Vincent v. Medtronic et al

Filing 37

MEMORANDUM Opinion and Order. Signed by the Honorable Manish S. Shah on 12/20/2016: Medtronic's motion to dismiss, 26 , is granted. Vincent's complaint is dismissed without prejudice. [For further detail see attached order.] A status hearing is set for 1/11/17 at 9:30 a.m. Notices mailed by Judicial Staff.(psm, )

UNITED STATES DISTRICT COURT
FOR THE NORTHERN DISTRICT OF ILLINOIS
EASTERN DIVISION
KIRK VINCENT,
Plaintiff,

No. 16 CV 02990

v.
MEDTRONIC, INC. and MEDTRONIC
USA, INC.,

Judge Manish S. Shah

Defendants.
MEMORANDUM OPINION AND ORDER
Plaintiff Kirk Vincent underwent a procedure to implant in his chest a
pacemaker and a pacemaker lead, which was designed, manufactured, and sold by
defendants Medtronic, Inc. and Medtronic USA, Inc. Ten years later, the pacemaker
lead had broken down, and Vincent had it removed. He claims the lead was
defective and had not been approved by the United States Food and Drug
Administration. Vincent filed this lawsuit seeking relief based on the Illinois
Consumer Fraud and Deceptive Business Practices Act and theories of strict
liability, negligence, and breach of express warranty. Defendants move to dismiss
Vincent’s claims. For the following reasons, the motion is granted.
I.

Legal Standards
To survive a motion to dismiss under Rule 12(b)(6), a complaint must contain

factual allegations that plausibly suggest a right to relief. Virnich v. Vorwald, 664
F.3d 206, 212 (7th Cir. 2011) (quoting Bell Atl. Corp. v. Twombly, 550 U.S. 554, 558
(2009)). “The purpose of a motion to dismiss is to test the sufficiency of the

complaint, not to decide the merits.” Triad Assocs., Inc. v. Chicago Hous. Auth., 892
F.2d 583, 586 (7th Cir. 1989). On a 12(b)(6) motion, a court may only consider
allegations in the complaint, documents attached to the complaint, documents that
are both referred to in the complaint and central to its claims, and information that
is subject to proper judicial notice. Geinosky v. City of Chicago, 675 F.3d 743, 745
n.1 (7th Cir. 2012). Executive and agency determinations are subject to judicial
notice and may be considered even if not mentioned in the complaint. Houston v.
United States, 638 F.App'x 508, 514 (7th Cir. 2016) (citing Fornalik v. Perryman,
223 F.3d 523, 529 (7th Cir. 2000)). A court must construe all factual allegations as
true and draw all reasonable inferences in the plaintiff’s favor, but a court need not
accept legal conclusions or conclusory allegations. Virnich, 664 F.3d at 212 (citing
Ashcroft v. Iqbal, 556 U.S. 662, 680–82 (2009)).
II.

Background
On February 12, 2004, plaintiff Kirk Vincent, diagnosed with intermittent

complete heart block, underwent surgery to install a pacemaker. [18] ¶ 9.1 The
pacemaker was connected to his heart with a screw-in pacemaker lead, a device
designed, manufactured, marketed, and sold by defendants Medtronic, Inc. and
Medtronic USA, Inc.2 [18] ¶¶ 9, 11. Medtronic represented in its marketing and
labeling that the lead, identified by model number 5076, had been approved by the
FDA as a “Class III” device through its premarket approval procedure. [18] ¶¶ 13,
Bracketed numbers refer to entries on the district court docket. The operative complaint is
[18].
1

Any distinction between the Medtronic entities is immaterial to the present motion, so
they will be referred to collectively as “Medtronic.”
2

2

14. But Medtronic did not tell Vincent or his treating physicians that it had
submitted the lead for supplemental approval just two days before the surgery, and
did not receive that approval until March 10. [18] ¶¶ 12, 14. The procedure was a
success, and Vincent experienced no complications. [18] ¶ 17.
Ten years later, however, Vincent discovered that the lead had fractured and
needed to be removed. [18] ¶ 18. He underwent two more surgeries to remove the
lead fragments and repair some of the damage they caused, but Vincent now has
permanent heart damage. [18] ¶¶ 19, 26–27. Vincent alleges that the lead’s
fragmentation resulted from defects in its design and manufacture. [18] ¶¶ 21–23.
Vincent also alleges that, before the surgery, Medtronic knew the lead carried a risk
of malfunctioning and fracturing, but failed to provide sufficient warnings of that
risk. [18] ¶ 15.
Vincent originally filed a complaint alleging a claim for “Product Liability,”
see [1], and Medtronic filed a motion to dismiss arguing that Vincent’s claims were
inadequately plead and preempted by federal law. See [13]. In response to that
motion, Vincent amended the complaint to include allegations that the lead had not
received FDA approval at the time of the initial procedure, and that Medtronic
failed to tell Vincent or his doctors of that fact. See [18]. The amended complaint
also alleges a claim for “Strict liability” rather than the original “Product Liability,”
and adds claims for “Negligence,” “Breach of Express Warranty,” and “Illinois
[Consumer] Fraud and Deceptive Business Practices.” See [18].3 In response to

Jurisdiction arises under 28 U.S.C. § 1332, because there is complete diversity between
the parties—Vincent is a citizen of Indiana, and the two Medtronic entities are citizens of
3

3

Medtronic’s arguments that Vincent failed to plausibly allege the breach of express
warranty and consumer fraud claims, Vincent agrees to the dismissal of those
claims without prejudice. See [31] at 3 n.5. Those claims are therefore dismissed
without further discussion.
III.

Analysis
Medtronic argues that Vincent’s state-law claims are preempted by the

Medical Device Amendments Act of 1976, 21 U.S.C. § 360c et seq., which amended
the Food, Drug and Cosmetic Act and established FDA oversight for medical
devices. “Class III” devices are those “purported or represented to be for a use in
supporting or sustaining human life or for a use which is of substantial importance
in preventing impairment of human health,” or “presents a potential unreasonable
risk of illness or injury.” 21 U.S.C. § 360c(a)(1)(C)(ii). Class III devices must undergo
a “rigorous” premarket approval process, in which a manufacturer typically submits
a multivolume application that the FDA spends an average of 1,200 hours
reviewing. Riegel v. Medtronic, Inc., 552 U.S. 312, 317–18 (2008). Once a device has
received premarket approval, the Act forbids the manufacturer to make any
changes to the device that would affect safety or effectiveness without FDA
permission; such changes are subject to a supplemental premarket approval
application. Riegel, 552 U.S. at 319; 21 U.S.C. § 360e(d)(6). That supplemental
application is “evaluated under largely the same criteria as an initial application.”

Minnesota—and the amount in controversy exceeds $75,000. [18] ¶¶ 1–3, 6. The events
giving rise to this suit occurred in this district, and no objection has been raised as to
venue. [18] ¶ 4.

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Riegel, 552 U.S. at 319 (citing 21 U.S.C. § 360e(d)(6); 21 CFR § 814.39(c)). “[T]he
FDA requires a device that has received premarket approval to be made with
almost no deviations from the specifications in its approval application, for the
reason that the FDA has determined that the approved form provides a reasonable
assurance of safety and effectiveness.” Riegel, 552 U.S. at 323.
The Act also contains a preemption provision. 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 any other matter included in a requirement
applicable to the device under this chapter.” 21 U.S.C. § 360k(a). Under this
provision, common-law claims for negligence and strict liability against medical
device manufacturers are expressly preempted if: (1) there are federal requirements
applicable to the device in question (which may take the form of the specifications
approved by the FDA during the premarket approval process), and (2) the commonlaw claims are based on state requirements that are different from, or in addition
to, those requirements and relate to safety and effectiveness. Riegel, 552 U.S. at
321–22. But § 360k does not bar state-law claims that are based on violations of
federal regulations, since the state-imposed duties in those claims “parallel” the
federal requirements. Bausch v. Stryker Corp., 630 F.3d 546, 552 (7th Cir. 2010); see
also Riegel, 552 U.S. at 330 (quoting Medtronic, Inc. v. Lohr, 518 U.S. 470, 495
(1996)).

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In addition to the express preemption provision, state-law claims are also
subject to implied preemption under the Act. See Buckman Co. v. Plaintiffs' Legal
Comm., 531 U.S. 341, 353 (2001). “Fraud-on-the-agency” claims rooted in violations
of federal administrative and reporting requirements, but not traditional state tort
law, are impliedly preempted. Id. at 353. To escape both express and implied
preemption, state-law claims must fit within a “narrow gap.” Bausch, 630 F.3d at
557–58 (quoting In re Medtronic, Inc., Sprint Fidelis Leads Prods. Liab. Litig., 623
F.3d 1200, 1204 (8th Cir. 2010)). “The plaintiff must be suing for conduct that
violates the [Food, Drug, and Cosmetic Act] (or else his claim is expressly
preempted by § 360k(a)), but the plaintiff must not be suing because the conduct
violates the [Food, Drug, and Cosmetic Act] (such a claim would be impliedly
preempted under Buckman ).” Id. (emphasis and alterations in original). In other
words, a state-law claim survives preemption if it alleges a violation of the Act in
the context of a pre-existing, “well-recognized duty owed to [the plaintiff] under
state law.” Bausch, 630 F.3d at 558.
Medtronic argues that Vincent’s claims are expressly preempted because the
lead received approval from the FDA under its premarket approval process, and
Vincent does not explicitly allege that the lead failed to meet its FDA-approved
specifications. Medtronic requests that judicial notice be taken of the facts that the
FDA granted premarket approval to an earlier version of the lead and multiple
supplemental premarket approvals as Medtronic modified the lead throughout the
years, including the August 31, 2000 supplemental premarket approval of the model

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5076 lead.4 Vincent does not object and, as publicly-available government agency
determinations that appear on an agency website, these approvals by the FDA are
subject to judicial notice. See Funk v. Stryker Corp., 631 F.3d 777, 783 (5th Cir.
2011). According to Medtronic, if the lead satisfied the requirements established by
the FDA in its premarket approval of the device (in either its original or modified
form), then Vincent could prevail on his claims only if a jury found that state law
imposed requirements that are different from, or in addition to, those federal
requirements. Such claims are expressly preempted.
Vincent responds that preemption does not apply to the lead at issue because
the FDA did not issue its approval of the device until after his surgery. He argues
that preemption does not apply because Medtronic waived its preemption defense
by failing to comply with 21 C.F.R. § 814.39, which provides the procedure of
obtaining supplemental premarket approval of a device when making changes that
affect the safety or effectiveness of that device. Vincent cites to a number of cases
for the proposition that parties are not entitled to statutory rights unless they
comply with the applicable statutory prerequisites, but this principle is not about
waiver of federal preemption. Medtronic’s compliance with regulations may bear on
whether the claim is preempted, but that conduct does not waive the congressional
determination to preempt state law.

The FDA’s March 1996 premarket approval of an earlier model of the lead can be found at
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P930039, and the
August 31, 2000 supplemental premarket approval of the model 5076 lead can be found at
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P930039S009.
4

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Waiver aside, the parties dispute whether Medtronic’s failure to obtain FDA
approval for the lead before the surgery means that all state-law claims related to
that lead necessarily escape preemption. At least one court has found that strict
liability and negligence claims were not preempted when the medical device at issue
was not approved by the FDA at the time the device was used. See Mears v.
Marshall, 944 P.2d 984 (Or.Ct.App. 1997). In Mears, the court reasoned that, before
premarket approval or supplemental premarket approval, no federal requirements
applied to the device, so state-law claims were not preempted. Id. at 992. Medtronic
notes that Mears predates Buckman, and argues that a claim about a device used
during an interim period between premarket and supplemental premarket approval
is better thought of as a claim based on a failure to adhere to 21 C.F.R. § 814.39.
Such a claim is about distributing a modified device without complying with the
procedure for obtaining FDA-approval for that modification, and would amount to
enforcement of an FDA requirement without implicating a common-law duty. That
kind of action may be brought by the FDA alone. See 21 U.S.C. § 337(a); Buckman,
531 U.S. at 349 n.4.
Medtronic is correct that the lead was subject to FDA regulations, which
satisfies the first part of the Riegel test. Even though the surgery took place before
Medtronic obtained supplemental premarket approval for the specific iteration of
the lead at issue, Vincent’s contention that no federal requirements applied to the
lead is incorrect. The original premarket approval process, along with any
supplemental premarket approvals obtained prior to the surgery, established

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federal requirements in the form of FDA-approved specifications and procedures.
Riegel, 552 U.S. at 322–23. Obtaining supplemental premarket approval for a
change in the lead’s specifications might change those requirements, but failing to
obtain that approval would not cause previously established requirements to simply
evaporate. See McMullen v. Medtronic, 421 F.3d 482, 487–88 (7th Cir. 2005)
(holding that federal requirements applied to a Class III medical device even though
defendant failed to comply with post-premarket approval requirements imposed by
the FDA). Mears is not persuasive. At the time of the surgery, federal requirements
applied to the lead, even though supplemental premarket approval was pending at
the time, and the preemptive effect of those requirements must be considered.
Vincent’s strict liability and negligence claims are both expressly and
impliedly preempted. Vincent alleges that the lead was unreasonably dangerous
due to its defective design and defective manufacture, and that Medtronic failed to
provide adequate warnings of the lead’s defective condition, risk of failure, and
FDA-approval status. But Vincent does not allege that Medtronic violated any
federal regulations in designing, manufacturing, or labeling the lead, or that such a
violation caused him injury. The only violation of federal regulations that Vincent
alleges is the failure to comply with procedures governing supplemental premarket
approval of a device. See 21 C.F.R. § 814.39. And Vincent does not allege that
Medtronic’s premature distribution of the lead breached any recognized state-law
duties or injured him in any way. As a result, Vincent’s claims do not fit into the
narrow gap between express and implied preemption. Because Vincent’s state-law

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claims are not based on violations of federal law, but instead assert violations of
state tort law “notwithstanding compliance with the relevant federal requirements,”
Riegel, 552 U.S. at 330, they are expressly preempted by 21 U.S.C. § 360k. To the
extent that Vincent brings claims based solely on Medtronic’s noncompliance with
the FDA’s supplemental premarket approval procedures, those claims are impliedly
preempted.
Medtronic emphasizes the fact that the lead received supplemental
premarket approval shortly after the surgery, suggesting that, because the
modification was eventually approved, state-law claims based upon that
modification are preempted. But that is not necessarily true. If the modification
made to the lead required FDA approval for the lead to conform to the FDA’s
standards of safety and effectiveness, then until that approval is given, that
modification is not incorporated into the applicable federal requirements. A jury
could be presented with a negligence claim based on that modification (and no
other, approved aspect of the device) and impose liability. If Vincent alleged that he
were harmed by a deviation from the FDA-approved specifications in place at the
time of the surgery, even if that deviation were the modification itself, he would be
alleging harm based on a violation of applicable federal law, and his claim would
escape preemption. But the complaint cannot be read to make such an allegation, so
Vincent’s claims are preempted.
While “[p]reemption is an affirmative defense, and pleadings need not
anticipate or attempt to circumvent affirmative defenses,” Bausch, 630 F.3d at 561

10

(citations omitted), Vincent does not object to Medtronic’s raising of the issue on its
Rule 12(b)(6) motion and instead requests an opportunity to amend his complaint.
Medtronic requests dismissal of the complaint with prejudice, because Vincent
already had one opportunity to amend his complaint in response to Medtronic’s first
motion to dismiss. Medtronic’s request is denied. Vincent’s complaint is dismissed
without prejudice, and he has leave to amend his complaint to articulate a claim
that is not preempted.
IV.

Conclusion
Medtronic’s motion to dismiss, [26], is granted. Vincent’s complaint is

dismissed without prejudice.
ENTER:
___________________________
Manish S. Shah
United States District Judge
Date: 12/20/16

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