Consumer rights took another hit on February 20^th when the U. S. Supreme Court, in a case styled Riegel v. Medtronic, Inc., 128 S.Ct. 999 (2008), held that the Food and Drug Administration’s (FDA) regulation of Class III medical devices bars all state law tort claims for medical injuries from devices approved by the FDA.  Many personal injury suits may have to be dismissed as a result of this ruling.  Most legal observers believe consumers have been stripped of rights they once were able to rely on, and justifiably so. 

In the case, Charles Riegel and his wife sued Medtronic, Inc., a catheter manufacturer, after Charles was seriously injured when a balloon catheter burst while he was undergoing angioplasty surgery.  Medtronic asked the Court to dismiss the lawsuit, arguing the Food, Drug, and Cosmetic Act preempted state-law damage actions brought by patients like Charles who have been injured by medical devices that had received pre-market approval from the FDA.  The Court agreed with the manufacturer and dismissed the Riegels’ case.

The Court held that a provision of the Medical Device Amendments to the Food, Drug, and Cosmetic Act preempts state-law claims seeking damages for injuries caused by Class III medical devices that had received approval from the FDA before the devices went on the market.  Basically, if the device passed the Class III FDA testing before going to market, consumers with injuries caused by these defectively designed or labeled medical devices have no right to sue the manufacturers of these products. 

Now, thanks to the decision in the Riegel case, manufacturers that make defective medical devices and fail to warn consumers of the defects are immune from liability.  Federal preemption is simply backdoor tort reform that is harmful to consumers.  So-called conservatives claim they are for smaller government and less governmental intrusion.  Yet, the Supreme Court seems to support the authority of federal administrative agencies – such as the FDA – to draft regulations that provide immunity to Corporate America for making and selling defective products. These rules take away the right of the states to protect its citizens from harmful products.  Congress must get involved in this fight and do the will of the American people. If decisions like this one spread to other products, consumers will be deprived of the right to seek justice in the courts. If you agree that federal preemption is bad, contact your U.S. Senator and members of the U.S. House of Representatives and ask them to stand up for the American people on this critically important issue.

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