CBS Sunday Morning is the top rated Sunday morning news show “in households, viewers and adults 25-54.” That’s a good thing, especially today. (Although when they do a great piece like they did this morning, you kinda wish they had ratings like 60 Minutes - but we’ll take it. )
Not to diminish in any way the wonderful segment on Patti Smith, but we’re mostly talking about the piece called “When Medical Implant Fail.” (Video here.) This was as close to a video version of the Center for Justice & Democracy’s’ report, Heart Sick as we’ve ever seen. (And I thought our post last week about Dick Cheney’s new heart was the best chance we’d get to discuss this topic!)
As CJ&D reported back in 2009, each year, over 100,000 cardiac defibrillators are implanted in patients’ hearts to monitor irregular heartbeats and if necessary, deliver a 700 volt electric shock to restore a heart to proper rhythm. Already scary. But imagine yours was defective? Unfortunately, 21-year-old Joshua Oukrop can’t imagine that, because his malfunctioning Guidant defibrillator killed him. Allan Gohde can’t either. He had the same defibrillator as Joshua's. When his widow Kathleen bent over his coffin, a loud beeping starting coming from his chest. This was the signal of a device malfunction. Had it not started to beep, the family never would have known that the defect killed Allan.
When the U.S. Supreme Court decided the case Riegel v. Medtronic in 2008, it closed the courthouse door to these patients, telling victims and their families that they had no recourse or any opportunity to be compensated. With that decision, the Court essentially placed blind faith trust in the FDA to protect the public. We wish the CBS Sunday Morning piece had paid some attention to the "immunity problem." But they get a pass for doing such a great job on the "FDA problem," and the agency’s regulatory megaflops over what are probably the most dangerous and recalled implants ever made.
CBS interviewed renowned cardiologist, Dr. Robert Hauser, who was Joshua’s doctor. In 2005, he and another cardiologist went to the New York Times, which then broke the story about this Guidant defibrillator that was short-circuiting at a rate of about once a month. Three years earlier the company had changed its manufacturing process to correct the problem but never told doctors and continued to sell its defective inventory. Patients died and the FDA kept this information from the public for many months. What’s more, this entire incident took place while the company was under special obligation to report device problems stemming from a 2003 plea agreement over its failure to disclose problems with defective aortic aneurysms stents. (See more in Heart Sick.)
Meanwhile, subsequent litigation (that is, before the Supreme Court unceremoniously stripped patients of their legal rights) revealed documents like one doctor’s letter to Guidant: “I am not critical of Guidant’s device problems – these devices are so complex, issues are expected. I will not, however, work with a company that put profit and image in front of good patient care and honesty in device manufacturing.”
Meanwhile, according to the the medical device industry flack interviewed by CBS, Americans have nothing to fear because the safety duo of the FDA and the industry, "working together have an exemplary safety record” and besides, the approval process is too slow and needs to be speeded up. Continues CBS:
But Dr. Hauser cautions that speeding up an already ineffective approval process could be dangerous, because there's also inadequate follow-up after a device hits the market - something called post-market surveillance.
"In the United States, there is no definite requirement for post-market surveillance for defibrillators and heart valves, artificial hearts and so forth," he said. "There's no absolute requirement. In other words, you wait for problems to be reported to you rather than actively seeking out problems, and there's a big difference."…
Last year, the Institutes of Medicine, an independent advisory group, issued a report stating that the FDA's current regulatory framework for most devices is so flawed it should be thrown out and replaced with a new system that "provides a reasonable assurance of safety and effectiveness.”
And here’s another idea. Congress also needs to fix the horribly misguided Riegel decision.