FEb 09 2009

• by MRSNO1MAX
• 2009-02-09 03:02:44
• Batteries & Leads
• 1705 views
• 3 comments

Lawsuits filed by victims of the defective Medtronic Sprint Fidelis lead are in legal limbo. Thanks to a ruling last year by the U.S. Supreme Court, it is unclear if they will be able to sue Medtronic for painful injuries caused by the Sprint Fidelis defibrillator lead. According to an article in the Minneapolis Star Tribune, the best hope for the victims of this faulty lead is a law passed by Congress to reverse the Supreme Court's decision.

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.

Because of the Supreme Court's Riegel decision, a federal judge in U.S. District Court in St. Paul dismissed several hundred cases filed by patients who claim they were injured by the Sprint Fidelis lead. 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.” In the decision, the judge said that it was up to Congress to change the law that bars such lawsuits.

Some in Congress are seeking to do just that. According to The Minneapolis Star Tribune, Rep. Henry Waxman, D- Calif. and Rep. Frank Pallone Jr., D-N.J., plan to introduce legislation that would ov turn the Supreme Court's Riegel ruling.

The Supreme Court decision "left consumers without any ability to get compensation for injuries caused by certain defective medical devices,'' Waxman said 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."

According to the Star Tribune, the Supreme Court ruling covers Class III medical devices, such as implantable defibrillators, which are theoretically subject to the greatest level of scrutiny by the FDA before they are approved. But lawyers representing Sprint Fidelis victims argue that the 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, the Star Tribune said.