Barbara E. Horn, of the Estate of Daniel Ray Horn, Deceased v. Thoratec Corporation

HORN, Barbara E. Executrix of the Ray Horn,

Estаte of Daniel Deceased, Appellant THORATEC CORPORATION.

No. 02-4597. States Court of Appeáls, United

Third Circuit. Argued on Dec. July Filed

GARTH, Judge. Circuit (“Horn”) from appeals Horn Barbara summary grant of Court’s the District (hereinafter Corp. Thoratec to judgment its determination 1), based “TCI” TCI are against Horn’s claims in the provision the express Citizen (Argued), Public Zeive Allison (the “Act”), Act and Cosmetic Drug Food M. Washington, John Group, Litigation 360k(a).2 affirm. We 21 U.S.C. Mussina, Travis, Rieders, Humphrey, Harris, & Waffen- Waters Humphrey, I. Bar- schmidt, Appellant for Williamsport, the and distributed manufactured TCI Horn.

bara E. as the device known assist ventricular left pump is a The HeartMate HeartMate. Brown, Rowe Winters, Mayer, A. Gary the flow between the blood that assists Alan E. Untereiner Maw, Washington, & patients aorta in and the heart’s ventricle Russell, Robbins, Englert, Or- (Argued), side The inlet conditions. with cardiac LLP, Washington, & Untereiner seck via to the heart surgically attached tube is Keefer, Wood, II, Rubendall, W. Charles the ventricle, blood from and carries vonN. Rahal, Harrisburg, Arnd Allen & tube The outlet side pump. into the heart Smith, Pittsburgh, Ap- for Waldow, Reed aorta, pump to the from the brings blood Corporation. Thoratec pellee body. There to the dispersed it is where Litigation Letter, Appellate exits Douglas pump a tube attached Maier, Attorney, Civil Counsel, con- Peter R. to an external and connects body Justice, Washing- Division, Department compres- air an console contains The sole. United States ton, Amicus Curiae the HeartMate. powers for sor which America. pertain to this case underlying facts The tube, which connects side the outlet Porter, Weiner, & Arnold N. Robert be- aоrta. The connection to the pump Product Curiae Washington, Amicus tube, and the called pump tween the Council, Advisory Inc. Liability con- “elbow,” an adapter into is inserted Al- Jarcho, Long & McKenna open port duit, Daniel G. into which is screwed Curi- LLP, for Amicus Washington, over dridge ring is secured A screw pump. of the United of Commerce con- Chamber remains ae to ensure the elbow America. and the adapter conduit States nected to screw is tied over the suture

pump. A adapter conduit FUENTES, ring and secured AMBRO, Before The HeartMate it will rotate.3 ensure GARTH, Judges. Circuit reference seq. For ease of §§ et formerly U.S.C. 360c Corporation, known 1. Thoratec Act as opinion, we refer to the throughout Cardiosystems, is referred Thermo Judge as preemption. District Court parties source Therefore, to defen- we also refer will TCI. dant-appellee as TCI. surgeon pre- at the arrives 3.The HeartMate manipulate surgeon need not assembled. to the Act Medical Device Amendments 2. The ring implants he when suture the screw Drug Administration the Food allow HeartMate. ("FDA”) See 21 regulate devices. medical approved by the FDA pursuant to the moved for summary judgment, arguing (“PMA”) Pre-Market Approval process set that Horn’s state law claims are expressly 360e(c) (discussed forth at 21 U.S.C. in preempted by 360k(a). U.S.C. depth, infra). The District granted TCI’s motion 17, January 1998, On husband, Horn’s 7, on 2002, November holding that Horn’s Horn, Daniel admitted was to Williamsport state common law claims were preempted. Hospital suffering a heart attack. He was The District Court applied a two-prong later to Hershey transferred Medical Cen- test endorsed the Sixth and Eleventh ter. Doctors there determined that Mr. Circuits,4 which instructs a state claim required Horn a heart transplant, they and attacking safety the of medical device is waited for a suitable donor heart to be- (1) preempted if the FDA has established 22, come 1998, available. On January Mr. specific federal requirements that ap- Horn’s condition deteriorated and a Heart- plicable to (2) device, and Mate was implanted in him provide to the state claim is from, circulatory different support. or in He was then trans- to, addition ferred to the specific an assisted living facility. federal require- ments. 3, 1998, May On Mr. Horn began to bleed spot from the where the HeartMate In granting TCI’s motion for summary tube body. exited his Thereupon, he un- judgment on express preemption grounds, derwent exploratory surgery at Hershey the (1) District Court found that the Center, Medical during Benja- which Dr. HeartMate’s process impos- min Sun discovered that the suture Mr. es a federal requirement applica- Horn’s HeartMate had worn off and the (2) ble to HeartMate, and if Horn were screw ring linking the pump output successful on her state law claims, “any side elbow had disconnected. The discon- judgment that the HeartMate was unsafe nection had allowed an air embolus to trav- or otherwise substandard would be in di- el to Mr. Horn’s brain. Although Dr. Sun rect [with]-i.e., conflict different from-the ring reconnected screw and again once FDA’s determination product linked elbow, pump it was too suitable for use.” Ct. Op. Dist. at 20.

late. Mr. Horn suffered a brain hemor- timely appeal This followed. rhage, and he was rendered brain dead. 8, 1998, May

On his organs were donated for transplant pronounced he was II. dead. jurisdiction We have to hear appeal this 28, April 2000,

On Horn filed a Com- pursuant to 28 U.S.C. Review plaint against TCI in the United States district grant court’s decision to a motion District Court for the Middle District for summary judgment plenary. Pennsylvania. Good Complaint alleged de- Co., man v. Mead Johnson fective & 534 F.2d manufacture of the (3d Cir.1976), HeartMate 573 denied, cert. failure to warn of the al- defects; leged it was based on Horn’s L.Ed.2d 748 claim that (1977); HeartMate’s output Hilfirty side v. Shipman, 91 F.3d elbow was (3d defectively designed. Cir.1996). TCI Medtronic, Inc., See Kemp v. (11th Cir.1999). F.3d (6th Cir.2000); 224-25 Medtronic, Goodlin v. (1) or in addi- is different which appropriate

Summary judgment un- applicable to, any requirement tion any issue as to genuine no when there is device, and chapter this der party is enti- moving fact and material safety or effec- (2) relates of law. See as a matter judgment tled to any other or to 56(e); tiveness of see also Armbruster Fed.R.Civ.P. appli- (3d in a included Cir. matter F.3d Corp., 32 Unisys chapter. record, to the device court cable 1994). examining the the benefit nonmoving party gives case, that her Horn contends In this from record. inferences all reasonable impose law claims would common 228, 232 Corp., v. Kmart Saldana good use applicable duties generally Newspapers, (3d Cir.2001); Gray York and to warn users manufacturing care in Cir.1992). (3d 1070, Inc., F.2d They would risks. attendant product’s the spеcific require- not, impose argues, she review plenary also exercises This Court HeartMate. respect with ments determi preemption a district court’s over Complaint Horn’s and 16 of Paragraphs 15 Travitz nation, question it is a law. as as of her action gravamen the forth set Health & Wel Dep’t ILGWU v. Northeast follows:5 (3d Cir.1994), Fund, fare action of pumping continual The 15.... denied, cert. HeartMate, natu- together with the TCI (1994); Shiley, Michael v. 128 L.Ed.2d movements, wearing the body caused ral Cir.1995). (3d 1321-22 and once placed, suture so away of the through, said move- worn the suture was III. ring the screw pump of the caused ment against Horn’s suit At whether issue is unscrewed. to become Penn- TCI, of action under alleging causes appro- an ring been of Had the screw law, expressly is common sylvania would design which and feasible priate the not need examine preempted. We ring to become the screw permit because implied preemption, doctrine of move- pump as a result unscrewed which the the Act under ment, something more durable or had ex- an of action contains the state causes the to secure been than suture used clause, obviates which press preemption thread- ring, had the screw or tightened implied to the doctrine any reference placed eyelet been with ed sleeve express preemption. The retaining did way that the suture such 360k(a), clause, provides: 21 U.S.C. of the portion the interior not run across under- directly ring beneath screw ‍‌‌​​‌​‌​​​​‌​​‌‌‌​‌‌​​‌‌​​‌‌‌​​‌​‌​‌​‌​‌​‌‌‌‌​​‌‍political or subdivision State [N]o sternum, the disconnection of the in effect side or continue may establish State Horn’s ultimately Mr. caused which to a device intended respect with - never occurred. have death any requirement human use warnings to should have issued TCI claims in summarized Horn's 5. The FDA has doctors, in the through either revisions following manner: first, correspondence labeling product two main claims: [P]laintiff makes (commonly called employed professionals a [suture] care that TCI health should rings letters”), design prevent against using screw used Doctor "Dear patient's place inside the hold the device in the device placed suture as device if the (plaintiff becoming disconnected chest from patient's sternum. face packaging would better alterna- TCI overlooked asserted that Br. at 4-5. Curiae Amicus Letter second, chose); [and] it tives to the (“The TCI Horn’s state common responds notification process impose law claims would no means comparable to pro- the PMA specifically applicable cess.”). ments that are HeartMate, such are expressly The number of medical devices that preempted. receive PMA year review each Lohr, Horn relies on Medtronic v. dwarfed number of those that are 135 L.Ed.2d 700 pursuant marketed to cleared Section (1996), Supreme Court case in- 510(k). In year fiscal for example, volved pacemaker. original represented only PMAs 54 of case, In that which we discuss in more 9,872 major submissions received. later, detail the FDA’s approval of the previous year, fiscal originаl PMAs in preemption did result 10,323 accounted for 49 of total submis- plaintiff Lohr’s state law claims because sions.6 approval process involved in that case As it HeartMate, concerns the TCI con-

was not the same approval pro- detailed tends that received FDA ap- cess that was employed by the FDA to proval of the HeartMate through the PMA approve the HeartMate. process, and not under the “substantial FDA determined that pacemaker the was equivalence” clearance standard of “substantially- equivalent” existing to an 510(k), § reading and Horn’s and 510(k) pursuant § device to FDA-approved analysis of “specificity” the of the law state Act, of the and therefore did not undergo requirement flawed, in Lohr is the Lohr the far thorough rigorous more and PMA decision is not controlling. agree. We 360e(c) § approval process under of the Act. It this latter type was of that

the HeartMate received. IV. FDA, The in its Amicus Curiae Letter This Court has addressed the of issue Court, to

Brief contrasted the the Act’s preemption before, express and 510(k) § equivalence” “substantial approv- those guide decisions us here. v. Gile 360e(c) process § al process with the Optical Corp., Radiation as follows: (3d Cir.), denied, cert. 513 U.S. A manufacturer can obtain an FDA (1994), S.Ct. 130 L.Ed.2d 342 the of finding equivalence’ by ‘substantial plaintiff brought state common law prod submitting pre-market to notification liability negligence ucts and against action agency accordance with Section an intraocular lens manufacturer. de We 510(k) 360(k). § of the [Act]. U.S.C. termined in that Gile state common law A found to ‘substantially device be may impose claims “requirements,” equivalent’ to a predicate is said § as that term is used (as to be ‘cleared’ FDA opposed Act, and that the state law requirements PMA). ‘approved’ by agency under a preempted by were the FDA. Id. at 541- pre-market A submitted un- notification 42. 510(h) der is thus entirely Section dif- PMA, Thereafter, include Michael v. Shiley, must ferent from (3d Cir.1995), data to demonstrate to FDA F.3d 1316 recipient of a sufficient that device is brought and See heart valve an against action safe effective. Lohr, at heart valve manufacturer for negligent (em- added). 6. phasis FDA Curiae Letter Amicus Br. at 12 requirements manufacturing” “good products strict design, and manufacture subjected, con- valve was the heart warranty of which implied of liability, breach un- proper bases for a stituted and fitness merchantability 360k(a). at 1324. warranty, § Id. express der breach purpose, heart at The FDA. Id. fraud Court following year, that the Act argued manufacturer valve Medtronic decided claims. Id. plaintiffs all of the (1996). In 2240, 135 L.Ed.2d 700 we preemption, the issue On earlier, the case, referred to which we that that: stated negligence common law asserted plaintiff [360k(a) only state pre-empts ] [SJection state law liability claims and and strict Further, pre- requirements. imposed mislabeling manufacture defective only when requirements those empts pace manufacturer against claims a previously add to from or they differ un FDA clearance given maker and relate requirement established equivalence” “substantial der regulated efficacy of the safety or to the from complaint Lohr’s stemmed process. from differs a state law device. When pacemaker. lead her a defective requirement to an or adds held the Lohr plurality A safety or law relates when against the manufacturer Lohr’s by the claims approved a device effectiveness pacemaker were 510(k)-approved Con- FDA, pre-empted. law is the state holding was impos- Key to this neither versely, preempted. a state when 510(k) pro- or adds nor from plurality’s opinion differs es “require- nor relates impose any federal an FDA does cess device device, of the rath- safety or effectiveness but is to the applicable ment” Lohr, in included an any matter 518 other standard.” or federal “generic er a is not the state law The Lohr requirement, 2240. at U.S. by § 360k. the more pre-empted consider whether Court did not 360e(c)-as § process under rigorous PMA that Michael’s at We concluded Id. 1323. 510(k) process-consti- § distinct from liability, strict negligence, claims of the regulation specific “a federal tutes warranties, and fraud on implied of breach HeartMate), (in this case the product”8 at Id. 1325- preempted. the FDA were re- turn, which, imposes in strict held significantly, we 31.7 Most upon the manufacturer.9 quirements labeling and as well as the process, PMA some, all, com- preempts not § but express war- claims for breach 7. Michael’s 506, 116 S.Ct. (based packaging 518 U.S. at valve’s mon law claims. ranty on the heart see, (based J., materials) concurring); e.g., on the manufac- Martin (Breyer, and fraud (5th Cir.2001); Medtronic, mate- promotional turer's advertisements rials), 254 F.3d v. subject (8th Howmedica, Inc., which were the neither 273 F.3d 785 v. Brooks not to be approval, were held Medtronic, Inc., FDA’s PMA Cir.2001); F.3d Kemp v. arising out of preempted because those claims Cir.2000); (6th Collagen Corp., Mitchell v. from state distinct private representations-as Cir.1997). (7th Where the fed- 126 F.3d 902 merely requirements-were state-enforced appli- requirement specifically at issue is eral remedies, state-imposed not common law device, Breyer Justice a particular cable to at 1325-31. remedies. common law concluded, any law claim im- state common preempted. Id. at device is plicating that Collagen Corp., 126 8. Mitchell Breyer con- S.Ct. 2240. Justice (7th 1997). Cir. plurality’s decision curred with 510(k)-ap- § against a claim common law Breyer's followed Justice Most circuits preempted, because Lohr, proved suggests device concurrence 1. The Federal Requirement labeling regulations requiring devices to carry warnings, 21 § C.F.R. 801.109 A. Analysis General (1995),the Lohr plurality stated: Federal Requirement [imposed un- The primary element distinguishing 510(k) § der reflect important ] but en- Lohr from the instant case is the fact that tirely generic concerns about device the HeartMate received FDA approval regulation generally, not the sort of con- 360e(c) through rigorous § PMA pro- cerns regarding device field cess, through “substantial regulation device that the statute or equivalence” process. The Lohr decision regulations were designed to protect did not address issue of whether the from potentially contradictory state re- process PMA imposed federal quirements. 360k(a). ments under It suggested, however, analysis would have 501, 116 at S.Ct. 2240. significantly been different if the We hold that the requirements im in Lohr issue had weathered a more exact- posed by the FDA upon the HeartMate ing federal investigation, such as the PMA when it granted PMA approval are process. 518 U.S. at precisely “the sort of concerns regarding a Indeed, the Lohr plurality distin- specific device” which guished the case from “a case which the intimated give rise to preemption Federal Government weighed has the com- 360k(a). portion This of our deci peting interests relevant to the particular sion in Michael v. Shiley, 46 F.3d at question, reached an unam- unchanged remains by the Lohr decis biguous conclusion about how those com- ion.10 peting considerations should be resolved a particular cases, case or set of and imple- ease, In this the HeartMate’s pro- mented that conclusion via a specific man- began cess in 1975 when its basic date manufacturers or producers.” Id. was completed. years after ten

Furthermore, in response live animal and pace- studies, human cadaver maker argument manufacturer’s that HeartMate granted was an investigational Lohr’s (“IDE”) state common exemption law claims were device by the FDA in preempted by the FDA’s “good begin manufac- order to clinical trials. Over the turing practices” regulatiоns, 21 years, C.F.R. next seven clinical trials of the (1995), §§ 820.20-820.198 by and the FDA HeartMate were conducted at hos- various § impose Comm., does not require- 341, 1012, a federal 121 S.Ct. 148 that specifically applicable ment partic- to a (2001), L.Ed.2d 854 held that a fraud on the ular device. brought FDA claim as a state of cause action impliedly was expressing without Orthopedic 10. In re Bone Screw Prods. Liab. any view on whether such a claim was ex- Litig., (3d 1998), 159 F.3d Cir. is not pressly preempted 360k(a). by § See id. at 501(k) case, the contrary. Orthopedic, §a 348 n. 121 S.Ct. 1012. dealing holding with the alternate of Mi- Medtronic, See also Martin respecting chael v. the claim F.3d of fraud on the FDA, (5th Cir.2001), that concluded Lohr which held had overruled the that Lohr did holding alternate affecting without overrule the prior prece- Fifth Circuit’s pre- emption any holdings Stamps determination or dent established Collagen Corp., other v. opinion. (5th aspect Cir.1993), Michael This Ortho- F.2d 1416 and that the pedic question came into Supreme when state law claims asserted in Martin were in Buckman Co. Legal v. preempted. Plaintiffs' manufacturing, HeartMate’s taining to the TCI submitted During period,

pitáis. FDA, labeling, distribution storage, packaging, ninety supplements more than 814.39, §§ 21 C.F.R. inquiries advertising. See made numerous and and FDA trials, clinical and its forth (setting the HeartMate 814.80 about concerning a device correspondence before including be obtained approval PMA ring marketed, and screw from the HeartMate’s leak may be manufactured changes subsequent approval applica- PMA supplementing method bonding agent and (i.e., of the the addition tion). held Appeal Other Courts PMA suture). its TCI submitted In consti- the FDA by approval that PMA FDA, supplemented to the application design, product’s tutes a sub- years with ensuing three it in the use, manufacturing meth- testing, intended and re- of amendments amount stantial labeling ods, standards performance 1994, after questions. sponses to See Brooks product. that is application, the of TCI’s review extensive Howmedica, Inc., 795-96 273 F.3d v. for com- the HeartMate FDA approved Medtronic, Inc., (8th Cir.2001); Kemp v. in the specified in the form mercial sale (6th Cir.2000); 216, 226-27 F.3d application. F.3d Collagen Corp., 126 v. Mitchell that, practical as a no doubt There is Cir.1997). (7th But see Goodlin imposed process the PMA reality, (11th Medtronic, Inc. 167 applicable to specifically were ments that Cir.1999).11 HeartMate, pre- triggered and that 360k(a). imposed It § emption under B. The Position12 - through a conditions mandatory created the FDA’s acknowledge that we While correspondence, decades-long process - it has been of statutes that interpretation per- alteration testing and device clinical us among instruction furnished Circuit was alone 11. The Eleventh Court in Lohr. Appeals ruled in Goodlin when it Courts of common law preempt given "Congress does not has That Court stated that involving PMA-approved devices. determining the unique claims role in Goodlin, Tenth Circuit at 1368. The preemptive effect.” scope of 360k’s Here, preempt the Act did has ruled U.S. at against expressly claim author- plaintiff’s position law tort common has been the FDA's manufacturer, but of the United medical device the Solicitor ized General undergo the Breyer prescient case did not in ac- at issue in that States. Justice 360e(c) analysis, underwent position but rather when he knowledging the FDA’s Investigative Ex rigorous Device far less wrote: Howmedica, (IDE) Oja v. ception process. fully responsible for admin- The ... FDA is Cir.1997). (10th responsibility means istering F.3d 782 That [Act]. the and, agency there- involvement informed fore, likely understanding the im- special argues of its footnote 12. The in dissent requirements, only pact of state and federal both preemption is entitled position on FDA's (or understanding whether indifference,” of as well as an thereby contending to "near which) may requirements interpre- extent to the disregard FDA’s we the should objectives. The FDA unique qualifica- interfere with as well as tation of Lohr its par- understandings into these regulations can translate and whether its tion determine accompa- (21 pre-emptive intentions ticularized U.S.C. interpretation of the FDA statute regulations. It nying rules and objectives its various 360k(a)) purposes § the and fulfill intentions, ex- those import can communicate denying the of the Congress. regulations, through in ample, statements particularized position, it in has FDA’s statements, and re- interpretive preambles, Heart- respect to the Brief with its Amicus Mate, sponses weight to comments. given has not the dissent charged by Congress with enforcing is not filed sion with the Supreme Court in oppo fully dispositive here, of the issues the sition to certiorari in Smiths Industries Supreme Court has instructed us that the Systems, Medical Kernats, Inc. v. preemption sig- determinatiоns are 139 L.Ed.2d 631 nificant and should inform our interpreta- (1998). However, those views have been 360k(a). § tion Indeed, expressly disclaimed rejected by the Court’s decision Lohr “substantially FDA in its Amicus Curiae Letter Brief to informed” by FDA, in the context of this Court. In its brief, current the FDA 510(k). § 116 S.Ct. has unequivocally expressed opinion Hence, we no hesitation in that state common law claims such as looking to the FDA for its interpretation of those by made against Horn a PMA-ap § in the medical device context. proved device are preempted. great With Lohr stated: particularity, the FDA specifically ad The regulations interpreting the dressed the HeartMate and concluded that scope §of 360k’s pre-emptive effect sup- because the device subject was the of PMA port view, Lohrs’ and our interpreta- approval 360e(c), under and not the sub tion of the pre-emption statute is sub- ject of equivalence” “substantial clearance stantially informed those regulations 510(k), the state law claims as ... Congress has given the FDA a serted Horn preempted.13 unique role determining the scope of FDA, when grant- pre-emptive 360k’s effect ... [I]n ed, imposes federal requirements based on

most cases state law will be pre-empt- highly detailed and prescriptive nature ed to the extent that the FDA has of the PMA process the approval or- promulgated ‘require- relevant federal der that results from it. In its Amicus ment.’ Because the FDA is the federal Curiae Letter Brief at pages 23-24, the agency to which Congress has delegated FDA writes: authоrity its to implement the provisions Act, of the agency uniquely quali- FDA can impose requirements by rule fied to determine whether a particular order, regardless of whether or not form of state law stands as an obstacle requirements initially were suggest- to the accomplishment and execution of ed to agency by an par- outside full purposes objectives of Con- ty.... Although the PMA approval or- and, gress, therefore, whether it should der does not itself expressly reiterate all be pre-empted. features de- device’s

Lohr, 518 495-96, U.S. at 116 S.Ct. 2240 sign, labeling, and manufacturing pro- (internal omitted). quotations citations and have, cesses must specifically ap- Horn, lav) us, in her before ‍‌‌​​‌​‌​​​​‌​​‌‌‌​‌‌​​‌‌​​‌‌‌​​‌​‌​‌​‌​‌​‌‌‌‌​​‌‍brief proves relied as a matter those features heavily on an FDA amicus curiae submis- set application and binds forth J., Id. at (Breyer, 116 S.Ct. 2240 “triggers array of a wide concurring (internal part) citations and imposed under state tort omitted). quotations law.” See Statement of Support Interest in Defendant Pacesetter’s Petition for Certifica 13. This present is the FDA's opinion. See Interlocutory tion for Appeal of the United Br., FDAAmicus Curiae Letter v. Horn Thora States of at Murphree America 5 & v. Paces Corp., (3d tec 2004 WL 1143720 May Cir. etter, al, (Tenn. Inc. No. 2004). et 005429-00-3 Cir It is consistent with the state 12, 2003). cuit Ct. Dec. Pacesetter, ment of interest Muiphree in v. Inc., in argued which it that approval by PMA 172 including often analysis, expert and mar- of and produce

the manufacturer between give-and-take substantial with compliance in product ket the manufacturer, ap- FDA and the agency FDA approved as sрecifications device, including detailed a new proves added). (emphasis manufac- design, for its specifications distinguished the clearly The also labeling, and use. ture, performance, 510(k) § substan- from the process PMA be may specifications Any of these was the process, which equivalence tial safety way that affects in changed [a] decision in Court’s subject of the FDA’s au- only with and effectiveness Lohr, writing: thorization. 510(k) clearance, a section Unlike added). (emphasis at Id. 20-21 two whether only determines which dissent, discussing Lohr v. Med- in substantially equivalent, products 180), (see at has Dissenting Op. tronic an exhaus- consummates approval PMA that Lohr was very salient fact ignored the efficacy of risks and into the inquiry tive decision equivalence” §a 510k “substantial a device.... 360e(c) is, § not, case PMA as this and Lohr, the Court surprisingly, the dramatic have discussed case. We holding against its premised approval pro- these two difference between had been device on the fact III and IV this Sections cesses both 510(k) through the Section only cleared emphasized opinion. We review.” a “limited form process, process mandates PMA 478, 116 Lohr, S.Ct. A at TCI) (in case, produce this manufacturer design may change manufacturer compliance, the HeartMate and market 510(k)-cleared aof Section labeling and with the only compliance, and to be long as it continues device by the approved specifications and ments predicate. its equivalent to substantially § cry from the 510k a far FDA. This is contrast to § In direct 807.81. C.F.R. Lohr, subject of was the process which ‘ap FDA does regime, PMA held Lohr Court notably the 510(k)~ to a Section prove’ changes comparable “by no means Rather, the manufactur device. cleared process.” its simply has to demonstrate er equivalent to substantially still Moreover, range is under predicate. its distinction significant This can a manufacturer make dissent’s changes that from the dis standably absent 510(k) without because, cleared device out ] to a as we point [§ cussion authority from prior prove Horn to getting any effort her opinion, approved de negligence, for a[PMA] broader than law claims general common de of a cleared A would neces vice. manufacturer or deficient labeling to, a Section notice the design, must submit or sarily vice differ add changes that ‘could labeling approved for manufacturing to FDA safety or effective affect See U.S.C. significantly by the FDA. pre-empted (see 808.1(b) device,’ represent p. or that 360k(a); ness C.F.R. use of ‘major Kemp in the intended v. change’ regulation); text of infra, (6th Medtronic, Inc., 807.81. device. C.F.R. Cir. Corp., 2000); Collagen v. devices], very Mitchell after ... For [PMA (7th Cir.1997), Papike Tamb thousands of process involving lengthy (9th Cir.1997), rands, 107 F.3d 737 many hours pages documentation v. Shiley, Michael 46 F.3d The only requirements asserted (3d Cir.1995). general Horn are requirements stemming from state common law: the HeartMate Thus, the District position, Court’s designed in a manner, defective it was position, position and our all are manufactured in a manner, defective accord: approval FDA’s PMA the manufacturer had failed to warn оf the imposed specific HeartMate federal re alleged defects. The thrust of Horn’s quirements upon the under HeartMate Complaint was that had the screw ring 360k(a) which, § explain infra, as we been a better and more feasible preempts Horn’s state common law claims. and had something more durable than a Mart, Inc., Hawkins v. Leslie’s Pool Cf. suture been used or had the threaded (3d Cir.1999) 250-51 (holding eyelet sleeve with the been placed differ- that labeling claims preempted by were ently in Mr. body, Horn’s his death would preemption similar clause in Federal In not have resulted.14 secticide, Fungicide and Rodenticide Act Horn has never claimed Pennsylva- that because, § in contrast to approval, nia has a requirement established spe- the EPA had incorporated specific labeling cific device content pertaining to the requirements could not changed be HeartMate.15 has alleged She never pre-approval).

without Pennsylvania requires all sutures for the HeartMate to be fabricated from a sub- 2. The Requirement State stance different than the suture which the approved. has Nor has she ever A. Analysis General alleged that there are require- State Requirement ments mandated the Commonwealth of Pennsylvania toas how a medical device issue is remaining whether Horn’s such the HeartMate must be fabricated state common-law claims constitute state designed or implanted within pa- requirements with respect to the Heart- body. Indeed, tient’s if alleged Horn had from, Mate which arе different inor addi- any “requirement” similar to these it to, the requirements. tion See would have claims, been fatal to her be- 360k(a). § earlier, U.S.C. As we noted cause each of them would have either been firmly established that a “requirement” to, in addition or different the feder- 360k(a) can include legal requirements al imposed through the ments arise out of state common-law FDA’s PMA the HeartMate. damages Gile, actions. See 22 F.3d at 541-42. Consequently, matter In the any absence of specific device that we must resolve whether requirements,16 are left we with Horn’s preempts state common law general common law negligence, claims of brought claims by Horn. design, defective etc. The question that allege Horn does not that TCI failed to from- Pennsylva- arise under the comply with the imposed by the Law, Hearing Registration nia Aid Sales FDA when it approved the At HeartMate. 6700-504(4), 6700-506, 6700-507(2), §§ P.S. argument, oral counsel for Horn twice stated see also 21 808.88. C.F.R. making that Horn was allegation. such an atTr. 7:20-8:12 & 10:12-14. her 16.In June 2004 Letter Brief at Horn case, Pennsylvania's only wrote: "In rely medical device re- Ms. does Horn quirements specifically exempt any device-specific requirements." 174 J., (Breyer, con 508, 2240 116 S.Ct. “gen- Id. at common law is: can Horn’s

remains we read Justice part). As curring “with claims, specific are not eral” a com concurring opinion, Breyer’s HeartMate, “re- constitute respect to” spe developed be un- law claim need not mon preemption that survive quirements” respect to” 360k(a)? cifically “with §der preempted. to be device order medical must, with the as it analysis begins, Our for Justice make little sense It would TCI, as Both Horn decision. Lohr to separately emphasize Breyer to write have consid- the authorities as well can under state law arising that duties 360k(a), § under preemption ered but simulta preemption, lead to regularly v. understandably read Medtronic tort plurality that agree with the neously interpreting starting point for as a Lohr to general always too are almost duties 360k(a) 21at regulations the FDA’s § v. Papike Tamb preemption. See warrant 808.1(d).17 They have also con- C.F.R. (9th rands, Cir. 107 F.3d the FDA’s PMA impact upon sidered 1997). reading of Jus logical more The general when of a medical device concurring opinion is that Breyer’s tice alleging negligence, tort claims carefully examine the state court should warn, defects, and the to failure to determine law claim in order common like, against the manufacturer are filed impose a sub that claim would whether Medtronic, See, v. e.g., Martin device. with, that conflicts stantive Cir.2001). (5th F.3d 573 to, specific greater or adds burden Lohr, sued Medtronic plaintiff In v. Col Mitchell requirement. See warn, failure negligent manufacture (7th 902, 911-12 lagen Corp., has claims Horn essentially the same Medtronic, Cir.1997); F.3d v. Kemp four-judge plu- against TCI. brought (6th Cir.2000); Martin v. Med claims that those rality in Lohr concluded (5th tronic, Cir. 581-83 not because “escape[d] pre-emption, 2001). com- duty judge-made is a of the source rule, their rather because but mon-law to Alexander Sando The dissent cites catego- outside the leaves them generality val, n. envisioned 360k ry requirements (2001), proposition for the 149 L.Ed.2d 517 devices such respect specific to’ be ‘with give courts do that the lower federal at pacemakers.” weight” to a concur precedential “much of the States ring opinion United Court, concurring opinion even where the joined in the Breyer Although Justice majority opinion. with the compatible in which plurality’s opinion section disagree, as Dissenting Op. 184. We See sepa- he appeared, wrote statement to this application principle has no that, plu- unlike the rately emphasize little resemblance Sandoval bears future case. convinced that rality, he was “not Sandoval, Justice Lohr. situation [§ ] incidents ” opinion merely observed or ‘rare.’ Scalia will be ‘few’ claims common-law act, existing making any thereby 808.1(d) provides: 21 C.F.R. appli- divergent requirements State or requirements local State or local Drug Food and Administra- or in when the different cable counterpart specific to, Drug tion has established Food and specific addition are other re- regulations or there ... Administration particular device to a quirements applicable in Lau by actions,” Lohr, a three-member concurrence enforced damages see Nichols, 563, 786, 491, 414 U.S. 94 S.Ct. 39 at 2240, 518 U.S. 116 S.Ct. Justice (1974), binding prece- Breyer L.Ed.2d 1 was not concluded that “ordinarily, insofar dent on an issue that the five-member as the pre-empts [FDA] require- Lohr, majority in Lau In statute, did not reach. ment embodied in rule, a state contrast, by Breyer regulation, Justice cast the so- action, or other administrative vote,” “swing сalled which was crucial to it pre-empt would also similar the outcome of the case and which without ment that takes the form of a standard of Moreover, majority. there could be no care or imposed by behavior a state-law Breyer Justice did not issues in his tort discuss action.” Id. at S.Ct. Stevens, J., concurring opinion that Justice (Breyer, in concurring part and dissent- writing Thus, on behalf of four-judge plurali- ing part). in Breyer’s Justice ratio- ty, did not reach. nale is the more narrow the two be- cause, although the Lohrs’ claims were not Splintered opinions by Supreme 360k(a), preempted by pre- he was not Court often result in some confusion as to join pared to in Justice Stevens’ sweeping opinion or rationale binding is on pronouncement that 360k almost never the lower federal In an attempt courts. preempts a state common law claim. situations, provide guidance some in such course, Court has instructed that the Of splintered decision in lower courts should follow the rationale Lohr unique Breyer because Justice by “taken joined those Members who concurred parts in some of Justice Stevens’ (thus in judgments on plurality the narrowest opinion making majori- it a grounds.” Gregg 153, v. Georgia, ty times), 428 U.S. opinion at join but did not in 2909, 169 n. 49 L.Ed.2d 859 parts. other dissenting colleague Our em- (1976) (plurality opinion); see phasizes also Marks that Breyer joined Justice in Part States, 188, 192-93, v. United plurality opinion, U.S. 97 V of the in which Justice (1977) (stating S.Ct. 51 L.Ed.2d 260 Stevens concluded that the Lohrs’ com- “[wjhen that, a fragmented Court decides mon-law claims did not constitute single case and no explаining rationale requirements they were not enjoys the result the assent of “specifically developed five Jus- respect ‘with to’ tices, holding may Lohr, ‘the be medical devices.” viewed that position taken those 116 S.Ct. 2240. principle This was not a Members who concurred in judgments that Breyer’s agreement. received Justice ’”); grounds.... narrowest concurring opinion, his Breyer Justice (1) Planned Parenthood Southeastern Pa. states that he must address two issues: (3d Cir.1991) v. Casey, 947 F.2d pre-empt whether the can “ever (2) (discussing action;” detail so, “narrowest tort state-law if wheth- ground” principle), on other er the FDA pre-empts brought the claims modified grounds, Lohr. Id. at (Brey- 116 S.Ct. 2240 (1992). er, L.Ed.2d J., concurring in part dissenting part). If the ground” approach “narrowest

applied Breyer’s opinion Justice In response to the question, first Justice significance. takes on added Breyer expressly “basically Whereas states that he “ Justice Stevens concluded agreefd]” with Justice O’Connor’s discus- simply most, was not to preempt point intended sion of that dissenting opinion. her all, let general alone common-law duties Justice O’Connor that “a concluded fair in the involved the FDA imposed by that state ments indicates reading ] of [§ la- manufacturing, as the fabrication pre-empted, design, claims are common-law states, the extent example, For itself the HeartMate. beling statute ‘any re- impose recognition alleges their that the Heart- Complaint Horn’s in addition different quirement’ designed such negligently Mate applicable to, FDCA come unscrewed ring the screw could (O’Con- Id. device.” This of the suture. presence spite Interestingly, Justice nor, J., dissenting). to require TCI would unquestionably claim statute “[t]he that also observed O’Connor by using ei- design HeartMate’s alter the requirement aof makes no mention itself ring. Yet or screw a different suture ther no sound basis and there is specificity, of by design approved as the HeartMate’s a restriction on determining that such by the approved remain the FDA would Id. exists.” ‘any requirement’ sale, and for national distribution issue, Thus, on the state require would design any changes four-mem- joined Breyer with Justice approval.20 FDA review further It majority.18 seems to make a dissent ber brief, in its ways with Justice has out merely parted pointed As TCI he that apply came time to ... it claims would when defect O’Connor “[Horn’s] claims common-law to the state entirely dif- rationale to use an either require TCI context) (in the Court. before con- ring the screw design than ferent or to pump, nect the outlet elbow plurality in Although Lohr suture, instead use different materials common not inform us of when opinion did posi- eyelet in a different place or to substantive may become requirements law Similarly, failure-to-warn claims her tion. that Horn’s arewe satisfied requirements, provide different require TCI would impose would state law claims19 general ap- from those warnings and instructions on TCI requirements substantive Br. at 45. TCI TCI to, proved by the FDA.” with, or add conflict preempt process does not juiy? If the a "dual ma- PMA as 18. This can be characterized general liability product [and suits Breyer joined jority” because Justice case require imposing (i.e., claims] ‍‌‌​​‌​‌​​​​‌​​‌‌‌​‌‌​​‌‌​​‌‌‌​​‌​‌​‌​‌​‌​‌‌‌‌​​‌‍common law pre- no plurality on result with PMA, approved then ments at odds with as to the emption), joined the dissent but with every device juries state will influence (i.e., claim common law can a state rationale and often regulation, conflict in numerous though was by § even 3601c be Inc.], Howmedica, ing ways. [v. See Brooks respect developed to” a specifically "with ("The arguments advanced at 797 Note, device). See particular medical ignore uni by the need for national Brooks Plurality Value Precedential of regulation, formity product one of the Decisions, 767-69 80 Colum. L.Rev. MDA.”) (citing explicit goals cases). (1980) (discussing majority dual 853,45 (1976)) ("If a H.R.Rep. substan No. appli differing requirements tial number emphasized June 2004 Letter her 19. Horn imposed by cable to medical case are "the in this at 7 that claims Brief govern than the Federal jurisdictions other general applica- state law claims based ment, unduly be commerce would interstate specific to devices.” bility, requirements burdened.”). liability products Unless general claims] law common [and claims Advisory Liability Council The Product preempted, the plaintiff's are such as brief: in its amicus curiae writes supplanted by be expert will determinations regulators, each provide myriad supposing jury could one common Even right likely the FDA to reach a proper one less than with incentives manufacturers safer, every result. products what about make its however, prohibited, by the FDA’s PMA “requirement” which is “different” from approval order from making any imposеd by such the FDA in the PMA changes. process, See C.F.R. and thus 814.80.21 preemption. requiring In its Amicus Brief,23 Curiae Letter

Because these state common law claims FDA wrote: and duties are in severe tension with Here, ... plaintiff seeks to impose in that they are either addi- liability based on asserted flaws in the to, tion or different the federal re- design, labeling and manufacture quirements established the FDA in HeartMate approved despite approving HeartMate, they are neces- the fact that it complied with FDA re- sarily preempted by federally imposed quirements. Thus, plaintiff does at- 360k(a).22 tempt to impose requirement different See, e.g., 228-37; Kemp, F.3d at from requirement [the imposed by] FDA Mitchell, at Papike, F.3d F.3d at 741-42.

There is allegation no that the Heart- Mate’s design, labeling, or methods of B. The FDA’s Position manufacture deviated from those set Our conclusion is reinforced forth in the PMA approved by FDA. by the analysis informed found in the Accordingly, any finding liability FDA’s amicus curiae brief. FDA The has based upon TCPs to satisfy a failure clearly expressed its view PMA ap- standard approved those different from proval in this requires case pre- by FDA in process the PMA would nec- emption. The FDA of Horn’s conceives essarily upon rest an implicit require- state common law as imposing claims a ment that designed, this device be man- provides § 21 C.F.R. 814.80 device Collagen sions claim that has incurred liabili- manufactured, may labeled, not be etc. in a ty despite under state law conformity its any manner inconsistent with conditions to PMA, requirements the of the the state law aрproval specified in the PMA approval order. claims must preempted.”). be considered TCI would supplemental have to submit a Insofar as Horn's claim is premised on the application setting PMA proposed forth its adequacies warnings of the ap- reviewed and changes seeking and approval FDA of those proved by order, approval FDA in its PMA changes. 814.3a(d). § 21 C.F.R. If the FDA Martin, preempted. it is also See 105 F.3d at reject application, were TCI's TCI would be (“To allow a state cause of action for left in the position untenable and unenviable inadequate warnings impose different having to comply conflicting with state and requirements or in addition to requirements; precisely federal the conflict required by regulations."). those The preemption provision is meant specimens PMA includes labeling pro- to avoid. device, posed to be used for the 21 U.S.C. Similarly, Horn's claim respecting TCI's 360e(c)(l)(F), labeling and pro- must negligence furnishing in not a 'Dear Doctor' "adequate vide directions for use.” 21 U.S.C. “warning letter pump that the heart shouldn't 352(f). Moreover, PMA approval expresses installed be if upward, the sutures would face the FDA's proposed determination sternum,” Horn, toward the June Letter labeling labeling meets detailed Br. to, as it would either add ments set regulations. Any in its forth or differ the federal changes design, labeling in the or manufac- establishing of the HeartMate. See turing processes safety that affect and effec- Corp., Mitchell v. Collagen at 913-14 tiveness must approval. receive FDA ("[T]о the extent that [the Mitchells' mislabel-

ing, misbranding and allega- adulteration] 23.FDA Amicus Curiae Letter at 17-18. Br. case. recent in another has voiced way that in a marketed ufactured to the Circuit by FDA. brief submitted way approved differs from Pacesetter, Murphree Tennessee added). (emphasis about al., concerns expressed et com- impact respect With preempting of not consequences regula- the federal claims on law tort

mon as Horn’s: claims such common law devices, the for medical tory framework FDA wrote: jury to sec- inappropriate [I]t actions threat- law tort common State judgment FDA’s scientific ond-guess reg- for the statutory framework en par- that is within a matter such devices, particularly of medical ulation FDA determines expertise. ticular ap- and FDA’s review regard to with device, including compo- scope actions labeling. State proval product appropriate comprises, and nents ex- by centralized characterized are not for the device.... pathway regulatory is- regulatory of device pert evaluation whether subsequently determines Instead, they encourage, sues. meets the the device judges juries lay require, fact a rea- makes agency standard. balancing of benefits second-guess the as to the decision and deliberate soned to their risks of regulation and pathway of correct - the central patient population intended the device. Juries approve whether - aof on behalf of FDA sometimes role knowledge and techni- lack the scientific of group individual or individuals. single necessary to make such expertise cal redetermination That individualized judgments.... can product risks the benefits and - threat of including the in result relief of individ- of hundreds prospect [T]he - penalties or damage awards significant determining propriety the juries ual on manufacturers pressure that creates ap- approvals, or particular neither warnings that FDA has to add apply those standards propriate scientifically nor found to be approved, of the order- is the antithesis approvals, FDA-ap- withdrawal required, or place in Congress put and ly scheme in con- from the market products proved implementing. with charged expert agency’s flict with the determina- uncertainty as to the status Such and products such safe

tion that chaos for create devices would medical can harm This situation effective. industry and FDA. regulated both by retarding research health public ‘defen- by encouraging development and the United States of Interest of Statement to avoid by manufacturers labeling’ sive Pacesetter, 7-9, Murphree v. of America scientifically liability, resulting state (Tenn. al, Circuit 005429-00-3 Inc. No. et warnings and underuti- unsubstantiated 2003). Dec. Ct. treatments. lization of beneficial earlier, majority Id. at 25-26.24 As we discussed emphasized in Lohr Amicus Curiae FDA’s its views to determine qualified” “uniquely FDA is opinion it case echo the Letter Brief merit, could jury court action in a state Pacing Sys., Martin v. Telectronics benefits, Cir.1997) ("Thus, (6th outweigh because F.3d 1090 the risks conclude requirement the FDA has under the federal from the is different out- benefits of the device determined that the requirement.”). and, weigh the state the risks form of whether ... by PMA, subject were the of extensive pre-empted” should be 360k. by consideration the FDA leading up to its 518 U.S. at 116 S.Ct. 2240. Horn approval, PMA any finding in Horn’s favor contends, however, that we give should no based on general her claims of negligence weight interpretation FDA’s be or defective desigp and manufacture-be cause the previously argued by a jury or a court-would necessarily did not support preemption, amount to a state substantive requirement any event, interpretation FDA’s “different to, or in addition the fed- is entitled to “near indifference.” See eral requirements imposed by the FDA.” Dissenting fn. 2 Op. Maj. Op. fn. Any finding such would “stand as an obsta- supra. We cannot agree that the FDA’s cle to the accomplishment and execution position deference, is entitled to no objective of’ the of the safety and effec- “near indifference” simply it rep tiveness of the HeartMate specifically and resents a departure from prior its position. would conflict with the federal require- In Chevron U.S.A. Inc. v. Natural Re imposed ments PMA. Geier v. Council, Inc., sources 467 U.S. Defense Co., American Honda Motor 837, 863-64, 104 81 L.Ed.2d 694 146 L.Ed.2d 914 (1984), Court held that a (2000). revised interpretation by agency an is enti tled to deference because “[a]n initial If, hold, as we express pre- agency interpretation is not instantly emption clause found at 21 U.S.C. carved in stone.” Accordingly, an agency pre-empts Horn’s state lаw may change its course long so as it can claims, then point there is no in discussing justify change its with a analy “reasoned “implied preemption,” a which our doctrine sis,” see Motor Vehicle Ass’n State Mfrs. dissenting colleague addressed length Co., Farm Mut. 29, Auto. Ins. 463 U.S. an attempt to bolster his conclusion that 103 S.Ct. (1983), L.Ed.2d and Lohr, opinion, governs this case. fully arewe persuaded that this standard Cipollone See v. Liggett Group, has been met.25 112 S.Ct. 120 L.Ed.2d 407 (1992) (“When Congress has

V. considered of pre-emption issue and has included Horn has not asserted that TCI has in the legislation enacted provision ex- any way failed to conform with the FDA plicitly issue, addressing that and when requirements prescribed by its PMA-nor that provision provides a reliable indicium it violated, deviated any of congressional intent with respect to the FDA’s federal regulations. statutes or authority, there is no to Because the need infer HeartMate, of the congressional labeling intent and the use, pre-empt instructions state laws for its the specification and from the provisions of the suture substantive leg- and its islation.”) (citations location when the is implanted, HeartMate quotations and internal as well as the omitted). other imposed We do not therefore address the 25. See United States v. Corp., consistency Mead 533 U.S. pronounce- with earlier and later 218, 228, ments, L.Ed.2d 292 and all give those factors which (2001) ("The weight accorded an adminis- power persuade, lacking power if to con- judgment trative particular in a case will de- (internal trol.'') quotations citations and omit- pend upon thoroughness evident its ted). consideration, validity its reasoning, its Addition- HeartMate, preempted. it is not “implied on arguments predicated

dissent’s allowing common-law ally, I believe preemption.” effect have the simply liability would our we, with together consequence aAs manu- other TCI and device encouraging read Appeal who sister Courts beyond FDA go above facturers have,26and we fashion as in the same Lohr clearly not standards, and this effect position, current with together of enhanc- purpose the MDA’s contradict preempted are claims Horn’s hold that re- I safety. therefore ing medical 360k(a). judgment of will affirm We dissent. spectfully judg- summary granting the District ment to TCI.

I. dissenting. FUENTES, Judge, Circuit majority’s with the quarrel have no I spe- is a process that the death, conclusion Barbara Following her husband’s governing regulation cific federal in the U.S. District a lawsuit Horn filed believe, however, that the I law, HeartMate.27 alleging Court, common under only at by looking erred District Court of TCI’s as a result husband died that her (the here regulation the federal In her whether pump. designed heart defectively device, PMA) to a suture on alleges complaint, she state law whether the examining through and not had worn HeartMate Mr. Horn’s device-specif- sued was which Horn under linking pump ring that the screw a state argues that common-law ic. Horn As a disconnected. had output side if claim only the state preempted Mr. claim result, traveled to air embolus an and the device-specific purportedly ma- brain, The causing his death. Horn’s is device- regulation preempting Hоrn’s common- jority has concluded that District responds TCI specific. negligence claims, grounded only the federal correctly analyzed require- Court “specific design, create defective Medtronic, equation, side and are therefore ments” state law I Inc. v. of the MDA. (1996), made that L.Ed.2d 700 however, gener- that Horn’s cannot agree, split inquiry. Circuits any spe- relevant impose claims alized common-law Ninth and with the Seventh question, on the “requirements” cific state-law requires 360k(a) preemption holding that § Circuits is because This HeartMate. regulation, device-specific only a re- against state only works preemption federal Corp., 126 F.3d Collagen v. or Mitchell that are “different quirements (7th Cir.1997); v. Tambrands Papike my In 912 requirements. to” federal addition (9th Cir.1997); and 742 F.3d seeking to 107 not view, is Horn’s suit because preemption that holding Tenth Circuit requirement on any specific impose pro- Howmedica, Inc., equivalence” § 510k “substantial F.3d 273 v. 26. See Brooks Medtronic, Inc., Cir.2001); (8th Maj. Op. 167. That v. not relevant. 785 Martin is cess Cir.2001); (5th Kemp v. Med pro- why F.3d 573 only 254 PMA speaks difference cir.2000); (6th tronic, Inc., 231 F.3d my requirement; specific federal is a cess 902, 913- Collagen Corp., 126 F.3d Mitchell majority over the disagreement is with (7th Cir.1997); Papike, 107 all, equation at but rather side of the (9th Cir.1997). implicates the state- suit whether Horn’s over in Lohr. specificity requirement reason, majority’s discussion 27. For this process between the of the difference four-justice additionally requires a device-specific Breyer agreed with a. bloc Howmedica, Inc., Oja v. (Stevens,- law. Kennedy, Souter Ginsburg) (10th Cir.1997). Although my 360k(a) “requirement” term §in colleagues acknowledge some kind of ambiguous, is and does not pre- entail the state-law specificity requirement, they ef emption of all common-law tort suits hold- fectively agree with the Seventh Ninth . ing manufacturers to higher standards in holding Circuits the most even than 488-89, the FDA. Id. at 116 S.Ct. claims, generalized tort (Stevens, such as those in J., (hereinafter plurality us,- the case before under “plurality”));28 505-06, id. at 116 S.Ct. 360k(a). § (Breyer, J., (hereinafter concurring “Breyer”)). The remaining four Justices I respectfully dissent this conclu- from disagreed, opining § bars all sion. regulations The FDA concerning claims, state-law otherwise, common-law or preemption clarify that preemption only that hold manufacturers to a higher stan- occurs when the FDA “has established than dard federal regulations. Id. at 511— specific counterpart regulations or there 12, 116 (O’Connor, J., S.Ct. 2240 concur- are other requirements applicable ring part (herein- and dissenting part to a device under the act.” 21 “dissent”)). after 808.1(d) added). (emphasis C.F.R. preemption clause does not “preempt State The plurality and Justice Breyer turned or local requirements general applica- to the above-quoted FDA regulations to bility purpose where the help determine when a common-law claim ment relates either to products other in constitutes a “requirement” UCC]) 360k(a). addition to (e.g., devices [the or to 498-99, 2240; Id. at 116 S.Ct. unfair trade practices the require- 505-06, id. at (Breyer). ments are not limited to devices.” 21 Relying on regulations, these the five Jus- 808.1(d)(1) added). C.F.R. (emphasis tices concluded that preеmption triggered by specific FDA regulations ap- the Supreme Court issued plying to a particular device, and not Lohr, a opinion fractured that examined generally applicable regulations, i.e., MDA preemption state law. The ma- those governing labeling jority of Lohr agreed that a medical 500-01, devices as a whole. Id. at strong presumption exists in favor of a 116 S.Ct. 2240. Part V of plurality scope narrow of polic- opinion, which Breyer joined, Justice also ing health is the traditional province of the stated the MDA does preempt states. 518 U.S. at 116 S.Ct. 2240. generalized claims, state-law negli- such as key Another factor in analyzing scope gence in manufacturing warn, or failure to of preemption Congress’s in pass- intent as opposed to state laws governing partic- ing legislation. Id. at ular 501-02, medical devices. Id. at however, S.Ct. 2240. split, The Court as S.Ct. 2240. to whether the MDA preempted state premised common-law claims Thus, on un- the Part V of the Lohr opinion, which suitability of a medical device under represents state Justices, the views of five ex- standards stringent more than the FDA cepted generalized claims like common-law standards governing the device. Justice negligent failure to warn and manufacture precise, 28. To be only I will only use the term portions four Justices. The of the Lohr "plurality” portions reference to opinion joined of Justice by five Justices will not be opinion Stevens’s joined by in Lohr that were accompanied any by parenthetical reference. super- would be regulations state fieity of Id. preemption. of MDA ambit from the specifici- if all that mattered ma- fluous Lohr 2240. The Moreover, regulation. state com- the federal “general ty of that reasoned jority require- not state generalized that “were exemption requirements” mon-law respect to’ the further by qualified ‘with developed is never ments specifically infringe kinds of not the requirements ... are devices those medical that condition Congress and Fi- that requirement. requirements generalized aon ability of federal impede the colleagues’ my feared would belie regulations nally, the spe- and enforce implement to regulators require- generalized conclusion 501,116 Id. at requirements.” cific federal merely they if preempted be ments can claims of Here, four Horn’s 2240. devices. of medical manufacture affect the of war- liability, breach strict negligence, (state-law claim 174-76 Maj. Op. at See general all are warn ranty failure to imposing the effect if it has preempted were not tort claims common-law device manufacturer on a greater burden de- govern to medical specifically crafted FDA). short, regulations than the scope vices, excepted from so are device- state-level the view that support 360k(a). §of 360k(a) pre- requisite is a specificity by the is bolstered This conclusion emption. by upon relied preemption, on

regulations published FDA has argues TCI above, majority. As mentioned the Lohr specific- contravening the state regulations has declared thе FDA regulations the cited but ity requirement, estab- FDA “has when the only occurs particu- context of that in the only state regulations counterpart specific lished requirements “general lar California ap- requirements specific there are other ... are devices specific to applicable not under to a plicable ato they applied are unless preempted not 808.1(d) add- (emphasis 21 C.F.R. act.” way to estab- in such as specific device say that ed). go regulations FDA-regulated an requirements” for lish and local State “there are other Thus, Fed.Reg. device. not are devices that that affect ments not are still requirements general 360k(a) they ] [§ preempted regulation; this preempted a de- applicable to ‍‌‌​​‌​‌​​​​‌​​‌‌‌​‌‌​​‌‌​​‌‌‌​​‌​‌​‌​‌​‌​‌‌‌‌​​‌‍‘requirements not are are that are requirements meaning [§ vice’ within if Even devices. affect ones that or local id., example “State as an and lists statement interpretation TCI’s applicability general requirements in the correct, statement one isolated were re- purpose where trump the ac- Register Federal addition products in other lates either to C.F.R., contained regulations tual UCC]) trade toor unfair (e.g., [the devices regulations those when especially which practices Supreme Court by the adopted been 21 C.F.R. limited devices.” 808.1(d)(1). speci- instructive.29 This reference to out, however, arguments pointed has itself put great emphasis colleagues My seem litigation brief, States in the United advanced sides with amicus on the FDA's indifference,” and to “near entitled Liability brief are Advi- Product and Amicus TCI. Horn merits as their own persuasive argu- only sory both advanced have also Council Corp., 533 U.S. v. Mead United States dictate. briefs on previous United States ments from 2164, 150 L.Ed.2d 121 S.Ct. as evidence scope 52). Notably, (2001) (cited Br. at in TCI preemption. As TCI their views favor argument against emption. Maj. Op. The main the state at 180. The Seventh lan- specificity requirement rests and Ninth perceived Circuits also a con- Breyer’s concurrence in guage of Justice tradiction ignore and chose to Justice joining After Part Breyer’s V, Lohr. V Stevens vote for Part instead credit- opinion, Breyer separately Justice wrote ing apparently contrary reasoning that common-law claims could in fact be Mitchell, his concurrence. 126 F.3d at they imposed preempted where different 912; Papike, 107 at 742. With all counterpart standards for devices than the respect my due colleagues and these Lohr, regulations. device-specific Courts, however, two Circuit I do not be- at (Breyer). 518 U.S. S.Ct. 2240 lieve that Breyer’s Justice concurrence is Breyer example Justice raised the in disagreement with Part ma- V the jury finding plaintiff for a in a negligence jority opinion.30 Breyer’s Justice opinion grounds hearing suit on the that a aid wire shows concern that in certain a situations inch, longer though than even fashion, through state could its common regulations approved had up wires law, a specific requirement for particu- a Breyer inches. Id. Justice concluded that lar example, plaintiff dеvice. For a could jury award would be even theory se, sue under a of negligence per though generalized it was based on the negligence premised where the on devi- negligence state tort law of it ation from a state requirement effectively device-specific established a (like for a device a 1-inch hearing aid requirement of 1-inch wires for hear- wire). Similarly, judge give could ing aids. Id. jury that, telling jury instruction as a law, matter of

My colleagues language have found this should find a manufac- Breyer negligent from Justice difficult to turer if it reconcile violated a certain agreement (i.e., his standard “you with with Part V of the should majority opinion, exempted gener- find the if negligent manufacturer it used inch”). pre- alized state causes of action from a hearing longer aid wire than 1 Indeed, gave regu- (Breyer). Lohr court deference to the FDA’s U.S. at S.Ct. 2240 particular, Breyer lations in to an explicitly amicus brief. the fact that Justice declined 518 U.S. at 116 S.Ct. 2240. join majority high- Conse- opinion Part VI of the quently, I believe that lights Lohr mandates that we join V his clear intent to Part in full. FDA, obey regulations issued rather Similarly, majority somehow turns Justice upon by than the amicus brief relied the ma- Breyer’s agreement with the Lohr dissent that jority. pre-empt "the MDA will sometimes a state- suit,” law tort id. at 116 S.Ct. 2240 added)-a (Breyer) (emphasis My colleagues incongruous statement that I find it that Jus- entirely agree Breyer agreement with-into an separately tice would “write with to em- phasize arising the Lohr that duties under state law dissent’s statement there is no regularly preemption, specificity requirement can lead to state-law but simulta- whatsoever. (dissent) neously agree plurality (quoted with the Id. at 116 S.Ct. 2240 tort 175). always general Maj. Op. contrary, duties are almost too to war- at To the Justice preemption.” Breyer Maj. Op. specificity rant 174. Not endorsed state-law re- Breyer's quirement by joining V is this an overstatement of Justice Part of Justice Ste- ("I language opinion, am not convinced that future vens’s and this therefore pre-emption "enjoys incidents of MDA of common- the assent of five Justices.” Marks v. States, 188, 192-93, ”), law claims will be 'few' or 'rare' it also United (1977). depicts plurality Accordingly, a false conflict: ex- 51 L.Ed.2d 260 pressed ground” approach frequency preemp- its views on the "narrowest evoked majority opinion, simply inapplicable tion in Part VI of its which Justice to evade the Breyer explicitly join. holding refused opinion. of Part V of the Lohr 184 argues that 485, 2240. TCI 116 S.Ct. specific involve examples

Both of these discarded. has since been presumption a device this imposed upon being requirement However, cites for that A all of the TCI law. cases through its common by the state (1) contrast, presump action, either found proposition does negligence simple language on because requirement tion irrelevant any specific impose not Marine, clear, Mercury 537 v. Sprietsma that device, simply alleges but 518, 51, 154 L.Ed.2d im- 123 S.Ct. designed/manufactured device was (2002); Foreign Crosby v. National properly. 8, Council, 363, n. Trade 530 U.S. case, suit is not Horn’s In this (2) (2000); or 2288, 147 L.Ed.2d 352 S.Ct. any specific impose requirement seeking to the inapplicаble presumption found It HeartMate, preempted. it is not on the question because it statute particular may cause of action true that Horn’s is province of with a traditional did not deal holding consequence have the indirect law, Legal Co. v. state Buckman Plaintiffs’ than higher to a standard the HeartMate 341, 347, Comm., 531 U.S. FDA, consequence but this does the (2001); v. States L.Ed.2d 854 United opinion by of the Lohr Part V sanctioned 108, 120 Locke, S.Ct. 529 U.S. Brey- expressly barred Justice and not (2000). conclusion, I L.Ed.2d 69 Moreover, my if even er’s concurrence. as I feel opinion, Part of the Lohr follow V colleagues correct content were do, hold that a state bound to we are Breyer’s concurrence contradicted Justice only if claim is it common-law V, of action would the correct course Part for specific requirement establishes majority opinion follow Part V as be to device, alleging than rather Court, elevate a not to Ac duty of care. generalized breach five-jus- one-justice above the concurrence finding of cordingly, the District Court’s Sandoval, majority. Alexander tice Cf. should be reversed.31 express preemption 5, 121 285 n. 532 U.S. (2001) (concurrence giv- is not L.Ed.2d II. majori- weight as precedential en as much compati- if concurrence is ty opinion, even express pre- no I would find Because majority opinion). ble with here, implied I would TCI’s emption reach conclude that argument, and Breyer’s concur- if Finally, even Justice preempt- V, impliedly claims are not Part equal weight Horn’s given rence werе exist in either preemption can Implied ed. “tie” should broken jurisprudential be (1) in- Congress a of situations: against two when presumption reference an entire Lohr, occupy tended scope preemption. wide ever, statutory only states that relevant V does suggests passing that Part TCI device-specific- actually state-level require compel the state- regulatory texts do “Although we relying do ity, sentence: requirement, but that the Lohr specificity level regulatory statutory and not believe that this majority state-specificity inferred the ‘general’ necessarily precludes fed- language language. V makes Part later ment from requirements pre-empting state from ever eral specificity is in fact a it that state-level clear 'general' requirements requirements, preemption. Id. at requirement impossi- preempted, ... being ever from (“These requirements there- S.Ct. 2240 overarching pre- ignore ble to concern its their escape preemption, ... because fore particular state emption where a occur category generality them leaves outside spe- to interfere with threatens be envisioned to 360k U.S. at cific federal interest.” devices”). respect to’ quoted language, how- This 'with 116 S.Ct. 2240.

185 (“field exclusively preemp- impliedly field of law suits are not preempted by (2) tion”), actually or when state law con- the MDA. supported This conclusion is by (“conflict preemp- presumption with federal law the flicts favor of a narrow tion”). E.g., Freightliner Corp. Myrick, scope prеemption, of mentioned above. 280, 287, 1483, Moreover, although 115 S.Ct. 131 the presence of an ex (1995). (§ 360k(a)) preemption press preemption L.Ed.2d 385 Conflict clause does (1) ways: in turn it not conclusively implied can be shown two rule out preemp tion, it impossible party comply imply “Congress for a with both does did not (2) pre-empt intend to requirements, Myr federal and state or the other matters.” ick, 288, 514 U.S. at Congressional state law frustrates intent. S.Ct. 1483. Here, only implied preemption Id. None of arguments TCI’s or USCC’s claim at issue is the frustration prong of persuasive toward finding implied preemp preemption: conflict TCI and Amicus Cu- Buckman, tion here. TCI relies on riae U.S. Chamber of Commerce 350, 121 1012, at U.S. S.Ct. for proposi (“USCC”) argue preemp- do not that field tion that the MDA implied pre allows for impossibility preemption tion or conflict Buckman, emption. however, found im apply. plied preemption of a claim state-law the defendant by had defrauded the FDA there is no express language

Since sending it false equivalency infor rely in a frustration conflict Id, mation. at 121 S.Ct. 1012. The analysis, key is, factor to consider un- conflict in Buckman existed because the surprisingly, Congressional purpose. E.g., MDA given power had the FDA full County, Barnett Bank Marion N.A. v. remedy discretion to perpe acts of fraud Nelson, 25, 31, it; trated on seeking state-law suit (1996). L.Ed.2d As the Lohr prosecute against fraud would observed, purpose court of the MDA necessarily conflict with the FDA’s discre protect by was to consumers ensuring the tionary forego decision to a fraud prosecu sаfety and effectiveness of medical de- tion against itself. Id. at 121 S.Ct. vices. 518 U.S. at 116 S.Ct. Indeed, the Buckman court distin Contrary to USCC’s and PLAC’s guished fraud-on-the-agency claims from assertions, protection of the medical de- suits based on “traditional state tort law industry vice regulation from excessive care,” principles duty which are a was minimal concern. Id. at principles involved this case. Id. at (plurality); S.Ct. 2240 see also id. at 352, 121 S.Ct. 1012. (MDA 116 S.Ct. 2240 motivated part concern on the reg- USCC, consumers and argument, TCI’s other echoed ulators, not industry). plurality spe- allowing is that state-law tort con- suits cifically disclaimed the idea of Congres- flicts with federal law because allows product liability juries sional “fear that second-guess actions the FDA’s determi- hamper development PMA-approved medical nation that conflict, at (plu- devices.” Id. 116 S.Ct. 2240 necessarily any safe. There is not rality).32 however, clearly pro-regulatory, This pro- allowing between the FDA’s TCI safety purpose consumer of the MDA to market the HeartMate and a state find- compels the conclusion that ing state common- HeartMate is unsafe: case; Breyer join plurality's agreeing 32. Justice did not he made no statement statutory purpose disagreeing detailed discussion of be- with it. Id. unnecessary analysis (Breyer). cause he found it there is no practice, while permitted posi two these way to reconcile natural (i.e., the state of here corresponding ban as a process the PMA is to see tions pumps). outlawing heart Pennsylvania III for Class minimum standards “floor” of from case, prohibited is mar TCI not devices, Under this “ceiling.” not a but HeartMate, simply must but keting the view, raise the standards a state could still liability if the of possibility with the live jurisdiction. safety within its own of Cf. Pennsylva up live to does not HeartMate Bank, 116 S.Ct. at 517 U.S. Barnett Al standards of care. applicable nia’s (federal banks to sell permitting law admittedly may liability though the risk neces does not in small towns insurance efforts, marketing to TCI’s be a deterrent banning such law sarily conflict with state held that the inci Supreme Court has sales, could be read federal law since liability un incurred regulation dental they extent sales to the permitting state law is less applicable generally der law). permitted by state intrusive, pre to prone and therefore less Bank that while Barnett argues USCC on the regulation than “direct emption, necessarily that there was recognized Goodyear projects.” operation of federal permission between federal contradiction Miller, Corp. Atomic v. 185- Barnett practice, prohibition state (1988). L.Ed.2d 158 rule that fed- produced bright-line Bank Pokorny to v. Ford also cites USCC practice in a engage to permission eral (3d Co., 1123-25 Motor liability incurred state law preempts Cir.1990), support proffered bright- to its Accordingly, practice. in that engaging engage to permission rule that federal line concludes, permission to USCC liability law preempts in practice triggers frustration HeartMate market practice. in that Po- by engaging incurred suit de- Horn’s against conflict however, distinguishable for komy, designed claring that the HeartMate pur as Barnett Bank: same reason Bar- defectively. USCC mischaracterizes in regulation Po- pose behind the federal Bank, however: nett give to komy specifically was automobile any rule on frus- lay down blanket did flexibility equip to choose manufacturers merely but fol- conflict preemption, tration safety manual their automobiles with belts looking procedure the normal lowed airbags. instead of automatic belts and/or if to determine legislature’s intent out, Pokomy court points Id. As Horn preemption existed. conflict frustration manufacturer’s claim rejected the The Barnett Id. based preempted also a claim regulation that a federal stat- court Bank concluded protective netting, lack of on a in to sell insurance permitting banks ute Congress no there was evidence a state statute ban- towns small Transportation Department contem purpose be- ning such sales because regula netting when the plated protective empower the federal statute was hind at 1126. In promulgated. Id. tion was contrast, Here, the MDA Id. banks. deed, Pokomy court allowed common- industry, but empower not created to way for the liability as a permissible “ by ensuring safe de- consumers protect automobile manufac to ‘encourage’ Thus, the conflict existed vices. safety features addi provide turers to exist here. Barnett Bank does not regula in” the federal tion to those listed case, Similarly, Id. the instant distinguishable is also tion. The instant case liability simply would allowing that Barnett Bаnk common-law Barnett Bank in from encouraging TCI and the effect of outright statutory ban with a state’s dealt Henry Deible; go McMillen; manufacturers to above other device Paul Mark standards, McKinley; beyond County; and this effect Jefferson Pine (Intervenor-defen clearly Township not contradict MDA’s Creek D.C.) purpose enhancing medical device safe- dants in ty.33

Leatherwood, Inc.

IV. Pennsylvania Department of Envi Supreme Five Justices of the Court have Protection; ronmental Jefferson joined an opinion requires specificity County, Pennsylvania; Pinecreek state claims in addition to fed- Administration; Township; Federal Aviation triggering eral Blakey Marion ** preemption under the Specificity MDA. claims is also appli- mandated Environmental, Khodara FDA regulations, cable to which we must Inc., Appellant. however, My colleagues, show deference. rejected binding both the No. 02-4038. instructions in Lohr and the United Appeals, States Court of

FDA regulations based on their perception Third Circuit. single opinion Justice’s in Lohr and litigation the FDA’s current position, to Argued ‍‌‌​​‌​‌​​​​‌​​‌‌‌​‌‌​​‌‌​​‌‌‌​​‌​‌​‌​‌​‌​‌‌‌‌​​‌‍Oct. 2003. Accordingly, we owe no deference. July Filed I respectfully must dissent: ENVIRONMENTAL, INC., KHODARA Partner, on Behalf of

General Eagle Environmental, L.P. BLAKEY; *Marion Federal Aviation Administration; Clearfield-Jefferson Regional Airport Authority;

Counties Johnson; Sekula; Donald R. Paul Miksich; William Frederick G. Mur ray; Morgan; Reitz; Tim Robert E. course, liability beyond Of shows that common- for state standards above and liability way impliedly FDA standards. is in no * MDA; obviously, express preemp- per Amended Clerk’s Order dated 01/16/03 ** preempt tion clause does some common-law per Amended Court’s Order dated 08/11/03

Case Details

Case Name: Barbara E. Horn, of the Estate of Daniel Ray Horn, Deceased v. Thoratec Corporation

Court Name: Court of Appeals for the Third Circuit

Date Published: Jul 20, 2004

Citation: 376 F.3d 163

Docket Number: 02-4597

Court Abbreviation: 3rd Cir.