This post is from the non-Reed Smith side of the blog.
Today’s mainstream media may be all about another “first” that happened yesterday, but our attention is drawn to a state to the south and west of all that hoopla, Oklahoma. Oklahoma doesn’t wade into the presidential political process until Super Tuesday, but in the drug and device world, Oklahoma gets center stage for getting PMA preemption just right.
The case is Nevolas v. Boston Scientific Corporation, 2016 U.S. Dist. LEXIS 9893 (W.D. Okla. Jan. 28, 2016) and it involved a spinal cord stimulator which is a Class III, pre-market approved medical device. That means the product is subject to the express preemption provision of the Medical Device Amendments of 1976 (“MDA”). As a reminder that provision provides that:
[N]o State . . . may establish or continue in effect with respect to a device intended for human use any requirement -- (1) which is different from, or in addition to, any requirement applicable under this chapter to the device, and (2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this chapter.
21 U.S.C. § 360k(a). With that, few if any products claims survive preemption. See Nevolas at *5. To do so, the claim must be a parallel violation claim. A parallel claim is a state law claim in which damages are sought for conduct that violates a specific federal regulation – thus state and federal law are equivalent and express preemption doesn’t apply. But the claim itself must be a recognized state law claim. Plaintiffs cannot sue solely because defendant’s conduct violated federal regulations – that would be an impermissible attempt to privately enforce the FDCA.
Much of the PMA preemption case law in recent years has been focused on defining parallel violation claims and much of it has developed in the context of motions to dismiss. Therefore, plaintiffs are faced with a double specificity hurdle. Parallel violation claims must be based on specific requirements applicable to the device at issue and the complaint must contain specific factual allegations to satisfy TwIqbal. This means the courts are determining whether the complaint sets forth “facts pointing to specific PMA requirements that have been violated.” Id. at *6. The Nevolas complaint fell far short. The allegations were “devoid of any factual support” for the contention that defendant “violated in unspecified ways” various federal requirements. Id. at *7. There was simply nothing specific in any of plaintiff’s allegations. Plaintiff cited to no specific facts. Plaintiff cited to no specific device-related requirements. At best plaintiff used conclusory language and referenced only general manufacturing regulations – not the type that support a parallel claim. Id. at *7-8.
At this point plaintiff argued that she could not have pleaded “more” because information on PMA devices is kept confidential and not available to plaintiff absent formal discovery. Id. at *9. While the court was sympathetic, it didn’t find plaintiff’s argument persuasive because plaintiff didn’t even attempt to allege a violation of a regulation that would support a parallel claim down the road:
The Court finds plaintiff's allegations that defendant was required to follow nonspecific federal regulations and current good manufacturing practice requirements, which are applicable to all manufacturers of all medical devices, are insufficient to state a plausible parallel claim upon which relief can be granted. Allowing a plaintiff to plead non-specific regulations as a basis for a parallel claim is inconsistent with the Supreme Court's reasoning in Riegel, as well as the pleading requirements articulated in Twombly [and]Iqbal.
It’s not a ground-breaking decision and plaintiff is being given a chance to amend. But, it does toss the entire complaint on preemption and it’s the first to do so this year. No deadlock here. A decisive defensive win in Oklahoma.