Thanks and a tip of the cyberhat to Tom Stayton for sharing with us a recent medical device preemption win in McCutcheon v. Zimmer Holdings, No. 06 C 6256 (N.D. Ill. Aug. 6, 2008) copy of slip opinion here. The case involves, as expected, a Class III PMA approved device, a knee replacement prosthesis.
Since Riegel controls, we won’t go into McCutcheon‘s general discussion of preemption. What we’re interested in now is what arguments the plaintiff made to avoid preemption and what the court did with them. In McCutcheon, those excuses were:
(1) Failure to disclose risk information to the FDA during the PMA process. Slip op. at 10. This argument got nowhere because, (a) there was no evidence to support it, and (b) it amounts to a hidden fraud-on-the-FDA claim that’s preempted by Buckman.
Although [plaintiff] has not formally asserted that [defendant] violated some kind of [state] prohibition against fraudulent representations to the FDA, her argument that [defendant] failed to disclose all relevant information to the agency essentially equates to that. Under Buckman, then, she cannot prevail.
(2) The defect in question was not discovered until after PMA. Slip op. at 11. This argument fails because, again there is no evidence, and further, this distinction is found only in Justice Ginsburg’s solo dissent. Id. 11-13.
(3) The court should give weight to a pre-Riegel decision against preemption by the Illinois Supreme Court. Slip op. at 13. This rather weak argument was rejected because the Supreme Court, being the highest court in the land for purposes of federal constitutional law, issued controlling precedent in Riegel. Id. at 13-14. Umm…. We fought a civil war over that, guys.
(4) The court “should act … according to a bill recently introduced in the House of Representatives that, if enacted,would overturn Riegel.” Slip op. at 14. “Legally bankrupt,” the court held (and we agree). It would be irresponsible to ignore controlling precedent in favor of merely prospective legislation. Id.
Keep those wins coming, guys.