254 F.3d 573 (5th Cir. 2001), 99-41089, Martin v Medtronic
|Docket Nº:||99-41089, 99-41090|
|Citation:||254 F.3d 573|
|Party Name:||BILLYE JEANNE MARTIN, Plaintiff-Appellant, v. MEDTRONIC, INC., Defendant-Appellee. LIBRA SALAZAR, Plaintiff-Appellant, v. MEDTRONIC, INC., Defendant-Appellee.|
|Case Date:||June 18, 2001|
|Court:||United States Courts of Appeals, Court of Appeals for the Fifth Circuit|
Appeals from the United States District Court for the Southern District of Texas.
Before REYNALDO G. GARZA, JOLLY, and HIGGINBOTHAM, Circuit Judges.
E. GRADY JOLLY, Circuit Judge:
In this consolidated appeal,1 we address a question of federal preemption: whether,
based on Medtronic's compliance with the Food and Drug Administration's ("FDA") rigorous premarket approval procedure ("PMA"), the plaintiffs' Texas common law products liability tort claims are preempted by 21 U.S.C. § 360k, the Medical Devices Amendments ("MDA") to the Food, Drug, and Cosmetic Act ("FDCA"). We have addressed this issue before. In Stamps v. Collagen Corp., 984 F.2d 1416, 1422 (5th Cir. 1993), we held that similar state product liability claims were preempted. Since we decided Stamps, however, the Supreme Court has spoken on the issue. See Medtronic, Inc. v. Lohr, 518 U.S. 470, 477, 116 S.Ct. 2240, 135 L.Ed.2d 700 (1996). The Supreme Court did not specifically decide the case before us, yet spoke in a way that overruled Stamps in part. Lohr is a difficult opinion to apply in this case; first, because it involves a process far less specific in its requirements than the PMA process involved in both this case and Stamps, and second, because on points important to this appeal, the Lohr court was fractured. In any event, we ultimately determine that for purposes of deciding this appeal, Stamps is binding precedent that controls the outcome of the case. Accordingly, we hold that the Texas state product liability claims in this case are preempted by the MDA, and we affirm the judgment of the district court dismissing the complaint.
Billye Jeanne Martin and Libra Salazar each claim that they were injured by Medtronic's defective pacemaker (Model 4004). They allege that the pacemaker contained a defective "ventricular lead," the wire that carries current into the heart muscle. Their product liability claims include negligence, gross negligence, strict liability, breach of warranty, and violation of the Texas Deceptive Trade Practices Act; all claims are based on alleged deficiencies in the safety and effectiveness of the design, manufacturing process, warnings, and labeling of the lead.
The district court initially granted Medtronic's motion for summary judgment only in part, finding that the MDA preempted Salazar's and Martin's design, manufacturing process, and warning claims. The district court reasoned that in all these areas, the FDA, through its PMA procedure,2 had approved Medtronic's product. The district court, however, denied summary judgment on the plaintiffs' claims that Medtronic had deviated from FDA requirements. Following further discovery, Medtronic renewed its summary judgment motion. The district court then granted the renewed motion, finding that appellants failed to produce evidence of alleged deviations, and entered judgment dismissing each complaint. These appeals, now consolidated, present the single issue of whether the FDA's PMA procedure preempts the state law tort claims.
We begin our consideration of this question of preemption by making a few preliminary observations that serve to place in context the even more precise issue before
us--to what extent is our case today decided by precedents of this court and the Supreme Court. The MDA classifies medical devices into three categories based on the degree of risk they pose to the public. Class I devices pose little or no risk to public health and are subject only to general controls on manufacturing. Class II devices are potentially more harmful and may be subject to regulations and product specifications. Class III devices, the most strictly regulated, are "[d]evices that either 'presen[t] a potential unreasonable risk of illness or injury,' or which are 'purported or represented to be for a use in supporting or sustaining human life or for a use which is of substantial importance in preventing impairment of human health.'" Lohr, 518 U.S. at 477 (quoting 21 U.S.C. § 360c(a)(1)(C)).
A pacemaker is classified as a "Class III" medical device. As such, it must undergo an indisputably thorough, rigorous, and costly premarket review (some 1,200 FDA man-hours at hundreds of thousands of dollars in cost) by the FDA. Under this PMA process, the manufacturer must give the FDA a "reasonable assurance" that the product is safe and effective. Although this term does not sound excessively demanding, the PMA process is rigorous. It requires manufacturers to submit detailed information regarding the safety and efficacy of their devices. This includes, among other things, full reports of all information that is known by the applicant, samples of both labeling and the device itself, and a full description of the methods and facilities used for manufacturing and installation of the device. See 21 U.S.C. § 360e(c)(1) (describing the components of a PMA application). The FDA then reviews the application, spending an average of 1,200 hours on each submission before granting marketing approval. The statutory basis for this process, and its exceptions, are set forth at length in Lohr, 518 U.S. at 477, and need not be reiterated here.
It is central to our resolution of this appeal that we have held that § 360k preempts these state products liability claims when the device manufacturer complies with the FDA's PMA process. See Stamps, 984 F.2d at 1422. In this appeal, it is not disputed that Medtronic has complied with the FDA's PMA process in the creation of its pacemakers. Thus, based on the holding of Stamps, the claims here should be preempted.
But yet there is a twist. After Stamps, the Supreme Court considered the scope of MDA preemption of state law claims in the "§ 510(k) notification" process,3 an exception to the far more demanding PMA review process. See Lohr, 518 U.S. 470. The § 510(k) process allows improvements to existing devices to be rapidly introduced into the market by foregoing the extensive review in the PMA process. Id. at 478. While the PMA process requires an inquiry into the risks and efficacy of each device through a variety of reports and submissions, as described above, the § 501(k) process only requires the manufacturer to show that the device is "substantially equivalent" to devices already on the market. Under the § 501(k) process, the manufacturer must submit proposed labeling, labels, and advertisements that describe the device, its intended use and the directions for its use; a statement indicating how the device is similar to or different from comparable products; a statement that the submitter believes that the information is accurate and complete; and any additional information necessary for the FDA Commissioner to
make a determination as to whether the device is "substantially equivalent." See Buckman Co. v. Plaintiffs' Legal Committee, 531 U.S. 341, 121 S.Ct. 1012, 1016, 148 L.Ed.2d 854 (2001); 21 C.F.R. §§ 807.87, 807.92. The manufacturer does not have to submit information on the safety or efficacy of the device. In contrast to the 1,200 hours that it takes to complete a PMA review, a § 510(k) review takes an average of 20 hours. Lohr, 518 U.S. at 479. As the Supreme Court has noted, "[t]he § 510(k) notification process is by no means comparable to the PMA process." Id. at 478-79.
Lohr, however, is highly relevant to this appeal because it considered in some detail the preemption statute that is applicable both to the § 510(k) process and the PMA process. Notwithstanding its relevance, the Supreme Court decision must be more than merely illuminating with respect to the case before us, because a panel of this court can only overrule a prior panel decision if "such overruling is unequivocally directed by controlling Supreme Court precedent." United States v. Zuniga-Salinas, 945 F.2d 1302, 1306 (5th Cir. 1991). This means that Stamps should apply to this case unless "an intervening Supreme Court case explicitly or implicitly overrul[es] that prior precedent." United States v. Short, 181 F.3d 620, 624 (5th Cir. 1999). Thus, the first, and ultimately only, question we face is the degree to which Stamps retains precedential value after the Supreme Court's decision in Lohr.
To resolve the impact of Lohr on our precedent in Stamps, we begin by setting out the relevant statutory and regulatory language that we must consider. Section 360k(a) ("General Rule") is the preemption provision of the MDA governing the extent to which the MDA preempts state law. It applies both to situations arising under the § 510(k) process and the PMA process. It states:
[N]o 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. § 360k(a). The FDA has promulgated regulations interpreting § 360k, which state:
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...
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