Saturday, April 21, 2012
A sharply divided three-judge panel of the Ninth Circuit ruled earlier this week in Stengel v. Medtronic, Inc. that the plaintiffs' state law failure-to-warn claim based on Medtronic's failure to provide disclosures to the FDA is impliedly preempted under the Medical Device Amendments of 1976 to the Food, Drug and Cosmetic Act.
The ruling deepens a circuit split, aligning the Ninth Circuit with the Eighth, and against the Fifth. It also leaves little, if any, daylight for a state law claim paralleling the MDA in the Ninth Circuit.
The case grows out of Richard and Mary Lou Stengel's claim against Medtronic for damages for injuries from a premarket approved medical device. The Stengels claimed, among other things, that Medtronic failed to report problems with the device; their proposed amended complaint read:
Under federal law and regulation, [Medtronic] was under a continuing duty to monitor the product after premarket approval and to discover and report to the FDA any complaints about the product's performance and any adverse health consequences of which it became aware and that are or may be attributable to the product.
The Stengels filed a state failure-to-warn claim, which paralleled the FDA reporting requirement, in state court, and Medtronic removed to federal court.
The Ninth Circuit ruled that the Stengels' state failure-to-warn claim was impliedly preempted under the MDA under Buckman Co. v. Plaintiffs' Legal Committee (2001). Buckman held that state fraud-on-the-FDA claims were preempted under the FDCA. The majority in Stengel said those claims were the same as the Stengels' claim for preemption purposes:
The Stengels' theory is that if Medtronic had acted wtih reasonable care in complying with the regulations that required it to provide information to the FDA, the FDA would have required Medtronic to warn physicians about the danger of inflammation connected to its pump and Stengel could have avoided the infury caused by the pump. This is precisely the same theory that was rejected in Buckman. The only difference is that, in Buckman, the defendant allegedly misinformed the FDA overtly by providing false information, whereas here the defendant allegedly misinformed the FDA tacitly by failing to report information that it had a duty to report. The policing of such conduct in both instances is committed exclusively to the federal government, and recognizing a state cause of action based on such conduct would conflict with the statutory scheme established by Congress.
Judge Noonan wrote in dissent that the Supreme Court specifically said in Medtronic, Inc. v. Lohr (1996) that state common law duties could parallel the MDA, so long as they were not expressly preempted by the MDA. The Court restated this in Riegel v. Medtronic (2008). Judge Noonan wrote that nothing in Buckman limited this statement, and that Riegel demonstrated its continuing validity.
Although the ruling this week leaves a theoretical opening for a state law claim that parallels the MDA, under the majority's approach it's hard to see what it is.