The Supreme Court’s decision in Riegel v. Medtronic, Inc., __ S.Ct. __, No. –6-179, 2008 WL 440744 (Feb. 20, 2008) fails to effect the type of mass exoneration of medical device manufacture wrongdoing as suggested by the Defense Bar; Corporate Defense Counsel and the Industry.

I. Riegel v. Medtronic

Riegel is not new law: it has been the law of a number of federal circuits for some years now. See Horn v. Thoratec Corp., 376 F.3d 163 (3d Cir.2004); Martin v. Medtronic, Inc., 254 F.3d 573 (5th Cir. 2001); Brooks v. Howmedica, Inc., 273 F.3d 785 (8th Cir. 2001); Kemp v. Medtronic, Inc., 231 F.3d 216 (6th Cir. 2000); Mitchell v. Collagen Corp., 126 F.3d 902 (7th Cir. 1997). In fact, Riegel does not affect the posture of most civil actions filed or to be filed against manufacturers (certainly not as a facial bar to pursuing the claim through discovery) because:
1. No decision on pre-emption can be made until discovery is closed and proper motions for summary judgment are before the Court,
2. Riegel is completely inapplicable to claims for manufacturing defect (See Riegel, supra, at n. 2.); breach of express and implied warranty of fitness for particular purpose (See Cipollone v. Liggett Group, Inc., 505 U.S. 504, 526, 112 S.Ct. 2608, 2622, 120 L.Ed.2d 407 (1992); and In re St. Jude Medical Inc. Silzone Heart Valves Products Liability Litigation, MDL 1396, 2004 WL 45503 (D. Minn. January 5, 2004)); deceptive trade practices (See Medtronic v. Lohr, 518 U.S. 470, 501-501 (1996)); and negligent misrepresentation (See Cipollone, 505 U.S. at 526, 112 S.Ct. at 2624).
3. Failure to warn claims are based on a duty to disclose mandated by federal law. Thus, the failure to warn claims are based on “parallel” federal and state requirements, precluding pre-emption. (See Riegel, slip op. at 17).

It is critical to understand what the decision does—and does not—stand for. Riegel involved a device known as an Evergreen Balloon Catheter, manufactured by Medtronic, Inc. of Minnesota. The catheter ruptured in the heart of Plaintiff Charles Riegel and he brought a lawsuit in federal court within in the Northern District of New York. He brought claims for strict liability, breach of implied warranty, negligence in design, testing, inspection, distribution, labeling, marketing and sale of the device. The District Court found those claims pre-empted by federal FDA law, and the Second Circuit agreed. 451 F. 3d 104 (2006). The District Court did not find pre-empted claims for breach of express warranty and negligent manufacturing. Riegel, supra, at n. 2. No claims were brought for fraud, misrepresentation or deceptive trade practices, so the Supreme Court did not rule on whether fraud, misrepresentation or deceptive trade practices claims were pre-empted.

What the Court did hold was that “premarket approval…imposes ‘requirements’ under the MDA as we interpreted it in Lohr.” Riegel, slip op at 9. The Court noted:
…the FDA requires a device that has received premarket approval to be made with almost no deviations from the specifications in its approval application, for the reason that the FDA has determined that the approved form provides a reasonable assurance of safety and effectiveness. Slip op at 10.

The Court noted that federal manufacturing and labeling requirements applicable across the board to almost all medical devices did not pre-empt the common-law claims of negligence and strict liability at issue in Lohr. The federal requirements, we said, were not requirements specific to the device in question—they reflected “entirely generic concerns about device regulation generally.” Slip op at 8-9. However, “premarket approval is specific to individual devices.” Slip op at 9. Because a PMA “is safety approval,” id., it can only follow that pre-emption relates only to the specific pre-market approval sought by the manufacturer and given by the FDA.

Having decided that a PMA imposes requirements specific to the device being approved, the Court then had to determine whether state common law claims imposed a requirement “different from or in addition to” the federal requirement. Riegel, slip op. at 10. The Court made clear that the federal statute “does not prevent a State from providing a damages remedy for claims premised on a violation of FDA regulations; the state duties in such a case ‘parallel,’ rather than add to, federal requirements.” Riegel, slip op. at 17 (emphasis added).

Finally, the Supreme Court addressed the FDA regulation on pre-emption, 21 CFR 808.1(d)(1), in a very murky passage. That regulation provides:
Section 521(a) does not preempt State or local requirements of general applicability where the purpose of the requirement relates either to other products in addition to devices (e.g., requirements such as general electrical codes, and the Uniform Commercial Code (warranty of fitness)), or to unfair trade practices in which the requirements are not limited to devices.

II. Pre-Emption Is Factually Intensive Requiring Discovery Prior to Adjudication.

Dismissal based on alleged pre-emption is inappropriate without an examination of a complete factual record. Riegel, supra, was decided after summary judgment, not on a motion to dismiss. Most, if not all, other significant medical device pre-emption decisions were decided after summary judgment. See, e.g. In re Vioxx Products Liability Litigation, 501 F.Supp.2d 776 (ED La., 2007); In re Guidant Corp. Implantable Defibrillators Products Liability Litigation, 2007 WL 844683 (D. Minn. 2007); In re Medtronic, Inc. Implantable Defibrillators Litig., 465 F.Supp. 2d 886 (D. Minn. 2006); Goodlin v. Medtronic, Inc., 167 F.3d 1367 (11th Cir.1999). Pre-emption decisions are based on what requirements are imposed on a medical device by the FDA, whether the claims at issue deal with those requirements or not, and whether the FDA requirements themselves have been violated.

Accordingly, though the industry hopes Riegel will allow it to do anything shy of criminal misconduct, it does not stand for such a proposition nor does it allow such relief. Rather, though it does change the law in several circuits and will frustrate the efforts of victims of defective medical devices which were approved through a full premarket approval process, if the companies violate the Medical Device Act and federal regulations, such actions give rise to viable and compensable claims.