonable risk of illness or injury. See
21 U.S.C. §360(a)(1)(C); Riegel 552 U.S. at 317. Because of
this, Class III devices are subjected to extensive regulation
before being introduced into the market; specifically, these
devices are required to go through a strenuous pre-market
approval (“PMA”) process to “provide reasonable assurance of
their safety and effectiveness.” Riegel 552 U.S. at 317. Once a
medical device successfully obtains PMA, the MDA “forbids the
manufacturer to make, without FDA permission, changes in design
specifications, manufacturing process, labelling, or any other
attribute, that would affect safety or effectiveness.” Id. at
319(citing 21 U.S.C. §360e(d)(6)(A)(i)).
In addition to device specific regulations, Class III
devices are also subject to Current Good Manufacturing Practices
(“CGMPs”). See Bass v. Stryker Corp., 669 F.3d 501, 511–512 (5th
5
Cir. 2012)(citing In re Medtronic, Inc. v. Sprint Fidelis Leads
Products Liability Litigation, 623 F.3d 1200, 1206 (8th Cir.
2010)). The FDA has described CGMPs as “an umbrella quality
system” providing “general objectives” for all device
manufactures. See In re Medtronic, Inc., 623 F.3d at 1206. The
requirements are applicable to “any finished device, as defined
in this part, intended for human use.” Rabb, 150 F.Supp.3d at
684 (citing 21 C.F.R. §820.1(a)(2)). The Seventh Circuit
articulated the binding nature of CGMPs in its decision in
Bausch v. Stryker Corp.;
“… federal law is clear: for manufacturers of Class
III medical devices, the Quality System Regulations
and Current Good Manufacturing Practices adopted by
the FDA under its delegated regulatory authority are
legally binding requirements ‘under this chapter.’ 21
C.F.R. § 820.1. ‘The failure to comply with any
applicable provision in this part [of the regulations]
renders a device adulterated under section 501(h) of
the act. Such a device, as well as any person
responsible for the failure to comply, is subject to
regulatory action.’ 21 C.F.R. § 820.1(c).”
630 F.3d 546, 555 (7th Cir. 2010); see also, Howard v. Sulzer
Orthopedics, 382 Fed.Appx. 436, 440 (6th Cir. 2010)(finding no
legal basis to distinguish between general requirements and
device-specific requirements). But see, In re Medtronic, 623
F.3d at 1207 (rejecting claims based on violations of Current
Good Manufacturing Practices).
6
It should be noted that in order for a plaintiff to bring a
claim against the manufacturer there is no requirement that the
FDA instigate an enforcement action or make a “formal” finding
that the manufacturer is in violation of federal requirements.
See Hughes v. Boston Scientific Corp., 631 F.3d 762, 772–773
(5th Cir. 2011).
After PMA (pre-market approval), manufacturers of Class III
devices must comply with a variety of post-approval conditions.
See Hughes 631 F.3d at 765(citing 21 U.S.C. §§360c-360j; 21
C.F.R. §§ 814.80, 814.82). If the manufacturer fails to comply
with the these conditions, the FDA may withdraw PMA. See id.
The FDA can also impose other remedies such as “additional
warnings or corrective labeling.” Id.
The PMA process and post-approval regulations are one
factor in the MDA’s coverage of the medical devices field. For a
holistic view of this highly regulated area, the Court next
looks to the MDA’s pre-emption of state law claims.
2. Pre-Emption Under the MDA and Parallel State Law Claims
Section 360k of the MDA contains an express preemption
provision that states:
“no 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
7
any other matter included in a requirement applicable to
the device under this chapter.”
21 U.S.C. §360k(a).
A two-pronged test determines whether Section 360k
expressly preempts a state law claim: (1) whether the federal
government has established requirements applicable to the
medical device, and (2) if so, whether the state law claim would
impose requirements that are “different from or in addition to”
the federal requirements. See Riegel, 552 U.S. at 321–322. The
first prong is satisfied when a Class III device has undergone
the pre-market approval (“PMA”) process. See Bass, 669 F.3d at
507.
The second prong permits a State to provide a remedy for
damages for claims premised on a violation of FDA regulations or
CGMPs, as long as the claim parallels the federal regulations.
See Bass, 669 F.3d at 509. The parallel claims doctrine allows
plaintiffs to employ state tort law as a “mechanism for
enforcing federal requirements.” See Raab, 150 F.Supp.3d at 686.
In Medtronic, Inc. v. Lohr, the Supreme Court rejected the idea
that Congress intended to preclude all common-law causes of
action by enacting §360k. 518 U.S. 470, 487 (1996). Such a
restriction would effectively remove “all means of judicial
recourse for those injured by illegal conduct.” Id. As the
Supreme Court wrote in Lohr, “Medtronic’s construction of §360k
8
would therefore have the perverse effect of granting complete
immunity from design defect liability to an entire industry
that, in the judgment of Congress, needed more stringent
regulation…” Id.
The Fifth Circuit has held that the PMA process “preempts
state tort causes of action to the extent that they relate to
safety, effectiveness, or other MDA requirements.” Gomez v. St.
Jude Medical Diag. Div. Inc., 442 F.3d 919, 929 (5th Cir. 2006).
To avoid preemption, the general assertions of a state law cause
of action cannot “threaten the federal PMA process
requirements.” See id. at 929–930. However, in cases where a
manufacturer is not protected from state tort liability by §360k
preemption, the claims are based on violation of applicable
federal requirements. See Williams v. Ciba Vision Corp., 100
F.Supp 3d 585, 590 (S.D. Miss. 2015)(citing Hughes, 631 F.3d at
767)).
After the issue of express preemption has been addressed,
courts often look to the issue of implied preemption, but
inasmuch as the Defendant has not addressed this issue, the
Court is not inclined to do so.
Applying Riegel’s two-pronged test to Knoth’s claim, we
first consider whether the FDA has established requirements
applicable to the Orbera gastric balloon. Any Class III device
9
that has received PMA by the FDA satisfies the first prong of
the test. See Bass, 669 F.3d at 507. As evidenced by the
complaint, the Orbera gastric balloon is a Class III device that
has received PMA and therefore the first prong is satisfied. To
satisfy the second prong, we must ask whether state law at issue
parallels the federal requirement or if it creates a requirement
that is “different from or in addition to a federal
requirement.” 21 U.S.C. §360k. Thus, we consider below the
elements of Knoth’s state-law claims to determine whether they
are parallel to the federal requirements.
Mississippi Products Liability Act
Knoth brings suit under The Mississippi Products Liability
Act (“MPLA”) and Mississippi common law. The MPLA applies “in
any action for damages caused by a product.” Miss. Code. Ann.
§11-1-63. The Defendant argues that the MPLA subsumes five of
the Plaintiff’s claims and that they should be dismissed
inasmuch as the MPLA is the exclusive remedy for a products
liability claim: (1) Breach of Implied Warranty, (2) Unjust
Enrichment, (3) Lack of Informed Consent, (4) violations of the
Mississippi Deceptive Trade Practices Act, and (5) Negligent
Training and Proctoring & Negligent Certification.
The legislature enacted the MPLA in 1993. At that time, it
was unclear as to what extent the MPLA supplanted pre-existing
10
products liability causes of action. See Mississippi Law of
Torts §15:3(“MLT”). However, in 2014, the legislature amended
the MLPA to include “designers” as entities to whom or to which
the MLPA applies. The amendment also added “negligence” as a
common law action subsumed by the MLPA. See MLT §15:3. As
amended, the MPLA applies to “any action for damages caused by a
product, including, but not limited to, any action based on a
theory of strict liability in tort, negligence or breach of
implied warranty, except for commercial damage to the product
itself.” Miss. Code Ann. §11-1-63. The MPLA recognizes three
traditional categories of product defects: (1) design defects,
(2) warnings/instructions defects, and (3) manufacturing
defects. See MLT § 15:3.
There have been recent clarifications as to the MPLA’s
relationship to state common law claims. Prior to 2014, the
issue was unsettled, with the Mississippi Supreme Court
indicating that the MPLA supplemented rather than supplanted
implied warranty actions. See MLT §15:3(citing Bennett v.
Madakasira, 821 So.2d 794, 808 (Miss. 2002)(holding that the
MPLA does not preclude a plaintiff from proceeding under a
breach of implied warranty theory in a products liability
case)(emphasis added)).
However, the 2014 amendments and the
Mississippi Supreme Court’s decision in Elliot v. El Paso Corp.
11
have clarified the state’s approach to these issues. 181 So.3d
263 (Miss. 2015). In Elliot the Mississippi Supreme Court wrote,
“In interpreting and applying the MPLA, we have
explained that ‘the MPLA provides the exclusive
remedy’ for products-liability claims, and ‘since [the
enactment of the MPLA], products-liability claims have
been specifically governed by statute, and a claimant,
in presenting his case, must pay close attention to
the elements of the cause of action and the liability
limitations enumerated in the statute.’ In other
words, the MLPA has abrogated products-liability
claims based on strict-liability or negligence
theories, and the MPLA now provides the roadmap for
such claims.”
Id. at 268. The court also noted that a case involving a product
defect — even a claim for breach of implied warranty — would be
subsumed by the MPLA. Id. at n.24.
Common Law Claims
Defendants argue in their Motion that the MPLA subsumes
Knoth’s common law claims and those claims must be dismissed.
The MPLA, which applies “in any action for damages caused by a
product, including, but not limited to, any action based on a
theory of strict liability in tort, negligence, or breach of
implied warranty, except for commercial damage to the product
itself,” provides, in relevant part:
“The manufacturer, designer or seller of the product shall
not be liable if the claimant does not prove by the
preponderance of the evidence that at the time the product
left the control of the manufacturer, designer or seller:
i.
(1) The product was defective because it deviated
in a material way from the manufacturer’s or
12
designer’s specifications or from otherwise
identical units manufactured to the same
manufacturing specifications, or (2) The product
was defective because it failed to contain
adequate warnings or instructions, or (3) The
product was designed in a defective manner, or
(4) The product breached an express warranty or
failed to conform to other express factual
representations upon which the claimant
justifiably relied in electing to use the
product; and
ii.
The defective condition rendered the product
unreasonably dangerous to the user or consumer;
and
iii.
The defective and unreasonably dangerous
condition of the product proximately caused the
damages for which recovery is sought.”
Miss. Code Ann §11-1-63(a).
The fact that the MPLA provides the exclusive remedy for
suits against a manufacturer, does not mean that common law
negligence or breach of implied warranty claims are disallowed.
See Young v. Bristol-Myers Squibb Co., No. 4:16-cv-00108-DMBJMV, 2017 WL 706320, *3 (N.D. Miss. Feb. 22, 2017). Instead,
they must be evaluated under the framework of the MPLA. Id.
However, as the court in Young wrote:
“Practically, where a common law claim is subsumed by
the MPLA and is brought alongside products liability
claims based on the same theory of recovery, the
proper course is to dismiss the common law claim to
the extent it is duplicative of the parallel products
liability counts. To the extent a subsumed common law
count is asserted ‘as an independent tort claim
outside the scope of the MPLA,’ the count must be
dismissed for failure to state a claim.”
13
Id. at *4. Therefore, within that framework, this court will
look to the common law claims that the Defendant argues are
subsumed by the MPLA.
Count Five – Implied Warranty
Claims for breach of implied warranty are subsumed by the
MPLA. Miss. Code Ann. §11-1-63; see also, Elliot, 181 So.3d 263
at n.24; Arnoult v. CL Medical SARL, No. 1:14-cv-271-KS-MTP,
2015 WL 5554301, *3 (S.D. Miss. Sept. 21, 2015)(writing that the
MPLA “specifically provides that it governs claims for breach of
an implied warranty arising from damage caused by a product.”)
Knoth claims that “Apollo impliedly warranted the product
to be of merchantable quality, safe, and fit for such use.
Apollo also impliedly warranted that the product was adequately
tested.” Amend. Compl. ¶ 126 [ECF No. 30]. Plaintiff alleges
that Apollo “withheld and concealed information about the
substantial risks of serious injury or death associated with use
of the device.” Id. at ¶ 127(a). To the extent these common law
claims are duplicative of Knoth’s product liability claims, the
common law claims must be dismissed. The Court grants Apollo’s
Motion to Dismiss Count Five insofar as it is asserted as an
independent tort claim outside the scope of the MPLA.
14
Count Six – Unjust Enrichment
The common law claim of unjust enrichment is subsumed by
the MPLA. Miss. Code Ann. §11-1-63. Knoth alleges that it is
unjust for Apollo to retain the payment made by Knoth for the
gastric balloon as the plaintiff did not receive a safe and
effective product for weight-loss purposes. See Amend. Compl. ¶¶
135-136 [ECF No. 30]. Accordingly, as this claim is asserted as
an “independent tort” outside the scope of the MPLA, it is
dismissed for failure to state a claim.
Count Seven – Lack of Informed Consent
Lack of informed consent is subsumed by the MPLA. Miss.
Code. Ann. §11-1-63. Knoth alleges that Apollo owed a fiduciary
duty to the Plaintiff to “provide and disclose all information
material to her care and treatment… all issues with the Orbera
gastric balloon system and the substantial risk of serious
injury or death associated with the device.” Amend. Compl. ¶
138. [ECF No. 30]. Accordingly, to the extent that the claim is
subsumed by the product liability failure to warn claim, Count
Seven will be dismissed as duplicative. To the extent Count
Seven attempts to impose liability on other grounds, it will be
dismissed for failure to state a claim.
15
Count Ten – Negligent Training and Proctoring & Negligent
Certification
In a products liability action, “a negligence claim
alleging failure to warn, train, educate, or draft a warning
plan… is a claim based upon products liability, and such a claim
must be analyzed under the MPLA.” Elliot, 181 So.3d at 269.
Here, the plaintiff alleges that Apollo did not “proctor and/or
properly instruct Plaintiff’s surgeons and attending staff as to
the safe use of its device nor how to detect complications which
its said device causes and is known to cause.” Amend. Compl. ¶
157 [ECF No. 30]. To the extent that Count Ten makes a commonlaw negligence claim based on the failure to train or certify,
it will be dismissed as duplicative. To the extent that Count
Ten attempts to impose liability on other grounds, it will be
dismissed for failure to state a claim.
Count Eight – Mississippi Deceptive Trade Practice Act
The Plaintiff’s allegation that Apollo violated the
Mississippi Deceptive Trade Practice Act is not a claim under
the MPLA. However, it must be dismissed as the Plaintiff has
failed to attempt to resolve the case through an informal
dispute settlement program approved by the Mississippi Attorney
General, as required under Miss. Code Ann. §75-24-15(2). As the
Plaintiff has not made any allegation that she attempted to
resolve the claim through any means other than this lawsuit, her
16
claim must be dismissed as a matter of law. See Wilson v. New
Palace Casino, L.L.C., No. 1:11-cv-447-HSO-JMR, 2013 WL 870350,
*12 (S.D. Miss. March 7. 2013).
Having considered the claims that are subsumed or dismissed
because of the MPLA, or for failure to attempt to resolve the
case through an informal dispute settlement, the court turns to
the remaining state-law claims to determine whether they are
preempted by 21 U.S.C. §360k.
3. Parallel Claims in the Context of Rule 12(b)(6)
Reigel, Lohr, and Buckman provide a framework for preemption
analysis. See Waltenburg v. St. Jude Medical, Inc., 33 F.Supp.3d
818, 827 (W.D. Ky. 2014). However, despite the framework, lower
courts have struggled to resolve the understandably thorny issue
of the degree of particularity required to establish a parallel
claim. See id. at 825. The disparity in resolving this issue is
apparent when comparing the decisions reached by the Seventh
Circuit in Bausch and the Eleventh Circuit in Wolicki-Gables v.
Arrow Intern, Inc., 634 F.3d 1296 (11th Cir. 2011). See Raab,
150 F. Supp.3d at 691.
The Seventh Circuit reversed the lower court’s decision to
dismiss a parallel claim for failing to plead with sufficient
particularity. See Bausch, 630 F.3d at 560. The Seventh Circuit
held that failure to identify the precise defect or the specific
17
federal regulatory requirements that the Defendant violated does
not support a Rule 12(b)(6) dismissal. See id. The Bausch court
highlighted the burden that Class III confidentiality has on
plaintiffs, and the bar it would impose on filing successful
parallel claims, i.e. plaintiffs not having access to necessary
documents and information critical to their claims because the
material is deemed confidential. See id. at 560–561.
The Eleventh Circuit requires an enhanced level of
pleading. The Wolicki-Gables panel opined, “Plaintiffs cannot
simply incant the magic words ‘[defendants] violated FDA
regulations' in order to avoid preemption.” See 634 F.3d at
1301. Parallel claims must be specifically stated in the initial
pleadings and a plaintiff must allege that the “defendant
violated a particular federal specification referring to the
device at issue.” See id. “To properly allege parallel claims,
the complaint must set forth facts pointing to specific PMA
requirements that have been violated.” Id.
The Fifth Circuit falls in the middle of these two extremes.
In Bass, the court wrote:
“Although the circuits are not in complete agreement as to
what constitutes a sufficient pleading ... [t]he key
distinction between complaints that are sufficient to
withstand a motion to dismiss and those that are not is ...
the existence of a manufacturing defect caused by a
violation of federal regulations and allegations connecting
18
a defect in the manufacture of the specific device to that
plaintiff's specific injury.”
See 669 F.3d at 511–512. The court in Bass agreed with Bausch’s
reasoning regarding the confidentiality of medical devices. As
the Court wrote, “asking the plaintiff to make more specific
allegations than those found in Bass’s complaint may make
pleading a parallel claim regarding defective manufacturing
nearly impossible.” Id. at 511.
The Fifth Circuit has held that the pleading standard for a
Class III medical device claim alleging a violation of federal
law is the same as the plausibility standard of Twombly. See id.
at 509. There is no heightened standard to plead a parallel
claim for a violation of federal regulations over medical
devices, unlike, as an example, the requirements to sustain a
plea for fraud.
The Fifth Circuit has determined that a plaintiff who
pleads a violation of Current Good Manufacturing Practices — a
significantly more general requirement — may succeed. See id. at
512. Other Circuits require a plaintiff to plead violations of
PMAs, specific to the device in question. See id. at 512. As
previously stated, the issue with this requirement is that a
Plaintiff will be unable to access, or have extreme difficulty
accessing, confidential PMAs prior to discovery, making a
sufficient pleading almost impossible. See id. at 511. It is
19
with these considerations that the Fifth Circuit determined that
a claim which alleges the Defendant violated CGMPs, is
sufficient.
Apollo relies on the stringent standard set by WolickiGables to support its argument that Knoth failed to plead with
specific particularity. See e.g., 634 F.3d 1296 (11th Cir.
2011). However, the court in Bass clearly rejected that strict
line of reasoning when it overturned the District Court’s
dismissal, which was predicated on the fact that Bass had only
alleged violations of CGMPs and not device specific violations.
See 669 F.3d at 512. The court in Wolicki-Gables requires devise
specific violations. As justification for this Court to dismiss
Knoth’s claim, Apollo cannot rely upon a standard which the
Fifth Circuit has rejected.
Whether Knoth Satisfactorily Plead Parallel Claims
The court in Bass found that the plaintiff pleaded a nonconclusory parallel claim. See Bass, 669 F.3d at 509. Bass
asserted that:
“(1) he received a Shell implant; (2) the FDA had
previously warned Stryker of bioburden in excess of
FDA regulations in its final rinse of the Shells; (3)
after Bass's surgery, Stryker ultimately voluntarily
recalled those Shells, including the Shell
specifically used in Bass's implant; (4) Bass suffered
from a loose Shell due to a lack of bony ingrowth; and
(5) the lack of bony ingrowth is a known effect of an
20
excess of bioburden and manufacturing residuals on
Shells.”
Id. at 510. Bass relied on Current Good Manufacturing Practices
(“CGMPs”) in his pleadings. Plaintiffs often do not have access
to specific federal requirements in the PMA prior to filing
suit. See id. at 512. Thus, the Fifth Circuit has held that a
lack of information specific to the device is not fatal so long
as the plaintiff can show a failure by the manufacturer to
conform with CGMPs, information in regard thereto is more
accessible to plaintiffs. Id. A manufacturer could be “liable
even in circumstances where it complied fully with the specific
[processes and specifications] approved by the FDA.” Howard v.
Sulzer Orthopedics, Inc., No. 09-3406, 2010 WL 2545586, at *5
(6th Cir. June 16, 2010).
In Bass, the plaintiff alleged that the device was
adulterated due to violations of 21 C.F.R. § 820.20(a),
820.20(b)(2) and 820.70(e). See 669 F.3d at 510. A formal
finding or enforcement action by the FDA is not a requisite to a
satisfactory parallel claim. Id. at 509. The relevant facts in
the Bass pleading were allegations that connected the defect in
the manufacture of the specific device to the plaintiff’s
specific injury. The Defendant was made aware of the defect,
that there was bioburden in excess of FDA regulations, and the
21
Plaintiff’s injury is a known effect of that specific
defect.
As such, we must then compare Knoth’s pleading. Knoth
pleaded:
(1)
That she received an Orbera gastric balloon, (2)
that the FDA issued three warning letters to
providers, one that addressed the potential
dangers of the Orbera balloon rupturing because
of spontaneous hyperinflation, (3) that Knoth
suffered from a ruptured gastric balloon, and (4)
that her injury, septic shock etc., is a common
effect of a ruptured balloon due to bacterial
contamination.
As with Bass, the question is whether Knoth pleaded that
Apollo’s failure to abide by the CGMPs resulted in the defect
that injured Knoth. The complaint makes several allegations of
failure to comply with the Federal Food, Drug and Cosmetic Act
(“FCDA”) — each specifically addressing the issue of spontaneous
hyperinflation and the resulting contamination of human blood
and tissue.
At this stage of the litigation, “discovery is necessary
before the plaintiff can be expected to provide a detailed
statement of the specific bases for her claim.” Bausch, 630 F.3d
at 558. Knoth’s complaint has satisfied the plausibility
standard of notice pleading as set forth in Twombly, “a claim
has facial plausibility when the plaintiff pleads factual
22
content that allows the court to draw the reasonable inference
that the defendant is liable for the misconduct alleged.”
Twombly, 550 U.S. at 556.
Apollo relies on Williams v. Ciba Vision Corp., to support
its assertion that Knoth has not sufficiently pleaded a parallel
claim. 100 F.Supp.3d 585 (S.D. Miss. 2015). In Williams, the
Plaintiff alleged that the Defendant “deviated from the
manufacturing process that had been pre-approved by the FDA… and
utilized a ‘modified (buffered tumbling) manufacturing process’
which resulted in a ‘biofilm formation within the lens….’” Id.
at 591. Judge Sul Ozerden dismissed the claim, writing:
“Plaintiff [Williams] does assert the basic legal
elements of a parallel claim, that Defendant deviated
from the pre-approved manufacturing process which in
turn caused a defect in the lens which in turn caused
her injury. However, Plaintiff has not stated any
facts to support the conclusory allegation that the
alleged ‘buffered tumbling process violated the preapproved manufacturing process or any requirement
specific to the MemoryLens IOL.”
Id. These facts differ from the case at hand because the court
in Williams was addressing an actual change in the manufacturing
process which the Defendant utilized in making its product. See
id. The Plaintiff’s failure to allege how this new manufacturing
process violated the pre-approval process was fatal to her
23
claim. However, in this case, the Court is not considering an
altered manufacturing process.
This case is more akin to Bass than to Williams. Inasmuch
as the FDA sent three warning letters to health care providers
regarding the possibility of the Apollo balloon spontaneously
hyperinflating, and since Knoth’s injury is consistent with
hyperinflation set forth in the FDA warning. The core difference
between Bass and this claim is that Apollo did not recall the
balloon, whereas Bass recalled its Shells because of the
manufacturing issue. See Bass, 669 F.3d at 509. However, the
manufacturer’s decision to recall a product is not a necessary
prerequisite to the assertion of a parallel claim.
Therefore, the Court concludes that Plaintiff’s claims for
relief are sufficiently plausible. See Raab, 150 F.Supp.3d 671
at 694(citing Elmore v. Smith & Nephew, Inc., No. 12 C 8347,
2013 WL 1707956, *5 (N.D. Ill. Apr. 19, 2013)). A plaintiff’s
pleading burden must “be commensurate with the amount of
information available to them.” Bausch, 630 F.3d at 561(quoting
In re Medtronic, 623 F.3d at 1212 (Melloy, J., dissenting)).
In this case, Knoth identified a specific medical device,
the Orbera gastric balloon system, that was manufactured and
24
produced by the defendant. Knoth sets forth specific
allegations that the Orbera gastric balloon was unreasonably
dangerous and that the defendant was negligent, citing several
violations of the CGMPs. For example, allegations that the
defendant “failed to accurately establish the in vivo life
expectancy of the Orbera gastric balloon system,” “failed to
validate the anticipated wear on both healthy tissue and the
Orbera gastric balloon prior to their release into commercial
distribution,” and “failed to appropriately respond to adverse
incident reports that strongly indicated the Orbera gastric
balloon was Malfunctioning (sic) [as defined in 21 C.F.R.
§803.3], or otherwise not responding to their Design Objective
Intent,” taken as true, suggest a defect in the Orbera balloon
as manufactured. Amend. Compl. ¶ 81(a), (b), & (h) [ECF No. 30].
Knoth’s allegations about experiencing a balloon rupture
and suffering from septic shock due to foreign contaminants in
her blood stream, plausibly tie the Defendant’s alleged
violations of the CGMPs to the defect in the Orbera gastric
balloon system. This defect could have made the product
unreasonably dangerous, ultimately causing the alleged injuries
suffered by Knoth.
The Court recognizes that, prior to discovery, it is often
times difficult for a plaintiff to allege specific violations of
25
Class III devices which have undergone PMA. This court finds
that the Plaintiff has met her pleading burden. See Bausch, 630
F.3d at 561 (noting that, in order for a plaintiff to plead a
parallel claim with specificity, she would “need access to the
confidential materials in the premarket approval application
setting forth the medical device's specifications. This is
simply not possible without discovery.”); Gelber v. Stryker
Corp., 788 F.Supp.2d 145, 156 (S.D.N.Y. 2011) (“By pleading the
conduct which plaintiffs allege violated the CGMP requirements,
describing evidence of the alleged violation, and directing
[defendants] to the CGMP requirements generally, plaintiffs have
given defendants more than ample notice of the alleged violation
of federal law.”); Tillman v. Smith & Nephew, No. 12 C 4977,
2013 WL 3776973, *5 (N.D. Ill. July 18, 2013)(allegations of
medical complications occurring after implantation, combined
with allegations of numerous CGMP violations, sufficient to
state claim for negligence and strict products liability).
As to the Defendant’s assertion that Knoth has not provided
sufficient facts to support her manufacturing defect claim, the
Court notes that “the victim of a genuinely defective product…
may not be able to determine without discovery and further
investigation whether the problem is a design problem or a
manufacturing problem. It is common, for example for injured
26
plaintiffs to plead both defective manufacture and defective
design and to pursue discovery under both theories.” Bausch 630
F.3d at 560. With Class III medical devices, an “injured patient
cannot gain access to that information without discovery.” Id.
Inasmuch as this Court has found that Knoth’s allegations
satisfy the pleading requirements under Twombly and Iqbal, we
must next determine whether any of the Plaintiff’s remaining
claims are preempted by §360k.
Plaintiff’s Remaining Claims
Counts One & Two: Negligence & Strict Liability – Manufacturing
and/or Design Defect
Knoth’s claim for Manufacturing Defect can proceed because,
as discussed above, it is premised on violations of the FDA
Regulations and Current Good Manufacturing Practices. As the
Fifth Circuit has held, “manufacturing defect claims may
proceed, because… to the extent they are premised on violations
of FDA regulations, they are parallel claims that are not
preempted.” Bass v. Stryker Corp., 669 F.3d 501, 515 (5th Cir.
2012). The MPLA claims do not impose different or additional
requirements than the FDA regulations. As such, to the extent
that Knoth has plausibly tied federal violations to a state law
cause of action, the claims are parallel and are not preempted.
See Raab, 150 F.Supp.3d at 692–693. Knoth’s manufacturing claim
27
must proceed under the MPLA, as it is the exclusive remedy for
products liability actions. Any claims of negligence or strict
liability are subsumed by the MPLA. Although Knoth’s headings
assert that she is pursuing a manufacturing claim under
negligence or strict liability, she has pleaded a manufacturing
claim as set forth under the MPLA. In her Amended Complaint,
Knoth alleges:
“Specifically, Plaintiff[] allege[s] that at the time
the subject components left Defendant’s control, (i)
one or more were defective because they deviated in a
material way from the manufacturer’s or designer’s
specifications, (ii) such defective condition rendered
them unreasonably dangerous to the user, and (iii)
such condition proximately caused the damages for
which recovery is sought herein.”
[ECF No. 30] at p. 21. This is a manufacturing claim as set
forth under the MPLA. See Miss. Code Ann. § 11-1-63.
To the extent, however, that Knoth is pursuing a claim that
the Orbera system design, as approved by the FDA in the PMA, is
defective, such claim is preempted. See Gomez v. St. Jude
Medical Daig. Div. Inc., 442 F.3d 919, 930 (5th Cir. 2006)(“to
permit a jury to second-guess the [defendant’s] design by
applying the Louisiana statutory standard for unreasonably
dangerous design would risk interference with the federally
28
approved design standards and criteria.”); see also,
Carlson v. Medtronic Inc., No. 3:13-cv-687-WHB-RHW, 2014 WL
11514911, at *4 (S.D. Miss. Aug. 28, 2014)(“[D]esign-related
defect claims whether sounding in strict liability or
negligence, are preempted because the FDA has already assessed
and approved the risks and utility of the existing design of the
[medical device]”).
The Supreme Court in Medtronic, Inc. v. Lohr, found that
state law negligent design claims are not preempted. See 518
U.S. at 487. However, in Lohr, the medical device at issue did
not go through a strenuous pre-market approval process but
entered the market without further regulatory analysis as a
§510(k) device that is “substantially equivalent” to a preexisting device. Id. at 478. Section 510(k)’s process is not
comparable to the pre-market approval process, as it takes an
average of 20 hours to complete the § 510(k) review as compared
to the 1,200 hours to complete pre-market approval. Id. at 478–
479.
Because Lohr addressed a medical device that was exempt
from pre-market approval, the Court proceeded with the
Plaintiff’s design claim. As the Court wrote, “[t]he 510(k)
process is focused on equivalence, not safety.” Id. at 493.
Multiple Circuits have distinguished this decision, finding that
29
claims of design defects cannot proceed for devices that undergo
pre-market approval. See Caplinger v. Medtronic, Inc., 784 F.3d
1335, 1345 (10th Cir. 2015); Walker v. Medtronic, Inc., 670 F.3d
569, 581 (4th Cir. 2012); Bausch v. Stryker Corp., 630 F.3d 546,
560 (7th Cir. 2010)(“If the problem turns out to be a design
feature that the FDA approved, section 360k will protect the
manufacturer.”); Horn v. Thoratec Corp., 476 F.3d 163, 177–178
(3rd Cir. 2004); Mendes v. Medtronic, Inc., 18 F.3d 13, 18 (1st
Cir. 1994)(writing that design defect claims are preempted if
the device received premarket approval).
Count Three – Negligence – Failure to Warn
Knoth alleges that Apollo violated the following federal
regulations for her failure to warn claim:
“Pursuant to 21 C.F.R. § 814.80, Defendant had a duty
and was required to manufacture, package, store,
label, distribute, and advertise it in a manner
consistent with the conditions for approval specified
by the FDA in the device’s PMA approval order.
Defendant violated this duty.
Pursuant to 21 C.F.R. § 814.82 and 814.84, Defendant
also had a duty and was required to provide all of the
post-approval reports and information identified by
the FDA in the device’s approval order including, but
not limited to, timely submission of informative
adverse reaction and device defect reports. Defendant
violated this duty.
Defendant failed to submit a PMA supplement for review
and approval by the FDA, in violation of 21 C.F.R. §
814.39.
30
Defendant sold, distributed and permitted use of its
devices in violation of the regulations prescribed
under 21 U.S.C. § 360j(e), 21 U.S.C. § 352(r).
Defendant violated its duty under 21
collect data and maintain records of
balloons that had failed, and report
the safety and effectiveness of such
U.S.C. § 360i to
Orbera® gastric
issues concerning
devices.”
Amend. Compl. ¶¶ 91, 92, 93, 94, & 95 [ECF No. 30]. Knoth relies
on Hughes v. Boston Scientific Corp., for her assertion that the
failure to warn claim can proceed. See e.g., 631 F.3d 762 (5th
Cir. 2011).
The court in Hughes made clear that the plaintiff’s state
law products liability claims were expressly preempted. See 631
F.3d at 768–769. “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].” Gomez, 442 F.3d at 931.
However, the court in Hughes permitted the plaintiff’s failure
to warn claim to proceed under a theory of negligence. As the
court wrote:
“… 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.”
31
Id. at 769. “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.” Id. at 770.
As such, Knoth asserts that she is able to bring a similar
failure to warn claim under a theory of negligence. However, the
Fifth Circuit’s decision in Hughes occurred prior the 2014 MPLA
amendments and the Mississippi Supreme Court’s decision in
Elliot. The Fifth Circuit premised its holding in Hughes on the
assumption “that a failure to warn claim may be pursued under
Mississippi law….” Id. at 769. As this court has previously
mentioned, the 2014 amendments and Elliot clarified the scope
and exclusivity of the MPLA. Significantly for this particular
claim, the 2014 amendments included “negligence” as a cause of
action for which the MPLA applies. A “negligence claim alleging
failure to warn… is a claim based upon products liability, and
such a claim must be analyzed under the MPLA.” Elliot, 181 So.3d
at 269.
Under the MPLA, the defendant can bring a products
liability claim for failure to warn if the “product was
defective because it failed to contain adequate warnings or
instructions.” Miss. Code Ann. §11-1-63(a)(i)(2). Any other
32
claim must be dismissed for asserting an independent tort claim
outside of the MPLA’s purview. Here, Knoth does not allege that
the Orbera gastric balloon failed to contain adequate warnings
or instructions – which would be expressly preempted by
§360k(a). Therefore, the MPLA does not include Knoth’s alleged
cause of action for failure to warn, so it must be dismissed for
stating an independent tort claim.
Count Four – Breach of Express Warranty
Knoth’s breach of express warranty claim is solely based
on Apollo’s false or misleading marketing. Knoth claims that the
marketing materials are false or misleading in violation of 21
U.S.C. §352(q). The Plaintiff alleges the following, resulting
in a breach of express warranty:
1) The ORBERA® website claims a patient will lose “3
Times the Weight”;
2) That the ORBERA® is the #1 Gastric Balloon;
3) That the procedure is a simple and safe nonsurgical procedure usually done in 20 minutes;
4) That Apollo selects only the most qualified
specialists to perform the ORBERA® weight loss
procedure;
5) That ORBERA® press releases compared the risk as
the same as a colonoscopy;
6) That the ORBERA® gastric balloon system is the most
studied intragastric balloon globally with impressive
weight loss and safety results; and
33
7) That the balloon inserted into the stomach is the
size of a grapefruit.
EFC 52 at p. 19. Knoth claims that these statements are false
and misleading because the “FDA did not approve” them. EFC 52 at
p. 19–20. An express warranty claim must fail as a matter of law
if it is contrary to the FDA’s approval of the medical device.
See In re Medtronic Inc., 623 F.3d at 1208. However, Knoth does
not allege that Apollo violated an express warranty for any
marketing materials that the FDA approved. Therefore, the
express warranty claim does not obstruct the FDA’s regulation of
the Class III devise, and the claim is not preempted.
Apollo argues in the alternative, that if the express
warranty claim is not preempted, it should be dismissed for
failure to plead specific facts “regarding the warranty and the
alleged false and/or misleading nature of it.” According to
Apollo, the Plaintiff has not alleged that the marketing
materials are false or misleading for any reason other than the
fact that they were not approved by the FDA. This Court finds
that it is premature to address the breach of express warranty,
an issue which will be considered after discovery or at trial.
Count Nine – Punitive Damages.
A claim for punitive damages is not a separate cause of
action but is based on the underlying cause of action. See Lewis
34
v. Intermedics Intraocular, Inc., No. 93-0007, 1993 WL
533976, *9 (E.D. La. Dec. 10, 1993). Therefore, the claim for
punitive damages survives this motion for summary judgment only
insofar as it relates to the plaintiff’s claims that were not
preempted by 21 U.S.C. § 360k(a) or subsumed by the MPLA. See
id.
CONCLUSION
The following claims are subsumed by the MPLA and are
dismissed as being duplicative or because they assert an
independent cause of action: Count Three – Negligence – Failure
to Warn, Count Five – Implied Warranty, Count Six – Unjust
Enrichment, Count Seven – Lack of Informed Consent, and Count
Ten – Negligent Training and Proctoring & Negligent
Certification. Count Eight, asserting that Apollo violated the
Mississippi Deceptive Trade Practice Act, is dismissed inasmuch
as there was no attempt to pursue resolution through an informal
dispute settlement program as required by statute.
The following claims are not preempted by the federal
Medical Device Amendments of 1976, 21 U.S.C. §360k, and
therefore, shall not be dismissed at this stage of the
litigation: Count Four – Breach of Express Warranty, and Count
Nine – Punitive Damages.
35
Count One – Negligence – Manufacturing and/or Design
Defect and Count Two – Strict Liability – Manufacturing and/or
Design Defect are dismissed in part. The Plaintiff’s design
defect claims are dismissed. The Plaintiff’s manufacturing
defect claims are dismissed to the extent that the claims allege
a duplicative or independent tort under the MPLA. However, Knoth
may proceed with a manufacturing claim to the extent that it is
brought as a violation of the MPLA.
Accordingly,
IT IS HEREBY ORDERED AND ADJUDGED that Defendant Apollo’s
Motion to Dismiss is GRANTED in part and DENIED in part.
SO ORDERED this the 8th day of November, 2019.
_/s/ David Bramlette________
UNITED STATES DISTRICT JUDGE
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