Louisiana medical device preemption upheld

Congratulations to my friends at Abbott, Simses & Kuchler for their successful representation of DuPont for a Mentor medical device product.  On preemption grounds, a federal judge in the Western District of Louisiana dismissed a state law based product liability claim against Mentor for a medical device (a paste made up of half Teflon and half glycerine) used for stabilization of vocal cords to assist in voice functionality. 

The case is Mathis v. E.I. DuPont De Nemours & Co. and Mentor Corporation, Civ. 06-0825, and can be found at Westlaw,  Slip Copy, 2008 WL 162156 (W.D.La.).

The preemption twist in this case is that the device at issue was approved by the FDA as part of a NDA (New Drug Application) in 1972.  The Medical Device Amendments were not enacted until 1976. It is those amendments that contain the express preemption provision for medical devices.  The 1976 amendments contained a provision  that deemed devices that went through the NDA process to be Class III devices. Thus, the device at issue is deemed to be a Class III device for the purposes of the FDA regulatory scheme.

Summary judgment was sought on preemption grounds.  The court reviewed traditional preemption law for these kinds of cases.  It specifically analyzed two Fifth circuit cases which reviewed PMA devices and preemption (Martin v. Medtronic, Inc., 254 F.3d 573, 577 (5th. Cir.2001) and Gomez v. St. Jude., 442 F.3d 919 (5th Cir.2006).

The court focused on the level of FDA scrutiny in the NDA process and in the process following the adoption of the Medical Device Amendments.  In light of the level of FDA involvement and scrutiny, the court felt that preemption was appropriate.  Specific failure to warn claims were made, and the court felt that as the FDA was significantly involved in their development, that preemption was appropriate.

The preemption wars continue while we await a decision in the Reigel case.

Comments

[Mike Shalhoub]

Laura - thank you for your comments and thoughts.

The fact is that the FDA was heavily involved both before the approval of the device in the Louisiana case, and afterwards. To accuse the FDA of corruption is a quite a stretch. To say that like many government agencies, they could be better funded, or more efficiently funded, is a good point. But, their level of involvement with Class III devices, coupled with the express preemption language in the Medical Device Act, makes a very strong legal case for preemption. The Supreme Court will decide this issue in short order, and then we can debate if they were right or not. If the court funds that there is preemption, then all Congress needs to do is repeal that provision, and perhaps preemption will disappear.

It is not a question of the public 'bowing to' the FDA. The FDA acts on behalf of the public, and the highly regulated nature of this industry is the reason that the preemption doctrine applies here in the first place.

Mike Shalhoub

[laura]

http://jaynesdays.blogspot.com/

This is a link to a blog that clearly explains the flawed reasoning that medical device and drug preemption advocates are dealing with. Far from being an all knowing, faultless administration, the FDA is actually fraught with corruption,lack of funds, overwork, and the inability to fully investigate and follow up on products they have approved for market. Should the public be expected to bow to the FDA's decisions and be left with no recourse when, by the FDA's own admission, they are a flawed administration?

[laura]

http://jaynesdays.blogspot.com/

This is a link to a blog that clearly explains the flawed reasoning that medical device and drug preemption advocates are dealing with. Far from being an all knowing, faultless administration, the FDA is actually fraught with corruption,lack of funds, overwork, and the inability to fully investigate and follow up on products they have approved for market. Should the public be expected to bow to the FDA's decisions and be left with no recourse when, by the FDA's own admission, they are a flawed administration?