Ruling for Medtronic limits device suits

Patients injured by approved devices will not be able to sue manufacturers under state law.

Courtney Sinner

A recent U.S. Supreme Court decision has drastically reduced the number of options available to patients injured by defective medical devices.

On Wednesday, the court ruled in favor of Fridley-based medical technology company Medtronic. The company often participates in research grants and medical school support for the University.

In an 8-1 decision, the court ruled that if federal regulators approved a device, patients injured by that device will not be able to sue medical manufacturers under state law.

The lawsuit was brought against Medtronic by New York resident Charles Riegel following the rupture of a Medtronic catheter in his coronary artery during heart surgery. He suffered severe injuries as a result.

After the 1996 incident, Riegel and his wife, Donna Riegel, sued the company, saying the device was designed, labeled and manufactured in violation of New York state law. Riegel died in 2004, but his wife continued the lawsuit.

The court’s ruling was based on the Medical Device Amendments of 1976, which bars states from imposing requirements “different from, or in addition to” federal requirements.

The Food and Drug Administration had approved Medtronic’s Evergreen Balloon Catheter at the time of the incident, but the company no longer makes that product.

Although the FDA must approve all medical devices before they can be marketed and sold, some states also had their own regulation schemes that companies had to comply with.

Justice Antonin Scalia wrote in the majority opinion that states may not be able to regulate these devices as well as the FDA, which spends 1,200 hours reviewing each application.

He wrote that the “rigorous” process may result in the “approval of devices that present great risks if they nonetheless offer great benefits in light of available alternatives.”

Allizon Zieve, an attorney who represented Donna Riegel, argued that all medical devices should be as safe as possible.

A statement on Medtronic’s Web site praised the ruling, saying the FDA’s pre-market approval process for medical devices is appropriate and effectively balances risks and benefits.

Justice Ruth Bader Ginsburg was the only dissenter in the case. She said the Medical Device Amendments were not originally intended to curtail lawsuits for injuries caused by defective designs.

Ginsburg wrote that the court’s decision “is at odds with the MDA’s central purpose: To protect consumer safety.”

Jonathan Kahn, an associate professor at Hamline University’s School of Law, said this kind of federal standardization is “quite a common practice.”

He said that for companies like Medtronic that operate in national markets, it can be very burdensome to comply with many different state regulations.

University law professor Michele Goodwin said although the matter is now in Congress’ hands, representatives probably wouldn’t make a change in the amendment for the next couple of years.

Goodwin said patients still have the option to sue in federal court, but it might be more difficult.

“So, it’s not as if there isn’t any recourse whatsoever,” she said. “It may simply be a less- accessible avenue for plaintiffs.”

Kahn said the decision “appears to give (Medtronic) immunity from products liability lawsuits.”

He said patients could still sue if the defect was a manufacturing problem, rather than a design problem.

“But if it was manufactured in accordance with the specifications that were approved by the FDA, then you pretty much probably can’t be sued; you probably have effective immunity,” Kahn said.