"Make it stop," Liz Fossum remembers thinking.
For about an hour early that November morning two years ago, Fossum's implanted defibrillator repeatedly shocked her heart -- 54 times all told. It felt like a horse was kicking her in the chest.
The 68-year-old grandmother from Golden Valley now knows that part of her heart device, an insulated wire made by Medtronic Inc., had been recalled by federal regulators because a small number had malfunctioned, occasionally causing unnecessary shocks.
Months later, physically worn out and emotionally fragile, Fossum decided to sue the Fridley-based medical technology giant in a product liability case.
But a U.S. Supreme Court ruling last year -- heralded by the Bush administration and the med-tech industry alike -- would have a crushing effect on hundreds of similar lawsuits. The high court restricted legal options for patients who claimed they've been injured by a defective device. If the Food and Drug Administration (FDA) approved the device following a rigorous review, the court said, then a suit by an aggrieved patient could not be filed under state laws.
Several hundred cases filed by patients who claim they were injured by the Sprint Fidelis lead were consolidated in U.S. District Court in St. Paul. Last month, a federal judge dismissed them as a result of the Supreme Court's decision. Cases filed in state court -- including Fossum's by the Minneapolis law firm Zimmerman Reed -- remain in limbo.
It was a stinging rebuke. "I feel like I've been shocked all over again," Fossum said.
The rulings have left hundreds of patients in a legal purgatory -- unable in many cases to get their day in court.
The Supreme Court decision "left consumers without any ability to get compensation for injuries caused by certain defective medical devices," said Rep. Henry Waxman, D- Calif., in a statement to the Star Tribune. "The Supreme Court assumed that FDA approval ensures medical devices are safe, but the many recent stories of patients harmed by faulty devices have proven that assumption false."
Waxman and Rep. Frank Pallone Jr., D-N.J., plan to introduce legislation that would circumvent the Supreme Court ruling and "protect Americans from dangerous medical devices."
Interestingly, one of the cosponsors of the Senate bill introduced last year was then-Illinois senator, now president, Barack Obama.
Recall issued
Part of a $4.2 billion industry, implantable cardioverter defibrillators (ICDs) have a deep connection to Minnesota. Medtronic is the market leader, followed by Boston Scientific Corp., which employs 3,000 in Arden Hills, and St. Jude Medical Inc. in Little Canada.
ICDs are tiny machines implanted in the chest that shock an errantly beating heart back into rhythm. The device typically is connected to the heart with several insulated wires, or leads. Since the first implant in 1980, the blockbuster devices have saved countless lives.
In October 2007, however, Medtronic stopped selling its popular lead, Sprint Fidelis, because it had fractured in a small number of cases, causing unnecessary shocks or, conversely, failing to work when needed. Medtronic attributed five deaths to the problem, and the FDA issued a recall.
Medtronic advised the approximately 268,000 patients implanted with the lead to contact their doctors. The company said that surgery to remove the leads from the body -- an often-difficult procedure because scar tissue forms around the wire -- may be riskier than leaving them in the body.
The recall left many patients weighing the odds: Leave intact a device that has fractured in less than 1 percent of patients, or remove it in a surgical procedure that has a 2 percent to 7 percent failure rate.
Thirty-year-old Katie Meyer of Zimmerman, Minn., decided to have her Sprint Fidelis lead removed after three inappropriate shocks left her prostrate on the floor of her apartment. Her doctor had recommended the procedure. "I had a bad feeling about [the surgery], but she was so scared of being shocked again," said her mother, Michele Meyer.
During the surgery at the Mayo Clinic in April 2008, Meyer's superior vena cava was torn and she went into cardiac arrest. Meyer, who was engaged to be married, spent the remaining eight months of her life hospitalized. She died on Dec. 19.
"I'm furious, disappointed and disgusted," said her mother, when asked about the Supreme Court ruling. "I'm a nurse, I have a lot of faith in medical devices, but this was a waste of an incredible life."
Hundreds of cases
The company is unsure how many Sprint Fidelis leads have been removed, but about 205,000 patients still have them. Although Medtronic, the FDA and an independent physician panel review reports of deaths possibly linked to the Fidelis lead, none agree on a number, said company spokesman Christopher Garland.
Once the recall was announced, it wasn't long before Medtronic was sued by patients alleging negligence, fraud, breach of warranties, and other claims. As of November 2008, about 930 Fidelis-related lawsuits had been filed against Medtronic, representing about 1,450 individual personal-injury cases.
In January, U.S. District Judge Richard Kyle granted Medtronic's motion to dismiss cases that had been consolidated in federal court. In a December securities filing, the company counted 255 Fidelis cases that remain in state courts, most of them in Minnesota. Since then, another 30 cases have trickled in. The future of those cases is unclear.
The company won't quantify how much it has spent on legal fees to defend itself against the Fidelis claims. But settlements in similar cases have been quite large. An earlier recall involving another Medtronic defibrillator led to a 2007 settlement of about 2,700 cases for $114 million. Of that amount, the plaintiffs' lawyers got $18.5 million.
"It's a concern to us because dollars spent on litigation are dollars that are diverted from research and innovation," said Christopher White, chief counsel of the med-tech industry group, AdvaMed. Sick patients demand the very latest in medical technology to treat their condition, but developing those products is extremely expensive.
Consumer and legal advocates claim that the prospect of costly litigation keeps device companies in check and pressures them to make the safest products possible.
That point is not lost on Mike Van Ort, a 54-year-old channel analyst for 3M whose Fidelis lead failed in October 2007, causing him to be shocked 17 times in a 10-minute period. Van Ort said the force of the shocks threw him across the family room of his Oakdale home.
"It's like being hit by a car," he says.
When he returned home from the hospital, Van Ort was so fearful he would be shocked again he was despondent, and couldn't stop crying. He felt paranoid and hid in the bedroom. "My sense of trust in the world was shattered," he says.
Ultimately, Van Ort landed in the mental health unit at Regions Hospital for a week. Counseling has helped him piece together much of his former life as a husband and father of three. But the best tonic, he says, was removal of his device.
Van Ort sued Medtronic, hoping the lawsuit filed by the Minneapolis firm Lockridge Grindal Nauen would result in more awareness about ICDs. People should know the device's failure rate, as well as the seriousness of a shock, he says.
When the Supreme Court ruled, Van Ort says he was "devastated."
Who regulates?
The core issue in the Sprint Fidelis case is how medical devices are regulated in the first place.
"Who do you want regulating medical devices?" said Mark Herrmann, a partner at the law firm Jones Day in Chicago. "The neutral experts at the FDA or a jury of 12 lay-people sitting in the presence of an injured plaintiff?"
The FDA's scientists and physicians are in a better position to craft medical device policy than a patchwork of laws throughout the United States, he said.
The Supreme Court ruling covers Class III medical devices, such as ICDs, which are subject to the greatest level of scrutiny by the FDA before they are approved. Typically, the manufacturer must prove the device is safe and effective through a series of clinical trials.
But plaintiffs' lawyers claim that the Sprint Fidelis lead was not subjected to the same level of clinical scrutiny as other Class III devices because its application piggybacked an earlier Medtronic lead approved by the agency. Furthermore, they say, FDA oversight of medical devices has been lax in recent years, attracting the attention of Congress and the Government Accountability Office.
Janet Moore • 612-673-7752
