Medical Devices: Supreme Court ruling 2008, Riegel v. Medtronic, Patients Who are Implanted with High-Risk Devices Not Allowed to Sue

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Supreme Court ruling 2008, Riegel v. Medtronic

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Patients Who are Implanted with High-Risk Devices

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Not Allowed to Sue

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If you are not certain you are willing to take on risk, more medical problems, grave risk, even death, do not get a device implant. Keep in mind what some orthopedic surgeons teach: Do not get an joint replacement until you absolutely cannot walk anymore.

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Let me take this opportunity to demand a 5 year followup study of spinal cord stimulators to include every death and every problem regardless of cause. It will never happen. The swamp is impervious to us.

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NPR interview today on risk of implanted medical devices.

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“…40 percent of conditional approvals haven’t had a post-approval study five years after it’s on the market. So people are being subjected to devices that scientists may have had serious concerns about, and yet, they don’t even know if they’re safe or not.

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…DAVIES: This is FRESH AIR. I’m Dave Davies in for Terry Gross….We’re speaking with medical journalist Jeanne Lenzer, who’s written a new book about the risks and implanted medical devices such as artificial joints, cardiac stents and pacemakers. She says they’re approved with far less scrutiny than new drugs, and some can cause serious harm. Her book is called “The Danger Within Us.”

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…Dennis Fegan, this firefighter and paramedic who suffered from epileptic seizures, and out of some desperation, got this vagus nerve stimulator planted in him, this little box with wires that would stimulate the vagus nerve that runs down his body and hopefully ease his epileptic seizures. He ended up in a life-threatening situation in [2006].

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LENZER: So one night, he was awakened about a – with a pain in his throat. About 2 in the morning, he woke up. And he knew that the pain in his throat was associated with a seizure, so he got up, and he put a vertical mark on his calendar on that date….And when his parents found him the next morning, they saw him stumble out of his room and fall unconscious onto the floor. And when he came to, he got up, sat down on a dining room chair and immediately fell face-first into the floor again. This time, you know, he’s afraid of falling again, so he wiggles across the room with his back against the wall. His legs are splayed in front of him. His jeans are soaked with urine. He looks half dead. His parents frantically call for an ambulance. By the time the ambulance gets there, he’s already passed out eight more times.

The paramedics, figuring he’s having seizures – as Dennis thought he was having seizures – gave him seizure medication that they injected in his arm. But it didn’t stop the seizures. So they rush him to the hospital, where the ER doctor also gives him more seizure medicine seeing his seizures. And again, he can’t stop the seizures. And the ER doctor is frantic. He, you know, thumps Fegan on the chest trying to bring him back to life. And that’s when he notices something very curious.

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Fegan’s heart is stopping at precisely three-minute intervals. This makes no sense to the ER doctor. He calls in a cardiologist. The cardiologist rushes downstairs, looks at him. They both see the same thing. And it’s only when the neurologist arrives – Fegan’s neurologist – who says, oh, Fegan has a VNS device, and it’s set to fire at exactly three-minute intervals. So the device, instead of stopping his seizures, was stopping his heart. So they rushed to turn off the device. And when they finally get it turned off, the seizures stop immediately and Fegan doesn’t have anymore. They send him up to the ICU to recover. And the next day, Fegan learns that his heart has been stopped by the device. And that launches him into a decade-long battle with FDA, regulatory authorities and the device manufacturer….

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LENZER: Right. And Fegan gets concerned about other people implanted with the device and wants to know whether it’s happening to other people, so he finds out about the FDA’s MAUDE database. It’s a database where all device adverse events are kept. And when he looks into the database, he sees that many people have actually had very similar experiences to his own, but also, many have died. And he’s wondering, you know, if I’d been found dead, he told me, everybody would have said I died of epilepsy rather than the device. And it’s only because he lived and there’s a recording in the ER of what happened to him that anyone knows it wasn’t because of epilepsy. It was because of the device.

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DAVIES: This raises one of the interesting issues about these devices and their regulation. The FDA has this database at which physicians and hospitals are expected to report problems – adverse events with medical devices. Sounds like it would be a smart way – and the FDA says it is the way – we look for red flags. Why doesn’t it work better?

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LENZER: Well, first of all, there’s a study showing that only about 1 percent of all serious adverse events make it into the FDA’s adverse event database. And something that really surprised me was, it turns out that the more serious the event was, the less likely it was to be reported. Manufacturers are supposed to report these adverse events. And there is some leeway granted to them about determining whether the device event was related or not to the device.

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So, you know, sometimes people cough and sneeze when they have a device. It doesn’t mean the device caused it. The problem is is that there’s no independent party assessing whether these problems are related to the device or not. So leaving that decision to the company presents a real conflict of interest.

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DAVIES: Yeah. So, for example, if someone died because this stimulator had actually stopped his heart, it could appear to be epilepsy and therefore would not appear as an adverse event associated with the device….

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…LENZER: That’s a big problem. And that’s something that I refer to as cure as cause, where – doctors assume that when a patient dies – and I did too when I was in practice – that a patient has a heart attack, they died of a heart attack and the bad heart rhythm that went with it. We don’t assume that it’s the drug or the device that we prescribed for the patient. And that’s a real problem because it turns out that the kind of studies we need – there really shouldn’t even be a decision about whether a side effect is due to the device or not.

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We should just count up all the adverse events, all the deaths that occur in the patients who are implanted and in the control group. And that would give us a far better picture because it turns out that the kind of studies we need – there really shouldn’t even be a decision about whether a side effect is due to the device or not….

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LENZER: Well, he was told that he could have the generator taken out but not the lead wires, the lead wires that tunneled up to his neck and were wrapped around the vagus nerve because many surgeons have found that the wires become enmeshed in scar tissue. And it just becomes too dangerous to try to tease those wires out of the scar tissue. They can tear and destroy the very nerves that are next to them and even the jugular vein and the carotid artery that are right adjacent to the vagus nerve. So it’s too dangerous a surgery, and they left the lead wires in but took the generator out.

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DAVIES: Dennis Fegan was frustrated by what happened to him, and one of the things he considers is a lawsuit. It turns out he is unable to sue and he learns why….

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LENZER: Well, it turns out there was a Supreme Court ruling in 2008 called Riegel v. Medtronic, and it’s also called the pre-emption ruling. And what it means is that patients who are implanted with high-risk devices that went through the premarket approval process called PMA are not allowed to sue. And the basis for that is – is that supposedly they underwent rigorous testing proving the device was safe.

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DAVIES: So patients can sue in the case of a drug that they think has harmed them but not in devices that have gone through this process.

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LENZER: Not in certain devices – that’s right – certain high-risk devices…

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DAVIES: You argue in this book that the FDA does a bad job of regulating these devices because they’ve become heavily influenced, maybe even captured by the industries they regulate….

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LENZER:That’s no longer the case. We’ve had a number of instances now, including an episode dubbed Devicegate in which all of the scientists agreed that certain devices should not be approved because they were unsafe and ineffective. And yet the devices were put on the market over the unanimous opinion of their own scientists when politicians made phone calls to FDA superiors. This is really stunning that politics is trumping science. And it’s getting worse now with 21st Century Cures Act that was passed in late 2016, which essentially is deregulating even further.

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…. Even if we read the studies that are released, we don’t know that we can trust them.

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Other Devices That Are Particularly Problematic

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And I’ll give you two examples of just how difficult the situation is. One of the people I talk about in the book is a man who was harmed by a hip implant. Well, it turns out that man is also an orthopedic surgeon who specializes in hip replacements, and yet he landed up being poisoned by his hip implant from cobalt that leaked out of the hip and destroyed his muscles and tissues and even caused some degree of heart damage.

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Another example is a Medtronic executive that I report on who had a Medtronic device implanted in her spine and suffered just terribly disabling and painful effects from that device. So even people who are insiders and who should know don’t really know….

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…The Sprint Fidelis leads that go to defibrillators pacemakers were found to have fractured and cause serious injury and death. And these were implanted in hundreds of thousands of people. And this is one of the problems with devices – is that, you know, what do you do once you’re implanted with something that may be dangerous? Having them removed in 15 to 18 percent of people, nearly 1 in 5 people suffered serious adverse events or death when they tried to remove the leads.

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Hip implants have leaked chromium and cobalt, and there are other problems. Pelvic mesh – again, a seemingly simple device. It’s just mesh after all – surgical mesh. And yet it has grated through tissues like a cheese grater through cheese and caused what’s called fistulas – holes between the rectum and the vagina and causing serious pain, infections, hemorrhage. There are all kinds of problems with medical devices that people might want to think about first.

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And one of the common things I hear from patients is, you know, now that I think of it, my problem wasn’t that serious. So a woman who has a little bit of urinary dribbling when she sneezes or gets excited goes and gets this pelvic mesh put in because a doctor recommends it and then has a lifetime of pain, infections and suffering. So I guess my best advice would be, if you’re not certain you really need something, it might be best to wait….

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LENZER: And ask if your ER doctors know how to take care of you. I mean, there was one tragic case of a woman with a vagus nerve stimulator who called her sister saying, oh, my God, my VNS is shocking me. I can feel it. It’s so painful. I dropped to my knees. And her sister told her, go. Go straight to the ER.

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And the young woman who was about 39 years old, a young mother, said, I can’t because they don’t have the tools to turn this off. I have to wait until my doctor comes in on Monday morning. She didn’t get to see her doctor on Monday morning because her 9-year-old daughter found her dead in the bathroom on Sunday night….

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 Risk of Devices  – New York Times Opinion

by medical journalist Jeanne Lenzer

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When Stephen Tower’s right hip gave out in 2006, he asked his surgeon to implant an artificial one — specifically, a metal-on-metal hip called the ASR XL, made by Johnson & Johnson. He knew what he was talking about: As an orthopedic surgeon, Dr. Tower specializes in complex hip replacements. But what he knew wasn’t enough to protect him from a defect in the device.

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Five years after his surgery, and in excruciating pain, Dr. Tower underwent more surgery, this time to have the device replaced. When the surgeon sliced into his hip, what he saw looked like a crankcase full of dirty oil. Tissue surrounding the hip was black. Cobalt leaking from the ASR hip had caused a condition called metallosis, destroying not only local muscle, tendons and ligaments, but harming Dr. Tower’s heart and brain as well.

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Despite Dr. Tower’s repeated efforts to warn his colleagues and the company that the implants were harming patients, Johnson & Johnson continued to market metal-on-metal hips. While it withdrew the ASR XL model from the market in 2010, citing slow sales, it continued to sell another, similarly problematic model, the Pinnacle, until 2013.

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More than 9,000 patients filed suit against the company, and on Nov. 16, six New York patients won a $247 million trial verdictfor serious harms caused by the Pinnacle hip implants and for failing to warn doctors and patients about its dangers. These suits and others are pulling back the curtain on what some doctors call the Wild West of medicine: the untested and largely unregulated medical device industry.

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About 32 million Americans — or about one in 10 — have at least one medical device implanted, from artificial joints to cardiac stents, surgical mesh, pacemakers, defibrillators, nerve stimulators, replacement lenses in eyes, heart valves and birth control devices….

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Although the standard for approval of a new drug usually calls for two randomized, controlled clinical trials, the standard for many medical devices is no standard at all. Since medical devices didn’t come under regulatory control by the F.D.A. until 1976, the agency simply grandfathered in all devices that were already on the market under a provision known as 510(k), which allows manufacturers to sell most new devices without requiring any clinical testing as long as the manufacturer says its product is “substantially equivalent” to an existing device.

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Even when devices are subjected to trials, the F.D.A. sometimes ignores danger signs detected by those studies. In 1997, during the approval process of the vagus nerve stimulator, a device made by Cyberonics to treat epilepsy, an F.D.A. adviser voiced concerns about a high death rate noted in patients with the device. But the agency didn’t stop the device from going to market. Instead, it awarded conditional approval, meaning that Cyberonics would have to conduct safety studies after the device was on the market.

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The agency didn’t even require Cyberonics to inform patients that there was concern about the death rate, or that they were effectively being made unwitting guinea pigs. When Cyberonics finally submitted five studies that it said proved the device was safe, it failed to include death data for any of the studies, a move the F.D.A. defended, saying the agency hadn’t asked the company to count deaths, only to “characterize” deaths.

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How it’s possible to characterize deaths without including any actual data on deaths is anyone’s guess.

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With such shockingly lax regulations, it’s no surprise that device recalls have risen over the years; in 2003, there were eight Class 1 device recalls, which the F.D.A. defines as indicating “a reasonable probability” that a device will “cause serious adverse health consequences or death.” In 2016, that number rose to 117, affecting hundreds of thousands of patients.

..In addition to the 510(k) pathway, medical device companies can avoid clinical testing for the highest risk devices through the supplement pathway by telling the F.D.A. they made a minor change to a previously approved device. The use of these loopholes is widespread: A study published in The Journal of the American Medical Association in 2009 found that only 5 percent of high-risk implanted cardiac devices even partly met the standard for drug testing.

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Metal hips are far from the only devices with catastrophic consequences. In October 2007, Medtronic, a leading medical device manufacturer, recalled the lead wires in its Sprint Fidelis defibrillator after they were found to fracture and misfire, harming or even killing patients. The devices had not been clinically tested and were approved for sale by the F.D.A. through the supplement pathway. But in this case, the “minor change” was a fatal one; the new wire was thinner and prone to fracture.

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By the time of the recall, 268,000 leads had been implanted in patients worldwide, the majority in the United States. After the recall, many patients rushed to have the devices removed, but removal posed its own dangers, causing major complications in 15 percent of patients.

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Even when devices are subjected to trials, the F.D.A. sometimes ignores danger signs detected by those studies. In 1997, during the approval process of the vagus nerve stimulator, a device made by Cyberonics to treat epilepsy, an F.D.A. adviser voiced concerns about a high death rate noted in patients with the device. But the agency didn’t stop the device from going to market. Instead, it awarded conditional approval, meaning that Cyberonics would have to conduct safety studies after the device was on the market.

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The agency didn’t even require Cyberonics to inform patients that there was concern about the death rate, or that they were effectively being made unwitting guinea pigs. When Cyberonics finally submitted five studies that it said proved the device was safe, it failed to include death data for any of the studies, a move the F.D.A. defended, saying the agency hadn’t asked the company to count deaths, only to “characterize” deaths.

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How it’s possible to characterize deaths without including any actual data on deaths is anyone’s guess.

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With such shockingly lax regulations, it’s no surprise that device recalls have risen over the years; in 2003, there were eight Class 1 device recalls, which the F.D.A. defines as indicating “a reasonable probability” that a device will “cause serious adverse health consequences or death.” In 2016, that number rose to 117, affecting hundreds of thousands of patients.

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It is not legal for me to provide medical advice without an examination.

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It is not a substitute for medical advice, diagnosis or treatment provided by a qualified health care provider.

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