The contours of the parallel claim exception: the supreme court's opportunity to define the ill-defined.

• Author: Sena, Jarett
• Position: Continuation of II. Diverging Doctrine in the Wake of Riegel B. General or Device-Specific Requirement through Conclusion, with footnotes, p. 320-354

1. Scope of Implied Preemption

   Not only do lower courts disagree about the scope of express preemption, but they also disagree about the scope of implied preemption. The Supreme Court in Buckman drew a distinction between the case at bar, where plaintiffs claims were impliedly preempted, and Lohp where the plaintiffs claims were not. (242) In Lohr, the plaintiffs' claims survived preemption because they were based on traditional state law theories of negligence. (243) By contrast, in Buckman, the plaintiffs' "fraud claims exist[ed] solely by virtue of the FDCA disclosure requirements." (244) It is clear from Buckman that not all claims avoid implied preemption. (245) What is less clear after Buckman is exactly which claims, other than fraud-on-the-FDA claims, if any, are impliedly preempted. The Sixth and Eighth Circuits have adopted an expansive view of Buckman to impliedly preempt traditional state law tort claims premised on FDA violations. By contrast, the Fifth, Seventh, and Ninth Circuits have limited Buckman's scope to fraud-on-the-FDA claims, thereby allowing traditional state law tort claims premised on FDA violations to avoid implied preemption.

   In Sprint Fidelis, the Eighth Circuit held that the plaintiffs failure-to-warn claim, alleging that Medtronic did not accurately and timely submit adverse event reports in violation of the MDR, was impliedly preempted. (246) The Court construed Buckman to require that "plaintiff must not be suing because the conduct violates the FDCA." (247) The Court found that the claim that Medtronic did not provide the FDA with sufficient information is "simply an attempt by private parties to enforce the MDA claims foreclosed by [section] 337(a) as construed in Buckman." (248)

   The Sixth Circuit reached a similar conclusion in Cupek v. Medtronic, Inc., when it impliedly preempted plaintiff's negligence per se claim. (249) In a negligence per se claim, the plaintiff relies on a violation of a statute or regulation to establish duty and breach in negligence. (250) In Cupek, a pre-Riegel case, plaintiffs alleged a negligence per se claim against Medtronic's pacemaker leads based on Medtronic's failure to comply with the FDA's conditions of approval. (251) The Sixth Circuit held that plaintiff's claim was a "disguised fraud on the FDA claim" and therefore was impliedly preempted. (252)

   Like the Sixth and Eighth Circuits, various district courts have expanded Buckman beyond fraud-on-the FDA to impliedly preempt traditional state law tort claims. In Lewkut v. Stryker Corp., the Southern District of Texas applied Buckman expansively to preempt Lewkut's manufacturing defect claims. (253) Lewkut alleged that Stryker's hip implant system was adulterated in violation of 21 U.S.C. [section] 351(h) of the FDCA. (254) To the extent that Lewkut alleged a parallel claim, the district court held that claim to be impliedly preempted because 21 U.S.C. [section] 337 "explicitly precludes private enforcement of federal laws regarding 'adulterated' devices." (255)

   Similarly, in Wheeler v. DePuy Spine, Inc., the Southern District of Florida held that plaintiff's negligence claim premised on violations of the FDCA was impliedly preempted. (256) In Wheeler; the plaintiff suffered severe leg and back pain allegedly due to two implanted artificial discs. (257) Plaintiff argued that DePuy violated the MDR by not accurately disclosing the number and extent of disc complications to the FDA. (258) The court held that "[although Plaintiff states that he is not bringing a fraud-on-the-FDA claim, the claim described by Plaintiff appears to be such a claim, and as such it should be addressed to the FDA." (259) As in Sprint Fidelis and Cupek, although the plaintiffs in Lewkut and Wheeler asserted traditional state law causes of action, both courts saw these claims as disguised fraud-on-the-FDA claims.

   As in Wheeler and DePuy, in McClelland v. Medtronic, Inc. the district court for the Middle District of Florida impliedly preempted the plaintiffs traditional state law tort claim. (260) In McClelland.' Breanne McCelland allegedly died from a defect in Medtronic's EnPulse Model E1DR21 pacemaker. (261) The plaintiff, decedent's mother, alleged that prior to decedent's death, Medtronic became aware that some of its pacemakers, including the E1DR21, were defective. Specifically, Medtronic knew that the E1DR21 was likely to "cause intense cardiac symptoms and failfure] to properly regulate cardiac rhythm." (262) The plaintiff brought negligence per se and failure-to-warn claims premised on Medtronic's failure to accurately and timely report E1DR21 incidents in violation of the FDCA. The district court stated:

   [T]he [MDA] provides that all actions to enforce the FDA requirements "shall be by and in the name of the United States[.]" ... In Buckman, the United States Supreme Court construed [section] 337(a) as impliedly preempting suits by private litigants "for noncompliance with the medical device provisions." In other words, claims based upon FDCA disclosure requirements, rather than traditional state tort law are impliedly preempted. (263) The McClelland court seemed to interpret Buckman very liberally to impliedly preempt all common law claims that are based on FDCA disclosure requirements. (264) Accordingly, both McClelland's negligence per se and failure-to-warn claims were impliedly preempted.

   The Middle District of Florida explained that McClelland's failure-to-warn claim was impliedly preempted because it was not based on common law, but rather based on Defendant's duty to warn pursuant to the FDCA and FDA regulations. (265) The court did note that the plaintiff could have avoided implied preemption if she alleged that Medtronic breached a duty to the decedent instead of to the FDA. (266) However, such an allegation would nonetheless be fatal because it would support express preemption. (267) According to the court, a failure-to-warn claim premised on a manufacturer's duty to warn the patient or the patient's physician would be expressly preempted because such a duty is not "genuinely equivalent" to any FDA requirement. (268) FDA regulations do not require manufacturers to warn individual doctors about the safety and effectiveness of a device. (269) Thus, plaintiff's claim "would hold [the defendant] liable under state law without having violated an equivalent federal law" and therefore would be expressly preempted, even if not impliedly preempted. (270)

   Another context in which district courts have expanded Buckman involves claims based on an off-label promotion theory. In Riley v. Cordis Corp., the District Court of Minnesota concluded that plaintiff's failure-to-warn claim was impliedly preempted to the extent that it was based on an off-label promotion theory. (271) In Riley, Cordis manufactured a Cypher stent, a drug-coated stent that is implanted in a coronary artery to open up the artery and improve blood flow. (272) The plaintiff suffered a blood clot when the Cypher stent was implanted through direct stenting. (273) Direct stenting occurs when the stent is implanted in an artery that has not previously been predilated with a balloon catheter. (274) Since the FDA did not approve direct stenting of the Cypher stent, it constituted an off-label use. (275) Plaintiff alleged that Cordis promoted the off-label use in a manner that was not authorized by the FDCA. (276) The court held the claim to be "impliedly preempted" under Buckman, because "promoting the off-label use of an FDA-approved medical device is not unlawful under 'traditional state tort law which had predated the federal enactments in question[]." (277)

   However, the Riley court did recognize that the plaintiff could have avoided implied preemption if Cordis (1) promoted the off-label use in a manner unauthorized by the FDCA, and (2) failed to include adequate warnings about the off-label use it was promoting. (278) The first allegation would protect the claim from express preemption since it is premised on a violation of the FDCA. (279) The second allegation would protect the claim from implied preemption because a duty to warn physicians or patients when an injury is reasonably foreseeable rests on traditional state law. (280)

   Although the court granted leave to amend, it would be quite difficult for the plaintiff in Riley to prevail on this narrow theory. (281) The plaintiffs claim would be expressly preempted if it solely alleged that manufacturer's off-label promotion triggered a duty to warn about the off-label use. As the court explained, under the FDCA a "manufacturer could disseminate information about an off-label use of a device without triggering the duty to provide instructions or warnings about that off-label use." (282) Therefore, the only way for plaintiff to prevail on this theory would be if the manufacturer changed the label while promoting off-label use. (283) However, since there are strict limitations on a manufacturer's ability to change its label post-approval, it likely will be difficult for plaintiff to amend the complaint and survive preemption. (284)

   In Caplinger v. Medtronic, Inc., the court also held plaintiff's off-label promotion theory to be impliedly preempted. (285) In Caplinger; the plaintiff suffered an injury after Medtronic's Infuse device was used for posterior-approach lumbar spine fusion surgery to correct a degenerative disc condition. (286) The use of Infuse during posterior fusion surgery was off-label because the FDA approved Infuse for anterior but not posterior surgery. The plaintiff brought a fraudulent misrepresentation claim and a negligence claim based on the theory that Medtronic promoted the off-label use of Infuse in posterior fusion surgery while downplaying its risks. (287) The court held that both of these claims were impliedly preempted because promotion of off-label use is governed by the FDCA. (288) The court concluded that '"off-label use' is a creature of the FDCA"...