The Supreme Court’s Ruling in Riegel v. Medtronic Will Not Stop the Pursuit of Justice
Friday, February 22, 2008
On February 20, 2008 the United States Supreme Court decided in an 8-1 decision that federal law “preempted” state tort lawsuits involving some defective medical devices. Without getting into all of the specifics of the case, the decision essentially means that victims of defective medical devices will have a more difficult time filing suits against manufacturers of defective medical devices, if that product was approved by the FDA through the premarket approval process or PMA. This decision may impact the Medtronic Sprint Fidelis leads cases, as well as cases involving all other defective medical devices, but it does not completely eliminate the opportunity for victims of these defective leads to seek compensation for their injuries.
Bearing in mind that the decision was just issued and is still being interpreted, it seems to leave room for legal action against Medtronic, for the serious defects associated with its Sprint Fidelis leads. The Court acknowledged that not all state law claims are preempted, but it failed to explicitly discuss what claims can survive. It is likely that claims relating to manufacturing defects will still be able to proceed in state courts. It also appears that claims based on specific violations of FDA regulations, that can be directly linked to a particular device may not be preempted.
Premarket Approval Process is Lacking
One of the basic problems with the decision is the assumption by the Supreme Court that the FDA premarket approval process is stringent enough to prevent dangerous medical devices from being approved. The decision seems to completely ignore the reality that medical device manufacturers can be less than honest with the FDA, by not supplying the agency with the results of all clinical studies, so it can make informed decisions. The Supreme Court also seems to have ignored the scandals involving blatant conflicts of interest that FDA employees have had with device and pharmaceutical manufacturers.
Once again, it is still too soon to interpret the full impact of the Supreme Court’s decision in Riegel v. Medtronic, but it is clear that it has eroded some of the rights and protections that Americans have relied on and deserve. It will now be up to legislative process to restore these precious rights. Congress can pass legislation that would, in essence, reverse the Supreme Court’s decision. Some leading members of Congress have already promised to introduce such legislation.
Preemption - Not What Congress Intended
Representative Henry A. Waxman of California, the chairman of the House Committee on Oversight and Government Reform, said “The Supreme Court’s decision strips consumers of the rights they’ve had for decades.” He added, “This isn’t what Congress intended and we’ll pass legislation as quickly as possible to fix this nonsensical situation.”
Senator Edward M. Kennedy of Massachusetts, the chairman of the Senate Health, Education, Labor and Pensions Committee, was also critical of the decision and promised action. Kennedy said, “Congress never intended that F.D.A. approval would give blanket immunity to manufacturers from liability for injuries caused by faulty devices. Congress obviously needs to correct the court’s decision. Otherwise, F.D.A. approval will become a green light for shoddy practices by manufacturers.”
There is no doubt that the Supreme Court’s decision in Riegel v. Medtronic benefits large corporations, at the expense of injured medical patients. While these corporations may have won this most recent battle, a group of motivated legislators appear determined to remedy this problem. If these legislators prove successful, the medical device industry may come to regret the decision in Riegel v. Medtronic, which initially appeared so beneficial to them.
Posted under: Medical Devices • Medtronic Sprint Fidelis Defibrillation Leads