Tuesday, March 17, 2009

A Riegel Wrinkle: "Adjunct Clinical Trial" Preemption

As you know, we watch the medical device preemption cases.

And we've discussed a case after Riegel finding preemption in the context of a device used in a clinical trial under an Investigational Device Exemption.

But here's a Riegel wrinkle. (In fact, we like this case so much that we might call it a regal Riegel wrinkle. In fact, . . . well, never mind.)

Anyway, it's Dorsey v. Allergan, No. 3:08-0731, slip op. (M.D. Tenn. Mar. 11, 2009) (here's the obligatory link). After the breast implant brouhaha in the very early '90s, McGhan Medical Corporation obtained FDA approval to conduct a clinical trial studying the use of breast implants in breast augmentation patients. That was the "core" study and was approved by the FDA in 1998. Id. at 2-3.

On a separate track, the FDA also approved McGhan's proposal to study breast implants used in breast reconstruction patients. That was the "adjunct" study, also approved in 1998. Id. at 2.

Plaintiff Susan Dorsey received Style 20 implants on November 9, 2005, as part of the adjunct study. Her consent form "indicated that the use of the implants was investigational and not FDA approved." Id. at 3. Dorsey allegedly began to experience pain and fatigue immediately after the surgery, and her implants were removed on September 29, 2006. The Style 20 implants received premarket approval from the FDA two months later, on November 17, 2006.

Dorsey pleaded one count of strict liability against Allergan, which manufactured the implants.

Allergan moved for summary judgment on the basis of preemption, citing, among other cases, Riegel v. Medtronic, 128 S. Ct. 999 (2008). Dorsey tried to distinguish Riegel on the grounds that (1) the Style 20 implants had not received premarket approval at the time of her surgery, and (2) her surgery was performed under the adjunct clinical trial, rather than the core one. Id. at 8.

The court rejected both arguments. First, the FDA ultimately granted premarket approval to the Style 20 implants. The FDA thus concluded that the devices were safe and effective. That finding undercut any claim that the devices were "unreasonably dangerous" for purposes of strict liability under Tennessee law. "[T]he subsequent approval by the FDA is a bar to Plaintiff's strict liability claim because the FDA has determined that the implants at issue are reasonably safe for consumers and there is no suggestion that the implants she received were somehow different than those ultimately approved by the FDA." Id. at 9.

Second, the use of the implants in an adjunct study, rather than a core one, was a distinction without a difference. "[W]hether the Style 20 implant was a part of the core or adjunct study, the FDA has approved its use and therefore Plaintiff's claim is preempted." Id. at 11.

"[R]egardless of how it was characterized (as a clinical or adjunct study), the record suggests that the information given to the FDA was consistent with the IDE protocol in the core study and Plaintiff has provided absolutely no evidence which would suggest otherwise." Id.

After Riegel, preemption should be available as a defense in PMA and IDE cases (and, depending on the facts, perhaps in others, too). There's no reason to distinguish between core and adjunct clinical trials, so we're pleased to see that argument laid to rest.

1 comment:

Regulatory Consulting said...

Good post!!!!!!