Ruling shields med-tech firms

Legal options for patients injured by defective medical devices were substantially limited Wednesday, when the U.S. Supreme Court sided with devicemaker Medtronic Inc., ruling that, if federal regulators approved a device, a suit could not be filed under state laws.

Heralded by Fridley-based Medtronic and closely watched by its rivals, the business-friendly ruling will have a broad impact on Minnesota's medical device industry, which spends millions every year defending hundreds of product liability claims.

But lawyers defending patients in these high-profile cases said the mere threat of litigation has been an incentive for devicemakers to produce the safest products possible. If a patient is harmed by a device, the lawyers said, they should have the right to sue the company that made it. The court's ruling virtually precludes that possibility.

The court voted 8-1 to bar a lawsuit filed by New Yorker Charles Riegel, who was injured after a Medtronic-made catheter burst during an angioplasty procedure in 1996.

Riegel required emergency bypass surgery.

He sued Medtronic, alleging design and manufacturing defects in the catheter (which is no longer made by the company), as well as inadequate labeling on the device's packaging. Riegel died in 2004, but his widow, Donna, continued the lawsuit on his behalf.

Allison Zieve, the Public Citizen lawyer who argued the case before the Supreme Court on behalf of the Riegels, said the ruling is "particularly scary after hearing recent reports that say the FDA [U.S. Food and Drug Administration] isn't up to the job of protecting the public from dangerous drugs and medical devices. We know that people will be injured as a result, and some of them will have no remedy."

"If a patient thinks that the device inside of them was designed in the wrong way, or if the label didn't tell them of all the risks or potential problems, they are pretty much left without a remedy."

The Riegel case probed whether manufacturers of sophisticated medical devices approved for sale by the FDA can be sued under consumer-friendly state laws, or whether they are preempted from such lawsuits.

Scalia calls FDA 'rigorous'

Writing for the court, Justice Antonin Scalia called the FDA's current "premarket" method for approving sophisticated devices "rigorous." The agency spends an average of 1,200 hours reviewing each company's application, which includes studies testing devices on real-world subjects to prove they are safe and effective.

But recent recalls of faulty heart defibrillators and pacemakers made by Medtronic and Boston Scientific Corp. have raised questions about whether the FDA is adequately staffed and funded to monitor medical devices, especially after they are implanted in patients. Those recalls led to separate settlements with aggrieved patients of more than $300 million.

Medtronic has long argued that the money spent on expensive legal settlements would be better spent on developing new technologies. "This is a very important decision which ensures that patients continue to have access to innovative, lifesaving medical devices," company President and CEO Bill Hawkins said.

Medtronic, the world's largest med-tech company with $12.3 billion in annual sales, hauled out some hefty legal firepower in arguments before the high court in December. Former Bush administration Solicitor General Theodore Olson called for a balance between the risk and benefits in new medical devices.

The lone dissenter in Wednesday's ruling was Justice Ruth Bader Ginsburg, who wrote, "It is difficult to believe that Congress would, without comment, remove all means of judicial recourse for large numbers of consumers injured by defective medical devices."

Possible loopholes

But some legal loopholes may still exist for patients harmed by medical devices.