Hawkins v. Medtronic, Inc. et al

Filing 42

OPINION AND ORDER denying 33 Motion to certify the Order for interlocutory appeal, or alternatively to reconsider the Order. Signed by Senior Judge Peter C Economus on 12/6/12. (jr1)

IN THE UNITED STATES DISTRICT COURT
FOR THE SOUTHERN DISTRICT OF OHIO
EASTERN DIVISION
CHRISTOPHER HAWKINS,
Plaintiff,
v.

Case No. 2:11-cv-1037
Judge Peter C. Economus

MEDTRONIC, INC., et al.

MEMORANDUM OPINION AND ORDER

Defendants.

Plaintiff Christopher Hawkins filed this action claiming that he was injured by a medical
device made by Defendant Medtronic, Inc. A more detailed background is set forth in this
Court’s September 24, 2012 Opinion and Order (the “Order”), in which the Court granted in part
Defendant’s Motion to Dismiss, dismissing Claims Three, Five, and Six. The Court denied the
motion as to Claim One (design and manufacturing defects), Claim Two (failure to warn), and
Claim Four (breach of warranty). This matter is before the Court on Defendant’s motion to
certify the Order for interlocutory appeal, or alternatively to reconsider the Order. (Dkt. 33.) For
the reasons that follow, Defendant’s motion is DENIED.
For an order to be appropriate for interlocutory appeal, this Court must find that it
“involves a controlling question of law as to which there is substantial ground for difference of
opinion,” and an immediate appeal “may materially advance the ultimate termination of the
litigation.” 28 U.S.C. § 1292(b).
I.

Controlling Questions of Law
Defendant correctly asserts that the Order involves the controlling and potentially fully

dispositive legal questions of federal preemption and adequacy of pleading. Plaintiff does not
address this issue in his response.

II.

Substantial Ground for Difference of Opinion
Defendant asserts that “the Order relies upon an interpretation of law that is contrary to

the great weight of other authority while applying outdated and superseded legal standards that
are not applicable in this case.” (Reply 10.) Defendant apparently argues that the Supreme
Court’s decision in Medtronic, Inc. v. Lohr, 518 U.S. 470, 474 (1996), sets forth “outdated and
superseded legal standards” because it was decided prior to Riegel v. Medtronic, Inc., 552 U.S.
312, 330 (2008); Bell Atl. Corp. v. Twombly, 550 U.S. 544, 570 (2007); and Ashcroft v. Iqbal,
129 S. Ct. 1937 (2009). Defendant makes two primary arguments: (A) that the “parallel claims”
standard set forth in Lohr does not apply here and (B) that the pleading standard applied in Lohr
no longer applies in light of Twombly and Iqbal. This Court cited each of those decisions in its
Order, setting forth the relevant and applicable holdings, but it will nonetheless revisit them here.
A.

Preemption Test

In Lohr, the Supreme Court held that the preemption provision of the Medical Device
Amendments of 1976 (“MDA”), contained in 21 U.S.C. § 360k(a), “simply was not intended to
pre-empt most, let alone all, general common-law duties enforced by damages actions.” Lohr,
518 U.S. at 491. The device at issue in Lohr was approved through the “§ 510(k) process,”
which bypassed the more rigorous process known as “premarket approval” or “PMA.” As the
Supreme Court summarized in Riegel, the Lohr Court “rejected the . . . contention that § 510(k)
approval imposed device-specific ‘requirements.’” Riegel, 552 U.S. at 322.
In Riegel, the Court more explicitly set forth the test to determine whether a state
requirement is pre-empted. Consistent with its analysis in Lohr, the Court held that it first “must
determine whether the Federal Government has established requirements applicable to” the
device in question. Riegel, 552 U.S. at 321. While the Court had determined in Lohr that

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§ 510(k) devices did not satisfy this first condition of preemption, it held in Riegel that the PMA
process, “in contrast, imposes ‘requirements’ under the MDA as we interpreted it in Lohr.”
Riegel, 552 U.S. at 322. Thus, § 510(k) devices do not satisfy the first condition of preemption,
but PMA devices automatically satisfy this first condition of the preemption test. Riegel, 552
U.S. at 322–23.
If the federal requirements satisfy the first condition, the Court “must then determine
whether [the plaintiff’s] common-law claims are based upon [state] requirements with respect to
the device that are ‘different from, or in addition to,’ the federal ones, and that relate to safety
and effectiveness.” Riegel, 552 U.S. at 321–22 (quoting § 360k(a)). The Court notes that
Defendant’s motion to dismiss misrepresented the Supreme Court’s holding in Riegel. 1 The
Riegel Court in fact held that the state law “duties underlying negligence, strict-liability, and
implied-warranty claims” were requirements subject to potential preemption. See Riegel, 552
U.S. at 327–28. However, the Court did not address whether such requirements in that case were
“different from, or in addition to” the federal requirements, and therefore preempted, because the
plaintiffs had not argued below that the state requirements were parallel to the federal
requirements. Id. at 330.
Defendant focuses on the difference between Lohr and Riegel, specifically on the
question of whether the device was approved under § 510(k) or the PMA process.

This

difference is most obviously relevant to the first condition of preemption, which Defendant
correctly concedes is satisfied. (Dkt. 16-1 at 4 (“Claims involving a PMA-approved device
automatically satisfy [this] first condition of the preemption test.”).)

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As this Court noted in its Order, “[a]ccording to Defendant, the Riegel Court held that ‘the MDA pre-empt[s]
claims of . . . breach of implied warranty.’ (Dkt. 16-1 at 10 (quoting Riegel, 552 U.S. at 320–21).) Defendant again
takes a quote out of context; the Riegel Court was merely stating the lower court’s ruling.”

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Because this case involves a PMA device, automatically satisfying the first prong of the
test, this second inquiry is the real focus of the Court’s analysis: “whether [the plaintiff’s]
common-law claims are based upon [state] requirements with respect to the device that are
‘different from, or in addition to,’ the federal ones, and that relate to safety and effectiveness.”
Riegel, 552 U.S. at 321–22 (quoting § 360k(a)). Defendant suggests that this Court applied an
“outdated” “parallel claim” standard from Lohr, asserting that Riegel instead sets forth the
standard applicable to PMA devices. However, as noted above, the only reason that the Riegel
Court did not discuss whether the state requirements were different from, or parallel to, the
federal requirements is that the plaintiffs in that case had not raised the issue below:
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, 116 S.Ct. 2240; see also id., at 513, 116
S.Ct. 2240 (O'Connor, J., concurring in part and dissenting in part).
. . . Although the Riegels now argue that their lawsuit raises
parallel claims, they made no such contention in their briefs before
the Second Circuit, nor did they raise this argument in their
petition for certiorari. We decline to address that argument in the
first instance here.
Riegel, 552 U.S. at 330 (emphasis added). The Riegel Court did not change the character of the
second inquiry set forth in Lohr—what Defendant refers to as the “parallel claims” test.
Considering that that the Riegel Court explicitly declined to reach the issue as a procedural
matter, it is difficult to understand any possible basis for Defendant’s argument that Riegel
changed the standard.

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B.

Pleading Standard

In Lohr, the Supreme Court held:
Although the precise contours of their theory of recovery have not
yet been defined (the pre-emption issue was decided on the basis
of the pleadings), it is clear that the Lohrs’ allegations may include
claims that Medtronic has, to the extent that they exist, violated
FDA regulations. At least these claims, they suggest, can be
maintained without being pre-empted by § 360k, and we agree.
Lohr, 518 U.S. at 495. Defendant correctly points out that Lohr (decided in 1996) was decided
before Twombly and Iqbal (decided in 2007 and 2009, respectively). This Court finds that Lohr
can be applied consistent with Twombly and Iqbal, however, and again notes its agreement with
the Western District of Kentucky that:
In the context of MDA preemption, Twombly and Iqbal make a
plaintiff’s job more difficult than it would be in a typical product
liability case. When facing MDA preemption, a plausible cause of
action requires, among other things, a showing that the alleged
violation of state law parallels a violation of federal law. This
additional step requires some greater specificity in the pleadings.
However, our appellate courts have been unable to agree upon the
precise level of that specificity. Nonetheless, . . . a plaintiff must
provide “more than labels and conclusions, and a formulaic
recitation of the elements of a cause of action will not do.”
White v. Stryker Corp., 818 F. Supp. 2d 1032, 1037 (W.D. Ky. March 25, 2011) (quoting
Twombly, 550 U.S. at 555) (emphasis added).
There may be room for disagreement as to the precise level of specificity required by
Twombly and Iqbal. However, the Court finds that Plaintiff has met the level of specificity
which reasonably may be expected prior to discovery, and which is both consistent with Lohr
and is sufficient “to ‘state a claim to relief that is plausible on its face.’” Iqbal, 129 S. Ct. at
1949 (quoting Twombly, 550 U.S. at 570).

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III.

Advancement of Litigation
Defendant asserts that “an appeal would materially advance this litigation because it has

the potential to ultimately terminate and resolve this action prior to the parties engaging in costly
and lengthy discovery, retaining experts, filing dispositive motions and proceeding to a jury
trial.” (Mot. 11.) Plaintiff, on the other hand, seeks “the opportunity to investigate why”
Defendant’s device malfunctioned and asserts that Defendant merely “seeks a second chance to
avoid engaging in any discovery.” (Resp. 2, 3.) If the Court believed that an interlocutory
appeal would likely result in this case’s dismissal, this factor would weigh in favor of Defendant.
For the reasons discussed above, however, an appeal is unlikely to materially advance this
litigation, but would rather likely delay it unnecessarily.
IV.

Conclusion
As discussed above, the Order involves controlling and potentially fully dispositive legal

questions. While there is some room for debate as to the applicable legal standards, the Order is
based on controlling Supreme Court precedent, and this Court does not believe that the ground
for difference of opinion is substantial enough to warrant an interlocutory appeal. Such an
appeal would not, in this Court’s opinion, be likely to materially advance this litigation. For
these reasons, Defendant’s Motion is DENIED. (Dkt. 33.)
IT IS SO ORDERED.

/s/ Peter C. Economus
UNITED STATES DISTRICT JUDGE

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