From a strictly legal sense, Medtronic Inc. (NYSE:MDT) has closed the book on its Sprint Fidelis debacle.
The company based in Fridley, Minnesota, won a landmark victory in the U.S. Supreme Court that effectively shields medical device makers from liability of Food and Drug Administration-approved devices.
And in October, Medtronic said it would pay $268 million to settle all lawsuits relating to its Sprint Fidelis leads, which were part of the company’s implanted heart defibrillators.
But I think it’s important to remember that Sprint Fidelis is very much alive and potentially not kicking. About 260,000 Sprint Fidelis leads have been implanted in patients in the United States, with 143,000 still active.
Earlier this year, UBS Investment Research released a report that said lead failures could accelerate over time, citing independent studies that predicted failure rates could hit 30 percent by four years. Medtronic’s own data suggests a 3 percent failure rate at three years. Fracture of Sprint Fidelis might have contributed to at least a dozen deaths.
So for tens of thousands of patients, the wires coursing through their bodies could still break apart at any minute. And for those patients who didn’t join the lawsuit … well, they’re out of luck.
Take Mandy Neves from Burleson, Texas. Three days after Medtronic announced its settlement, Neves’ Sprint Fidelis leads failed, sending her to the hospital for emergency surgery to remove the wires.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
Nevis told WFFA-TV in Dallas/Ft. Worth that she declined to join the lawsuit because she thought she was doing “the right thing.”
“I was sent letters from attorneys saying, ‘Hire us. You may be entitled to compensation,’ ” she told the television station. “And I actually didn’t think I’d have to sign up. I didn’t know for sure if my device was going to fracture.”
Medtronic will pay $1,400 for the wires. But Nevis, who has insurance, faces a $140,000 hospital bill.
You can certainly say Nevis has no one blame to but herself. Even Nevis admits that, in hindsight, she should have joined the lawsuit.
But let’s face it, not everyone believes in suing or fully understands the complex legal issues behind settlements. Nevis’ situation, I’m pretty sure, is not unique.
You also can say that there are no sure things in life. Medical device therapy is inherently risky.
But I’m here to remind everyone that while Medtronic’s legal woes may be over, the emotional, financial and medical struggles of patients with Sprint Fidelis wires are only just beginning.
