Consumers v. Huge Corporations: The Medical Device Debate

Joe Saunders
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Posted by Joe SaundersSeptember 20, 2008 11:59 AM
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It's a classic David vs. Goliath scenario with the US Supreme Court appearing to side with the large corporations instead of individual consumers.

Last February in Riegel v. Medtronic, the Supreme Court ruled that a severely injured person was barred or pre-empted from filing a lawsuit against Medtronic Corporation because the medcial device manufactured by Medtronic had been previously approved by a federal regulatory agency, namely the FDA, even though the medical device caused severe injuries to the patient. This is good news for big business who continue to scream for less regulation and oversight so that they are free to reap the financial rewards of their medical device products, even those that cause severe injuries to consumers. In a case to be heard this fall by the Supreme Court, a woman, Diana Levine lost her arm because of a drug's interaction with arterial blood that led to gangrene requiring amputation. Wyeth, the manufacturer of the drug Phenergan was mislabeled and led directly to the amputation. Yet, Ms. Levine has had to take her case all the way to the US Supreme Court because of the federal pre-emption law. In essence, federal pre-emption bars victims from seeking justice in the court system. It also gives huge corporations from Wyeth to continue to recklessly and aggressively produce products that are unsafe and cause severe harm to patients. If corporations such as Wyeth have no oversight or accountability we can expect the same sort of cataclysmic events we've seen this past week in the financial sector of our economy.

3 Comments

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amir fahmzy
Posted by amir fahmzy
September 20, 2008 5:54 PM

where are the rest of your facts? what is the injury rate in the drug trial. how many consumers would be affected. this is nothing more than an op-ed piece if you cant provide facts to let readers make informed decisions

dave
Posted by dave
September 20, 2008 11:02 PM

Wyeth, the manufacturer of the drug Phenergan was mislabeled and led directly to the amputation.

Thomas A Sharon RN MPH
Posted by Thomas A Sharon RN MPH
September 24, 2008 6:33 PM

The facts as mentioned in this report are unclear. I believe, the word "arterial" might have been confused with "venous" and drugs do not interact with blood. They dissolve in the blood plasma. Durgs can have an injurious effect on blood as well as any of the vital organs. There are also drug interactions to worry about.

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