Drug and Medical Device Manufacturers Beware; State-law Parallel Claims Threaten

As failure-to-warn claims, the decades-old staple of medical products liability, are relegated to the trash bin of tort jurisprudence, a new and more potent approach—parallel claims—has emerged. What are parallel claims, where did they come from, why did they emerge, and when will the Supreme Court clear up the issue?

With the advent of mass tort litigation for claims involving Food and Drug Administration (FDA) approved products in the 1980’s, the defensive doctrine of federal preemption emerged in fits and starts and, since the mid 1990’s, has gradually swung the pendulum toward dismissal of claims, relegating claimants to those few venues where jurists, flummoxed by the lack of a remedy, forged a tenuous path forward. Whether Congress has intentionally refused, or simply neglected to provide a private remedy for tort claimants is unclear. What is increasingly clear is that trial courts are finding room in Supreme Court rulings to permit state-law tort claims to proceed. Claimants are also finding a willing advocate in the FDA itself, which has flip-flopped from its prior view favoring preemption to its position that now assists private litigants in pursuing private tort and Lanham Act “labeling” claims under the Food Drug and Cosmetic Act (FDCA).

Parallel Claims: What Are They And Where Did They Come From?

A triumvirate of Supreme Court cases forms the foundation for federal preemption and parallel claims for medical devices under the FDCA (SeeMedtronic, Inc. v. Lohr,518 U.S.470 (1996), Buckman v. Plaintiffs’ Legal Comm.,531 U.S. 341 (2001)and Reigel v. Medtronic, Inc.,552 U.S. 312 (2008)). These opinions gave birth to another trio of Supreme Court cases addressing preemption in the context of approved drugs (See Wyeth v.Levine, 555 U.S. 555 (2009), Pliva v. Mensing, 131 S. Ct. 2567 (2011)andMut. Pharm. Co. v. Bartlett, 133 S. Ct. 2466 (2013)).

In Lohr, the Supreme Court stated 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 purportstoallow tort claims where the plaintiff is “relying on traditional state tort law” but not where 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 state law create a requirement related to safety or effectiveness that is “different from or in addition to the federal requirement.” Reigel, 552 U.S. at 322. While the precise contour of purported “parallel claims” is uncertain, no court allows claims that seek to impose liability despite compliance with the applicable FDCA.

Something Odd in the (5th, 7th and 9th) Circuits: Out of the shadows of these Supreme Court opinions, a trilogy of Circuit Court opinions have arisen that threaten to up-end medical products liability. See Bausch v. Stryker Corp., 630 F.2d 546 (7th Cir. 2010), Hughes v. Boston Scientific,631 F.3d 762 (5th Cir. 2011), and Stengel v. Medtronic, Inc., 704 F.3d 1224 (9th Cir. en banc 2013), cert. denied (U.S. June 23, 2014) (No. 12-1351). In Bausch v. Stryker Corp., the Seventh Circuit noted:

The idea that Congress would have granted civil immunity to medical device manufacturers for their violations of federal law that hurt patients is, to say the least, counter-intuitive. That protection does not apply where the patient can prove that she was hurt by the manufacturer’sviolation of federal law.

Bausch, 630 F.2d at 549. This claim’s permissive sentiment is echoed inHughes v. Boston Scientific Corp., where the Fifth Circuit stated that Riegeland Lohr “make clear” that a manufacturer is not protected from state tort liability when the claim is based on the manufacturer’s violation of applicable federal requirements. Hughes, 631 F.3d at 765. The court inHughes further observed: “[w]e are persuaded that any additional ‘formal’ finding or enforcement action by the FDA is not an ‘implicit precondition’ to suit under the facts of this case.”) Id. at 762.

The Supreme Court and Stengel:With Stengel v. Medtronic, a significant stepchild was poised to join the triumvirate of Supreme Court cases that gave birth to parallel claims. In Stengel, the Ninth Circuit reinstated purported state-law failure-to-warn claims, stating that the “[Medical Device] Amendments do not preempt a state-law claim for violating a state-law duty that parallels a federal-law duty.” Citing Lohr the Court stated:

Given the ambiguities in the statute and the scope of the preclusion that would occur otherwise, we cannot accept [the manufacturer’s] argument that by using the term ‘requirement,’ Congress clearly signaled its intent to deprive the States of any role in protecting consumers from the dangers inherent in many medical devices.

Lohr, 518 U.S. at 489. The government filed an amicus brief in the Supreme Court asserting that all the Circuit Courts are wrong concerning parallel claims yet arguing for denial of certiorari. The government’s newly minted view is:

Section 360k(a) does not preempt respondents’ straightforward claim that petitioner should have brought new safety information to physicians’ attention through a CBE revision to the device’s labeling, because such a claim implicates no preemptive device-specific federal requirement.

On June 23, 2014 the Supreme Court denied certiorari in Stengel leaving intact the Ninth Circuit’s reversal of the District Court decision denying plaintiffs’ motion to assert a parallel state-law failure-to-warn claim. With the denial of cert by the Supreme Court, the case is remanded to the district court to determine whether the plaintiffs should be permitted to further amend their complaint in light of the Ninth Circuit’s opinion.

Further feeding the fire of private claims under the FDCA, private tort claimants have a peculiar bedfellow in three curious Lanham Act cases brought by manufacturers asserting claims that parallel the FDCA. SeeAllergan et al. v Athena, No. 2013-1286, 2013 U.S. App. LEXIS 25746 (Fed. Cir. Dec. 30, 2013); POM v. Coca Cola, 2014 U.S. Lexis 4165 (2014), and GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc., 2:13-CV-00726 –ER (ED PA Mar. 2014).

In a curious juxtaposition, the government’s newly minted support of private litigation under the FDCA allows ample room for state law to meddle, yet the same government retains a possessive hand on its own power to regulate. With the Supreme Court tied in knots over if, why, when and how to reign in the ever expansive Fourth Branch of government (See generallyChevron v. Natural Resources Defense Council, 467 U.S. 837 (1987), Decker v. Northwest Envtl. Def. Ctr., 2013 LEXIS 2373 (2013), Christopher v. SKB2012 U.S. LEXIS 4657 (2012) and Util. Air Regulatory Group v. EPA,2014 U.S. LEXIS 4377 (2014), perhaps the only issue more confounding than preemption is the deference to be given governmental agencies in the first instance.

Manufacturers of FDA regulated products have enjoyed a decade of generally favorable rulings on the issue of federal preemption and deference to the primacy of FDA jurisdiction limiting or dismissing claims, but the political climate, the courts’ emerging approaches and the government are reshaping the litigation landscape. While it is unclear if or when the Supreme Court will rule on the diverging views in the Circuits on state-law parallel claims, it is evident that tort claimants will look to the Ninth Circuit opinion in Stengel as the talisman for their medical products liability claims.