Friday, December 19, 2008

Preemption and Investigational Devices after Riegel

One of the questions we've been asking - but not finding answers - is where exactly do investigational medical devices (IDE) fit in to the preemption rubric after Riegel. Investigational devices, after all, are PMA, only their applications haven't been approved yet. Since IDE devices are subject to the same regulations as PMA devices, only at an earlier stage of the process, it seems logical that IDE requirements would preempt tort requirements for the same reasons as in Riegel.


But no courts had considered the question - until now.


A tip of the cyberhat to Sean Saxon over at Wheeler, Trigg for passing along to us the first decisions (two identical rulings by the same judge) we've seen holding that, because IDE devices are subject to the same PMA regulatory scheme that was at issue in Riegel, product liability claims against such devices are subject to the same degree of preemption recognized in Riegel: The primary takeaway:

IDE approvals are within the express purview of the MDA, are a step on the way to potential Pre Marketing Approval, and the court is unable to differentiate the application of the preemption provisions of the MDA. The preemption provisions apply to IDE approvals.

Robinson v. Endovascular Technologies, Inc., No.: 1-03-CV-009655, slip op. at 3 (Cal. Super. Santa Clara Co. Dec. 17, 2008); Norks v. Endovascular Technologies, Inc., No.: 1-03-CV-010668, slip op. at 3 (Cal. Super. Santa Clara Co. Dec. 17, 2008). Nor could plaintiffs pursue claims alleging "fraudulent conduct of a defendant in approving an IDE," due to Buckman preemption. Id. at 3-4. This was not a case where the FDA had concluded that it was defrauded and ordered the device off the market. Id. at 4.


So there you have it - at least one court's answer: Manufacturers of investigational devices may rely upon the same extensive preemption that Riegel recognized with respect to devices that had completed the PMA process.

1 comment:

Ted Heise said...

It should be recognized that IDEs are often used to gather clinical data that are required for some 510(k) products.