Horn v. Thoratec Corp

• Court: Court of Appeals for the Third Circuit
• Decided: July 20, 2004
• Docket: 02-4597
• Status: Published

Opinion

Opinions of the United 2004 Decisions States Court of Appeals for the Third Circuit

7-20-2004

Horn v. Thoratec Corp Precedential or Non-Precedential: Precedential

Docket No. 02-4597

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Recommended Citation "Horn v. Thoratec Corp" (2004). 2004 Decisions. Paper 434. http://digitalcommons.law.villanova.edu/thirdcircuit_2004/434

This decision is brought to you for free and open access by the Opinions of the United States Court of Appeals for the Third Circuit at Villanova University School of Law Digital Repository. It has been accepted for inclusion in 2004 Decisions by an authorized administrator of Villanova University School of Law Digital Repository. For more information, please contact Benjamin.Carlson@law.villanova.edu. PRECEDENTIAL Allison Zeive (Argued) Public Citizen Litigation Group UNITED STATES COURT OF 1600 20 th Street, N.W. APPEALS Washington, D.C. 20009 FOR THE THIRD CIRCUIT __________ John M. Humphrey Rieders, Travis, Mussina, Humphrey, No. 02-4597 Harris, Waters & Waffenschmidt __________ 161 West Third Street P.O. Box 215 BARBARA E. HORN, Executrix Williamsport, PA 17703 of the Estate of Daniel Ray Horn, Deceased, Attorneys for Appellant Barbara E. Horn

Gary A. Winters Appellant Mayer, Brown, Rowe & Maw 1909 K Street, N.W. v. Washington, D.C. 20006

THORATEC CORPORATION. Alan E. Untereiner (Argued) __________ Robbins, Russell, Englert, Orseck & Untereiner LLP On Appeal from the United States 1801 K Street, N.W., Suite 411 District Court Washington, D.C. 20006 for the Middle District of Pennsylvania Civil Action No. 00-CV-00779 Charles W . Rubendall, II District Judge: Honorable James F. Keefer, Wood, Allen & Rahal McClure, Jr. 210 Walnut Street __________ P.O. Box 11963 Harrisburg, PA 17108-1963 Argued on December 11, 2003 Arnd N. von Waldow ___________ Reed Smith 435 Sixth Avenue Before: AMBRO, FUENTES, and Pittsburgh, PA 15219 GARTH, Circuit Judges Attorneys for Appellee Thoratec (Opinion Filed: July 20, 2004) Corporation

1 Douglas Letter, Appellate Litigation (hereinafter “TCI”1 ), based on its Counsel determination that Horn’s claims against Peter R. Maier, Attorney TCI are preempted by the express Civil Division, Room 9012 preemption provision in the Food Drug 601 D Street, N.W. and Cosmetic Act (the “Act”), 21 U.S.C. Department of Justice § 360k(a).2 We affirm. Washington, D.C. 20530-0001 I. Attorneys for Amicus Curiae United TCI manufactured and distributed States of America the left ventricular assist device known as the HeartMate. The HeartMate is a pump Robert N. Weiner that assists the blood flow between the Arnold & Porter heart’s ventricle and the aorta in patients 555 12th Street, N.W. with cardiac conditions. The inlet side Washington, D.C. 20004 tube is surgically attached to the heart via the ventricle, and carries blood from the Attorneys for Amicus Curiae heart into the pump. The outlet side tube Product Liability Advisory Council, Inc. brings blood from the pump to the aorta, where it is dispersed to the body. There is Daniel G. Jarcho a tube attached to the pump that exits the McKenna Long & Aldridge LLP body and connects to an external console. 1900 K Street, N.W. The console contains an air compressor Washington, D.C. 20006 which powers the HeartMate. The facts underlying this case Attorneys for Amicus Curiae pertain to the outlet side tube, which Chamber of Commerce of the United States of America 1 __________ Thoratec Corporation, formerly known as Thermo Cardiosystems, Inc., is OPINION referred to by the parties and the District __________ Court Judge as TCI. Therefore, we will also refer to defendant-appellee as TCI. 2 Garth, Circuit Judge: The Medical Device Amendments to the Act allow the Food and Drug Barbara Horn (“Horn”) appeals Administration (“FDA”) to regulate from the District Court’s grant of medical devices. See 21 U.S.C. §§ 360c et summary judgment to Thoratec Corp. seq. For ease of reference throughout this opinion, we refer to the Act as the source of preemption.

-1- connects the pump to the aorta. The which Dr. Benjamin Sun discovered that connection between the pump and the the suture on Mr. Horn’s HeartMate had tube, called the “elbow,” is worn off and the screw ring linking the pump to the output side elbow had inserted into an adapter conduit, which is disconnected. The disconnection had screwed into the open port of the pump. A allowed an air embolus to travel to Mr. screw ring is secured over the elbow to Horn’s brain. Although Dr. Sun ensure that it remains connected to the reconnected the screw ring and once again adapter conduit and the pump. A suture is linked the pump to the elbow, it was too tied over the screw ring and secured to the late. Mr. Horn suffered a brain adapter conduit to ensure it will not hemorrhage, and he was rendered brain rotate.3 The HeartMate was approved by dead. On May 8, 1998, his organs were the FDA pursuant to the Pre-Market donated for transplant and he was Approval (“PMA”) process set forth at 21 pronounced dead. U.S.C. § 360e(c) (discussed in depth, infra). On April 28, 2000, Horn filed a Complaint against TCI in the United On January 17, 1998, Horn’s States District Court for the Middle husband, Daniel Horn, was admitted to District of Pennsylvania. The Complaint Williamsport Hospital suffering a heart alleged defective design and manufacture attack. He was later transferred to of the HeartMate and failure to warn of Hershey Medical Center. Doctors there the alleged defects; it was based on Horn’s determined that Mr. Horn required a heart claim that the HeartMate’s output side transplant, and they waited for a suitable elbow was defectively designed. TCI donor heart to become available. On moved for summary judgment, arguing January 22, 1998, Mr. Horn’s condition that Horn’s state law claims are expressly deteriorated and a HeartMate was preempted by 21 U.S.C. § 360k(a). implanted in him to provide circulatory support. He was then transferred to an The District Court granted TCI’s assisted living facility. motion on November 7, 2002, holding that Horn’s state common law claims were On May 3, 1998, Mr. Horn began preempted. The District Court applied a to bleed from the spot where the two-prong test endorsed by the Sixth and HeartMate tube exited his body. Eleventh Circuits,4 which instructs that a Thereupon, he underwent exploratory state claim attacking the safety of a surgery at Hershey Medical Center, during

3 4 The HeartMate arrives at the See Kemp v. Medtronic, Inc., 231 surgeon pre-assembled. The surgeon need F.3d 216, 224-25 (6th Cir. 2000); Goodlin not manipulate the screw ring or suture v. Medtronic, Inc., 167 F.3d 1367, 1371 when he implants the HeartMate. (11th Cir. 1999).

-2- medical device is preempted if (1) the party the benefit of all reasonable FDA has established specific federal inferences from the record. Saldana v. requirements that are applicable to that Kmart Corp., 260 F.3d 228, 232 (3d Cir. particular device, and (2) the state claim is 2001); Gray v. York Newspapers, Inc., different from, or in addition to, the 957 F.2d 1070, 1078 (3d Cir. 1992). specific federal requirements. This Court also exercises plenary In granting TCI’s motion for review over a district court’s preemption summary judgment on express preemption determination, as it is a question of law. grounds, the District Court found that (1) Travitz v. Northeast Dep’t ILGWU Health the HeartMate’s PMA approval process & Welfare Fund, 13 F.3d 704, 708 (3d imposes a specific federal requirement Cir. 1994), cert. denied, 511 U.S. 1143 applicable to the HeartMate, and (2) if (1994); Michael v. Shiley, Inc., 46 F.3d Horn were successful on her state law 1316, 1321-22 (3d Cir. 1995). claims, “any judgment that the HeartMate III. was unsafe or otherwise substandard would be in direct conflict [with]—i.e., At issue is whether Horn’s suit different from—the FDA’s determination against TCI, alleging causes of action that the product was suitable for use.” under Pennsylvania common law, is Dist. Ct. Op. at 20. This timely appeal expressly preempted. We need not followed. examine the doctrine of implied preemption, because the Act under which II. the FDA preempted the state causes of We have jurisdiction to hear this action contains an express preemption appeal pursuant to 28 U.S.C. § 1291. clause, which obviates any reference to the Review of a district court’s decision to doctrine of implied preemption. The grant a motion for summary judgment is express preemption clause, 21 U.S.C. § plenary. Goodman v. Mead Johnson & 360k(a), provides: Co., 534 F.2d 566, 573 (3d Cir. 1976), [N]o State or political cert. denied, 429 U.S. 1038 (1977); subdivision of a State may Hilfirty v. Shipman, 91 F.3d 573, 577 (3d establish or continue in Cir. 1996). effect with respect to a Summary judgment is appropriate device intended for human only when there is no genuine issue as to use any requirement – any material fact and the moving party is entitled to a judgment as a matter of law. See Fed. R. Civ. P. 56(c); see also (1) which is different from, Armbruster v. Unisys Corp., 32 F.3d 768, or in addition to, any 777 (3d Cir. 1994). In examining the requirement applicable record, the court gives the nonmoving under this chapter to the

-3- device, and 15. . . . The continual pumping action of the TCI HeartMate, together with (2) which relates to the natural body movements, safety or effectiveness of caused the wearing away of the device or to any other the suture so placed, and matter included in a once the suture was worn requirement applicable to through, said movement of the device under this the pump caused the screw chapter. ring to become unscrewed. In this case, Horn contends that her state common law claims would impose 16.Had the screw ring been generally applicable duties to use good of an appropriate and care in manufacturing and to warn users of feasible design which would the product’s attendant risks. They would not permit the screw ring to not, she argues, impose specific become unscrewed as a requirements with respect to the result of pump movement, HeartMate. Paragraphs 15 and 16 of or had something more Horn’s Complaint set forth the gravamen durable than a suture been of her action as follows:5 used to secure the tightened screw ring, or had the 5 The FDA has summarized Horn’s threaded sleeve with the claims in the following manner: eyelet been placed in such a way that the retaining suture [P]laintiff makes two main did not run across the claims: first, that TCI interior portion of the screw should have employed a [suture] design to prevent the screw rings used to hold the product labeling or the device in place inside correspondence to health the patient’s chest from care professionals becoming disconnected (commonly called “Dear (plaintiff asserted that TCI Doctor letters”), against overlooked better using the device if the alternatives to the design it suture as placed in the chose); [and] second, that device packaging would TCI should have issued face the patient’s sternum. warnings to docto rs, through either revisions in FDA Amicus Curiae Letter Br. at 4-5.

-4- ring directly beneath the A manufacturer can underside of the sternum, obtain an FDA finding of the disconnection which ‘substantial equivalence’ by ultimately caused Mr. submitting a pre-market Horn’s death would never notification to the agency in have occurred. accordance with Section 510(k) of the [Act]. 21 U.S.C. § 360(k). A device TCI responds that Horn’s state common found to be ‘substantially law claims would impose state equivalent’ to a predicate requirements that are specifically device is said to be ‘cleared’ applicable to the HeartMate, and as such by FDA (as opposed to are expressly preempted. ‘approved’ by the agency under a PMA). A pre- Horn relies on Medtronic v. Lohr, market notificatio n 518 U.S. 470 (1996), a Supreme Court submitted under Section case which involved the FDA’s approval 510(k) is thus entirely of a pacemaker. In that case, which we different from a PMA, discuss in more detail later, the FDA’s which must include data approval of the device did not result in sufficient to demonstrate to preemption of the plaintiff Lohr’s state FDA that the device is safe law claims because the approval process and effective. See Lohr, involved in that case was not the same 518 U.S. at 478-79 (“The § detailed approval process that was 510(k) notification process employed by the FDA to approve the is by no means comparable HeartMate. In Lohr, the FDA determined to the PMA process.”). that the pacemaker was “substantially equivalent” to an existing FDA-approved device pursuant to § 510(k) of the Act, The number of and therefore did not undergo the far more medical devices that receive thorough and rigorous PMA approval PMA review each year is process under § 360e(c) of the Act. It was dwarfed by the number of this latter type of approval that the those that are marketed HeartMate received. pursuant to cleared Section The FDA, in its Amicus Curiae 510(k). In fiscal year 2003, Letter Brief to this Court, contrasted the § for example, original PMAs 510(k) “substantial equivalence” approval represented only 54 of the process with the § 360e(c) PMA process 9,872 major submissions as follows: received. The previous fiscal year, original PMAs

-5- accounted for 49 of 10,323 of implied warranty of merchantability and total submissions. 6 fitness for a particular purpose, breach of express warranty, and fraud on the FDA. Id. at 1321. The heart valve manufacturer As it concerns the HeartMate, TCI argued that the Act preempted all of the contends that because it received FDA plaintiff’s claims. Id. at 1322. On the approval of the HeartMate through the issue of preemption, we stated that: PMA process, and not under the [S]ection [360k(a)] “substantial equivalence” clearance pre-empts only state standard of § 510(k), and because Horn’s imposed requirements. reading and analysis of the “specificity” of Further, it pre-empts those the state law requirement in Lohr is requirements only when flawed, the Lohr decision is not they differ from or add to a controlling. We agree. previously established FDA IV. requirement and relate to the safety or efficacy of the This Court has addressed the issue regulated device. When a of the Act’s express preemption before, state law differs from or and those decisions guide us here. In Gile adds to an FDA requirement v. Optical Radiation Corp., 22 F.3d 540, and when a state law relates 541 (3d Cir.), cert. denied, 513 U.S. 965 to the safety or effectiveness (1994), the plaintiff brought a state of a device approved by the common law products liability and FDA, the state law is negligence action against an intraocular pre-empted. Conversely, lens manufacturer. We determined in Gile when a state law neither that state common law claims may impose imposes requirements nor state “requirements,” as that term is used differs from or adds to an in § 360k(a) of the Act, and that the state FDA requirement nor law requirements were preempted by the relates to the safety or FDA. Id. at 541-42. effectiveness of the device Thereafter, in Michael v. Shiley, or to any other matter Inc., 46 F.3d 1316 (3d Cir. 1995), the included in an FDA recipient of a heart valve brought an requirement, the state law is action against the heart valv e not pre-empted by § 360k. manufacturer for negligent manufacture and design, strict products liability, breach Id. at 1323. We concluded that Michael’s claims for negligence, strict liability, 6 FDA Amicus Curiae Letter Br. at breach of implied warranties, and fraud on 12 (emphasis added).

-6- the FDA were preempted. Id. at 1325-31.7 this holding was the plurality’s opinion Most significantly, we held that the PMA that the § 510(k) process does not impose process, as well as the labeling and “good any federal “requirement” applicable to the manufacturing” requirements to which the device, but is rather a “generic federal heart valve was subjected, constituted standard.” Lohr, 518 U.S. at 486-87. The proper bases for preemption under § Lohr Court did not consider whether the 360k(a). Id. at 1324. more rigorous PMA process under § 360e(c) —as distinct from the § 510(k) The following year, the Supreme process —constitutes “a specific federal Court decided Medtronic v. Lohr, 518 regulation of the product” 8 (in this case the U.S. 470 (1996). In that case, to which we HeartMate), which, in turn, imposes strict referred earlier, the plaintiff asserted F D A requ irements upon the common law negligence and strict liability manufacturer. 9 claims and state law defective manufacture and mislabeling claims against the manufacturer of a pacemaker that was given FDA clearance under the 8 Mitchell v. Collagen Corp., 126 § 510(k) “substantial equivalence” F.3d 902, 911 (7th Cir. 1997). process. Lohr’s complaint stemmed from 9 Most circuits have followed a defective lead in her pacemaker. Justice Breyer’s concurrence in Lohr, A plurality of the Lohr Court held which suggests that § 360k(a) preempts t h a t Loh r’s claim s aga inst th e some, but not all, common law claims. manufacturer of the § 510(k)-approved 518 U.S. at 506 (Breyer, J., concurring); pacemaker were not preempted. Key to see, e.g., M artin v. Medtronic, 254 F.3d 573 (5th Cir. 2001); Brooks v. Howmedica, Inc., 273 F.3d 285 (8th Cir. 2001); Kemp 7 Michael’s claims for breach of v. Medtronic, Inc., 231 F.3d 216 (6th Cir. express warranty (based on the heart 2000); Mitchell v. Collagen Corp., 126 valve’s packaging materials) and fraud F.3d 902 (7th Cir. 1997). Where the ( b a s e d o n t h e m a n u f a cturer’ s federal requirement at issue is specifically advertisements and promotional applicable to a particular device, Justice materials), neither of which were the Breyer concluded, any state common law subject of the FDA’s PMA approval, were claim implicating that device is preempted. held not to be preempted because those Id. at 505. Justice Breyer concurred with claims arising out of p r i v ate the plurality’s decision that a common law representations—as distinct from state claim against a § 510(k)-approved device requirements—were merely state-enforced is not preempted, because common law remedies, and not state- § 510(k) does not impose a federal imposed common law remedies. 46 F.3d requirement that is specifically applicable at 1325-31. to a particular device.

-7- 1. The Federal Requirement the federal requirements [imposed under § 510(k)] A. General Analysis of the Federal reflect important but Requirement entirely generic concerns The primary element distinguishing about device regulation Lohr from the instant case is the fact that generally, not the sort of the HeartMate received FDA approval concerns regarding a through the rigorous § 360e(c) PMA specific device or field of process, not through the § 510(k) device regulation that the “substantial equivalence” process. The statute or regulations were Lohr decision did not address the issue of designed to protect from whether the PMA process imposed federal potentially contradictory requirements under state requirements. § 360k(a). It suggested, however, that the analysis would have been significantly 518 U.S. at 501. different if the device at issue in Lohr had weathered a more exacting federal We hold that the requirements investigation, such as the PMA process. imposed by the FDA upon the HeartMate Lohr, 518 U.S. at 501. Indeed, the Lohr when it was granted PMA approval are plurality distinguished the case from “a precisely “the sort of concerns regarding a case in which the Federal Government has specific device” which the Supreme Court weighed the competing interests relevant intimated would give rise to preemption to the particular requirement in question, under reached an unambiguous conclusion about § 360k(a). This portion of our decision in how those competing considerations Michael v. Shiley, Inc., 46 F.3d at 1324, should be resolved in a particular case or remains unchanged by the Lohr decision.10 set of cases, and implemented that conclusion via a specific mandate on manufacturers or producers.” Id. 10 In re Orthopedic Bone Screw Furthermore, in response to the Prods. Liab. Litig., 159 F.3d 817, 825 (3d pacemaker manufacturer’s argument that Cir. 1998), is not to the contrary. Lohr’s state common law claims were Orthopedic, a § 501(k) case, in dealing preempted by the FDA’s “good with the alternate holding of Michael manufacturing practices” regulations, 21 respecting the claim of fraud on the FDA, C.F.R. §§ 820.20-820.198 (1995), and by concluded that Lohr had overruled the the FDA labeling regulations requiring alternate holding without affecting the devices to carry warnings, 21 C.F.R. § preemption determination or any other 801.109 (1995), the Lohr plurality stated: holdings of the Michael opinion. This aspect of Orthopedic came into question

-8- three years with a substantial amount of amendments and responses to FDA In this case, the HeartMate’s PMA questions. In 1994, after extensive process began in 1975 when its basic review of TCI’s application, the FDA design was completed. In 1985, after ten approved the HeartMate for commercial years of live animal and human cadaver sale in the form specified in the studies, the HeartMate was granted an application. investigational device exemption (“IDE”) by the FDA in order to begin clinical There is no doubt that, as a trials. Over the next seven years, clinical practical reality, the PMA process trials of the HeartMate were conducted at imposed requirements that were various hospitals. During this period, TCI specifically applicable to the HeartMate, submitted more than ninety supplements to and that triggered preemption under § the FDA, and the FDA made numerous 360k(a). It imposed mandatory conditions inquiries about the HeartMate and its — created through a decades-long process clinical trials, including correspondence of correspondence, clinical testing and concerning a leak from the HeartMate’s device alteration — pertaining to the screw ring and approval of subsequent HeartMate’s manufacturing, packaging, design changes (i.e., the addition of the storage, labeling, distribution and bonding agent and suture). In 1992, TCI advertising. See 21 C.F.R. §§ 814.39, submitted its PMA application to the 814.80 (setting forth requirement that FDA, and supplemented it in the ensuing PMA approval be obtained before device may be manufactured or marketed, and method for supplementing PMA when the Supreme Court in Buckman Co. application). Other Courts of Appeal have v. Plaintiffs' Legal Comm., 531 U.S. 341 held that PMA approval by the FDA (2001), held that a fraud on the FDA claim constitutes approval of the product’s brought as a state cause of action was d e s i g n , testin g , i n t e n ded use , impliedly preempted without expressing manufacturing methods, performance any view on whether such a claim was standards and labeling that is specific to expressly preempted by § 360k(a). See id. the product. See Brooks v. Howmedica, at 348 n.2. Inc., 273 F.3d 785, 795-96 (8th Cir. 2001); Kemp v. Medtronic, Inc., 231 F.3d See also Martin v. Medtronic, 254 216, 226-27 (6th Cir. 2000); Mitchell v. F.3d 573, 583 (5th Cir. 2001), which held Collagen Corp., 126 F.3d 902, 913 (7th that Lohr did not overrule the Fifth Cir. 1997). But see Goodlin v. Medtronic, Circuit’s prior precedent established in Inc. 167 F.3d 1367, 1377 (11th Cir. Stamps v. Collagen Corp., 984 F.2d 1416 (5th Cir. 1993), and that the state law claims asserted in Martin were preempted.

-9- 1999).11 While we acknowledge that the FDA’s interpretation of statutes that it has B. The FDA’s Position12 been charged by Congress with enforcing

11 The Eleventh Circuit was alone among the Courts of Appeals when it ruled 96. Here, the FDA’s position has been in Goodlin that § 360k(a) does not preempt expressly authorized by the Solicitor common law claims involving PMA- General of the United States. Justice approved devices. Goodlin, 167 F.3d at Breyer was prescient in acknowledging 1368. The Tenth Circuit has ruled that the the FDA’s position when he wrote: Act did not preempt a plaintiff’s common The . . . FDA is fully law tort claim against a medical device responsible for manufacturer, but the device at issue in administering the [Act]. that case did not undergo the § 360e(c) That responsibility means PMA analysis, but rather underwent the far informed agency less rigorous Investigative Device involvement and, therefore, Exception (IDE) process. Oja v. special understanding of the Howmedica, 111 F.3d 782 (10th Cir. likely impact of both state 1997). and federal requirements, as well as an understanding of 12 The dissent in its footnote 2 whether (or the extent to argues that the FDA’s position on which) state requirements preemption is entitled only to “near may interfere with federal indifference,” thereby contending that we objectives. The FDA can should disregard the FDA’s interpretation translate these of Lohr as well as its unique qualification understandings into to determine whether its regulations and particularized pre-emptive interpretation of the FDA statute (21 intentions accompanying its U.S.C. § 360k(a)) fulfill the purposes and various rules and objectives of Congress. In denying the regulations. It can import of the FDA’s position, which it has communicate those particularized in its Amicus Brief with intentions, for example, respect to the HeartMate, the dissent has through statements in not given weight to the instruction regulations, preambles, furnished to us by the Supreme Court in interpretive statements, and Lohr. responses to comments. That Court stated that “Congress has given the FDA a unique role in Id. at 505-06 (Breyer, J., concurring in determining the scope of § 360k’s pre- part) (internal citations and quotations emptive effect.” Lohr, 518 U.S. at 495- omitted).

-10- is not fully dispositive of the issues here, execution of the full the Supreme Court has instructed us that purposes and objectives of the FDA’s preemption determinations are Congress, and, therefore, significant and should inform our whether it should be interpretation of § 360k(a). Indeed, the pre-empted. Supreme Court’s decision in Lohr was “substantially informed” by the FDA, in the context of § 510(k). Lohr, 518 U.S. at Lohr, 518 U.S. at 495-96 (internal 495. Hence, we have no hesitation in citations and quotations omitted). looking to the FDA for its interpretation of Horn, in her brief before us, relied § 360k(a) in the medical device context. heavily on an FDA amicus curiae Lohr stated: submission filed with the Supreme Court The FDA regulations in opposition to certiorari in Smiths interpreting the scope of § Industries Medical Systems, Inc. v. 360k’s pre-emptive effect Kernats, 522 U.S. 1044 (1998). However, support the Lohrs’ view, those views have been expressly and our interpretation of the disclaimed and rejected by the FDA in its pre-emption statute is Amicus Curiae Letter Brief to this Court. substantially informed by In its current brief, the FDA has those regulations . . . unequivocally expressed the opinion that Congress has given the state common law claims such as those FDA a unique role in made by Horn against a PMA-approved determining the scope of § device are preempted. With great 360k’s pre-emptive effect . particularity, the FDA specifically . . [I]n most cases a state addressed the HeartMate and concluded law will be pre-empted only that because the device was the subject of to the extent that the FDA PMA approval under § 360e(c), and not has promulgated a relevant the subject of “substantial equivalence” federal ‘requirement.’ clearance under § 510(k), the state law Because the FDA is the claims asserted by Horn are preempted.13 federal agency to which Congress has delegated its 13 authority to implement the This is the FDA’s present provisions of the Act, the opinion. See FDA Amicus Curiae Letter agency is uniquely qualified Br., Horn v. Thoratec Corp., No. 02-4597 to determine whether a (3d Cir. May 11, 2004). It is consistent particular form of state law with the FDA’s statement of interest in stands as an obstacle to the Murphree v. Pacesetter, Inc., in which it a c c o mp l i s h me n t a n d argued that PMA approval by the FDA “triggers preemption of a wide array of

-11- The FDA, when PMA approval is (emphasis added). granted, imposes federal requirements The FDA also clearly distinguished based on the highly detailed and the PMA process from the § 510(k) prescriptive nature of the PMA process substantial equivalence process, which and the approval order that results from it. was the subject of the Supreme Court’s In its Amicus Curiae Letter Brief at pages decision in Lohr, writing: 23-24, the FDA writes: Unlike a section F D A can impose 510(k) clearance, which requirements by rule or only determines whether order, regardless of whether two products are or not the requirements substantially equivalent, were initially suggested to P M A a p p r o v al the agency by an outside consummates an exhaustive party . . . . Although the inquiry into the risks and PMA approval order does efficacy of a device. . . . not itself expressly reiterate all of the specific features the d e v ice’s design, In Lohr, not labeling, and manufacturing surprisingly, the Court processes must have, it premised its holding against specifically approves as a preemption on the fact that matter of law those features the device had been cleared set forth in the application only through the Section and binds the manufacturer 510(k) process, a “limited to produce and market the form of review.” Lohr, 518 product in compliance with U.S. at 478. A the specifications as manufacturer may change approved by FDA. the design and labeling of a Section 510(k)-cleared device as long as it continues to be substantially requirements imposed under state tort equivalent to its predicate. law.” See Statement of Interest in Support 21 C.F.R. § 807.81. In of Defendant Pacesetter’s Petition for direct contrast to the PMA Certification for Interlocutory Appeal of regime, FDA does not the United States of America at 5 & 7, ‘approve’ changes to a Murphree v. Pacesetter, Inc. et al, No. Section 510(k)-cleared 005429-00-3 (Tenn. Circuit Ct. Dec. 12, device. Rather, the 2003). manufacturer simply has to

-12- demonstrate that its device effectiveness only with is still subst antiall y FDA’s authorization. equivalent to its predicate. Moreover, the range of changes that a manufacturer Id. at 20-21 (emphasis added). can make to a [§ 510(k)] The dissent, in discussing Lohr v. cleared device without Medtronic (see Dissenting Op. at __), has getting prior authority from ignored the very salient fact that Lohr was FDA is broader than for a a § 510k “substantial equivalence” [PMA] approved device. A decision and not, as this case is, a manufacturer of a cleared §360e(c) PMA case. We have discussed device must submit a the dramatic difference between these two Section 510(k) notice to approval processes in both Sections III FDA only for changes that and IV of this opinion. We have ‘could significantly affect emphasized that the PMA approval safety or effectiveness of process mandates that the manufacturer (in the device,’ or that represent this case, TCI) produce and market the a ‘major change’ in the HeartMate in compliance, and only in intended use of the device. compliance, with the requirements and 21 C.F.R. § 807.81. specifications approved by the FDA. This is a far cry from the § 510k process which was the subject of Lohr, and which . . . For [PMA notably the Lohr Court held was “by no devices], after a very means comparable to the PMA process.” lengthy process involving Lohr, 518 U.S. at 478-79. thousands of pages of documentation and many This significant distinction is hours of expert analysis, and understandably absent from the dissent’s often including substantial discussion because, as we point out in this give-and-take between the opinion, any effort by Horn to prove her agency and the general common law claims of negligence, m a nu f acturer, FDA labeling or deficient design would approves a new device, necessarily differ from, or add to, the including detailed design, manufacturing or labeling specifications for its design, approved and pre-empted by the FDA. manufacture, performance, See 21 U.S.C. § 360k(a); 21 C.F.R. § labeling, and use. Any of 808.1(b) (see p. 17, infra, for text of these specifications may be regulation); Kemp v. Medtronic, Inc., 231 changed in [a] way that F.3d 216 (6th Cir. 2000); Mitchell v. affects safety and Collagen Corp., 126 F.3d 902 (7th Cir.

-13- 1997), Papike v. Tambrands, Inc., 107 Horn. F.3d 737 (9th Cir. 1997), and Michael v. The only state requirements Shiley, Inc., 46 F.3d 1316, 1323 (3d Cir. asserted by Horn are general requirements 1995). stemming from state common law: the Thus, the District Court’s position, HeartMate was designed in a defective the FDA’s position, and our position are manner, it was manufactured in a all in accord: the FDA’s PMA approval of defective manner, and the manufacturer the HeartMate imposed specific federal had failed to warn of the alleged defects. requirements upon the HeartMate under § The thrust of Horn’s Complaint was that 360k(a) which, as we explain infra, had the screw ring been of a better and preempts Horn’s state common law more feasible design and had something claims. Cf. Hawkins v. Leslie’s Pool more durable than a suture been used or Mart, Inc., 184 F.3d 244, 250-51 (3d Cir. had the threaded sleeve with the eyelet 1999) (holding that labeling claims were been placed differently in Mr. Horn’s preempted by similar preemption clause in body, his death would not have resulted.14 Federal Insecticide, Fungicide and Horn has never claimed that Rodenticide Act because, in contrast to Pennsylvania has established a § 510(k) approval, the EPA had requirement of specific device content i n c o r p o r a te d s p e c i f i c l a b e l i n g pertaining to the HeartMate.15 She has requirements that could not be changed never alleged that Pennsylvania requires without pre-approval). all sutures for the HeartMate to be 2. The State Requirement fabricated from a substance different than the suture which the FDA has approved. A. General Analysis of the State Requirement 14 The remaining issue is whether Horn does not allege that TCI Horn’s state common-law claims failed to comply with the requirements constitute state requirements with respect imposed by the FDA when it approved the to the HeartMate which are different from, HeartMate. At oral argument, counsel for or in addition to, the federal requirements. Horn twice stated that Horn was not See 21 U.S.C. § 360k(a). As we noted making such an allegation. Tr. at 7:20- earlier, it is firmly established that a 8:12 & 10:12-14. “requirement” under § 360k(a) can 15 Pennsylvania’s only medical include legal requirements that arise out of device requirements which are specifically state common-law damages actions. See exempt from preemption arise under the Gile, 22 F.3d at 541-42. Consequently, Pennsylvania Hearing Aid Sales the only matter that we must resolve is Registration Law, 35 P.S. §§ 6700-504(4), whether § 360k(a) preempts the particular 6700-506, 6700-507(2), see also 21 state common law claims brought by C.F.R. § 808.88.

-14- Nor has she ever alleged that there are regulations at 21 C.F.R. § 808.1(d).17 specific requirements mandated by the They have also considered the impact Commonwealth of Pennsylvania as to how upon the FDA’s PMA approval of a a medical device such as the HeartMate medical device when general state tort law must be fabricated or designed or claims alleging negligence, design defects, implanted within the patient’s body. failure to warn, and the like, are filed Indeed, if Horn had alleged any against the manufacturer of the device. “requirement” similar to these it would See, e.g., Martin v. Medtronic, 254 F.3d have been fatal to her claims, because each 573 (5th Cir. 2001). of them would have either been in In Lohr, the plaintiff sued addition to, or different from, the federal Medtronic for negligent manufacture and requirements imposed through the FDA’s failure to warn, essentially the same claims PMA approval of the HeartMate. Horn has brought against TCI. The four- In the absence of any specific judge plurality in Lohr concluded that device requirements,16 we are left with those claims “escape[d] pre-emption, not Horn’s general common law claims of because the source of the duty is a judge- negligence, defective design, etc. The made common-law rule, but rather question that remains is: can Horn’s because their generality leaves them common law “general” claims, which are outside the category of requirements that not specific “with respect to” the HeartMate, constitute “requirements” that 17 survive preemption under 21 C.F.R. § 808.1(d) provides: State or local requirements § 360k(a)? are preempted only when Our analysis begins, as it must, the Food and Drug with the Lohr decision. Both Horn and A d m i n i st r a t io n h a s TCI, as well as the authorities that have e s t a b l i s h e d s p e ci f i c considered FDA preemption under § counterpart regulations or 360k(a), have understandably read there are other specific Medtronic v. Lohr as a starting point for requirements applicable to a interpreting § 360k(a) and the FDA’s particular device under the act, thereby making any existing divergent State or local r e q u i r ements applicable to the device different from, or in 16 In her June 2004 Letter Brief at addition to, the specific 10, Horn wrote: “In this case, Ms. Horn Food and Drug does not rely on any device-specific Admi nistration requirements.” requirements. . .

-15- § 360k envisioned to be ‘with respect to’ for the proposition that the lower federal specific devices such as pacemakers.” courts do not give “much precedential Lohr, 518 U.S. at 502. weight” to a concurring opinion of the United States Supreme Court, even where Although Justice Breyer joined in the concurring opinion is compatible with the section of the plurality’s opinion in the majority opinion. See Dissenting Op. which that statement appeared, he wrote at ___. We disagree, as this principle has separately to emphasize that, unlike the no application to this case. Sandoval plurality, he was “not convinced that bears little resemblance to the situation in future incidents of [§ 360k(a)] pre- Lohr. In Sandoval, Justice Scalia merely emption of common-law claims will be observed that the opinion of a three- ‘few’ or ‘rare.’” Id. at 508 (Breyer, J., member concurrence in Lau v. Nichols, concurring in part). As we read Justice 414 U.S. 563 (1974), was not binding Breyer’s concurring opinion, a state precedent on an issue that the five-member common law claim need not be developed majority in Lau did not reach. In Lohr, by specifically “with respect to” a particular contrast, Justice Breyer cast the so-called medical device in order to be preempted. “swing vote,” which was crucial to the It would make little sense for Justice outcome of the case and without which Breyer to write separately to emphasize there could be no majority. Moreover, that duties arising under state law can Justice Breyer did not discuss issues in his regularly lead to preemption, but concurring opinion that Justice Stevens, simultaneously agree with the plurality writing on behalf of the four-judge that tort duties are almost always too plurality, did not reach. general to warrant preemption. See Papike v. Tambrands, Inc., 107 F.3d 737, Splintered opinions by the Supreme 742 (9th Cir. 1997). The more logical Court often result in some confusion as to reading of Justice Breyer’s concurring which opinion or rationale is binding on opinion is that a court should carefully the lower federal courts. In an attempt to examine the state common law claim in provide some guidance in such situations, order to determine whether that claim the Supreme Court has instructed that the would impose a substantive requirement lower courts should follow the rationale that conflicts with, or adds a greater “taken by those Members who concurred burden to, a specific federal requirement. in the judgments on the narrowest See Mitchell v. Collagen Corp., 126 F.3d grounds.” Gregg v. Georgia, 428 U.S. 902, 911-12 (7th Cir. 1997); Kemp v. 153, 169 n.15 (1976) (plurality opinion); Medtronic, 231 F.3d 216, 230 (6th Cir. see also Marks v. United States, 430 U.S. 2000); Martin v. Medtronic, 254 F.3d 188, 192-93 (1977) (stating that, “[w]hen 573, 581-83 (5th Cir. 2001). a fragmented Court decides a case and no single rationale explaining the result The dissent cites to Alexander v. enjoys the assent of five Justices, ‘the Sandoval, 532 U.S. 275, 285 n.5 (2001),

-16- holding of the Court may be viewed as in other parts. Our dissenting colleague that position taken by those Members who emphasizes that Justice Breyer joined in concurred in the judgments on the Part V of the plurality opinion, in which narrowest grounds . . . .’”); Planned Justice Stevens concluded that the Lohrs’ Parenthood of Southeastern Pa. v. common-law claims did not constitute Casey, 947 F.2d 682, 693 (3d Cir. 1991) specific state requirements because they (discussing in detail the “narrowest were not “specifically developed ‘with ground” principle), modified on other respect to’ medical devices.” Lohr, 518 grounds, 505 U.S. 833 (1992). U.S. at 501. This was not a principle that received Justice Breyer’s agreement. In If the “narrowest ground” approach his concurring opinion, Justice Breyer is applied to Lohr, Justice Breyer’s states that he must address two issues: (1) opinion takes on added significance. whether the FDA can “ever pre-empt a Whereas Justice Stevens concluded that “§ state-law tort action;” and (2) if so, 360(k) simply was not intended to pre- whether the FDA pre-empts the claims empt most, let alone all, general common- brought by Lohr. Id. at 503 (Breyer, J., law duties enforced by damages actions,” concurring in part and dissenting in part). see Lohr, 518 U.S. at 491, Justice Breyer concluded that “ordinarily, insofar as the [FDA] pre-empts a state requirement In response to the first question, embodied in a state statute, rule, Justice Breyer expressly states that he regulation, or other administrative action, “basically agree[d]” with Justice it would also pre-empt a similar O’Connor’s discussion of that point in her requirement that takes the form of a dissenting opinion. Justice O’Connor standard of care or behavior imposed by a concluded that “a fair reading of [§ state-law tort action.” Id. at 504-05 360k(a)] indicates that state common-law (Breyer, J., concurring in part and claims are pre-empted, as the statute itself dissenting in part). Thus, Justice Breyer’s states, to the extent that their recognition rationale is the more narrow of the two would impose ‘any requirement’ different because, although the Lohrs’ claims were from, or in addition to, FDCA not preempted by § 360k(a), he was not requirements applicable to the device.” prepared to join in Justice Stevens’ Id. at 512 (O’Connor, J., dissenting). sweeping pronouncement that § 360k Interestingly, Justice O’Connor also almost never preempts a state common observed that “[t]he statute itself makes no law claim. mention of a requirement of specificity, and there is no sound basis for Of course, the splintered decision determining that such a restriction on ‘any in Lohr is unique because Justice Breyer requirement’ exists.” Id. joined in some parts of Justice Stevens’ plurality opinion (thus making it a Thus, on the state requirement majority opinion at times), but did not join issue, Justice Breyer joined with the four-

-17- member dissent to make a majority.18 It come unscrewed in spite of the presence seems that he merely parted ways with of the suture. This claim unquestionably Justice O’Connor when it came time to would require TCI to alter the apply that rationale to the state common- HeartMate’s design by using either a law claims (in a § 510(k) context) before different suture or screw ring. Yet the the Court. HeartMate’s design as approved by the FDA would remain approved by the FDA Although in Lohr the plurality for national distribution and sale, and any opinion did not inform us of when changes to the design would require common law requirements may become further FDA review and approval.20 substantive requirements, we are satisfied that Horn’s general state law claims19 would impose substantive requirements on 20 TCI that would conflict with, or add to, The Product Liability Advisory the requirements imposed by the FDA Council writes in its amicus curiae brief: involved in the design, manufacturing, Even supposing one jury could fabrication and labeling of the HeartMate. provide manufacturers with proper For example, Horn’s Complaint alleges incentives to make its products that the HeartMate was negligently safer, what about every jury? If the designed such that the screw ring could PMA process does not preempt state product liability suits [and general common law claims] 18 This can be characterized as a imposing requirements at odds with “dual majority” case because Justice the approved PMA, then juries in Breyer joined with the plurality on the every state will influence device result (i.e., no pre-emption), but joined regulation, in numerous and often with the dissent as to the rationale (i.e., a conflicting ways. See Brooks [v. state common law claim can be pre- Howmedica, Inc.], 273 F.3d at 797 empted by § 360k even though it was not (“The arguments advanced by specifically developed “with respect to” a Brooks ignore the need for national particular medical device). See Note, The uniformity in product regulation, Precedential Value of Supreme Court one of the explicit goals of the Plurality Decisions, 80 Colum. L. Rev. MDA.” (citing H.R. Rep. No. 853, 756, 767-69 (1980) (discussing dual 45 (1976) (“If a substantial number majority cases). o f d i f f e r i n g r eq u i r e me n ts applicable to a medical device are 19 Horn emphasized in her June imposed by jurisdictions other than 2004 Letter Brief at 7 that “the claims in the Federal government, interstate this case are based on state law claims of commerce would be unduly general applicability, not requirements burdened.”). Unless products specific to devices.” liability claims [and general

-18- As TCI has pointed out in its brief, with § 360k(a) in that they are either in “[Horn’s] design defect claims . . . would addition to, or different from, the federal require TCI either to use an entirely requirements established by the FDA in different design than the screw ring to approving the HeartMate, they are connect the outlet elbow to the pump, or necessarily preempted by federally to use different materials instead of a imposed PMA requirements under § suture, or to place the eyelet in a different 360k(a).22 See, e.g., Kemp, 231 F.3d at position. Similarly, her failure-to-warn claims would require TCI to provide different warnings and instructions from 22 Similarly, Horn’s claim those approved by the FDA.” TCI Br. at respecting TCI’s negligence in not 45. TCI is prohibited, however, by the furnishing a ‘Dear Doctor’ letter “warning FDA’s PMA approval order from making that the heart pump shouldn’t be installed any such changes. See 21 C.F.R. 814.80.21 if the sutures would face upward, toward Because these state common law the sternum,” Horn, June 2004 Letter Br. claims and duties are in severe tension at 9, is preempted as it would either add to, or differ from, the federal requirement common law claims] such as establishing the design of the HeartMate. plaintiff’s are preempted, the See Mitchell v. Collagen Corp., 126 F.3d FDA’s expert determinations will at 913-14 (“[T]o the extent that [the be supplanted by a myriad of Mitchells’ mislabeling, misbranding and common law regulators, each one adulteration] allegations claim that less likely than the FDA to reach a Collagen has incurred liability under state right result. law despite its conformity to the requirements of the PMA, the state law 21 21 C.F.R. § 814.80 provides that claims must be considered preempted.”). a device may not be manufactured, Insofar as Horn’s claim is premised labeled, etc. in a manner inconsistent with on the adequacies of the warnings any conditions to approval specified in the reviewed and approved by the FDA in its PMA approval order. TCI would have to PMA approval order, it is also preempted. submit a supplemental PMA application See Martin, 105 F.3d at 1100 (“To allow setting forth its proposed changes and a state cause of action for inadequate seeking FDA approval of those changes. warnings would impose different 21 C.F.R. § 814.3a(d). If the FDA were to requirements or requirements in addition reject TCI’s application, TCI would be left to those required by federal regulations.”). in the untenable and unenviable position The PMA includes specimens of the of having to comply with conflicting state labeling proposed to be used for the and federal requirements; precisely the device, 21 U.S.C. § 360e(c)(1)(F), and this conflict the § 360k(a) preemption labeling must provide “adequate directions provision is meant to avoid. for use.” 21 U.S.C. § 352(f). Moreover,

-19- 228-37; Mitchell, 126 F.3d at 911-15, requirement imposed by] Papike, 107 F.3d at 741-42. FDA. . . B. The FDA’s Position Our preemption conclusion is There is no allegation reenforced by the informed analysis found that the HeartMate’s design, in the FDA’s amicus curiae brief. The labeling, or methods of FDA has clearly expressed its view that manufacture deviated from PMA approval in this particular case those set forth in the PMA requires preemption. The FDA conceives approved by FDA. of Horn’s state common law claims as Accordingly, any finding of imposing a “requirement” which is liability based upon TCI’s “different” from that imposed by the FDA failure to satisfy a standard in the PMA process, and thus requiring differe n t f r o m those preemption. In its Amicus Curiae Letter approved by FDA in the Brief,23 the FDA wrote: P M A process w o u ld necessarily rest upon an . . . Here, plaintiff implicit requirement that seeks to impose liability this device be designed, based on asserted flaws in manufactured or marketed the design, labeling and in a way that differs from manufacture of the the way approved by FDA. HeartMate as approved by FDA despite the fact that it (emphasis added). c o mp l i e d w i t h F DA With respect to the impact of state requirements. Thus, common law tort claims on the federal plaintiff does attempt to regulatory framework for medical devices, impose a requirement the FDA wrote: different from [th e State common law tort actions threaten the PMA approval expresses the FDA’s statutory framework for the determination that the proposed labeling regulation of medical meets the detailed labeling requirements devices, particularly with set forth in its regulations. Any changes in regard to FDA’s review and the design, labeling or manufacturing approval o f p r o d u ct processes that affect safety and labeling. State actions are effectiveness must receive FDA approval. not characterized by centralized expert 23 FDA Amicus Curiae Letter Br. at evaluation of devic e 17-18.

-20- regulatory issues. Instead, Id. at 25-26.24 they encourage, and in fact The FDA’s views in its Amicus require, lay judges and Curiae Letter Brief in this case echo the juries to second-guess the opinion it has voiced in another recent balancing of benefits and case. In a brief submitted to the Circuit risks of a specific device to Court of Tennessee in Murphree v. their intended patient Pacesetter, Inc., et al., the FDA expressed population – the central role concerns about the consequences of not of FDA – sometimes on preempting state common law claims such behalf of a single individual as Horn’s: or group of individuals. That individualized [I]t is inappropriate redetermination of the for a jury to second-guess benefits and risks of a FDA’s scientific judgment product can result in relief – on such a matter that is including the threat of within FDA’s particular significant damage awards expertise. FDA determines or penalties – that creates the scope of a device, pressure on manufacturers including the components it to add warnings that FDA comprises, and the has neither approved, nor appropriate regulatory found to be scientifically pathway for the device. . . . required, or withdrawal of FDA subsequently FDA-approved products determines whether the from the market in conflict device meets the PMA with the agency’s expert approval standard. The determination that such agency makes a reasoned products are safe and and deliberate decision as to effective. This situation can harm the public health by retarding research and 24 Martin v. Telectronics Pacing developme n t and by Sys., Inc., 105 F.3d 1090 (6th Cir. 1997) encouraging ‘defensive (“Thus, because under the federal labeling’ by manufacturers requirement the FDA has determined that to avoid state liability, the benefits of the device outweigh the resulting in scientifically risks and, under the state requirement, a unsubstantiated warnings jury in a state court action could conclude and underutilization of that the risks outweigh the benefits, the beneficial treatments. state requirement is different from the federal requirement.”).

-21- the correct pathway of that we should give no weight to the regulation and whether to FDA’s interpretation because the FDA approve the device. Juries previously argued that PMA approval did l a c k t h e sc i e n t if ic not support preemption, and in any event, knowledge and technical the FDA’s interpretation is entitled only to expertise necessary to make “near indifference.” See Dissenting Op. such judgments. . . . fn.2 and Maj. Op. fn.12, supra. We cannot agree that the FDA’s position is entitled to no deference, or “near [T]he prospect of indifference” simply because it represents hundreds of individual a departure from its prior position. In juries determining the Chevron U.S.A. Inc. v. Natural Resources propriety of particular Defense Council, Inc., 467 U.S. 837, 863- device approvals, or the 64 (1984), the Supreme Court held that a appropriate standards to revised interpretation by an agency is apply to those approvals, is entitled to deference because “[a]n initial the antithesis of the orderly agency interpretation is not instantly scheme Congress put in carved in stone.” Accordingly, an agency place and charged the FDA may change its course so long as it can with implementing. justify its change with a “reasoned analysis,” see Motor Vehicle Mfrs. Ass’n v. State Farm Mut. Auto. Ins. Co., 463 U.S. Such uncertainty as 29, 42 (1983), and we are fully persuaded to the status of medical that this standard has been met.25 devices would create chaos V. for both the regulated industry and FDA.

25 See United States v. Mead Corp., Statement of Interest of the United States 533 U.S. 218, 228 (2001) (“The weight of America at 7-9, Murphree v. accorded to an administrative judgment in Pacesetter, Inc. et al, No. 005429-00-3 a particular case will depend upon the (Tenn. Circuit Ct. Dec. 12, 2003). thoroughness evident in its consideration, As we discussed earlier, a majority the validity of its reasoning, its of the Court in Lohr emphasized that the consistency with earlier and later FDA is “uniquely qualified” to determine pronouncements, and all those factors whether a particular form of state law . . . which give it power to persuade, if lacking should be pre-empted” by § 360k. Lohr, power to control.”) (internal citations and 518 U.S. at 496. Horn contends, however, quotations omitted).

-22- Horn has not asserted that TCI has (“When Congress has considered the issue in any way failed to conform with the of pre-emption and has included in the FDA enacted legislation a provision explicitly addressing that issue, and when that requirements prescribed by its PMA—nor provision provides a reliable indicium of that it deviated from, or violated, any of congressional intent with respect to state the FDA’s federal statutes or regulations. authority, there is no need to infer Because the design of the HeartMate, the congressional intent to pre-empt state laws labeling and the instructions for its use, from the substantive provisions of the and the specification of the suture and its legislation.”) (citations and internal location when the HeartMate is implanted, quotations omitted). We therefore do not as well as the other requirements imposed address the dissent’s arguments predicated by the PMA, were the subject of extensive on “implied preemption.” consideration by the FDA leading up to its PMA approval, any finding in Horn’s As a consequence we, together with favor based on her general claims of our sister Courts of Appeal who have read negligence or defective design and Lohr in the same fashion as we have,26 and manufacture—be it by a jury or a together with the FDA’s current position, court—would necessarily amount to a hold that Horn’s claims are preempted by state substantive requirement “different § 360k(a). We will affirm the judgment of from, or in addition to, the federal the District Court granting summary requirements imposed by the FDA.” Any judgment to TCI. such finding would “stand as an obstacle to the accomplishment and execution of” the objective of the safety and effectiveness of the HeartMate specifically and would conflict with the federal requirements imposed by the PMA. Geier v. American Honda Motor Co., 529 U.S. 861, 873 (2000). If, as we hold, the FDA’s express preemption clause found at 21 U.S.C. § 360k(a) pre-empts Horn’s state law 26 See Brooks v. Howmedica, Inc., claims, then there is no point in discussing 273 F.3d 785 (8th Cir. 2001); Martin v. “implied preemption,” a doctrine which Medtronic, Inc., 254 F.3d 573 (5th Cir. our dissenting colleague addressed at 2001); Kemp v. Medtronic, Inc., 231 F.3d length in an attempt to bolster his 216 (6th cir. 2000); Mitchell v. Collagen conclusion that Lohr, a § 510(k) opinion, Corp., 126 F.3d 902, 913-14 (7th Cir. governs this case. See Cipollone v. 1997); Papike, 107 F.3d 737, 742 (9th Cir. Liggett Group, Inc., 505 U.S. 504 (1992) 1997).

-23- Barbara E. Horn v. Thoratec Corporation, I. No. 02-4597 I have no quarrel with the FUENTES, Circuit Judge, dissenting. majority’s conclusion that the PMA process is a specific federal regulation Following her husband’s death, governing the HeartMate.27 I believe, Barbara Horn filed a lawsuit in the U.S. however, that the District Court erred by District Court, under state common law, looking only at whether the federal alleging that her husband died as a result regulation here (the PMA) was specific to of TCI’s defectively designed heart pump. a particular device, and not examining In her complaint, she alleges that the whether the state law under which Horn suture on Mr. Horn’s HeartMate had worn sued was device-specific. Horn argues through and that the screw ring linking the that a state common-law claim is pump to the output side had disconnected. preempted only if the state claim is device- As a result, an air embolus traveled to Mr. specific and the purportedly preempting Horn’s brain, causing his death. The federal regulation is device-specific. TCI majority has concluded that Horn’s responds that the District Court correctly common-law claim s, grounded in analyzed only the federal side of the negligence and defective design, create equation, because Medtronic, Inc. v. Lohr, “specific requirements” under state law 518 U.S. 470 (1996), made that the only and are therefore preempted by § 360k(a) relevant inquiry. The Circuits are split on of the MDA. I cannot agree, however, that this question, with the Seventh and Ninth Horn’s generalized common-law claims Circuits holding that preemption requires impose any spe cific sta te-law only a device-specific federal regulation, “requirements” on the HeartM ate. This is Mitchell v. Collagen Corp., 126 F.3d 902, because § 360k(a) preemption works only 912 (7th Cir. 1997); Papike v. Tambrands against state requirements that are Inc., 107 F.3d 737, 742 (9th Cir. 1997); “different from, or in addition to” federal and the Tenth Circuit holding that requirements. In my view, because Horn’s suit is not seeking to impose any specific requirement on the HeartMate, it is not 27 For this reason, the majority’s preempted. Additionally, I believe that discussion of the difference between the allowing common-law liability would PMA process and the § 510k “substantial simply have the effect of encouraging TCI equivalence” process is not relevant. Maj. and other device manufacturers to go Op. at 13. That difference only speaks to above and beyond FDA standards, and this why the PMA process is a specific federal effect would clearly not contradict the requirement; my disagreement with the MDA’s purpose of enhancing medical majority is not over the federal side of the device safety. I therefore respectfully equation at all, but rather over whether dissent. Horn’s suit implicates the state-law specificity requirement in Lohr.

-24- preemption additionally requires a device- preempted state common-law claims specific state law. Oja v. Howmedica, premised on the unsuitability of a medical Inc., 111 F.3d 782, 789 (10th Cir. 1997). device under state standards more stringent Although my colleagues acknowledge than the FDA standards governing the some kind of state-law specificity device. Justice Breyer agreed with a four- requirement, they effectively agree with Justice bloc (Stevens, Kennedy, Souter and the Seventh and Ninth Circuits in holding Ginsburg) that the term “requirement” in § that even the most generalized tort claims, 360k(a) is ambiguous, and does not entail such as those in the case before us, are the preemption of all common-law tort preempted under § 360k(a). suits holding manufacturers to higher standards than the FDA. Id. at 488-89 I respectfully dissent from this (Stevens, J., plurality (hereinafte r conclusion. The FDA regulations “plurality”))28 ; id. at 505-06 (Breyer, J., concerning preemption clarify that concurring (hereinafter “Breyer”)). The preemption only occurs when the FDA remaining four Justices disagreed, opining “has established specific counterpart that § 360k(a) bars all state-law claims, regulations or there are other specific common-law or otherwise, that hold requirements applicable to a particular manufacturers to a higher standard than device under the act.” 21 C.F.R. § federal regulations. Id. at 511-12 808.1(d) (emphasis added). The (O’Connor, J., concurring in part and preemption clause does not “preempt State dissenting in part (hereinafter “dissent”)). or local requirements of general applicability where the purpose of the The plurality and Justice Breyer requirement relates either to other products turned to the above-quoted FDA in addition to devices (e.g., [the UCC]) or regulations to help determine when a to unfair trade practices in which the common-law claim constitutes a state requirements are not limited to devices.” “requirement” under § 360k(a). Id. at 498- 21 C.F.R. § 808.1(d)(1) (emphasis added). 99; id. at 505-06 (Breyer). Relying on these regulations, the five Justices In 1996, the Supreme Court issued concluded that preemption is only Lohr, a fractured opinion that examined triggered by specific FDA regulations MDA preemption of state law. The applying to a particular device, and not by majority of the Lohr Court agreed that a strong presumption exists in favor of a narrow scope of preemption because 28 To be precise, I will only use the policing health is the traditional province term “plurality” in reference to portions of of the states. 518 U.S. at 485. Another Justice Stevens’s opinion in Lohr that key factor in analyzing the scope of were joined by only four Justices. The preemption is Congress’s intent in passing portions of the Lohr opinion joined by five the legislation. Id. at 485-86. The Court Justices will not be accompanied by any split, however, as to whether the MDA parenthetical reference.

-25- generally applicable FDA regulations, i.e., device under the act.” 21 C.F.R. § those governing the design or labeling of 808.1(d) (emphasis added). The medical devices as a whole. Id. at 500-01. regulations go on to say that “there are Part V of the plurality opinion, which other State and local requirements that Justice Breyer joined, also stated that the affect devices that are not preempted by [§ MDA does not preempt generalized state- 360k( a ) ] b e c a u s e t h e y a r e n ot law claims, such as negligence in ‘requirements applicable to a device’ manufacturing or failure to warn, as within the meaning of [§ 360k(a)],” id., opposed to state laws governing particular and lists as an example “State or local medical devices. Id. at 501-02. requirements of general applicability where the purpose of the requirement Thus, Part V of the Lohr opinion, relates either to other products in addition which represents the views of five to devices (e.g., [the UCC]) or to unfair Justices, excepted generalized common- trade practices in which the requirements law claims like failure to warn and are not limited to devices.” 21 C.F.R. § negligent manufacture from the ambit of 808.1(d)(1). This reference to the MDA preemption. Id. at 501-02. The specificity of state regulations would be Lohr majority reasoned that “general state superfluous if all that mattered was the common-law requirements” that “were not specificity of the federal regulation. specifically developed ‘with respect to’ Moreover, the exemption of generalized medical devices . . . are not the kinds of state requirements is never qualified by the requirements that Congress and the FDA further condition that those requirements feared would impede the ability of federal infringe on a generalized federal regulators to implement and enforce requirement. Finally, the regulations belie specific federal requirements.” Id. at 501. my colleagues’ conclusion that generalized Here, Horn’s four claims of negligence, state requirements can be preempted if strict liability, breach of warranty and they merely affect the manufacture of failure to warn are all general common- medical devices. See Maj. Op. at 16-18 law tort claims that were not crafted (state-law claim is preempted if it has the specifically to govern medical devices, and effect of imposing a greater burden on a so are excepted from the scope of § device manufacturer than the FDA). In 360k(a). short, the regulations support the view that This conclusion is bolstered by the state-level device-specificity is a requisite FDA regulations on preemption, relied for § 360k(a) preemption. upon by the Lohr majority. As mentioned TCI argues that the FDA has above, the FDA has declared that published regulations contravening the preemption only occurs when the FDA state specificity requirement, but the cited “has established specific counterpart regulations only state that in the context of regulations or there are other specific a particular California law “general requirements applicable to a particular

-26- requirements not applicable to specific The main argument against the state devices . . . are not preempted unless they specificity requirement rests in the are applied to a specific device in such a language of Justice Breyer’s concurrence way as to establish requirements” for an in Lohr. After joining Part V of the FDA-regulated device. 45 Fed. Reg. Stevens opinion, Justice Breyer wrote 67321, 67322. Thus, general requirements separately that common-law claims could are still not preempted under this in fact be preempted where they imposed regulation; the only state requirements that different standards for devices than the are preempted are ones that affect specific c o u n te r pa r t d e v i c e -s p e c if i c F DA devices. Even if TCI’s interpretation of regulations. Lohr, 518 U.S. at 504 this statement were correct, one isolated (Breyer). Justice Breyer raised the statement in the Federal Register would example of a jury finding for a plaintiff in not trump the actual regulations contained a negligence suit on the grounds that a in the C.F.R., especially when those hearing aid wire was longer than 1 inch, regulations have been adopted by the even though FDA regulations had Supreme Court as instructive.29 approved wires up to 2 inches. Id. Justice Breyer concluded that this jury award would be preempted even though it was 29 based on the generalized state tort law of My colleagues seem to put great negligence because it effectively emphasis on the FDA’s amicus brief, established a device-specific state which sides with TCI. Horn and Amicus requirement of 1-inch wires for hearing Product Liability Advisory Council have aids. Id. also both advanced arguments from previous United States briefs on the scope My colleagues have found this of 360k(a) preemption as evidence in language from Justice Breyer difficult to favor of their views on preemption. As reconcile with his agreement with Part V TCI has itself pointed out, however, of the majority opinion, which exempted arguments advanced by the United States generalized state causes of action from in a litigation brief are entitled to “near preemption. Maj. Op. at 16. The Seventh indifference,” and are only as persuasive and Ninth Circuits also perceived a as their own merits dictate. United States contradiction and chose to ignore Justice v. Mead Corp., 533 U.S. 218, 228 (2001) Breyer’s vote for Part V, instead crediting (cited in TCI Br. at 52). Notably, the Lohr the apparently contrary reasoning in his court gave deference to the FDA’s concurrence. Mitchell, 126 F.3d at 912; regulations in particular, not to an amicus Papike, 107 F.3d at 742. With all due brief. 518 U.S. at 495-96. Consequently, respect to my colleagues and these two I believe that Lohr mandates that we obey Circuit Courts, however, I do not believe the regulations issued by the FDA, rather that Justice Breyer’s concurrence is in than the amicus brief relied upon by the disagreement with Part V of the majority majority.

-27- opinion.30 Justice Breyer’s opinion shows concern that in certain situations a state could fashion, through its common law, a specific requirement for a particular 30 device. For example, a plaintiff could sue My colleagues find it under a theory of negligence per se, where incongruous that Justice Breyer would the negligence is premised on deviation “write separately to emphasize that duties from a specific state requirement for a arising under state law can regularly lead device (like a 1-inch hearing aid wire). to preemption, but simultaneously agree Similarly, a judge could give a jury with the plurality that tort duties are instruction telling the jury that, as a matter almost always too general to warrant of law, it should find a manufacturer preemption.” Maj. Op. at 16. Not only is negligent if it violated a certain standard this an overstatement of Justice Breyer’s for a device (i.e., “you should find the language (“I am not convinced that future manufacturer negligent if it used a hearing incidents of MDA pre-emption of aid wire longer than 1 inch”). Both of common-law claims will be ‘few’ or these examples involve a specific ‘rare’”), it also depicts a false conflict: the requirement being imposed upon a device plurality expressed its views on the by the state through its common law. A frequency of preemption in Part VI of its simple negligence action, in contrast, does opinion, which Justice Breyer explicitly not impose any specific requirement on the refused to join. Lohr, 518 U.S. at 508 device, but simply alleges that the device (Breyer). Indeed, the fact that Justice was designed/manufactured improperly. Breyer explicitly declined to join Part VI of the majority opinion highlights his clear In this case, because Horn’s suit is intent to join Part V in full. Similarly, the not seeking to impose any specific majority somehow turns Justice Breyer’s requirement on the HeartMate, it is not agreement with the Lohr dissent that “the preempted. It is true that Horn’s cause of MDA will sometimes pre-empt a state-law action may have the indirect consequence tort suit,” id. at 503 (Breyer) (emphasis of holding the HeartMate to a higher added)–a statement that I entirely agree standard than does the FDA, but this with–into an agreement with the Lohr consequence is sanctioned by Part V of the dissent’s statement that there is no state- Lohr opinion and not expressly barred by law specificity requirement whatsoever. Justice Breyer’s concurrence. Moreover, Id. at 512 (dissent) (quoted in Maj. Op. at even if my colleagues were correct that the 17). To the contrary, Justice Breyer content of Justice Breyer’s concurrence endorsed a state-law specificity requirement by joining Part V of Justice Stevens’s opinion, and this requirement the “narrowest ground” approach evoked therefore “enjoys the assent of five by the majority is simply inapplicable to Justices.” Marks v. United States, 430 evade the holding of Part V of the Lohr U.S. 188, 192-93 (1977). Accordingly, opinion.

-28- contradicted Part V, the correct course of reversed.31 action would be to follow Part V as the II. majority opinion of the Supreme Court, not to elevate a one-justice concurrence Because I would find no express above the five-justice majority. Cf. preemption here, I would reach TCI’s Alexander v. Sandoval, 532 U.S. 275, 285 implied preemption argument, and n. 5 (2001) (concurrence is not given as conclude that Horn’s claims are not much precedential weight as majority impliedly preempted. Implied preemption opinion, even if concurrence is compatible can exist in either of two situations: (1) with majority opinion). when Congress intended federal law to Finally, even if Justice Breyer’s concurrence were given equal weight to 31 Part V, this jurisprudential “tie” should be TCI suggests in passing that Part broken by reference to the presumption V does not actually require state-level against a wide scope of preemption. Lohr, device-specificity, relying on the sentence: 518 U.S. at 485. TCI argues that this “Although we do not believe that this presumption has since been discarded. statutory and regulatory language However, all of the cases TCI cites for that necessarily precludes ‘general’ federal proposition either (1) fou nd th e requirements from ever pre-empting state presumption irrelevant because the requirements, or ‘general’ state language was clear, Sprietsma v. Mercury requirements from ever being preempted, Marine, 537 U.S 51, 62-63 (2002); Crosby . . . it is impossible to ignore its v. National Foreign Trade Council, 530 overarching concern that pre-emption U.S. 363, 374 n. 8 (2000); or (2) found the occur only where a particular state presumption inapplicable to the particular requirement threatens to interfere with a statute in question because it did not deal specific federal interest.” Lohr, 518 U.S. with a traditional province of state law, at 500. This quoted language, however, Buckman Co. v. Plaintiffs’ Legal Comm., only states that the relevant statutory and 531 U.S. 341, 347 (2001); United States v. regulatory texts do not compel the state- Locke, 529 U.S. 89, 108 (2000). In level specificity requirement, but that the conclusion, I would follow Part V of the Lohr majority inferred the state-specificity Lohr opinion, as I feel we are bound to do, requirement from that language. Part V and hold that a state common-law claim is later makes it clear that state-level preempted only if it establishes a specific specificity is in fact a requirement for requirement for a particular device, rather preemption. Id. at 502 (“These state than alleging breach of a generalized duty requirements therefore escape pre- of care. Accordingly, the District Court’s emption, . . . because their generality finding of express preemption should be leaves them outside the category of requirements that §360k envisioned to be ‘with respect to’ specific devices”).

-29- occupy an entire field of law exclusively devices.” Id. at 490 (plurality).32 This (“field preemption”), or (2) when state law clearly pro-regulatory, pro-consumer actually conflicts with federal law safety purpose of the MDA compels the (“conflict preemption”). E.g., Freightliner conclusion that state common-law suits are Corp. v. M yrick, 514 U.S. 280, 287 not impliedly preempted by the MDA. (1995). Conflict preemption can in turn be This conclusion is supported by the shown in two ways: (1) it is impossible for presumption in favor of a narrow scope of a party to comply with both federal and preemption, mentioned above. Moreover, state requirements, or (2) the state law although the presence of an express frustrates Congressional intent. Id. Here, preemption clause (§ 360k(a)) does not the only implied preemption claim at issue conclusively rule out implied preemption, is the frustration prong of conflict it does imply that “Congress did not intend preemption: TCI and Amicus Curiae U.S. to pre-empt other matters.” Myrick, 514 Chamber of Commerce (“USCC”) do not U.S. at 288. a r g ue that field preemption or None of TCI’s or USCC’s impossibility conflict preemption apply. arguments are persuasive toward finding Since there is no express language implied preemption here. TCI relies on to rely on in a frustration conflict Buckman, 531 U.S. at 350, for the preemption analysis, the key factor to proposition that the MDA allows for consider is, unsurprisingly, Congressional implied preemption. Buckman, however, purpose. E.g., Barnett Bank of Marion found implied preemption of a state-law County, N.A. v. Nelson, 517 U.S. 25, 31 claim that the defendant had defrauded the (1996). As the Lohr court observed, the FDA by sending it false § 501(k) purpose of the MDA was to protect equivalency information. Id. at 343. The consumers by ensuring the safety and conflict in Buckman existed because the effectiveness of medical devices. Lohr, MDA had given the FDA full power and 518 U.S. at 476. Contrary to USCC’s and discretion to remedy acts of fraud PLAC’s assertions, protection of the perpetrated on it; a state-law suit seeking medical device industry from excessive to prosecute fraud against the FDA would regulation was a minimal concern. Id. at necessarily conflict with the FDA’s 490-91 (plurality); see also id. at 476 discretionary decision to forego a fraud (MDA was motivated by concern on the prosecution against itself. Id. at 349. part of consumers and regulators, not industry). The plurality specifically 32 disclaimed the idea of a Congressional Justice Breyer did not join the “fear that product liability actions would plurality’s detailed discussion of statutory hamper the development of medical purpose because he found it unnecessary for analysis of the case; he made no statement agreeing or disagreeing with it. Id. at 508 (Breyer).

-30- Indeed, the Buckman court distinguished Horn’s suit declaring that the HeartMate is fraud-on-the-agency claims from suits designed defectively. USCC based on “traditional state tort law mischaracterizes Barnett Bank, however: principles of the duty of care,” which are the Supreme Court did not lay down any the principles involved in this case. Id. at blanket rule on frustration conflict 352. preemption, but merely followed the normal procedure of looking to the TCI’s other argument, echoed by legislature’s intent to determine if USCC, is that allowing state-law tort suits frustration conflict preemption existed. conflicts with federal law because it allows Id. at 32-37. The Barnett Bank court juries to second-guess the FDA’s concluded that a federal statute permitting determination that the PMA-approved banks to sell insurance in small towns device is safe. There is not necessarily any preempted a state statute banning such conflict, however, between the FDA’s sales because the purpose behind the allowing TCI to market the HeartMate and federal statute was to empower banks. Id. a state finding that the HeartMate is Here, in contrast, the MDA was not unsafe: the natural way to reconcile these created to empower industry, but to protect two positions is to see the PMA process as consumers by ensuring safe devices. Thus, a “floor” of minimum standards for Class the conflict that existed in Barnett III devices, but not a “ceiling.” Under this Bank does not exist here. view, a state could still raise the standards of safety within its own jurisdiction. Cf. The instant case is a lso Barnett Bank, 517 U.S. at 31 (federal law distinguishable from Barnett Bank in that permitting banks to sell insurance in small Barnett Bank dealt with a state’s outright towns does not necessarily conflict with statutory ban of a permitted practice, while state law banning such sales, since federal there is no corresponding ban here (i.e., law could be read as permitting sales to the the state of Pennsylvania outlawing heart extent that they are permitted by state law). pumps). In this case, TCI is not prohibited from marketing the HeartMate, but must simply live with the possibility of liability USCC argues that while Barnett if the HeartMate does not live up to Bank recognized that there was not Pennsylvania’s applicable standards of necessarily a contradiction between federal care. Although the risk of liability may permission and state prohibition of a admittedly be a deterrent to TCI’s practice, Barnett Bank produced a bright- marketing efforts, the Supreme Court has line rule that federal permission to engage held that the incidental regulation incurred in a practice preempts state law liability by liability under generally applicable state incurred by engaging in that practice. law is less intrusive, and therefore less Accordingly, USCC concludes, the FDA’s prone to preemption, than “direct permission to market HeartMate triggers regulation on the operation of federal frustration conflict preemption against

-31- projects.” Goodyear Atomic Corp. v. safety. 33 Miller, 486 U.S. 174, 185-86 (1988). IV. USCC also cites to Pokorny v. Ford Five Justices of the Supreme Court Motor Co., 902 F.2d 1116, 1123-25 (3d have joined an opinion that requires Cir. 1990), to support its proffered bright- specificity of state claims in addition to line rule that federal permission to engage specific federal requirements for the in a practice preempts state law liability triggering of preemption under the MDA. incurred by engaging in that practice. Specificity of state claims is also mandated Pokorny, however, is distinguishable for by the applicable FDA regulations, to the same reason as Barnett Bank: the which we must show deference. My purpose behind the federal regulation in colleagues, however, have rejected both Pokorny was specifically to give the binding instructions of the Supreme automobile manufacturers flexibility to Court in Lohr and the FDA regulations choose to equip their automobiles with based on their perception of a single manual safety belts instead of automatic Justice’s opinion in Lohr and the FDA’s belts and/or airbags. Id. As Horn points current litigation position, to which we out, the Pokorny court rejected the owe no deference. Accordingly, I must manufacturer’s claim that the regulation respectfully dissent. also preempted a claim based on a lack of protective netting, because there was no evidence that Congress or the Department of Transportation contemplated protective netting when the regulation was promulgated. Id. at 1126. Indeed, the Pokorny court allowed common-law liability as a permissible way for the state to “‘encourage’ automobile manufacturers to provide safety features in addition to those listed in” the federal regulation. Id. Similarly, in the instant case, allowing common-law liability would simply have the effect of encouraging TCI and other device manufacturers to go above and 33 beyond FDA standards, and this effect Of course, this only shows that would clearly not contradict the MDA’s common-law liability is in no way purpose of enhancing medical device impliedly preempted by the MDA; obviously, the express preemption clause does preempt some common-law liability for state standards above and beyond FDA standards.

-32-