Setting Time Bombs in Our Chests: Our Unreliable FDA

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:

Comments

[AdvaMed]

It’s no secret that medical devices save lives every day. It’s also no secret that virtually all cutting-edge medical technologies, indeed all medical treatments for that matter, carry some risks. We accept these risks because medical technologies like artificial heart valves, pacemakers, and fetal monitors enhance, extend, and save millions of human lives.
Consider that a person with an ICD (implantable cardioverter defibrillator) has a 98% chance of surviving sudden cardiac arrest; a person without an ICD has a 5% chance.
This rigorous approval process ensures that manufacturers receive explicit, uniform guidelines about how each device should be manufactured, marketed, used and labeled – and it ensures that patients and physicians are given clear guidance about the safety and effectiveness of medical devices. This process cannot be replicated in any single state or courtroom. Patients also have the right to sue. Under the current system, patients can sue and recover damages from a manufacturer if the device was not manufactured or marketed according to FDA specifications, guidelines or regulations.
Contrary to its name, the Medical Device Safety Act will wreak havoc with the rigorous PMA-approval process for life-saving devices – only about 30 or 40 devices are approved through this process each year – and will not protect patient safety. The legislation will allow state courts and lay juries, not scientists and physicians, to make determinations about the safety of medical treatments and potentially lead to a patchwork of 50 different state regulations.

[blood1]

Yes, there are problems at the FDA. Some of the problems include:
Political appointees to the head instead of someone who really does want the job...just look at the number of heads in the past few years.
Budget - they have received fewer and fewer dollars to do a herculean job.
Personnel - the turn over rate is high and those with some experience are leaving and new hires are poorly trained.
Demand - there is an outcry to fast-track the so-called Lifesaving devices - made by the media, but prompted by the manufacturer. Approvals are faster, but that may be one of the problems instead of a solution.

You only get what you pay for and if you want quality, you have to pay for it too. Ask any researcher how long it takes to review some one elses research..­.and of course if there is a backlog, more time...how do you want them to choose which to review first.

System is broken - it needs money to hire and retain qualified staff. It needs time to do its job adequately. So complain to the government directly instead of calling the FDA!

[Joshua Sophy]

Here is information on the kickbacks paid to physicians on behalf of medical device companies: http://www.newsinferno.com/archives/5376#more-5376

[Photofarm]

The real problem is that we have come think of medical miracles as so common place that we expect perfect results. 20 years ago this person would have probably died, but is still living today, even though not perfectly.

[PlaceboStudman]

Thank you Mr Millhiser for this article. You point out only one of the problems with the current under funding and under staffing of the FDA. If you've seen any of my posts here, you'll see that I am a strong vocal advocate for improving FDA approval process of technology, and the unmentioned here but still very much a problem issue of the medications we take. It is no longer a big dark secret that many of the medications we take, which have been FDA approved have serious drastic and even fatal side effects, from depression and suicidal ideation, to organ failure. Mostly due to the wholly unnecessary cost boosting additives, fillers and preservatives that are included in our medication. Even over the counter medications often contain ingredients that do more harm than good. Anyone who is on an aspirin or tylenol regimen knows they have to be careful or face serious kidney or liver damage. So, Mr Millhiser, the question is, what can we do to improve the approval procedures for the FDA and force them to remove many of the harmful and completely unnecessary ingredients in our medication

[Samson1]

This just comes down to the question of whether or not we want to pay for it in taxes. The answer is often no or that there are more important priorities. Everyday I hear public comments on the evening news and read them in the press and the gist of them is we want lots of services from government but we don't want to pay for it, ever. Well, too bad. This is one of many things you get to reward your greed and stinginess. Ultimately, we all pay in one way or another, what is your highest priority? Feed the poor? Universal healthcare? Fix the roads and highways and bridges? Public transit? National security? A new national power grid? Save the world from climate change? I seriously doubt we can do everything, so what we need is a real and meaningful discussion of appropriate priorites. Not something I expect to see anytime soon!