Nos. 95-754, 95-886

In the








On Writ of Certiorari to the United States Court of Appeals for the Eleventh Circuit



Brian Wolfman

(Counsel of Record)

Allison M. Zieve

Alan B. Morrison

Public Citizen Litigation Group

1600 20th Street, N.W.

Washington, D.C. 20009

Laurence H. Tribe

Hauser Hall 420

1575 Massachusetts Avenue

Cambridge, MA 02138

Robert L. Cowles

Daniel C. Shaugnessy

Cowles & Shaugnessy

Suite 901

233 East Bay Street

Jacksonville, FL 32202

Robert F. Spohrer

Spohrer, Wilner & Maxwell

444 East Duval Street

Jacksonville, FL 32202

Attorneys for Respondents

March 29, 1996


Do the Medical Device Amendments to the federal Food, Drug, and Cosmetic Act, 21 U.S.C. Sec. 360c et seq., preempt state-law tort claims to recover money damages for injuries caused by a defective medical device?


Respondents/cross-petitioners Lora Lohr and Michael Lohr hereby respond to the opening brief of petitioner/cross-respondent Medtronic, Inc., which argues that the court of appeals erred in holding that the Lohrs' common-law design-defect claim is not preempted by the Medical Device Amendments ("MDA") to the Food, Drug, and Cosmetic Act ("FDCA"). In this brief, we show that the MDA does not preempt the Lohrs' design-defect claim, in part because the MDA imposed no design requirements with respect to the medical device at issue--Medtronic's Model 4011 pacemaker lead. The Lohrs are supported by the United States, whose brief examines each of the statutory and regulatory provisions relied on by Medtronic and demonstrates that none of them imposes design obligations on the manufacturers of medical devices. Brief for the United States, at 10, 14, 19-21. (See Footnote 1)

I. Before turning to the particulars of our argument, we note one fundamental point that Medtronic fails to confront: its reading of the statute would leave persons injured by medical devices without any federal or state remedy at all.

When Congress was considering legislation that ultimately became the FDCA in 1938, it specifically rejected a proposal to include a private right of action for damages caused by faulty or unsafe products regulated under the Act, on the ground that such a right of action already existed under state common law. See, e.g., Hearings Before a Subcomm. of the Comm. on Commerce of the United States Senate on S. 1944, 73d Cong., 2d Sess. 400, 403 (1933); see also Lohr Open. Br. 31 n.10. Similarly, since the FDCA's inception, it has been universally held that the Act does not preempt common-law damages actions, even with respect to drugs, which are subject to demanding premarket approval for safety and effectiveness. See Hurley v. Lederle Laboratories, 863 F.2d 1173, 1176-78 & n.2 (5th Cir. 1988)(rejecting preemption and reviewing case law). As the Lohrs' opening brief demonstrated, there is not a shred of evidence that, when adopting the MDA in 1976, Congress gave even a moment's thought to changing this regime for medical devices and preempting all common-law claims involving them. Nevertheless, Medtronic asserts that Congress reversed four decades of practice on the unsubstantiated theory that the preservation of traditional state tort remedies would somehow wreak havoc on the medical device industry and destroy the viability of the federal regulatory structure--even though the experience with the FDCA proves such fears to be groundless. Medtronic Open. Br. 34-35.

To be sure, when the Act was amended in 1976 to add the MDA, Congress enacted a preemption provision, 21 U.S.C. Sec. 360k(a). But because damages actions had co-existed for decades with the FDCA, Congress surely would have been explicit if it had wished to overturn the complementary system of federal regulation and state tort compensation for injured consumers. Indeed, it would be irrational to suppose that Congress preserved damages actions for consumers injured by foods, drugs, and cosmetics, but wanted to obliterate such actions for consumers injured by medical devices. To the contrary, Congress specifically referred, without criticism, to the litigation surrounding the Dalkon Shield tragedy, see, e.g., H.R. Rep. 853, 94th Cong., 2d Sess. 8 (1976)("House Report"), and noted that section 360k(a) preempts state legislative efforts, id. at 45-46, but was deafeningly silent about overriding state tort law. See Brief for the United States, at 14-15 ("That [legislative] silence is significant in light of Congress's specific awareness of the numerous personal injuries caused by the Dalkon Shield")(footnote omitted)(citing Silkwood v. Kerr-McGee Corp., 464 U.S. 238, 251 (1984)).

As explained in the Lohrs' opening brief (at 16-34), preemption of state damages claims under section 360k(a) is at odds with the statute's text, overall structure, history, and purpose, and with the authoritative regulations of the Food and Drug Administration ("FDA")--the agency charged by Congress with implementing the MDA. Indeed, this understanding was so clear that for 16 years after the MDA's passage no court countenanced the preemption of state damages actions that Medtronic asserts was Congress' unambiguous intent in 1976. See Lohr Open. Br. 31-32 & n.11. At the very least, the "clear and manifest" intent necessary to override state common law is not present in section 360k(a), Hillsborough County v. Automated Medical Laboratories, Inc., 471 U.S. 707, 715 (1985), and Medtronic's bid to escape from the tort system should be rejected.

II. Medtronic has failed to show that the MDA's preemption provision, 21 U.S.C. Sec. 360k(a), encompasses state damages actions. The company relies almost exclusively on Cipollone v. Liggett Group, Inc., 505 U.S. 504 (1992), for the proposition that "requirement" in section 360k(a) includes state common law, as though Cipollone's reading of that term automatically applies to all Acts of Congress and relieves courts of the duty to focus on the statute at hand. Thus, the company simply ignores the particular aspects of the statutory text and legislative history that led to the ruling in Cipollone, and which are not present in the context of section 360k(a). Moreover, Medtronic overlooks the many textual indications that "requirement" in section 360k(a) includes only positive enactments of state legislative and administrative bodies. See also Lohr Open. Br. 16-28.

In addition, for there to be preemption under section 360k(a), there must be a requirement established or continued in effect by "a State or political subdivision of a State." No one would ordinarily describe an award of damages by a jury or judge as being issued by a "State or political subdivision of a State." And it is impossible to say that a federal jury or judge--before whom most medical-device personal-injury cases are heard--is in any sense "a State or political subdivision" thereof.

III. Even if section 360k(a) were held to preempt some damages actions, it would not preempt the Lohrs' design-defect claim because, as the Eleventh Circuit held (Pet. App. 24a-29a, 35a), only state laws that are "different from, or in addition to" an MDA requirement are preempted and the MDA contains no requirements concerning device design. Medtronic does not point to any specific requirements applicable to the design of pacemaker leads, but nevertheless argues that the section 510(k) notification process, under which the company marketed the Model 4011 lead as substantially equivalent to a pre-MDA device, establishes requirements that preempt the Lohrs' design-defect claim. Medtronic's argument is fundamentally flawed because it proceeds from the premise that the FDA "authorized" the design of the pacemaker lead implanted in Lora Lohr, see Medtronic Open. Br. i, 44, when in fact the agency did nothing of the sort. As the United States has explained, the FDA does not approve the design of any medical device, let alone one that, like the Model 4011 pacemaker lead, was effectively grandfathered onto the market. Brief for the United States, at 20.

Beyond this basic defect, Medtronic is incorrect for two further reasons. First, the text of section 360k(a) and the FDA's authoritative preemption regulations dispositively refute Medtronic's argument. See 21 C.F.R. Sec. 808.1(d). They establish that, because there are no MDA requirements that are subject-specific (pertaining to device design) and device-specific (pertaining to pacemaker leads), the Lohrs' design defect claim is not preempted.

Second, even if section 360k(a) did not demand that federal device requirements be subject-specific and device-specific for preemption to occur, the Lohrs' design-defect claim would not be preempted because the section 510(k) notification procedure does not impose requirements that relate in any way to device design. The 510(k) notification procedure--under which Medtronic marketed its pacemaker lead as "substantially equivalent" to a pre-MDA, unregulated device--does not establish any preemptive "requirements" pertaining to safety and effectiveness, and thus it has no bearing on the Lohrs' state design-defect claim.



The Lohrs' opening brief in No. 95-886 explained in detail that 21 U.S.C. Sec. 360k(a) does not expressly preempt damages actions. In its opening brief in No. 95-754, Medtronic makes three arguments in support of its claim that section 360k(a) overrides state damages actions as well as positive state enactments: (1) the word "requirement" in section 360k(a) includes common law; (2) the phrase "State or political subdivision of a State" refers to juries and judges, as well as legislative and administrative bodies; and (3) abolition of state tort law in medical device cases is consistent with the purposes of the Food, Drug, and Cosmetic Act. As we now show, none of Medtronic's contentions is correct.

A. Medtronic's Interpretation Of "Requirement" In Section 360k(a) Is Incorrect.

With regard to the statutory text, Medtronic focuses almost exclusively on the word "requirement" to argue that common-law tort claims are preempted by section 360k(a). Medtronic Open. Br. 38. Because that word was interpreted to include the common law in section 5(b) of the Public Health Cigarette Smoking Act of 1969 ("the 1969 Act") in Cipollone v. Liggett Group, Inc., 505 U.S. 504 (1992), Medtronic maintains that "requirement" must carry the same meaning in section 360k(a). Nothing of that sort follows. As discussed in the Lohrs' opening brief (at 16-34), the statutory context in which "requirement" appears in the MDA, including the text of the preemption provision itself, shows that section 360k(a) does not preempt common-law damages actions. We do not repeat those arguments here, but respond only to Medtronic's new arguments.

To fully understand why Cipollone provides little guidance here, it is necessary to review the plurality's rulings on both statutory provisions at issue in that case. The plurality first considered the preemptive effect of section 5(b) of the Federal Cigarette Labeling and Advertising Act of 1965, which provided that "no statement relating to smoking and health shall be required in the advertising of [properly labeled] cigarettes." Cipollone, 505 U.S. at 518 (quoting 1965 Act)(emphasis in original). The Court concluded that this provision, including the word "required," preempted only positive law. Id. The 1969 Act contained a new section 5(b), however, which preempted any "requirement or prohibition based on smoking and health ... imposed under State law," id. at 515, and which extended to all "obligations with respect to the advertising or promotion' of cigarettes." Id. at 520 (quoting 1969 Act).

In light of these changes, the Court's analysis of the preemption provision of the 1969 Act flowed from a "compar[ison] to its predecessor in the 1965 Act," id., based not only on the differences in language quoted above, but also on important aspects of the legislative history suggesting that the 1969 Act's provision was broader in scope. Id. at 520-23. "In the context of such revisions and in light of the substantial changes in wording," the Court rejected the plaintiff's "claim that the 1969 Act did not alter the reach of 5(b)," and held that "requirement" in the 1969 Act could include some common-law claims. Id. at 520-21 (footnote omitted). It is clear for yet another reason that it was the contrasting contexts of the two Acts, and not just the appearance of the word "requirement" in the 1969 Act, that proved determinative in Cipollone: The 1965 Act preempted "statement[s] related to smoking and health ... required" in cigarette advertising, and yet this Court held that the 1965 Act did not reach common-law damages claims.

In contrast, section 360k(a) has not been amended since its enactment in 1976. And nothing analogous to the interpretive guide provided by the amendments to section 5(b) in Cipollone is present in the history of section 360k(a). Accordingly, for this reason alone, Medtronic's simplistic attempt to import the Cipollone plurality's ruling should be rejected.

Moreover, there is a good reason for the Congress that enacted the MDA to have used the word "requirement" in section 360k(a)--a reason which does not carry any suggestion that damages actions are within the preemptive reach of that section. "Requirement" is used in section 360k(a) to describe both the federal law that can have preemptive effect and the state laws that are candidates for preemption, strongly suggesting that the two have the same meaning. See Lohr Open. Br. 17-19.

This correspondence between the types of federal law that have preemptive effect and the types of state laws that are preempted is found in other preemption provisions interpreted by this Court. Thus, in Cipollone, the 1965 Act used the word "statement" to describe candidates for preemption because it is "statements" about the health effects of cigarettes that appear on cigarette packaging. See Cipollone, 505 U.S. at 518-19. Similarly, the preemption provision of the National Traffic and Motor Vehicle Safety Act at issue in Freightliner Corp. v. Myrick, 115 S. Ct. 1483, 1486 (1995), preempts state highway safety "standards" because the federal agency that administers the Safety Act is principally a "standard"-setting agency. See 49 U.S.C. Sec. 30111.

Under the MDA, the FDA may, among other things, promulgate performance standards, issue premarket approvals, and demand that particular devices carry specific warning statements. See, e.g., 21 C.F.R. Sec. 801.420(c)(2). Rather than list the different kinds of administrative actions that the MDA authorizes, Congress chose one term--"requirement"--to apply to the regulatory actions of the federal government and then, quite sensibly, used the same word in the same sentence to describe which state actions are preempted. Seen from this perspective, "requirement" in the MDA, like "statement" in the 1965 Act or "standard" in the Safety Act, was simply an easy way to describe the regulatory actions of both federal and state governments. (See Footnote 2)

B. A Jury Award Is Not Issued By A "State Or Political Subdivision Of A State" Within The Meaning Of Section 360k(a).

In order to prevail, Medtronic must demonstrate that a jury award in a medical device case is issued by a "State or political subdivision of a State" within the meaning of section 360k(a). Medtronic Open. Br. 40. In trying to squeeze damages awards within the ambit of this statutory language, Medtronic's argument begins and ends by claiming that a jury is a "quintessential governmental body." Medtronic Open. Br. 40 (quoting Edmonson v. Leesville Concrete Co., 500 U.S. 614, 624 (1991)).

Although jury selection, see id., or a judicial decision, cf. Shelley v. Kraemer, 334 U.S. 1 (1948), is state action for some purposes, that is wholly beside the point in this context. The question here is one of statutory construction--whether the "ordinary meaning" of "State or political subdivision of a State" includes juries or judges. See American Tobacco Co. v. Patterson, 456 U.S. 63, 68 (1982)(quoting Richards v. United States, 369 U.S. 1, 9 (1962)). In common parlance, one would not describe a civil jury--whose principal functions are to assess liability and apply the common law--as a "State or political subdivision of a State."(See Footnote 3) Likewise, that description would be a very unusual and awkward way to refer to a judge.

Furthermore, the great majority of personal-injury cases involving medical device are filed in, or removed to, federal court on the basis of diversity of citizenship (as the reported MDA preemption cases make evident). Certainly, the decision of a federal judge or a federal jury to award damages is not the action of a "State or [its] political subdivision." It is no answer, as one of Medtronic's amici claims, see Brief Amicus Curiae of General Motors Corp. ("General Motors Br."), at 13-14, that the federal jury or judge in a medical device case would be applying state law. Section 360k(a) refers to "States" or their "political subdivisions" as the entities that "establish or continue in effect" device "requirements." Federal juries and judges simply do not have that role in state tort actions. (See Footnote 4)

The Court's decision in Gregory v. Ashcroft, 501 U.S. 452 (1991), is closely analogous on this point and provides significant additional support for the Lohrs' position. In Gregory, the question was whether state judges were "employee[s]" within the meaning of the Age Discrimination in Employment Act ("ADEA") and therefore could not be forced to leave the bench at age 70, as the Missouri constitution requires. The Court recognized that the term "employee" was expansive and that the language upon which Missouri chiefly relied--the ADEA's exemption for state "appointees on the policymaking level"--would be "an odd way for Congress to exclude judges." Id. at 467. However, the Court held that, in light of the presumption against preemption, for the ADEA to override Missouri law, "it must be plain to anyone reading the Act that judges are included." Id. Thus, because the ADEA's text was "ambiguous," id., and did not plainly include judges, the Act was held not to preempt the Missouri provision at issue.

Here, for the reasons explained above, the most natural reading of the MDA's reference to a requirement imposed by a "State or political subdivision of a State" is that it does not include a damages verdict of a state (or federal) judge or jury applying state law. However, even if there were ambiguity on that question, as in Gregory, the requisite plain statement to preempt state damages claims appears nowhere in the text of section 360k(a).

C. Medtronic's Policy Justification For Preemption of Medical Device Damages Actions Is Misplaced.

Medtronic, joined by some of its amici, maintains that Congress must have intended to preempt common-law damages claims under section 360k(a) because such claims "assert regulatory obligations under state law that are as potent as a positive law enactment." Medtronic Open. Br. 37. This argument is incorrect as a matter of fact and law.

In the real world, positive law is almost always a more "potent" regulatory device than is a common law action for damages, because such an action does not prevent a company from selling its products, but at most obligates the company to pay for the injuries that those products have caused. The principal feature of positive-law regulatory enactments, however, is that failure to comply is a sufficient basis for keeping the product off the market, without the need to show harm resulting from the failure to comply. For example, in 1970, California enacted a medical device statute under which certain devices may be kept off of the market if they are found lacking in safety and effectiveness. See H.R. Rep. 853, 94th Cong., 2d Sess. 45-46 (1976)("House Report"). Similarly, other states have enacted statutes which forbid the sale of particular medical devices unless they contain certain required labels. See, e.g., Smith v. Pingree, 651 F.2d 1021 (5th Cir. Unit B 1981); see Fla. Stat. Ann. Sec. 484.051 (West 1991 & Supp. 1996).

On the other hand, in the common-law context, jury verdicts require only that damages be paid to the injured party. Therefore, the defendant can always choose to internalize the costs of the tort system without altering its product. For instance, despite dozens of suits concerning the defective Shiley heart valve, see Lohr Open. Br. 32 n.11, it took years before intense FDA regulatory pressure drove the device from the market. See The Bjork-Shiley Heart Valve: "Earn As You Learn," Staff Report of the Subcommittee on Oversight and Investigations of the Energy and Commerce Committee of the U.S. House of Representatives, 101st Cong., 2d Sess., Comm. Print 101-R, at 7-20 (Feb. 1990). (See Footnote 5)

In fact, while strict products liability may seek to improve product safety, one of its core principles is that, because some potentially dangerous products will inevitably cause harm on occasion, it is often beneficial to society as a whole both to keep the product on the market and to compensate injured parties through the tort system. Prosser & Keeton on Torts 536-57, 692-93 (4th ed. 1984); Morris on Torts 240-41 (2d ed. 1980). To be sure, in some situations, particularly where serious injuries are suffered by many individuals, see House Report, at 8, lawsuits can prod a manufacturer to remove a hazardous product from the market or change its design--the kinds of actions that can be achieved with swift assurance by direct regulation. However, in general, Medtronic's assertion that state tort law has the same effect as direct regulatory action is demonstrably false.

Moreover, as a legal matter, Medtronic's protestations about tort law's asserted regulatory effect prove far too much. If Medtronic were correct, whenever Congress sought to regulate a particular product and preempt state positive law, all common-law actions that provided a remedy for injuries caused by that product would be swept away without consideration of the fundamental differences between the goals of the regulatory and tort regimes. However, the Court has repeatedly and emphatically rejected that approach. In Cipollone, for instance, seven members of the Court held that, although the 1965 Act expressly preempted state regulatory law, it did not preempt common law, noting that "[t]here is no general, inherent conflict between [express] federal pre-emption of state [regulatory] requirements and the continued vitality of state common law damages actions." 505 U.S. at 518 (plurality); id. at 533-34 (Blackmun, J., concurring).

Similarly, in Silkwood v. Kerr-McGee Corp., 464 U.S. 238 (1984), the Court acknowledged that state positive law directly "regulating the safety aspects of nuclear development" was preempted by the Atomic Energy Act, id. at 250, but held that the plaintiff's state damages action concerning an unsafe nuclear plant was not preempted. In so ruling, the Court held that it would be improper to interpret federal statutes to "remove all means of judicial recourse" for those seeking compensation for injuries without a clear statement to that effect. See id. at 251. Thus, this Court has recognized that Congress can, and often does, preempt positive law, while leaving intact the states' historical role in compensating their citizens through the tort system.


A. Section 360k(a) Does Not Preempt The Lohrs' Design-Defect Claim Because There Are No Federal Requirements Specifically Concerning Device Design Let Alone The Design Of Pacemaker Leads.

As explained in the Lohrs' opening brief (at 39-42), section 360k(a) provides that state law is not preempted unless there is a specific federal requirement "applicable to the device," and the corresponding state law is "different from, or in addition to" that federal requirement. Thus, even assuming that section 360k(a) reaches damages actions, the Lohrs' design-defect claim would be preempted only if federal requirements were imposed specifically upon manufacturers of pacemaker leads, and only if those requirements applied to the design of those leads.

1. Medtronic's contrary argument is based on the proposition that the section 510(k) process--under which a manufacturer is permitted to market a device that is substantially equivalent to a pre-MDA device--is itself a federal requirement that preempts the Lohrs' design-defect claim under section 360k(a). Under Medtronic's interpretation, because the MDA required Medtronic to submit a 510(k) notification pertaining to the Model 4011 pacemaker lead before it could be implanted in Lora Lohr, any other state device requirement that is applicable to the device is "different from, or in addition to" the federal 510(k) notification "requirement," and thus is preempted. Medtronic's expansive interpretation of section 360k(a) is at odds with the statutory text and the overall structure of the MDA.

First, the phrase "applicable to the device" as used in sections 360k(a)(1) and (a)(2) is best read as pertaining only to device-specific requirements, rather than to general requirements. This phrase means that the requirement must be applicable to a particular type of device, not to all devices or a very wide range of devices. After all, if the establishment of general federal requirements were sufficient to trigger preemption of all state-law claims, section 360k(a) might as well have stated that "all state law is preempted on the effective date of this Act," since the MDA imposed a number of general requirements on that date. 21 U.S.C. Sec. 360(a)-(j)(1982); see id. Sec. 360j(a)(1982).

Second, the MDA was enacted against the backdrop of this Court's deeply ingrained presumption against preemption, which may be overcome only where the federal statute clearly ousts state law. Hillsborough County v. Automated Medical Laboratories, Inc., 471 U.S. 707, 715-16 (1985). The Court has consistently rejected the eradication of state law on the basis of general federal regulatory controls and has "look[ed] for special features warranting preemption." Id. at 719. Thus, there is no reason to ascribe to Congress an all-encompassing preemptive intent, where the text comfortably accommodates a much more sensible, moderate approach.

Third, Medtronic's position expands the term "different from, or in addition to" beyond all reasonable bounds. Medtronic reads that phrase to preempt a state device requirement on a particular subject matter--such as device design--where any federal regulation exists concerning that device, on the ground that the state law is "in addition to" the federal regulation, no matter how general the federal requirement may be or how unrelated it is to the subject matter of the state device requirement. Medtronic Open. Br. 44. On that basis, the FDA's authority to order labeling changes to a marketed device, 21 C.F.R. Sec. 895.25, would be "different from, or in addition to" a claim regarding a device's design--as Medtronic argued unsuccessfully in the court below. See Pet. App. 28a.

Such reasoning would effectively eliminate all state tort liability for medical devices. That statutory construction, however, is plainly untenable, particularly since the phrase "different from, or in addition to," when read in conjunction with section 360k(a)'s insistence that there be a federal requirement "applicable to the device," appears in the statute not to enlarge the preemptive field, but to narrow it. See Brief for the United States, at 22-28. Thus, the "different from, or in addition to" language indicates that, for preemption to occur, there must be an overlap between the federal and state requirements--what the FDA calls the need for "specific counterpart" requirements. 21 C.F.R. Sec. 808.1(d). It makes no sense to say, as does Medtronic, that the MDA's general requirement to file a 510(k) notification is "different from, or in addition to" a state-law design-defect claim. It is true, of course, that these two things are different in some sense, but if that were all that was required by section 360k(a), "for all practical purposes pre-emption would never run its course." New York Conference of Blue Cross & Blue Shield Plans v. Travelers Ins. Co., 115 S. Ct. 1671, 1677 (1995). As noted earlier, if the mere existence of any federal requirement applicable to a device preempted all other state device laws applicable to that device--without any inquiry into subject matter--Congress much more sensibly would have drafted section 360k(a) to declare that "all state law relating to medical devices is preempted."

Section 360k(a), however, assures that there is preemption only where federal and state law have focused on the same subject matter. For instance, a state could not demand that the labels for hearing aids be substantially reworded, as that would be "different from" the mandatory federal label. See 21 C.F.R. 801.420(c)(2). Nor could a state demand that a lengthy new section be added to the hearing-aid label, as that would be "in addition to" the federal label. But the general federal labeling guidelines do not preempt a state's specific labeling requirements for a particular type of device, because those specific state requirements would not be "different from, or in addition to" any specific federal requirement. Accord 21 C.F.R. Sec. 808.1(d)(6)(ii). (See Footnote 6)

2. Medtronic's expansive interpretation of section 360k(a) makes no sense in the context of the MDA as a whole. As explained in the Lohrs' opening brief (at 4-5), the MDA "grandfathered" devices already in commercial distribution. Those devices were not required to undergo premarket approval ("PMA") until the FDA required PMA applications for the particular type of device in question. See 21 U.S.C. Secs. 360e(b), 351(f)(2)(B). All devices placed in Class III, unless reclassified into Class I or II, will be required to undergo PMA at some time in the future. However, until the FDA promulgates a regulation demanding the filing of PMA applications, manufacturers of new Class III devices are free to market their devices under section 510(k), if their devices are substantially equivalent to grandfathered devices. Id. Secs. 360e(b)(1)(B), 360c(f)(1)(A).

According to Medtronic, on the date of the MDA's enactment, all state laws concerning the design, manufacture, or labeling of medical devices--that is to say, all state laws regarding medical devices--were "different from, or in addition to" the section 510(k) notification process and were thus preempted under section 360k(a). Such a result would be manifestly irrational since it would defeat a central purpose of the new law: to provide more protection to consumers of medical devices than had been the case prior to the MDA's enactment. Under Medtronic's interpretation of the law, the MDA would override state law--both positive enactments and common law--in areas where federal requirements are not yet in place, and consumers would have absolutely no protection while the statute was being implemented because they would not have the benefit of either state or federal law. But, as the FDA put it in promulgating its preemption regulations, Congress did not intend "that the Amendments should result in less protection for the public, which would be the natural consequence of State Controls being eliminated during the considerable period of time it will take for FDA to fully implement the new authorities provided in the Amendments." 43 Fed. Reg. 18661, 18663 (May 2, 1978).

3. Not only is the Lohrs' interpretation of section 360k(a) mandated by the statutory language and structure, it is also compelled by the FDA's interpretation of that section, which is entitled to substantial deference. Hillsborough County, 471 U.S. at 714-15 (citing Chevron U.S.A., Inc. v. Natural Resources Defense Council, Inc., 467 U.S. 837, 842-45 (1984)). 21 C.F.R. Sec. 808.1(d) provides that

<BLOCKQUOTE>State or local requirements are preempted only when the Food and Drug Administration has established specific counterpart regulations or there are other specific requirements applicable to a particular device under the act, thereby making any existing divergent State or local requirements applicable to the device different from, or in addition to, the specific Food and Drug Administration requirements. (emphasis added).</BLOCKQUOTE>

Medtronic argues that this regulation means that a federal requirement can have preemptive effect even if it is applicable to medical devices generally. In so arguing, Medtronic merely restates its position that the statute confers on any federal device requirement an all-encompassing preemptive effect that overrides any state device law. Medtronic Open. Br. 34. But if the general requirement that a 510(k) device be "substantially equivalent" to a pre-MDA device were sufficient to trigger preemption of a particular state device requirement, the two uses of the word "specific" in section 808.1(d) would be superfluous. Moreover, the FDA's insistence that federal preemptive requirements apply to a "particular device" would make no sense if the general 510(k) process, applicable to thousands of devices, could trigger preemption. Finally, the concept of "counterpart regulations" expressed in section 808.1(d) is a repudiation of Medtronic's position, since that phrase demands a close subject-matter connection between the federal and state requirements. Thus, 21 C.F.R. Sec. 808.1(d) demonstrates that the Lohrs' design-defect claim can be preempted only if federal law establishes requirements concerning the design of pacemaker leads.

Even if the meaning of section 808.1(d) were open to dispute, the FDA's other regulatory pronouncements leave no doubt as to the interpretation adopted by the agency. See Hillsborough County, 471 U.S. at 714-15 (deferring to regulatory commentary containing FDA's interpretation of preemptive scope of statute that FDA administered); cf. Ford Motor Co. v. Milhollin, 444 U.S. 555, 565 (1980)(agency's interpretation of its own regulations controlling unless "demonstrably irrational"). As described in the Lohrs' opening brief (at 40, 43), the FDA declared in promulgating the MDA's preemption regulations that state hearing-aid labeling regulations were not preempted until the agency's own specific hearing-aid labeling regulations took effect on August 25, 1977. 43 Fed. Reg. at 18662 (May 2, 1978). And, even then, other state laws regulating "other facets of hearing-aid distribution" were not thereby preempted. Id. This FDA interpretation is significant for two reasons. First, it demonstrates that federal requirements must be specific, not general, in order to preempt state-law requirements. For instance, if general federal regulations were broadly preemptive of specific state regulation, then the general device labeling regulations, which predated the MDA itself, would have preempted state labeling requirements with respect to hearing aids. See 21 C.F.R. Sec. 201.1 et seq. (1975)(recodified at 21 C.F.R. Sec. 801.1 et seq., in 41 Fed. Reg. 6896 (Feb. 13, 1976)). Second, the FDA's interpretation supports the Lohrs' view that, for preemption to occur, there must be a close fit between the subject matters of the federal and state requirements.

Medtronic does not, of course, embrace the FDA's regulations. However, the company does implicitly concede that, in order for preemption to occur, there must be some subject-matter congruence between the federal law that is said to preempt and the state law that is said to be preempted. Thus, for instance, Medtronic asserts that the section 510(k) process imposes safety and effectiveness requirements as to device design and then argues from that premise that the 510(k) process preempts the Lohrs' design-defect claim. Medtronic Open. Br. 32-39, 41-43. But once Medtronic makes that concession, as it must if section 360k(a) is to have any rational stopping point, cf. New York Conference, 115 S. Ct. at 1677, then the FDA's regulations and other authoritative pronouncements implementing section 360k(a) are valid and entitled to deference. Requiring that preemptive federal requirements be device-specific and pertain to the same subject-matter as a "counterpart" state requirement, see 21 C.F.R. Sec. 808.1(d), is certainly a "permissible construction" of section 360k(a). See Chevron, 467 U.S. at 843. (See Footnote 7)

4. With the foregoing principles in mind, application of section 360k(a) to the Lohrs' design-defect claim is straightforward. Neither the MDA nor any FDA regulation addresses device design. No federal requirements direct that any medical device be designed in a particular manner or even that general design guidelines be followed. See Brief for the United States, at 20-21.

Medtronic does not point to any design requirements applicable to pacemaker leads or to devices generally, but nevertheless asserts that the Lohrs' claims are "different from, or in addition to" federal requirements "because they would require Medtronic to change the Model 4011 design authorized by the FDA under federal law." Medtronic Open. Br. at 44 (emphasis added). As explained in the Lohrs' opening brief (at 20), the Lohrs' claims would, if successful, only require Medtronic to pay damages. More fundamentally, section 360k(a) does not use the word "authorized," but applies only to "requirements," and, in any event, the FDA never "authorized" the design of the Model 4011. As explained infra at 24-27, the FDA never scrutinized the Model 4011 for safety and effectiveness at all, let alone approved its design (which the FDA does not do for any device). Accord Brief for the United States, at 20. Indeed, as amicus United States argues, because, under the MDA, "[t]he design of a device originates with its manufacturer[,] [e]ven if design specifications could be characterized as requirement[s]' in some sense, once the FDA clears the device under Section 510(k), they are not requirement[s] applicable to the device under th[e Act].'" Id. at 24 (citing 21 U.S.C. 360k(a)(2)(emphasis in original)).

Accordingly, the MDA does not preempt the Lohrs' design-defect claim.

B. Neither The 510(k) Notification Process Nor An FDA Determination Of "Substantial Equivalence" To A Pre-MDA Device Preempts The Lohrs' Design-Defect Claim.

Even if section 360k(a) did not require that federal requirements be subject-specific and device-specific as a prerequisite for preemption, the Lohrs' design-defect claim would not be preempted by section 510(k) for another reason: Nothing in the 510(k) process establishes a requirement concerning safety and effectiveness or any other device-related requirement that has any bearing on the Lohrs' state-law design claim. In short, because a jury award in favor of the Lohrs' on their design-defect claim would not be "different from, or in addition to" any demands made by the 510(k) process, the Lohrs' design-defect claim is not preempted.

1. The 510(k) Notification Procedure Has No Preemptive Effect On The Lohrs' Design-Defect Claim.

In an attempt to show some kind of federal approval for the design of its pacemaker lead, Medtronic mischaracterizes both the 510(k) notification procedure and the meaning of substantial equivalence under the MDA. When Medtronic notified the FDA in 1982 that it planned to market the Model 4011 pacemaker lead on the basis of the lead's substantial equivalence to a pre-MDA device, the MDA required only that the notification be filed and that the manufacturer wait 90 days before marketing the device. See 21 U.S.C. Sec. 360(k). The law did not even require an FDA determination that the device was substantially equivalent to a grandfathered, unregulated device. See Leflar, Public Accountability and Medical Device Regulation, 2 Harv. J.L. & Tech. 1, 29 (1989)("The statute does not explicitly require FDA to make any determination about substantial equivalence in response to a premarket notification, nor indeed to take any action whatever").(See Footnote 8) Put simply, in 1982, obtaining a finding of substantial equivalence was not a federal "requirement ... applicable to the device." Thus, contrary to Medtronic's argument (Medtronic Open. Br. 20), the FDA's letter stating that the Model 4011 was substantially equivalent to a pre-MDA device could not possibly have any preemptive effect on the Lohrs' design-defect claim.

In any event, even if Medtronic had been required to obtain the FDA's finding of substantial equivalence, that requirement would have had no preemptive effect, as the Eleventh Circuit held. Pet. App. 26a-27a. Medtronic's principal response is that a jury's award of damages on the Lohrs' design-defect claim would be "different from, or in addition to" the requirement that a manufacturer secure an FDA substantial equivalence determination because the FDA's determination is a finding of the safety and effectiveness of the device's design. "That argument," as the United States has explained, "reflects a misunderstanding of the 510(k) process." Brief for United States, at 19.

First, neither the MDA nor any regulation promulgated thereunder states that a finding of substantial equivalence is a finding regarding the device's safety and effectiveness. To the contrary, when Medtronic filed its 510(k) notification, the FDA required only that the manufacturer's notification contain information supporting an assertion of "substantial equivalence" to a device marketed prior to the MDA's effective date, i.e., a device that itself had never been reviewed for safety and effectiveness. See 21 C.F.R. Sec. 807.87(h)(1982). This point is forcefully underscored by the FDA's November 30, 1982 letter to Medtronic, which says nothing about the safety and effectiveness of the Model 4011; finds only that the device was "substantially equivalent to devices introduced into interstate commerce prior to May 28, 1976"; and concludes by stressing that the agency's determination of substantial equivalence "does not in any way denote official FDA approval of your device." Lohr Open. Br., at App. 10a-11a.

Second, Medtronic's position is directly at odds with the structure of the substantial equivalence procedure. As explained in the Lohrs' opening brief (at 6), the substantial equivalence standard does not provide for review of a device's safety and effectiveness. Rather, it was "designed to ensure that [the Act] did not give manufacturers of pre-Amendments Class III devices a competitive advantage over manufacturers who sought to market similar devices after the Amendments were enacted." Brief for the United States, at 4 (emphasis in original). In 1982, then-FDA Commissioner Arthur Hull Hayes, Jr. described section 510(k) concisely:

[In the FDA's] view, the 510(k) provision of the law is a procompetition mechanism that permits firms to make and quickly market me-too versions of pre-1976 devices. The Congress apparently believed that a firm whose device happened to be on the market before enactment of the amendments and was never subject to preclearance by FDA should not enjoy a lengthy monopoly at the expense of other firms and ultimately the consumer.

FDA Oversight: Medical Devices; Hearing before the Subcomm. on Oversight and Investigations of the House Comm. on Energy and Commerce, 97th Cong., 2d Sess. 9 (July 16, 1982)(quoted in Kahan, Premarket Approval Versus Premarket Notification, 39 Food Drug Cosm. L.J. at 515 n.26). Thus, the substantial equivalence criterion had nothing to do with reviewing devices for their safety and effectiveness, but rather was a way to permit the marketing of devices without bestowing an unfair advantage on the manufacturers of existing devices. As a result, until the FDA acts to implement the MDA's PMA process, "the vast majority of ... substantially equivalent post-Amendments devices, including the device at issue here, [will be] effectively grandfathered from the regulation appropriate to their classification.'" Brief for United States, at 6 (quoting S. Rep. 513, 101st Cong., 2d Sess. 15 (1990)).

Medtronic also claims that Congress sought to enshrine the substantial equivalence process as a permanent substitute for premarket approval for certain Class III devices. From this premise, Medtronic argues that the FDA's decision not to require PMAs for Class III devices is a form of intentional non-regulation that is entitled to preemptive effect. See Medtronic Open. Br. 29-30. But even assuming that the FDA had made a decision not to regulate, such non-regulation does not preempt state law, as the Court held just last Term. Myrick, 115 S. Ct. at 1487.

Indeed, as noted in the Lohrs' opening brief (at 37-38), the FDA has recognized this very point and ruled that the marketing of a device under 510(k) does not represent an affirmative regulatory action by the agency, but rather reflects the simple fact that the FDA has yet to implement the statute as contemplated by Congress. See 21 C.F.R. Sec. 807.97. On this basis, the agency has ruled on more than one occasion that the states are free to require pre-market approval for Class III 510(k) devices until the FDA issues a final regulation calling for PMA applications for the particular device in question. 45 Fed. Reg. 67321, 67323 (Oct. 10, 1980); 43 Fed. Reg. at 18664 (May 2, 1978). That is, the FDA has determined that Florida could have, through its own PMA process, removed the Model 4011 from the market entirely before it injured Lora Lohr. In light of this agency interpretation--which is entitled to deference under Chevron--it is difficult to conceive how the Lohrs' claims could possibly be preempted, since they only seek an award of damages.

In any event, Medtronic's claim that the 510(k) process was intended as a permanent substitute for premarket approval is contradicted by the statutory text. The 1976 law in fact defines Class III devices as those that must undergo premarket approval. See Pub. L. No. 94-295, Sec. 2, 94th Cong., 2d Sess., 90 Stat. 541, 552-56 (1976). The statutory structure assumed that grandfathered devices placed in Class III would be required to undergo PMA 30 months thereafter, and no one anticipated that, after device classification (which occurred for pacemaker leads in 1980), the FDA would fail to call for PMA applications. See Brief for United States, at 6; S. Rep. 513, 101st Cong., 2d Sess. 14 (1990)(FDA's failure to call for PMAs "created an unintended grandfather' provision"). The legislative history of the 1976 Act confirms this understanding and specifically repudiates Medtronic's position:

[C]lassification of a device into class III do[es] not trigger immediate application of ... premarket approval requirements. Classification into class III does, however, serve the important purpose of providing notice to manufacturers ... of such devices that they must begin preparation for submission of applications for premarket approval. The Committee believes that the thirty month "grace period" afforded after classification of a device into class III before a device must obtain premarket approval is sufficient time for manufacturers ... to develop the data [necessary for PMA applications].

House Report, at 42; see also Lohr Open. Br., at App. 10a (FDA's November 1982 substantial equivalence letter reminding Medtronic that Class III devices, such as pacemaker leads, will be required to undergo premarket approval in the future). (See Footnote 9)

2. Medtronic's Reliance On Non-Statutory Materials Does Not Advance Its Position.

Unable to identify any language in the MDA demonstrating that the 510(k) process involves a safety and effectiveness determination, Medtronic relies entirely on isolated statements contained in governmental reports and regulatory commentary. Medtronic Open. Br. 24-26. However, even on that score, the authorities support the Lohrs' position. As pointed out in the Lohrs' opening brief (at 36 n.15), a plethora of governmental reports and legal commentary make plain that the 510(k) process does not involve a review of a device's safety and effectiveness, but rather only a determination of equivalence to devices that themselves underwent no safety and effectiveness review. None of these materials is more relevant to this case than the General Accounting Office's study of Medtronic's pacemaker leads, including the Model 4011, which concluded that the "FDA's 510(k) review process ... does not require FDA to determine that any of these models are safe and effective--and FDA has not done so." See Cardiac Pacemaker Leads, at 1.

The two non-statutory sources upon which Medtronic relies fail to support its position. First, the company quotes a small portion of a 1990 government report, ironically subtitled "Problems Still to Be Overcome," which states that the FDA reviews differences between pre- and post-MDA devices to see if those differences present issues of safety and effectiveness. See Medtronic Open. Br. 24 (quoting report). This excerpt says nothing about whether the agency reviews a device to determine whether it is safe and effective. It indicates only that, even where a post-MDA device is different from a pre-MDA device, i.e., not equivalent, the post-MDA device may still be marketed under section 510(k) if those differences are unrelated to safety and effectiveness. Moreover, the report states that, where there is true substantial equivalence because there "are no differences" between the two devices, safety and effectiveness are completely irrelevant. See Medtronic Open. Br. 24 (quoting report).

Moreover, this report cannot overcome the FDA's response to a 1990 study by the Department of Health and Human Services' Inspector General concerning systemic problems in the 510(k) review process. That study considered the FDA's failure to obtain device specimens, to require device testing in support of claims of substantial equivalence, and to conduct plant inspections. U.S. Dept. of Health and Human Services, Office of Inspector Gen'l, Internal Control Weaknesses in the Food and Drug Administration's Medical Device 510(k) Review Process, ID No. A-15-89-00065, at 10-11 (July 5, 1990). FDA officials explained that no such inspections were performed because the 510(k) process "is not intended [to] determine[] premarket approval." Id. at 11 (emphasis in original). Similarly, in commenting on the Inspector General's Report, the Public Health Service (the FDA's parent agency) disagreed with the Inspector General's criticisms on the ground "that 510(k) reviews determine substantial equivalence, not safety and effectiveness." Id. at Addendum, p. 9 (emphasis added); accord id. at 5.

Finally, lacking support in the 1976 Act, Medtronic relies on a 1994 regulatory commentary issued in conjunction with regulations implementing the Safe Medical Devices Act of 1990. See Medtronic Open. Br. 26 (quoting 59 Fed. Reg. 64287, 64288 (Dec. 14, 1994)). Plainly, this 1994 commentary has no bearing on the meaning accorded to "substantial equivalence" by the 94th Congress in 1976. In any event, even the portion of the commentary discussed in Medtronic's brief indicates only that, for some time prior to 1990, the FDA had interpreted the substantial equivalence standard to mean that 510(k) devices should be no less safe or effective than their predicate devices, which themselves had never been scrutinized for safety and effectiveness. Moreover, another portion of that commentary quotes a 1990 FDA publication concerning the 510(k) process that firmly repudiates Medtronic's position. (See Footnote 10)

3. The Definition Of "Substantial Equivalence" In The Safe Medical Devices Act Of 1990 Does Not Help Medtronic.

Medtronic also argues that a congressional definition of substantial equivalence enacted as part of the Safe Medical Devices Act of 1990 demonstrates that the substantial equivalence finding for the Model 4011 involved a review of the device's safety and effectiveness. Medtronic Open. Br. 25. This argument is incorrect for several reasons.

First, the 1990 definition, which is discussed in the Lohrs' opening brief (at 34-35), obviously did not apply to Medtronic's 1982 510(k) application. Recognizing this problem, Medtronic asserts, based on legislative history from the 1990 law, that the Act merely codified prior FDA practice. Medtronic Open. Br. 25-26. Whether this assertion is accurate as a general matter says nothing about whether this informal practice, rather than statutes or regulations, can establish a preemptive "requirement" under 21 U.S.C. Sec. 360k(a). See Brief of the United States, at 26 ("Informal agency determinations" are not "requirements" that have preemptive effect under section 360k(a)); 21 C.F.R. Sec. 10.90(b)(1)(FDA policy guidelines are not legal requirements). Nor would the existence of an informal FDA practice reveal whether that practice was applied with respect to any particular 510(k) notification. Thus, it cannot possibly form the basis for preemption under section 360k(a).

Second, the substantial equivalence definition in the 1990 Act did not apply to the Model 4011's 510(k) notification in 1982. "[T]he agency itself conceded in 1985 [that] no written guidelines existed to assist it in reviewing 510(k) submissions." Leflar, Medical Device Regulation, 2 Harv. J.L. & Tech. at 48-49 (citing an FDA report). It was not until the issuance of a 1986 "guidance document" that the FDA "finally articulated its view of what constitutes substantial compliance,'" id. at 53, and it is that 1986 guidance which was substantially adopted in the 1990 legislation. Compare id. (discussing 1986 guidance), with Pub. L. No. 101-629, Sec. 12, 104 Stat. 4523 (1990)(codified at 21 U.S.C. Sec. 360c(i)(1)). Thus, the 1990 definition of substantial equivalence was not applied in this case.

Third, to the extent that it is relevant at all, the 1990 law strongly supports the Lohrs' position. Under that law, a device can be marketed as "substantially equivalent" in one of two situations. The first is when the device is sold for the same intended use and "has the same technological characteristics" as a previously-marketed "predicate device." 21 U.S.C. Sec. 360c(i)(1)(A)(i). Medtronic concedes that "the statutory language does not explicitly refer to ... safety and effectiveness," but, without citation to any authority, nonetheless claims that this statutory language requires a review of the device's safety and effectiveness. Medtronic Open. Br. 25. That claim is plainly incorrect. In this situation, if a device has the same intended uses and technological characteristics as the predicate device, it is "substantially equivalent" regardless of the predicate device's safety and effectiveness.

Alternatively, even where a device does not share the predicate device's technological characteristics, it can still be deemed substantially equivalent if it is neither less safe nor less effective than the predicate device. 21 U.S.C. Sec. 360c(i)(1)(A)(ii). Even if this provision had been in effect in 1982, it would have provided no assistance to Medtronic for several reasons. To start, it is only an alternative criterion for market entry which may or may not be applied with respect to any particular 510(k) notification, as the court of appeals below noted. Pet. App. 26a. Further, this definition actually creates more concern about safety and effectiveness than does the first definition because it permits devices to reach the market that are less closely related to devices already in commercial distribution than does a simple finding that two devices share the same technological characteristics.

Finally, it is an oxymoron to assert, as does Medtronic, that a device can be equivalent in safety and effectiveness to a device that itself escaped safety and effectiveness review. As the Fifth Circuit put it in rejecting the very argument advanced by Medtronic here, "[t]o say that a new device is as safe as its predicate thus indicates nothing, absolutely, about how safe either product is; a new device may be as safe as a predicate device that itself is unreasonably dangerous." Feldt v. Mentor Corp., 61 F.3d 431, 438 n.12 (5th Cir. 1995), cert. pending, No. 95-1214 (U.S. docketed Jan. 30, 1996); see also Adler, A Step in the Right Direction, 43 Food Drug Cosm. L.J. at 516 ("If the earlier device poses a severe risk or is ineffective, then the later device may also be risky or ineffective. The FDA must permit the later device to be sold")(footnote omitted)). The court of appeals below came to a similar conclusion. It noted that 21 C.F.R. Sec. 807.97--the regulation stating that an FDA determination of substantial equivalence "does not in any way denote official approval of the device"--"makes obvious sense because the FDA could hardly find a device as safe and effective' as a grandfathered device whose safety and effectiveness were never established by MDA procedures." Pet. App. 26a (citation omitted).

4. The FDA's Regulation Concerning The Criteria For Filing 510(k) Notifications Has No Preemptive Effect.

Finally, Medtronic maintains that 21 C.F.R. Sec. 807.81(a)(3)(i) preempts the Lohrs' design-defect claim. Under that regulation, a manufacturer may not modify a device marketed pursuant to section 510(k) in a manner "that could significantly affect the safety and effectiveness of the device" without filing another 510(k) notification. Thus, Medtronic asserts, a verdict in favor of the Lohrs on the basis of defective design would require the company to file a new 510(k) notification, thereby imposing state-law design requirements on the company. See Medtronic Open. Br. 27, 45. This argument is fundamentally flawed.

Section 807.81(a)(3)(i) does not constitute a federal "requirement applicable ... to [a] device" that is "different from, or in addition to" the Lohrs' design-defect claim because there are a host of contingencies that make section 807.81(a)(3)(i) inapplicable to the Model 4011 at present, or even after an award of damages to the Lohrs. First, a jury verdict in favor of the Lohrs on their design-defect claim might or might not be based on the jury's judgment that the design of the Model 4011 should have been different in a "manner that could significantly affect the safety and effectiveness of the device" under section 807.81(a)(3)(i). In fact, if the Lohrs prevail on strict liability grounds, see Complaint Pars. 9-12, Eleventh Circuit Record Excerpts 9, the jury's verdict would not imply that the device should be redesigned at all. See Pet. App. 33a-35a (discussing the Lohrs' strict liability claims); cf. Silkwood, 464 U.S. at 276 n.3 (Powell, J., dissenting)("There is no element of regulation when compensatory damages are awarded, especially when liability is imposed without fault as authorized by state law").

Second, section 807.81(a)(3)(i) would not even arguably be implicated after the jury's verdict, unless Medtronic were to decide that, in addition to compensating the Lohrs, it wanted to remove the device from the market and offer a new device in its place. But to use section 360k(a)'s language, Medtronic would not be required by federal law to do either. Finally, even assuming that the jury's verdict implied that the product should be redesigned, that verdict could be substantively "different from, or in addition to" a federal requirement only