IN THE UNITED STATES DISTRICT COURT

FOR THE SOUTHERN DISTRICT OF OHIO

EASTERN DIVISION

CHRISTOPHER HAWKINS,

Plaintiff,

v.

MEDTRONIC, INC., et al.

Defendants.

Case No. 2:11-cv-1037

Judge Peter C. Economus

MEMORANDUM OPINION AND ORDER

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.

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.

Controlling Questions of Law

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II.

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the great weight of other authority while applying outdated and superseded legal standards that 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Court’s decision in Medtronic, Inc. v. Lohr, 518 U.S. 470, 474 (1996), sets forth “outdated and 

superseded legal standards” because it was decided prior to Riegel v. Medtronic, Inc., 552 U.S. 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.

Substantial Ground for Difference of Opinion

A.

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. 

Preemption Test

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

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.”).) 

. Id. at 330.

 

1 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.

In Lohr, the Supreme Court held:

Pleading Standard

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

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). 

. 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.”

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.

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.

Advancement of Litigation

IV.

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.)

Conclusion

IT IS SO ORDERED.

UNITED STATES DISTRICT JUDGE

/s/ Peter C. Economus

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