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that is forbidden by the FDCA [Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 301 et seq.].” Riley v. Cordis Corp., 625 F. Supp. 2d 769, 776 (D. Minn. 2009).
Even if a plaintiff’s claims should escape express preemption under Riegel, they must also clear the implied preemption hurdle. To avoid implied preemption, a claim must “rely[ ] on traditional state tort law which had predated the federal enactments in question [ ],” Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341, 349 n.4, 353 (2001), and must not merely be a claim by a private litigant to enforce the
FDCA, which is the exclusive province of the federal government. 21 U.S.C. § 337(a). For example, “fraud on the FDA,” or claims against a manufacturer for making false statements to the FDA during the pre- market approval process may be preempted. 531 U.S. at 352. In sum, “the conduct on which the claim is premised must be the type of conduct that would traditionally give rise to liability under state law—and that would give rise to liability under state law even if the FDCA had never been enacted.” Riley, 625 F. Supp. 2d at 777. Thus, Riegel and Buckman “create a narrow gap” through which a medical device product liability claim must fit to avoid express or implied preemption. Id. at 778. To make it through the gap,
“a plaintiff has to sue for conduct that violates a federal requirement (avoiding express preemption), but cannot sue only because the conduct violated that federal requirement (avoiding implied preemption).” Mink v. Smith & Nephew, Inc., 860 F.3d 1319, 1327 (11th Cir. 2017).
Specificity Necessary to Plead a Parallel Claim
There is a split in authority at the federal appellate level on the degree of specificity required to plead
a parallel claim. See, e.g. Ashley A. Williams, Surviving Medical Device Preemption Under 21 U.S.C. 360K: Clarifying Pleading Standards for Parallel Claims in the Wake of Twombly and Iqbal, 9 Seton Hall Circuit Rev. 109, 111 (2013). “While some courts allow for generalized allegations of violations of FDA standards, others demand that plaintiffs point to specific defects in the devices and specific FDA requirements that have been violated.” Id. at 120.
For instance, in Wolicki-Gables v. Arrow Int’l, Inc., 634 F.3d 1296, 1301-1302 (11th Cir. 2011), the court affirmed the dismissal of a complaint that did not “set forth any specific problem, or failure to comply with any FDA regulation that can be linked to the injury alleged.” See also Caplinger v. Medtronic, Inc., 784 F.3d 1335, 1337 (10th Cir. 2015) (affirming dismissal of plaintiff’s complaint because she failed to “identify any legally viable federal requirement that might parallel and thus permit her claims.”). But in Bausch v. Stryker Corp., 630 F.3d 546, 560 (7th Cir. 2010), the court did not require the plaintiffs to “specify the precise defect or specific [F]ederal regulatory requirements that were allegedly violated.” The Bausch court provided three reasons for its decision: first, Fed. R. Civ. P. 9(b) does not have a special requirement that a medical device claim be pled with particularity, like it does for fraud claims; second, a plaintiff may not be able to determine without discovery whether the alleged defect is a design or manufacturing one; and third, with Class III medical devices, the information critical to plaintiff’s claims, including
FDA premarket approval documents, are confidential and not accessible to plaintiffs absent discovery. 630 F.3d at 560. The court also reasoned that if the plaintiff accessed and inspected the medical device outside the discovery process in order to plead with more specificity, it would risk charges of spoliation of evidence. Id. at 561.
In a more recent trend, as the Twombly plausibility standard has continued to gain traction, courts have more explicitly couched their decisions in the framework of that case. For instance, in Irizarry v. Abbott
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