By Ronald V. Baker
Andrews Publications Staff Writer

The U.S. Supreme Court has agreed to consider a New York man's claim that a federal trial judge and appellate court misapplied its landmark federal preemption ruling on medical device cases in dismissing his design-defect suit over a failed Medtronic catheter.

The U.S. Justice Department had submitted a brief in support of Medtronic, urging the high court to reject the case.

The agency said the two court rulings supporting plaintiff Charles Riegel's review petition were issued soon after the Supreme Court's landmark decision in Medtronic v. Lohr, 518 U.S. 470 (1996), and have been supplanted by a host of contradictory federal appellate court opinions.

The complex Lohr ruling involved the express preemption provision in the Medical Device Amendments to the Food, Drug and Cosmetic Act[JMc1].

In Lohr the Supreme Court held that the MDA preempt state statutory or common-law requirements, including state law tort claims, that are "different from or in addition to" device-specific federal requirements governing the safety or effectiveness of a medical device.

However, the Lohr court majority ruled that the MDA did not preempt some of the plaintiff's defective-design claims because the pacemaker in that case was only approved under the Food and Drug Administration's "equivalency" process. Therefore, the agency had not imposed device-specific safety and efficiency requirements.

In Riegel's case the Supreme Court will focus on whether the MDA's express preemption provision bars state law claims for damages caused by medical devices certified as safe and effective through the FDA's "pre-market approval" process.

Riegel says PMA certification relates only to device design and performance generalities and does not bar suits over defects in specific devices.

He filed his lawsuit against Medtronic after an Evergreen balloon catheter burst inside him during a 1996 angioplasty. He then needed emergency heart surgery.

The complaint alleged labeling and manufacturing defects, negligence, strict liability, and breach of express and implied warranties.

The U.S. District Court for the Northern District of New York granted summary judgment for Medtronic based on federal preemption.

The U.S. Court of Appeals for the 2nd Circuit affirmed the decision in May 2006.

Riegel petitioned for Supreme Court review three months later[JMc2].

He has maintained that his position on federal preemption is supported by the 11th Circuit's decision in Goodlin v. Medtronic Inc., 167 F.3d 1367 (11th Cir. 1999), and the Illinois Supreme Court's ruling in Weiland v. Telectronics Pacing Systems, 721 N.E.2d 1149 (Ill. 1999).

Medtronic said the PMA-based certification of medical products constitutes a "device-specific" regulation that any state law design-defect claim would thwart by imposing standards that are different from or in addition to those that are federally mandated.

"The 2nd Circuit correctly held that FDA approval of a medical device through the PMA process can create federal requirements applicable to the device that would preempt conflicting state requirements," Medtronic told the Supreme Court in a brief opposing review.

"Although the court in Lohr did not directly reach that question, both the majority and dissenting opinions are fully consistent with a finding that the PMA process can impose preemptive federal requirements," the company said.

Arguing against review of Riegel's case, Medtronic said the Evergreen catheter's approval through the PMA process involved the FDA's review of an "immense amount of scientific data," resulting in the agency's determination that the device, as designed, is "both safe and effective."

In its amicus brief supporting Medtronic the Justice Department told the Supreme Court that given the pro-preemption rulings by the 3rd, 5th, 6th, 7th and 8th Circuits since Goodlin and Weiland, the 11th Circuit and Illinois Supreme Court may instead wish to "reconsider their earlier approach should this issue arise in future cases litigated within those jurisdictions."

Riegel's merits brief is due by Aug. 27.

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Riegel et al. v. Medtronic Inc., No. 06-179, cert. granted (U.S. June 25, 2007).