ON APPEAL FROM THE UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF PENNSYLVANIA (D.C. Civil Action No. 93-02725)
Before: COWEN, NYGAARD and ALITO, Circuit Judges
Opinion Filed: September 29, 1995)
Hugh and Lorraine English sued Mentor Corporation, alleging claims based upon strict product liability, negligence, breach of express and implied warranty, loss of consortium by Mrs. English, and punitive damages. Mr. English had a Mentor inflatable penile prosthesis implanted. The device malfunctioned and appellants sued Mentor in the Pennsylvania Court of Common Pleas. Mentor removed the case to the federal district court, which granted summary judgment in its favor, holding that appellants' claims were preempted by the Medical Device Amendments to the Food, Drug, and Cosmetic Act of 1938, 21 U.S.C. 360c-360rr.
Appellants raise two issues on appeal: (1) whether the Medical Device Amendments of 1976 preempt their state law tort and contract claims against the manufacturer of a Class III medical device; and (2) whether the Amendments also preempt these claims for a medical device cleared for marketing under the "substantial equivalence" exception to the general rule requiring a full Premarket Approval process. We will affirm in part, reverse in part, and remand the cause.
The Medical Device Amendments classify medical devices as Class I, II or III devices, depending upon their potential danger to the public. Class III devices are the most dangerous, the most heavily regulated, and include the prosthesis implanted in Mr. English. Generally with Class III devices, the manufacturer must submit a detailed "Premarket Approval" application to the FDA, 21 U.S.C. 360e(c)(1), and obtain Premarket Approval before they can be marketed to the public. Id. Section(s) 360c(a)(1)(C).
There are two exceptions to this requirement. First, Class III devices may receive an "Investigational Device Exemption" (or "IDE") from the FDA, id. Section(s) 360j(g), which permits the device to be tested on human subjects without obtaining Premarket Approval. Id. Section(s) 360e(a). Second, absent formal premarket approval, the FDA has permitted manufacturers to market new inflatable penile implants by completing the "510(k) procedure," which requires a demonstration that the new device is "substantially equivalent" to other penile implants already on the market before the passage of the MDA. *fn1 21 U.S.C. Section(s) 360c(f)(3); 21 C.F.R. Section(s) 807.81-807.100. Absent such a demonstration, a device may not be marketed until obtaining the full premarket approval described above.
Under this 510(k) procedure, the FDA must decide whether a new device is in fact substantially equivalent to a device already on the market prior to 1976. See 21 U.S.C. Section(s) 360c(f)(3). Pursuant to 21 U.S.C. Section(s) 360c(i)(1)(A), a device is considered "substantially equivalent" if the device:
(i) has the same technological characteristics as the predicate device, or
(ii)(I) has different technological characteristics and information submitted that the device is substantially equivalent to the predicate device contains information, including clinical data if deemed necessary by the Secretary, that demonstrates that the device is as safe and effective as a legally marketed device, and (II) does not raise different questions of safety and efficacy than the predicate device.
This substantial equivalence determination therefore requires the manufacturer to provide information to the FDA in order to ensure that "the device is safe, effective and performs as well as or better than the [predicate] device...." 21 C.F.R. Section(s) ...