One important point to clear up per the Supreme Court’s 8-1 decision in the Medtronic pre-emption case -- when product manufacturers provide fraudulent information to FDA, or deliberately withhold information about safety problems associated with their products, preemption doesn’t offer them protection and they can and should be held accountable.
The problem is that the current liability system doesn’t reward lawyers who focus on these real public health concerns. Instead, the most experienced and well-financed law firms know that the biggest payouts regularly go to those who take advantage of the FDA’s best efforts to promote the safe and effective use of medications and medical technology. More and more often, these “mass tort†firms specialize in taking a new product warning label or withdrawal decision by the FDA, and view it as a signal to go forward with all guns blazing. Their bullets, unfortunately but not unpredictably, hit multiple innocent targets and result in a wounded American health care system.
Upon hearing the Court’s verdict, Senator Kennedy said, “In enacting legislation on medical devices, Congress never intended that F.D.A. approval would give blanket immunity to manufacturers from liability for injuries caused by faulty devices.†And Representative Waxman, America’s Oversighter-in-Chief commented that, “The Supreme Court’s decision strips consumers of the rights they’ve had for decades. 'This isn’t what Congress intended, and we’ll pass legislation as quickly as possible to fix this nonsensical situation."
“Nonsensical?†To the contrary, entirely sensical. Hence 8-1.
The problem is that the current liability system doesn’t reward lawyers who focus on these real public health concerns. Instead, the most experienced and well-financed law firms know that the biggest payouts regularly go to those who take advantage of the FDA’s best efforts to promote the safe and effective use of medications and medical technology. More and more often, these “mass tort†firms specialize in taking a new product warning label or withdrawal decision by the FDA, and view it as a signal to go forward with all guns blazing. Their bullets, unfortunately but not unpredictably, hit multiple innocent targets and result in a wounded American health care system.
Upon hearing the Court’s verdict, Senator Kennedy said, “In enacting legislation on medical devices, Congress never intended that F.D.A. approval would give blanket immunity to manufacturers from liability for injuries caused by faulty devices.†And Representative Waxman, America’s Oversighter-in-Chief commented that, “The Supreme Court’s decision strips consumers of the rights they’ve had for decades. 'This isn’t what Congress intended, and we’ll pass legislation as quickly as possible to fix this nonsensical situation."
“Nonsensical?†To the contrary, entirely sensical. Hence 8-1.
