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. In his Amended Complaint, Plaintiff alleges that the

device, a Medtronic Implantable Pulse Generator, Model #7425 (hereinafter “IPG”), was 

defective and had to be replaced due to Defendant’s failure to satisfy its obligations under the 

Federal Food, Drug, and Cosmetic Act, as amended by the Medical Device Amendments of 

1976, 21 U.S.C. § 301 et seq. (Am. Compl. ¶ 39.) Plaintiff filed this action asserting various 

causes of action under Ohio law. This matter is before the Court for consideration of 

Defendant’s Motion to Dismiss. (Dkt. 16.) For the reasons set forth below, the Court hereby 

GRANTS IN PART and DENIES IN PART Defendant’s Motion.

I.

Plaintiff asserts the following facts. On October 15, 2009, the IPG was surgically 

implanted into Plaintiff’s back. The IPG is designed to send electrical pulses to the spinal cord 

in order to interfere with the transmission of pain signals and replace them with a tingling 

sensation called parasthesia. (Am. Compl. ¶ 9.) For a few months, the IPG worked as expected. 

(Id. at ¶ 12.) However, in late December 2009 or early January 2010, Plaintiff began 

experiencing painful shocks at the implant site, even when he occasionally turned off the device 

in an attempt to alleviate the shocks. (Id. at ¶¶ 13–14.) On numerous occasions, Plaintiffs’ 

Background

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doctors, with the assistance of a Medtronic agent, unsuccessfully attempted to fix the IPG. (Id. at 

¶¶ 15–16.) On March 22, 2010, Plaintiff’s doctor, after consulting with a Medtronic agent, 

determined that the IPG needed to be replaced. (Id. at ¶ 17.) On March 31, 2010, the IPG was 

excised and replaced by a new model. (Id. at ¶ 18.)

II.

Congress enacted the Medical Device Amendments of 1976 (“MDA”) “to provide for the 

safety and effectiveness of medical devices intended for human use.” Medtronic, Inc. v. Lohr, 

518 U.S. 470, 474 (1996) (quoting 90 Stat. 539). The MDA “classifies medical devices in three 

categories based on the risk that they pose to the public.” Id. at 477. Class I devices present no 

unreasonable risk of illness or injury and are subject to minimal regulation. Id. at 477–78 (citing 

21 U.S.C. § 360c(a)(1)(A)). Class II devices are potentially more harmful and must comply with 

increased regulation but may be marketed without advance approval. Id. at 478 (citing 21 U.S.C. 

§ 360c(a)(1)(B)). Class III devices either “present[] a potential unreasonable risk of illness or 

injury” or are “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.” Id. at 

478 (citing § 360c(a)(1)(C). Before a manufacturer may introduce a new Class III device to the 

market, the manufacturer must provide the FDA with a “reasonable assurance” that the device is 

safe and effective through a rigorous process known as “premarket approval” or “PMA.” Id. at 

478 (citing 21 U.S.C. § 360e(d)(2)).

Preemption Under The Medical Device Amendments 

At issue in this case is the preemption provision of the MDA, contained in 21 U.S.C. 

§ 360k(a), which provides generally1

. . . no State . . . may establish or continue in effect with respect to 

a device intended for human use any requirement—

that:

 

1 Section 360k(b) provides that exemptions may be granted to states under certain circumstances.

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(1) which is different from, or in addition to, any 

requirement applicable under this Act 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 Act.

The Supreme Court has held that this provision “simply was not intended to pre-empt most, let 

alone all, general common-law duties enforced by damages actions.” Medtronic, Inc. v. Lohr, 

518 U.S. 470, 491 (1996).2

[s]tate 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. 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.

 Rather, 

Riegel v. Medtronic, Inc., 552 U.S. 312, 330 (2008) (citing § 360k(a)(1); Lohr, 518 U.S. at 495). 

In fact, the Supreme Court has noted that “[t]he presence of a damages remedy does not amount 

to [an] additional or different ‘requirement’ . . . ; rather, it merely provides another reason for 

manufacturers to comply with identical existing ‘requirements’ under federal law.” Lohr, 518 

U.S. at 495.

To determine whether a state requirement is pre-empted, the Court first “must determine 

whether the Federal Government has established requirements applicable to” the device in 

question. Riegel, 552 U.S. 312, 321 (2008) (quoting § 360k(a)). The Supreme Court has 

interpreted § 360k(a) “in a manner ‘substantially informed’ by the FDA regulation set forth at 21 

CFR § 808.1(d),” which regulation states that “state requirements are pre-empted ‘only when the 

Food and Drug Administration has established specific counterpart regulations or there are other 

 

2 In Lohr, Medtronic “argue[d] that the plain language of the statute pre-empts any and all common-law claims 

brought by an injured plaintiff against a manufacturer of medical devices.” Lohr, 518 U.S. at 486. The Court found 

that, under Medtronic’s view of the statute, “Congress would have barred most, if not all, relief for persons injured 

by defective medical devices,” with the “perverse effect of granting complete immunity from design defect liability 

to an entire industry that, in the judgment of Congress, needed more stringent regulation.” Id. at 487.

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specific requirements applicable to a particular device.” Riegel, 552 U.S. at 322 (citing Lohr, 

518 U.S. at 495, 500–01); 21 CFR § 808.1(d). 

Defendant correctly points out that “[c]laims involving a PMA-approved device 

automatically satisfy [this] first condition of the preemption test.” (Dkt. 16-1 at 4.) In Riegel, 

the Supreme Court held that PMA “imposes ‘requirements’ under the MDA as [that Court] 

interpreted it in Lohr” because, “[u]nlike general labeling duties, [PMA] is specific to individual 

devices.” Riegel, 552 U.S. at 322–23.

If the federal requirements satisfy the first condition of the preemption test, 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)). “[R]eference to a State’s ‘requirements’ includes its common-law duties,” including, 

for example, common-law causes of action for negligence and strict liability. Riegel, 552 U.S. at 

323–24 (citing Lohr, 518 U.S. at 512). As noted above, because “[s]tate requirements are preempted under the MDA only to the extent that they are ‘different from, or in addition to’ the 

[federal] requirements.” Riegel, 552 U.S. at 330 (citing § 360k(a)(1); Lohr, 518 U.S. at 495). 

Where the preemption issue is decided on the pleadings, and the complaint has not 

defined “the precise contours of [the plaintiff’s] theory of recovery,” but “it is clear that the . . . 

allegations may include claims that [the defendant] has, to the extent that they exist, violated 

FDA regulations,” the Supreme Court has held that these claims “can be maintained without 

being pre-empted by § 360k.” Lohr, 518 U.S. at 495.

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III.

Defendant seeks dismissal under Federal Rule of Civil Procedure 12(b)(6), which 

requires dismissal if the complaint fails to state a claim upon which relief can be granted. While 

Rule 8(a)(2) requires a pleading to contain a “short and plain statement of the claim showing that 

the pleader is entitled to relief,” in order “[t]o survive a motion to dismiss, a complaint must 

contain sufficient factual matter, accepted as true, to ‘state a claim to relief that is plausible on its 

face.’” Ashcroft v. Iqbal, 129 S. Ct. 1937, 1949 (2009) (quoting Bell Atl. Corp. v. Twombly, 550 

U.S. 544, 570 (2007)). Furthermore, “[a]lthough for the purposes of a motion to dismiss [a 

court] must take all of the factual allegations in the complaint as true, [it] [is] not bound to accept 

as true a legal conclusion couched as a factual allegation.” Id., 129 S. Ct. at 1949–50 (quoting 

Twombly, 550 U.S. at 555) (internal quotations omitted). 

Standard of Review

The context of MDA preemption affects the application of this standard, as explained by

the Western District of Kentucky:

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). However, as noted above, the Supreme Court has 

held 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. 

Lohr, 518 U.S. at 495.

. 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.”

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IV.

Because Plaintiff’s claims involve a PMA-approved device and therefore satisfy the first 

condition of preemption, the Court moves on to determine whether each claim against Defendant 

Medtronic is based on a parallel state requirement or one that is “different from, or in additional 

to” the federal requirements.

Plaintiffs’ Claims

A.

In Count One, Plaintiff alleges that Defendant “designed, manufactured, distributed and 

sold the IPG [], an unreasonably dangerous, malfunctioning, and defective product to Ohio 

consumers, including Plaintiff Hawkins.” (Am. Compl. 41.) Plaintiff alleges that the IPG 

“contained a design and/or manufacturing defect, was adulterated, failed to comply with PreMarket Approval specifications, was not safe and/or effective, was non-conforming, and/or 

violated performance standards.” (Id. at 43.) Plaintiff alleges that this “defect rendered [the 

IPG] more dangerous than an ordinary consumer would expect when used in an intended or 

reasonably foreseeable manner.” (Id.) Plaintiff alleges that Defendant has therefore violated the 

statutes and regulations listed below and is strictly liable for the resulting injuries (id. at 43, 44):

Count One: Design and Manufacturing Defects

i. The following sections of the Ohio Revised Code:

a. Section 2307.74, which provides that “[a] product is defective in manufacture 

or construction if, when it left the control of its manufacturer, it deviated in a 

material way from the design specifications, formula, or performance 

standards of the manufacturer, or from otherwise identical units manufactured 

to the same design specifications, formula, or performance standards.” 

b. Section 2307.75, which provides generally that “a product is defective in 

design or formulation if, at the time it left the control of its manufacturer, the 

foreseeable risks associated with its design or formulation . . . exceeded the 

benefits associated with that design or formulation.” 

ii. The MDA, including but not limited to the following sections of Title 21 of the U.S. 

Code:

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a. Section 351, which describes the circumstances under which a “device shall 

be deemed to be adulterated.”

b. Section 360(e), by which the Court assumes Plaintiff meant § 360e, which sets 

forth the rules regarding the PMA process.

c. Section 360(d), by which the Court assumes Plaintiff meant § 360d, which 

sets forth the rules regarding performance standards.

d. Section 360(h), by which the Court assumes Plaintiff meant § 360h, which 

sets forth the rules regarding the FDA’s authority to issue notifications 

regarding unsafe devices and provide other remedies.

iii. The following sections of Title 21 of the Code of Federal Regulations: 

a. Section 820.1, which sets forth the scope of the FDA’s quality system 

regulation.

b. Section 820.5, which requires medical device manufacturers to establish and 

maintain a quality system. 

c. Section 820.20, which provides for management responsibility.

d. Section 820.22, which requires quality audits.

e. Section 820.25, which sets qualification requirements for manufacturer 

personnel.

f. Section 820.30, which provides that manufacturers must “establish and 

maintain procedures to control the design of the device in order to ensure that 

specified design requirements are met.”

g. Section 820.70, which sets forth rules regarding production and process 

controls.

h. Section 820.72, which sets forth rules regarding inspection, measuring, and 

test equipment.

i. Section 820.75, which sets forth rules regarding process validation.

j. Section 820.80, which requires manufacturers to “establish and maintain 

procedures for acceptance activities . . . includ[ing] inspections, tests, or other 

verification activities.

k. Section 820.86, which requires manufacturers to identify the “conformance or 

nonconformance of product with acceptance criteria . . . throughout 

manufacturing, packaging, labeling, installation, and servicing of the product 

to ensure that only product which has passed the required acceptance activities 

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is distributed, used, or installed.”

l. Section 820.90, which requires manufacturers to “establish and maintain 

procedures to control product that does not conform to specified 

requirements.”

m. Section 820.100, which requires manufacturers to “establish and maintain 

procedures for implementing corrective and preventive action” to address 

nonconforming product.

1. Design Defect

Defendant incorrectly argues that design defect claims are automatically preempted under 

the MDA. “[W]here the FDA has specifically approved of the design of the device for 

investigational purposes, the Sixth Circuit has held that “[t]o allow a cause of action for design 

defect . . . would thwart the goals of safety and innovation.” Martin v. Telectronics Pacing Sys., 

105 F.3d 1090, 1099 (6th Cir. 1997) (emphasis added). The same analysis does not

In Kemp, which was decided on summary judgment, “[t]he essence of plaintiffs’ [state 

law design defect claim was] that Medtronic failed to coat the lead” to a pacemaker to a uniform 

thickness. Kemp, 231 F.3d at 229. Because the Sixth Circuit found that the specific federal 

requirements established through the PMA process did “not include a requirement as to the 

thickness” of the coating, that Court concluded that the plaintiff’s state law claim “would . . . 

impose a requirement different from and in addition to those established by the FDA.” Id. at 

230. The state law claim was therefore preempted. Id. 

apply to a 

non-investigational device approved through the PMA process; however. See Kemp v. 

Medtronic, Inc., 1999 U.S. Dist. Lexis 22470, *26–27 (S.D. Oh. Jan. 12, 1999) (holding that the 

same analysis applies, dismissing design defect claims), overruled, Kemp v. Medtronic, 231 F.3d 

216, 226 (6th Cir. Ohio 2000) (affirming on different grounds after determining that the 

purported state requirements exceeded the specific design requirements imposed through the 

PMA process). 

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As in Kemp, the state law design requirements must not exceed the specific design 

requirements imposed through the PMA process. Because the preemption issue here must be 

decided on the pleadings, and the complaint has not defined “the precise 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. However, because “it is clear that the . . . allegations . . . 

include claims that [Defendant] has . . . violated FDA regulations,” these claims “can be 

maintained without being pre-empted by § 360k.” See Lohr, 518 U.S. at 495. The Court 

therefore DENIES Defendant’s motion as to Plaintiff’s design defect claim. 

2. Manufacturing Defect

Defendant asserts simply that “[a] manufacturing defect claim is undeniably preempted,” 

quoting Riegel for the proposition that “the MDA preempt[s] a negligent manufacturing claim 

insofar as it [is] not premised on the theory that [the defendant] violated federal law.” (Dkt. 16-1 

at 7–8 (quoting Riegel, 552 U.S. at 320). While Defendant’s quotation from Riegel is taken out 

of context, the Supreme Court did hold that the MDA “does not prevent a State from providing a 

damages remedy for claims premised on a violation of FDA regulations

While the complaint has not defined “the precise contours of [the plaintiff’s] theory of 

recovery,” and the Court cannot engage in a detailed comparison of the specific state and federal 

requirements at issue, it 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. See Riegel, 552 U.S. at 330; Lohr, 518 U.S. 

at 495. 

; the state duties in such a 

case ‘parallel,’ rather than add to, federal requirements.” Riegel, 552 U.S. at 330 (emphasis 

added) (citing Lohr, 518 U.S. at 495).

The Court notes that if, following the completion of discovery, it appears that Plaintiff 

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cannot sustain a claim under state requirements that parallel federal requirements, Defendant 

would be free to file a motion for summary judgment.

B.

In Count Two, Plaintiff alleges that Defendant “knew or should have known of the 

potential for and/or actual presence of the defect,” and, “[h]aving such knowledge, Defendant 

failed to provide adequate warnings and/or instructions, both at the time of marketing and 

afterwards.” (Am. Compl. ¶ 49.) Plaintiff alleges that Defendant thus violated the following 

statutes and regulations (id. at 49–50):

Count Two: Failure to Warn

i. Ohio Revised Code §§ 2307.76 and 2307.80, which provide a cause of action for 

product liability against a manufacturer which knows or should have known about a 

risk and fails to provide reasonable warning or instruction regarding the risk.

ii. 21 U.S.C. § 360(h), by which the Court assumes Plaintiff meant § 360h, which sets 

forth the rules regarding the FDA’s authority to issue notifications regarding unsafe 

devices and provide other remedies.

iii. 21 U.S.C. § 360(i), by which the Court assumes Plaintiff meant § 360i, which 

requires manufacturers to establish and maintain records, make reports, and provide 

information to assure that devices are not adulterated or misbranded and to otherwise 

assure safety and effectiveness.

iv. 21 C.F.R. §§ 803.50 and 803.52, which describe reporting requirements.

v. 21 C.F.R. § 814.82, which describes allowable post-PMA requirements.

Defendant argues that Plaintiff’s failure to warn claim is preempted, citing In re 

Medtronic Inc., 592 F. Supp. 2d 1147, 1159 (D. Minn. 2009), in which that court held that 

“[m]andating that a manufacturer provide warnings beyond those on the device label would 

impose requirements ‘different from, or in addition to’ those approved by the FDA, and are thus 

preempted.”

To the extent that Plaintiffs allege that Defendants’ FDA-approved warnings “were 

inadequate under Ohio law,” such claims would be preempted. Kemp, 231 F.3d at 237. 

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However, to the extent that Plaintiff alleges “a claim for breach of [Medtronic’s] duty under state 

law to warn . . . of potential risks . . . based on information obtained subsequent to FDA approval 

of the device,” it is not clear whether such a claim would be preempted. Id. (not reaching the 

question).

As with Count One, the complaint has not defined “the precise contours of [the 

plaintiff’s] theory of recovery,” and the Court cannot engage in a detailed comparison of the 

specific state and federal requirements at issue. It is clear from the allegations, however, that 

Plaintiff’s claim is premised on the theory that Defendant violated federal law. The Court 

therefore DENIES Defendant’s motion as to Count Two. See Riegel, 552 U.S. at 330; Lohr, 518 

U.S. at 495. 

The Court notes that if, following the completion of discovery, it appears that Plaintiff 

cannot sustain a claim under state requirements that parallel federal requirements, Defendant 

would be free to file a motion for summary judgment.

C.

In Count Three, Plaintiff alleges that Defendant “failed to establish and/or maintain 

adequate distribution, installation, handling, and/or inspection instructions and/or procedures” in 

violation of the MDA and 21 C.F.R. §§ 820.140, 820.150, 820.160, and 820.170. (Am. Compl. 

¶ 54.) 

Count Three: Negligent Handling

Because Plaintiff does not identify a cause of action under Ohio law, and the MDA 

provides none, Lohr, 518 U.S. at 487, Count Three is DISMISSED.

D.

In Count Four, Plaintiff alleges that “Defendant breached its expressed and implied 

warranties regarding the safety and utility of its defective IPG [].” (Am. Compl. ¶ 58.)

Count Four: Breach of Express and Implied Warranties

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1. Express Warranty

Defendant argues that Plaintiff’s claim of breach of express warranty is preempted, citing 

the Fifth Circuit’s decision in Gomez v. St. Judge Med. Diag Div., Inc., 442 F.3d 919, 932 

(2006). (Dkt. 16-1 at 10.) In Gomez, the Fifth Circuit stated that, according to all but one of the 

appellate courts which had considered the issue, a district court must “look through the general 

duties imposed by the state-law causes of action and consider the effect a successful lawsuit . . . 

would have and determine whether they threaten the federal PMA process requirements.” 

Gomez, 442 F.3d at 929–30. The Fifth Circuit held that the plaintiff’s claim for breach of 

express warranty under Louisiana law was preempted because it would rely on a factual finding 

that the defendant’s representations regarding the medical device were untrue. “Because those 

representations—including the label, warnings, and [instructions for use]—were approved by the 

FDA through the PMA process, the duties arising under [state law] relate to, and are potentially 

inconsistent with, the federal regulatory scheme.” Gomez, 442 F.3d at 932. 

Here, however, a claim for breach of express warranty does not require a finding that the 

representations are untrue. The elements of such a claim under Ohio law are as follows:

(1) the manufacturer of the product, through advertising, makes 

representations regarding the quality and merit of its 

product,

(2) the representations are aimed directly at the ultimate 

consumer, urging the consumer to purchase the product, 

(3) the consumer, relying on the manufacturer’s representations, 

does purchase the product, and 

(4) the consumer suffers harm as a result of that reliance.

Wagner v. Roche Lab., 709 N.E.2d 162, 166 (Ohio 1999) (citing Rogers v. Toni Home 

Permanent Co., 167 Ohio St. 244 (1958)). Because an Ohio claim for breach of express 

warranty does not require a finding that the manufacturer’s representations are untrue, the Court 

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finds that a successful lawsuit would not “threaten the federal PMA process requirements.” See 

Gomez, 442 F.3d at 929–30. 

Defendant develops no other arguments as to this claim, and its motion is DENIED as to 

Plaintiff’s claim for breach of express warranty.

2. Implied Warranty

The elements of an Ohio claim for breach of implied warranty claim are:

(1) the existence of a defect in the product manufactured and 

sold by the defendant,

(2) the defect existed when the product left the hands of the 

defendant, and

(3) the defect was the direct and proximate cause of the 

plaintiff's injuries. 

Tompkin v. Philip Morris USA, Inc., 362 F.3d 882, 903 (6th Cir. 2004) (citing White v. DePuy, 

Inc., 129 Ohio App. 3d 472, 718 N.E.2d 450, 455–56 (Ohio Ct. App. 1998)). While Plaintiff 

does not identify the federal violations that correspond to this claim, his other claims clearly 

identify such violations.

According 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. 

The Riegel Court in fact held that the state law “duties underlying negligence, strict-liability, and 

implied-warranty claims” were requirements subject to potential

While the complaint has not defined “the precise contours of [the plaintiff’s] theory of 

preemption. 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.

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recovery,” and the Court cannot engage in a detailed comparison of the specific state and federal 

requirements at issue, it 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 implied warranty claim. See Riegel, 552 U.S. at 330; Lohr, 518 U.S. at 

495. 

The Court notes that if, following the completion of discovery, it appears that Plaintiff 

cannot sustain a claim under state requirements that parallel federal requirements, Defendant 

would be free to file a motion for summary judgment.

E.

In Count Five, Plaintiff alleges that “Defendant provided a defective product which failed 

to conform to [Defendant’s] representations,” and that Defendant “negligently and/or 

fraudulently misrepresented the safety and utility of” the IPG, in violation of Ohio Revised Code

§ 2307.77 and 21 C.F.R. § 801.6. (Am. Compl. ¶ 63.)

Count Five: Negligent and Fraudulent Misrepresentation

The Sixth Circuit has held that, in the context of investigational devices, claims under 

Ohio Revised Code § 2307.77 are preempted by the MDA. Martin v. Telectronics Pacing Sys., 

105 F.3d 1090, 1100 (6th Cir. 1997) (citing Martin v. Telectronics Pacing Sys., 70 F.3d 39, 42 

(6th Cir. 1995)). Finding no reason to distinguish representations made regarding investigational 

devices from representations made regarding non-investigational devices, the Court GRANTS

Defendant’s motion as to Count Five.

F.

In Count Six, Plaintiff alleges that Defendant “fail[ed] to adequately and accurately 

record and/or report a malfunction, adverse event, reportable event, and/or product problem 

associated with [the IPG],” in violation of 21 U.S.C. § 360(i) and 21 C.F.R. §§ 803.1, 803.10, 

803.50, 803.52, 814.82, 820.65, 820.90, 820.184, 820.186, 820.198, 820.200, and 821.25. (Am. 

Count Six: Failure to Report

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Compl. ¶ 68.) Plaintiff alleges that Defendant “failed to have a system to identify defective 

products, to maintain a quality system record, [and] to maintain a device history record[;] and 

failed to properly investigate and/or report a complaint or service a device.” (Id.)

The MDA provides no private cause of action, Lohr, 518 U.S. at 487, and Plaintiff 

identifies no cause of action under Ohio law. Even assuming that Ohio law provides a cause of 

action for Claim Six, such a claim would be preempted by the MDA. The Supreme Court has 

held that a “state-law fraud-on-the-FDA claim[] [would] conflict with, and [is] therefore 

impliedly pre-empted by federal law.” Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341, 

348 (2001). The Buckman Court explained that the FDA is amply empowered to punish and 

deter fraud against it, and the agency uses this authority “to achieve a somewhat delicate balance 

of statutory objectives” that “can be skewed by allowing fraud-on-the-FDA claims under state 

tort law.” Buckman, 531 U.S. at 348. Claim Six therefore fails to state a claim upon which relief 

can be granted and is hereby DISMISSED.

V.

For the reasons discussed above, Defendant’s Motion is GRANTED as to Counts Three, 

Five, and Six and DENIED as to Counts One, Two, and Four. (Dkt. 16.) COUNTS THREE, 

FIVE, and SIX are hereby DISMISSED.

Conclusion

IT IS SO ORDERED.

UNITED STATES DISTRICT JUDGE

/s/ Peter C. Economus - September 24, 2012

Case: 2:11-cv-01037-PCE-MRA Doc #: 30 Filed: 09/24/12 Page: 15 of 15 PAGEID #: <pageID>