On May 10, 1996, a New Yorker named Charles Riegel was wheeled into an operating room with a badly blocked right coronary artery.
The doctor tried snaking a catheter through an artery to the blockage, where a balloon would be inflated to break up the hardened plaque, a common procedure called angioplasty. Several catheters didn't work. Then the balloon on the final catheter -- made by Medtronic Inc. -- burst. Riegel lost consciousness and required emergency bypass surgery.
Riegel survived and sued the Fridley-based medical technology giant in New York state, alleging design and manufacturing defects and inadequate labeling with the device.
This Tuesday, his case will be heard by the U.S. Supreme Court in a proceeding that will be closely watched in Minnesota, home to hundreds of medical technology companies.
Although Riegel died in 2004, his widow, Donna, has carried on with the 11-year-old case, which began as a relatively simple product liability claim. Now, the case raises the issue of whether medical device companies selling sophisticated products approved by federal regulators can be sued under state laws by patients who have been injured by those devices. Millions of dollars in legal costs are at stake.
The case has wide-ranging implications for patients, doctors and device makers in Minnesota medical technology companies that include St. Jude Medical Inc. and major operations of Boston Scientific Corp., not to mention Medtronic, the world's largest med-tech company with $12.3 billion in annual sales.
In an amicus brief filed in the Riegel case, AdvaMed, a medical technology industry organization, argued that the Food and Drug Administration (FDA) should be the sole regulator of medical devices -- no other legislative or regulatory entity is better positioned to ensure the timely access to safe and effective medical devices.
"I think you should put this in the hands of an expert federal agency, which sets up one set of standards that applies nationally,'' said Mark Herrmann, a partner at the law firm Jones Day, who has followed the Riegel case closely. "Having a jury of 12 people, with an average of a high school education and in the presence of an injured person in the courtroom, decide whether or not the medical device company did things that were right or wrong is a bad situation for society,'' he said.
But Allison Zieve, an attorney with the watchdog group Public Citizen who is presenting the Riegel case, argues that patients who have been harmed by device should have the right to sue the company that made the product. Otherwise, she says, there is no other way for the patient to be compensated for an injury that wasn't his fault.
Medtronic asserts that because the FDA has a rigorous approval process for medical devices, which often involves tests on human patients, federal law "preempts" it from state claims relating to a device's safety and effectiveness. Lower courts have agreed.
Medtronic also says that Riegel's doctor did not use the angioplasty balloon properly or follow instructions on its label.
Each year, the company spends millions to defend itself from dozens of such suits -- money it claims could be used to develop new medical devices.
But Zieve, of Public Citizen, rejects that claim. "A medical device company can either develop and market products or it can go out of business. Medtronic is sued all the time and yet it continues to develop and market new devices. It's a cost of doing business.''
Medtronic has hauled out some hefty legal firepower to present its case. Former U.S. Solicitor General Theodore Olson will argue on behalf of Medtronic for 20 of the company's allotted 30 minutes. Olson has argued numerous cases before the high court on issues ranging from federal securities regulation to immigration. He successfully represented now-President George W. Bush in cases against then-Vice President Al Gore involving the 2000 presidential election.
The remaining 10 minutes of Medtronic's allotted time will be devoted to a representative from the current U.S. solicitor general's office, which filed an amicus brief on behalf of the FDA in favor of preempting companies from state claims.
"Subjecting a manufacturer to liability for not departing from an FDA-approved design or label would interfere with FDA's ability to protect public health by balancing the risks and benefits of a particular design or label,'' the brief states.
But Zieve says the scrutiny involved with the FDA approval process "can only do so much, especially with medical devices where you ethically can't have large clinical trials.'' Unlike studies involving a drug, where patients can stop taking a pill, medical devices are often implanted in the body and difficult, if not impossible, to remove.
"In many cases the hazard of a device comes to light only after it comes to market,'' Zieve added. "A lot of information about bad devices has come to light through litigation, as opposed to through regulatory process. Often litigation proceeds before the FDA or the manufacturer take any action'' with a faulty device.
The mere threat of litigation pressures manufacturers to make the safest devices possible, she said. Removing that influence "would be to put a lot more pressure on the regulatory scheme than it was ever intended to bear.''
Janet Moore • 612-673-7752