If your FDA-approved medical device injures, disables or kills you, that's too bad. The "doctrine of pre-emption" protects manufacturers from all liability. You're on your own. You have no recourse. The multibillion-dollar global conglomerates that design and produce these (often laughably flawed) devices, admit they assumed President Obama would revoke the handy pre-emption escape hatch, which is unfair and irrational -- not to mention cruel -- but it has remained intact. Well-funded lobbyists: priceless.
Case in point: Her beloved husband of more than 50 years had a defibrillator implanted in his chest to save his life if his heart stopped beating. Instead, the ultra-sophisticated device killed him. He was feeling pretty good until it malfunctioned, zapping him with 1,400 volts through the right ventricle. He cried out, falling onto the couch. As his wife ran toward him, it surged through him again. She took him in her arms. A third massive jolt slammed him.
The defibrillator-gone-mad tore into his heart 30 more times, until both he and the battery were dead. The device had gotten so hot, it burned a hole through his chest.
The multibillion-dollar corporation that made the defibrillator wasn't liable. Firms that make life-sustaining medical devices are exempt from prosecution, thanks to their lobbying finesse. Thousands of people every year are injured, permanently disabled or killed by their products. Sorry about that, but you're on your own.
There is a good chance that you or someone you know is wired up to one of these gadgets.
Ten months ago, my 92-year-old mother's pacemaker failed. She blacked out, smashing her head into the corner of a kitchen counter and fracturing her pelvis as she hit the floor. After a new pacemaker was implanted, she was in a nursing home for two months -- where she wasn't even allowed to walk for weeks -- and was sent home in a severely debilitated state.
(UPDATE: St Jude Medical Inc., the maker of her pacemaker, said on January 14, 2013, that it had received a warning letter from U.S. health officials concerning manufacturing issues at its Sylmar, California, plant, where it makes cardiac rhythm management devices. In a regulatory filing, St Jude said the FDA had noted in the letter that it would not approve certain new product applications until the quality system violations were corrected.)
My mother's beautiful, joyous, energetic, generous and independent life was devastated. She has been brutally victimized, and she will never be the same. She remains in chronic pain. She can no longer do many of the things she was able to do for herself before the incident. She is weak and unsteady. She is obliged to lie down on a heating pad several times a day due to pain and fatigue. Before the incident, her days were filled with pleasurable activity, inside and out. Her vigor, alertness and competence amazed everyone. Today, she is terribly diminished. Legally speaking, there is no guilty party. The manufacturer is absolutely free of liability, thanks to Congress and its "just say yes" approach to lobbyists.
The horrific assault on this innocent, tender woman is one of the saddest things I have ever experienced. The perpetrator has never even sent her a note to say, "Sorry about that!"
THE BEAT GOES ON
Millions of cardiac devices have been implanted in the U.S. during the past 20 years. More than 750,000 people currently have a defibrillator -- which can emit up to 1,700 volts of electricity -- and nearly a million have a pacemaker. The $10 billion heart-device industry -- dominated by Medtronic, St. Jude and Guidant (now known as Boston Scientific) -- sells millions of its products around the world every year. To be fair, countless lives are prolonged as a result.
But do patients give their informed consent to have a dangerous appliance implanted in their chests, and to absolve the manufacturer of all responsibility if the device damages them? I don't think so.
And even well before that, do those enlisted in clinical trials for heart devices understand the risks they face? A December 9, 2013, article in the New York Times casts doubts, as those who have invested millions in an unreliable, potentially lethal heart pump press for the studies to move forward (http://www.nytimes.com/2013/12/10/business/heart-device-opens-debate-abo...).
About half the people I know who are retirement age or older have a pacemaker or defibrillator. None of them had ever heard of the "doctrine of preemption" -- which blithely lets manufacturers off the hook if the device harms them -- until I told them about it. The three cardiologists I called to get their opinion of preemption had never heard of it either, and the editors of the nation's two top cardiology journals declined to take a stand. This is mind-boggling. It certainly makes one wonder if their loyalty is to patients or to device-makers.
TAKE ANOTHER LITTLE PIECE OF MY HEART
What makes the situation particularly galling is the growing evidence that "a vast majority of people who get cardiac implants never need them," according to the New York Times. It is one more aspect of the health-care system that is designed to enrich corporations and doctors rather than helping patients.
(Three years before her collapse in the kitchen, my mother, who had never had heart trouble -- or any health trouble, and didn't even have a primary care doctor -- went to an emergency room after having fainted. She had fainted three other times in the past 20 years, each time from dehydration. Despite that medical history, and the likelihood that dehydration was the culprit once again, she was rushed into surgery to implant a pacemaker. When she made an appointment, as directed, to see a cardiologist the following week, he said, "I see no evidence whatsoever that you need a pacemaker.")
The manufacturer of my mother's pacemaker denies that its device or the "lead" (the wire that attaches the pacemaker to the heart) malfunctioned. But after she was admitted to the hospital, and before her problem had been diagnosed, her condition was monitored via telemetry, and she experienced one brutal wave of vertigo and nausea after another, which clearly registered on the monitors. It was horrifying to see her subjected to these onslaughts -- spasms, moans and flailing about -- during which she felt she was dying. This was not her heart malfunctioning and violently attacking her. Her heart is and always has been fine. She has no heart disease. She had a flawed pacemaker, which was removed hours later.)
More and more people are being sliced open and wired up to these devices, even as improved treatment of cardiac disease with drugs, diet and behavioral changes is reducing the need for them.
Since 85 percent of those who use pacemakers and defibrillators are over 65, Medicare and Medicaid spend billions of our tax dollars to implant the devices, and then -- since the manufacturers aren't liable -- they spend billions more on hospitals, surgeries and rehab when the devices malfunction. (Medicare paid more than $75,000 for my mother's second surgery and so-called rehab after having paid about $45,000 for the initial implantation and $20,000 for the pacemaker.)
Why should taxpayers foot the bill when hugely profitable corporations screw up? The patients themselves -- the victims of malpractice -- are liable for tens of millions of dollars in expenses not covered by Medicare.
FEELING DISHEARTENED YET?
How can these multinational conglomerates possibly be free of liability when their incompetence or negligence devastate -- or even terminate -- patients' lives? If you find it hard to believe, join the club.
The lawyers and health-care analysts I interviewed about the policy of "federal preemption" agree that it is an outrage, even by Washington, D.C., standards, where money can buy you pretty much anything.
An FDA official admitted to Sen. Charles E. Grassley (R-Iowa) that, "There's a lot of stuff going on under the table."
"How can Americans rest easy about the safety of these life-saving products?" Grassley asked.
The FDA's device review system got a lot of unwanted attention in the fall of 2010 after a group of scientists complained that the agency pressured them to approve medical devices despite their own reservations about the health risks. In an open letter to President Barack Obama, the scientists called for "sweeping measures" to end "the systemic corruption and wrongdoing that permeates all levels of the FDA."
Just last week, it was revealed that the FDA put under sweeping surveillance five dissident scientists who had been expressing their concerns about the FDA device-approval process to Congress, the media, the president's office and their attorneys.
"What began as a narrow investigation into the possible leaking of confidential agency information by five scientists quickly grew in mid-2010 into a much broader campaign to counter outside critics of the agency’s medical review process, according to the cache of more than 80,000 pages of computer documents generated by the surveillance effort," the New York Times reported. A sort of "enemies list" was compiled, the Times added.
The scientists reportedly intend to sue the FDA on their own behalf. But who will sue on behalf of the public over the chummy, corrupt relationship between Congress, the FDA and device makers?
In a related development, the FDA said in March 2013 that it was moving to toughen regulation of the industry that produces external heart defibrillators — devices used to jolt a failing heart back into its regular rhythm — after tens of thousands of malfunctions and hundreds of deaths in recent years.
(Update: A September 9, 2013 article in the New York Times substantiates what I have learned in my extensive coverage of the FDA (http://well.blogs.nytimes.com/2013/09/09/new-concerns-on-robotic-surgeri...). Its approval process in general, and for medical devices in particular, is lax and ethically compromised. Its monitoring, via stern "warning letters," is regarded as a joke by the industry. Both doctors and device-makers fail to report the vast majority of malfunctions, injuries and deaths that are caused by approved products. And the FDA fails to act on the complaints it does receive, even when there are hundreds of them.
(An April 30, 2014 New York Times article notes the same futility in reporting problems to the FDA when nutritional supplements are the issue, even when deaths are occurring. “We’ve all been working under the premise that once a dangerous supplement is identified, the F.D.A. will swiftly remove it from the market,” Dr. Pieter Cohen of Harvard Medical School said. “But what I’ve come to realize over the last several years is that dangerous supplements remain on store shelves sometimes indefinitely or much longer than they should be.” The FDA, his colleagues note, is truly a "toothless tiger." http://well.blogs.nytimes.com/2014/04/30/why-dangerous-supplements-linge...)
(UPDATE: Now the FDA, as of Sept. 25, 2013, will presume to regulate mobile medical apps. Oh great! Millions of people are already using these apps, some of which are "moderate" to "high" risk. And on the same day of the FDA announcement, it was petitioned by 40 state attorneys general to regulate e-cigarettes. It can't even regulate itself!!)
"In health care, one fifth of the economy, we have this haphazard smattering of reports that relies on voluntary self-reporting with no oversight, no enforcement and no consequences," Dr. Martin A. Makary, an associate professor of surgery at Johns Hopkins, told the Times.)
BRACED FOR REFORM
The device makers know they have a ridiculously sweet deal -- no accountability! -- and they know it can't last.
Much to my surprise, a senior executive at one of the top three cardiac device-makers in the country acknowledged to me, off the record, that the industry is dreading, but expecting, eventual reform.
"When Obama won, we thought, 'Boy, it's over for us now.' We were sure he'd get preemption overturned. We thought everything would change. But nothing has changed. In fact, we're under less scrutiny than ever," he said.
Even Consumer Reports felt compelled to weigh in on this disgraceful state of affairs in March, 2012, according to LegalExaminer.com: "The doctrine of federal preemption has got to go," it stated. "Patient safety is truly at risk until it is eliminated."
I contacted the public-affairs offices of the top three cardiac device-makers in the country asking for their position on preemption. I explained that I was making an honest attempt to understand their point of view. I wasn't prepared to demonize them -- I assume they are decent people who believe in what they are doing. But all of them -- Medtronic, St. Jude and Guidant -- declined to comment, without explanation. According to industry journal Mass Device, it is an "explosive" issue.
The industry had been braced for preemption to be rescinded in the massive health-care overhaul, but it was left intact. Obama did attempt to impose a small excise tax on medical devices, to help fund health-care reform, but the manufacturers had such a fit, with the help of their D.C. lobbying powerhouse, AdvaMed, that the House of Representatives struck it down on June 7, 2012. The industry claimed the tax would be a "job killer," would "stifle innovation," putting the U.S. at a global disadvantage, and would put dynamic, young, smaller firms out of business.
"It's unprecedented to tax a company that's not yet profitable, and 70 percent of device makers aren't yet profitable," one business owner, Michael Minogue, told Chris Arnold on NPR's "Morning Edition" on July 3. He said a 2 percent tax on his firm, AbvioMed, would be $4 million, about 15 percent of what it pays for research & development and more than it pays pay for employee health care. Minogue says his company is just becoming profitable, so that's more than his entire profit for this year.
BIG HEART ATTACKS OVER A LITTLE TAX
Notwithstanding the industry's tantrum, the excise tax was upheld as part of the U.S. Supreme Court’s affirmative ruling June 29 on the health-care law.
Despite its stratospheric profits, and despite the fact that it is outsourcing thousands of jobs to get even richer, and despite the fact that American taxpayers shell out billions of dollars in assuming responsibility for its product defects, the industry is still griping about "giving back" a paltry 2.3 percent gratuity -- in the form of what is essentially a sales tax that they can pass along to their customers, according to economists such as Paul Van de Water -- and some are still plotting ways to get the tax removed.
(An April 2, 2013, article in the New York Times reports that the device makers have waged an intensive pressure assault on Congress, sweetened by tens of millions of dollars in contributions, and that it has won over a large majority, including 34 Democrats. It now seems likely that this tax, which was intended to help provide insurance coverage to the poor, will be revoked, the Times says.)
(Today – Oct. 17, 2013 -- the government shutdown has ended, and the medical-device industry, which waged an intense lobbying campaign, says it has garnered enough support to achieve a full repeal of the excise tax by early next year. Medical-device manufacturers allocate only a sliver of profits to research and development The industry’s enormous profits are a result of anticompetitive practices. Exorbitant prices fuel enormous profits — profits that dwarf both the medical-device tax and the industry’s investments in research and development. The United States spends about 50 percent more on the top five medical devices, compared with Europe and Japan, leading to $26 billion annually in excess spending, according to Topher Spiro, vice president for health policy at the Center for American Progress. http://www.nytimes.com/2013/10/17/opinion/the-myth-of-the-medical-device.... )
On June 26, Congress passed a measure that will collect increased fees for the FDA from device and drug makers in exchange for an expedited approval process.
That's all we need -- more speed. A previous increase in user fees for approval of new drugs cut the pre-market time nearly in half. Major recalls and reports of serious adverse events among patients don't speak well for devoting less time to safety and effectiveness considerations.
The new Congressional measure also permits those with clear conflicts of interest to participate in the approval process, according to critics. Public Citizen, Inc., is urging its members to voice their opposition to this additional corruption of the process.
The industry supported this part of the overhaul aggressively, which is always a bad sign.
AN ACHY-BREAKY PROTOCOL
The 1976 Medical Devices Act, which is an amendment to the Food, Drug and Cosmetics Act, exempts from liability Class III medical devices, which are “purported or represented to be for a use in supporting or sustaining human life or for a use which is of substantial importance in preventing impairment of human health,” or which “present a potential unreasonable risk of illness or injury.”
Doesn't it seem totally counter-intuitive to make these devices LESS ACCOUNTABLE when they are so important to sustaining life? By what twisted logic would we not require any accountability for a product that presents an "UNREASONABLE" risk? Why doesn't the FDA refuse approval until the device presents no risk, or reasonable risk?
Class III also denotes “a device for which insufficient information exists to determine that general controls are sufficient to provide reasonable assurance of its safety and effectiveness,” according to federal regulations (21CFR860.3).
In addition to pacemakers and defibrillators, the Class III designation applies to intraocular lenses, artificial hips, pulse generators, automated external defibrillators, implanted cerebella stimulators, and (surprisingly) HIV diagnostic tests and endosseous (dental) implants. In 1998, in response to safety concerns, the FDA reclassified breast implants as Class III devices.
WHEN YOU LEARN THE TRUTH, YOUR HEART SINKS
Is anyone else alarmed and confused by this?
One of the medical device industry's rationales for the special treatment it receives is that innovation would be stifled if it had to spend time and money defending itself in court when its products caused harm.
This, of course, is patently absurd.
"New and better devices will, over time, supersede older and less efficient ones; but that is a consequence of market forces and not regulation, " writes Professor David C. Vladeck of the Georgetown University Law Center.
And the current regime, which leaves device makers protected from the outside world while it "innovates," hasn't produced impressive results at all, according to Standard and Poor's.
"The medical device industry has produced little in the way of new products that would be considered revolutionary,'' its report concludes. "It's been 'more of the same' for many years."
Another excuse for relieving the industry of liability is that before a Class III medical device can be marketed, it must be approved by the FDA in what is referred to, ad nauseam, as "a rigorous process."
The manufacturer supposedly must persuade the FDA that the device has been competently designed, and that there is a ''reasonable assurance that the device is safe and effective," according to the Supreme Court, which has been called upon more than once to bring some clarity to this regulatory bizarro world.
It seems to me that the device should be safe "beyond a reasonable doubt," and that the manufacturers should be liable when it malfunctions, just as all other manufacturers are.
The primary route by which approval is obtained is the premarket approval (PMA) process. All supporting material provided to the FDA during the Class III scrutiny comes from the device maker, which can tweak it (and omit negative data) with no oversight. No outside opinions and no clinical trials by objective third parties are required. The process can take up to two years, but device makers have found more than one way to expedite it and decrease the scrutiny.
The thinking behind the Medical Device Act seems to be that if a product can pass the FDA's "rigorous" inspection, any failure of that product should not be blamed on the device-maker -- it's essentially an act of God. They can't help it if things go wrong every once in awhile!
HEARTS OF STONE
Obviously, that's ridiculous. Anyone who reads the newspaper knows that there has been one "emergency advisory" and recall after another of these FDA-approved products. The widely held notion that the approval process is thorough and effective is pure myth, and a very self-serving one.
The manufacturers could not possibly have proven their products to be safe. They're not safe. And apparently, they don't care.
"Under the FDA's approach, the company has only weak financial incentives to withdraw a defective device from the market, little incentive to make changes to improve the device's safety, and almost no incentive to warn patients and physicians of possible defects," Georgetown's Vladeck asserts.
Consumers Union agreed, in a February, 2012, statement: "The FDA has been criticized by public health experts and consumer advocates because many medical devices have been recalled as potentially lethal after having been approved by the FDA without scientific clinical trials proving that the devices were safe or effective. In a scathing report issued last summer, the well-respected Institute of Medicine (IOM) urged the FDA to trash its current system, which approves more than 95 percent of medical devices on the basis that they are 'substantially equivalent' to older medical products."
A September 9, 2013 article in the New York Times substantiates what I have learned in my extensive coverage of the FDA (http://well.blogs.nytimes.com/2013/09/09/new-concerns-on-robotic-surgeri...). Its approval process in general, and for medical devices in particular, is lax and ethically compromised. Its monitoring, via stern "warning letters," is regarded as a joke by the industry. Both doctors and device-makers fail to report the vast majority of malfunctions, injuries and deaths that are caused by approved products. And the FDA fails to act on the complaints it does receive, even when there are hundreds of them.
"In health care, one fifth of the economy, we have this haphazard smattering of reports that relies on voluntary self-reporting with no oversight, no enforcement and no consequences," Dr. Martin A. Makary, an associate professor of surgery at Johns Hopkins, told the Times.
(New rules published on September 20, 2013, "after years of pressure," will enable federal health regulators to begin tracking millions of medical devices, using a new electronic tracking system meant to protect patients by catching problematic implants earlier." The tracking system follows years of highly publicized recalls of (medical devices) that have been plagued by design and manufacturing flaws," according to the New York Times http://www.nytimes.com/2013/09/21/business/fda-to-require-tracking-codes....)
Despite chronic product failures, the industry's tireless AdvaMed lobbyists have been persistent and shrill in their demands that the FDA approval process be made even more lenient. They complain that it costs tens of millions of dollars to get their products approved, and that the European process is so much more efficient that new devices are made available there between two and six years sooner than they are here.
They complain about the unreliability and turnover of personnel at the FDA. They use blatant scare tactics in asserting that the U.S. is in imminent danger of losing its position as the innovation leader worldwide in the medical-device realm, because FDA scrutiny is so "stifling." They warn that they have been "forced" to move big chunks of their operations overseas to remain competitive, and may be forced to move more.
And they claim that even though the approval process in Europe is much faster and cheaper, the rate of product failure and recalls is virtually identical to that in the U.S. (nothing to brag about).
This is propaganda -- or, if you prefer, advocacy -- that is clearly negated by the documented facts about flaws and failures of medical devices in the U.S.
Moreover, nothing in AdvaMed's high-powered presentation makes the case that device makers should not be liable when their products cause disability or death, or when they are recalled because of dangerous design flaws. In fact, their position paper doesn't even mention the issue of preemption. When I asked the group's media-relations director if Europe has a "doctrine of preemption," I didn't receive a response. I tried again to get an answer from AdvaMed about this pivotal question and was rebuked.
I did an extensive review of EU documents and was unable to find anything that relieves medical device-makers of liability.
Why should Americans pay the price -- both in dollars and in pain and suffering -- when these exceedingly profitable products are defective?
OWNER OF A BROKEN HEART
One lawsuit after another has been filed on behalf of those whose lives were ended or permanently disabled due to the failure of an FDA-approved cardiac device. These cases have been coldly repudiated by the legal system, all the way to the Supreme Court. Even so, victims of flawed devices continue to file suit, hoping to find a way around the doctrine of preemption.
In the pivotal 1996 Lohr v. Medtronic case, the Court came to a shocking conclusion, from which it hasn't wavered, according to the Pepperdine Law Journal: "For Mrs. Lohr (who had been implanted with a Medtronic pacemaker) and numerous consumers who rely on medical devices, federal preemption means that they bear the risk and cost of any injury resulting from the manufacturer's negligent acts or unreasonably dangerous defective product." At that time, Medtronic had a 50 percent market share.
Justice Stevens was eloquent and refreshingly sensible in his dissent: "Preemption is contrary to the purpose of the Medical Devices Act," he wrote. "Finding that the MDA preempts all common law claims would leave the injured consumer, whom the MDA was meant to protect, with no legal relief from a company’s negligent design or manufacturing."
That's the way it is: No relief.
STOP DRAGGIN' MY HEART AROUND
Justice Stevens went on to add that it would be difficult to believe that Congress would take away all means of legal recourse from injured consumers without making that explicit, which it did not.
In the 2008 decision in Riegel v. Medtronic, the Supreme Court reiterated "complete immunity from liability" for manufacturers of Class III devices.
Justice Ruth Ginsberg, the lone dissenter in the case, made the obvious point that, "The process for approving new drugs is at least as rigorous as the premarket approval process for medical devices,” yet drug-makers are liable for the safety and effectiveness of their products.
Drug-makers, of course, face liability claims constantly, as their painstakingly tested and "proven" products damage patients or make them susceptible to life-threatening conditions. Ginsberg rightfully declared that medical devices are no more deserving of special immunity than drugs are.
TAKE ANOTHER LITTLE PIECE OF MY HEART
Consumer Reports has castigated the pre-market approval process and device-makers' immunity from prosecution. After looking through the reports of 29,000 deaths and serious injury caused by defective cardiac implants, it stated:
"The bottom line is that the FDA fails to ensure that patients are implanted with safe devices, especially when so little is asked of the device manufacturers."
The New England Journal of Medicine agreed, in a March 2012 editorial: "Patients in the United States continue to be exposed to under-performing and potentially hazardous medical devices after they have been approved by the Food and Drug Administration (FDA), despite multiple recalls and tragic adverse events."
The reality is that "our government has taken huge steps backward over the past decade in patient safety, as the lack of accountability from the device manufacturers will continue to trump any improvements that are made to increase the effectiveness of the FDA and, ultimately, patients will not be truly safe until federal medical device preemption is eliminated," Consumer Reports concluded.
For the time being, you're on your own when these "life-sustaining" appliances turn on you, literally attacking you. The manufacturer was through with you the moment the doctor slipped the device into your chest and sewed you up.
LISTEN TO YOUR HEART
A growing tide of doubt and scrutiny is engulfing the world of cardiac devices. Are patients with heart problems presented with nonsurgical options? Apparently not very often. Critics contend that most patients could more safely and less expensively be treated with medications and diet/lifestyle changes.
Are they given an explanation of the risks versus the benefits of implanted devices? If they were, that would be bad for business.
The data clearly lend credence to the theory that these devices are being aggressively marketed to doctors -- just as drugs are -- and that the doctors have been persuaded one way (good-old-boy network) or another (payments and gratuities) to use the devices whenever it's remotely defensible.
And the industry has gotten pretty darn cozy with the cardiologists, who are "significantly more likely than other specialists to receive payments from industry," according to a study in TheHeart journal. "Further research should address the overall appropriateness of relationships between different specialist groups and drug-, device-, and medically related industries," the authors conclude.
TAKIN' CARE OF BUSINESS
(In fact, in 2011 alone, Medtronic was fined $23.5 million and St. Jude was fined $16 million by the Justice Department for paying kickbacks to physicians for implanting their brands of pacemakers and defibrillators. The usual "thank you" gratuity was $2,000 per device.)
Thousands of patients each year suffer when an implanted cardiac device malfunctions, and the more complex the devices become, the more often they malfunction. The "New Generation Quartet Ventricular Heart Lead" from St. Jude uses four pacing electrodes and up to ten pacing configurations.
Scott Gottlieb, the FDA's deputy commissioner for policy, said in 2005: "When we looked across the annual reports we receive about these products, we have found increasing problems with some devices. This happened even as these devices got smaller, more sophisticated and more robust in their lifesaving benefits."
Every day, there are people who black out and drive into oncoming traffic or tumble down stairs, drown in a backyard pool or bleed to death internally, break their hips in a fall or sustain a head injury, when their implanted devices go haywire.
UNBREAK MY HEART
But these people -- who are really victims of assault -- need to be understanding, the courts have implied. They are entitled to no compensation whatsoever. The profit-bloated companies that make the devices do the best they can. I was going to say "make a good-faith effort," but if you read the internal memos, you realize that that isn't always true.
Device makers have continued -- for years, in some instances -- to sell products that they knew were flawed, a fact that is proven by their own internal memos. There were injuries, there were deaths, there were reports of product defects that were bound to injure patients if something wasn't done.
The device makers did nothing, until they had no alternative.
The industry has been forced to launch one recall after another, each affecting tens of thousands of patients, due to design flaws.
MONEY FOR NOTHING
Since the manufacturers bear no liability, patients have to pay for additional surgeries to remove the defective product and implant a new one. They must also pay for whatever other care is required, even when the products' dangers are egregious enough for the FDA to order the recall officially as a medical emergency.
When one of these appliances fails to work, it is common for the patient to collapse. Head injuries and broken bones -- including hips -- are not uncommon. A fundamentally healthy, active senior citizen can go straight to a wheelchair and need nursing home care for the rest of his life. Sorry people! The device makers go on their merry way, unscathed by the devastation they leave behind.
Despite the evidence that cardiac devices are often implanted in those who don't need them, the defibrillator market alone has grown to nearly 750,000 per year at a cost of more than $80,000 for each device and the surgery to implant it (Medicare shelled out $5 billion in 1995 for the procedure).
The questions about risk versus benefit are equally applicable for pacemakers, but close to 1.5 million are installed annually around the world.
RUMBLINGS IN THE HEARTLAND
A Health Technology Assessment undertaken by the National Institutes of Health concluded that "the evidence of short- to medium-term patient benefit from ICDs (implantable cardioverter-defibrillators) is strong, but cost-effectiveness modelling indicates that the extent of that benefit is probably not sufficient to make the technology worthwhile."
A 2012 Medscape article reported that "at least four notable, published ICD trials have failed to demonstrate a significant survival benefit to ICD therapy over optimal medical therapy."
Still, the number of implantations is growing "exponentially," according to the British Medical Journal.
There are three classes of heart patients, according to Brian Olshansky, MD, a professor in the Division of Cardiology at the University of Iowa Hospitals and Clinics. Only Number One could clearly benefit from an implanted cardiac device. Number Two should involve a careful, collaborative decision by the patient and at least one cardiologist. Number Three can be better and more safely managed without an implanted device.
TAKE THE MONEY AND RUN
More and more, though, doctors are cutting people open with little if any deliberation, and sliding those gadgets in, "just to play it safe." The problem is, it's not safe. It's Big Business.
The Journal of American Cardiology is alarmed: "The indications for implantable cardioverter-defibrillators (ICDs) for the prevention of sudden cardiac death have rapidly expanded over the past 10 years. Clinical trial data have quickly been implemented into guidelines without critical reassessment of the strengths and limitations of the evidence. ICD therapy has inherent risks including infection, unnecessary shocks, potential for pro-arrhythmia, device malfunction, highly publicized manufacturer advisories, and procedural complications, which can adversely affect morbidity and quality of life. A reappraisal of the benefits and potential hazards of ICD therapy will enable physicians to a have a more mutually informed and balanced dialogue with their patients."
WE ARE ALL JUST PRISONERS HERE, OF OUR OWN DEVICE
This point of view, which has been expressed by researchers repeatedly -- and which applies to pacemakers as well -- has had no impact on the market.
Thousands of the devices develop problems annually in the U.S. alone, with no liability incurred.
Nowhere else in our economy is this logic applied. If something you purchase injures or kills you, the maker is liable.
A TOTAL ECLIPSE OF THE HEART
In the Riegel case, mentioned earlier, the Supreme Court "overturned 30 years of consumer protections by ruling that any Class III device approved under the FDA’s premarket approval process would receive complete immunity from state tort law claims, even if the manufacturer knew of potential dangers associated with the product," writes H. Dennis Tolley, a professor of statistics at Brigham Young University.
As I have pointed out, internal memos document that device makers have continued to sell products they knew were flawed, and they failed to warn doctors or patients about possible problems.
Tolley estimates that Medicare will pay $1 billion for the 2007 FDA-ordered recall of Medtronic's Sprint Fidelis lead alone (the lead is a wire that attaches the pacemaker or defibrillator to the heart).
UPDATE: Another big, costly, Class 1 Medtronic recall was announced by the FDA on Nov. 16, 2013. Some 15,000 guidewire units used to implant heart devices are involved. Class 1 means there is a reasonable potential to cause serious injury or death.
RHYTHM IS GONNA GET YOU
The Medtronic Sprint Fidelis defibrillator lead is prone to fracture and was recalled after 665 failures and five reported deaths, according to a 2009 article in Heart Rhythm journal. "Approximately 150,000 patients at risk for sudden death in the United States have Sprint Fidelis leads. The rate of Sprint Fidelis lead failure may be increasing, and physicians are confronted with the decision (of whether) to replace the lead prophylactically."
Despite several of these little boo-boos, Medtronic's annual sales more than doubled and its profits almost tripled over a five-year period. Over the past 35 years, one model of lead after another has been shown to be defective. Each recall has added to the staggering financial burden that has been passed along to American taxpayers. Meanwhile, shares in Medtronic's stock have returned an average of 15.6 percent a year since 1980, according to The Motley Fool web site.
Medtronic, the "principal player in the worldwide medical technology race," distributes products and services to five million patients each year, generating $9 billion in annual sales.
IF YOU'VE GOT THE MONEY, THEY'VE GOT THE TIME
But even prior to the big "recall season" that began in 2010, Medtronic recalled two defibrillators. A total of 30,000 patients responded, and then paid for a second surgery.
In 2004, the FDA ordered a "high urgency" recall of Medtronic's Micro Jewell II (the world's "smallest and lightest implantable cardioverter-defibrillator") and GEM DR ICDs ("GEM is the first model in a "new generation of GEM defibrillators "that has advanced detection and diagnostic capabilities, and also has enhanced longevity," the company announced in 2000).
In issuing its recall of these two devices, the FDA said: "There is a reasonable probability that use of the product will cause serious injury or death."
Both products had been gushingly presented to the media in 1996 by CEO William George, who bragged that the FDA had approved the new devices "less than two months after initial submission in September."
JUST BEAT IT
In 1992, Medtronic's stated goal was to have the shortest time-to-market in the industry, a goal that would require a reduction of its development cycle from 18 to 12 months, according to EcoMert Strategic Organizational Consulting. "The design-cycle time of its pacing products has been reduced by 50 percent in the last decade, and Medtronic has managed to turn out four generations of its implantable defibrillators in two years in its efforts to stay ahead of its major rivals."
Medtronic has adopted a policy of "obsoleting its own products," to boost sales, the consulting firm adds.
By 1994, the firm had cut its premarket time to six months, CEO George told a Congressional subcommittee. Even so, he whined about this "burden," and complained about foreign competition. Medtronic "has had to move at least 12 new businesses and new product lines outside the U.S. to remain competitive, because of delays in the FDA process," he said. He added that there were "26 life-sustaining cardiac products that are available overseas but not in the U.S." because of the "onerous" approval process.
SIXTEEN TONS -- WHAT DO YOU GET?
If the FDA's oversight is such a heavy burden, how does one faulty device after another get approved?
If the FDA were doing its job, it would have been lobbying nonstop for the repeal of the Medical Devices Act, which releases device makers from liability. It would also require much more rigorous testing -- not less, which the industry advocates -- that would involve clinical trials conducted by objective experts who were answerable to the FDA, not the companies.
The disastrous aftermath of the status quo has been obvious for years. There are thousands of Class III products that have been put on the market, implanted in clueless patients, and later found to be defective.
WHO YOU GONNA CALL?
Even the General Accountability Office has jumped into fray, castigating the FDA's obviously ineffective premarket process.
The FDA website lists over 160 "highest priority" device recalls for 2009 alone, according to BYU's Tolley, which means "there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death."
Even after the FDA issues an urgent recall of a flawed device, the manufacturer is not liable for the costs or the devastating physical damage its products have caused. It is not liable even if it has withheld -- sometimes for years -- evidence that its product posed a danger to patients. It is not prosecuted for lying to the federal government for financial gain.
ANYONE WHO HAD A HEART
In June 2005 Guidant recalled 29,000 implanted defibrillators after never having alerted the FDA, doctors or patients to a potentially fatal flaw that it had known about for three years. It was only the highly publicized death of a 21-year-old man, Joshua Oukrop -- who was mountain biking with his fiance on a trail through red rock country in Utah -- and an imminent New York Times story on preemption, that forced Guidant's disclosure.
The Times obtained information for its article only after filing a Freedom of Information Act claim. Neither Guidant nor the FDA had been willing to release the data voluntarily.
Guidant then recalled or issued warnings for about 88,000 heart defibrillators -- including its top seller, the Contak Renewal 3 -- and almost 200,000 pacemakers because of reported malfunctions.
"Without the looming threat of tort liability, the company had little incentive -- economic or regulatory -- to (issue alerts about product defects)," a Pepperdine Law Journal article states.
Medtronic, the market leader, and St. Jude Medical, the third major player, subsequently announced product recalls involving tens of thousands of patients. Two years later, Medtronic recalled 200,000 Sprint Fidelis-brand leads after fractures began developing, but by then there had been several deaths reported, as well as hundreds of malfunctions and injuries. St. Jude and Guidant issued 50,000 recalls for the same product.
Then there was St. Jude's heralded Riata defibrillator lead, which threaded its way through the chest walls of about 79,000 patients in the U.S. alone. It started eroding through its protective coating in some patients, thereby jolting them unconscious with raw electric shocks. One study found the flaw in 15 percent of patients, but other studies show the actual number may be double that, according to MSNBC's Sara Wright. (In May 2012, she named St. Jude as one of four medical device firms exhibiting "bad behavior and egregious medical device troubles.")
SHOCK AND AWE
In December 2011, the FDA issued an urgent recall of several models of St. Jude's Riata leads.
"Leads with externalized conductors may develop electrical dysfunction and not work as intended. In the event the device does not work as intended, should a life-threatening heart rhythm occur, pacing or defibrillation therapy may not be delivered as intended. This may result in serious adverse events, including death," the FDA stated.
The recall was launched a full year after St. Jude sent an "Important Product Information" letter to doctors, and several years after the defects were acknowledged internally. These letters are generally poorly used by doctors, who apparently don't think it's their job to deliver someone else's bad news to patients.
Six months later, the failure rate had increased by 17 percent.
Dr. Edward J. Schloss of Cincinnati points to "high-voltage fatalities with a pretty clear pattern of insulation abrasion" as the impetus for the initial letter.
An estimated 128,000 patients worldwide still have a St. Jude's Riata lead implanted in their bodies, according to the New York Times.
St. Jude refuses to disclose how many deaths involving short-circuits and other electrical failures have resulted, the Times adds. But the Minneapolis Star Tribune reported in May 2012 that the "survivability" of Riata leads that remain in patients is steadily declining.
In study earlier this year at Vanderbilt, about a third of Riata leads had protruding wires. Nearly a third of those showed electrical failures, according to the Wall Street Journal, which attacked St. Jude's credibility in reporting the magnitude of the problem. Its data are based "only on complaints filed by doctors, and on products returned to St. Jude for inspection after patients die or have the device removed. They don’t account for problems that aren’t actively relayed to the company," it charged. The vast majority of patients and doctors do not submit reports to device manufacturers, or even to the FDA, as the FDA itself has acknowledged. (When the malfunctioning pacemaker was removed from my mother's chest, it was thrown in the trash.)
St. Jude lashed back at reports of 22 deaths resulting from erosion of its Riata lead, charging that arch-rival Medtronics Sprint Quattro lead had resulted in 377 fatalities, according to MassDevice journal. Each firm disputes the other's numbers, so the squabble over who has killed more people continues.
To the companies involved, it's not really a squabble -- it's a fierce public relations battle for a global market that is almost inconceivable it its scope.
But left unanswered amid the noise, according to the Journal of Cardiology, was the question: How closely had St. Jude been examining those deaths for signs pointing to a broader problem involving the Riata lead? The firm had gotten reports from Germany and Northern Ireland about lead erosion, on top of data from the U.S., but the St. Jude lead safety board decided at that time that it was premature to alert doctors about the exposed wire problem, according to Dr. Bruce Wilkoff of the Cleveland Clinic.
Even before that alarming information had been released about the Riata model, St. Jude Medical issued an advisory to doctors about its QuickSite and QuickFlex Left-Ventricular (LV) leads, according to Forbes magazine. The company said it would no longer sell these leads, because there had been reports of lead conductors protruding dangerously from their silicone insulation, just as there were with the embarrassing Riata leads.
The company estimates that "only" 3-4 percent of the 171,000 patients who received the newer leads may have wire protruding from the insulation, but safety data released by device makers has proven to be very unreliable in the past.
“The withdrawal of QuickFlex and QuickSite for the same issue adds credence to the argument that there may be an inherent flaw in the material or design of St. Jude’s cardiac rhythm management leads,” wrote Jefferies & Co. analyst Raj Denhoy.
Mizuho Securities analyst Michael Matson called the issue “another black eye” for St. Jude Medical.“We think this news is likely to further aggravate St. Jude’s customers and frustrate investors,” Matson told the Washington Post.
(St Jude hurriedly sent an upbeat release reassuring its investors about its expectations, plans and prospects, including potential clinical successes, anticipated regulatory approvals and future product launches, as well as projected revenues, margins, earnings and market share. Stockholders were understandably skeptical. And stockholders are everything. Or, to be more straightforward: money is everything.)
TURN THE BEAT AROUND
Yet another "new and improved" lead, the Durata, was introduced with a great deal of fanfare in January 2012 as a resounding departure from St. Jude's string of failures.
St. Jude CEO Daniel Starks said the new lead was protected "by a proprietary material that we call Optim...which is 50 (times) more resistant to abrasion than silicone. Customers can only get the benefit of Optim protection against insulation failures and Optim protection against lead abrasion from St. Jude Medical."
The company's web site hyped the new material as "a proven platform of long-term durability."
The Durata is "designed for durability in even the most challenging cases," and St. Jude's testing found "zero events of externalized conductors," thanks to Optim.
They really should watch their language. It seems that Optim isn't optimal after all.
On June 12, 2012, St. Jude shares dropped 6 percent on news that its greatly heralded new "state-of-the-art" Durata lead was experiencing problems that TheHeart journal characterized as "Riata-like." Rumors had been circulating among doctors and patients for some time that Durata would be yet another dangerous flop. (Just two months earlier, St. Jude had sent the S&P into a tizzy when its stock plunged over another scandal.)
On Aug. 21, the New York Times reported on a new study that casts further doubt about the resistance of Optim to life-threatening abrasion. St. Jude’s stock fell more than 4 percent the week before, after the F.D.A. announced it was ordering the company to perform additional safety tests. (http://www.nytimes.com/2012/08/22/business/cardiologist-warns-about-safe....)
Then, in mid-November, St. Jude provided a federal report critical of the Optim-enhanced Durata to the SEC. Even though it had blacked out the name of the product, the company lost $1 billion of its value almost immediately. On Nov. 26, analysts said the company's latest misfire would likely cause yet another plunge in its stock price, which has already fallen 16 percent this year. (News Analysis: A Name Blacked Out, a Reputation at Risk)
LIVE AND LET DIE
The FDA said the lead carrying electricity from the Durata defibrillator to the heart was exposed through its insulation, despite St. Jude's claims about its costly new material.
Although 44 percent of doctors in one survey had said months ago that they would not implant the new lead because of ongoing doubts about St. Jude's competence, there are 250,000 patients who have this now-suspect product embedded in their chests.
At some point, in the wake of all these embarrassing product failures, the industry promised safety reforms and "objective" advisory panels. The reforms clearly didn't work. The oversight panels have been limp-wristed at best and openly contemptuous of patient safety at worst.
Several publications that have attempted to interview members of these panel have been rebuffed or given vague and frankly cavalier answers to questions about patient safety. All of this, and much more, points to the failure of the industry's oversight panels, which were created entirely because it was being hit with one public-relations nightmare after another.
That hasn't stopped.
DON'T GO BREAKIN' MY HEART
In May, 2012, the FDA announced yet another plan to implement "a more rigorous safety-monitoring program that could more quickly remove faulty devices from the market," according to the Wall Street Journal.
What is so hard about doing this? The FDA has been making the same promise for years. How many people have to die before this so-called regulatory agency gets tough?
The "reporting protocol" is absurdly lax, providing no incentive and no convenient means for patients and doctors to submit problems to the FDA. It's like trying to report fraud to Medicare. You spend 40 minutes on hold, and then your information is filed away forever.
When I attempted to file a report on the FDA web site about my mother's defective pacemaker, the process was so cumbersome and exasperating that I almost gave up. On one page, I was forced to check a box saying "the patient died" before I was allowed to proceed to the following page.
On July 3, 2012, the FDA released yet another proposal to improve the detection of device problems before tens of thousands of people are injured or killed by them. The idea, which was originally mandated in a 2007 law (typical) and won't even begin to be implemented until 2014 at best (if at all) is to assign a tracking number to each Class III medical device. A Brave New World of patient protection. Right.
HEARTS AND MINDS: VERY LITTLE OF EITHER
This scenario requires that doctors and hospitals maintain comprehensive databases and that the FDA monitor all of these repositories to track trends in device flaws. If there actually were a will to keep tabs on the safety of these devices, tracking numbers wouldn't be necessary. In fact, neither the medical establishment nor the FDA has seen fit to invest the slightest bit of effort in providing the most basic reporting to each other or to the public. The device makers, as we have previously noted, have made an effort all right -- to suppress reports of product malfunctions.
This new FDA gimmick, if it's even implemented, has little chance of being effective unless minds and mindsets are radically changed.
DON'T STOP THINKING ABOUT TOMORROW
In March, 2012, the University of Michigan announced that its engineering researchers have designed a device that harvests energy from the reverberation of heartbeats through the chest and converts it to electricity to run a pacemaker or an implanted defibrillator. These mini-medical machines send electrical signals to the heart to keep it beating in a healthy rhythm. They hope to build a prototype soon from their detailed blueprints.
By taking the place of the batteries that power them today, the new energy harvester could save patients from repeated surgeries. An incision is currently the only way to replace the batteries, which last five to 10 years.
LEADERSHIP MEANS NEVER HAVING TO SAY 'LEADS'
Medtronic announced in 2010 that it was developing a pacemaker so small, it can be implanted directly into your heart via catheter and permanently latch itself into the flesh with tiny claws. Doctors will theoretically be able to monitor and adjust the pacemaker wirelessly, even, perhaps, from a cellphone. This would sound quite interesting, if it weren't for Medtronics' track record. Instead, it just sounds terrifying. Tiny claws -- oh great!
A year later, St. Jude invested millions of dollars in Nanostim, Inc., a privately-owned developer of miniaturized, leadless pacemakers. It gained the right to buy the firm if certain benchmarks are met.
(UPDATE: On Oct. 13, 2013, St. Jude announced it had indeed purchased Nanostim Inc., for $123.5 million, and said the company’s core technology, a tiny wireless pacemaker implanted entirely inside the heart, has won European Union approval. http://www.bloomberg.com/news/2013-10-14/st-jude-buys-nanostim-as-pacema...)
MY HEART WILL GO ON AND ON
Ironically, although these cardiac devices are often defective, and even deadly, they keep working brilliantly when a patient is ready to die. They keep you alive, even when you are brain dead. They keep you alive when your living will says you wish to be "let go." They keep you alive when your family directs medical personnel to "pull the plug."
Doctors have indicated an unwillingness to deactivate life-sustaining devices. Many of them feel that there is a difference between allowing a terminal patient to die by withholding life support, versus directly causing the patient's death by "killing" an implanted apparatus. When the American Journal of Hospice and Palliative Care asked the three top device makers for guidance, the response was, "That's not our job. That's the doctor's job."
None would provide materials to help doctors and patients address end-of-life situations in which a pacemaker or defibrillator would pose a problem.
MY HEART'S DESIRE
It seems that very few cardiac patients -- or even their doctors -- are aware of the doctrine of preemption. When my mother's pacemaker malfunctioned, leaving her life in ruins, I was so consumed with grief that it didn't occur to me for two or three months that someone should be held responsible.
That was when I learned that no one is responsible.
We can change this. I really believe that preemption will not stand once the general public becomes aware of the outrageously privileged status which medical device-makers have obtained for themselves. Let's spread the word and take them down.
UPDATE: “When we got the data, we said, ‘Wow,’ ” said Dr. Randall C. Starling, a cardiologist at Cleveland Clinic. Yet another study shows the dangers of an FDA-approved heart device, a left ventricular pump. http://www.nytimes.com/2013/11/28/business/3-hospital-study-links-heart-....
UPDATE: The price of medical devices is hugely inflated, according to an August 13, 2013 New York Times article. For example, an artificial hip costs only about $350 to manufacture in the United States, but it sells for about $15,000. The surgery is close to $50,000.
The Times reports : "As the United States struggles to rein in its growing $2.7 trillion health care bill, the cost of medical devices like joint implants, pacemakers and artificial urinary valves offers a cautionary tale. Like many medical products or procedures, they cost far more in the United States than in many other developed countries.
Makers of artificial implants — the biggest single cost of most joint replacement surgeries — have proved particularly adept at commanding inflated prices, according to health economists. Multiple intermediaries then mark up the charges....So why are implant list prices so high, and rising by more than 5 percent a year?
In the United States, nearly all hip and knee implants are made by five companies, which some economists describe as a cartel...Device makers typically require doctors’ groups and hospitals to sign nondisclosure agreements about prices, which means institutions do not know what their competitors are paying. This secrecy erodes bargaining power and has allowed a small industry of profit-taking middlemen to flourish: joint implant purchasing consultants, implant billing companies, joint brokers.
There are as many as 13 layers of vendors between the physician and the patient for a hip replacement, according to Kate Willhite, a former executive director of the Manitowoc Surgery Center in Wisconsin. The basic design of artificial joints has not changed for decades. But increased volume — about one million knee and hip replacements are performed in the United States annually — and competition have not lowered prices, as would typically happen with products like clothes or cars."
UPDATE May 28, 2014: Another big win for the medical device industry, based on meager benefits: "The Food and Drug Administration approved a new implantable device to help doctors monitor patients with severe heart failure as they go about their day. The agency cleared the CardioMEMS HF System for patients who were hospitalized in the previous year because of heart failure. The device uses an implanted sensor in the peripheral artery to measure blood pressure and heart rate. The information is wirelessly transmitted to an electronic database that can be retrieved by patients’ physicians. The F.D.A. cleared the device based on a study of 550 patients in which those with the device had significantly fewer heart-failure-related hospitalizations than those without it. (What none of the media or FDA coverage mentioned is that the clinical trial showed only a 28 percent reduction in heart failure hospitalizations at 6 months, despite its substantial cost. The FDA characterizes it as "reasonably safe.") Larry Biegelsen, a Wells Fargo analyst, said in a research note that the device, manufactured by CardioMEMS, based in Atlanta, could reach annual sales of $259 million by 2018." Two days later, I have learned, this company was acquired by St. Jude Medical. How auspicious! (http://www.nytimes.com/2014/05/29/business/fda-approves-heart-device-tha...)