A federal judge dismissed lawsuits that were filed in federal court on behalf of thousands of patients who have been implanted with dangerous Sprint Fidelis defibrillator-wires. It has been shown that the wires are prone to fracturing and transmitting electric shocks, which can cause severe injuries and death, and they were recalled by the FDA in October 2007. In dismissing the cases, the judge recognized that the plaintiffs have suffered injuries from using the defibrillators, but concluded that the lawsuits were preempted by federal law, citing Riegel v. Medtronic. In Riegel, a case decided last year, the U.S. Supreme Court held that federal medical device regulations prevent plaintiffs from bringing state product liability lawsuits unless the manufacturer is in violation of FDA regulations. This decision creates a “compliance defense” for the device manufacturers. As long as they abide by FDA regulations, and even though the devices they produce are shown to be dangerous and harmful, the medical device companies cannot be sued on behalf of the people whom their products have injured or killed.
The Supreme Court is currently considering a similar case involving prescription drugs and it will soon issue its ruling on whether federal law also preempts drug product liability cases. If the Court concludes that these lawsuits are indeed preempted, thousands of patients will have no legal recourse for injuries and deaths caused by prescription drugs. This would shield drug companies from liability for creating drugs that are initially approved by the FDA but later recalled after they are found to be harmful or deadly.
For the full story, click here.