Discussion of the applicability of preemption doctrine in medical device product liability cases usually centers on two types of devices: (1) Class III medical devices approved pursuant to FDA’s premarket approval process, and (2) devices cleared through the less rigorous 510(k) process. A recent case reminds us of a different pathway to approval, which carries the same preemptive effect as premarket approval: Product Development Protocol (“PDP”).
The 1976 Medical Device Amendments (“MDA”) to the Food, Drug, and Cosmetic Act establish two avenues for obtaining approval of a Class III medical device: (1) the PMA process or, in the alternative, (2) the PDP process. A device sponsor wishing to use the PDP process, rather than the PMA process, must obtain advanced permission from the FDA. The PDP process is usually reserved for devices with technology that is already well understood by the FDA. The PDP for a device reflects an agreement between the device sponsor and the FDA setting forth what the sponsor must do to demonstrate the safety and effectiveness of the device. The required contents of a PDP are set forth in 21 U.S.C. § 360e(f)(3)(B). If, upon review of documentation submitted by the sponsor, the FDA determines that the requirements of the PDP have been met, the FDA will declare the PDP complete.
Last month, the Fifth Circuit issued an unpublished decision in Rodriguez v. American Medical Systems, Inc., 2014 WL 7399048 (5th Cir. Dec. 31, 2014), affirming the district court’s grant of summary judgment on preemption grounds. The decision is noteworthy because Rodriguez appears to the be first federal appellate court decision addressing preemption in the PDP context. The device at issue in Rodriguez was a Class III inflatable implant device, manufactured by American Medical Systems, and approved through the PDP process. Id. at *1-2.
The Rodriguez court explained that, “A state law tort claim to recover for injuries allegedly caused by a medical device is preempted if two requirements are met: (1) ‘the Federal Government has established requirements applicable to [the device]; and (2) the claims are based on state law requirements that are different from, or in addition to the federal ones, and that relate to safety and effectiveness.’” Id. at *1 (alteration in original). “Class III devices that are approved through the FDA’s rigorous pre-market approval process (‘PMA’) automatically satisfy the ‘federal requirements’ prong of the preemption analysis.” Id. at *2 (citing Riegel v. Medtronic, Inc., 552 U.S. 312, 322-23 (2008)).
As the plaintiff presented “no argument that the PDP and PMA procedures should be treated differently under the preemption analysis” and other persuasive authority counseled that they should be treated the same, the court “assume[d] that a device which has been approved through the PDP process meets the federal requirements prong of the preemption analysis.” Id.at *2. It further found that the plaintiff’s claims were pleaded such that they would impose additional or different requirements than the federal ones and, therefore, satisfied the second prong of the analysis. Id. at *3-4.
While Rodriguez is the first appellate court decision to address the issue, PDP preemption has sporadically arisen before various district courts over the past decade. Each court to address the issue has held that “the PMA and PDP process are to be treated synonymously” for purposes of preemption. See, e.g., Betterton v. Evans, 351 F. Supp. 2d 529, 525 (N.D. Miss. 2004).
As several courts have acknowledged, there is statutory support for treating the PDP and PMA processes similarly for purposes of preemption. The MDA provides that a device which has been approved through the PDP process “shall be considered as having [PMA] approval.” 21 U.S.C. § 360(f)(1). Additionally, 21 C.F.R. § 814.19 states that, “A class III device for which a product development protocol [PDP] has been declared completed by FDA under this chapter will be considered to have an approved PMA.”
Moreover, the rationale that underlies preemption in cases of PMA approval applies equally to the PDP context. “The FDA approval of [a] product through the PDP process represents the FDA’s conclusion that it has received ‘reasonable assurance’ of the product’s safety.” Cowen v. Am. Med. Sys., Inc., 2006 WL 3542704, at *2 (E.D. Mich. Dec. 7, 2006). To permit a jury verdict finding a defect in the product or its warnings would “impliedly require more of [the] [d]efendant than what the FDA already required.” Id. “[S]uch requirements would be ‘different from’ or ‘in addition to’ those set forth by the FDA” and, accordingly, are preempted. Id.
Thus, as with PMA preemption cases, in the context of PDP preemption, we will likely see plaintiffs attempting to avoid dismissal on preemption grounds by asserting “parallel claims”—claims premised on allegations that the device manufacturer violated a federal requirement specific to the FDA’s PMA approval of the device. In affirming the decision to dismiss in Rodriguez, the Fifth Circuit found that no such parallel claims had been pleaded. Rodriguez, 2014 WL 7399048 at *3 (plaintiff failed to plead a parallel claim because he “d[id] not plead a violation of any federal requirement relating to designing or manufacturing of the implant, either those specific to the AMS 700 MS or those generally applicable to the manufacturing of medical devices”). Accordingly, the plaintiff’s claims were a straightforward attempt to impose on the manufacturer requirements that were “different from” or “in addition to” those set forth by the FDA in the PDP process.