Medtronic Inc. (NYSE: MDT) said Thursday it will pay $268 million to settle all U.S. lawsuits relating to its faulty Sprint Fidelis defibrillator leads.
Under the agreement reached with plaintiffs’ lawyers, the parties will seek dismissals of litigation across the country, including cases in Minnesota state court, as well as appeals being reviewed by the U.S. Court of Appeals for the Eighth Circuit and the Minnesota Court of Appeals.
The company based in Fridley, Minnesota, said it could back out of the agreement if those cases are not dismissed. Medtronic, which did not admit any wrongdoing, will record a special charge in the second quarter, ending in October.
If successful, the agreement finally would conclude one of the darkest chapters in Medtronic’s history.
When Medtronic first rolled out Fidelis, the company hailed it as a next-generation technology — a lead thinner and easier to implant than its older Sprint Quattro models.
In 2007, Medtronic stopped selling the leads after reports their wires broke apart inside the body. Many lawsuits from investors and patients followed, culminating in a major Supreme Court decision that ruled Medtronic could not be held liable for a device that met the FDA’s toughest regulatory standards.
Last year, Medtronic told doctors that lead failures may have factored into at least 13 deaths. About 260,000 Sprint Fidelis leads have been implanted in patients in the United States, with 143,000 still active.
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.
