must determine if the state requirements are different from, or in addition to, the federal requirements.
A majority of the Medtronic Court concluded that each of the plaintiff's claims survived the preemption analysis. The Court placed great emphasis on the device in question, a pacemaker, and the fact that it had not undergone the rigorous PMA process. The pacemaker only reached the marketplace because it was "substantially equivalent" to another device, and the Court observed that the 510(k) process focused only on equivalence, not on safety. Id. at 2254. Therefore, no device-specific regulation by the FDA existed, which is a condition for preemption of state requirements by the MDA.
III. Applying Medtronic to the Instant Case
As the Court has noted previously, the PMA screening process that the Ligament satisfied is significantly more demanding than the "substantially equivalent" process at issue in Medtronic. During the PMA process, the federal government has "weighed the competing interests relevant to the particular requirement in question, reached an unambiguous conclusion about how those competing considerations should be resolved in a particular case or set of cases, and implemented that conclusion via a specific mandate on manufacturers or producers." Medtronic at 2258. Therefore, this Court follows the teaching of the majority of those that have considered the issue, and determines that the PMA process constitutes the type of specific federal regulation of a product that can have a preemptive effect under the MDA. See, e.g., Mitchell v. Collagen Corp., 126 F.3d 902 (7th Cir. 1997); Steele v. Collagen Corp., 54 Cal. App. 4th 1474, 63 Cal. Rptr. 2d 879 (Ct. App. 1997); Easterling v. Cardiac Pacemakers, 986 F. Supp. 366, 1997 U.S. Dist. LEXIS 18896, 1997 WL 732422 (E.D.La. 1997); Fry v. Allergan Medical Optics, 695 A.2d 511 (R.I.), cert. denied, 139 L. Ed. 2d 291, 118 S. Ct. 374 (1997); but see Sowell v. Bausch & Lomb, Inc., 230 A.D.2d 77, 656 N.Y.S.2d 16 (App. Div. 1997); Lakie v. SmithKline Beecham, 965 F. Supp. 49 (D.D.C. 1997).
As the Court determined in the March 1995 Opinion, plaintiff's state law tort claims that defendant generally was negligent, careless, and reckless in the manufacture, design, construction, labeling, packaging, distribution, and sale of the Ligament, as well as the plaintiff's claim for breach of implied warranty, impose safety and effectiveness requirements that are different from, or in addition to, those established under FDA regulations. See March 1995 Opinion at 12-13, 18. Consequently, there has been no change in the controlling case law for plaintiff's claims that are not specific to the Ligament implanted in Richman; her motion to modify the Court's decision as to these claims must fail.
Plaintiff contends, however, that her claim is also rooted in the negligent manufacture of the specific Ligament that was implanted in her. The March 1995 Opinion held that the MDA likewise preempted these claims as a matter of law, because the weight of the case law mandated that the FDA is responsible for investigating alleged failures to comply with its standards, and that no private right of action exists to enforce a manufacturer's compliance with FDA requirements. See March 1995 Opinion at 14-15. The Supreme Court's opinion in Medtronic, however, calls for a different result. The Justices unanimously concluded that a state common law action is not preempted if it imposes duties that mirror the FDA regulations. A cause of action under this theory would not impose any different or additional duties on the manufacturers, but would provide only an additional remedy to plaintiff. Therefore, to the extent that Richman's claim of negligent manufacturing alleges that Gore failed to meet the standards set forth in the PMA process, the MDA does not preempt this claims. See Mitchell, 126 F.3d at 914 (MDA does not preempt claims alleging that defendant failed to meet the standards set forth in the PMA process); see also Easterling, 986 F. Supp. 366, 1997 WL 732422 at *9. Accordingly, the MDA does not prevent Richman from pursuing her claim that in the manufacture of the specific Ligament implanted into the plaintiff, Gore varied from the standards set by the FDA during the PMA process. This is the only claim, however, that survives.
For the reasons stated above, plaintiff's motion to modify the Court's March 24, 1995 Opinion is HEREBY GRANTED in part and DENIED in part. The parties are directed to appear at a pre-trial conference in Courtroom 18B at 500 Pearl Street on January 23, 1998 at 11:00 a.m.
New York, New York
December 30, 1997
Peter K. Leisure