June 25, 2014

Supreme Court Reinforces Need for Robust Adverse Event Reporting Process

On June 23, 2014, the United States Supreme Court denied certiorari in Medtronic, Inc. v. Stengel, leaving in place the Ninth Circuit's en banc decision permitting a failure-to-warn claim against a pre-market approval (PMA) medical device based on an alleged failure to report adverse events to the FDA.

Mr. Stengel alleged that a PMA-approved implantable pain pump manufactured by Medtronic caused him injury. Medtronic moved to dismiss Mr. Stengel's tort claims on the basis of federal preemption. The District of Arizona agreed, and a three-judge panel of the Ninth Circuit affirmed. The Ninth Circuit reheard Mr. Stengel's appeal en banc, and reversed and remanded. Medtronic appealed to the U.S. Supreme Court, which denied certiorari. Stengel represents the latest chapter in the judiciary's ongoing struggle to define the scope of so-called "parallel" claims that can survive federal preemption in cases involving PMA devices. It also reinforces the need for medical device companies to ensure they have robust procedures for adverse event reporting.

Typically, manufacturers of PMA devices enjoy broad preemption of state law product liability claims. In Riegel v. Medtronic, Inc., the Supreme Court held that the Medical Device Amendments to the Federal Food, Drug and Cosmetic Act (FDCA) expressly preempt state law claims that would impose requirements that are "different from, or in addition to" federal requirements established under the FDCA. In an earlier case, Buckman Co. v. Plaintiffs' Legal Comm., the Court held that enforcement of the FDCA is exclusively the province of the federal government, and that there is no private right of action for violation of the FDCA. Thus, state law claims that would impose different or additional requirements than the FDCA and/or that are based solely on the violation of the FDCA itself are preempted.

Since Riegel and Buckman, plaintiffs bringing claims against PMA devices have faced long odds in most jurisdictions. In sum, a plaintiff must plead a "parallel" claim – one premised on a violation of the FDCA and a "parallel" state law that would exist absent the FDCA. Many courts have adopted a narrow interpretation of what constitutes a "parallel" claim, requiring plaintiffs to walk a very narrow factual and legal path if they hope to avoid early dismissal.

In Stengel, the Ninth Circuit considerably widened that path by permitting Mr. Stengel's failure-to-warn claim to proceed based on Medtronic's alleged failure to report adverse events to the FDA in violation of the FDCA. The "parallel" state law claim identified by the Ninth Circuit was a general state law duty to warn. Thus, even though Arizona law does not expressly require manufacturers to report adverse events to the FDA, the Ninth Circuit found that Arizona law does recognize that a manufacturer can breach its general duty to warn by failing to inform a third party (such as the FDA) of newly discovered risks, if there is reasonable assurance that the third party would then provide that information to the person whose safety depended on it (like Mr. Stengel and his physician). By doing so, the Ninth Circuit effectively created a new state law cause of action for failure to report adverse events to the FDA.

Nevertheless, while Stengel may make it easier for plaintiffs to state a claim premised on noncompliance with reporting regulations, they will still have trouble proving those claims. Plaintiffs who survive a motion to dismiss will have the daunting task of presenting evidence that had manufacturers reported adverse events to the FDA, the FDA would have forced some action that would have prevented plaintiffs' injuries.

In the meantime, the Supreme Court's refusal to grant certiorari presents yet another reminder for medical device manufacturers to assess the adequacy of their adverse event reporting. Manufacturers should evaluate their procedures on adverse event reporting to confirm that they correctly and clearly explain the circumstances that require a report to the FDA, and the steps employees must take to fulfill their reporting obligations. Manufacturers should also carefully audit their employees' compliance with existing procedures, and rectify any gaps to limit exposure in product liability litigation.

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