"The FDA Has Become a Joke," Says Specter

A recent ruling by the U.S. Supreme Court states that once the FDA approves a medical device, the manufacturer is immune to lawsuit even if said device causes injury to the recipient. This ruling has now come under fire in the Senate Committee on the Judiciary.

Strange bedfellows keep popping up in the health care debate, probably because health concerns cut across party lines like a laser through a marshmallow. In this case we see two often opposing voices raise in ire at the testimonies presented to them: Sen. Patrick Leahy, D-Vt., and Sen. Arlen Specter, R-Pa.

Harrowing personal testimony from two women in particular brought down anger from both of these veteran legislators. First was Bridget Robb, who on December 7, 2007, suffered a defibrillator malfunction that shocked her heart 31 times in the span of a few minutes. When she arrived at the hospital, luckily still alive, she discovered the device had been recalled months earlier. ABC News recounts the details in an article by Ynuji DeNies, Sheila Evans, and Stephanie Dahl, including the details of how Robb was prevented from taking legal action by the Supreme Court ruling mentioned above.

Then came the story of Maureen Kurtek, a lupus sufferer whose story would shock just about anyone. Her full testimony is transcribed on the U.S. Senate Committee on the Judiciary website here. I would like to share with you her summation from the end of it, especially the second paragraph:

[...] all of this pain and suffering was caused by an insurance company that failed to provide me with a treatment that I had received six times prior at the same hospital under the same insurance provider with good effective results. Previously, this treatment had helped my body increase its ability to fight infection and keep my platelet count at a normal level. This treatment was prescribed for me by at least seven doctors and two specialists and was never considered to be experimental by them. This treatment, although expensive, was necessary for me. And, my insurance company delayed my treatment.

I stand before you today with a tracheotomy scar on my neck, five amputated finger tips and an amputated right foot where I still experience phantom pains. Life ceased as I had known it. I can no longer jog or dance. I can not wear stylish shoes on special occasions such as my son's graduation, and I have to wear an orthopedic shoe which I can assure you is not the dream of any woman. During my time in the hospital, I missed my son's spelling bee, piano recital, his confirmation at church and baseball games. These are events I can never get back.

Due to this law, insurance companies can get away with denying care and delaying treatment without any consequences. This is wrong. We need to change this law so no families will have to suffer the way mine has.

The ABC Article provides us with the responses of our esteemed Senators:

"The Supreme Court has ignored the intent of Congress in passing these measures, oftentimes turning these laws on their heads, and making them protections for bug business rather than for ordinary citizens," Leahy said. "I hear this buzzword of activist judges and I can't think of anything more activist than these decisions."

[...] Sen. Arlen Specter, R-Pa., put the blame on the FDA which approved the faulty device. "The FDA has become a joke," Specter said.

Whichever way this goes, it will have far reaching implications both for medical device manufacturers and the patients who rely on their devices. Specter, the ranking Republican on the committee, was harshly critical of the Bush Administration for delaying requests for FDA funding reportedly calling it "criminal negligence."

The ongoing battle for reform is taking place in courtrooms and governmental chambers across the nation with bipartisan efforts cropping up more and more frequently as cases like these shine a media spotlight on the broken aspects of the American health care system. A "perfect storm" has arrived heralding oncoming change. Becoming engaged and informed on this issue is of utmost importance for us all.

SOURCE: "Young Daughter: 'Mommy's Dying': Bridget Robb Can't Take Legal Action Because Device Was FDA-Approved" 06/11/08
SOURCE: "Testimony of Maureen Kurtek before the Senate Committee of the Judiciary" 06/11/08
photo courtesy of DBKing, used under its Creative Commons license