IN THE SUPERIOR COURT OF FUL TON CQlJ~;¥;::~li'Ir~ffi=j:l STATE OF GEORGIA

Plaintiff,

) ) ) ) ) ) ) ) ) ) ) ) )

Civil Action File no. 2014-CV-245871

ARTHUR LA TIMER,

v.

MEDTRONIC, INC., MEDTRONIC SOF AMOR DANEK USA, Inc., PEACHTREE NEUROSURGERY, P.C., and NORTHSIDE HOSPITAL, INC.,

Defendants.

FINAL ORDER GRANTING MOTION OF DEFENDANTS MEDTRONIC SOFAMOR DANEK USA, INC. AND MEDTRONIC, INC. TO DISMISS COMPLAINT

This matter came before the Court on the Motion to Dismiss of Defendants Medtronic,

Inc. and Medtronic Sofamor Danek USA, Inc. ("Medtronic").

This Court, having considered the grounds for the Motion to Dismiss, including

Plaintiffs complaint, all briefing, and judicially noticeable materials before the Court, and

having considered the applicable law, FINDS, ORDERS, and ADJUDGES as follows:

Findings of Fact

1. Plaintiff Arthur Latimer asserts claims in connection with Medtronic's Infuse®

Bone GraftlL T -CAGE® Lumbar Tapered Fusion Device ("Infuse"), a prescription medical

device.

2. The Infuse device comprises two components, the two-part Infuse Bone Graft

component (which includes a recombinant human bone morphogenetic protein (rhBMP) capable

of initiating bone growth and an absorbable collagen sponge) and the LT-Cage component.

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Compl, ~ 10; see also INFUSE® Bone GraftlLT-CAGE® Lumbar Tapered Fusion Device,

Important Medical Information, No. 0381148 Rev. D (Feb. 2012) (attached as Exhibit 3 to the

Affidavit of Victoria D. Lockard ("Lockard Aff.")).

3. On July 2, 2002, the federal Food and Drug Administration (FDA) granted

premarket approval (PMA) to the Infuse device under PMA Number P000058, Docket No. 02M-

0310. Compl. ~ 12; see also 68 Fed. Reg. 1620, 1621 (Jan. 13,2003) (Table 1. _ List of Safety

and Effectiveness Summaries for Approved PMAs Made Available July 1, 2002, through

September 30, 2002, P000058/02M-0310), http://www.gpo.gov/fdsys/pkg/FR-2003-01-

13/pdf/03-662.pdf (attached as Exhibit 5 to Lockard Aff.); Approval Order Letter from D.

Schultz, Deputy Dir. For Clinical and Review Policy, Office of Device Evaluation, FDA, to R.

Treharne, Senior Vice President, Medtronic Sofamor Danek, Re: P000058 (July 2, 2002), http://

www.accessdata.fda.gov/cdrh_docs/pdf/P000058A.pdf (attached as Exhibit 2 to Lockard Aff.).

4. In granting premarket approval, the FDA designated Infuse a "restricted device"

(21 U.S.C. § 360j(e)) under 21 U.S.C. § 360e(d)(1)(B)(ii). Lockard Aff. Ex. 2, at 1. Pursuant to

that designation, "[ t ]he sale, distribution, and use of th[ e] device are restricted to prescription use

In accordance with 21 CFR § 801.109." Id.; see also

Id. Ex. 3, at 1. Given that restriction, Medtronic can sell the Infuse device only to doctors and

hospitals, not patients.

5. The premarket approval process is the FDA's most '"rigorous''' review and

approval process. Riegel v. Medtronic, Inc., 552 U.S. 312, 317 (2008) (quoting Medtronic, Inc. v.

Lohr, 518 U.S. 470, 477 (1996)). "The premarket approval process includes review of the

device's proposed labeling." Id. at 318. "[T]he FDA may grant premarket approval only after it

determines that a device offers a reasonable assurance of safety and effectiveness." Id. at 323

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(citing 21 U.S.C. § 360e(d». "Once a device has received premarket approval," federal law

"forbids the manufacturer to make, without FDA permission, changes in design specifications,

manufacturing processes, labeling, or any other attribute, that would affect safety or

effectiveness." Id. at 319.

6. The FDA-approved label for the Infuse device in effect at the time of Plaintiff's

surgery-the INFUSE® Bone GraftlLT-CAGE® Lumbar Tapered Fusion Device, Important

Medical Information, No. 0381148 Rev. D (Feb. 2012) (attached as Exhibit 3 to Lockard Aff.

and as Exhibit B to Plaintiff's Opposition to Response in Oppostion to Motion to Dismiss of the

Medtronic Defendants )-contained various warnings. I Among other warnings, the label advised:

a. that the device is "indicated for spinal fusion procedures ... from L2-S1,"

i.e., in the lumbar-not cervical-spine;

b. that the device's "safety and effectiveness" when "implanted at locations

other than the lower lumbar spine ... have not been established";

c. that "severe" adverse events have been observed when the device was

used in "cervical spinal fusions";

d. that two patients implanted with the device during clinical trials were

found to have cancer within 24 months of their surgery; and,

Like the fact of the FDA's grant of Premarket Approval to the Infuse device, which Plaintiff affirmatively alleges in his complaint, the labeling mandated by the agency is judicially noticeable as a matter of public record "not subject to reasonable dispute" and "[ c] apable of accurate and ready determination by resort to sources whose accuracy cannot reasonably be questioned." O.C.G.A. § 24-2-201(b)(2). Moreover, the label-which Plaintiff also submitted as an exhibit to his opposition to Medtronic's motion to dismiss-is implicitly incorporated in Plaintiff's complaint, which alleges what constitutes "off-label" uses of the device. See, e.g., Compl. ~~ 11-12. Nevertheless, dismissal of Plaintiff's complaint does not depend on the label's contents.

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e. that the device "should not be used in the vicinity of a resected or extant

tumor, in patients with any active malignancy or patients undergoing

treatment for a malignancy."

7. The FDA-approved label for the Infuse device also states that "[n]o warranties,

express or implied, are made" and that "[i]mplied warranties of merchantability and fitness for a

particular purpose or use are specifically excluded." Lockard Aff. Ex. 3, at 5.

8. Plaintiff does not allege that Medtronic failed to provide his surgeon the FDA-

mandated warning label; nor does Plaintiff allege that design of the Infuse device he received

deviated in any way from the FDA-approved design.

9. Plaintiff alleges that his surgeon used the Infuse device in an "off-label" manner,

i.e., in a manner that was not indicated on the device's FDA-approved label. In particular,

Plaintiff alleges that on May 8, 2012, his surgeon implanted the Infuse device in Plaintiffs

cervical spine. Compl. ~ 27.

10. On July 1, 2008, almost four years before Plaintiffs surgery, the FDA issued a

Public Health Notification warning physicians of "life-threatening complications associated with

recombinant human bone morphogenetic protein in cervical spine fusion." FDA, Public Health

Notification, Life-Threatening Complications Associated with Recombinant Human Bone

Morphogenetic Protein III Cervical Spine Fusion, July 1, 2008,

http://www.fda.gov/medicaldevices/safety/alertsandnotices/publichealthnotifications/ucm062000

.htm (attached as Exhibit 4 to Lockard Aff.).

11. Plaintiff alleges that "several months" after his surgery he "began experiencing

intense pain in his groin area during intercourse" and upon seeking medical attention "learned

that he had developed prostate cancer." Compl. ~ 28.

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12. Plaintiff alleges that, "[g]iven the heavy correlation between off-label Infuse

applications and incidents of cancer, including incidents of prostrate [sic] cancer, it is evident

that Medtronic's Infuse product either caused [Plaintiff's] cancer directly or rapidly accelerated

its growth." Compl. ~ 29.

13. Plaintiff's allegations regarding the purported carcinogenicity ofInfuse are based

on a study involving Amplify-a device that Plaintiff admits "contained a higher concentration

of rhBMP-2" than the Infuse device. CompI. ~ 21. Plaintiff does not allege that his surgery

involved such a concentration of rhBMP-2.

14. Plaintiff alleges that "a medical paper published in 2009 discussing the clinical

results of Amplify tests had failed to reveal a known, statistically significant link between

Amplify's rhBMP-2 content and cancer." CompI. ~ 22. Plaintiff further alleges that "[t]he

doctors who wrote this paper had received millions of dollars from Medtronic." Id. Plaintiff,

however, does not allege that his surgeon ever read or relied on the unidentified article. Nor does

Plaintiff allege any facts that, if true, would establish that the article's unidentified authors were

acting as agents of Medtronic when authoring the article.

15. Although Plaintiff generally alleges that Medtronic improperly promoted off-label

use of the Infuse device (CompI. ~ 13) and that his surgeon "would never have recommended the

Infuse device ... had the full dangers" associated with such use "not been intentionally obscured"

by Medtronic (id. ~ 30), Plaintiff does not allege any facts that, if true, would suggest that his

surgeon was ever the recipient of any off-label marketing by Medtronic or that his surgeon ever

relied on such marketing.

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Plaintiff's Claims and Medtronic's Motion to Dismiss

16. Plaintiff asserts state-law claims against Medtronic for fraud, including fraudulent

misrepresentation and fraud in the inducement (Cornpl. ~~ 35-38); strict products liability,

including failure to warn, design defect, and misrepresentation (id. ~~ 39-42, 46-48); negligent

products liability (id. ~~ 43-45); breach of express and implied warranties (id. ~~ 49-54); and

alleged violations of state consumer protection laws (id. ~~31-38).

17. Medtronic moves to dismiss Plaintiffs complaint on the ground that most, if not

all, of Plaintiff's state-law claims are expressly and/or impliedly preempted by federal law, and

that even if not preempted, Plaintiff's claims fail as a matter of Georgia law. With respect to

preemption, Medtronic argues that Plaintiffs claims-with the possible exception of any fraud

claims predicated on alleged affirmative misrepresentations-are expressly preempted under the

Medical Device Amendments (MDA) to the federal Food, Drug, and Cosmetic Act (FDCA), 21

u.s.C. § 360k(a) and/or impliedly preempted, either because they would stand as an obstacle to

Congress's objectives as set forth in 21 U.S.C. § 337(a) or would demand conduct that is

contrary to, and thus would conflict with, federal law.

18. Plaintiff disputes Medtronic's contentions. As a threshold matter, Plaintiff argues

that § 360k(a) does not apply in this case because, according to Plaintiff, his surgeon's supposed

use of the Infuse Bone Graft component without the L T -Cage component means that Plaintiff did

not receive the device that had been granted premarket approval by the FDA.2 In the alternative,

Plaintiff contends that even if § 360k(a) does apply to this case, his claims escape express

2 Although Plaintiff argued in his opposition to Medtronic's motion that his surgeon failed to use the Infuse device's LT-Cage component in his surgery, that supposed fact is not alleged in Plaintiffs complaint. But, for the reasons explained below, the disposition of this case does not depend on whether his surgeon used the L T -Cage component.

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preemption. Finally, Plaintiff disputes Defendants' assertions that his claims are impliedly

preempted and barred on independent state-law grounds.

Conclusions of Law

19. At a minimum, a complaint must contain '''[a] short and plain statement of the

claims showing that the pleader is entitled to relief. '" Fairfax v. Wells Fargo Bank, NA., 312 Ga.

App. 171, 171 (2011) (quoting O.C.G.A. § 9-11-8(a)(2)(A». To avoid dismissal, a complaint

"must contain more than a formulaic recitation of the elements of a legal cause of action."

Charles H Wesley Educ. Found., Inc. v. State Election Bd., 282 Ga. 707, 714 & n.7 (2007)

(citing Bell Atl. Corp. v. Twombly, 550 U.S. 544, 555 (2007); Papasan v. Allain, 478 U.S. 265,

286 (1986».

20. "In all averments of fraud or mistake, the circumstance constituting fraud or

mistake shall be stated with particularity." O.C.G.A. § 9-11-9(b). "'It is well settled that a

general allegation of fraud amounts to nothing-it is necessary that the complainant show, by

specifications, wherein the fraud consists. Issuable facts must be charged. '" Fairfax, 312 Ga.

App. at 172 (2011) (quoting Dockens v. Runkle Consulting, Inc., 285 Ga. App. 896,900 (2007»;

see, e.g., Fortson v. Freeman, 313 Ga. App. 326, 328 (2011) (affirming dismissal where

complaint "failed to allege any specific facts to state a cause of action for fraud").

21. "The Supremacy Clause" of the United States Constitution "provides that 'the

Laws of the United States ... shall be the supreme Law of the Land ... any Thing in the

Constitution or Laws of any state to the Contrary notwithstanding. '" Oneok, Inc. v. Learjet, Inc.,

135 S. Ct. 1591, 1594-95 (2015) (quoting U.S. Const. art. VI, cl. 2). Thus, "[a] fundamental

principle of the Constitution is that Congress has the power to preempt state law." Crosby v.

Nat 'I Foreign Trade Council, 530 U.S. 363, 372 (2000).

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22. If a claim is preempted by federal law, it must be dismissed. See, e.g., Thomas v.

Bank of Am. Corp., 309 Ga. App. 778, 784 (2011) (affirming order of dismissal because "federal

banking law preempts all of [plaintiff's] claims").

23. Federal law preempts-i.e., supersedes-state law under three circumstances:

"First, when acting within constitutional limits, Congress is empowered to pre-empt state law by

so stating in express terms." Hillsborough Cnty. v. Automated Med. Labs., Inc., 471 U.S. 707,

713 (1985). Second, "[w]hen Congress intends federal law to 'occupy the field,' state law in that

area is preempted." Crosby, 530 U.S. at 372. Finally, "state law is naturally preempted to the

extent of any conflict with a federal statute," either because "it is impossible for a private party to

comply with both state and federal law" or because "under the circumstances of [a] particular

case, [the challenged state law] stands as an obstacle to the accomplishment and execution of the

full purposes and objectives of Congress." Id. (internal quotation marks omitted).

24. Plaintiff asserts that a presumption against preemption "applies in tort cases such

as this." Response in Opposition to Motion to Dismiss of the Medtronic Defendants 8-9. But

even if there is such a presumption, that presumption is overcome here. The Supreme Court of

the United States has twice rejected application of such a presumption in the medical-device

context. Interpreting 21 U.S.C. § 360k(a) in Riegel, an eight-justice majority rejected the lone

dissenter's reliance on such a presumption, concluding instead that "the text of the statute"

plainly evinced Congress's intent to displace "the tort law of 50 States." 552 U.S. at 326; see

also id. at 316 (Congress enacted 21 U.S.C. § 360k(a) to "swe[ep] back some state obligations"

and replace them with "a regime of detailed federal oversight."); cf id. at 334 (Ginsburg, J.,

dissenting). And interpreting 21 U.S.C. § 337(a) in Buckman Co. v. Plaintiffs' Legal Committee,

531 U.S. 341, 347-48 (2001), the Court held that there is "no presumption against pre-emption"

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for state-law claims effectively seeking to enforce FDCA requirements because "the relationship

between a federal agency and the entity it regulates is inherently federal in character" and

because policing such requirements "is hardly 'a field which the States have traditionally

occupied. '" Thus, a presumption against preemption does not preclude the preemption of

Plaintiffs claims in this case.

25. State-law claims arising from injuries allegedly caused by Class III prescription

medical devices with premarket approval are subject to express preemption under 21 U.S.C.

§ 360k(a). Section 360k(a) preempts any claim that would impose a state-law safety or

effectiveness "requirement[] with respect to the device that [is] 'different from, or in addition

to'" the federal requirements imposed through the premarket approval process. Riegel, 552 U.S.

at 322 (quoting 21 u.s.c. § 360k(a)(1)).

26. Section 360k(a) creates a two-step test for determining if state-law claims are

preempted. See, e.g., Wolicki-Gables v. Arrow Int'l, Inc., 634 F.3d 1296, 1300-01 (11th Cir.

2011), aff'g 641 F. Supp. 2d 1270 (M.D. Fla. 2009); Cline v. Advanced Neuromodulation Sys.,

Inc., 17 F. Supp. 3d 1275, 1279 (N.D. Ga. 2014). First, a court must determine whether "the

Federal Government has established requirements applicable to" the medical device. Riegel, 552

U.S. at 321. Ifit has, the court then must determine whether the state-law claims would impose

"requirements with respect to the device that are 'different from, or in addition to'" the federal

requirements. Id. at 322. Where both conditions are satisfied, the state-law claims are expressly

preempted.

27. In Riegel, the U.S. Supreme Court held that "[p]remarket approval ... imposes

[federal] 'requirements'" as that term is used in § 360k(a). 552 U.S. at 322. Accordingly, any

device that has received premarket approval, such as Infuse, "automatically satisflies] the first

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prong of the Riegel test." McClelland v. Medtronic. Inc., 944 F. Supp. 2d 1193, 1199 (M.D. Fla.

2013); see also Caplinger v. Medtronic, Inc., 784 F.3d 1335, 1340 (10th Cir. 2015) (Caplinger

II) ("[D]evice-specific federal requirements apply to Infuse: the device endured the premarket

approval process."). Riegel also held that state common-law claims Impose

"requirements ... 'with respect to devices'" within the meaning of § 360k(a). 552 U.S. at 327.

Thus, as authoritatively interpreted in Riegel, § 360k(a) expressly preempts any state-law claim

that would impose a requirement respecting the safety or effectiveness of a device with

premarket approval that is "'different from, or in addition to'" the requirements imposed by

federallaw.ld. at 321 (quoting 21 U.S.C. § 360k(a)(1».

28. There is a narrow exception to express preemption under § 360k(a) for claims that

'''parallel,' rather than add to, federal requirements." Riegel, 552 U.S. at 330 (quoting Lohr, 518

U.S. at 495). To be "parallel," a claim must rest on the violation of a state-law requirement that is

"identical" to a federal requirement. Lohr, 518 U.S. at 495; accord Otis-Wisher v. Medtronic,

Inc., --- F. App'x ----, 2015 WL 3557011, at *1 (2d Cir. 2015) (Otis-Wisher II) "The Supreme

Court instructs that a state law claim must be 'identical' to an existing federal requirement for

such a claim to survive § 360k preemption."). Establishing liability via a parallel claim is thus

"more difficult than it would be in a typical product liability case." White v. Stryker Corp., 818 F.

Supp. 2d 1032, 1037 (W.D. Ky. 2011). "To state a 'parallel' claim" that avoids express

preemption under § 360k(a), "a plaintiff must allege (1) the violation of a specific federal

requirement applicable to the device; (2) the violation of an identical state-law duty; and (3) that

the predicate federal violation caused his or her injuries." Millman v. Medtronic, 2015 WL

778779, at *4 n.2 (D.N.J. 2015); accord, e.g., Wolicki-Gables, 634 F.3d at 1300-01.

10 A TL 20829328v1

29. Plaintiffs claims also are subject to 21 U.S.C. § 337(a), which provides that all

actions to enforce the FDCA "shall be by and in the name of the United States." Section 337(a)

mandates that the FDCA and its implementing regulations be "enforced exclusively by the

Federal Government." Buckman, 531 U.S. at 352. The U.S. Supreme Court has held that § 337(a)

impliedly preempts any claim for which the existence of the federal regulatory scheme is a

"critical element." Id. at 353. Thus, "[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 [FDCA's] medical device provisions." Id. at 349 n.4.

30. Even if a claim escapes express preemption under § 360k(a), it might nevertheless

be impliedly preempted, because "neither an express pre-emption provision nor a saving clause

'bar[s] the ordinary working of conflict preemption principles.'" Buckman, 531 U.S. at 352

(quoting Geier v. Am. Honda Motor Co., 529 U.S. 861, 869 (2000)).

31. Together, "Riegel and Buckman create a narrow gap through which a plaintiff's

state-law claim must fit if it is to escape express or implied preemption." Bryant v. Medtronic,

Inc., 623 F.3d 1200, 1204 (8th Cir. 2010) (internal quotation marks omitted); accord, e.g., Perez

v. Nidek Co., 711 F.3d 1109,1120 (9th Cir. 2013). For the reasons explained below, the Court

concludes that Plaintiffs claims do not pass through that gap and must therefore be dismissed.

32. More than two dozen state and federal courts around the country have already

addressed the issues presented in this case. Although the emerging case law is not entirely

uniform, there is a clear consensus among the reported cases that claims such as those asserted

here are preempted entirely or in large measure. See Otis-Wisher II, 2015 WL 3557011 (2d Cir.

2015), aff'g 951 F. Supp. 2d 592 (D. Vt. 2013) (Otis-Wisher I); Caplinger II, 784 F.3d 1335,

aff'g 921 F. Supp. 2d 1206 (W.D. Okla. 2013) (Caplinger I)~ Arthur v. Medtronic, Inc., --- F.

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Supp. 3d ----, 2015 WL 5012312 (E.D. Mo. 2015) (Arthur II); Anderson v. Medtronic, Inc., 2015

WL 2115342 (S.D. Cal. 2015); Hafer v. Medtronic, Inc., --- F. Supp. 3d ----, 2015 WL 1648978

(W.D. Tenn. 2015), reconsideration denied (June 17,2015); Schouest v. Medtronic, Inc., --- F.

Supp. 3d ----, 2015 WL 1283965 (S.D. Tex. 2015) (Schouest 11); Thorn v. Medtronic Sofamor

Danek USA, Inc., --- F. Supp, 3d ----, 2015 WL 328885 (W. D. Mich. 2015); Dunbar v.

Medtronic, Inc., 2014 WL 3056026 (C.D. Cal. 2014); Arvizu v. Medtronic, Inc., 41 F. Supp. 3d

783 (D. Ariz. 2014); Arthur v. Medtronic, Inc., 2014 WL 3894365 (E.D. Mo. 2014) (Arthur 1);

Zaccarello v. Medtronic, Inc., 38 F. Supp. 3d 1061 (W.D. Mo. 2014); Scanlon v. Medtronic

Sofamor Danek USA Inc., 61 F. Supp. 3d 403 (D. Del. 2014); Martin v. Medtronic, Inc., 32 F.

Supp. 3d 1026 (D. Ariz. 2014); Brady v. Medtronic, Inc., 2014 WL 1377830 (S.D. Fla. 2014);

Beavers-Gabriel v. Medtronic, Inc., 15 F. Supp. 3d 1021 (D. Haw. 2014); Schouest v. Medtronic,

Inc., 13 F. Supp. 3d 692 (S.D. Tex. 2014) (Schouest 1); Blankenship v. Medtronic, Inc., 6 F.

Supp. 3d 979 (E.D. Mo. 2014); Schuler v. Medtronic, Inc., 2014 WL 988516 (C.D. Cal. 2014);

Hawkins v. Medtronic, Inc., 2014 WL 346622 (E.D. Cal. 2014); Ledet v. Medtronic, Inc., 2013

WL 6858858 (S.D. Miss. 2013); Houston v. Medtronic, Inc., 957 F. Supp. 2d 1166 (C.D. Cal.

2013) (Houston I); Kashani-Matts v. Medtronic, Inc., 2013 WL 6147032 (C.D. Cal. 2013);

Dawson v. Medtronic, Inc., 2013 WL 4048850 (D.S.C. 2013); Gavin v. Medtronic, Inc., 2013

WL 3791612 (E.D. La. 2013); Angeles v. Medtronic, Inc., 2014 WL 1649684 (Minn. Dist. Ct.

2014) (Angeles 1), aff'd in substantial part, 863 N.W.2d 404 (Minn. Ct. App. 2015) (Angeles 11);

Buccelli v. Mayer, 2015 WL 398594 (Fla. Cir. Ct. 2015); Cales v. Medtronic, Inc., 2015 WL

4081908 (Ky. Cir. Ct. 2015) (Cales 11), denying reconsideration of2014 WL 6600018 (Ky. Cir.

Ct. 2014) (Cales 1); Lawrence v. Medtronic, Inc., 2013 WL 4008821 (Minn. Dist. Ct. 2013);

Wendt v. Bernstein, 2013 WL 3199361 (Ill. Cir. Ct. 2013); Raborn v. Albea, 2012 WL 6600475

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(La. Civ. Dist. Ct. 2012), aff'd on other grounds, 144 So. 3d 1066 (La. Ct. App.2014). This

Court agrees with the majority view and concludes that Plaintiffs claims are expressly and/or

impliedly preempted.

33. There is no merit to Plaintiffs assertion that § 360k(a) does not apply because

Plaintiffs surgeon supposedly implanted the Infuse device without its LT-Cage component.

Although "using the INFUSE Bone Graft component alone was an off-label use" of the Infuse

device (Gavin, 2013 WL 3791612, at *12), "[n]othing depends on whether the plaintiff seeks to

use state law to impose requirements for off-label uses or on-label uses" (Caplinger II, 784 F.3d

at 1344). The relevant question under § 360k(a) is "not whether there are federal requirements

applicable to a particular use of a device; the question is whether there are federal requirements

applicable 'to the device," Riley v. Cordis Corp., 625 F. Supp. 2d 769, 779 (D. Minn. 2009)

(quoting 21 U.S.C. § 360k(a)(I)). "Nothing in the statute suggests that the preemption analysis

somehow depends on how the device is used." Id.; accord Hafer, 2015 WL 1648978, at *9;

Caplinger 1,921 F. Supp. 2d at 1218. Indeed, the suggestion that that § 360k(a) does not apply

because Plaintiffs surgeon supposedly used the Infuse device in an off-label manner "is clearly

inconsistent with Riegel[,] which also involved the off-label use of a medical device." Gavin,

2013 WL 3791612, at *12. It is, moreover, well established that "a device receiving premarket

approval cannot be separated into its component parts to avoid application of express

preemption." Gross v. Stryker Corp., 858 F. Supp. 2d 466, 487 (W.D. Pa. 2012); see also, e.g.,

Smith v. Depuy Orthopaedics Inc., 552 F. App'x 192, 196 (3d Cir. 2014); Duggan v. Medtronic,

Inc., 840 F. Supp. 2d 466, 471 (D. Mass. 2012); Riley, 625 F. Supp. 2d at 780. Therefore,

"[p ]remarket approval imposes federal requirements on the INFUSE device as a whole as well as

each of its component parts, including the INFUSE Bone Graft Component." Hawkins, 2014 WL

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346622, at *6; accord, e.g., Hafer, 2015 WL 1648978, at *9; Martin, 32 F. Supp. 3d at 1035-36;

Ledet, 2013 WL 6858858, at *3; Houston 1,957 F. Supp. 2d at 1176; Gavin, 2013 WL 3791612,

at *11-12.

34. Nor is there any merit to Plaintiffs suggestion that § 360k(a) does not apply to his

claims because Medtronic allegedly promoted off-label uses of the Infuse device.' By its terms,

§ 360k(a) applies whenever the federal government has established "any requirement

applicable ... to the device," and preempts any different or additional state-law rule "which

relates to the safety or effectiveness of the device." As numerous other courts have held,

"nothing in § 360k(a) suggests that the preemption analysis somehow depends on how the device

is being promoted to be used." Caplinger 1,921 F. Supp. 2d at 1218; see also, e.g., Caplinger II,

784 F.3d at 1344; Hawkins, 2014 WL 346622, at *6; Gavin, 2013 WL 3791612, at *11.4

35. Whether or not federal law prohibits off-label promotion, Plaintiff cannot

maintain a claim based on off-label promotion as such. "Even if Plaintiff[] had stated a parallel

claim that escapes express preemption under § 360k(a), any such claim predicated on alleged

3 Medtronic contends that federal law does not prohibit off-label promotion. Although there is support for that assertion in recent case law (see United States v. Caronia, 703 F.3d 149, 166 (2d Cir. 2012); Brady, 2014 WL 1377830, at *5; Schuler, 2014 WL 988516, at *1; Dawson, 2013 WL 4048850, at *6; Underwood v. Rhone-Poulenc Rorer Pharm., Inc., 890 So. 2d 429, 431 (Fla. Dist. Ct. App. 2004», this Court need not resolve the question, because Plaintiffs claims are preempted even if federal law does prohibit off-label promotion. Whether or not federal law prohibits off-label promotion, Plaintiff does "not state a parallel state-law claim" based on off-label promotion as such "because there is no state law duty to abstain from off-label promotion." Thorn, 2015 WL 328885, at *8; accord, e.g., Martin, 32 F. Supp. 3d at 1045; Beavers-Gabriel, 15 F. Supp. 3d at 1041. 4 One widely criticized decision, Ramirez v. Medtronic Inc., 961 F. Supp. 2d 977 (D. Ariz. 2013), suggests the contrary. But "Ramirez has been rejected-for good reason-by numerous courts." Beavers-Gabriel, 15 F. Supp. 3d at 1035. Indeed, "the majority of other courts ... have rejected Ramirez" (Martin, 32 F. Supp. 3d at 1036), because it "is not consistent with the text of § 360k(a) [or] the scope of federal requirements imposed on Class III devices." Houston v. Medtronic, Inc., 2014 WL 1364455, at *5 (C.D. Cal. 2014) (Houston II); see also, e.g., Angeles II, 863 N.W.2d at 413 (rejecting Ramirez); Brady, 2014 WL 1377830, at *4 (same).

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off-label promotion ... would be 'impliedly preempted under Buckman and [21 U.S.C.]

§ 337(a).'" Cales I, 2014 WL 6600018, at *10 (quoting Caplinger I, 921 F. Supp. 2d at 1219);

see also Hafer, 2015 WL 1648978, at *9 ("Any claim based solely on off-label promotion would

... be impliedly preempted."). This is because "the concept of 'off-label use' is a creature of the

FDCA, is defined by the FDCA, and is not a part of [ state] law." Caplinger I, 921 F. Supp. 2d at

1219-20, 1224; accord, e.g., Hafer, 2015 WL 1648978, at *9; Martin, 32 F. Supp. 3d at 1045;

Beavers-Gabriel, 15 F. Supp. 3d at 1041; Blankenship, 6 F. Supp. 3d at 990; Hawkins, 2014 WL

346622, at *19; Gavin, 2013 WL 3791612, at *17; In re Zyprexa Prods. Liab. Litig., 2008 WL

398378, at *5 (E.D.N.Y. 2008). Accordingly, any claim based on off-label promotion "would be

in substance a claim for violating the FDCA" (Dawson, 2013 WL 4048850, at *6), and therefore

barred by 21 U.S.C. § 337(a) as interpreted by the u.s. Supreme Court in Buckman.

36. Plaintiffs complaint can be read as asserting failure-to-warn claims under various

legal theories, including negligence, strict liability, and statutory fraud. Regardless of the label

assigned, to the extent each claim rests on a contention that Medtronic failed to inform Plaintiff

or his surgeon about risk allegedly associated with use of the Infuse device, each "is, 'at bottom,

a failure to warn claim.'" Timberlake v. Synthes Spine, Inc., 2011 WL 711075, at *7 (S.D. Tex.

2011). The gravamen of each claim is that Medtronic should have provided warnings different

from or in addition to those required by the FDA. Any such claim, regardless of the theory under

which it is brought, is expressly preempted by § 360k(a). As the u.S. Supreme Court explained

in Riegel, § 360k(a) "[s]urely ... would pre-empt a jury determination that the FDA-approved

labeling for a [device] violated a state common-law requirement for additional warnings."

Riegel, 552 U.S. at 329; see also id. at 320 (affirming dismissal of "claims of strict liability ...

and negligence in the ... labeling ... of the [device]"); accord, e.g., Otis-Wisher II, 2015 WL

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3557011, at *2; Caplinger II, 784 F.3d at 1336-47; Wolicki-Gables, 634 F.3d at 1301-02; Hafer,

2015 WL 1648978, at *13; Brady, 2014 WL 1377830, at *8; Caplinger I, 921 F. Supp. 2d at

1221, 1223; Leonard v. Medtronic, Inc., 2011 WL 3652311, at *8 (N.D. Ga. 2011); Haynes v.

Cyberonics, Inc., 2011 WL 3903238, at *1 (N.D. Ga. 2011); Buccelli, 2015 WL 398594, at *4.

37. Plaintiffs claims under Georgia's Fair Business Practices Act and Uniform

Deceptive Trade Practices Act might in theory be able to escape express preemption under

§ 360k(a), but only to the extent that they are predicated on alleged affirmative

misrepresentations rather than purported omissions. As another court considering claims arising

from Medtronic's alleged off-label promotion of the Infuse device recently explained, "the key

dividing line" for preemption purposes is the "distinction between claims premised on false

misrepresentations and those premised on omissions." Schouest I, 13 F. Supp. 3d at 701. Absent

an allegation that Medtronic failed to provide a warning that was required by the FDA through

the PMA process, a "fraud by omission claim is expressly preempted by § 360k(a)," because the

underlying state-law "disclosure requirement" would necessarily be '''different from, or in

addition to' the requirements applicable" under federal law. Perez, 711 F.3d at 1118; accord,

e.g., Littlebear v. Advanced Bionics, LLC, 896 F. Supp. 2d 1085, 1091 (N.D. Okla. 2012) ("fraud

by nondisclosure is expressly preempted"); Ali v. Allergan USA, Inc., 2012 WL 3692396, at *17

(E.D. Va. 2012) ("cause of action for fraud by nondisclosure is ... preempted by the MDA

because it would impose requirements under [state] law that add to federal requirements");

Leonard, 2011 WL 3652311, at *11 (fraud claim predicated on alleged concealment "is

preempted because it would require Medtronic to give different, additional warnings about the

[device's] safety and effectiveness, which is strictly prohibited without FDA approval"). Thus,

Plaintiffs fraud claims could "avoid preemption" only "as to affirmative misrepresentations."

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Hafer, 2015 WL 1648978, at *12. As discussed below, however, Plaintiffs statutory fraud

claims fail without regard to preemption, because Plaintiff has failed to plead fraud with the

particularity required by O.C.G.A. § 9-11-9(b).

38. In opposition to Medtronic's motion to dismiss, Plaintiff argued that his failure-

to-warn claims are based on a state-law duty that parallels 21 C.F.R. § 803.50, the federal

regulation requiring that device manufacturers report certain adverse events to the FDA. Yet

even if that were correct, it would not help Plaintiff in this case, because nowhere in his

complaint does Plaintiff allege a violation of 21 C.F .R. § 803.50. At most, the complaint vaguely

alleges that certain journal articles might have failed to include a full accounting of all adverse

events. But that does not describe a violation of § 803.50. The regulation requires that

manufacturers report certain adverse events to the FDA; it says nothing about the reporting of

adverse events in journal articles.

39. Even ifit had been adequately pleaded, an alleged violation of21 C.F.R. § 803.50

cannot support a parallel claim because there is no duty under Georgia law to report adverse

events to the FDA. Cf McClelland v. Medtronic, Inc., 2012 WL 5077401, at *6 (M.D. Fla. 2012)

(claim based on duty to submit adverse-event reports to the FDA expressly preempted because a

"state law duty to warn the [patient] or her physician" is not parallel to "manufacturer reporting

requirements to the FDA"); see also, e.g., Pinsonneault v. St. Jude Med., Inc., 953 F. Supp. 2d

1006, 1016 (D. Minn. 2013) (same). Thus, as another court recently held, "allegations that

Medtronic failed to report adverse events to the FDA do not state a parallel claim." Cales I, 2014

WL 6600018, at *10; accord, e.g., Lake v. Kardjian, 874 N'y.S.2d 751, 755 (Sup. Ct. 2008)

("the alleged failure ... to comply with the MDA's reporting requirements does not constitute a

'parallel claim"').

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40. Moreover, regardless whether such claims are expressly preempted, "[a]l1 claims

predicated on the failure to comply with adverse event reporting requirements are impliedly pre-

empted." Littlebear, 896 F. Supp. 2d at 1092; accord Bryant, 623 F.3d at 1205 (claim that

manufacturer was negligent for "not timely fil[ing] adverse event reports, as required by federal

regulations" impliedly preempted as "simply an attempt by private parties to enforce the MDA");

Hafer, 2015 WL 1648978, at *13 (claims based upon "failure to file adverse event reports with

the FDA ... [are] impliedly preempted under Buckman"); Byrnes v. Small, 60 F. Supp. 3d 1289.

1297 (M.D. Fla. 2015) ("[T]o the extent that the claim is based on [an alleged] failure to report

adverse events to the FDA, it is impliedly preempted"); McClelland, 2012 WL 5077401, at *7

("claims based upon FDCA disclosure requirements ... are impliedly preempted"); Cales 1,2014

WL 6600018, at *10 (failure-to-warn claim "predicated on ... an alleged failure to submit

adverse-event reports to the FDA would be impliedly preempted under Buckman and 21 U.S.C.

§ 337(a)") (internal quotation marks and alteration omitted); Purchase v. Advanced Bionics,

LLC, 896 F. Supp. 2d 694, 696 (W.D. Tenn. 2011) ("private rights of action to enforce FDA

administrative and reporting requirements are prohibited by 21 U.S.C. § 337(a),,).5

41. Plaintiff's design-defect claim is expressly preempted by § 360k(a). Although

Plaintiff alleges that the Infuse device had a defective design, he does not allege that its design

was anything other than the design approved by the FDA through the premarket approval

process. Thus, "to prevail on this claim, Plaintiff[] would need to establish that the Infuse Device

5 In any event, Plaintiff's claim necessarily fails because the complaint does not allege a causal connection between any purported failure to report adverse events and Plaintiff's alleged injury. See Cline, 17 F. Supp. 3d at 1287 (dismissing failure-to-warn claim where "Plaintiff d[id] not plausibly allege that she was injured as a result of Defendant's failure to timely file" adverse­ event reports); Simmons v. Boston Scientific Corp., 2013 WL 1207421, at *5 (C.D. CaL 2013) (dismissing failure-to-warn claim as inadequately pleaded where complaint did not allege facts to "support an inference" that the defendant had failed to report reportable adverse events to the FDA and that the alleged failure had a "causal relationship to the [plaintiff's alleged] injury").

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should have been designed in a manner different than that approved by the FDA." Beavers­

Gabriel, 15 F. Supp. 3d at 1040; accord, e.g., Byrnes, 60 F. Supp. 3d at 1298; Blankenship, 6 F.

Supp. 3d at 989; Schou est I, 13 F. Supp. 3d at 707; Angeles II, 863 N.W.2d at 420. Riege/­

which held that § 360k(a) preempts "claims of strict liability ... and negligence in the design" of

a device (552 U.S. at 320)-squarely forecloses any such claim, which would necessarily

"establish design requirements different from, or in addition to, federal requirements for the

Infuse Device." Caplinger 1,921 F. Supp. 2d at 1222; accord, e.g., Hafer, 2015 WL 1648978, at

* 14. Indeed, a state-law claim that would require a medical device to have a design different

from that approved by the FDA through the PMA process is a frontal "attack[] on the risklbenefit

analysis that led the FDA to approve" the device. Bryant, 623 F.3d at 1206; accord, e.g., Kemp v.

Medtronic, Inc., 231 F.3d 216, 219 (6th Cir. 2000); Martin, 32 F. Supp. 3d at 1044; Houston I,

957 F. Supp. 2d at 1177; Kashani-Matts, 2013 WL 6147032, at *4. Accordingly, "this is the

exact type of claim that is expressly preempted under § 360k(a)." Caplinger 1,921 F. Supp. 2d at

1222.

42. To the extent that Plaintiff contends that Georgia law required Medtronic to

change Infuse's design or labeling without FDA approval, his claims are impliedly preempted,

because federal law affirmatively prohibits manufacturers from changing the design or labeling

of PMA-approved devices without obtaining prior or ultimate FDA approval. See 21 C.F.R.

§ 814.39; Riegel, 552 U.S. at 319. Any claim predicated on the contention that Medtronic was as

a matter of state law required to adopt a different design or label fails, because, "[ u ]nder the

Supremacy Clause, state laws that require a private party to violate federal law are pre-empted."

Mut. Pharm Co. v. Bartlett, 133 S. Ct. 2466, 2470 (2013); see also Crosby, 530 U.S. at 372.

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43. Plaintiff alleges that Medtronic breached express and/or implied warranties that

Infuse was "safe[]." CompI. ~ 50. For Plaintiff to prevail on this claim, a jury would need to find

that Infuse "was not safe and effective" as labeled. Gavin, 2013 WL 3791612, at *15-16

(emphasis added); Hafer, 2015 WL 1648978, at *16 (same); Caplinger I, 921 F. Supp. 2d at

1222 (same); Lawrence, 2013 WL 4008821, at *5 (same). But that would conflict with the

FDA's conclusive determination in granting premarket approval that "there is a 'reasonable

assurance' of the device's 'safety and effectiveness.'" Riegel, 552 U.S. at 318. Because the

imposition of state-law liability for the alleged breach of a purported warranty as to the safety or

effectiveness of medical device that has received premarket approval would effectively require

that such a device be safer or more effective than demanded by the FDA, "[cjourts have

consistently found that state law claims for breach of warranties based on the safety or

effectiveness of [such a] device, impose requirements 'that are different from, or in addition to'

federal regulations, and thus are preempted." Thomas v. Alcon Labs., 2013 WL 10888983, at *5

(N.D. Ga. 2013) (dismissing express-warranty claim as expressly preempted under § 360k(a))

(quoting Riegel, 552 U.S. at 330, in tum quoting 21 U.S.C. § 360k(a)(I)); see also, e.g., Leonard,

2011 WL 3652311, at * 1 0 (dismissing as expressly preempted express-warranty claim based on

allegation that the manufacturer had "expressly warranted the [device] to be safe and highly

reliable").

44. In opposition to Medtronic's motion to dismiss, Plaintiff made no effort to defend

the viability of his implied-warranty claim. In support of his express-warranty claim, Plaintiff

argued that this Court should follow Cline, 914 F. Supp. 2d at 1300, and Horn v. Boston

Scientific Neuromodulation Corp., 2011 WL 3893812, at *12-13 (S.D. Ga. 2011), both of which

allowed certain express-warranty claims to proceed. But Cline and Horn are readily

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distinguishable, because in each case the warranty at issue was ''unrelated to safety or efficacy."

Cline, 914 F. Supp. 2d at 1299; see also Horn, 2011 WL 3893812, at *10 ("Plaintiff is not suing

for a breach of a promise about safety, effectiveness, or any other requirement imposed by the

FDA or the PMA."); see also Thomas, 2013 WL 10888983, at *5 n.8 (distinguishing Horn).

Here, by contrast, the purported warranty at issue relates to the "safe[ty]" of the Infuse device.

CompI. ~ 50.

45. Even if they were not expressly preempted, Plaintiffs express- and implied-

warranty claims would fail in any event because any warranty claims implicating the safety or

effectiveness of a PMA-approved medical device-such as the warranty claims asserted here­

are, at the very least, impliedly preempted. As the U.S. Court of Appeals for the Eighth Circuit

has explained, "[t]o succeed" on such claims, plaintiffs "must persuade a jury that [the devices in

question] were not safe and effective, a finding that would be contrary to the FDA's approval" of

those devices through the PMA process. Bryant, 623 F.3d at 1208; accord Hafer, 2015 WL

1648978, at *16; Ledet, 2013 WL 6858858, at *5-6; Gavin, 2013 WL 3791612, at *15;

Caplinger I, 921 F. Supp. 2d at 1222. For that reason, such "warranty claim[s] interferer] with

the FDA's regulation of Class III medical devices and [are] therefore conflict preempted."

Bryant, 623 F.3d at 1208; accord, e.g., Hafer, 2015 WL 1648978, at *16 ("Plaintiffs' allegations

of a breached warranty of safety and effectiveness directly contradict the FDA's analysis of

safety and effectiveness.").

46. Regardless whether they avoid preemption under federal law, Plaintiff's failure-

to-warn claims fail as a matter of Georgia law, because at the time of Plaintiffs surgery,

Medtronic had no duty to warn Plaintiff or his surgeon. Medtronic had no duty to warn Plaintiff

directly, because "the manufacturer of a prescription drug or medical device does not have a duty

21 A TL 20829328v1

to warn the patient of the dangers involved with the product, but instead has a duty to warn the

patient's doctor, who acts as a learned intermediary between the patient and the manufacturer."

McCombs v. Synthes (U.S.A.), 277 Ga. 252,253 (2003); see also Williams v. Am. Med. Sys., 248

Ga. App. 682,685 (2001); Presto v. Sandoz Pharm. Corp., 226 Ga. App. 547, 548 (1997); Lance

v. Am. Edwards Labs., 215 Ga. App. 713, 716 (1994). At the time of Plaintiffs 2012 surgery,

Medtronic had no duty to warn Plaintiffs surgeon, because where '''[a] product is vended to a

particular group or profession, the manufacturer is not required to warn against risks generally

known to such group or profession.'" Exxon Corp. v. Jones, 209 Ga. App. 373, 375 (1993)

(quoting Eyster v. Borg-Warner Corp., 131 Ga. App. 702 (1974». Here, Infuse's FDA-mandated

label and the FDA 2008 Public Health Notification establish that the very risks Plaintiff allegedly

encountered were already known to the medical community.

47. Having failed to respond to Medtronic's arguments, Plaintiff effectively concedes

that his claims under Georgia's Fair Business Practices Act and Uniform Deceptive Trade

Practices Act fail. The former exempts from its scope any "[a]ctions or transactions specifically

authorized under laws administered by ... any regulatory agency of ... the United States."

O.C.G.A. § 10-1-396(1). The latter exempts from its purview "[cjonduct in compliance with the

orders or rules of or a statute administered by a federal ... agency." Id. § 10-1-374(a)(1).

Because it is undisputed that the FDA granted premarket approval to-and thereby authorized

sale of-the Infuse device, Plaintiff cannot rely on either statute. Plaintiffs statutory claims also

fail because the Fair Business Practices Act applies only to "consumer transactions," not the sale

of prescription medical devices (see id. §§ 10-1-392(a)(lO), 10-1-393),6 and because only

6 "Consumer transactions" are limited to sales (and certain other transactions) "for personal, family, or household purposes." O.C.G.A. § 10-1-392(a)(10). "Infuse, a prescription medical device, is not purchased for personal use, but is instead prescribed by a doctor and

22 A TL 20829328v1

injunctive relief, not damages, is available under the Uniform Deceptive Trade Practices Act

(see, e.g., Energy Four, Inc. v. Domier Med. Sys., Inc., 765 F. Supp. 724, 731 (N.D. Ga. 1991».

48. Plaintiffs fraud claims fail in any event, because they are not pleaded with the

requisite particularity. "In all averments of fraud or mistake, the circumstance constituting fraud

or mistake shall be stated with particularity." O.C.G.A. § 9-11-9(b).7 Plaintiff generally alleges

that Medtronic misrepresented the risks supposedly associated with cervical use of the Infuse

device (Compl. ~~ 33, 37), but does not specifically allege what misrepresentations were made,

by whom they were made, to whom they were made, or when they were made. And although

Plaintiff "alleges generally that Medtronic paid spine surgeon 'opinion leaders' to promote off-

label use of the Infuse Device" (Kashani-Matts, 2013 WL 6147032, at *5; cf Compl. ~ 13), such

installed in a patient." Otis-Wisher, 951 F. Supp. 2d at 601 (dismissing claim brought under Vermont consumer protection statute). Although this appears to be a question of first impression in Georgia, courts applying other jurisdictions' similarly worded statutes have repeatedly held that prescription medical devices, such as Infuse, are not consumer goods because they are not directly available to the general public, but require a physician's prescription. See, e.g., Reeves v. Pharma.Iet, Inc., 846 F. Supp. 2d 791, 798 n.2 (N.D. Ohio 2012) (finding that a "prescription medical device is not a good for personal, family or household use and thus is not a consumer good" under Ohio law); In re Minn. Breast Implant Litig., 36 F. Supp. 2d 863, 876 (D. Minn. 1998) (noting that surgically implanted medical devices are not consumer products under the Magnuson-Moss Act, which defines consumer products as those "normally used for personal, family or household purposes"); Goldsmith v. Mentor Corp., 913 F. Supp. 56, 63 (D.N.H. 1995) (finding that the prosthetic heart valve was not a consumer product under the Magnuson-Moss Act); Kanter v. Warner-Lambert Co., 122 Cal. Rptr. 2d 72, 86 (Ct. App. 2002) (head lice treatment is not a "consumer product" for purposes of Magnusson-Moss Act); Hogan v. Maryland State Dental Ass'n, 843 A.2d 902,906 (Md. Ct. Spec. App. 2004) (holding that dental fillings are not "consumer goods" under Maryland statute because they are "selected and used by a practitioner as part of a professional service"). 7 Because they are based on "averments of fraud or mistake," Plaintiff's claims under Georgia's Uniform Deceptive Trade Practices Act and Fair Business Practices Act are subject to O.C.G.A. § 9-11-9(b). "Most courts construing claims alleging violations of the Federal Deceptive Trade Practices Act or its state counterparts have required the heightened pleading standards of Rule 9(b)." Stires v. Carnival Corp., 243 F. Supp. 2d 1313, 1322 (M.D. Fla. 2002). And the Fair Business Practices Act "differs from common law fraud" only insofar as "it eliminates two of the five required elements of fraud: scienter and intent to deceive." Campbell v. Beak, 256 Ga. App. 493, 498 (2002).

23 A TL 20829328v1

allegations are insufficient to sustain Plaintiffs fraud claims, because "off-label marketing ... is

itself not inherently fraudulent." In re Actimmune Mktg. Litig., 614 F. Supp. 2d 1037, 1051 n.6,

1054 (N.D. Cal. 2009), aff'd, 464 F. App'x 651 (9th Cir. 2011). To avoid dismissal under

O.C.G.A. § 9-11-9(b), Plaintiff must identify a particular misrepresentation attributable to

Medtronic on which his surgeon reasonably relied. See, e.g., Martin, 32 F. Supp. 3d at 1040;

Houston I, 957 F. Supp. 2d at 1180-81; Lawrence, 2013 WL 4008821, at *7; Angeles I, 2014

WL 1649684, at *4-6. Here, the complaint "is lacking in substantive, nonconclusory facts."

Kashani-Matts, 2013 WL 6147032, at *5. It does not identify with particularity any purportedly

false statement upon which Plaintiff or his surgeon supposedly relied, justifiably or otherwise.

Accordingly, Plaintiffs fraud and misrepresentation claims must be dismissed. See Fortson, 313

Ga. App. at 328 (affirming dismissal where complaint "failed to allege any specific facts to state

a cause of action for fraud"); see also Fairfax, 312 Ga. App. at 172; Little v. Fleet Fin., 224 Ga.

App. 498, 500 (1997).

49. Similarly, Plaintiffs design-defect claim must be dismissed because it does not

meet the basic pleading requirements of O.C.G.A. § 9-11-8(a)(2)(A). To avoid dismissal, a

complaint "must contain more than a formulaic recitation of the elements of a legal cause of

action." Wesley Educ. Found., Inc., 282 Ga. at 714. Here, Plaintiff has not identified any

particular design feature of the Infuse device that is alleged to be defective.

50. Plaintiffs warranty claims would have to be dismissed, even if they were not

preempted by federal law. To recover for a breach of warranty under Georgia law, a plaintiff

must demonstrate privity between himself and the defendant. "[I]f a defendant is not the seller to

the plaintiff-purchaser, the plaintiff as the ultimate purchaser cannot recover on the implied or

express warranty, if any, arising out of the prior sale by the defendant to the original purchaser,

24 A TL 20829328v1

such as distributor or retailer from whom plaintiff purchased the product." Lamb v. Georgia-

Pacific Corp., 194 Ga. App. 848, 850 (1990) (internal quotation marks omitted). Thus, in Gowen

v. Cady, 189 Ga. App. 473, 476 (1988), the Georgia Court of Appeals held that because there

was no privity between a hospital patient and the manufacturer of the medical devices used to

treat that patient, she could not assert breach-of-warranty claims against the device manufacturer.

See also Andrews v. RAM Med., Inc., 2012 WL 1358495, at *3 (M.D. Ga. 2012) (patient treated

with medical device at a hospital may not maintain action against manufacturer); In re Mentor

Corp. ObTape Transobturator Sling Prods. Liab. Litig., 711 F. Supp. 2d 1348, 1366 (M.D. Ga.

2010) (same). Here, Plaintiff does not allege that he was in privity with Medtronic.8 Accordingly,

his warranty claims must be dismissed.

51. Plaintiffs warranty claims would fail even if he had been in privity with

Medtronic, because Medtronic disclaimed all warranties. Georgia law recognizes that a

manufacturer may disclaim express and implied warranties. See O.C.G.A. § 11-2-316. In this

case, Medtronic has done exactly that. Infuse's FDA-approved label clearly states that "[n]o

warranties, express or implied, are made" and that "[i]mplied warranties of merchantability and

fitness for a particular purpose or use are specifically excluded." Lockard Aff. Ex. 3, at 5. This

unambiguous declaration defeats any implied or express warranty claim, including any based on

alleged statements outside the Infuse device's labeling. See Stephens v. Crittenden Tractor Co.,

187 Ga. App. 545, 548 (1988) (seller's clear disclaimer of warranty negated conflicting

statements and representations alleged to have been made by seller's employees); accord Gill v.

8 Plaintiff cannot allege that he was in privity with Medtronic. Pursuant to 21 U.S.C. § 360e(d)(I)(B)(ii), the FDA has designated Infuse a "restricted device" (21 U.S.C. § 360j(e)); "[ t ]he sale, distribution, and use of th[ e] device are" therefore "restricted to prescription use in accordance with 21 CFR § 801.109." Lockard Aff. Ex. 2, at 1; see also id. Ex. 3, at 1. Thus, Medtronic may sell the Infuse device only to doctors and hospitals, not patients.

25 A TL 20829328v1

Bluebird Wanderlodge, 2004 WL 5311477, at *3-4 (M.D. Ga. 2004) (same); see also Scanlon,

61 F. Supp. 3d at 413 (dismissing warranty claim arising from off-label use of Infuse given

"conspicuous disclaimer of all warranties" on device's FDA-approved label); Scovil v.

Medtronic, Inc., 995 F. Supp. 2d 1082, 1097-98 (D. Ariz. 2014) (breach-of-warranty claim fails

because the Infuse label "conspicuously disclaimed all warranties").

52. Finally, because Plaintiff's complaint fails to identify a specific express warranty

that Medtronic purportedly made, his express warranty claim is inadequately pleaded. A

complaint must '''give the defendant fair notice of what the ... claim is and the grounds upon

which it rests'" and "must contain more than a formulaic recitation of the elements of a legal

cause of action." Wesley Educ. Found., 282 Ga. at 713-14 & n.7. Thus, "when a pleader seeks to

allege a cause of action based on an express warranty, the petition must expressly set forth these

essential allegations, or the facts otherwise alleged must demand the inference that the warranty

relied on was made, and understood by both parties, to be applicable to the particular sale

involved, or the petition will be subject to a general demurrer." Atlanta Tallow Co. v. John W

Eshelman & Sons, Inc., 110 Ga. App. 737, 750 (1964). Because Plaintiff has not alleged any

facts that would suggest the existence of an express warranty, his express-warranty claim must

be dismissed.

53. Given these findings and conclusions, Medtronic's Motion to Dismiss is

GRANTED and all of Plaintiff s claims against Medtronic, Inc. and Medtronic Sofamor Danek

USA, Inc. are hereby dismissed with prejudice. Pursuant to O.C.G.A. § 9-11-54(b), the Court

finds there is no just reason for delay and directs the entry of final judgment in favor of

Medtronic, Inc. and Medtronic Sofamor Danek USA, Inc. on all claims as indicated above.

26 A TL 20829328v1

The Honorable Wendy Shoob Judge, Superior Court of Fulton County, Georgia

ORDER PREPARED BY: Lori G. Cohen Victoria Davis Lockard Evan C. Holden

GREENBERG TRAURIG LLP 3333 Piedmont Road NE, Suite 2500 Atlanta, Georgia 30305 (678) 553-2100 (678) 553-2212 (fax)

Andrew E. Tauber (pro hac vice)

MA YER BROWN LLP 1999 K Street, NW Washington, DC 20006-1101 (202) 263-3324 atauber@mayerbrown.com

Attorneys for Defendants Medtronic, Inc. and Medtronic Sofamor Danek USA, Inc.

Copies via email.

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