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June 14, 2010

Comments

Reader

Just to be clear... some of your statements aren't quite factual:
"The medical device industry is currently immune from all liability (forget liability "caps") for killing or hurting people with defective, implantable medical devices." Actuality: They are immune from liability for those products designed and manufactured in compliance with regulations. They are not immune from liability for a defective product not in line with FDA regulations.

Secondly and similarly, your statement: "Michigan’s law that eliminates the right of anyone in the state to sue a drug company for marketing an unsafe or lethal drug."
Actuality: Michigan's law eliminates liability for drugs in full compliance with FDA regulations. It takes an average of 10 years and costs an average of $800 million to get a drug approved by the FDA. The support for Michigan's law lies in the belief that the FDA is better suited to decide to allow a drug to be sold in the US than a judge and jury considering one situation in a vacuum.

Just wanted to set the record straight.

Joe Consumer

Thousands of these defective heart devices have failed over the years, some short-circuiting and killing patients. This was despite the device undergoing an FDA approval process that is supposed to ensure safety but doesn’t. As the U.S. Supreme Court itself said n Wyeth v. Levine, “Congress did not intend FDA oversight to be to be the exclusive means of ensuring drug safety and effectiveness... The FDA has limited resources to monitor the 11,000 drugs on the market and manufacturers have superior access to information about their drugs, especially in the postmarketing phase as new risks emerge." Moreover, "[T]he FDA long maintained that state law offers an additional, and important, layer of consumer protection that complements FDA regulation." Michigan now stands as the only state in the nation that prohibits the state from protecting its own citizens from the unsafe government-approved drugs.

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