Jessica M. Karmasek Jun. 14, 2013, 5:30pm

WASHINGTON (Legal Newsline) -- A group of defense lawyers, in an amicus brief filed in the U.S. Supreme Court earlier this week, argued that the court should take up a case over the Medical Device Amendments to the federal Food, Drug and Cosmetic Act.

DRI -- The Voice of the Defense Bar filed its 21-page amicus brief in Medtronic v. Stengel Monday. The group, which represents more than 20,000 defense lawyers, contends the court should grant Medtronic's petition for certiorari, or review.

The group argues that a prior ruling by the U.S. Court of Appeals for the Ninth Circuit is "at best highly questionable" and presents a "clear divergence" from other circuit decisions.

The core issue in the case is the preemptive effect of the federal MDA to the FDCA.

Medtronic's pain pump is a medical device that infuses prescription medication through a catheter to relieve severe spinal pain.

Plaintiff Richard Stengel, who had a pump manufactured by Medtronic surgically implanted in 2000, brought several causes of action in an Arizona state court against the company for injuries allegedly sustained from his use of the pump.

After Medtronic timely removed the case to the U.S. District Court for the District of Arizona, it moved to dismiss on the ground that all of the plaintiff's claims were barred as a matter of law by the express preemption provision of the MDA.

The district court granted Medtronic's motion to dismiss and denied Stengel's motions.

Subsequently, a three-judge panel of the Ninth Circuit affirmed. The panel held that the plaintiff's claims were expressly preempted, with the failure-to-warn claim being the one possible exception.

The panel also recognized that to the extent that the plaintiff's failure-to-warn claim sought to enforce federal regulations governing the reporting of product complaints to the FDA, that claim was barred under a straightforward application of Buckman Co. v. Plaintiffs' Legal Comm. Buckman prohibits private plaintiffs from usurping the FDA's exclusive authority to enforce its own regulatory scheme.

The panel's majority concluded that most state law claims involving medical devices were preempted unless they asserted that the state requirements were identical to federal requirements governing medical devices.

Because Stengel alleged additional requirements, the majority determined that his claims were preempted.

At the same time, the panel majority acknowledged that "there is a division among the circuits whether state failure-to-warn claims are preempted by Buckman."

The Ninth Circuit granted rehearing en banc and, on Jan. 10, reversed.

The court held that Medtronic had a "continuing duty to monitor the product and to discover and report to the FDA any complaints about the product's performance and any adverse health consequences of which it became aware and that are or may be attributable to the product."

This, the court said, was parallel to an Arizona state law negligence-based duty to warn patients, or their physicians.

In its brief Monday, DRI raised concerns about undermining Congressional intent in enacting the MDA, and watering down the court's controlling precedent regarding the preemptive reach of the MDA.

The group argued that medical device manufacturers need a national set of standards to follow, rather than forcing them to navigate 50 state legislatures with 50 different court systems.

"This case presents an excellent vehicle to clarify the extent to which federal regulatory law -- not state tort law -- controls whether and how a manufacturer must comply with federal law," DRI members Eric Magnuson and Scott Flaherty wrote.

"Certiorari should be granted in order to conclusively answer whether a state law claim founded on an alleged reporting violation to the FDA -- no matter how it is framed -- is expressly preempted, or fits within the scope of implied preemption."

Read DRI's complete amicus brief here.

From Legal Newsline: Reach Jessica Karmasek by email at

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