Brief for Cross-Petitioners Lora Lohr and Michael Lohr

Nos. 95-754, 95-886

In the

SUPREME COURT OF THE UNITED STATES

October Term, 1995

Medtronic, Inc.,

Petitioner/Cross-Respondent,

v.

Lora Lohr and Michael Lohr,

Respondent/Cross-Petitioners.

On Writ of Certiorari

to the United States Court of Appeals

for the Eleventh Circuit

Brief for Cross-Petitioners Lora Lohr and Michael Lohr

Brian Wolfman

(Counsel of Record)

Allison M. Zieve

Alan B. Morrison

Public Citizen Litigation Group

1600 20th Street, N.W.

Washington, D.C. 20009

(202) 588-1000

Robert L. Cowles

Daniel C. Shaugnessy

Cowles & Shaugnessy

Suite 901

233 East Bay Street

Jacksonville, FL 32202

(904) 359-9500

Robert F. Spohrer

Spohrer, Wilner & Maxwell

444 East Duval Street

Jacksonville, FL 32202

(904) 354-8310

Laurence H. Tribe

Hauser Hall 420

1475 Massachusetts Avenue

Cambridge, MA 02138

(617) 495-4621

Attorneys for Cross-Petitioners

March 1, 1996


QUESTION PRESENTED

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?


OPINIONS BELOW

The opinion of the court of appeals is reported at 56 F.3d 1335 (11th Cir. 1995), and is reproduced in the appendix to the petition in No. 95-754 ("Pet. App.") at 1a. The unreported opinion of the United States District Court for the Middle District of Florida is reproduced at Pet. App. 1b.

JURISDICTION

The judgment of the court of appeals was entered on July 3, 1995. Cross-respondent filed a timely petition for rehearing and suggestion for rehearing in banc on July 24, 1995, which the court of appeals denied on August 15, 1995 (Pet. App. 1e). The petition for writ of certiorari in No. 95-754 was filed on November 13, 1995, and the cross-petition was filed on December 6, 1995. The Court granted the petition and the cross-petition on January 19, 1996. This Court has jurisdiction under 28 U.S.C. Sec. 1254(1) and Rule 12.5 of this Court.

STATUTES AND REGULATIONS INVOLVED

The principal statutes and regulations involved in this case are reproduced in the appendix to this Brief ("App.").

STATEMENT OF THE CASE

Approximately five years ago, a pacemaker manufactured by cross-respondent Medtronic, Inc., and implanted in cross-petitioner Lora Lohr, failed suddenly, causing injuries to Ms. Lohr and requiring her to undergo emergency surgery. Pet. App. 6a. The question presented is whether cross-petitioners are entitled to seek compensation for their injuries under Florida common law, or whether, as Medtronic maintains, a federal law enacted in 1976, for the purpose of protecting consumers from potentially dangerous medical devices, was intended to bar their access to their state tort systems entirely.

A.The Basic Structure Of The Medical Device Amendments.

1. Legislative Background.

Under federal law, a "medical device" includes a vast array of products, such as tongue depressors, band-aids, tampons, bone screws, hip replacements, artificial heart valves, and pacemakers. See 21 U.S.C. Sec. 321(h). Prior to 1976, medical devices were largely unregulated. Although the Food and Drug Administration ("FDA") had limited authority to seize adulterated and misbranded devices already on the market, it lacked the authority to prevent the entry of a medical device on the market that it had had for many years with respect to drugs. See H.R. Rep. 853, 94th Cong., 2d Sess. 8-10 (1976)("House Report"); see id. at 11 (a "serious drawback of the existing authority is that FDA cannot act against a hazardous medical device until after it is on the market").

By the mid-1970's, the peril of this regulatory gap had become clear. There had been a series of public health hazards caused by dangerous devices. Most notable was the defectively designed Dalkon Shield intrauterine device, which had entered the market without regulatory scrutiny and had caused numerous deaths and thousands of serious injuries to otherwise healthy women. See House Report, at 8; S. Rep. 33, 94th Cong., 1st Sess. 1-2, 6-7, reprinted in 1976 U.S.C.C.A.N. 1070-72, 1075-76.

In 1976, responding to the preventable harms caused by such devices, id., Congress enacted the Medical Device Amendments ("MDA") to the Food, Drug and Cosmetic Act. Pub. L. No. 94-295, 90 Stat. 539 (1976)(codified at 21 U.S.C. Sec. 360c et seq.). The principal purpose of the MDA was to increase consumer protection by preventing the distribution of dangerous devices and providing a structure through which devices would reach the market. See House Report, at 1-12. Congress placed authority for implementing the MDA in the Secretary of Health, Education, and Welfare (now Health and Human Services), who delegated that responsibility to the FDA. Id. at 13.

2. Device Classification.

Under the MDA, each medical device falls into one of three classes, depending on its medical importance and its potential for causing harm to patients. House Report, at 34. Class I devices, such as tongue depressors, are those for which the MDA's "general controls" applicable to all devices, such as recordkeeping and good manufacturing guidelines, see 21 U.S.C. Secs. 360i(a), 360j(f), are sufficient to provide reasonable assurance of safety and effectiveness. Id. Sec. 360c(a)(1)(A).

Class II devices, such as tampons, 21 C.F.R. Sec. 874.3300(b)(2), are those for which general controls alone are insufficient to protect public health. See 21 U.S.C. Sec. 360c(a)(1)(B). Although the statute originally required the FDA to promulgate performance standards for Class II devices, not a single standard was ever issued. Adler, The 1976 Medical Device Amendments: A Step in the Right Direction Needs Another Step in the Right Direction, 43 Food Drug Cosm. L.J. 511, 523 & n.82 (1988); S. Rep. 513, 101st Cong., 2d Sess. 15 (1990). Thus, in 1990, Congress amended the MDA to make Class II devices subject to "special controls," which may include, in the FDA's discretion, performance standards, post-market surveillance, patient registries, and other measures deemed appropriate by the FDA. Pub. L. No. 101-629, Sec. 5(a), 104 Stat. 4517-18 (1990); see 21 U.S.C. Sec. 360c(a)(1)(B).

Finally, Class III devices are those which operate to sustain human life, are of substantial importance in preventing impairment of human health, or pose potentially unreasonable risks to patients. 21 U.S.C. Sec. 360c(a)(1)(C); see 21 C.F.R. Sec. 860.3(c)(3). In theory, Class III devices must undergo premarket approval ("PMA") by the FDA, a process which obligates the manufacturer to design and implement a clinical investigation and to submit the results of that investigation to the FDA. See 21 U.S.C. Sec. 360e(c)(1); 21 C.F.R. Sec. 814.20. The manufacturer's PMA application must also contain proposed labeling for the device, a sample of the device, and other information. See generally id. The FDA may grant premarket approval only if it finds that there is "reasonable assurance" that the device is safe and effective. 21 U.S.C. Sec. 360e(d)(2).

3. Exceptions To The Premarket Approval Process.

The PMA process does not apply to the vast majority of devices because of two related exceptions. First, a device on the market prior to the effective date of the 1976 Act--a so-called "grandfathered" device--was not required to undergo premarket approval, even if it was a Class III type of device. See, e.g., 21 U.S.C. Sec. 360e(b)(1)(A); 21 C.F.R. Sec. 814.1(c)(1). Manufacturers of pre-MDA devices do not have to seek premarket approval until 30 months have passed since the FDA classified the device in Class III, and 90 days have elapsed since the FDA's issuance of a final regulation calling for PMA applications for that specific type of device. 21 U.S.C. Secs. 360e(b), 351(f)(2)(B).

Second, a device marketed after the MDA's effective date--such as the pacemaker implanted in Lora Lohr (see Pet. App. 6a)--may bypass the PMA process if the device is "substantially equivalent" to either a "grandfathered" pre-MDA device, or a Class I or Class II device. 21 U.S.C. Secs. 360e(b)(1)(B), 360c(f)(1)(A). This exception to premarket approval, known as the "510(k)" process, simply requires the manufacturer to notify the FDA under section 510(k) of the Act of its intent to market the device at least 90 days prior to the device's introduction on the market, and to explain the device's substantial equivalence to a pre-MDA "predicate device." 21 U.S.C. Sec. 360(k); see id. Sec. 360c(f)(1). The 510(k) process is much less expensive than obtaining a PMA and has other marketing advantages as well. See Pet. App. 19a n.14 (citing Leflar, Public Accountability and Medical Device Regulation, 2 Harv. J.L. & Tech. 1, 47 & n.273 (1989)). (See Footnote 1)

Section 510(k) notifications are required for most Class I and Class II devices, but premarket approval is not a part of the statutory design for those devices. With respect to Class III devices, however, substantial equivalence was intended as a stop-gap measure, so that companies that sold grandfathered devices did not gain a competitive advantage during the period in which the FDA classified devices and implemented the statute, after which both pre- and post-MDA Class III devices would be required to undergo PMA. Kahan, supra, 39 Food Drug Cosm. L.J. at 514-15; Adler, supra, 43 Food Drug Cosm. L.J. at 513; see House Report, at 30; S. Rep. 513, supra, at 14-15. In fact, the FDA has not yet required PMAs for most Class III devices, and over 80 percent of them--including critical devices, such as pacemakers--enter the market without premarket approval (i.e., as substantial equivalents to grandfathered devices). H.R. Rep. 808, 101st Cong., 2d Sess. 14, reprinted in 1990 U.S.C.C.A.N. 6307. Significantly, unlike the PMA process, the 510(k) notification process does not call for scrutiny of a device's safety and effectiveness. Compare 21 C.F.R. Sec. 814.45(c)(PMA), with id. Sec. 807.100(b)(510k).

4. State Regulatory Efforts And Preemption Under the MDA.

During the MDA enactment process, Congress was informed of state regulatory programs, most notably in California, that had stepped into the federal regulatory vacuum and required that devices undergo premarket approval before their commercial distribution. House Report, at 45 (noting that California required PMA for intrauterine devices). Concluding that state premarket scrutiny, even if not uniform, was preferable to no premarket scrutiny at all, Congress crafted a provision that would permit state regulatory programs to remain in place until the FDA had implemented specific counterpart federal regulations, but thereafter would preempt conflicting state and local regulatory measures. Id. Thus, 21 U.S.C. Sec. 360k(a) provides that States may not "establish or continue in effect with respect to a device ... any requirement" that is "different from, or in addition to" certain federal device "requirements" issued under the MDA. 21 U.S.C. Sec. 360k(a)(reproduced in App. 1a). Even then, Congress authorized the FDA to grant state and local governments exemptions from preemption for their medical device laws in certain circumstances. See 21 U.S.C. Sec. 360k(b)(discussed infra at 23-27).

B. Facts.

This case involves injuries caused by a Medtronic pacemaker and its related components, including the lead, which is a wire connected to the pacemaker that delivers the electrical impulse to the heart. See Pet. App. 6a; 21 C.F.R. Sec. 870.3680(b)(describing "permanent pacemaker electrode"). Although pacemaker leads were classified as Class III devices more than 16 years ago, 45 Fed. Reg. 7943, 7945 (Feb. 5, 1980), the FDA has never issued a regulation under 21 U.S.C. Sec. 360e(b) calling for PMA applications for such devices. See 21 C.F.R. Sec. 870.3680(c)("No effective date has been established of the requirement for premarket approval" for pacemaker leads). The particular lead in question is Medtronic's Model 4011. R1-37, Ex. 1, Par. 6. (See Footnote 2)

On October 20, 1982, Medtronic notified the FDA of its intent to market the Model 4011. R1-37, Ex. 1, at Ex. A. (See Footnote 3) In a letter issued 40 days later, the FDA stated that the device had been found substantially equivalent to a pre-MDA device. Id. The FDA told Medtronic that it could market the device subject only to the Class I "general controls" applicable to all devices. Id. The FDA emphasized that "this letter does not in any way denote official FDA approval of your device," and warned the company about creating any "misleading" impression to the contrary. Id. Thus, the Model 4011 lead reached the market solely on the basis of its substantial equivalence to devices that themselves were never evaluated for safety and effectiveness. As a government report specifically analyzing the repeated failures of Medtronic's pacemaker leads explained:

As of 1984, 15 new Medtronic polyurethane-insulated pacemaker leads had been marketed since the first was introduced in 1977. Because each new lead was determined to be "substantially equivalent" to a previously marketed lead ... each one "piggybacked" on its predecessors through FDA's 510(k) review process. This process does not require FDA to determine that any of these models are safe and effective -- and FDA has not done so.

U.S. General Accounting Office, Medical Technology: For Some Cardiac Pacemaker Leads, the Public Health Risks are Still High 1 (GAO/PEMD-92-20 Sept. 1992).

In January 1987, cross-petitioner Lora Lohr was implanted with a Medtronic pacemaker, including the 4011 lead. On December 30, 1990, Ms. Lohr's pacemaker failed, resulting in a "complete heart block," which required her to undergo emergency surgery and replacement of her pacemaker. Complaint Pars. 4, 7, Eleventh Circuit Record Excerpts ("RE") 7, 8. Her treating physician attributed the pacemaker failure to a defect in the lead. Pet. App. 6a; see Dep. of Robert L. Pekaar, M.D., at 13, 26-28 (Sept. 8, 1993), R1-28 (exhibit folder).

C. Proceedings And Decisions Below.

Cross-petitioners Lora and Michael Lohr filed this case on March 9, 1993, in Florida state court. The complaint alleged that Medtronic had designed, manufactured, and assembled its pacemaker in an unreasonably dangerous manner and that the pacemaker was prone to sudden, catastrophic failure. The complaint further alleged that Medtronic had failed to warn Ms. Lohr or her physicians of the product's tendency to life-threatening failure, despite Medtronic's knowledge of other prior failures. As a result of the pacemaker's failure, Ms. Lohr suffered pain, scarring, physical handicap, and mental suffering, and sought compensation for those injuries, as well as for future expenses to be incurred in restoring her health. Michael Lohr, Lora Lohr's husband, claimed loss of consortium based on his wife's injuries. Complaint, Pars. 8, 9-14, RE 8-9.

Medtronic removed the case to the United States District Court for the Middle District of Florida under 28 U.S.C. Sec. 1441 on the basis of diversity of citizenship. Pet. App. 6a. It then filed a motion for summary judgment on the ground that the Lohrs' tort claims were preempted by 21 U.S.C. Sec. 360k(a), the MDA provision which concerns state-law "requirements" that are "different from, or in addition to" certain federal requirements established under the MDA. Pet. App. 7a. The district court denied the motion, holding that the Lohrs' common-law claims would not pose an obstacle to the objectives of the MDA. Pet. App. 5d. The court subsequently reversed itself and granted summary judgment to Medtronic in light of the Eleventh Circuit's decision in Duncan v. Iolab Corp., 12 F.3d 194 (1994)(per curiam), which the district court interpreted as requiring preemption of all product liability claims concerning a medical device. Pet. App. 2b.

The Eleventh Circuit reversed in part and affirmed in part. It began by noting that, under its per curiam decision in Duncan, section 360k(a) preempted at least some common-law tort claims. Pet. App. 11a. The court of appeals also ruled that the section 510(k) process, because it merely "grandfathers" onto the market devices that are similar to pre-MDA devices, does not itself establish preemptive "requirements." Pet. App. 27a ("the 510(k) process is focused on equivalence, not safety"). The court further held that there were no MDA requirements relating to device design applicable to the pacemaker leads that could be said to preempt the Lohrs' design-defect claim under section 360k(a). Pet. App. 26-29a.

However, the Eleventh Circuit also held that the Lohrs' failure-to-warn and manufacturing-defect claims were preempted, not on the basis of specific MDA requirements relating to warnings for, or the manufacture of, pacemaker leads, but on the basis of the FDA's regulations pertaining to prescription device labeling and good manufacturing, which are applicable to medical devices generally. Pet. App. 29a-32a. To reach that result, the court relied on an FDA regulation which, as a prerequisite to preemption of a state device requirement under section 360k(a), demands that there be a "specific counterpart [FDA] regulation[]" or "other specific requirement[] applicable to a particular device under the act...." 21 C.F.R. Sec. 808.1(d). In doing so, the court rejected the Lohrs' claim that, under section 808.1(d), the federal requirement must be specific to the particular type of device--here, pacemaker leads--in order to trigger preemption under section 360k(a). Pet. App. 20a-21a.

Finally, despite the language of section 360k(a), which preempts only those state and local requirements that are "different from, or in addition to" requirements under the MDA, the court of appeals held that the Lohrs' manufacturing-defect and failure-to-warn claims would be preempted even if they sought only to enforce the federal MDA requirements in those areas. The court found one of its prior preemption rulings controlling on that issue. See Pet. App. 13a (citing Papas v. Upjohn Co., 985 F.2d 516 (11th Cir.), cert. denied, 114 S. Ct. 300 (1993)).

SUMMARY OF THE ARGUMENT

Medtronic's position is that 21 U.S.C. Sec. 360k(a) grants device manufacturers a blanket tort immunity. This view is at odds with the MDA's text, structure, history, and purpose, and with authoritative FDA regulations concerning the scope of MDA preemption. Nowhere in the MDA or its legislative history did Congress so much as hint, let alone express in "clear and manifest" terms, Hillsborough County v. Automated Medical Laboratories, Inc., 471 U.S. 707, 715 (1985), that the Act comprehensively abolished state common-law remedies historically available to injured medical device users. Against the backdrop of a series of public health tragedies in which patients died or were seriously injured by defective medical devices, Congress enacted the MDA "to assure the[ir] safety and effectiveness." Conference Report, H.R. Rep. 1090, 94th Cong. 2d Sess. 1 (1976). It is unthinkable that Congress would have left injured medical device consumers with no means of obtaining compensation for their injuries, and with significantly less protection than they had prior to the MDA's enactment.

I. Under 21 U.S.C. Sec. 360k(a), a State may not "establish or continue in effect with respect to a medical device" a "requirement" that is "different from, or in addition to" certain "requirements" "applicable to" a medical device under the MDA. The term "requirement" in section 360k(a) encompasses only positive law, such as statutes and regulations, rather than damages actions, and thus does not reach the Lohrs' claims for compensation under Florida common law.

Section 360k(a) refers once to state-law "requirements" that are candidates for preemption and twice to federal "requirements" that may have preemptive effect. The federal "requirements" flow solely from positive law--the MDA and its regulations. To interpret state-law "requirements" as including actions for damages would thus run counter to the basic rule of statutory construction that multiple uses of the same word in the same statute should be accorded the same meaning. Sullivan v. Stroop, 496 U.S. 478, 484 (1990). The MDA's legislative history confirms this view, as it refers to the statute's state-law requirements as "regulations," a term which does not include common law, Cipollone v. Liggett Group, Inc., 505 U.S. 504, 519 (1992), and mentions only positive enactments of state legislatures as candidates for preemption. H.R. Rep. 853, 94th Cong., 2d Sess. 45-46 (1976).

Further, section 360k(a) preempts only state-law requirements "with respect to a device." Unlike state statutory or regulatory requirements which tell device manufacturers how to produce their devices, the general common-law duties under which the Lohrs seek compensation are not requirements "with respect to a device" under section 360k(a). Rather, if the Lohrs prevail at trial, Medtronic will be obligated only to pay damages, but it will not be required to do anything with "respect to [the] device."

Two other MDA provisions further demonstrate that the common law is beyond the reach of section 360k(a). First, 21 U.S.C. Sec. 360k(b) permits the FDA to grant states exemptions from preemption for any state "requirement" that is preempted under section 360k(a). Subsection (b), however, does not apply to damages claims, as shown both by its text and the FDA's implementing regulations. For example, the FDA's regulations--which are entitled to deference--contemplate exemptions only for "any statute, rule, regulation or ordinance" that a state has "enacted." 21 C.F.R. Secs. 808.20(a), 808.20(c)(1). Thus, the presence of subsection (b) in the statute bolsters the conclusion that section 360k(a) does not apply to damages actions. See Rake v. Wade, 113 S. Ct. 2187, 2193 (1993).

Second, 21 U.S.C. Sec. 360h(d) provides that, even where the FDA orders a manufacturer to repair or replace a faulty medical device, compliance with the order "shall not relieve" the manufacturer "from liability under ... State law." This provision shows that Congress understood that the MDA and state tort law would coexist, and that it did not intend the enactment of landmark consumer protection legislation to immunize medical device manufacturers from product liability actions.

II. Quite apart from whether 21 U.S.C. Sec. 360k(a) can, under some circumstances, preempt common-law claims, the claims in this case are not preempted because there are no preemptive federal requirements "applicable to" the pacemaker lead implanted in Lora Lohr. Under section 360k(a), state law concerning medical devices may be preempted only if there are device-specific federal requirements, either in the MDA itself or in regulations issued by the FDA, that directly conflict with the requirements established under state law. See also 21 C.F.R. Sec. 808.1(d).

Medtronic's pacemaker lead entered the market through the MDA's 510(k) notification procedures, under which Medtronic marketed the device based on its substantial equivalence to a device that was grandfathered onto the market when the MDA was enacted in 1976. See 21 U.S.C. Sec. 360(k); 21 C.F.R. Sec. 807.87. That process did not establish any requirements pertaining to the device's safety and effectiveness--much less any such requirements that conflict with the Lohrs' common-law claims. See id. Sec. 807.97. Moreover, because there are no specific manufacturing or labeling requirements applicable to the device, there is no preemption of the Lohrs' damages claims, which are premised on defective manufacture of the device and Medtronic's failure to warn of its prior problems.

This understanding of 21 U.S.C. Sec. 360k(a) is confirmed by the FDA's preemption regulations, which are entitled to substantial deference. Hillsborough County, 471 U.S. at 713. They provide that preemption may occur 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....

21 C.F.R. Sec. 808.1(d). Under this regulation, for there to be preemption, there must be federal requirements specific to pacemaker leads that address the same subject matters upon which the Lohrs' state-law suit is based.

The court of appeals held that the Lohrs' manufacturing-defect and failure-to-warn claims were preempted by the FDA's good manufacturing and prescription labeling guidelines, which apply to devices generally. Those holdings are at odds with the regulatory command that the federal requirement be applicable to a "particular device." Accord 21 C.F.R. Sec. 808.1(d)(6)(ii); see also Moore v. Kimberly-Clark Corp., 867 F.2d 243 (5th Cir. 1989)(federal regulation requiring a specific warning for tampons preempted common-law duty-to-warn claim, but not claims that device was defectively designed and manufactured, in absence of specific federal design or manufacturing requirements for tampons). Because pacemaker leads are not subject to any device-specific manufacturing or labeling specifications, they are not subject to any requirements that preempt the Lohrs' common-law claims based on manufacturing defects or a duty to warn.

III. Finally, even if the Lohrs' claims were held to be "requirements" that could trigger preemption under section 360k(a), those claims could still go forward if the state-law duties on which the suit is based did not contravene federal standards in those areas. This conclusion is required by the plain terms of section 360k(a), which preempt state requirements only if they are "different from, or in addition to" federal law, not if they apply the same substantive standards. See also 21 C.F.R. Sec. 808.1(d)(2). Here, for instance, the Lohrs' manufacturing-defect claim could proceed based on the standards set out in the FDA's general manufacturing guidelines. See 21 C.F.R. Part 820.

ARGUMENT

Several important aspects of this Court's jurisprudence converge in this case. First, despite the supremacy of federal law whenever applicable, a party seeking preemption of state law bears a heavy burden. There is a strong presumption against preemption that may be overcome only by "clear and manifest" congressional intent to the contrary. Hillsborough County v. Automated Medical Laboratories, Inc., 471 U.S. 707, 715 (1985); see also Hawaiian Airlines, Inc. v. Norris, 114 S. Ct. 2239, 2243 (1994); Wisconsin Public Intervenor v. Mortier, 501 U.S. 597, 605, 611 (1991).

This presumption is even stronger where, as in this case, preemption would displace the historic power of the states to protect the health and safety of their citizens. Rice v. Santa Fe Elevator Corp., 331 U.S. 218, 230 (1947). Moreover, where preemption of common-law claims would leave injured individuals without any state or federal remedy, which is the result sought by Medtronic here, this Court ascribes preemptive intent to Congress only in the most compelling circumstances. English v. General Electric Co., 496 U.S. 72, 87-90 (1990); Silkwood v. Kerr-McGee Corp., 464 U.S. 238, 251 (1984). These basic precepts are not mere precedential idiosyncracies, but are deeply embedded in the "federal-state balance" fundamental to the constitutional plan. Hillsborough County, 471 U.S. at 717; Jones v. Rath Packing Co., 430 U.S. 519, 525 (1977). Thus, the "plain statement rule" of the Court's Supremacy Clause jurisprudence "is nothing more than an acknowledgement that the States retain substantial sovereign powers under our constitutional scheme, powers with which Congress does not readily interfere." Gregory v. Ashcroft, 501 U.S. 452, 461 (1991).

Finally, in the preemption context, as in others, the views of an agency charged with administering a statutory scheme are 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)). Here, the MDA is accompanied by a considerable body of FDA regulations and other authoritative agency pronouncements which narrowly construe the MDA's preemptive effect and establish that the Lohrs' claims are not preempted.

I. THERE IS NO PREEMPTION OF DAMAGES CLAIMS UNDER THE MDA, AS EVIDENCED BY ITS LANGUAGE, HISTORY, AND PURPOSE.

With due regard for the foregoing principles, the ultimate touchstone of preemption analysis is congressional intent. Hawaiian Airlines, 114 S. Ct. at 2243. Thus, the question presented here is whether, in enacting the MDA, Congress intended to eliminate state-law damages claims of the sort brought by the Lohrs. In this regard, it is important to understand the breadth of Medtronic's position in this case. Medtronic argues not only that 21 U.S.C. Sec. 360k(a) reaches some damages claims, but that marketing a device on the basis of substantial equivalence to a pre-MDA device preempts all common-law claims, including those based on negligence in device design and manufacture and on failure to warn of known hazards from use of the product. In effect, Medtronic argues that, in enacting a consumer protection statute, the 94th Congress simultaneously barred access to the tort system for patients injured by potentially life-threatening medical devices.

Congress, however, did not enact such a radical incursion into the common law of the 50 states. Taken together, the language of the MDA's preemption provision, 21 U.S.C. Sec. 360k(a), other relevant provisions of the MDA, the statute's history and purpose, and the FDA's preemption regulations, demonstrate that the express preemption provision of section 360k(a) does not foreclose any state-law damages suits seeking compensation for injuries caused by medical devices.

A. 21 U.S.C. Sec. 360k(a) Does Not Preempt State-Law Damages Claims.

Analysis of congressional intent begins with the language of the MDA's preemption provision:

Except as provided in subsection (b) of this section, no State or political subdivision of a State may establish or continue in effect with respect to a device intended for human use any requirement-

(1) which is different from, or in addition to, any requirement applicable under this chapter to the device, and

(2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this chapter.

21 U.S.C. Sec. 360k(a)(App. 1a). Although the word "requirement" was construed in Cipollone v. Liggett Group, Inc., 505 U.S. 504 (1992), to encompass common-law claims in the specific context of one of the preemption provisions at issue there, "requirement" as used in section 360k(a) was intended to preempt only positive state law, not common-law tort claims, because the context here is very different from that in Cipollone.

1. Cipollone interpreted the term "requirement" only in the context of the Public Health Cigarette Smoking Act of 1969 ("the 1969 Act"). Because it did not hold that "requirement" must include the common-law whenever it is used, Cipollone did not resolve the question whether the word "requirement" as used in the MDA covers damages actions. Indeed, as Cipollone noted in holding that there was no preemption of common-law claims under the Federal Cigarette Labeling and Advertising Act of 1965 (the 1969 Act's predecessor), "[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. Thus, Cipollone recognized that Congress can, and often does, expressly preempt only state positive law.

"Language, of course, cannot be interpreted apart from context." Smith v. United States, 113 S. Ct. 2050, 2054 (1993); see also Brown v. Gardner, 115 S. Ct. 552, 555 (1994)("a word is known by the company it keeps")(citing Jarecki v. G.D. Searle & Co., 367 U.S. 303, 307 (1961)). In section 360k(a), "requirement" appears three times. The latter two uses of the term are references to federal requirements and, therefore, must refer to requirements imposed pursuant to statute or regulation under the MDA. These two uses do not refer to damages remedies or to the common law, because they are not the kinds of "requirements" applicable to devices under federal law. See Kennedy v. Collagen Corp., 67 F.3d 1453, 1460-61 (9th Cir. 1995)(Reinhardt, J., concurring); Haudrich v. Howmedica, Inc., 642 N.E.2d 206, 209-10, 204 Ill. Dec. 744 (Ill. App. 1994); Adler & Mann, Preemption and Medical Devices: The Courts Run Amok, 59 Mo. L. Rev. 895, 926 (1995).

The first use of "requirement" in section 360k(a), on which Medtronic relies, refers to the actions of states and their political subdivisions that are candidates for preemption under the MDA. The term is not modified in any way to distinguish it from the latter two uses, nor does it contain any embellishment or reference to damages actions or to the common law. Thus, the first use of "requirement" can include common-law damages actions only if it means something different from the subsequent uses of that term in the very same sentence.

However, there "is no reason to believe that Congress meant the term [requirement] to mean one thing" in the first part of section 360k(a) "but to mean something else altogether" the next two times it appears. Comm'r v. Lundy, 116 S. Ct. 647, 655 (1996). To the contrary, "the interrelationship and close proximity of these provisions ... present a classic case for application of the normal rule of statutory construction that identical words used in different parts of the same act are intended to have the same meaning.'" Id. (quoting Sullivan v. Stroop, 496 U.S. 478, 484 (1990)(internal quotations and case citations omitted)); see also, e.g., United States Department of Treasury v. Fabe, 113 S. Ct. 2202, 2215 (1993) (Scalia, J., dissenting) (referring to foregoing principle as "basic rule of statutory construction").

These multiple uses of the word "requirement" in section 360k(a) sharply differentiate this case from Cipollone. There, "requirement" was used only once: "no requirement or prohibition based on smoking and health shall be imposed under State law with respect to the advertising or promotion of any cigarettes the packages of which are labeled in conformity with the provisions of this Act." 505 U.S. at 515 (quoting relevant statutory language). The use of "requirement" thus referred to the totality of "State law," which reasonably may include common law and which was critical to the Cipollone plurality's holding that some common-law claims were within the statute's preemptive reach. Id. at 522-23. Further, the 1969 Act made no mention at all of federal "requirements." Instead, it used different nomenclature--"labeled in conformity with the provisions of this Act"--to refer to the means by which the 1969 Act has preemptive effect. Id. at 515. Here, by contrast, the language of section 360k(a) does not target for preemption the totality of "State law," and, as explained above, this very provision uses "requirement" twice to refer only to federal positive law.

2. Under section 360k(a), only state requirements "with respect to a device" are candidates for preemption. This language also demonstrates that preemption under section 360k(a) is limited to state positive law. The duties under which tort plaintiffs seek compensation are not duties "with respect to a device," but rather are general obligations concerning the conduct of persons who manufacture and sell all types of products. For instance, the Lohrs seek compensation under common-law duties that obligate all manufacturers to design and manufacture their products with due care and to warn of their products' dangers. Even if those duties were "requirements" in some sense, they are not requirements "with respect to a device" under section 360k(a).

On the other hand, the positive-law requirements to which section 360k(a) is directed are, in fact, requirements "with respect to a device." For example, a Florida statute requires that specific labeling appear on hearing-aid packages before the hearing aid may be sold. See Smith v. Pingree, 651 F.2d 1021 (5th Cir. Unit B 1981). That requirement "with respect to a device" properly raised a preemption question because of its potential conflict with the FDA's hearing-aid labeling regulations. See 21 C.F.R. Sec. 801.420; see also 21 C.F.R. Secs. 808.53-.101 (governing status of similar positive state-law requirements under section 360k(a)).

This contrast between positive-law requirements "with respect to a device" and general common-law duties underscores a fundamental difference between the purposes of the two regimes. Like the Florida statute, a "requirement with respect to a device" obligates the seller to take a particular action concerning the device, for instance, to label the device in a particular manner or to manufacture it to certain specifications. If the seller does not satisfy the requirement, it cannot sell the device. Like the Lohrs' claims here, however, common-law claims do not require manufacturers to take any action with respect to a device. Thus, if the Lohrs prevail at trial, Medtronic will be obligated only to compensate the Lohrs. At some point, tort verdicts in cases involving Medtronic's 4011 lead may prompt the company to take some action with "respect to [the] device," but those verdicts will not require Medtronic to do so. This distinction drawn by section 360k(a) between positive law and common law reflects what, as noted earlier, the plurality recognized in Cipollone: "There 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. See Kennedy, 67 F.3d at 1459.

The FDA has interpreted section 360k(a) in the same manner. In promulgating its preemption regulations, the agency stated that many state statutes "are not requirements with respect to a device' within the meaning of [section 360k(a)] because they generally pertain either to persons who manufacture devices or distribute devices...,and not directly to devices. In order for a State provision to be a requirement with respect to a device within the meaning of [section 360k(a)]--and thereby a candidate for preemption--it must relate to the device itself." 43 Fed. Reg. 18661, 18663 (May 2, 1978). Cf. 21 C.F.R. Sec. 808.1(d)(no preemption under section 360k(a) of requirements of general applicability that apply to other products in addition to devices, such as uniform commercial code and unfair trade practices statutes); see also Mulligan v. Pfizer, 850 F. Supp. 633, 636 (S.D. Ohio 1994)(rejecting preemption of generally applicable common-law rules, contrasted with specific Ohio statute with respect to hearing aids). (See Footnote 4)

Because common-law duties such as those relied on by the Lohrs are not requirements with respect to a device, they are not preempted under section 360k(a).

3. Finally, section 360k(a) states that "[n]o State or political subdivision of a State may establish or continue in effect" certain device "requirements." Construing an award of damages to a tort plaintiff as "establishing or continuing in effect" a device requirement is at odds with this Court's oft-stated "assum[ption] that the legislative purpose is expressed by the ordinary meaning of the words used.'" American Tobacco Co. v. Patterson, 456 U.S. 63, 68 (1982)(quoting Richards v. United States, 369 U.S. 1, 9 (1962)); see Haudrich, 642 N.E.2d at 210. That "ordinary meaning" is confirmed in two respects.

First, in 1976, when the MDA was enacted, Congress was aware that states might "establish" programs to regulate medical devices, since some states had already done so. House Report, at 45. Thus, it is reasonable to assume that section 360k(a)'s reference to the "establishment" of device "requirements" meant the enactment of state medical device programs. At the same time, the duties relied on by tort claimants are general duties under the common law that had been "established" over hundreds of years. Thus, section 360k(a)'s limited prohibition on the future "establishment" of device requirements simply could not have been a reference to common-law duties.

Second, while a post-1976 jury award in a device case would represent confirmation of a pre-existing common-law duty--for instance, the duty to act non-negligently--only an inept grammarian would describe an award of damages in a tort case as "continuing in effect [a requirement] with respect to a device." On the other hand, it is common parlance to say that a previously-"established" statute or regulation remains in force or "continues in effect." (See Footnote 5)

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In sum, the rule that intent to preempt be "clear and manifest" and the related presumption against preemption applies not only to the existence of preemption, but also to its scope. E.g., New York State Conf. of Blue Cross & Blue Shield Plans v. Travelers Ins. Co., 115 S. Ct. 1671, 1677 (1995). Here, the language of section 360k(a) taken as a whole falls far short of the requisite plain statement and demonstrates that common-law claims are not preempted. (See Footnote 6)

B. Other Provisions Of The MDA Confirm That 21 U.S.C. Sec. 360k(a) Does Not Preempt State-Law Damages Claims.

1. The existence of subsection (b) of 21 U.S.C. Sec. 360k further manifests Congress' understanding that subsection (a) does not preempt damages claims. Subsection (b) permits states to seek exemptions from the FDA for their device laws that would otherwise be preempted under subsection (a). The language of subsection (b) parallels that of subsection (a) and allows a "State or political subdivision" to exclude from preemption state "requirements" that are "applicable to a device for human use." See App. 1a-2a. In other words, subsection (b) allows the FDA to grant exemptions for any type of requirement that may be preempted under subsection (a).

Although subsections (a) and (b) apply to the same "requirements," the statutory language, the FDA's preemption regulations, and common sense make clear that subsection (b) does not include judgments in tort actions. First, it is difficult to imagine the basis for a state to obtain an exemption for a damages action in light of the relevant statutory criteria: that the state requirement be (1) more stringent than the federal requirement, or (2) required by "compelling local conditions." 21 U.S.C. Sec. 360k(b). Without considering the evidence advanced by particular tort plaintiffs or reviewing jury instructions in hundreds of cases, it would be infeasible, if not impossible, for a state to seek a blanket exemption for its common law on the ground that it was "more stringent" than federal law. Furthermore, it makes little sense to say that providing compensation to medical device victims is "compell[ed] by local conditions," rather than by a state's general interest in assuring that its citizens have remedies for their injuries.

Nor could Congress have expected states to petition the FDA for exemptions for individual plaintiffs on a case-by-case basis. As one court put it, "if the term requirement' were interpreted so as to include tort law, the exemption provision [of Sec. 360k(b)] would be rendered absurd; is the State supposed to petition the Secretary of Health and Human Services after every verdict in favor of an IUD tort plaintiff?" Callan v. G.D. Searle & Co., 709 F. Supp. 662, 667 (D. Md. 1989); accord Kociemba v. G.D. Searle & Co., 680 F. Supp. 1293, 1298 (D. Minn. 1989) (dicta); cf. New Jersey Guild of Hearing Aid Dispensers v. Long, 75 N.J. 544, 384 A.2d 795, 813-14 (1978)(existence of Sec. 360k(b) is strong evidence of narrow preemptive scope of Sec. 360k(a)). See also 21 C.F.R. Sec. 808.5(b)(2)(indicating that state requirements are not eligible for exemption from preemption unless they have been "issued in final form," which, when applied to tort claims, would be after final judgment).

In short, the state-law "requirements" referred to in sections 360k(a) and 360k(b) are co-extensive, and plainly state-law "requirements" under subsection (b) cannot rationally be construed to include damages claims. Thus, interpreting section 360k(a) "requirements" to include damage claims would be at odds with the canon of statutory construction that repeated uses of the same word in the same statute--here, in the very next subsection--should be accorded the same meaning. See supra at 17-19.

The FDA is of the same view. The agency's regulations implementing section 360k(b)--which are entitled to deference, Hillsborough County, 471 U.S. at 714-15--begin by stating that a "State or political subdivision may apply . . . for an exemption from any requirement it has enacted and that is preempted...." 21 C.F.R. Sec. 808.20(a)(emphasis added)(App. 7a-9a). Similarly, the FDA requires state and local governments to submit "any statute, rule, regulation or ordinance" with respect to each "requirement" for which an exemption is sought. Id. (emphasis added)(App. 5a). All applications seeking exemption from preemption must identify the "title of the chief administrative officers of the State or local agency that has primary responsibility for administration of the requirement," 21 C.F.R. Sec. 808.20(c)(1), which would be nonsensical with respect to damages claims since they are not "administered" by state or local "agenc[ies]." See also 21 C.F.R. Sec. 808.1(d)(6)(ii)(in deciding whether state requirement is preempted in first instance, "the determinative factor is how the requirement is interpreted and enforced by the State or local government and not the literal language of the statute...")(emphasis added). Thus, the FDA has construed "requirement" under both subsections (a) and (b) identically and in neither context has it included jury awards or common-law claims. (See Footnote 7)

The FDA has also encouraged state and local governments to obtain the agency's views on the MDA's preemptive scope before enacting new device laws. As the FDA put it, an "advisory opinion might be sought or issued when a State or local government is contemplating the issuance of a statute or regulation. In such cases, the advisory opinion could address the question of whether the rule or regulation as proposed would be preempted under section" 360k(a). 42 Fed. Reg. at 30385 (emphasis added); see also id. (making references to state requirements as "statutes," "regulations," "ordinances," and "relevant background material including legislative histories, hearing reports, and similar material"). In addition, the FDA has indicated that a state "requirement" is not "eligible for exemption from preemption" unless it has been "issued in final form." 21 C.F.R. Sec. 808.5(b)(2) (App. 7a). Only regulations and ordinances and similar enactments, not common-law duties, are "issued in final form." Thus, the FDA's regulations regarding section 360k(b) provide further confirmation that the term "requirement" as used throughout section 360k was not intended to cover damages claims. See Rake v. Wade, 113 S. Ct. 2187, 2193 (1993)("statutory terms are often clarified by the remainder of the statutory scheme--because the same terminology is used elsewhere in a context that makes [its] meaning clear"). (See Footnote 8)

2. Subsection (d) of 21 U.S.C. Sec. 360h also confirms the Lohrs' understanding of section 360k(a). Under section 360h, the FDA has the power to notify health professionals and the public of unreasonable risks associated with devices and to order device manufacturers to repair, replace, or provide refunds with respect to devices that pose such risks. "Of vast significance" to the preemption analysis, Mulligan, 850 F. Supp. at 636, is subsection (d), entitled "Effect on Other Liability." That subsection provides:

Compliance with an order issued under this section shall not relieve any person from liability under Federal or State law. In awarding damages for economic loss in an action brought for the enforcement of any such liability, the value to the plaintiff in such action of any remedy provided him under such order shall be taken into account.

Thus, section 360h(d) "specifically contemplates state law liability and damages" against manufacturers of medical devices, even after the FDA issues an order under section 360h. Mulligan, 850 F. Supp. at 636. Considered in conjunction with the statute's other provisions, the FDA's regulations, and the presumption against preemption, section 360h(d) is powerful evidence that the statute contemplated that state-law damages actions would coexist with MDA regulation. Id. As the Court observed in Silkwood in a related context, "the only congressional discussion concerning the relationship between the ... [statute] and state tort remedies indicates that Congress assumed that such remedies would be available." 464 U.S. at 251.

C. The Purpose And History Of The MDA Confirm That Damages Claims Are Not Preempted Under Section 360k(a).

The MDA's purpose and history also demonstrate that section 360k(a) preempts only positive state-law enactments. The MDA was passed "to protect the public health by amending the Federal Food, Drug, & Cosmetic Act to assure the safety and effectiveness of medical devices." Conference Report, H.R. Rep. 1090, 94th Cong. 2d Sess. 1 (1976). The Senate Report directly traced the Act's origins to the Dalkon Shield disaster:

On January 28, 1975, the Health Subcommittee conducted a hearing which once again underlined the urgency of enacting medical device legislation. The hearing focused on the Dalkon shield, an IUD which was used by two million American women, and hundreds of thousands of women overseas, before the very significant health hazards of the device became known. All witnesses before the Committee, including the Commissioner of the Food and Drug Administration, testified that many of the deaths and much of the illness attributed to this device could have been prevented if medical device legislation, as provided in the reported bill, had been in effect when the Dalkon shield was developed.

S. Rep. 33, 94th Cong., 1st Sess. 1-2, reprinted in 1976 U.S.C.C.A.N. 1070-72. As the bill's sponsor stated on the Senate floor, the focus of the MDA is on consumer protection: "The legislation is written so that the benefit of the doubt is always given to the consumer. After all, it is the consumer who pays with his health and his life for medical device malfunctions." 121 Cong. Rec. 10688 (1975) (Sen. Kennedy).

Prior to enactment of the MDA, individuals could and did seek redress for injuries caused by medical devices through state-law damages actions. House Report, at 8. Congress' concern with the injuries caused by the Dalkon Shield surely did not impel it to decrease the remedies available to injured device users. In fact, Congress was aware of the important function played by the many suits brought against the Dalkon Shield's manufacturer. The House Committee that sponsored the legislation cited these suits as evidence of the enormity of the public health tragedy that could have been avoided had effective federal regulation been in place. House Report, at 8; see also S. Rep. 33, 94th Cong., 1st Sess. 1-2, reprinted in 1976 U.S.C.C.A.N. 1070-71. Having acknowledged the role of the civil justice system both in bringing the Dalkon Shield problem to light and in compensating the victims, Congress surely would not, in the same breath, have "remove[d] all means of judicial recourse" for the victims of such future calamities without a word to that effect. See Silkwood, 464 U.S. at 251. (See Footnote 9)

Moreover, while the legislative history mentions nothing about preemption of damages claims, it does say something about the types of state law that are preempted. The House Report states that once a particular MDA requirement was in place, that requirement would preempt corresponding statutory provisions "governing regulation of devices by States and localities." House Report, at 45. The Report specifically mentions the 1970 California medical device statute. Id. The committee's reference to the California statute and similar enactments as state regulation is significant because Cipollone emphasized repeatedly that "the term regulation' most naturally refers to positive enactments, not to common-law remedies." 505 U.S. at 519; see also id. at 523 (same).

The legislative history's silence on preemption of damages remedies and its concomitant discussion of the potential for preemption of state regulatory programs take on even greater significance in light of this Court's precedents, which not only establish a presumption against preemption, but also require unmistakable evidence of preemptive intent to abolish common-law remedies where federal law provides no damages remedy. See, e.g., Silkwood, 464 U.S. at 251. Here, the MDA contains no express private right of action for damages, and courts are in agreement that there is no implied right of action under the Food, Drug, and Cosmetic Act, of which the MDA is a part. See Bailey v. Johnson, 48 F.3d 965, 967-68 (6th Cir. 1995)(reviewing case law). It would be inimical to this Court's Supremacy Clause jurisprudence to hold, as Medtronic urges, that Congress deprived consumers of any means of obtaining compensation for their injuries, where the statute makes no mention of preemption of common-law claims and where nothing in the legislative history so much as hints at such a drastic result. (See Footnote 10)

Finally, in stark contrast to recent lower court rulings that section 360k(a) preempts an array of common-law claims, no court came to such a conclusion for 15 years after the MDA's enactment. In the MDA's early years, the states obtained the FDA's views on whether their medical device statutes and regulations were preempted, see, e.g., 45 Fed. Reg. 67321-67338, while the tort system continued unaffected. E.g., Tetuan v. A.H. Robins, Co., 738 P.2d 1210 (Kan. 1987). Case law construing 21 U.S.C. Sec. 360k concerned the MDA's preemptive effect on positive law, with most courts holding that even those regulatory efforts were not preempted in the absence of specific federal regulations on the same subject as the state regulation. See, e.g., Smith v. Pingree, 651 F.2d 1021 (5th Cir. Unit B 1981); New Jersey Guild, 384 A.2d 795.

As late as 1989, the only serious question regarding preemption of damages actions was whether, in light of a specific FDA-mandated warning label for tampon packaging, tort claimants harmed by defective tampons could maintain suit on the ground that the warning was inadequate. Compare, e.g., Moore v. Kimberly-Clark Corp., 867 F.2d 243 (5th Cir. 1989), with Callan, 709 F. Supp. 662. Not until 1992 did any appellate court rule that preemption occurred merely because the defendant marketed a device through FDA procedures, e.g., Slater, 961 F.2d 1330; King v. Collagen Corp., 983 F.2d 1130 (1st Cir.), cert. denied, 114 S. Ct. 84 (1993), or that the MDA's general controls--which are applicable to all devices--had preemptive effect on garden-variety negligence and strict liability claims. Mendes v. Medtronic, Inc., 18 F.3d 13, 18 (1st Cir. 1994). (See Footnote 11)

While this history did not, of course, inform the 94th Congress that enacted the MDA, it is nonetheless significant to the question now before the Court. Since statutes are to be interpreted according to their "ordinary meaning," American Tobacco Co., 456 U.S. at 68, and preemption exists only where that is Congress' "clear and manifest" intent, Hillsborough County, 471 U.S. at 715, then surely if section 360k(a)'s purpose was comprehensive "tort reform," that purpose would not have taken so long to emerge. To the contrary, for 15 years the MDA was recognized for precisely what it was--much-needed consumer protection legislation, with a modest preemption provision enacted to override positive state law in particular circumstances. (See Footnote 12)

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Statutory interpretation requires more than an arid focus on one word or phrase in isolation. As Learned Hand put it more than 60 years ago, "the meaning of a sentence may be more than that of the separate words, as a melody is more than the notes, and no degree of particularity can ever obviate recourse to the setting in which all appear, and which all collectively create." Helvering v. Gregory, 69 F.2d 809, 810-11 (2d Cir. 1934), aff'd, 293 U.S. 465 (1935). In keeping with that view, the task here demands that the words of section 360k(a) be interpreted together and in the context of the statute as a whole, and with deference to the views of the agency charged with its administration. Seen from that perspective, section 360k(a) does not include damages claims, and the Eleventh Circuit's decision upholding Medtronic's preemption defense should be reversed.

II. EVEN IF SECTION 360k(a) PREEMPTS SOME DAMAGES CLAIMS, IT DOES NOT DO SO IN THIS CASE.

A. The 510(k) Notification Process Does Not Impose A Federal Requirement That Preempts The Lohrs' Claims.

The court of appeals correctly rejected Medtronic's argument that the 510(k) notification procedure establishes a preemptive safety and effectiveness "requirement applicable ... to" the Model 4011. Pet. App. 27a. As noted earlier, in October 1982, Medtronic notified the FDA that its Model 4011 pacemaker lead was substantially equivalent to a pre-MDA device, which gave Medtronic the right to market the product 90 days thereafter. App. 10a; see 21 U.S.C. Sec. 360(k)(1982). (See Footnote 13)

At that time, "substantial equivalence" was not defined by statute, and the FDA required only that the manufacturer's 510(k) notification include basic information directed toward showing the device's similarity to a predicate device. 21 C.F.R. Sec. 807.87 (1982). In 1990, Congress defined "substantial equivalence." Pub. L. No. 101-629, Sec. 12, 104 Stat. 4523 (1990)(codified at 21 U.S.C. Sec. 360j(i)(1)); see also 57 Fed. Reg. 58403 (1992)(codified at 21 C.F.R. Sec. 807.100). Under that definition, a manufacturer need only show that the device has the same intended uses and technological characteristics as the predicate device, regardless of the predicate device's safety and effectiveness. 21 C.F.R. Sec. 807.100(b)(1). And even if the device does not share the same technological characteristics as the predicate device, it may still be deemed substantially equivalent, if the manufacturer can show that the device is equivalent in safety and effectiveness to the predicate device (which itself was not reviewed for safety and effectiveness). Id. Sec. 807.100(b)(2). (See Footnote 14)

Therefore, at the time the Model 4011 was marketed, Medtronic's only obligation was to submit a notification explaining the basis for its claim of substantial equivalence to a pre-MDA device. That action alone allowed Medtronic to market the device 90 days later. But even assuming that the 1990 statutory definition had been applied to the Model 4011 when it entered the market in 1982, and assuming further that the lead did not share the same technological characteristics as its predecessors (which cannot be determined from the record), the device entered the market simply because the FDA believed that the device was neither less safe nor less effective than a "grandfathered" device, which itself had never been reviewed for safety and effectiveness. Thus, even under these extremely generous assumptions, the 4011 lead was marketed and implanted in Lora Lohr without any agency review (much less approval) f