Waltenburg et al v. St. Jude Medical, Inc. et al
MEMORANDUM OPINION & ORDER granting in part and denying in part 13 Motion to Dismiss. Signed by Senior Judge Thomas B. Russell on 7/18/2014. cc: Counsel(KJA)
UNITED STATES DISTRICT COURT
WESTERN DISTRICT OF KENTUCKY
CIVIL ACTION NO. 3:13-CV-01106-TBR
SHAWN WALTENBURG, et al.
ST. JUDE MEDICAL, INC., et al.
MEMORANDUM OPINION AND ORDER
This matter is before the Court upon Defendants St. Jude Medical, Inc., and
Pacesetter, Inc.’s Motion to Dismiss. (Docket No. 13.) Plaintiffs Shawn Waltenburg
and Jamie Waltenburg have responded, (Docket No. 16), and Defendants have replied,
(Docket No. 19). This matter now is ripe for adjudication. For the reasons that follow,
Defendants’ Motion will be GRANTED IN PART and DENIED IN PART.
Implantable cardioverter defibrillators (ICDs) are life-saving devices used to
detect and treat irregular heart rhythms. An ICD can correct slow heart rates, pace
rapid heart rates, and administer electrical impulses to stabilize a heart and allow it to
return to an appropriate rhythm. Wires called “leads” are attached to an ICD and then
inserted through a major vein and attached directly to the muscle on the inside of the
heart, thereby connecting the ICD to the heart. Electrodes that sense the heart’s
rhythm are built into the leads and are positioned where they can monitor the
heartbeat. Lower voltage electrodes can provide pacing therapy to correct irregular
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Electrical impulses for defibrillation are provided through higher
voltage conducting leads.
Plaintiff Shawn Waltenburg (Mr. Waltenburg) was implanted with a St. Jude
“Riata” lead, model number 1580, on September 9, 2004. Plaintiffs claim that shortly
after implantation, Mr. Waltenburg began to experience recurring unexplained
episodes of defibrillator discharge in which he received electrical shocks from the
defibrillator. Mr. Waltenburg states that he was advised by his physicians in October
2012 that “his Riata lead showed signs of inside-out erosion of the conductors.”
(Docket No. 16, at 2.) Mr. Waltenburg says his physicians continue to monitor the
lead but have not recommended removal because of the serious risks associated with
such a procedure. Plaintiffs allege that Mr. Waltenburg has suffered both physical and
emotional injuries, including “inappropriate electrical shocks, medical treatment
including diagnostic testing, compromised lead insulation, increased lead impedance,
and electrical abnormalities in his Riata lead which have caused him physical pain and
discomfort and ha[ve] resulted in medical treatment and hospitalization, as well as
severe mental anguish.” (Docket No. 16, at 3.)
Plaintiffs originally filed this action in Jefferson Circuit Court on October 18,
2013. (See Docket No. 1-1, at 4.) Defendants subsequently removed to this Court on
November 11, 2013. (Docket No. 1.) Defendants filed their first motion to dismiss on
December 16, 2013. (Docket No. 5.) Plaintiffs responded and requested leave to
amend their Complaint. (Docket No. 8.) The Court granted Plaintiffs’ request and
denied Defendants’ first motion to dismiss with leave to refile after the filing of
Plaintiffs’ Amended Complaint.
(Docket No. 9.)
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Plaintiffs thereafter filed their
Amended Complaint on February 14, 2014. (Docket No. 10.) In their Amended
Complaint, Plaintiffs assert four primary claims: (1) strict liability manufacturing
defect; (2) negligent manufacture; (3) negligence per se; and (4) negligent failure to
warn. (Docket No. 10, at 28-32.) Plaintiffs also assert a claim for punitive damages,
and Jamie Waltenburg asserts a derivative claim for loss of consortium. (Docket No.
10, at 32.) Defendants now renew their Motion to Dismiss, arguing that Plaintiffs
have failed to state a plausible claim for relief and that Plaintiffs’ claims are preempted
by federal law.
The Federal Rules of Civil Procedure require that pleadings, including
complaints, contain a “short and plain statement of the claim showing that the pleader
is entitled to relief.” Fed. R. Civ. P. 8(a)(2). A complaint may be attacked for failure
“to state a claim upon which relief can be granted.” Fed. R. Civ. P. 12(b)(6). When
considering a Rule 12(b)(6) motion to dismiss, the court will presume that all the
factual allegations in the complaint are true and will draw all reasonable inferences in
favor of the nonmoving party. Total Benefits Planning Agency v. Anthem Blue Cross
& Blue Shield, 552 F.3d 430, 434 (6th Cir. 2008) (citing Great Lakes Steel v.
Deggendorf, 716 F.2d 1101, 1105 (6th Cir. 1983)).
Even though a “complaint attacked by a Rule 12(b)(6) motion to dismiss does
not need detailed factual allegations, a plaintiff’s obligation to provide the grounds of
his entitlement to relief requires more than labels and conclusions, and a formulaic
recitation of the elements of a cause of action will not do.” Bell Atl. Corp. v. Twombly,
550 U.S. 544, 555 (2007) (citations omitted).
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Instead, the plaintiff’s “[f]actual
allegations must be enough to raise a right to relief above the speculative level on the
assumption that all the allegations in the complaint are true (even if doubtful in fact).”
Id. (citations omitted). That is, a complaint must contain enough facts “to state a
claim to relief that is plausible on its face.” Id. at 570. A claim becomes plausible
“when the plaintiff pleads factual content that allows the court to draw the reasonable
inference that the defendant is liable for the misconduct alleged.” Ashcroft v. Iqbal,
556 U.S. 662, 678 (2009) (citing Twombly, 550 U.S. at 556). If, from the well-pleaded
facts, the court cannot “infer more than the mere possibility of misconduct, the
complaint has alleged—but it has not ‘show[n]’—‘that the pleader is entitled to
relief.’” Id. at 679 (alteration in original) (quoting Fed. R. Civ. P. 8(a)(2)). “[O]nly a
complaint that states a plausible claim for relief survives a motion to dismiss.” Id.
When resolving a motion to dismiss pursuant to Rule 12(b)(6), the Court may
consider the complaint and any exhibits attached thereto, public records, items
appearing in the record of the case, and exhibits attached to the defendant’s motion to
dismiss provided such are referenced in the complaint and central to the claims
therein. Bassett v. Nat’l Collegiate Athletic Assoc., 528 F.3d 426, 430 (6th Cir. 2008);
see also Stringfield v. Graham, 212 F. App’x 530, 535 (6th Cir. 2007) (explaining that
documents “attached to and cited by” the complaint are “considered parts thereof
under Federal Rule of Civil Procedure 10(c)”).
Defendants argue that the Plaintiffs’ Amended Complaint should be dismissed
because their principal claims in Counts I through IV are preempted by federal law
and, even if such claims are not preempted, Plaintiffs have failed to sufficiently state
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their claims under the requirements of Twombly and Iqbal. The Court will begin by
discussing the relevant statutory and regulatory background before turning to the issue
of preemption and the Plaintiffs’ particular claims.
Statutory and Regulatory Background
In 1976, Congress enacted the Medical Device Amendments (MDA), 21
U.S.C. § 360c et seq., to the Food, Drug and Cosmetic Act (FDCA), 21 U.S.C. § 301
The MDA established various levels of oversight for medical devices
depending on the degree of risk posed. Class I, which is subject to the lowest level of
oversight and requires only “general controls,” includes such devices as elastic
bandages and examination gloves. See § 360c(a)(1)(A). At the other end of the
spectrum are Class III devices, which receive the highest level of federal oversight and
require “premarket approval.” See § 360c(a)(1)(C). A device is classified under Class
III where the device “is purported or represented to be for a use in supporting or
sustaining human life . . . or presents a potential risk of illness or injury” and it cannot
be established that a less stringent classification “would provide reasonable assurance
of its safety and effectiveness.” § 360c(a)(1)(C)(i)–(ii). It is undisputed that the Riata
lead at issue here is a Class III device.
Premarket approval generally
As noted above, Class III devices must undergo premarket approval prior to
marketing and sale. See id. Premarket approval, or “PMA,” has been described by the
Supreme Court as a “rigorous” process. Medtronic, Inc. v. Lohr, 518 U.S. 470, 477
(1996). A manufacturer must submit what is typically a multivolume application that
includes, among other things, full reports of all studies and investigations of the
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device’s safety and effectiveness that have been published or should reasonably be
known to the applicant; a “full statement” of the device’s “components, ingredients,
and properties and of the principle or principles of operation”; “a full description of
the methods used in, and the facilities and controls used for, the manufacture,
processing, and, when relevant, packing and installation of, such device”; samples or
device components required by the Food and Drug Administration (FDA); a specimen
of the proposed labeling; and any other relevant information.
21 U.S.C. §
After completing its review, the FDA may grant or deny
premarket approval, and may condition approval on adherence to performance
standards, restrictions on sale and distribution, and/or compliance with other
requirements. See 21 C.F.R. §§ 814.82, 861.1(b)(3). The FDA also is free to impose
device-specific restrictions by regulation. See 21 U.S.C. 360j(e)(1). The FDA spends
an average of 1,200 hours reviewing each application, Lohr, 518 U.S. at 477, and will
grant premarket approval only if it finds there is a reasonable assurance of the device’s
safety and effectiveness, see 21 U.S.C. § 360e(d).
Once a device has received premarket approval, it “may not be manufactured,
packaged, stored, labeled, distributed, or advertised in a manner that is inconsistent
with any conditions to approval specified in the PMA approval order for the device.”
21 C.F.R. § 814.80. Thus, a manufacturer is forbidden to make, without the FDA’s
permission, any changes in design specifications, manufacturing processes, labeling,
or any other attribute that would affect safety or effectiveness. See 21 U.S.C.
§ 360e(d)(6)(A)(i); 21 C.F.R. § 814.39(a)-(b). If the manufacturer wishes to make any
such changes, it must submit, and the FDA must approve, an application for
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supplemental premarket approval, or a “PMA supplement.”
See 21 U.S.C.
§ 360e(d)(6); 21 C.F.R. § 814.39(a). The same procedures that apply to applications
for a PMA also apply to applications for PMA supplements. See id.; 21 C.F.R.
After premarket approval, a device is subject to continued reporting
requirements. See 21 U.S.C. § 360i; 21 C.F.R. § 814.84. These requirements include
the obligation to submit periodic reports to the FDA informing the agency of any
“[u]npublished reports of data from any clinical investigations or nonclinical
laboratory studies involving the device” as well as any “[r]eports in the scientific
literature concerning the device” that the applicant knows of or reasonably should
21 C.F.R. § 814.84(b)(2). The applicant also must report to the FDA no
later than 30 days after “receiv[ing] or otherwise becom[ing] aware of information,
from any source, that reasonably suggests that a device . . . (1) [m]ay have caused or
contributed to death or serious injury; or (2) [h]as malfunctioned and this device . . .
would be likely to cause or contribute to a death or serious injury, if the malfunction
were to recur.” 21 C.F.R. § 803.50(a)(1)–(2). The FDA has the power to withdraw
premarket approval where it determines that a device is unsafe or ineffective, 21
U.S.C. § 360e(e)(1), and to order the recall of a device where there is a reasonable
probability that the device would cause serious adverse health consequences or death,
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Premarket approval of the Riata leads
The PMA process for the Riata leads began in 1995 with the submission of an
application to market the Riata’s predecessor, the “Ventritex TVL.” The FDA granted
premarket approval to the Ventritex TVL lead in May 1996.
In 2002, Defendants
submitted, and the FDA approved, a PMA Supplement in which Defendants sought
approval to modify the Ventritex TVL lead and to market versions of the modified lead
under the trade name “Riata Series 1500 Defibrillation Lead System,” which included
Riata model 1580. 2 Between the approval of that supplement, PMA Supplement 14,
and the implantation of Mr. Waltenburg’s Riata lead in September 2004, the FDA
approved four additional supplements, PMA Supplements 15 through 18. 3
Federal preemption derives from the Supremacy Clause of the United States
Constitution. The Constitution establishes the laws of the United States as “the
supreme Law of the Land . . . any Thing in the Constitution or Laws of any State to
the Contrary notwithstanding.” U.S. CONST. art. VI, cl.2.
Thus, state laws that
The parties identify this premarket approval as PMA No. P950022. (See Docket Nos. 10, at 7; 13-1,
This PMA Supplement was the fourteenth supplement to PMA No. P950022 and is identified as
“S014.” For purposes of this Opinion, the Court will refer to this supplement as “PMA Supplement
14.” Subsequent PMA Supplements will be referred to in a similar fashion using their numerical
identifier (e.g., “PMA Supplement 15,” “PMA Supplement 16,” and so on).
PMA Supplement 15 approved an extension of the shelf life for Riata leads; PMA Supplement 16
approved two new Riata models; PMA Supplement 17 approved the addition of a fluoroscopic marker
in the helix tip, the addition of new lead lengths, and minor modifications to the suture sleeve; and
PMA Supplement 18 approved modification to the Riata lead family to include integrated bipolar leads
in Riata model numbers 1560, 1561, 1562, 1590, 1591, and 1592. Summaries of each of these PMA
Supplements can be found on the FDA’s website at FDA.GOV, http://www.accessdata.fda.gov/scripts/
cdrh/cfdocs/cfPMA/pma.cfm (search PMA number “P950022”) (last updated July 14, 2014). To date,
the FDA has approved more than 80 supplements to PMA No. P950022.
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conflict with federal laws or regulations are preempted. E.g., Malone v. White Motor
Corp., 435 U.S. 497, 504 (1978). A court considering a preemption challenge “is not
to pass judgment on the reasonableness of state policy,” but “is instead to decide if a
state rule conflicts with or otherwise stands as an obstacle to the accomplishment and
execution of the full purposes and objectives of the federal law.”
Bradshaw, 512 U.S. 107, 120 (1994) (citations omitted) (internal quotation marks
omitted). To do so, the Court must “ascertain Congress’ intent in enacting the federal
statute at issue.” Metro. Life Ins. Co. v. Massachusetts, 471 U.S. 724, 738 (1985).
Preemption “is compelled whether Congress’ command is explicitly stated in the
statute’s language or implicitly contained in its structure and purpose.” Id. (citations
Preemption therefore comes in two forms: express and implied.
preemption is found when Congress declares a clear intent to preempt state law.
Hillsborough Cnty. v. Automated Med. Labs., Inc., 471 U.S. 707, 712-13 (1985); see
also State Farm Bank, FSB v. Reardon, 539 F.3d 336, 341-42 (6th Cir. 2008)
(explaining that express preemption exists “where either a federal statute or regulation
contains explicit language indicating that a specific type of state law is preempted”).
Implied or implicit preemption is subdivided into two categories: conflict preemption
and field preemption. Reardon, 539 F.3d at 342 (citation omitted). The former exists
“where compliance with both federal and state regulations is a physical impossibility,
or where state law stands as an obstacle to the accomplishment and execution of the
full purposes and objectives of Congress”; the latter exists when “the scheme of
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federal regulation is so pervasive as to make reasonable the inference that Congress
left no room for the States to supplement it.” Id.
Preemption under the MDA
The MDA contains an express preemption clause, which provides:
[N]o State or political subdivision of a State may establish or
continue in effect with respect to a device intended for human use
(1) which is different from, or in addition to, any
requirement applicable under this chapter to the device,
(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).
Since its enactment, the Supreme Court has decided three
principal preemption cases involving the MDA. But despite the guidance offered by
those decisions, courts have struggled to discern the precise scope of MDA
The first case addressing preemption under the MDA was Medtronic, Inc. v.
Lohr, decided in 1996. 518 U.S. at 470. There, after her pacemaker failed, the
plaintiff alleged a number of negligence claims under state law against the
pacemaker’s manufacturer. Among those claims, the plaintiff alleged that the
manufacturer breached its duty to use reasonable care in the sale of the pacemaker by
its failure to warn her or her physicians of the pacemaker’s tendency to fail, despite
the manufacturer’s knowledge of earlier failures. Id. at 481. The Court held that none
of the plaintiff’s state-law claims were preempted, writing: “Nothing in § 360k denies
[a state] the right to provide a traditional damages remedy for violations of common-
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law duties when those duties parallel federal requirements.” Id. at 495. In regard to
her failure-to-warn claim, the Court focused on the generality of the state-law duty to
[T]he predicate for the failure to warn claim is the general duty to
inform users and purchasers of potentially dangerous items of the
risks involved in their use. These general obligations are no more a
threat to federal requirements than would be a state-law duty to
comply with local fire prevention regulations and zoning codes, or
to use due care in the training and supervision of a work force.
These state requirements therefore escape pre-emption, not
because the source of the duty is a judge-made common-law rule,
but rather because their generality leaves them outside the category
of requirements that § 360k envisioned to be “with respect to”
specific devices such as pacemakers.
Id. at 501-02.
Buckman Co. v. Plaintiffs’ Legal Committee was the second case to address
preemption under the MDA. 531 U.S. 341 (2001). The Buckman plaintiffs brought
state-law negligence claims alleging injuries from the implantation of orthopedic bone
screws, a Class III medical device. In regard to defendant Buckman, which was a
consulting company and did not manufacture the screws, the plaintiffs alleged that
Buckman had made fraudulent misrepresentations to the FDA in the course of
obtaining PMA approval for its client, the screws’ manufacturer. Id. at 343-44. The
Court characterized these claims against Buckman as “fraud-on-the-FDA claims” and,
as such, concluded that they “conflict with, and are therefore impliedly pre-empted by,
federal law.” 4 Id. at 348. The Court explained:
The Buckman Court expressly limited its holding to the issue of implied preemption, noting: “[W]e
express no view on whether these claims are subject to express pre-emption under 21 U.S.C. § 360k.”
531 U.S. at 348 n.2.
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Th[is] conflict stems from the fact that the federal statutory scheme
amply empowers the FDA to punish and deter fraud against the
Administration, and that this authority is used by the
Administration to achieve a somewhat delicate balance of statutory
objectives. The balance sought by the Administration can be
skewed by allowing fraud-on-the-FDA claims under state tort law.
The Buckman Court distinguished the claims in Lohr, which arose from the
manufacturer’s alleged breach of state-law duties, from those asserted by the Buckman
plaintiffs, which alleged no state-law claim and instead focused exclusively on
Buckman’s alleged fraud on the FDA during the PMA process.
See id. at 352
(discussing Lohr, 518 U.S. at 481). After noting that “the relationship between a
federal agency and the entity it regulates is inherently federal in character because the
relationship originates from, is governed by, and terminates according to federal law,”
the Court concluded:
In the present case . . . the fraud claims exist solely by virtue of the
FDCA disclosure requirements. Thus, although [Lohr] can be read
to allow certain state-law causes of actions that parallel federal
safety requirements, it does not and cannot stand for the
proposition that any violation of the FDCA will support a state-law
In sum, were plaintiffs to maintain their fraud-on-the-agency
claims here, they would not be relying on traditional state tort law
which had predated the federal enactments in questions [sic]. On
the contrary, the existence of these federal enactments is a critical
element in their case.
Id. at 352-53.
The third and most recent case to address MDA preemption is Riegel v.
Medtronic, Inc., which was decided in 2008.
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552 U.S. 312 (2008).
plaintiffs sued Medtronic under state law after a catheter in the lead plaintiff’s
coronary artery ruptured. The catheter, an FDA-approved Class III device, had been
inflated to a higher pressure than recommended on the FDA-approved label. Id. at
320. The plaintiffs claimed that the catheter was defective under state law. The Court
held that the plaintiffs’ claims were expressly preempted by the MDA because state
law imposed more stringent safety requirements than did federal law. Id. at 325. Still,
the Court was careful to state that Lohr remained good law:
State requirements are pre-empted under the MDA only to the
extent that they are “different from, or in addition to” the
requirements imposed by federal law. § 360k(a)(1). Thus, § 360k
does not prevent a State from providing a damages remedy for
claims premised on a violation of FDA regulations; the state duties
in such a case “parallel,” rather than add to, federal requirements.
Lohr, 518 U.S. at 495.
Id. at 330.
MDA preemption in the context of Rule 12(b)(6)
Collectively, Lohr, Buckman, and Riegel provide a framework for the
appropriate preemption analysis. Nevertheless—and, frankly, understandably—lower
courts have struggled to resolve one of the major preemption questions that has arisen
since Riegel: In the context of a Rule 12(b)(6) motion to dismiss, what degree of
particularity is required to establish a parallel claim and avoid preemption?
The first major post-Riegel decision to address this issue was In re Medtronic,
Inc., Sprint Fidelis Leads Products Liability Litigation, a case in which the Eighth
Circuit, in a divided opinion, affirmed a multidistrict litigation court’s dismissal of
failure-to-warn, design-defect, and manufacturing-defect claims on the basis of
express preemption. 623 F.3d 1200 (8th Cir. 2010) (2-1 decision). That court read
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Riegel and Buckman as “creat[ing] a narrow gap through which a plaintiff’s state-law
claim must fit if it is to escape express or implied preemption.” Id. at 1204 (quoting
Riley v. Cordis Corp., 625 F. Supp. 2d 769, 777 (D. Minn. 2009)). The Eighth Circuit
found that each of the plaintiffs’ claims were expressly preempted under § 360k(a)
because the plaintiffs did not allege with sufficient specificity a deviation from the
specific federal requirements in the PMA. See id. at 1205-07.
The Sixth Circuit has yet to weigh in directly on this issue, and, since Riegel
and In re Medtronics, different circuit courts have adopted different approaches as to
the required pleading specificity in the context of MDA preemption.
On one end of the spectrum is the Seventh Circuit’s decision in Bausch v.
Stryker Corp., which thus far has required the least specificity to plead a claim that
will survive a motion to dismiss. 630 F.3d 546 (7th Cir. 2010), cert. denied, 132 S. Ct.
There, the district court granted the defendants’ motion to dismiss,
holding that the plaintiff’s common-law claims were preempted by the MDA. The
district court also denied the plaintiff’s motion to amend her complaint. The Seventh
Circuit reversed, finding that the plaintiff’s claims that she was injured by the
defendants’ alleged violations of federal law were not preempted. In so doing, the
Bausch panel made clear that a plaintiff need not identify the precise defect or the
specific federal regulatory requirements that were allegedly violated in order to
comply with Rule 8. Id. at 560. In this regard, the Bausch panel wrote:
Defendants object that the original complaint does not specify
the precise defect or the specific federal regulatory requirements
that were allegedly violated. Although the complaint would be
stronger with such detail, we do not believe the absence of those
details shows a failure to comply with Rule 8 of the Federal Rules
of Civil Procedure or can support a dismissal under Rule 12(b)(6).
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The Seventh Circuit based its decision in part on the fact that “in the context of
Class III medical devices, much of the critical information is kept confidential as a
matter of federal law [and] there is no public access to complete versions of [the
FDA’s premarket approval] documents.” Id. at 560. Thus, the court reasoned that
“[i]f plaintiffs must allege that the defendant violated a particular FDA-approved
specification before discovery, then it is difficult to appreciate how any plaintiff will
ever be able to defeat a Rule 12(b)(6) motion.” Id. at 561 (quoting In re Medtronic,
623 F.3d at 1212 (Melloy, J., dissenting)).
On the other end of the spectrum is the Eleventh Circuit’s decision in WolickiGables v. Arrow International, Inc., a decision which set forth a standard requiring the
highest degree of pleading specificity. 634 F.3d 1296 (11th Cir. 2011). Adopting an
approach embraced by many district courts, 5 the Wolicki-Gables panel held that a
plaintiff must allege a PMA-specific violation in order to survive preemption under
Plaintiffs cannot simply incant the magic words ‘[defendants]
violated FDA regulations’ in order to avoid preemption. Parallel
claims must be specifically stated in the initial pleadings. A
plaintiff must allege that [the] defendant violated a particular
federal specification referring to the device at issue. To properly
allege parallel claims, the complaint must set forth facts pointing to
specific PMA requirements that have been violated.
See, e.g., Ilarraza v. Medtronic, Inc., 677 F. Supp. 2d 582, 589 (E.D.N.Y. 2009); In re Medtronic,
Inc. Sprint Fidelis Leads Prods. Liab. Litig., 592 F. Supp. 2d 1147, 1158 (D. Minn. 2009), aff’d, 623
F.3d 1200 (8th Cir. 2010) (2-1 decision); Parker v. Stryker Corp., 584 F. Supp. 2d 1298, 1301 (D. Colo.
2008); Rollins v. St. Jude Med., 583 F. Supp. 2d 790, 799-800 (W.D. La. 2008).
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Id. at 1301 (second alteration in original) (citations omitted) (internal quotation marks
Though the approaches taken in these cases are not perfectly aligned, the
extent to which they differ is not beyond reconciliation. 6 The Fifth Circuit effectively
synthesized In re Medtronic, Bausch, and Wolicki-Gables in Bass v. Stryker Corp., a
case in which the plaintiff asserted strict liability and negligence claims based on
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 a defect in the manufacture of the specific device to
that plaintiff’s specific injury.
669 F.3d 501, 511-12 (5th Cir. 2012) (emphasis in original). The Fifth Circuit went on
to offer the following illustration:
[S]uppose a manufacturer had represented to the FDA in its preapproval documentation that each hip implant component would be
sterilized for ten minutes at 800 degrees. We would accept a
parallel claim that pleaded that the manufacturer instead sterilized
the component at only 200 degrees for five minutes, as that would
“violate” what it told the FDA. However, if the plaintiff’s claim
was that proper sterilization required twenty minutes at 1000
degrees or some other method of sterilization altogether, this claim
would not be allowed, as it would “add to” the regulatory
Id. at 512-13.
This point previously was recognized by this Court in White v. Stryker Corp.: “These cases reveal
the different approaches to resolving MDA preemption issues, though one can overstate the differences.
No doubt, specific factual and procedural differences among the cases partially explain the different
results.” 818 F. Supp. 2d 1032, 1039 (W.D. Ky. 2011) (discussing Bausch and Wolicki-Gables, among
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Yet despite the possibility of reading these seemingly incongruous decisions as
somehow in sync, the precise question presently before this Court remains
unanswered—namely, is it sufficient to allege that the Defendants violated FDA
regulations by deviating from the FDA-approved processes and procedures in the
PMA or, instead, must the Plaintiffs identify the particular FDA regulations and set
forth facts pointing to the particular PMA requirements that are alleged to have been
violated? The Court has found no clear answer to this question, as there appears to be
case law supporting both possibilities.7
Several recent decisions—two by this Court and one by the Eastern District of
Kentucky—provide useful points of comparison. In the first case, White v. Stryker
Corp., this Court granted the defendant’s motion to dismiss upon finding that the
plaintiff had failed to plead the degree of specificity required to establish a parallel
claim and avoid preemption. 818 F. Supp. 2d 1032 (W.D. Ky. 2011). The plaintiff in
White underwent a total hip arthroplasty in which a medical device known as the
“Trident System” was implanted. Several years later, the plaintiff learned that the
Trident System had failed and sued the manufacturer, alleging that “defendants failed
to manufacture [the Trident System] according to FDA approved standards and
Compare Franzese v. St. Jude Med., Inc., 2014 WL 2863087, at *3 (E.D.N.Y. June 23, 2014)
(noting that “the law is clear that Plaintiffs must identify a specific federal regulation allegedly
violated”), and Simon v. Smith & Nephew, Inc., 2013 WL 6244525, at *4 (S.D.N.Y. Dec. 3, 2013) (“To
avoid preemption and satisfy the Twombly and Iqbal pleading standards, plaintiffs suing with regard to
a PMA-approved device cannot simply make the conclusory allegation that defendant’s conduct
violated FDA regulations.”), with Hawkins v. Medtronic, Inc., 909 F. Supp. 2d 901, 906 (S.D. Ohio
2012) (citing the Supreme Court’s decision in Lohr, 518 U.S. at 495, for the proposition that “to avoid
preemption, the complaint need not define ‘the precise contours of [the plaintiff’s] theory of recovery,’
if it alleges that the defendant has violated FDA regulations” (alteration in original)); Hofts v.
Howmedica Osteonics Corp., 597 F. Supp. 2d 830, 838-39 (S.D. Ind. 2009) (discussing Lohr to suggest
that the district court’s decision in In re Medtronic “is an unusually stringent application of Twombly
and Rule 8 of the Federal Rules of Civil Procedure at the motion to dismiss stage”).
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procedures for medical devices.” Id. at 1033 (alteration in original). A review of the
docket in that case reveals that the plaintiff’s complaint and amended complaint
merely alleged that the device was defective and that the defendant designed,
manufactured, and distributed the device. See White v. Stryker Corp., No. 3:10-CV544-JGH, Docket No. 1-3 (filed Aug. 16, 2010); Docket No. 7-1 (filed Oct. 1, 2010).
The amended complaint did reference FDA standards, but did so in conclusory
fashion: “The subject hip replacement device . . . was defective . . . in that the
defendants failed to manufacture it according to FDA approved standards and
procedures for medical devices including but not limited to the standards and
procedures set forth in the [MDA].” Id., Docket No. 7-1, at 1. The same general
reference to “FDA approved standards and procedures” also was used in regard to the
plaintiff’s negligent-manufacture claim. Id., Docket No. 7-1, at 1. This Court, relying
on the standards set out in In re Medtronic and Wolicki-Gables, found the plaintiff’s
claims insufficiently specific to avoid dismissal, writing:
The Amended Complaint neither cites any particular federal
standard or procedure, nor does it generally state how the alleged
defect deviated from a federal standard or procedure.
. . . [I]t contains only the most general allegations of product
liability [and] negligence . . . . It does not identify any particular
design flaw, manufacturing impropriety or product defect. It does
not assert either a PMA-specific standard or a GMP regulation, the
violation of which might form the basis for a state law action.
Rather, in a general manner it purports to limit otherwise broad
state law claims only to those circumstances involving
noncompliance with an FDA standard. In the face of the narrow
pleading window required to avoid preemption, Plaintiff has done
White, 818 F. Supp. 2d at 1033, 1039.
Page 18 of 38
In the second case, Steiden v. Genzyme Biosurgery, this Court reached the
opposite conclusion and denied the defendant’s motion to dismiss. 2012 WL 2923225
(W.D. Ky. July 18, 2012). The plaintiff in Steiden received an injection of “SynviscOne,” a Class III medical device, and immediately suffered an adverse reaction. In his
original complaint, he sued the device’s manufacturer, Genzyme, alleging strict
liability. The defendant moved to dismiss, and the plaintiff moved to amend his
complaint to add allegations that “Genzyme failed to comply with the FDA’s
premarket approval requirements in the continued manufacture, distribution and sale
of Synvisc-One®” and that “Genzyme manufactured, held, sold, and delivered an
adulterated dose of Synvisc-One®.” Id. at *1-2. In contrast to White, the Steiden
decision made no mention of Wolicki-Gables and instead relied primarily on the
Seventh Circuit’s decision in Bausch.
The Court read Bausch as holding “that
although the original complaint did not specify the precise defect or the specific
federal regulatory requirements that were allegedly violated, the absence of those
details did not provide a valid basis for dismissal under Rule 12(b)(6).” Id. at *3
(citing Bausch, 630 F.3d at 560). The Court then likened the facts before it to those in
Bausch and distinguished them from those in White:
[T]he facts appear to be fairly simple and straightforward. It is
claimed that on a particular date, both of Steiden’s knees were
injected with Synvisc–One®, and he allegedly suffered an
immediate adverse reaction in one of them. He claims that the
product was adulterated, that Genzyme violated federal [current
good manufacturing practices], the PMA for the device, and state
law prohibiting the manufacture and sale of adulterated medical
We find the factual allegations before us indistinguishable from
those in Bausch where the plaintiff cited to the above-referenced
FDA letter stating that the device was “adulterated.” Nothing more
Page 19 of 38
specific was required in Bausch to state a plausible claim for
adulteration. Similarly, we find that the allegation of adulteration
based on the occurrence of an immediate adverse reaction in one
knee to the injection of Synvisc–One® contains sufficient
specificity to satisfy Iqbal and Twombly.
In White, the plaintiff did not allege any specific manufacturing
failure or violation of any federal standard. He alleged general
claims of product liability, negligence and warranty. By contrast,
Steiden has alleged that the means by which he was injured was
the injection into his knee of an adulterated dose of Synvisc–One®.
He claims that . . . the PMA . . . w[as] violated thereby.
Id. at *5 (citations omitted).
Finally, in the third case, Kitchen v. Biomet, Inc., the Eastern District of
Kentucky followed this Court’s reasoning in White and granted the defendant’s motion
to dismiss. 2014 WL 694226 (E.D. Ky. Feb. 21, 2014). The plaintiff in Kitchen
underwent surgery to receive an “Oxford” partial knee implant.
subsequently failed, and the plaintiff had to undergo further surgery. She sued the
implant’s manufacturer alleging, among other things, negligence and strict liability.
Id. at *1. In regard to her negligence claim, the plaintiff’s amended complaint alleged:
18. The Oxford partial knee implant was defective in one or
more of the following respects:
(f) failure to comply with Quality System Regulation and
Current Manufacturing Practices required by the FDA in
21 C.F.R. § 820.72 to 820.90. Among other things, these
regulations require manufacturers to put in place suitable
processes to test products for compliance with product
specifications, to check and document compliance with
product specifications before products are accepted for
sale and use, and to identify and control non-conforming
Page 20 of 38
19. Because of these effects, the knee implant failed to comply
and operate within the terms of its Pre-Market Approval from The
Food and Drug Administration.
Id. at *2 (alterations in original). The plaintiff’s strict liability claim similarly alleged
that “[b]ecause of its defects, the knee implant failed to comply and operate in terms
of its Pre-Market Approval.” Id. Relying on White, the Eastern District concluded:
“Plaintiff refers to a broad category of federal regulations and fails to allege how the
device violated those regulations or how that deviation caused her injuries. This lack
of specificity is fatal to her claim.” Id. at *5. The court punctuated its conclusion
further by distinguishing this Court’s decision in Steiden: “In this case, as in White and
in contrast to Steiden, Plaintiff fails to identify the federal regulation violated by
Defendants, how the product deviated from the FDA approved process and how such
deviation caused her injury. Simply incanting that a manufacturer violated federal
regulations does not pass Iqbal/Twombly muster.” 8 Id. at *6.
The Court has reviewed the dockets of these three cases and compared the
claims and allegations pleaded in each with those of the Plaintiffs here. 9 The factual
Based on this Court’s review of the dockets in White, Steiden, and Kitchen, the comparisons drawn
by the court in Kitchen are somewhat puzzling. For example, the Kitchen decision seems to state that
the Steiden plaintiff identified specific federal regulations alleged to have been violated. See Kitchen,
2014 WL 694226, at 6. However, neither the complaint nor the amended complaint in Steiden did, in
fact, identify any specific federal regulation. See Steiden v. Genzyme Biosurgery, No. 3:11-CV-441CRS, Docket No. 1-1 (filed Aug. 5, 2011); Docket No. 21 (filed July 18, 2012). Moreover, the Kitchen
decision seems to gloss over a number of seemingly specific allegations as to why the device in
question there was defective. See Kitchen v. Biomet, Inc., No. 0:13-CV-18-HRW, Docket No. 23, at 4,
¶ 18(a) (filed Sept. 26, 2013). Ultimately, this Court’s reading of the amended complaint in Kitchen
appears to reveal allegations that are much more similar to those in Steiden than to the meager
allegations presented in White.
As referenced above, the complaint and amended complaint in White appear at Docket No. 1-3 and
Docket No. 7-1, respectively, in Civil Action No. 3:10-CV-544-JGH (W.D. Ky); the complaint and
amended complaint in Steiden appear at Docket No. 1-1 and Docket No. 21, respectively, in Civil
Page 21 of 38
allegations presently before this Court unquestionably are more specific than those in
White and Kitchen. They also are appreciably more specific than those that survived
dismissal in Steiden. Here, Plaintiffs assert claims sounding in strict liability and
negligence, in essence alleging that the Riata leads were defective because the actual
manufacture of those leads deviated from the specifications and protocols set forth in
the federal regulations and the PMA. (See Docket No. 10, at 28-32.) Nothing more
specific was required in Steiden to overcome dismissal under Rule 12(b)(6). And
unlike the scant factual allegations in White, here, the Plaintiffs support their claims
with a number of specific allegations as to how Defendants deviated from the
specifications in the PMA. (See Docket No. 10, at 21-24, ¶¶ 75-81, 84.)
Furthermore, in considering the sufficiency of the pleadings, the Court finds
much of the Seventh Circuit’s reasoning in Bausch particularly persuasive. Although
the Plaintiffs’ Amended Complaint does not make specific reference to the precise
PMA requirements allegedly violated, the absence of such details can hardly provide a
solid basis for dismissing their claims at this stage. See Bausch, 630 F.3d at 560 (“If
plaintiffs must allege that the defendant violated a particular FDA-approved
specification before discovery, then it is difficult to appreciate how any plaintiff will
ever be able to defeat a Rule 12(b)(6) motion.”). Indeed, Plaintiffs do not appear to
have had access to PMA Supplements 14 through 18 prior to the filing of Defendants’
Motion to Dismiss,10 and there is nothing to indicate that Plaintiffs had access to the
Action No. 3:11-CV-441-CRS (W.D. Ky.); and the amended complaint in Kitchen appears at Docket
No. 23 in Civil Action No. 0:13-CV-18-HRW (E.D. Ky.).
PMA Supplements 14 through 18 were filed under seal as attachments to Defendants’ Motion to
Dismiss. (See Docket Nos. 15; 15-1 through -18.)
Page 22 of 38
original PMA when either their Complaint or Amended Complaint was filed. See id.
(noting that “in the context of Class III medical devices, much of the critical
information is kept confidential as a matter of federal law [and] there is no public
access to complete versions of [the FDA’s PMA] documents.”).
For these reasons, the Court is satisfied that the claims in Plaintiffs’ Amended
Complaint are pleaded with sufficient particularity to satisfy the notice-pleading
requirements of Rule 8 and to survive dismissal under Rule 12(b)(6). 11
Preemption and Plaintiffs’ Particular Claims
Having found that Plaintiffs’ claims pass muster under Rule 8, the Court still
must determine whether those state law claims are preempted, either expressly or
impliedly, by federal law. Therefore, the Court now turns to the particular claims
asserted in Plaintiffs’ Amended Complaint. Defendants argue that Plaintiffs’
manufacturing-defect claims are expressly preempted because Plaintiffs have failed to
state parallel claims. Defendants also argue that Plaintiffs’ failure-to-warn claim is
both expressly and impliedly preempted.
And, finally, Defendants argue that
Plaintiffs’ negligence per se claim is not cognizable under Kentucky law and, even if it
was, is impliedly preempted. The Court will consider each of these claims in turn.
The Court’s conclusion on this point is consistent with at least one other decision in this Circuit.
See Hawkins, 909 F. Supp. 2d at 906 (“[T]o avoid preemption, the complaint need not define ‘the
precise contours of [the plaintiff’s] theory of recovery,’ if it alleges that the defendant has violated FDA
regulations.” (quoting Lohr, 518 U.S. at 495)).
Page 23 of 38
Strict liability manufacturing defect
Defendants argue that Plaintiffs’ manufacturing-defect claims are expressly
preempted under § 360k(a).
Preemption analysis under § 360k(a) involves two
(1) whether the Federal Government has established requirements
applicable to the device in question; and (2) whether the asserted state-law claims
impose any requirements with respect to the device that are different from, or in
addition to, the federal requirements. Riegel, 552 U.S. at 321-22. The Supreme Court
recognizes that the extensive PMA process that Class III devices must endure imposes
requirements under the MDA, thus satisfying the first part of this inquiry. See id. at
322-23. Plaintiffs do not dispute that the FDA has established requirements for the
Riata leads. (See Docket No. 16, at 7.) Thus, the Court’s inquiry here is limited to
whether the Plaintiffs’ claims would impose state-law requirements “different from, or
in addition to,” the requirements imposed by the FDA through the PMA process.
In Riegel, the Supreme Court offered some guidance as to what it means for a
state requirement to be different from, or in addition to, an MDA requirement,
explaining that state-law claims “premised on a violation of FDA regulations” are
“parallel” claims that do not impose requirements different from, or in addition to,
federal requirements. Accordingly, § 360k(a) does not preempt these parallel claims.
The Court therefore must determine whether Plaintiffs have established “parallel”
Count I of Plaintiffs’ Amended Complaint asserts a claim in strict liability,
alleging that the Riata leads possess a manufacturing defect because the actual
manufacture of those leads deviated from the specifications set forth in the federal
Page 24 of 38
regulations and required by the PMA and PMA Supplements.
Earlier in their
Amended Complaint, Plaintiffs specifically identify some eight alleged deviations
from those approved specifications that they say make the Riata leads defective: (1)
“failure to manufacture the internal conductors, or cables, at sizes consistent with the
specifications. . . . result[ing] in increased movement of the conductors, or cables,
within the insulation thereby causing inside out abrasion;” (2) “[f]ailure to
manufacture insulation diameters consistent with the specifications lead[ing] to
increased movement of the cables within the outer silicone as well as an increased risk
of abrasion at thinner insulation sites, leading to an increased risk of device failure;”
(3) “failure to consistently apply a lubricious interface inside the lumen between the
inner and outer insulation [which] may have led to increased friction within the lead
body, promoting abrasion and/or externalization;” (4) “fail[ure] to comply with the
approved methods and/or specifications of curing and sterilization during the
manufacture [which] resulted in reduced tensile strength of the silicone insulation;” (5)
“process[ing] the leads in a solution which caused the cables and/or conductors to
stretch and then vibrate when exposed to electrical charge thru [sic] silicone, further
increasing the risk of abrasion to the leads;” (6) “fail[ure] to consistently trim and/or
remove excess adhesive and/or silicone from the outer lead body [which] result[ed] in
both inconsistent thickness and less smooth insulation both of which contribute to the
abrasion of the lead;” (7) “fail[ure] to crimp with a controlled, uniform, degree of
force [which] resulted in insecure crimps over the length of the [l]ead, which also
leads to increased movement of the lead and diminishes the integrity of the
insulation—both of which lead to abrasion”; and (8) “fail[ure] to adequately inspect
Page 25 of 38
and/or test the leads and their component parts to ensure consisten[cy] with approved
specifications and procedures.” (Docket No. 10, at 21-24, ¶¶ 75-81, 84.)
Defendants argue that Plaintiffs’ manufacturing-defect claims are expressly
preempted because they fail to state a parallel claim. More specifically, Defendants
state that at least six of these alleged requirements do not appear in PMA Supplements
14 through 18. According to Defendants, “the alleged requirements upon which
[Plaintiffs] base their manufacturing-defect claims simply do not exist.” (Docket No.
13-1, at 24.)
Defendants therefore urge that any manufacturing-defect claim
predicated on the existence of these purported requirements is expressly preempted
because it necessarily would impose state-law requirements in addition to, or different
than, those imposed by the FDA through the PMA process.
As an initial matter, Defendants may be correct that the specifications they are
alleged to have deviated from do not appear in PMA Supplements 14 through 18.
Notably absent from Defendants’ argument, however, is any mention of the original
PMA for the Riata’s predecessor, the Ventritex TVL, or of the previous PMA
While the Riata brand may not have appeared until PMA
Supplement 14, the specifications applicable to those leads include the specifications
approved in the original PMA as well as those approved in earlier PMA Supplements.
See Kemp v. Medtronic, Inc.,
231 F.3d 216, 227 (6th Cir. 2000) (“[T]he PMA
Supplement process . . . builds upon the rigorous PMA process . . . . Hence, because
the FDA has already made a determination as to the safety and effectiveness of the
underlying device in the original PMA, it can evaluate only the proposed
modifications presented in the PMA Supplement while relying on its earlier approval
Page 26 of 38
of the original device.”), cert. denied, 534 U.S. 818 (2001). In Kemp v. Medtronic,
Inc., the Sixth Circuit explained:
[T]he PMA process establishes specific federal requirements for a
Class III device. It is true that in granting approval for a Class III
device, the FDA does not set forth the reasons justifying its
decision. Impliedly, however, the FDA has relied upon both the
PMA submission approved for the original Class III device and
the PMA Supplement providing specific information on the
proposed modification in question. These specific submissions
form the basis of the FDA’s approval of the PMA Supplement.
Thus, we conclude the specific requirements applicable to the
[medical device] include the entire relevant PMA and
accompanying PMA Supplement, rather than certain portions
thereof. . . . [T]he information submitted to and approved by the
FDA in both the . . . PMA and as modified by the . . . PMA
Supplement comprise the specific federal requirements applicable
to [the medical device].
231 F.3d at 228 (emphasis added). Therefore, the PMA Supplements for the Riata
leads supplemented, rather than supplanted, the PMA requirements for its predecessor,
the Ventritex TVL. On this point, the District of New Jersey, applying the Sixth
Circuit’s decision in Kemp, succinctly noted:
Moreover, DePuy’s PMA supplement for the LCS–P/S Knee’s
“tibial” component supplemented, rather than supplanted, the PMA
requirements for its predecessor, the LCS–Knee. As one court of
appeals has explained, “a PMA Supplement proposes changes to a
device that has already received rigorous review and approval
during the original PMA process.” Hence, because “the PMA
Supplement process builds upon the rigorous PMA process,” the
FDA evaluates “the proposed modifications presented in the PMA
Supplement while relying on its earlier approval of the original
device.” In determining whether FDA regulations impose specific
requirements applicable to the LCS–P/S Knee, this Court considers
the FDA’s approval of the PMA for the LCS–Knee as well as its
approval of the PMA supplement for the LCS–P/S Knee.
Page 27 of 38
Steele v. DePuy Orthopaedics, Inc., 295 F. Supp. 2d 439, 449 n.9 (D.N.J. 2003)
(internal citations omitted) (quoting Kemp, 231 F.3d at 227). To be sure, this Court
and a number of other district courts have recognized that the federal requirements
established by FDA approval “consist of ‘the totality of the design, manufacturing
processes, and labeling when coupled with the prohibition against modifying them’ as
found in the ‘entire relevant PMA and accompanying PMA Supplement[s].’” Enlow v.
St. Jude Med., Inc., 210 F. Supp. 2d 853, 858 (W.D. Ky. 2001) (quoting Kemp, 231 F.
3d at 228); accord Purchase v. Advanced Bionics, LLC, 896 F. Supp. 2d 694, 697
(W.D. Tenn. 2011); Hughes v. Cook, 452 F. Supp. 2d 832, 841 (W.D. Tenn. 2006); In
re Medtronic, Inc., Implantable Defibrillators Litig., 465 F. Supp. 2d 886, 893 (D.
Minn. 2006); Moore v. Sulzer Orthopedics, Inc., 337 F. Supp. 2d 1002, 1008 (N.D.
As noted above, state-law claims premised on violations of FDA regulations
are parallel—and thus not preempted under § 360k(a)—to the extent they do not
impose state-law requirements different from, or in addition to, federal requirements.
Under Kentucky law, a manufacturing defect exists when a product leaves the hands
of the manufacturer in a defective condition because it was not manufactured or
assembled in accordance with its specifications. Gentry v. Gen. Motors Corp., 2006
WL 1382293, at *1 (W.D. Ky. May 15, 2006) (referencing Greene v. B.F. Goodrich
Avionics System, Inc., 409 F.3d 784, 788 (6th Cir. 2005)); Ford Motor Co. v.
McCamish, 559 S.W.2d 507, 509-11 (Ky. Ct. App. 1977). Kentucky has adopted the
RESTATEMENT (SECOND) OF TORTS § 402A, Greene, 409 F.3d at 788 (citing Dealers
Transp. Co. v. Battery Distrib. Co., 402 S.W.2d 441, 446-47 (Ky. 1965)), under which
Page 28 of 38
a defendant is held strictly liable if the plaintiff proves the product was “in a defective
condition unreasonably dangerous to the user or consumer,” id. (quoting Montgomery
Elevator Co. v. McCullough ex rel. McCullough, 676 S.W.2d 776, 780 (Ky. 1984)).
“Unreasonably dangerous” means “a product that is ‘dangerous to an extent beyond
that which would be contemplated by the ordinary consumer who purchases it, with
the ordinary knowledge common to the community as to its characteristics.’” Greene,
409 F.3d at 789 (quoting RESTATEMENT (SECOND)
TORTS § 402A cmt. i).
“Defective” means “that the product does not meet the reasonable expectations of the
ordinary consumer as to its safety.” Greene, 409 F.3d at 789 (quoting Worldwide
Equip., Inc. v. Mullins, 11 S.W.3d 50, 55 (Ky. Ct. App. 1999)).
Thus, to state a parallel claim and avoid preemption under § 360k(a), Plaintiffs’
state-law manufacturing-defect claim must not impose requirements different from, or
in addition to, federal requirements. At this early stage in the litigation, it would be
difficult, if not impossible, for the Plaintiffs to allege specific deviations from the
confidential PMA documentation that they could only obtain through the discovery
process. As such, it similarly is difficult, if not impossible, for the Court to determine
whether Plaintiffs have failed to allege specific deviations from the PMA and PMA
Supplements because, at least at this stage in the litigation, the Court simply is unable
to compare the particular state and federal requirements at issue.
District of Ohio faced an analogous situation in Hawkins v. Medtronic, Inc., a case also
decided in the context of a Rule 12(b)(6) motion to dismiss. 909 F. Supp. 2d 901
(S.D. Ohio 2012). There, the court noted that “[b]ecause the preemption issue here
must be decided on the pleadings, and the complaint has not defined ‘the precise
Page 29 of 38
contours of [the plaintiff’s] theory of recovery,’ the Court can not engage in a detailed
comparison of the specific state and federal requirements at issue.” Id. at 908 (quoting
Lohr, 518 U.S. at 495). The court then went on to reject the defendant’s arguments
that the plaintiff’s strict liability claims were preempted, concluding: “[I]t is clear
from the allegations that Plaintiff’s claim is in fact premised on the theory that
Defendant violated federal law. The Court therefore DENIES Defendant’s motion as
to Plaintiff’s manufacturing defect claim.” Id. (citing Riegel, 552 U.S. at 330; Lohr,
518 U.S. at 495).
The Court reaches the same conclusion here as did the court in Hawkins.
Plaintiffs’ Amended Complaint alleges that Defendants’ manufacture of the Riata leads
deviated from the PMA and PMA Supplements. Plaintiffs’ strict liability
manufacturing-defect claim is therefore predicated on violations of federal regulations.
See, e.g., Bass, 669 F.3d at 512 (“To the extent a plaintiff can show that the FDAapproved processes and procedures were not followed, and that the injury was caused
by this deviation, the plaintiff’s claim will be parallel.”). Thus, at this early stage in
the litigation, and to the extent Plaintiffs claim that the device was defectively
manufactured because it did not comply with the FDA-approved specifications, the
Court finds that Plaintiffs have successfully alleged a parallel claim sufficient to
survive preemption under § 360k(a).
However, the Court notes that if after the
completion of discovery it appears that Plaintiffs cannot maintain a manufacturingdefect claim based on state requirements that parallel federal requirements, Defendants
are certainly free to move for summary judgment, at which point the Court will
reevaluate the issue of preemption.
Page 30 of 38
Count II of Plaintiffs’ Amended Complaint alleges that Defendants had a duty
to manufacture the Riata leads consistent with the applicable specifications set forth in
the PMA and PMA Supplements, that Defendants breached that duty, and that Mr.
Waltenburg has sustained and continues to sustain injury as a result. Under Kentucky
law, a plaintiff can advance both a strict-liability claim and a negligence claim against
the manufacturer of a product for injury suffered by that product. See Ostendorf v.
Clark Equip. Co., 122 S.W.3d 530, 535 (Ky. 2003) (referencing Williams v. Fulmer,
694 S.W.2d 411, 413 (Ky. 1985)). A negligence claim requires proof that “(1) the
defendant owed the plaintiff a duty of care, (2) the defendant breached the standard by
which his or her duty is measured, and (3) consequent injury.” Pathways, Inc. v.
Hammons, 113 S.W.3d 85, 88 (Ky. 2003) (citing Mullins v. Commonwealth Life Ins.
Co., 839 S.W.2d 245, 247 (Ky. 1992)). Because Plaintiffs’ negligent-manufacture
claim essentially is premised on the same allegations as their strict liability
manufacturing-defect claim, much of the Court’s analysis above is equally applicable
here. To the extent the duty of care owed and the breach of that duty derive from
federal law violations, Plaintiffs’ negligent-manufacture claim does not impose
different or additional requirements. This claim therefore survives preemption, at least
at this juncture. Again, however, if it appears that after the completion of discovery
Plaintiffs cannot maintain their negligent-manufacture claim based on state
requirements that parallel federal requirements, the Court may revisit the issue of
preemption at the summary judgment stage.
Page 31 of 38
Negligence per se
Count III of Plaintiffs’ Amended Complaint asserts a claim of negligence per
se and references a litany of federal regulations as defining the applicable standard of
care. Defendants argue that this claim fails for several reasons, principally because
Kentucky law does not recognize a negligence per se claim premised on a violation of
federal law. Plaintiffs seem to have conceded this point as they have not responded in
opposition to this argument.
Defendants are correct that a negligence per se claim premised on violations of
federal law is not cognizable under Kentucky law.
Kentucky Revised Statute
§ 446.070 codifies the common-law claim of negligence per se in Kentucky. 12 “In
accord with traditional legal principles related to the common-law concept of
negligence per se, the statute applies when the alleged offender violates a statute and
the plaintiff comes within the class of persons intended to be protected by the statute.”
St. Luke Hosp., Inc. v. Straub, 354 S.W.3d 529, 534 (Ky. 2011). However, “Kentucky
courts have held that the ‘any statute’ language in KRS 446.070 is limited to Kentucky
statutes and does not extend to federal statutes and regulations.” Young v. Carran, 289
S.W.3d 586, 589 (Ky. Ct. App. 2008) (citing T & M Jewelry, Inc. v. Hicks, 189 S.W.3d
526, 530 (Ky. 2006)); see also Pace v. Medco Franklin RE, LLC, 2013 WL 3233469,
at *2 (W.D. Ky. June 25, 2013); Cummings v. BIC USA, Inc., 2011 WL 1399768, at *3
(W.D. Ky. April 13, 2011). “The Kentucky General Assembly did not intend for KRS
446.070 to embrace the whole of federal laws and the laws of other states and thereby
Kentucky Revised Statute § 446.070 provides: “A person injured by the violation of any statute
may recover from the offender such damages as he sustained by reason of the violation, although a
penalty or forfeiture is imposed for such violation.”
Page 32 of 38
confer a private civil remedy for such a vast array of violations.” Hicks, 189 S.W.3d at
530; see also Alderman v. Bradley, 957 S.W.2d 265, 266 (Ky. Ct. App. 1997) (holding
that the “reach [of § 446.070] is limited to violations of Kentucky statutes and does
not extend to federal regulations”).
Thus, the law of Kentucky is clear that
“[v]iolations of federal laws and regulations and the law of other states do not create a
cause of action based on KRS 446.070.”
St. Luke Hosp., 354 S.W.3d at 534.
Accordingly, Plaintiffs’ negligence per se claim fails as a matter of law and will be
Negligent failure to warn
Count IV of Plaintiffs’ Amended Complaint alleges that Defendants had a
continuing duty to monitor the Riata leads after FDA approval and to discover and
report to the FDA any complaints and issues regarding the device’s performance of
which they became aware. Plaintiffs allege that Defendants breached that duty by
failing to provide timely and adequate postapproval reports, and by failing to conduct
adequate risk analyses and investigations regarding safety issues and potential defects.
Plaintiffs claim that they have suffered and continue to suffer injury as a direct result
of Defendants’ breach. Plaintiffs further allege that had Defendants complied with
their duties as required by federal law, this information would have reached the public,
including Plaintiffs and/or Mr. Waltenburg’s physicians, in time to prevent Plaintiffs’
Because the Court finds that Plaintiffs’ negligence per se claim is not cognizable under Kentucky
law, the Court need not address Defendants’ alternative argument that this claim is impliedly preempted
under 21 U.S.C. § 337(a) and Buckman.
Page 33 of 38
Defendants read Count IV as asserting two failure-to-warn theories: (1) that
Defendants had a continuing duty to provide ongoing warnings, and (2) that
Defendants had a continuing duty to monitor the device postapproval and to discover
and report to the FDA information about device safety and performance. (See Docket
No. 13-1, at 33.) Defendants argue that under either theory Plaintiffs’ failure-to-warn
claim is both expressly and impliedly preempted.
To state a parallel claim and avoid express preemption under § 360k(a),
Plaintiffs’ negligent failure-to-warn claim must not impose a state-law duty different
from, or in addition to, the federal-law duties under the MDA.
imposes a general duty on manufacturers and suppliers to warn of dangers known to
them but not known to persons whose use of the product can reasonably be
anticipated.” Watters v. TSR, Inc., 904 F.2d 378, 381 (6th Cir. 1990) (citing Garrison
v. Rohm & Haas Co., 492 F.2d 346, 352 (6th Cir. 1974); Post v. Am. Cleaning Equip.
Corp., 437 S.W.2d 516 (Ky. 1968)); see also Smith v. Parker-Hannifin Corp., 2014
WL 1418288, at *7 (W.D. Ky. Apr. 14, 2014). This duty may arise under general
negligence principles; however, “[a] defendant’s duty to warn is confined to risks
either known or knowable by the exercise of reasonable care.” Prather v. Abbott Labs,
960 F. Supp. 2d 700, 712 (W.D. Ky. 2013) (citing C & S Fuel, Inc. v. Clark Equip. Co.,
552 F. Supp. 340, 347 (E.D. Ky. 1982)). In Smith v. Louis Berkman Co., this Court
further recognized that the duty to warn may be ongoing:
A continuing duty to warn may arise after manufacture or
distribution, where something changes about the product, the
experience with its use, or the knowledge of the manufacturer or
user. This duty may arise if the manufacturer learns of significant
product failures . . . . The issue is whether the manufacturer knew
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of an increased risk for any reason. As a consequence, requiring
the manufacturer to undertake the duty to notify users of such
new developments may be warranted.
894 F. Supp. 1084, 1092 (W.D. Ky. 1995) (internal citation omitted) (citing Watters,
904 F.2d at 381). As for the federal requirements, after PMA approval, a manufacturer
of a Class III device is required to comply with certain medical-device-reporting
requirements. For instance, under 21 U.S.C. § 360i and 21 C.F.R. § 803.50, a device
manufacturer is required to report to the FDA device failures and adverse health events
of which the manufacturer is aware.
Plaintiffs argue that the reports required under the applicable federal
regulations are collected and published to the public so that both medical professionals
and the general public can obtain safety data on medical devices. Plaintiffs insist that
“through this procedure, the FDA imposes a duty to warn equivalent to that under
Kentucky law.” (Docket No. 16, at 17.) Defendants argue that Plaintiffs’ failure-towarn claim is expressly preempted because “the duty to submit adverse-event reports
to the FDA is not identical to the state law duty to warn doctors.” (Docket No. 13-1, at
Not surprisingly, courts have reached divergent results as to whether a failureto-report claim such as that alleged here will survive preemption under § 360k(a). For
example, in a thoroughly reasoned decision, the District of Minnesota concluded that
the plaintiffs’ failure-to-warn claim was expressly preempted because the state
common-law duty to warn was not equivalent to the federal duty to properly issue
reports to the FDA. See Pinsonneault v. St. Jude Med., Inc., 953 F. Supp. 2d 1006,
1015 (D. Minn. 2013). Contrarily, the Ninth Circuit, in an en banc decision also
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handed down last year, found that the plaintiffs’ negligent failure-to-warn claim was
not preempted because the claim was premised on a state-law duty that paralleled the
manufacturer’s duty under the MDA. See Stengel v. Medtronic Inc., 704 F.3d 1224,
1233 (9th Cir. 2013) (en banc), cert. denied, --- S. Ct. ---, 2014 WL 2807193 (June 23,
2014). The Ninth Circuit’s decision in Stengel comports with recent decisions by the
Fifth and Seventh Circuits. See Hughes v. Boston Scientific Corp., 631 F.3d 762, 769771 (5th Cir. 2011); Bausch, 630 F.3d at 555-58.
Upon reviewing the relevant caselaw, the Court finds particularly persuasive
the Ninth Circuit’s en banc decision in Stengel and the Fifth Circuit’s in Hughes v.
Boston Scientific Corp. Significantly, both of those decisions are clearly supported by
the Supreme Court’s decision in Lohr, which held that a state-law negligence claim
based on the manufacturer’s duty to warn about dangers of a medical device was
parallel and thus not preempted by § 360k(a). See 518 U.S. at 481, 501-02. Like the
plaintiffs in Stengel, Hughes, and Lohr, the Plaintiffs here assert a negligence claim
based on the manufacturer’s violation of the state-law duty to warn.
precedent set by those decisions, the Plaintiffs’ failure-to-warn claim will be
preempted only to the extent that it purports to impose liability despite Defendants’
compliance with FDA regulations. It follows that to the extent their claim is based on
Defendants’ failure to comply with FDA regulations, that claim is not preempted by
§ 360k(a). At this early stage of the litigation, the Court is satisfied that the Plaintiffs’
failure-to-warn claim does not impose any requirements different from, or in addition
to, the federal reporting requirements. Accordingly, to the extent their claim is based
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on Defendants’ violation of the applicable federal reporting requirements, the Court
finds that the Plaintiffs’ failure-to-warn claim is not expressly preempted.
The Court reaches a similar conclusion on the issue of implied preemption.
Again, there is certainly caselaw to support the argument that Plaintiffs’ failure-towarn claim is impliedly preempted under 21 U.S.C. § 337(a) and the Supreme Court’s
decision in Buckman. 14 See, e.g., Pinsonneault, 953 F. Supp. 2d at 1016-17. But, at
least at this juncture, the Court remains of the opinion that the most compelling
authorities on this issue are the Ninth and Fifth Circuit’s decisions in Stengel and
Hughes, respectively. Hughes concluded that a plaintiff’s negligent failure-to-warn
claim was not impliedly preempted because such a “claim is not analogous to the
‘fraud-on-the-FDA’ theory in Buckman” where the plaintiffs “were attempting to assert
a freestanding federal cause of action based on violations of the FDA’s regulations
[and] did not assert violation of a state tort duty.” Hughes, 631 F.3d at 775. Here,
much like the plaintiff in Hughes, Plaintiffs are alleging a recognized state tort claim
based on the underlying state-law duty to warn about the dangers or risks of a product.
They seek to prove Defendants’ breach of that duty by showing that Defendants
violated the applicable federal reporting requirements. As such, the Court is satisfied
that Plaintiffs’ claim is not impliedly preempted by § 337(a) as construed in Buckman.
Section 337(a) generally provides that all actions for enforcement or to restrain violations of the
FDCA “shall be by and in the name of the United States.” In Buckman, the Supreme Court held that the
plaintiffs’ claims were impliedly preempted by federal law, noting that “the FDA . . . has at its disposal
a variety of enforcement options,” and that “[t]he FDCA leaves no doubt that it is the Federal
Government rather than private litigants who are authorized to file suit for noncompliance with the
medical device provisions.” 531 U.S. at 348-49 & n.4 (interpreting 21 U.S.C. § 337(a)).
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Defendants move for dismissal of Plaintiffs’ final two claims for loss of
consortium and punitive damages on the basis that these claims are dependent on
Plaintiffs’ other claims. Because the Court will allow Plaintiffs’ claims for strict
liability manufacturing defect, negligent manufacture, and negligent failure to warn to
proceed, there is no basis to dismiss Plaintiffs’ derivative claims at this time.
Therefore, having considered Defendants’ Motion and being otherwise
sufficiently advised, consistent with the foregoing;
IT IS HEREBY ORDERED that Defendants’ Motion to Dismiss, (Docket
No. 13), is GRANTED IN PART and DENIED IN PART. Defendants’ Motion is
GRANTED as to Plaintiffs’ claim in Count III for negligence per se. Defendants’
Motion is DENIED with respect to Plaintiffs’ other claims.
IT IS SO ORDERED.
July 18, 2014
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