The Justices asked the White House to weigh in on a lawsuit that questions preemption laws for medical devices, which have shielded many companies by immunizing FDA-approved devices from patient complaints.
The lawsuit, Medtronic v. Stengel, has gone circles in the court system for years, with the latest coming to the attention of the Supreme Court after an appeals court ruled that preemption laws don’t protect Medtronic from negligence claims.
Preemption holds that patients can’t sue medical device makers in state courts over products that went through the FDA’s most stringent review process, called pre-market approval. But the justices left open a loophole to allow state suits that allege a "parallel claim" that the company in question broke FDA regulations.
In 2000, plaintiff Richard Stengel began using Medtronic’s SynchroMed EL pain pump, an implanted device that delivers medication directly to the spine via an intrathecal catheter. In 2005, Stengel began developing symptoms of paralysis from an inflammation in his spine around the catheter tip. The device and most of the inflammation were removed, "but not in time to prevent the granuloma from rendering Stengel permanently paraplegic," according to court documents.
The FDA approved the first SynchroMed pump in 1998 and later granted approval for the iteration used to treat Stengel. Medtronic recalled that device in 2008.
Medtronic last year won a preemption ruling, but the case resurfaced with Stengel’s lawyers claiming that Medtronic was negligent in reporting issues with the implantable pain pump. Medtronic asked the Supreme Court to hear the case after a judge in January ruled that Stengel can proceed with his claims.
The lawsuit is part of a growing trend, with patients and their lawyers making negligence claims in order to get around preemption laws. The same strategy arose in plaintiffs seeking damages in cases over Medtronic’s troubled Infuse bone-growth protein, with judges in 2 states so far issuing seemingly conflicting rulings about the validity of such lawsuits.
The Minnesota medical device titan has had a lot of high-profile court action lately, with the Supreme Court ruling this week that it won’t hear Medtronic’s (NYSE:MDT) appeal of a $74 million win scored by Edwards Lifesciences (NYSE:EW) in their patent war over heart valve technology.
Medtronic had some better luck in August, when the U.S. Solicitor General filed an amicus brief effectively siding with Medtronic, arguing that Boston Scientific (NYSE:BSX) bears the burden of proof in a long-running patent infringement beef that’s also headed for the Supreme Court.
MDT shares were down 1.2%, trading at $52.72 as of about 4:15 p.m. today.