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Why didn't Medtronic recall sooner?
Big cardiac clinics across the country stopped using Medtronic's Fidelis defibrillator lead in early February because they considered it unsafe. So why did the company wait till October to recall it? And why did it blame doctors' technique for some of the malfunctions?
Those are the questions the Wall Street Journal poses today in a piece that not only questions Medtronic's actions, but also the FDA's system for regulating medical devices, which aren't subject to the stringent testing prescription drugs undergo before hitting the market.
- read the article in the Wall Street Journal (sub. req.)
Related Articles:
Medtronic recall spawns inquiry. Report
Did patient lawsuit spur Medtronic recall? Report
Medtronic withdraws defibrillator part. Report
Medtronic's fortunes depend on new stent. Report
Comments
Medtronic had to wait until now to recall its Fidelis defibrillator leads--the ones which actually killed the principal in the case Riegel vs Medtronic, in December 2004.
You see, the company desperately needed a company-friendly United States Supreme Court judge, to rule against the plaintiff (both Charles Riegal and, after his death, his wife Donna's Public Citizen-brought lawsuit). Medtronic's faulty leads killed Charles Riegel, and megalomaniac Justice Antonin Scalia provided this cover when he ruled that "even if the product turns out to be defective, the *pre-approval by the FDA" effectively holds Medtronic harmless from all lawsuits by injured parties, class-action or other."
They didn't DARE recall the product until now that Scalia gave Medtronic this essential legal cover to keep on introducing untested medical products into unsuspecting patients' bodies--and then and ONLY then--to "study" the products.
Happy now, new test-ees? I would advise one thing--the minute that patients hear that they "need" any kind of surgical intervention--that they go to another land to have these things installed. In every land in the world EXCEPT America--Medtronic would be absolutely liable for their products' failures.
Yes, these devices are overly expensive. After all, after enough American deaths, they may have to actually cough up some money to the injured parties in unstructured legal settlements (called "go away money" by most of the profession.
The bad news here (yes, there's more!) is that the Medical Product Safety Act 2008, which was to override the USSC for the first time in history, probably is going to die, what with all the attention carefully having been removed from it by what the public now laughingly calls "the media".
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