Thursday, November 27, 2008

Happy Preemption Thanksgiving

A tip of the hat and an extra helping of turkey for Tom Stayton for sending along a copy of a new medical device preemption decision, Link v. Zimmer.

The product: a total knee replacement device called the "natural knee II." It's a class III pre-market approved device (naturally). It had to be replaced after four 1/2 years in plaintiff's body. The FDA considered the PMA for three years before finally approving it.

Plaintiff claims it caused "further osteolysis" (a progressive condition), and because it used materials "prone to wear" (tell us when you find something that isn't).

To the surprise of absolutely nobody the court applies Riegel and finds there is preemption. Slip op. at 5-

To the more interesting issues - any discussion of alleged loopholes?

Youbetcha.

Non-compliance. Zimmer established its ongoing compliance with the FDA's conditions of approval. Slip op. at 8-9. How? You'll have to take a look at the filing, because plaintiff's counsel couldn't follow the rules.

Fraud on the FDA. Plaintiff argued that the defendant "did not fully and honestly disclose all informationrelevant to the safety of the [device] to the FDA." Slip op. at 9. After noting plaintiff had no proof of the allegation, the court held that, in any event, "any allegations that [defendant] committed a fraud upon the FDA are also preempted." Id. (citing Buckman).

Post-approval. Plaintiff claimed that Riegel doesn't apply because that alleged defects only "came to light after [the device] received premarket approval." Slip op. at 9-10. Since the FDA isn't going to approve a device it knows is defective, this is an argument that Riegel doesn't apply to anything. The court found there was no evidence, and in any event the argument failed because it was based on the lone dissent in Riegel.

Congressional intent. Plaintiff urged the court to ignore the Supreme Court because Congress didn't mean what it said in the express preemption provision and might change it. Slip op. at 10. The court (being nice) followed Riegel's observation that the text of the statute is the best indicator of congressional intent.

No loopholes in Riegel.

2 comments:

hg said...

Thanks for this report. You note, "the court held that, in any event, "any allegations that [defendant] committed a fraud upon the FDA are also preempted."

I ask again: is there anything other than a successful prosecution by FDA/DOJ (OCI) for fraud that would relevantly "count" as a fraud finding by the agency?

Thank you.

Soronel Haetir said...

HG,

Personally I would hope not, even Perhaps an administrative finding as part of a less than prosecution that the company volunteers to undergo. Such a finding would only open the door however, it would still remain that whatever was withheld etc would need to be relevant to the patient action.

I see this openning as quite narrow.