I wanted to thank you for your piece on the issue of the FDA, medical device companies, the corruption surrounding them and the laws they got enacted to prevent victims of defective products from suing them. I am one of those people. I had a defective lead (the wire that that connects my defibrillator to the heart itself) installed and when it failed, the device shocked me repeatedly. The device manufacturers euphemistically refer to those shocks as "inappropriate" and the sensation "uncomfortable but fleeting", but I and many other patients I have spoken with call them excruciating and terrifying. It had only been installed a few weeks before and so I had to undergo surgery again to have it replaced. It turns out the failed product was a new one, supposedly improved, that had recently been sanctioned by the FDA. After the second surgery, the electrophysiologist who performed the operation followed up with the manufacturer and was told by someone there that they had already been "looking into" reports of other failures. The stress on my body from the second surgery soon caused my heart to go into an abnormal rhythm, which triggered additional shocks (10 in five minutes because the device itself couldn't actually correct that particular kind of arrhythmia) and the whole incident was nearly fatal.

Even so it was still more than six months before the company issued a recall, though doctors like mine (who is one of the leading experts in these surgeries in all of new England) had refused to continue implanting them much earlier. I sought legal counsel afterwards and my attorney recommended joining a class-action suit that was in the works, rather than trying to go at them on my own. I took that advice even though at the time I was less interested in suing them for making a defective product than I was for their knowing it was defective, but still allowing it to be placed inside my body. These products are extremely expensive to develop and the company's brass must have decided it was more profitable to continue to sell as many as possible before they were forced to recall them, in part because they had recently successfully lobbied for a new law they thought would protect them from lawsuits.

And as of today, that's exactly what happened. The judge hearing the case threw it out citing the new law that said since the FDA had approved the device the manufacturer was protected from suits. Since then however, there have been numerous press reports that scientists and other whistleblowers within the agency are beginning to expose the corruption at the heart of the Bush FDA's symbiotic relationship with the manufacturers - and in addition to outright graft and administrative incompetence, the certification process had been reduced to the manufacturer telling the FDA the product was safe and the FDA then certifying it was so. That, coupled with the fact that Congress has begun to consider clarifying the law in question to remove the protection loophole court decisions have provided the manufacturers, leads me to hope our rights will eventually be restored in this case. It is, of course, only the cost of punitive sanctions that will protect the public from the greed of under-regulated corporations like this.

Many people who received this and other defective parts and devices have been killed by them. I'm one of the lucky ones. All I had to do was suffer the torture of the "inappropriate" shocks; go through unnecessary additional surgeries; become so sick afterwards I nearly died; lose 20 pounds in 10 days as a result; miss a lot of work - it was months before I was back to my full, regular schedule; and suffer from repeated nightmares to this day of the device failing and shocking me again and again.

This is all part of what happens when the deregulation fetishists have their way. Add in that the political appointees entrusted with the agencies created to protect us from the unscrupulous have in fact worked to weaken and destroy the oversight we ought to have learned time and time again is necessary. The result is a world where the powerful control the legal process to the point where they can make profit trump public safety and morality. While we face many other pressing problems, I would hope we can find time to urge our representatives to support legislation that will restore sanity to the process and the necessary resources to protect us to the agencies charged with doing so.

Sincerely,
sleon