Even while acknowledging that Medtronic Inc.’s defective Sprint Fidelis defibrillator lead caused serious injuries to plaintiffs, a federal judge yesterday dismissed dozens of Sprint Fidelis lawsuits on the grounds of preemption. Preemption is a legal doctrine that federal regulation of a product – such as a medical device – bars lawsuits filed under state law.
Medtronic suspended sales of its Sprint Fidelis Leads in October 2007, after receiving reports of 5 fatalities linked to lead fractures. A lead is a wire that connects an implantable defibrillator to the heart. When it breaks, the defibrillator can emit a massive and painful shock. And in the worse case scenario, the fractured lead can prevent a defibrillator from sending a necessary, lifesaving shock to the heart. Replacing a lead is not an easy procedure, as the invasive surgery can cause the tissue of the blood vessels and heart to tear. In fact, replacing a defibrillator lead is so risky that patients with Sprint Fidelis Leads were told to leave the defective components in place unless they fracture.
Before the recall, Sprint Fidelis leads had been implanted with 90% of Medtronic’s defibrillators. According to the Wall Street Journal, 268,000 defective Sprint Fidelis Leads had been implanted worldwide, and about 235,000 people still had these leads in their chests when the recall was issued. Not surprisingly, the Sprint Fidelis recall spawned scores of personal injury lawsuits.
Last February, the Supreme Court ruled in a case called Riegel vs. Medtronic (which did not involve the Sprint Fidelis lead) that the Medical Device Amendments of 1976 to the Food, Drug, and Cosmetic Act that require Food & Drug Administration (FDA) approval of medical devices preempt product liability lawsuits in state courts. That law clearly says that states can’t maintain requirements that are different from federal standards. But Congress didn’t specify if those federal standards preempted state common law claims.
Medtronic and the Bush Administration asserted that allowing state personal injury lawsuits against the makers of defective medical devices amounts to a state “requirement” different from FDA requirements because such complaints are based on state laws. Eight members of the high court agreed with Medtronic. The Court recently heard another case, Wyeth vs. Levine, that could extend a similar lawsuit shield to drug makers.
But the doctrine of preemption is a controversial one, and many believe it puts patients at risk. In an Amicus Brief filed in Wyeth vs. Levin, the editors of the New England Journal of Medicine said the FDA ‘’is in no position’’ to guarantee drug safety, and that product liability lawsuits can serve as ‘’a vital deterrent’’ and protect consumers if drug companies don’t disclose risks.
In a ruling yesterday, U.S. District Judge Richard H. Kyle dismissed dozens of Sprint Fidelis lawsuits. In his decision, the judge wrote that “the court recognizes that at least some plaintiffs have suffered injuries from using Sprint Fidelis leads, and the court is not unsympathetic to their plight. But plaintiffs assert claims for which the court simply cannot provide a remedy.”
Judge Kyle also wrote that it was up to Congress to change the law that bars such lawsuits. That is something that could happen. According to The Wall Street Journal, Democrats in both houses of Congress have introduced bills to overturn the Riegel decision. President-elect Barack Obama, who would have to sign such a law once it was passed, was a co-sponsor of the Senate bill.
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