Parallel Claims, The First Amendment And FDA's Permissive View Of Private Enforcement

The tracks of "parallel claims" are often federal claims treated as parallel state law claims when viewed by a court through a lens focused on providing a remedy. With the circuit courts divided on how to define "parallel claims," the government has been flip-flopping from its previous view favoring preemption to a permissive view favoring private enforcement of the Food Drug and Cosmetic Act (FDCA). The Supreme Court has had a number of opportunities to add clarity to the confusion, but neglected to do so most notably in Stengel v. Medtronic, 2013 U.S. App. Lexis 621 (9th Cir. Jan. 10, 2013), cert. denied (U.S. June 23, 2014). The Court invited the government to weigh in on the issue in Stengel and the government's position supported the purported parallel claim while recognizing the disarray in the lower courts applying the parallel claim doctrine. The government's permissive view of private claims under the FDCA has been advanced more recently in two cases, Allergan et al. v. Athena, 738 F.3d 1350 (Fed. Cir. 2013), cert. denied (No. 13-1286) (June 29, 2015) and Amarin v. FDA, 1:15-cv-03588-PAE, Doc. 73 (S.D.N.Y. Aug. 7, 2015). In these two cases there has been a further shifting of a tectonic plate and the bedrock upon which preemption rests has undergone a seismic shift that has yet to be fully realized. In Allergan v Athena the issue was whether the FDA is the sole arbiter of deciding whether conduct and statements render a product a new drug. Both of these cases were brought by manufacturers and the holdings in both are double edged swords. In Amarin v FDA, the government suffered a devastating blow to the untenable position it has taken concerning the landmark First Amendment ruling in U.S. v. Caronia, 703 F.3d 149 (2d Cir. 2012), upholding the First Amendment prohibition of the power to regulate truthful speech concerning approved products.

Before defense counsel and manufacturers applaud too loudly, we might consider that the sword that cut the FDA's power to criminalize truthful speech in both Caronia and Amarin has two sides and the second side may cut deeper and create a duty to speak. The sharper edge of the sword may well be to undercut reliance on the FDA as the sole arbiter of claims arising under the FDCA. Indeed, reliance on the FDA's primary jurisdiction and discretion to control manufacturer's communications has been the bulwark of preemption defense for failure to warn claims. Where the FDA's power is limited, so too is the preemption defense.

The Birth of Parallel Claims—A Brief History

Three Supreme Court cases form the foundation for federal preemption and parallel claims for medical devices under the FDCA. See Medtronic Inc. v. Lohr, 518 U.S. 470 (1996); Buckman v. Plaintiffs' Legal Comm., 531 U.S. 341 (2001); Riegel v. Medtronic, Inc., 552 U.S. 312 (2008). Another trio of Supreme Court cases addresses preemption in the context of approved drugs. See Wyeth v. Levine, 555 U.S. 555 (2009); Pliva Inc. v. Mensing, 131 S. Ct. 2567 (2011); Mut. Pharm. Co. v. Bartlett, 133 S. Ct. 2466 (2013).

In Lohr, the Supreme Court held that the FDCA does not preempt "a traditional damages remedy for violations of common-law duties when those duties parallel federal requirements." Lohr, 518 U.S. at 495. Buckman purports to refine the issue, allowing tort claims when plaintiffs are "relying on traditional state tort law" but not when the FDCA "is a critical element in their case." Buckman, 531 U.S. at 353. In Riegel, the Court established a two-prong test for determining if a state-law tort claim could proceed: (1) has the FDA established applicable "requirements"? and (2) does the state law at issue create a requirement related to safety or effectiveness that is "different from or in addition to the federal requirement?" Riegel, 552 U.S. at 322. Despite these Court rulings, the precise contours defining "parallel claims" remain uncertain.

In the confusion that has followed, courts have reached various conclusions, and the government has morphed from being possessive of claims under the FDCA to being permissive of state claims under the FDCA. Further muddling the parallel claim landscape are three circuit court opinions that permitted state law tort claims for conduct under the FDCA. See Bausch v. Stryker Corp., 630 F.3d 546 (7th Cir. 2010), cert. denied, 132 S. Ct. 498 (2011); Hughes v. Boston Scientific, 631 F.3d 762 (5th Cir. 2011); Stengel v. Medtronic, Inc., 704 F.3d 1224 (9th Cir. 2013) (en banc).

In Bausch v. Stryker Corp., the Seventh Circuit focused on the violation of federal law as supporting the state law claim and reversed the trial court dismissal on preemption grounds. 630 F.3d at 546. The court was befuddled that Congress would leave a plaintiff without a remedy. Accusing the defendant of attempting to stretch the bounds of preemption, the court tore the fabric of preemption, concluding that preemption "protection does not apply where the patient can prove that she was hurt by the manufacturer's violation of federal law." Id. at 549-50. Accordingly, the Seventh Circuit held that "the [Supreme] Court's opinions in Lohr and Riegel expressly left the door open for state law claims based on violations of federal law." Id. at 550. In reaching this decision, the court relied on the following explanation of the distinction provided by the Supreme Court in Lohr based on "the right to provide a traditional damages remedy for violations of common-law duties when those duties parallel federal requirements." The Court observed that a state law claim does not trample preemption considerations because "[t]he presence of a damages remedy does not amount to the additional or different 'requirement' that is necessary under the statute; rather, it merely provides another reason for manufacturers to comply with identical existing 'requirements' under federal law." Lohr, 518 U.S. at 495 (reversing dismissal of complaint). Thus, determining whether the plaintiff is enforcing the FDCA or pursuing a state law claim premised on a violation of the FDCA is a distinction with a difference.

The court in Bausch also discussed Riegel at length, remarking that section 360k preempted the state requirements implicit in the Riegel case's common law claims that were different from or in addition to the federal requirements. Bausch, 630 F.3d at 552. The court observed that "§360k does not prevent a State from providing a damages remedy for claims premised on a violation of FDA regulations; the state duties in such a case 'parallel,' rather than add to, federal requirements." Id.

Bausch is not without its critics. For example, the district court in Hafer v. Medtronic, Inc., No. 2:13-cv-02340, slip op. (W.D. Tenn. Apr. 13, 2015), expressly rejected Bausch, taking issue with the idea that a violation of federal law removes preemption concerns. Id. at fn. 6.

In Hughes v. Boston Scientific Corp., 631 F.3d 762 (5th Cir. 2011), the court held that the plaintiff's state-law failure-to-warn claim was not preempted "to the extent that this claim is predicated on Boston Scientific's failure to comply with the applicable federal statutes and regulations." Id. at 764. The Fifth Circuit stated that Riegel and Lohr "make clear" that a manufacturer is not protected from state tort liability when the claim is based on the manufacturer's violation of federal requirements. Id. at 767.

The Fifth Circuit found that state law product liability claims that purport to impose liability despite compliance with the FDA design and manufacturing specifications, as approved by the FDA during the premarket approval (PMA) process, seek to impose different or additional state duties and the federal law expressly preempts them. Id. at 769. However, the court reached a different conclusion about the state law claims based on a failure to comply with federal regulations. Id. The court reasoned that "§360k does not prevent a State from providing a damages remedy for claims premised on violation of FDA regulations." Id. at 769. According to the court, the state duties that "parallel" the federal requirements were "accurately report[ing] serious injuries and malfunctions of the [Hysteroscopic Thermal Ablation] device as required by the FDA's [Medical Device Reporting] regulations." Hughes, 631 F.3d at 770.

In Bass v. Stryker, 669 F.3d 501 (5th Cir. 2012), the court further defined the necessity of pleading a violation of federal law to avoid preemption. In that case, the plaintiff claimed that a hip replacement product malfunctioned and caused injury, alleging a variety of state law claims. The court explained that the FDA need not have found a violation but that "the cause of action survived where the plaintiff provided expert testimony showing that the medical device manufacturer had "violated the plain text of the [Medical Device Reporting] regulations." Id. at 509-10 (citations omitted).

The court in Bass went on to state that if "a plaintiff pleads that a manufacturer of a Class III medical device failed to comply with either the specific processes and procedures that were approved by the FDA or the...