Elizabeth and Clifford Kemp v. Medtronic, Inc.

IV above, forth set the reasons

For court is the district

judgment of

AFFIRMED. KEMP, and Clifford

Elizabeth

Plaintiffs-Appellants,

v.

MEDTRONIC, INC., Defendant-

Appellee.

No. 99-3720. Appeals, Court of

United States

Sixth Circuit. 3, 2000 May

Argued: Nov.

Decided and Filed: plain- found court The district law.

Ohio either were tiffs’ claims genuine issue present or failed MDA summary fact, awarded of material Medtronic, defendant-appellee judgment reasons set (“Medtronic”). For the Inc. of below, judgment we affirm forth court. district

I. BACKGROUND Eliza- plaintiff December In late the Bethesda to was admitted Kemp beth com- Room Emergency Hospital North weakness, dizziness, profound plaining testing revealed malaise. Cardiac and In order block. atrioventricular complete heartbeat, on Kemp’s Mrs. regulate im- 2, 1992, surgically doctors January and pacemaker a Model 4004M planted briefed), and (argued M. Utter Gregory Medtron- by defendant lead, manufactured (briefed), Keating, Gilligan Francis Louis ic, Inc. OH, Cincinnati, Klekamp, Muething & later, in June years than three More Appellants. began experiencing Kemp Mrs. briefed), (argued and M. Parker Thomas at- fainting spells, and current dizziness An- & (briefed), Roetzel Sanjay Varma K. Model of her the failure tributable OH, A. Akron, Karen Carroll dress, regu- properly lead pacemaker 4004M Cincinnati, Andress, (briefed), Roetzel & 4, 1995, Then, on June late her heartbeat. OH, Appellee. garage in the Kemp fainted while Mrs. floor. the concrete fell to home and her GILMAN, Circuit and MOORE Before: head, fall, hit her she of her a result As McKEAGUE, Judge.* District Judges; headaches, pain, facial suffering awoke and It was later determined pain. and neck J., McKEAGUE, D. delivered by bilat- were caused symptoms that these GILMAN, J., court, which opinion of blood These hematomas. eral subdural 237-38), MOORE, (pp. J. joined. pres- to relieve surgery required clots concurring opinion. separate delivered skull, after and even Kemp’s sure Mrs. loss experience continued surgery she OPINION ca- and motor cognitive and sight, speech, McKEAGUE, Judge. District Kemp spent Mrs. Consequently, pability. hospitals us to determine requires and out of appeal months in This three some continues rehabilitation, Amendments she Device and the Medical whether and seq., et from resulting §§ (“MDA”), disorders 21 U.S.C. 360c related of 1976 suffer in her fall. Food, Cosmetic Drug injuries sustained to the Federal seq., §§ 301 et preempt Act, 21 U.S.C. Development the Medtronic A. liabili- products common law 4004M Model se, negligence per ty alleging tort claims Med- dispute this center of At the Drug Administra- the Food fraud on lead, the pacemaker tronic’s under (“FDA”), failure warn tion * designation. sitting by Michigan, McKeague, United W. David Honorable District Judge for the Western States District implanted device in Mrs. A Kemp. pace- material, as inner insulation and designed device, maker lead is a medical used in the 4004M lead to have inner and outer (com- conjunction pulse generator with a conductor coils with a platinum sputter monly referred pacemaker), to as a that is coating. barrier represented designed to rhythm monitor and correct that the addition of platinum sputter irregularities in the human heart. Before prevented better the coils from metal-ion pacemaker a new may lead oxidation, marketed degradative process observed sold to public, the manufacturer pacemaker earlier employing models must first receive one of forms of polyurethane (such various insulation pelleth- governmental ane). clearance from the FDA. In In its 4004M PMA Supplement, 1982, the FDA granted Medtronic an in- Medtronic represented that platinum vestigational exemption from the sputter functioned as a barrier between (“PMA”) premarket approval process to pellethane fluids, insulation and bodily permit clinical 4003, trials of the Model a preventing direct contact and avoiding predecessor to the Model 4004M. Follow- metal-ion oxidation. The addition of this trials, ing clinical Medtronic submitted the platinum sputter coating constituted a Model 4003 to the FDA for a complete manufacturing design and change necessi- PMA review. After the FDA accepted, tating the filing of a Supplement reviewed, and evaluated the applica- with the FDA. tion, it was panel referred to a of experts. The FDA approved the Model 4004M panel specifically compared the per- PMA Supplement 28, on March 1990. formance of silicone and polyurethane as Thereafter, however, an inspection insulating and materials concluded that significant revealed a risk of failure for the options both physi- should available 4004M lead degradation due to poly- cians. The Model ultimately material, urethane insulating and Octo- PMA approval ceivеd from the FDA on 1993, ber Medtronic issued a Health and 29, July Safety Alert recalling 74,000 some Model later, years 18, 1988, Two July Med- 4004M leads. tronic submitted a PMA Supplement to the 4004,

FDA for the Model proposed B. Procedural Posture significant several modifications to the 24, January On Kemp Elizabeth Model 4003. In addition to the Model and Medtronic, her husband Clifford sued specifications already approved by alleging ten common law statutory FDA, the Model 4004 PMA Supple- products liability tort claims under Ohio addressed, others, ment among modifica- Moving law. for summary judgment, incorporating tions the use of insulation Medtronic argued plaintiffs’ all of state law made of pellethane polyurethane. 80A claims were preempted by express 31, 1989, On October Medtronic filed a provision MDA, preemption 360k. application for the Mod- The United District States Court for the el 4004M bipolar lead. A lead like the largely Southern District of Ohio agreed, 4004M pacemaker Model lead finding consists the MDA preempted plaintiffs’ coil, an inner conductor outer conductor products liability strict claims defective coil, insulation, inner and outer insulation. design, warn, failure and nonconfor- fail, Should the inner insulation the lead representations, mance to well as their may circuit, short fail to sense the claims for negligent design, negligent fail- occurs, heartbeat. If warn, such failure then ure to express breach of and implied pacemaker regulate cannot warranties, heart- misrepresenta- fraudulent properly, arrhythmia beat or arrest tion with respect ap- medical devices may result. Medtronic manufactured the proved through the ap- FDA’s premarket using pellethane Model 4004M process. 2326-80A proval The district court did not liability for a manufactur- strict claim for totally preempted MDA find however, ing defect. claims, and ruled devi- Model 4004M alleging the any claims motion to de- Medtronic’s Addressing were specifications ated from requirements applica- specific termine per- court then The district preempted. 4004M, the district to the Model ble com- file an amended mitted the Model 4004M PMA reviewed court that effect. plaint to and determined six established approval process January plain- Accordingly, determining requirements. com- amended eight-count filed an tiffs the district court requirement, sixth complaint amended I of the plaint. Count ruled: Medtronic’s per se for alleges negligence there The sixth Model 4004M to manufacture the failure be- barrier coat protective must be a FDA standards with the accordance insula- coil and the the conductor tween by the imposed tion, platinum composed which is alleg- II Count Supplement. 4004M PMA Pages appears And that sputtering. failure for Medtronic’s negligence per se es VI-52 and VI-61. (1) change order engineering an submit within specifications other There are coverage of varied the thickness I don’t think Supplement. the (2) coating; provide sputter рlatinum the the most they because for are relevant FDA; the A test results to Solution to the electrodes they relate part (3) biostability test results canine provide emitted and type of be steroid required by representations as in this not at issue things which are III-VII Supplement. Counts in case. in the event Med- allege claims that arise Paragraphs I would note product different manufactured a tronic complaint of the amended through 60 Finally, the FDA. approved from that sputtering allege platinum must claim for presents a derivative VIII Count plaintiffs allege this consistent. And plaintiff of consortium on behalf of loss of Medtronic’s on the basis entirely dependent Kemp, which Clifford winding process of coil description wife’s claims. upon his winding examination of post and the being But I not see this wires. do 22, 1999, Medtronic moved January On design specification. all pleadings on judgment for allegations Para- There are also except complaint counts of amended changed graph 135 that I, claims arguing plaintiffs’ Count for coverage and thickness analysis pursuant were That is not a platinum sputtering. 12, 1999 January in the district court’s Supplement. The of the PMA part filed that separate In a motion order. sput- regarding platinum specifications judicial for a day, Medtronic moved same very are tering in the PMA “specific federal re- of the determination me appear it does not general, and to the Model quirements” level required particular that the pre- at a Ruling from the bench 4004M. platinum sputtering. granted court hearing, the district trial court then The district on the J.A. at 2941-42. judgment for motion Medtronic’s in the amended com- II, IV, V, VI, paragraphs and VII struck pleadings on Counts improperly alleging plaint The dis- complaint. amended barrier, sputter failed platinum altered the motion granted court also Medtronic’s trict A and canine biostabili- provide Solution on Count judgment pleadings results, failed to warn ty test complaint, except III of the amended Model 4004M learned a of defects that it could be read to assert the extent Food, after Federal Drug and Cosmetics Act to Supplement. regulate allow the FDA to medical devices. The MDA divides medical devices into remaining Plaintiffs’ claims in I Counts three categories, or classes. The most negligence and III asserted per se and strict FDA regulation is reserved for Class liability, respectively, alleged strict devices, (1) III defined as those which: are Medtronic failed to manufacture the Model to be used supporting or sustaining 4004M according specifications. to FDA human life or that are of substantial im- The final alleged claim Count VIII portance in preventing impairment pub- derivative loss of consortium claim on be- (2) health; lic present potential unrea- Thereafter, half of Kemp. Clifford Med- sonable injury. risk illness or See 21 tronic again summary moved for judg- 360c(a)(l)(C)(ii)(I-II). U.S.C. To market ment, granted and the district court III Class device within the United opinion motion a written April dated Stаtes, the manufacturer must either sub- mit product its to the FDA for premarket (“PMA process”), or qualify for II. STANDARD OF REVIEW exceptions one of two to this time-intensive This Court reviews a district court’s regulatory review. The PMA process in- grant summary judgment de novo. See scrutiny volves close Terry Agency, Barr Sales Inc. v. All-Lock FDA, and approval requires that the FDA Co., Inc., (6th Cir.1996). 96 F.3d conclude that it has received “reasonable A summary motion for judgment should be assurances of safety [the device’s] and ef- granted “if the pleadings, deposition, an- fectiveness” from the Id. manufacturer. swers to interrogatories, and admissions 360c(a)(l)(C). end, To that manufactur- file, affidavits, together any, with the if provide ers must the FDA with samples of show that there is no genuine as to issue device, an outline of the device’s com- any material fact and that moving par- ponents, a description of the manufactur- ty is entitled a judgment to as a matter of ing process, copies proposed labels, of the 56(c). law.” Fed.R.Civ.P. summary On other various information. 21 See judgment, the Court views the and all facts 814.20(b). § C.F.R. The FDA then reviews inferences drawn therefrom in light such submissions for an average of 1200 most favorable to the nonmoving party. hours before either approving disap- or Co., See Matsushita Elec. Indus. Ltd. v. proving .150; §§ the device. Id. see 812.1— Corp., 574, 587, Zenith Radio 475 U.S. 106 also Collagen Mitchell v. Corp., 126 F.3d (1986). S.Ct. 89 L.Ed.2d 538 (7th.Cir.1997). 905 A may gain regulato- manufacturer also III. ANALYSIS ry for a Class III through clearance device appeal presents This fractious issues one of twо exemptions from the pro- PMA sharply have divided various First, permits cess. the statute devices circuit courts which have considered them: “substantially are equivalent” to medi- express preemption whether the provision cal devices in existence 1976 mar- to be MDA, 360k, § preempts law state keted and approval, sold without PMA tort of action negligence, causes “fraud order not to stifle competition with tech- FDA,” on the and failure to warn commit- nology existing at the time of enact- ted a defendant manufacturer of a ment of the MDA. See 21 U.S.C. Class III prior both subsequent device § 360j(g)(l). This limited form of review having to FDA approval received “premarket is known as notification” or PMA Supplement. 510(k) § process,” “the and averages only 1976, Congress enacted the Medical 20 hours opposed of review as some to Amendments, Device which modified the 1200 hours in the process. PMA Mar- See 222 to, of, defect or known adverse reaction Sys., 105 F.3d Pacing

tin v. Telectronics Furthermore, (6th Cir.1997); device. approved Reeves v. 1090, 1095 FDA, (5th report must 446 manufacturer F.3d Corp., 103 AcroMed chemical, oth- Cir.1997). physical or “[a]ny significant in the or deterioration device change er Second, innovative representing devices speci- to meet the of the device failure an in- marketed under technology may be approved in the fications established (“IDE”), an exemption device vestigational cause or contribute death could ‍​​​‌​‌​‌‌‌‌​‌‌‌‌‌​​‌​​‌​‌​‌‌‌‌​​​​​​‌​​‌‌‌‌‌​​‌‌‍allows for rеgimen experimental are not correctable injury but or serious in human to be utilized devices unapproved pro- adjustments or other maintenance permits An IDE manufacturer trials. approved in the label- cedures described would be that otherwise market “a device origi- (emphasis at 997-99 ing.” J.A. performance with a comply required nal). premarket or to have standard conducting investiga- purpose for the PREEMPTION PRINCIPLES IV. 21 812.1. that device.” C.F.R.

tions of under the Accordingly, operating a device Express Preemption Sec- A. Under pre- exemption comply IDE need not 360k tion during the approval requirements market Supremacy The Clause 360j(g); 21 trial See U.S.C. period. provides Constitution United States §§ C.F.R. 812-813. ... shall of the United States the “Laws merely propose manufacturer Should Law of the Land.” U.S. supreme be the III that has al- modify a Class Const, VI, Hence, law that cl. 2. “state art. ready approval pursuant received ef law is hvithout conflicts with may sub- process, the manufacturer ” Inc., Group, Cipollone Liggett v. fect.’ than rather re- mit 504, 516, 2608, 120 U.S. S.Ct. for review. submitting the entire device (1992). Central determin L.Ed.2d 407 814.39, pro- §§ 814.80. See C.F.R. preemption divining ing questions of a PMA applicable cedures 517-18, Congress’ intent. Id. to an as those are the same importance of In view of the historic PMA, only although the original areas, police the these states’ federalism provide the manufacturer quires safety public health and powers relating pro- the necessary support information by fedеral unless are not law § 814.3(g). posed modifications. See id. clearly ex to do so is Congress’ intent to a grants approval If the Flori Hillsborough pressed. County, See Supplement, it does application or a PMA Inc., Labs., 471 Medical da v. Automated in a subject so to conditions described 2371, 707, 715, 85 L.Ed.2d 105 S.Ct. U.S. Approv- of entitled document “Conditions here, (1985). Moreover, where as (1) the three-page requires form al.” This express an Congress preemp has included labeling proposed to submit manufacturer statute, may not provision in a a court tion (2) limits prior marketing; of the implied preemp it to consider beyond look labeling advertising FDA-approved Rather, “Congress’ enactment tion. “[bjefore (3) device; specifies that for the pre-emptive reach of provision defining safety or making any change affecting the beyond that that matters implies a statute device, manufac- [the effectiveness Cipollone, pre-empted.” are not reach turer submit a PMA shall] at 112 S.Ct. 2608. U.S. (4) FDA;” requires approval by and review lies dispute At the center of the instant post-approval the manufacturer to submit MDA, expressly which section the date 360k reports one-year at intervals from (5) law certain state requires preempts and approval; of FDA devices: medical any governing incidents report manufacturer political State or subdivision of a [N]o 2240. Proceeding from this point of initial may State establish or continue in agreement, however, effect the Justices’ under respect to a standing device intended for diverged. Stevens, Justice writ any ing human use requirement— Justices, himself and three other rejected the (1) defendant’s assertion from, different addi- § 360k preempts all common to, law suits be any requirement tion applicable un- such always cause claims constitute device, “re chapter der this quirements.” Stevens reasoned that (2) safety which relates to the or effec- broad urged by construction defendant tiveness of the device or to other “require far greater interference matter included in a appli- remedies, legal with state producing a seri cable to the device chapter. under this ous intrusion into state sovereignty while 360k(a). 21 U.S.C. simultaneously wiping out the possibility of Medtronic, Inc. v. Lohr B. remedy for [plaintiffs’] alleged inju 488-89, 116 ries.” Id. at S.Ct. 2240. Medtronic, Lohr, In Inc. v. 518 U.S. (1996), 135 L.Ed.2d 700 Justice opinion Stevens’ found support Supreme Court question addressed plain in the language §of 360k. He rea- the MDA whether preempts various com- soned that the use of the “require- term mon tort law claims. device in Lohr ment,” rather than the term “remedy,” review, had not undergone a PMA but had indicated that Congress intended to approved been instead pursuant to the preempt “device-specific enactments of “substantially equivalent” exception found positive by law legislative or administra- 510(k). §in decision, In a five to four bodies, tive not the application general Court held that none of com- rules of common by judgеs law and ju- mon law tort preempted by claims were 487-88, ries.” Id. at 116 S.Ct. 2240. Ac- the MDA. 501-02, U.S. 116 cordingly, plurality concluded “that S.Ct. 2240. Justice plurality Stevens’ Congress 360k, when enacted it was opinion joined was by Kennedy, Justices primarily concerned with the problem of Souter, and Ginsburg. Justice O’Connor specific, conflicting statutes reg- state in part concurred in part, dissented ulations general rather than the duties en- opinion joined her by was the Chief forced common-law actions.” Id. at Justice, and Justices Scalia and Thomas. 489, 116 S.Ct. 2240. Breyer part Justice concurred in and in Reaching conclusion, the opposite Jus- judgment, joined five of the seven opinion joined tice O’Connor an wrote parts Justice opinion. Hence, Stevens’ three other in dissent. Justices their five sections Justice opinion Stevens’ view, a duty common-law within came (Sec- in which Breyer Justice concurred meaning of the “requirement” term II, III, I, VII) tions V and form opin- in used 360k because common law ion of in the Court Lohr. of action “operate causes to require manu-

Because the MDA contains an express facturers to comply with common-law provision, preemption majority a 510, duties.” Id. at 116 S.Ct. 2240. agreed that (O’Connor, J., Justices the issue devolved to in concurring part and dis- determining the extent to which the MDA senting part). Therefore, in these four a preempts law state claims. Id. would hold a reading” Justices “fair of at Furthermore, 116 S.Ct. 2240. the statute “indicates that state common- speaking majority for a in Court prеempted law claims are ... to the extent V, Part Justice Stevens concluded that the recognition their impose ‘any would Lohr plaintiffs could requirement’ from, maintain at least in different or addition some to, state tort law for actions violations of FDCA to the regulations. 494-95, Id. at 116 S.Ct. device.” Id. at 116 S.Ct. 2240. imposed care or of behavior standard joining Jus- the Justices contrast

stark to action. tort a state-law block the O’Connor opinion, tice Stevens’ law 504-05, 116 common that the state 2240. not believe S.Ct. did Id. at preempted. “specific” to to be had appeals of courts The various common- Rather, reasoning, under their aris preemption issues of confronted have they im- if preempted claims were law mighti struggled have the MDA ing under from, in or “different obligations posed in the effort language with Lohr’s ly of federal to,” requirement addition Part of Justice Ste holding. V its discern (“The however, makes no mention Justice Id. statute in which opinion, law. vens’ concurred, helpful guida there is specificity, and requirement provides Breyer in First, ambiguity a that such both determining “[t]he nce.1 basis no sound exists.”). grant the congressional statute —and ‘any requirement’ on restriction matter con on the authority agency and in concurring part in Breyer, Justice a ‘sound basis’ provide within tained it— explicitly nevertheless judgment, agen weight giving substantial interpreta- O’Connor’s agreed Justice Id. cy’s statute.” view law certain common causes tion that Second, attempting de 2240. S.Ct. “require- state could constitute aсtion duties constitut common law termine what federal conflict with that would ments” the Court “requirements,” ed preempted. thus be “requirements” explain that: took pains invite anomalous To hold otherwise ov [the Act’s] impossible ignore it is Breyer, Justice consequences, ‍​​​‌​‌​‌‌‌‌​‌‌‌‌‌​​‌​​‌​‌​‌‌‌‌​​​​​​‌​​‌‌‌‌‌​​‌‌‍reasoned oc pre-emption erarching concern to illustrate hypothetical a set forth who a state re only particular where cur analysis: his a to interfere with threatens quirement The stat federal interest.... specific that, particu- respect Imagine a therefore, a require regulations, ute and federal component, a hearing lar aid alleged comparison careful between wire, a requires 2-inch regulation MDA requirement and ly pre-empting a regulation requires agency a state but require state pre-empted allegedly law, If the federal embod- wire. 1-inch they fall to determine whether ment regulation, agency “2-inch” ied scope of pre-emptive the intended within agency “1-inch” the state pre-empts regulations. statute similarly it not why would regulation, 499, 116 Id. at tort action pre-empt state-law circuit courts that Consequently, those liability upon defendant premises question have considered a 1-inch failure to use manufacturer’s § 360k of the MDA effect of preemptive by jury persuaded (say, an wire award emphasis translated Lohr’s have testimony that the use of expert (1) whether regulations focus negligent)?.... than wire is more 1-inch countеr- specific FDA has established that ordinari- I believe Consequently, or regulations other part pre-empts MDA state ly, (2) insofar as the applicable to that are requirements; statute, (3) in a device; embodied state make and thus state particular from, rule, or other administrative addition regulation, different regulations to, requirements. See action, pre-empt specific a similar it would also 910; In Mitchell, accord re F.3d at 126 of a takes the form States, 430 U.S. v. grounds." Marks United single no rationale commands 1. When 990, 193, 188, L.Ed.2d 260 51 Supreme agreement Court, Justices of the of five Hence, (1977). Breyer’s concurrence Justice holding may be viewed “the interpret- in heightened significance takes by Members who con- position taken those holding. ing narrowest Lohr’s on the judgment curred in the Orthopedic Bone Liability Screw Products suffered. In a opinion unanimous affirm- (3d Litig., 159 F.3d ing Cir. the district grant court’s of summary 1998)(“Bone I”); Screw Goodlin v. judgment Med defendant, to the this Court (11th tronic, Inc., that, 167 F.3d Cir. noted general “unlike the federal re- 1999). However, require state or local quirements Medtronic, in discussed merely ments that “affect regulations devices” are not governing investigational de- if regulations such are not “re essentially vices are device specific.” Id. quirements applicable to a device” within at 1097. The Martin court further ob- the meaning of.the MDA. served that “there are no specific regula- governing pacemakers tions like the one Specific Requirements

C. Federal issue; hoiuever, аpplication at approval process under the IDE is Hence, device matter, as a threshold we must added). specific.” (emphasis Id. Reason- first determine whether the FDA has es- ing that the extensive review un- specific tablished requirements ap- by dertaken the FDA explored “the plicable to the pacemaker Model 4004M methods, facilities, and controls used for through PMA process. Plaintiffs draw device,” manufacture of the Martin went our attention to the recent decision of the on to affirm the district ruling court’s Eleventh Circuit of Appeals Court plaintiffs defect, Medtronic, manufacturing Inc., v. Goodlin 167 F.3d 1367 defect, design (11th inadequate warning, suppli- Cir.1999), which exact addressed this liability er spousal derivative claims nearly issue facts. In indistinguishable preempted by § were 360k. Goodlin, Id. With re- the Eleventh Circuit held that gard claim for nonconfor- approval of a Supplement PMA does express mance to representations, Martin establish federal requirements specific found the plaintiff waived the claim flatly device. disagree, Defendants failing to properly address- the argument arguing that our decision in Martin v. to the district court. See id. at 1100-01. Inc., Pacing Telectronics Systems, (6th Cir.1997), F.3d 1090 holding that IDE Defendant contends the logic same approval constitutes guided this Court in Martin compels a quirements, applies a to the PMA fortiori finding that FDA’s process. Supplement for the Model 4004M Martin, we question confronted the lead established device-specific require- whether common law statutory ments, tort because PMA Supplement approval (and brought claims under Ohio law were the underlying approval) is even preempted by FDA a Class more difficult to obtain than IDE approval. granted III device under the IDE exemp- Vehemently disagreeing, plaintiffs cite plaintiff tion. Martin filed suit argue Goodlin and the PMA implant after her experimental application process generally, and the —an that combined the functions of a defibril- 4004M PMA process particu- lator, cardioverter, pacemaker— larly, do not establish federal malfunctioned. See id. 1092. The specific to the device.2 Because the Elev- plaintiff then brought five claims under enth Circuit presented tackled the issue Ohio tort law for injuries that she on largely indistinguishable here facts in opinion predating In an Supreme proval “specific does not require constitute a Medtronic, Court’s 1996 decision in Inc. v. particular ment to a device” under Lohr, panel of the Ninth Circuit reversed a 808.1(d), 21 C.F.R. held 360k grant summary judgment favor preempt MDAdoes not state common law tort defendant manufacturer of a Class III device general applicability. Kennedy claims of v. undergone had approval. Focusing that upon (9th Collagen Corp., 67 F.3d 1459-60 regulations promulgated 1995) (emphasis original). Cir. FDA, opined the Ninth ap- Circuit that PMA the requirement upon any ascertainable

Goodlin, plaintiffs and held none Id. now consider device.” we preempted, were claims in analysis relation the Goodlin Goodlin, argue plaintiffs In line with case. instant require- in the absence of that Supple- PMA ments, of a approval was Kemp, Lisa Goodlin Like Elizabeth granted preemptive not be 4004M ment should with a Medtronic implanted the issu- Plaintiffs further assert effect. her heartbeat. regulate lead to pacemaker setting forth approval a form letter ance of Following receipt of the October Approval” does “Conditions of by generic Safety Alert letter issued and Health FDA, specif- FDA has established that the mean instigation at the design requirements applicable ic pacemaker to have her elected Goodlin In- 4004M. and manufacture of the Model Although her precaution. as a removed FDA has deed, note that indica- did not demonstrate pacemaker regulations re- promulgated federal failure, against never brought suit tion of Goodlin pacemaker the manufacture design garding and claiming negligent that disagree Plaintiffs also com- leads. under Florida liability products strict Supplement ruled the FDA involvement court mon law. The district IDE as that claims, is as involved process because Goodlin’s MDA propose and thus application, approved the Model the FDA had ratio- distinguish Mart» on this Court process, granted and through the ap- nale.3 summary judgment to Medtronic. On Circuit panel of the Eleventh peal, by plaintiffs’ persuaded We are not court. judgment of the district

versed the disagree with respectfully arguments, Goodlin, 167 F.3d at 1368-69. See panеl the conclusions drawn Supreme Court’s decision Parsing the impor Circuit in Goodlin. Most Eleventh whether inquired court the Goodlin what conception of con tantly, Goodlin’s produces process, “the FDA’s “requirement” is irreconcilable stitutes pro- has finding that the manufacturer analysis holding in Martin with our safety assurances of vided the reasonable specific federal approval IDE establishes necessary to market the and effectiveness in question. for the device device, necessary impo- into the translates imposes IDE no “as Although ” at requirement.’ Id. ‘specific sition of prerequisite certainable substantive process, reviewing the PMA explained 1375. After in Martin approval,” this Court concluded that PMA approval process the Goodlin court application that the only finding device-specific require approval “represents under the IDE is a preemptive market a ef proposal manufacturer’s has ment that nevertheless Martin, reasonably the FDA of F.3d at 1097. Our device has assured fect. See that advanced safety analysis comports and effectiveness” and the device’s Circuit, which has held and consider- the Seventh “[djespite specificity FDA constitutes by the approval ... neither the “PMA rigor review] able of [PMA design, testing, product’s of a device and its FDA’s actual review methods, use, per manufacturing intended agency’s information nor the supporting and is labeling” formance standards imposes of the device eventual being accuracy of information of Charles H. assume 3. Plaintiff offers the affidavit accuracy Approval of in- Kyper, presented of the Premarket Director assume Kyper avers that: prior Staff from 1981-1990. submissions. presented in formation ap- Supplement application Typically, is not re- of PMA A PMA reviews rigor a PMA. Re- viewed with the same allocat- the time plications are allocated ^lh like a is much view of a PMA ed a PMA. 510(k) application that both review J.A. 311. being presented change focus on the Mitchell, “specific product.” substantially equivalent to devices extant 913; Martin, F.3d at accord 105 F.3d at in By contrast, 1976 or as an IDE. a PMA 1097. Supplement proposes changes a device already has rigorous received review Moreover, although process the IDE approval during the original PMA identical, and the PMA are not Hence, process. because the FDA has al- comparison of governing regulations ready made a determination as to the safe- reveals no material differences.4 Further- ty and effectiveness of the underlying de- more, PMA Supplement for the Model PMA, in vice the original it can evaluate composed 4004M is of more than a hun- only proposed presented modifications submission, PMA, dred-page if like the in the PMA Supplement while relying on ultimately grants the FDA approval to the approval its earlier original device. in question, modification it means that the FDA has “received reasonable assurances Finally, plaintiffs’ argument safety [the device’s] effectiveness.” FDA never promulgated has specific regu Reg. 51 Fed. at 26355. The FDA does not governing lations pacemakers produces a reach approving such conclusion in result contrary to our understanding of pursuant device IDE exemption, Lohr' s holding. plaintiffs’ Under both very which permit its nature exists to proposed analysis Goodlin, and under no experimental implanted devices to be to cause of action involving any Class III gather Hence, in data human trials. we device approved pursuant to the PMA agree with the analysis district court’s process would ever be preempted because “preemption analysis regarding products merely the FDA approves disapproves or approved through PMA process fully is the device in question, and does not set products approved through forth Hence, the basis for its decision. ac the PMA Supplement process.” J.A at cording plaintiffs’ position, preemption 1369. § under 360k would be exceedingly rare. Motivating Breyer’s Justice join refusal to any

Plaintiffs further fail to adduce evi- Part VI of Justice opinion Stevens’ suggesting dence that a approved device Lohr, however, was his lack of pursuant to the conviction Supplement process, that “future incidents of pre-emp MDA upon rigorous builds pro- cess, tion of common-law claims will be receives ‘fevf scrutiny less than does ” Lоhr, ‘rare.’ 518 U.S. at exempted 116 S.Ct. from PMA un- J., 2240. (Breyer, part concurring der the IDE exemption process that was concurring Indeed, judgment). found to specific requirements constitute we Rather, agree Breyer that, with Martin. Justice in enact expert 360k, merely ing Congress avers that a PMA Supplement pre intended the is emption reviewed with the of some rigor same as a state-law causes of ac tion, PMA. readily This distinction is an given under- intent effect this Court’s requires standable because a PMA ruling. Following review Martin logic Martin, of a previously unapproved then, device that we hold that FDA not qualify does for exemption either as Supplement, Model 4004M PMA fact, omitted). significant the Martin court Similarly, found it applicant a PMA process, required under the IDE quired the FDA regarding to submit information “[t]he methods, in, regarding information ties, “the facili- methods used and the facilities and con- for, manufacture, and controls used for manufacture ... processing, trols used device, and, person packing, storage, in sufficient detail so appropriate, where in- generally device, good familiar manufacturing stallation of the in sufficient detail so practices knowledgeable judg- can make a person generally that a familiar with current quality ment about the good manufacturing practice control used in the can make a Martin, manufacture knowledgeable of the device.” judgment quality about (quoting F.3d 21 C.F.R. control used in the manufacture of the de- 812.20(b)(2)) (internal §. 814.20(b)(4)(v). quotation marks vice.” 21 C.F.R. prohibi- with the coupled labeling ap- of conditions with the together taken —when repre- them—that modifying against tion FDA, by the on the device imposed proval “ap- requirement specific federal sents the specific federal constitutes to the device.” MDA] [the under plicable device. to the 360k(a)(l). § 21 U.S.C. Requirements Applicable Specific D. attempt court’s The district agree. We Model 4004M from requirements the relevant parse and PMA application PMA Medtronic’s ap- the FDA’s Having determined effort an admirable while Supplement, constitutes the Model 4004M proval of the volumi- portions of the relevant discern invoking preemption specific requirement concerning nous submissions 360k, determine we must next under 4004M, comport with does not Model the imposed by are specific requirements what process approval PMA the actual the 4004M of Model approval the FDA’s (explicitly) (impliedly) and Mitchell Martin the district Before Supplement. PMA process PMA the to hold that upon relied court, that the deter- stipulated parties the requirements federal specific establishes applica- specifications of the FDA mination true that in III It is device. for Class awas pacemaker lead to the 4004M ble device, III Class approval for a granting court’s of law the determina- matter the not set forth reasons does the FDA issue, the dis- on the hearing At a tion. howev- Impliedly, justifying its decision. specifications that six trict court ruled thе PMA er, upon relied both FDA has the the during by the were determined original the Class approved for submission 4004M for the Supplement PMA pro- Supplement and the PMA III device lead.5 proposed the viding specific information appeal Although specific does Medtronic These question. modification decision, argues it the court’s of FDA’s from the district form basis submissions Thus, Supplement. approval” “PMA of the PMA approval the FDA’s appeal ap- specific taken we conclude Approval,” the “Conditions include the to the Model 4004M plicable administra- comprise the FDA’s together, accompanying relevant PMA and entire Supple- response to Medtronics’ tive por- certain rather than Supplement, ment, re- establishing specific the Model In the case tions thereof. part As Model 4004M. quirements for the 4004M, then, submitted to the information submitted process, Medtronic of the PMA FDA in both the by the and approved specif- request a detailed by modified PMA and Model 4003 par- design, using particular ic device of a comprise Model 4004M PMA and la- manufacturing processes ticular requirements applica- specific concedes approved, Once bels. pacemak- 4004M to Medtronic’s Model ble manufacturing processes, design, that the er lead. may not be modified without and labels modifi- unless the approval, further CLAIMS V. PLAINTIFFS’ safety or the device’s cations do not affect Negligence Per A. Se 814.39. C.F.R. effectiveness. See totality determined that Thus, argues Having it is 4004M are es- quirements for Model manufacturing processes, design, diameter alloy, .005 inches require- nickel identified 5. The district court six (5) platinum; the insu- directly applicable sputter coated with were that it ments believed claims, polyure- follows: 2363-80A plaintiffs’ summarized as must be made of lation thicknesses; and, thane, (6) specified (1) polyurethane four The lead must have protective barrier coat be- must be there tines; (2) made coils the conductor must insulation the conductor coil (3) tween alloy; must the lead of MP35N nickel platinum sputtering. composed insulation; (4) con- polyurethane have J.A. at 2941-42. See MP35M must be constructed from ductors 15, 1988, tions, tablished the July and alleging that such failure consti- combined with tuted negligence per se. The essence of conditions of set forth plaintiffs’ argument is that Medtronic FDA, we turn to take up particu- failed to coat the lead with a uniform 500 light lar claims in analysis above to angstroms of platinum sputtering, result- they determine whether impose state-law ing in the sale of a misbranded or adulter- requirements from, “different or in addi- product.6 ated us, Before plaintiffs merely to,” tion federal requirements. I Counts contend Lohr, that under a negligence per and II of plaintiffs’ first amended com- se claim any survives application of pre- plaint allege negligence per se for failure emption under 360k. to comply with the FDA requirement to To preempt claims, these feder manufacture and sеll the Model 4004M “ requirements al must ‘applicable be to Pacemaker as FDA I, In approved. Count the device’ question ... and ‘specific’to plaintiffs generally allege Medtronic failed ‘particular device.’” 518 U.S. at to manufacture the Model 4004M as 500, 2240; 116 S.Ct. Martin, see also quired by the FDA and thus sold mis- F.3d at 1098. To branded determine whether adulterated product. and/or plaintiffs’ negligence per Count I se alleges further claims that are Medtronic’s preempted, however, failure to we must manufacture the first Model 4004M deter mine whether pacemaker lead by as required the FDA resulted in failure, insulation established FDA approval proxi- which of the Model mately caused Mrs. 4004M Kemp’s injuries. Supplement establish a re quirement required as thickness and Building I, on Count Count II alleges coverage platinum sputter barrier. that was required by Medtronic the condi- tions of approval set forth 21 C.F.R. I, Addressing Count the district court § 814.84 to seek for any granted summary judgment Medtronic, change affecting “safety and effective- ruling that claim platinum ness of the device.” Plaintiffs contend sputtering may have failed prevent insu- that Medtronic violated conditions of lation failure constitutes a claim for design approval for the pacemaker Model 4004M defect, and is preempted. therefore lead and 21 C.F.R. by failing 814.84 district court further ruled that neither the submit to a March 1989 deviation Model 4003 PMA nor the Model 4004M authorization and engineering change or- required Medtronic to der concеrning the coverage of platinum manufacture the Model 4004M lead with a sputter coating over coils, the conductor by particular platinum thickness of sputter- failing to provide results of canine biosta- ing, and if plaintiffs’ common law tests, bility failing to provide data otherwise, claims asserted they would con- from clinical devices laboratory studies stitute a requirement from, “different inor involving the 4004M. to,” addition the non-specific federal re- court,

Before the district quirement. elect- such Accordingly, claims down, ed distill Counts I and II focusing would be preempted. With respect solely on Medtronic’s alleged II, failure to Count district granted court defen- manufacture the pacemaker Model 4004M dant’s motion for summary judgment on lead in conformance with the FDA-ap- grounds of preemption, relying on de- our proved 4004M PMA Supplement specifica- Johnson, in Bailey cision v. 48 F.3d response In their to defendant’s motion for "protective er awith barrier coat of [sic] summary judgment plain- March between the coil conductor and the insula- tiffs characterized their as claims follows: tion, composed platinum sput- which negligence Plaintiffs' per se and strict liabili- tering." ty solely claims focus on Medtronic’s failure J.A. at 2801. to manufacture the pacemak- Model 4004M includ- 4004M (6th Cir.1995), private held no sputter platinum that the specification ed a a violation for exists of action cause angstroms uniform Act. would be coat Food, Cosmetics Drug and Federal аsser- at best tenuous represents thick judg- court’s of the district support worst, mischarac- outright an and, at tion arguments. three ment, makes in their Both record. terization manufactured it First, contends plaintiffs re- argument, in oral briefs in conformance lead 4004M the Model the Model asserted peatedly Second, Medtronic requirements. called designed, originally specifications, law, an action under Ohio argues a “uniform barrier sputter platinum only predicated se can per negligence state- thick.” Plaintiffs’ angstroms Third, Medtronic statutory violation. on a In- in the record. support find no ments plain- ground affirm on us to asks flatly contra- deed, the record find that we to cir- claims seek se negligence per tiffs’ calling Instead of position. plaintiffs’ dicts should Congress intent cumvent the angstroms, of 500 thickness a uniform for attempts impermissible as be order) change re- (engineering ECO the al- for of action private causes to create coating specification original that the veals Food, Drug and the leged violations be 500 shall “[c]oating thickness provided, Act. Cosmetics Medtronic ± and that angstroms,” 200 the result reached with agree We “100 to 1000 call design to for the modified respect plain to with court by the district of the minimum of 85% a over angstroms claims, we do so yet per se negligence tiffs’ 993. There- J.A. at circumference.” wire agree we While reasons. for different not for was specification original fore premised a claim that plaintiffs рlaintiffs as angstroms 500 uniform requirements established violation of assert, called for rather but peatedly the PMA through III for Class in thick- angstroms 700 300 to range of we ‍​​​‌​‌​‌‌‌‌​‌‌‌‌‌​​‌​​‌​‌​‌‌‌‌​​​​​​‌​​‌‌‌‌‌​​‌‌‍automatically preempted, is not ness.7 that the district conclude nevertheless Furthermore, Model nowhere summary judgment granted properly court we find that do 4004M pre claims as plaintiffs’ to Medtronic representation express an made Medtronic that sented, we find because coverage of the or thickness as to the requirements established Apparently barrier. sputter platinum Sup 4004M PMA Model of the to the impediment glaring recognizing this as to requirement not include plement do claims, neverthe- plaintiffs their success platinum of the coverage thickness or binding made Medtronic less contend jury to find permit To barrier. sputter of the to the thickness as representations failing to manufac negligent Medtronic submissions barrier sputter platinum platinum with a 4004M ture the Model and subse- prior FDA both made angstroms of uniform barrier sputter July 1988 Model quent to require impose a be thickness would to Supplement. to in addition from and ment different It follows FDA. by the

those established First, contend plaintiffs are per se claims negligence plaintiffs’ the thickness represented preempted. barrier be sputter platinum the conductor 100% of angstroms firm- over leaves us record Our review notification premarket in the coils argument that ly plaintiffs’ convinced change engineering order. plain- explicitly authorization argument, asked we 7. At oral 986-90; pages do not they con- These what at 991-93. identify in the record J.A. tiffs coverage of a thickness tended established reference contain response, sputter platinum barrier. for the barrier. internal deviation plaintiffs cited Medtronic's 4016A, Model a pacemaker not in the chain platinum, and [t]hermal annealing tubing of development of the Model In- 4004M. in an inert atmosphere (e.g., argon ni- deed, the Model given 4016A was FDA trogen).” Id. 605-06. The text goes on 510(k) pursuant clearance to a premark- to state “[t]he Model 4016A pacing notification, et rather than FDA approval lead also incorporated these improve- pursuant to the process. In answer ments.” Id. at 606. Combining these ref- to an FDA inquiry regarding the effect of erences, plaintiffs maintain they amount platinum sputter on weight distribution a representation that the Model 4004M lead the Model during 4016A its PMA Supplement incorporates all of the premarket process, notification specifications submitted with the Model represented that because “the thickness of premarket 4016A notification. platinum coating only Ang- (Á), stroms it is unlikely that it changes Given the differences between the Model the weight throughout distribution the 4016A and the 4004M, plaintiffs’ lead, thereby affecting electrode stability.” argument fails to persuade us. Under- Id. at 852. Plaintiffs point next to mathe- scoring the specious nature of matical calculations that interpret claim is the fact that the Model 4016A was calling 100% the conductor coils merely judged substantially equivalent sputtered at a thickness of ang- pursuant 510(k) process, and was stroms. argue Plaintiffs that repre- these not approved reviewed and pursuant to the sentations were incorporated into the Mod- process.8 PMA rejected Lohr the notion el 4004M PMA Supplement by Medtronic’s 510(k) that § the approval process estab- statement the Model 4004M PMA Sup- lishes specific federal requirements for a plement concerning the sputter barrier device. 493, 518 U.S. at 116 S.Ct. that, Model “[t]he 4016A pacing lead also By contrast, 2240. the implication clear of incorporated these improvements.” J.A. the holding in Martin and express the at 606. import of our today decision is that FDA We utterly are unconvinced that a state- approval pursuant to a PMA Supplement ment in the Model 4004M Supple- PMA specific establishes federal requirements ment merely points out that the for the in question. Thus, we focus addition a platinum sputter barrier was representations on the Medtronic made in incorporated earlier, in an unrelated model the Model 4004M PMA Supplement which pacemaker is sufficient to establish a re- specific established its require- quirement for the Model 4004M. As a ments to the exclusion of other submis- background consideration, the text from sions.9 Accordingly, any representations the Model 4004M PMA Supplement that made in September 28, 1987, 4016A plaintiffs claim incorporates the 4016A notification, premarket which did not re- premarket placed notification is not in full ceive FDA-approval, inapplicable are context. After describing the modifica- the FDA-approved Model 4004M which re- tions 4003, over Model the Model FDA approval ceived after undergoing the 4004M Supplement PMA states in summa- PMA process. “Therefore, tion: improvements two incor-

porated into the Models are: The second plaintiffs 4004/4504 submission rely on [b]arrier coating the conductor coils with to establish a thickness for 8. 510(k) Medtronic course, submitted its notifica- PMA, 9. Of the Model the ances- tion for bipolar its Model 4016A 4004M, transvenous tor of the Model also established 28, lead September on 1987. Model The quirements applicable Model 4004M 4016A was a modification of the Model 4016 analysis, under our require- but such judged which was substantially equivalent to ments are at not issue here. 28, prior 1976, leads May marketed pursu- ant process August 1985. J.A. at 774. serve cannot Supplement PMA el 4003M voluntarily with- is the Model 4004M applicable requirements the Mod- to establish drawn through its 4004M, Med- established Model November On el 4003M.10 when Supplement. PMAa

tronic submitted Model 4003M modify it decided record, carefully scrutinized Having sputter barrier.11 platinum a incorporate Med- is confirmed: initial observation our submission, Med- to this attachment In an 4004M the Model represented tronic de- states, sputtering “[t]he tronic barrier, sputter platinum a contain platinum angstroms only 500 posits barrier represent not did but Therefore, the physical coil. conductor thickness. particular would have un- virtually are the coil properties requirements established specific federal dimensions, and elec- i.e., flexural changed 4004M the Model Therefore, perfor- properties. trical require- contain thus PMA Supplement as a change will not leads mance of the a barrier 4004M have the Model ment that J.A. sputtering process.” this result of negli- and a claim sputter, platinum included in language, this Based on of such on the lack per premised se gence contend plaintiffs application, a withdrawn As preempted. a barrier would thickness represented however, plaintiffs, argued by pled and for the sputter barrier platinum man- failing to negligent was a uni- lead was pacemaker Model 4004M platinum had product ufacture angstroms. form 500 ang- a uniform sputter barrier statements rely on Again, Because thickness. stroms III de the Class inapplicable to are Most Model 4004M. in question, vice require- no thickness contain 4004M Sup the Model significantly, favor on ment, jury verdict by voluntarily withdrawn was plement se claims negligence per plaintiffs’ received Medtronic, never and thus “different a amount to state re necessary to establish approval to,” from, the federal inor addition IV(d), in held Part As we quirements. neg- It follows quirements. coupled Supplement, the PMA supra, it is Con- preempted. claims are per se ligence set forth approval the conditions of with judgment the affirm we sequently, letter, establishes the FDA’s to this regard issue. district court for a requirements specific federal the Supplement device. The Class III the B. on Fraud lead, 4003M, can unipolar a for the Model is complaint original the Count VII the to establish reasonably be deemed Misrepresentation,” “Fraudulent entitled 4004M, a bipo Model for the requirements uni “Medtronic, its through and alleges Furthermore, 4003M the Model lar lead. advertising, in the of conduct form course chain of 4004M’s not in the Model was 4004M] of the [Model and sale promotion, rather, modifi proposed development; represent leads, purposely knowingly and was sputter platinum adding cation and to product consumers ed to the 1991, after the submitted were community that the leads Hence, medical in 1988. 4004M the Model func purposes, would intended fit for Mod- their in the withdrawn reference contained 4003M, PMA-ap- Model 11. The Medtronic voluntarily withdraw wrote to 10. 1989, 23, poly- unipolar ais proved June on on Supplement for the Model its PMA coil with a conductor pacing lead urethane 1992, 10, acknowl- and the FDA December sub- coated. not barrier that was 18, on December edged such withdrawal the ad- specifying mitted PMA J.A. at 814.44(g)(3); 1992. See 21 C.F.R. platinum sputter on coat of a barrier dition of 2877. 19, J.A. at 2883. November

233 defect, tion without and were appropriate ing of the Third Circuit in I, Bone Screw in persons use with heart conditions which it characterizes as a minority posi- requiring pacemakers.”12 J.A. at 42. In tion adopted by no court, other circuit brief, however, their plaintiffs characterize urges us to hold with the Seventh Circuit this claim FDA,” as “Fraud on the and in Mitchell that the earlier Third Circuit argue the district court erred by relying decision in Michael maintains vitality its Inc., on Michael v. Shiley, 46 F.3d 1316 even after the Supreme Court’s decision in (3d Cir.1995), and Klein v. Biscup, 109 Lohr. Alternatively, Medtronic contends 855, App.3d Ohio 673 (1996), N.E.2d 225 to that the principle implied conflict pre- find this claim was preempted by federal emption dictates that we hold plaintiffs’ argued, law.13 As plaintiffs’ claim is simi fraud on the FDA claim to be preempted. lar to the fraud on the FDA present claim law, Under Ohio a claim of fraudu panel ed to a of the Third Circuit In re lent misrepresentation requires plaintiff Orthopedic Bone Screw Products Liability prove “(a) following (3d Litig., 817, 159 elements: Cir.1998) F.3d 821-22 — representation or, (Bone where I), there is a duty Screw granted, cert. U.S. disclose, -, fact, (b) concealment aof 2739, 120 is 147 L.Ed.2d 1004 material (2000), (c) hand, transaction at which concluded that “Lohr over made falsely, with knowledge rules everything in of its falsity, Michael that would or with such utter disregard prevent plaintiff from pursuing a reckless cause ness as to of action whether it is for fraudulent true or misrepresentation false that knowledge (d) may inferred, be based common law principles.” Bone intent I, (footnote misleading Screw 159 F.3d at another into relying omit it, (e) ted). upon justifiable Similarly, plaintiffs reliance upon cite Dutton v. representation or concealment, (f) Acromed Corp., 117 804, Ohio App.3d resulting injury (1997), proximately N.E.2d by causеd argue that the reliance.” Lamko, Cohen v. Inc., district court’s reliance on Ohio Klein mis St.3d (1984) 462 N.E.2d placed. Dutton held (per that Klein does not curiam). again, survive the Once Supreme preempt Court’s this com holding in claim, mon-law concluded that the plaintiffs established fraud 4004M PMA claim was not preempt ‘applicable ed “must MDA. device’ in question ... ‘specific’ and to a initially responds Medtronic by arguing ‘particular Martin, device.’” 105 F.3d at that Ohio law does recognize a com- 1098. (quoting 518 U.S. at mon-law cause of for alleged action fraud 2240). aon federal agency. Moreover, Medtronic contends that the district court properly presented issue here reaches to the extended our decision in Martin to find heart sharp split between the various preemption. rejects Medtronic the hold- Courts of Appeals.14 The Seventh Circuit original complaint Plaintiffs’ alleges thus claims for fraud on 12. preempted. the FDA are that fraudulently Medtronic misrepresented J.A. at 1370-71. the plaintiffs Model 4004M to physi- and their 14.Count VII of original complaint argued cians. As before the district court and does not explicitly allege however, that appeal, on plaintiffs purport to have fraudulently approval obtained of the Model claimed that Medtronic fraudulently obtained by presenting false information to by FDA failing to submit Solution A Rather, plaintiffs FDA. results, merely results, claim that test canine test and other lab- misrepresented the Model 4004M oratory prior receiving data approval. FDA plaintiffs physicians. and prove their To ruling, In its expressly district court falsity the required however, representation of Medtronic's 13. Klein, relied on both and Michael and claim, also under the third element of the noted that Bailey, our decision in 48 F.3d at plaintiffs must establish 968, supported its conclusion that state-law falsely represented 4004M was to be for the Model laboratory tests submit tersely, maintained steadfastly, albeit has require- 4004M, merely “parallels” federal committed fraud alleging claims if, instead, impose ments, it threatens made or representations through and preempted requirements, are process additional during the different in holding Supreme Court’s after preempted. even thus is (“We Mitchell, F.3d at 914 Lohr. See imposed requirement Concluding that a was this issue to believe continue fraud on the FDA of action for by a cause in the Third Circuit correctly by decided federal simply parallels Inc.”). In con stark Shiley, v. Michael Third Circuit preempted, is not thus in has trast, Goodlin the Eleventh Circuit it a 1001 makes § that 18 U.S.C. noted state-law preemption, that no held statement to make a fraudulent crime to a PMA from claims flows that 21 C.F.R. agency, federal deci and the Third Circuit’s Supplement, noti- every pre-market 807.87(J)requires § I held that Screw state-law sion Bone to contain a statement fication are not on the FDA fraud alleging claims is believed contained therein information Supreme light of the Court’s foreclosed truthful. See Goodlin, manufacturer to at 167 F.3d in Lohr. See decision I, at 823. Based 159 F.3d I, Bone Screw 1381-82; F.3d Bone Screw the Bone requirements, the issue federal significance of these two Recognizing coun com- across the “the state plaintiffs I court concluded for thousands Screw recently granted plaintiffs] Supreme upon [by Court try, the mon law relied certiorari, following ques limited to the any obligation [defen- impose does not preempts law tion: “Whether Id. federal law.” inconsistent dant] fraud on the alleging tort claims state-law analysis is the Third this against Set during the Drug Administration Food Shiley, v. holding Michael Circuit’s clearance marketing regulatory adopted after Circuit which the Seventh medical devices.” to certain Corp. its Collagen v. Lohr in Mitchell Committee, Legal Co. v. Buckman Plaintiffs’ decision, court held the Michael pre-Lohr — --, U.S. 120 S.Ct. granted, rt. ce 2739, 147 claim for that permitting (2000). L.Ed.2d forward would go the FDA to fraud on language of Lohr We return under a different impose whether a com- determination guide our law, thus was state FDA” “fraud on the claim mon-law First, significantly, most 360k. “dif- requirement, to a amounts state-law permitting court Michael concluded to,” from, addition or in ferent open go forward the claim held Five Justices requirements. scrutiny of judicial box pandora’s that “[n]oth- in Part of the Lohr decision V ultimately “could decision-making, which right state] denies ing [a 360k court whether that a determine require damages remedy for provide traditional submitted [the defendant] the information when duties violations common-law truthful, complete, whеther it was was require- parallel those duties to avoid procedures FDA sufficed whether Lohr, U.S. 116 ments.” and whether misrepresentation, a material Hence, whether must determine we ap- have have or would should the FDA that Medtronic alleging claim plaintiffs’ misrepresen- despite proved the fraudulently obtained Michael, 1329. In F.3d at tations.” to sub- by failing FDA approval from the short, dis- court feared the Michael results, by failing to mit Solution A test adjudi- required would be studies, trict courts by failing canine perform allege "fraud on the expressly does not very claim FDA," safe and effective—the determination necessarily implied in a claim is approval. such granting PMA by made the FDA allegations. although plaintiffs’ VII Consequently, Count law, cate claims “applying state to regulations. [and] view, In our permitting perform the same initially functions en- plaintiffs to bring such actions does not trusted FDA.” Id. Secondly, the equate to a “parallel” state law require- Michael court permit reasoned a ment as contemplated Lohr; by rather, fraud claim based on allegedly false repre- such actions could conceivably impose both by sentations made a manufacturer would “different” and “additional” state law re- conflict with longstanding precedent quirements in addition to the federal re- against permitting implied causes of action quirements specific to the Class III device Food, violations the Federal Drug established through the PMA process. Id.; and Cosmetics Act.15 aсcord Bailey v. Initially, Johnson, Michael, as noted (6th a Cir.1995). jury 48 F.3d presented a common-law Expressly relying on this claim of two-pronged fraud on the analysis, FDA panel might that, a conclude Seventh Circuit but held the for the plaintiffs alleged misrepresentations claims fraud made were preempted manufacturer, tersely-worded the FDA would have ruling, stating its withheld belief that Michael’s of the device because it holding on this issue maintained its vitality had not received reasonable assurance of even after Supreme ruling Court’s in the device’s safety and effectiveness. To Mitchell, Lohr. See 126 F.3d at 914. make such showing, plaintiffs would have to adduce expert testimony from those fa- Having carefully considered the miliar with procedures, conduct dis- question, we are convinced that the Third covery of employees, and establish analysis Michael, Circuit’s adopted by alleged misrepresentations ren- Mitchell, the Seventh Circuit in correctly dered the device not safe and effective for states the law and that nothing in Lohr’s its intended use. Effectively, actions for holding impairs Michael’s reasoning. As a fraud on the FDA would allow individual background consideration, we note that juries to undertake a counterfactual FDA in Lohr did not present a review, and conclude that ‍​​​‌​‌​‌‌‌‌​‌‌‌‌‌​​‌​​‌​‌​‌‌‌‌​​​​​​‌​​‌‌‌‌‌​​‌‌‍the' FDA would “fraud on the FDA” claim before the Su not have approved the However, device. preme Furthermore, Court. although tort “Congress allocated the FDA responsibili- claims for fraudulent misreрresentation ty to design and manage have been long part of law, the common in approval result claims alleging safest and fraud on agencies most effective have medical possible. devices never come within the police “historic Congress powers States,” assigned also the FDA the re- consideration that sponsibility becomes to approve relevant or disapprove when determining scope applications of preemption under market medical 360k. devices.” Michael, 518 U.S. at 46 F.3d S.Ct. 2240. It at 1329. Furthermore, is one note, thing to agree as did the we majority opinion permitting the “searching I, in Bone inquiry” Screiu provides that federal law of FDA procedures internal penalties for personnel fraudulent statements made runs counter to both congres- government agencies. It quite sional anoth Hence, intent sound policy. we er to say that because federal hold law crimi to allow common-law suits for conduct, nalizes such private litigants may fraud on the FDA to go forward would bring a civil suit presenting theory permit juries novel to reach a different conclu- of liability under state common law to en sion than the FDA did in approving force an alleged violation agency federal question, device in thereby a dif- imposing position This U.S.-, has 2739, also been advanced 120 147 1004 L.Ed.2d the Solicitor General (2000) (" for the United as States agency’ ‘fraud on the claims could Amicus Curiae recommending Supreme subject countless, аgencies federal to highly grant Court certiorari Buckman Co. v. intrusive inquiries into their internal delibera n — Committee, Legal granted, tions”). cert. Plaintiffs’

236 hold is FDA,” we which by the required than ferent analysis. foregoing with accordance Id. requirements. the federal prem- claim a fraud Finally, permitting to Warn C. Failure representations false ised on claim is inadequate warning Plaintiffs’ conflict the PMA during Code Revised Ohio under brought im- no precedent well-established with 2307.76, provides generally under exists action right of private plied the manufactur- defective where is product ob- previously have As FDCA. we warnings when adequate fails to issue er served: knew, reasonably or manufacturer of a that a violation determination [T]he to known, risk of harm have should will FDCA as the such statute federal determine, to It is difficult the consumer. a matter liability is not tort create state plaintiffs’ however, underlying basis ability to A state’s of state law. solely court the district presented as claim aas basis violation statute use a federal com- original in their set forth As below. per liability negligence and tort for state “At the ambiguous: IV Count plaint, Congress, intent of on the depends se and 4004 Models time the merely on the intent and not Plaintiffs, supplied were 4004M leads decision Thus, congressional state. result were defective products action private cause provide not to warn- adequate give failure to Medtronic’s impor- quite the FDCA becomes under insulation, in- polyurethane regarding ings, aof propriеty considering tant failure, testing.” J.A. and lack of sulation for viola- action per se negligence state at 39. the FDCA. tion of read as could be statement This 290, 313- F.2d Litig., 857 re Bendectin In in the warnings found that the asserting Cir.1988). answer (6th Returning to 14 by the approved literature and label squarely it was before question when this were 4004M for Model cause Court, private no we held this noted As law. under inadequate Ohio violation exists for of action however, submitted above, the information 967; see Bailey, 48 F.3d at FDCA. See in the Model approved 337(a) (restricting FDCA 21 U.S.C. also infor including 4004M PMA — States); by the United to suits enforcement warnings and disclaim regarding mation Prod- Orthopedic Bone re Screw accord require federal comprise ers— 193 F.3d Litigation, Liability ucts pacemaker to defendant’s ments Labs, v. (3d Cir.1999); Inc. PDK 788-89 to the extent Accordingly, lead. (2d Friedlander, Cir. F.3d adequa on the premised claim is Matkari, Labs., 1997); Inc. v. Mylan approved warnings reviewed cy of the Cir.1993). (4th are States F.3d on “fraud FDA, analysis of the our by the com- authority enforce granted equally claim applies the FDA” require- the specific pliance claim, claim is and the warn failure to process. by the PMA ments established Martin, 105 See similarly preempted. allega- premised suit Any common-law (“To cause of a state at 1100 allow F.3d fraud committed tions that im warnings would inadequate action for amend- MDA thus violated the FDA require different pose sub- ments in its required by those addition to ments in precedent governing conflicts with mission regulations.”). right implied no holding that in this circuit also be could IV Count Fed- statement for a violation exists of action separate however, wholly read, assert Plain- Food, Act. Cosmetics Drug and eral acquired defendant claim that distinct prior decision our tiffs cannot circumvent ap- the FDA subsequent information “fraud on claim as by characterizing their proval of the Model 4004M MOORE, before Circuit Judge, concurring. implantation of the device that lead would I agree with the majority that pursuant a reasonable manufacturer pa- warn to our decision in Martin v. Telectronics tients and the medical community. Unfor- Pacing Inc., Systems, (6th 105 F.3d 1090 tunately, plaintiffs did not to re- attempt Cir.1997), the FDA’s approval of the Model solve ambiguity this until the district after and the FDA’s court had already granted defendant sum- conditions approval imposed on the mary claim, judgment on the 4004M pacemaker lead constitute a specific court clearly construed the claim—consis- requirement, thereby triggering tent with parties’ arguments accor- —in the possibility of preemption under dance with the former understanding and 360k(a) § U.S.C. of the Kemps’ state law latter, not this alternative meaning. claims to the extent the state law claims are different from or addition to Because had ample op the federal requirements. portunity clarify ambiguity this in—both I also agree that the specific federal original their complaint and their brief established the FDA ap- opposition to defendant’s first motion for proval of the Model 4004M do not include summary judgment yet failed to do so in — as to the thickness or cover- manner, timely it apparent is age of the platinum sputter Be- barrier. they claim argue now appeal was never cause Mrs. Kemp’s negligence claim is properly presented to the district court premised on a failure of the device to not properly is addressed by this achieve a uniform thickness of plati- Court in the first instance. Accordingly, sputter barrier, num negligence her claim we need effect, not address preemptive preempted; jury could not find in § if any, of 360k on a claim for breach favor of Mrs. Kemp on the negligence duty manufacturer’s under state law to claim without imposing requirement “dif- warn patients or the medical community of from, ferent or in addition to” the federal potential particular risks of a medical de requirement. 21 360k(a)(l). U.S.C. vice based on information obtained subse I agree as well with the more general quent to FDA approval of the device. principle stated majority that “a Further, because of defects, these pleading premised claim on the violation of FDA we decline to remand this issue requirements established for a Class III district court for proceedings. further device through the process is not preempted.” automatically Maj. Op. ante D. Spousal Derivative Claim at 230. Thus as majority recognizes, a for negligence claim per se premised light the foregoing analysis finding the absencе of platinum sputter barrier Elizabeth Kemp’s claims are preempt- required by would by § MDA, ed 360k of the Kemp’s Clifford not be because the claim state derivative spousal similarly claim is not impose requirements different preempted. from or additional to federal require- ments. VI. CONCLUSION The claim that Medtronic committed a For reasons, the foregoing we conclude fraud on the FDA by improperly failing to claims are preempted and submit certain tests and laboratory data we AFFIRM the judgment of the district the FDA during the rais- court. shown, Defendant however, has not es federalism concerns. Rather than force good cause continuing the ap- seal on analysis of this claim preemp- into the pellate briefs, and accordingly 360k(a) the seal is tion framework and Medtron- hereby ic, LIFTED. Inc. v. 518 U.S. 116 S.Ct.

238 FDA fraud on the a claim of as (1996), presented in- I would 700 L.Ed.2d misrepresentations fraudulent of this than nature rather peculiar focus on

stead Kemp’s appellate from to her. appears It claim. that, al- because asserts that she brief majority’s sum, with the disagree I In to by Medtronic misrepresentations leged of fraud on the claim theory regarding erroneously FDA, approved the FDA the con- with agree nonetheless FDA but 4004M, therefore should she must be dismissed. that that claim clusion on a damages state-law recover able negli- with the conclusion agree I in favor of A claim. determination fraud by Kemp is raised claim gence per se effectively would claim Kеmp on this fraud na- particular because of preempted process. approval the entire aside set need that we agree claim. I ture of her explore be able litigants would only Not § 360k of whether the issue not address decision- challenge the administrative duty of breach of a claim preempts agency, but federal making process after discovered patients of warn risks between easily arise could conflicts also of a device. litigation and fraud results of state-law civil through federal enforcement

federal mislead- for false or penalties criminal See, e.g., FDA.

ing submissions §§ 333. 831(q)(2),

U.S.C. any event, point Kemp fails viability of a “fraud upholding the law

Ohio dam- agency” claim for a federal

against product. user of to an individual ages America, UNITED STATES v. by Kemp, Dutton case cited Plaintiff-Appellee, 804, 691 App.3d Corp., 117 Ohio Acromed (1997), not characterize v. does N.E.2d on claim of fraud claim as a Defendant-Appellant. LEWIS, Walter misrepresen- a claim rather involves but No. 98-3619. status a medical device’s tation traditional individual. Such to the affected Appeals, Court of States United certainly are not fraud claims Sixth Circuit. 360k(a) Lohr, explained [a state] 360k denies “[n]othing 26, 1999 Argued: Oct. damages provide a traditional right to 3, 2000 Nov. and Filed: Decided of common-law remedy for violations federal parallel duties when those duties 518 U.S.

requirements.” Moreover, allowing a state made misrepresentations claim for

fraud conflict our not patient ‍​​​‌​‌​‌‌‌‌​‌‌‌‌‌​​‌​​‌​‌​‌‌‌‌​​​​​​‌​​‌‌‌‌‌​​‌‌‍Johnson, 48 Bailey v. F.3d

decision

(6th Cir.1995), the federal holding that

Food, Act Drug and Cosmetic does cause of private

impliedly provide a provisions, of its since for a violation action premised would be state fraud claim law as a behavioral using Supreme by the

standard endorsed is problem fatal Kemp’s in Lohr.

Court solely appeal her fraud claim

Case Details

Case Name: Elizabeth and Clifford Kemp v. Medtronic, Inc.

Court Name: Court of Appeals for the Sixth Circuit

Date Published: Nov 1, 2000

Citation: 231 F.3d 216

Docket Number: 99-3720

Court Abbreviation: 6th Cir.