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The Medical Equipment Design Blog is the place for conversation and discussion about medical grade materials and products, electrical and electronic equipment, computers, imaging & software, and home healthcare & diagnostics as used in the medical industry. Here, you'll find everything from application ideas, to news and industry trends, to hot topics and cutting edge innovations.

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Ruling May Have Device Lawsuits Cooling

Posted March 14, 2008 8:45 AM

On February 20, 2008, the U.S. Supreme Court handed medical device manufacturers a huge dose of liability protection. The Court granted that FDA approval of certain medical devices in accordance with the 1976 Food, Drug and Cosmetic Act shields manufacturers from product liability lawsuits filed in state courts. The ruling preempts state regulation of medical devices and prevents a patchwork of different state-level safety requirements. Some may view it as abandoning state-level oversight and any means of judicial recourse for consumers. What's your take on the court case ruling?

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#1

Re: Ruling May Have Device Lawsuits Cooling

03/15/2008 1:44 PM

In the U. S. the epidemic of lawsuits has absolutely paralyzed the medical proffession. You cannot watch any of the 500 plus channels on the tube for more than 5 minutes without hearing some ambulance chaser yelling about "Have you ever used this or that or done this or that?" Then lets sue, I'll get you tons of money. The result is unaffordable health care. All medical devices, medicines, procedures, etc. have to charge enough to cover extravagent court judgements.

This might just be the first step toward correcting this unsustainable problem.

I vote "Yaaaay!

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#2

Re: Ruling May Have Device Lawsuits Cooling

03/17/2008 11:31 AM

Here's a better idea - give the FDA (as well as other regulatory agencies including the USDA, EPA, DOT, etc.) sufficient funding to be able to actually test these (and other) devices to ensure they will work as advertised. Then the product liability issue goes away in part, because we'll have things that ARE operable, not just 'promised to be' operable. As is, the FDA often as not must rely on testing by the manufacturers, and they will always tell the truth, right?

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