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Ian Millhiser Headshot

Setting Time Bombs in Our Chests: Our Unreliable FDA

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After a career spent driving trucks, Ed Gilleon developed a dangerous aortic aneurysm, and surgeons implanted a device known as a "AneuRx stent graft" to prevent his largest blood vessel from rupturing. Within months, Gilleon started experience tremendous pain as the device dislodged and migrated down his bloodstream, eventually blocking his kidneys. Though doctors were able to perform emergency surgery to implant a new device, they could not remove the stent that is still lodged near his kidneys. Gilleon can no longer feel his right leg, he takes morphine to dull the pain, and he lives every day terrified of the device which was supposed to save his life. In Gilleon's own words, "I know any jarring motion or any bend could kill me; that is what I live with every day."

Joshua Oukrop was born with a genetic heart defect which could cause his heart to suddenly fail, but his doctors assured him that a defibrillator implanted in his chest would save his life. Confident that he could trust the device that he relied on to restart his heart, Joshua went about his life, met a woman he thought about marrying, and believed that he could have a long life together with her. The couple were mountain biking together in Utah when his heart failed--and the defibrillator immediately short circuited. Joshua fell off his bike and died; he was 21 years old.

Like all potentially dangerous medical devices sold in this country, the devices which failed Ed and Joshua were approved by the Food and Drug Administration (FDA) before they could be sold in the United States. Yet these dangerous medical implants are only two of the hundreds of devices which have survived the FDA screening process, only to be pulled from the market after they caused numerous injuries or deaths.

According to a report released yesterday by the Center for Justice and Democracy, a shocking 573 recall notices were issued between 1992 and 2002, covering more than two million implants which had already been sold to doctors--and in many cases implanted into patients. Every one of these recalled devices were approved by an FDA approval process which is wholly inadequate to the task of protecting American consumers without significant help from private lawsuits.

The FDA can barely keep up with the volume of work it faces. In 2005 alone, the FDA approved nearly 3,200 applications to market a new device to physicians and patients. Yet the FDA employs only a fraction of the armies of scientists, physicians and other researchers who are employed by the medical device industry. Lacking sufficient resources to monitor thousands of medical devices on their own, the FDA relies on the industry itself to disclose potential problems in the devices it regulates.

Needless to say, device manufacturers are not always forthcoming. Throughout the 1980s and 1990s, a device known as the Björk-Shiley heart valve malfunctioned in hundreds of the 86,000 patients it was implanted in--resulting in at least 900 deaths. Yet, according to a year-long investigation conducted by the House Subcommittee on Oversight and Investigations, the product remained on the market for years because its manufacturer "continually provided the medical community with incomplete and misleading information regarding the number of strut fractures and the severity of the problem." Significantly, the company failed to disclose to the FDA evidence showing that the valve was prone to fracture until after the device was approved, and it failed to reveal that--even as the device was being implanted in heart patients nationwide--the company was altering its own manufacturing practices because of concerns about the device's safety.

And this was not an isolated incident. At the time that Joshua Oukrop's defibrillator short-circuited, its manufacturer knew of at least 25 other incidents where the device had similarly malfunctioned. Yet, according to the New York Times, the company continued to sell its inventory of defective devices, even after it altered its own manufacturing practices to address this defect; and it kept the device's defect a secret the entire time. A few years earlier, the same company--Guidant Corporation--pled guilty to ten felony counts for failing to notify the FDA about problems with a stent graft similar to the one implanted in Ed Gilleon.

As unwilling as the industry is to disclose damning information about their products, there is a simple way to learn the secrets that medical device makers do not want doctors to know: lawsuits. When an injured patient--or their begrieved survivors--sues a medical device maker, they have a right to discover how the company's product is made, and to uncover evidence that it is defective. They can find information that was long kept secret from the FDA, and they can often provide this hidden information to consumers and the medical profession. If they win their case, they impose a financial consequence on the manufacturer--sending an important message to profit-driven companies: if you hide key facts from the public, you will pay for it.

Shockingly, however, a recent Supreme Court decision declares that medical device makers have almost total lawsuit immunity--meaning that one of the most reliable means of dislodging information from secretive companies no longer exists. Thanks to a one year-old decision by Justice Scalia, virtually all cases brought by people like Joshua Oukrop and Ed Gilleon are simply tossed out of court shortly after they are filed. Our inadequate FDA is left to go-it-alone against companies that now have every reason to keep damaging information about their products secret.

Fortunately, there is a way to fix this problem. Congress is currently considering a bill called the Medical Device Safety Act, which will overturn Justice Scalia's decision and restore people like Joshua and Ed's ability to hold medical device makers accountable for their actions. Until this bill passes, the FDA's lackluster screening process is the only thing standing between the millions of Americans who rely on medical devices to save their lives, and the fate which befell Joshua Oukrop and Ed Gilleon.

When I blog here at Huffington Post, I customarily finish my pieces with a punchy line about why Congress should pass a particular bill, or the President should nominate a particular kind of judge. In this case, however, nothing I can say will do justice to the terrible suffering faced by victims of defective medical devices. Rather than ending my piece with another snappy pitch for the Medical Device Safety Act, I will let the victims speak for themselves: