U S Supreme Court Ruling On Drug Preemption Reminds Us That Medical Devices Should Follow Suit

Mike Bryant
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Posted by Mike BryantMarch 19, 2009 9:46 AM

This past week, saw a victory for consumers with the U S Supreme Court's decision in Wyeth v. Levine. Basically, the decision allowed state law to stand in cases against drug manufactures. It's time the court also looks at the use of preemption to protect those injured by medical devices.

The issues is one of preemption. A topic that members here at the Injuryboard have spent a lot of time on. Do federal laws and regulations preempt state laws? It's a question of state's rights and if individual states can set the laws to protect their own citizens. It's also a question of who's making the laws. Presently, big business is being protected by eight years of pointed regulations that were meant to shield them from liability.

The argument they make is that without the certainty of one national law, they won't make the devices. That they need to rely upon the FDA to grant approval or the system won't work. Taking part in a cost-benefit analysis that includes that though the patients "injured by medical devices make for great news stories...patients who don't get the devices that never made it to the market because of the risk of litigation won't get the same attention" and "will just die."

Recently, a local federal court threw out the cases of thousands of patients with heart-defibrillator wires that have been shown to fracture and dispatch potentially lethal shocks. The court reasoned that despite the injuries, preemption was the law of the land. Hopefully, this new ruling will be extended to recognize that there are individual states that make up that land.

2 Comments

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Daniel 8791
Posted by Daniel 8791
March 19, 2009 7:49 PM

Yes, the United States is much larger than most countries so I would say that the states of the union need to be free to decide and rule for the most part on issues related to things such as medical devices and most pharmaceuticals. I say this because I believe it can be watched and balanced more fairly by local law makers rather than an "outside entity" located likely somewhere in or near Washington D.C.; possibly preventing a wall of mystery and collusion that would be very difficult to track down and find the source of it's being.

Mike BryantInjuryBoard Attorney Member
Posted by Mike Bryant
March 20, 2009 4:30 AM

State's rights are very important for protecting the consumers. Thanks for taking the time to read and comment.

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