A Bush-era scandal that could have killed Cheney

You corrupt the process by which approvals are granted while you're successfully arguing in court that people harmed by those same approvals have no right to sue. The word for that is chutzpah.

At the same time the Bush Administration was successfully denying patients the right to sue makers of medical devices approved by the Food and Drug Administration, it was destroying the same agency's device approval process.

Given the known heart problems of then Vice President Dick Cheney (right), it means he could have been killed by a defibrillator that did not deserve approval and his family would have had no redress for their loss.

Researchers at UC San Francisco found that half of all FDA approvals for heart devices from January of 2000 to December of 2007 were based on a single study.

In 2008 alone such devices were implanted over 1.7 million times in the U.S. The study was published in the Journal of the American Medical Association.

A second study in the American Journal of Therapeutics, written by a team that includes a current FDA official, said the quality of pre-market clinical studies of such devices during the period varied widely, and that minorities and women were underrepresented in the trials that did take place.

In 2008 the U.S. Supreme Court ruled in Riegel vs. Medtronic that patients damaged by such devices should have no right to sue for damages in state courts, that FDA approval pre-empted  such suits.

Then Vice President Cheney had a heart defibrillator implanted in 2001 but needed a procedure to control an irregular heartbeat in 2007 and again in 2008.

Advamed, the trade group representing device makers, had not issued a press release on the studies as this was written. But in an interview with the Wall Street Journal an official criticized the JAMA study, claiming its authors did not have access to all the data submitted, and claimed the agency spent 1,200 hours analyzing each device approval.

Under new FDA chair Margaret Hamburg, the Administration is preparing new guidelines for pre-approvals, including follow-ups on all patients in pre-market trials.

Hamburg had the head of the device division, Daniel Schultz, resign in August after experts told the President personally they felt pressure to approve devices they were unsure of.  Congress is now investigating.

But think about it a second. You corrupt the process by which approvals are granted while you're successfully arguing in court that people harmed by those same approvals have no right to sue.

Love or hate President Bush, the man's Administration had chutzpah.

This post was originally published on Smartplanet.com

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