Recently, the U.S. Supreme Court ruled on two cases that have serious implications for defective drug and defective medical device lawsuits in our country. Interestingly, the two decisions were rather contradictory — one expanded the rights of victims while the other limited their ability to receive compensation for their injuries.
In Riegel v. Medtronic, the Supreme Court ruled that federal approval of medical devices preempts state laws governing litigation of these products. In other words, if you have been injured by a defective medical device that was federally approved for use with your medical condition, you will not be able to collect damages because the device had been previously approved for use.
In Wyeth v. Levine, the Supreme Court ruled in favor of the victim, stating that defective drugs that have received FDA approval will not be given preemption benefits. In other words, even if a drug has been approved for use, the pharmaceutical company can still be held liable for damages suffered if the drug is defective.
Clearly, the Supreme Court is making a distinction between the laws governing drugs and medical devices. But why have they done so, and is this distinction appropriate?
There is a legal basis for this distinction. The Medical Device Amendments of 1976 contain a preemption clause, which led to the Supreme Court ruling in favor of medical device manufacturers. However, the Food, Drug, and Cosmetic Act, which governs the regulation of pharmaceutical products, does not contain a similar clause, resulting in the ruling in favor of injured consumers.
In the wake of these two decisions by the Supreme Court, Congress has revisited this question. They have recently introduced the Medical Device Safety Act of 2009, which would eliminate the preemption laws that provide protection for medical device manufacturers against lawsuits when their products are defective. If this law passes, drugs and medical devices will be regulated by the same principles.
Congress should be applauded for proposing legislation that will expand the rights of victims injured by defective medical devices. It seems absurd that manufacturers are not held responsible when their devices fail to function properly. Making manufacturers accountable for the safety of their products would undoubtedly raise quality control standards and help provide victims of defective devices with the compensation they need to cover medical expenses and lost wages incurred as a result of their injuries.
Given the complex and intricate laws governing these products, it is essential that you consult an attorney who specializes in product liability law if you suffer an injury from a defective drug or medical device. The success of your claim will likely hinge on your attorney’s ability to navigate through these complicated laws.
If you have a defective drug or defective medical device claim in the Jacksonville, Florida area, please contact the Law Offices of Hardesty, Tyde, Green, & Ashton, P.A. today to schedule a consultation.
