Supreme Court Ruling Restricts Lawsuits For Medical Device Injuries

A February 20, 2008 U.S. Supreme Court decision in Estate of Riegel v. Medtronic protects large corporations at the expense of injured consumers. Justice Scalia authored the Supreme Court decision handed down today that finds that civil liability claims involving Class III medical devices that have been approved by the FDA under the premarket approval process (PMA) are preempted by federal law. As a result, many lawsuits by injured consumers may be dismissed even though the device manufacturing company was negligent in causing the injury or death. This ruling will restrict some of the legal claims that have been made against Medtronic as a result of the defects in the Medtronic Sprint Fidelis heart device leads. However, there still may be some legal theories upon which these claims can be brought.
This decision does not apply to class II medical devices such as the Kugel Mesh Hernia Patches and the Stryker defective hip failure cases. It also does not apply to pharmaceutical drug liability cases such as Seroquel or Zyprexa. Nor does the decision apply to medical devices approved through the FDA’s 510(k) approval process.
I hope that the U.S. Congress will act to pass a bill to restore consumer rights. The combination of FDA approval and review as well as state consumer protection laws that has co-existed for many years has served as a double layer of protection of the public health. The Court decisions reduces consumers rights and remedies with respect to defective and dangerous medical devices marketed in our Country.