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Over a quarter of a million heart patients were implanted with Sprint Fidelis leads, wires connecting the heart to a device that slows dangerously fast heartbeats. In many patients, however, the leads were defective and electrocuted them from the inside. Fractures in the leads caused these patients to suffer painful and unnecessary shocks, injuring or killing many of them.
Yet when these victims tried to hold the leads' manufacturer accountable for these injuries, the judge tossed them out of court. Citing a recent Supreme Court decision---decided exactly one year ago today---that grants almost total lawsuit immunity to the manufacturers of dangerous medical devices, the judge declared that he was powerless to help the many people electrocuted by a device intended to save their lives.
This case is not an isolated incident; it is only the most recent skirmish in a campaign by medical device manufacturers, drug companies and health insurers to ensure that, no matter how wrongful or illegal their actions, no person injured by such a company will ever be able to hold it accountable in court. Moreover, in many cases these companies have achieved such immunity by convincing judges to misinterpret laws Congress intended to protect patients, consumers and the insured.
In the 1970s, for example, a contraceptive device known as the Dalkon Shield caused numerous infections and deaths. Congress responded by requiring the FDA to approve new medical devices. Even though Congress enacted this law to protect consumers from dangerous devices, the Supreme Court recently held that the law prevents state tort suits against medical device manufactures. In other words, even though every state's common law obligates defective device manufacturers to compensate people injured by the defect, the Court held that states are powerless to enforce such law.
Similarly, in 1974, Congress passed the Employee Retirement Income Security Act or "ERISA" to ensure workers could rely on their pensions and employer-provided health plans. Yet instead of reading ERISA as Congress intended--to protect workers who receive employee benefits such as health insurance--the Supreme Court has transformed ERISA into a shield protecting health plans which wrongfully deny lifesaving coverage to such workers.
Consider the case of Phyllis Cannon, who died of leukemia after her insurer refused to cover an essential transplant, or that of James Lind, a construction manager with Multiple Sclerosis who was able to continue working, until his insurer suddenly refused to pay for the prescription that kept his MS at bay. Cannon, Lind and many like them were told the same thing by the courts: it does not matter if your insurer broke the law; we cannot help you.
When courts permit the health care industry to ignore the law, the public's health suffers. If insurers know that they are free to deny lifesaving but expensive coverage to their customers, they have no reason to keep their promises to sick patients. Similarly, if manufacturers of faulty devices can continue to market them without consequence, nothing prevents them from injuring future patients.
Thanks to their wildly successful campaign for total lawsuit immunity, health insurers and medical device manufacturers have profited at the public's expense. The new Congress, however, already has a blueprint which will allow it to roll back some of the Supreme Court's worst decisions protecting the health care industry. With progressives now dominating both houses of Congress, the time is ripe to revive the Patients' Bill of Rights, which restores the ability of people like Phyllis Cannon and James Lind to hold rogue health plans accountable in state court. Congress can also ensure the safety of medical devices like the Sprint Fidelis leads by enacting the Medical Device Safety Act, which revives the states' authority to protect their citizens against dangerous medical devices. Indeed, as Congress prepares to consider the President's ambitious health care plan, both bills deserve to be part of their agenda.
Yet, as Cannon and Lind know all too well, the mere fact that Congress intends to protect sick patients does not guarantee that the courts will read the law as Congress intended. Ultimately, the best solution for bad judging is good judges. President Obama must not forget this when he names his first appointments to the bench.
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The FDA certification precludes a suit in state court? As constituted and managed over the last eight years, this effectively precludes any redress of damages or injury, pain or suffering by these patients.
I left Cordis Corporation in 1982. They had been Medtronic's first domestic competitor. At that time the pacemakers Cordis made were failing by the tens of thousands, and Cordis executives ultimately suffered criminal consequences for misrepresenting the severity, cause and numbers of failed pacemakers. Shiley Labs, a heart valve manufacturer for whom I also previously sold, suffered a similar fate when its mechanical heart valves fractured and disintegrated, causing catastrophic deaths among patients implanted with valves that failed. Again, the executives responsible and the company faced civil AND criminal prosecution. Cordis had been second in their market, and Shiley first, in volume of sales.
So, it seems the legacy of the Reagan/Bush appointments to the bench are to strip the American People of redress when Medtronic, the leading manufacturer of electrophysiological systems, is accused of marketing defective devices that can injury and kill when they fail.
The laws have changed little if at all since Cordis and Shiley had to face justice. What has changed, is the view of business from the bench, at least the bench where Justice Scalia sits!
Congress must rewrite the law to clarify it for the good justices. Manufacturers must be held accountable for bad designs, deceptive practices, and poor manufacturing processes, whether they are making peanut paste, or pacemakers!
I have worked in the Insurance Industry and can tell you that they are nothing but a bunch of Gangsters. I got out because of that very fact. Better to sleep at night and not having to tell your kids that you are supporting them by denying other kids life support. Ya know what I mean!
At birth we pick up yeast in the canal which goes on to cause the Vaginal infections, weight gain allergies,asthma osteporosis acid reflux acne all part of what is called in medical community as THE SILENT KILLER that DEMS/REP have said has it's grip on this Nation children thru to heart disease. Allergy/asthma meds fine print tells you while pharma meds give temporary reprieve in the long run it makes COPD WORSE and everyday YOU'RE ON PHARMA MED/ANTIBIOITICS you are one day CLOSER to the X PERCENT on stimulus bill which will be left to DIE. In addition to VETS when they come home it will be YOU left to silence the screams of YOU/CHILDREN/VETS without meds. Children will be most vulnerable because their IMMUNE SYSTEMS are not formed yet. LEGISLATION is needed to kick out STIMULUS NOW. GOOGLE HR 219, American Center for Law and Justice, Michelle Malkin or Campaign to Save Soc Security and Medicare -A project of the National Assoc for uniformed Services
This website has more info. on HB 676.
http://conyers.house.gov/index.cfm?FuseAction=Issues.Home&Issue_id=063b74a4-19b9-b4b1-126b-f67f60e05f8c
The original problem started with these words, " the less care they, (HMOs) give them, (sick people), the more money, (HMOs), they make."
This quote was from Richard M. Nixon, (President), about the HMO Act of 1973. Edward Kennedy pushed it through Congress.
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Transcript of taped conversation between President Richard Nixon and John D. Ehrlichman (1971) that led to the HMO act of 1973:
Ehrlichman: "Edgar Kaiser is running his Permanente deal for profit. And the reason that he can - the reason he can do it - I had Edgar Kaiser come in - talk to me about this and I went into it in some depth. All the incentives are toward less medical care, because -"
Ehrlichman: " the less care they give them, the more money they make."
President Nixon: "Fine."
In the Senate, (Ted) Kennedy, author of the HMO Act, also encouraged its passage: ``I have strongly advocated passage of legislation to assist the development of health maintenance organizations as a viable and competitive alternative to fee-for-service practice. I believe that the HMO is the best idea put forth so far for containing costs and improving the organization and the delivery of health-care services.''
On December 29, 1973, President Nixon signed the HMO Act of 1973 into law.
This is what the Country needs now!
http://www.house.gov/conyers/news_hr676.htm
The only way that Americans will ever be free of corporate rule is to remove the government that the corporations have put in place, including the "supreme" court. The next three or four years are going to suck anyway. We might as well have another American revolutionary war.
People like me, who came from another country can always go back if they get sick and get good medical treatment for the fraction of the cost. I know that I will never be destitute or homeless, because of my medical bills. If this situation happens I will pack and go. But where can Americans go? This is truly cruel country when it comes to health care and health insurance. I am surprised that Americans are not rioting.
Our cruel, profit-driven "healthcare" system will never change as long as people like Scalia and the members of Congress have a terrific, taxpayer-funded health insurance plan. They see no need for change.
A Harvard Medical School, not Harvard Law, said that if the USA wants better heath care there need to be more and larger law suits.
Only 1 in 14 people who have a suit ever file.
Ian, I couldn't agree with you more. As a lifelong feminist and decent human being, I literally cried when Obama signed the Lilly Ledbetter Act. (For that matter, I cried off-and-on all day on November 5, tears of pure relief. Did it again on January 20.) That SCOTUS decision was beyond shameful, and Obama's judicial appointments will br critical to both the short- and long-term welfare of the American citizenry, in all their many faces...
This sounds like another Bush legacy...
See Ian Millhiser's Profile
You are exactly right that this is the legacy of George W. Bush's deregulatory agenda, and that of Presidents Reagan and Bush I before him. Even though the American people voted for change in November, the Supreme Court remains exactly the same as it was at the height of Bush's power, and it can do a great deal to thwart progressive change and advance its own pro-corporate, anti-worker, anti-consumer agenda.
The Lilly Ledbetter Act, which overturned one of the Supreme Court's most egregious recent decisions, is a good start. But the right-wing justices are still emboldened, and they still think that they can continue their assault on ordinary Americans. They need to lose their boldness, and the only way that's going to happen is if Congress and the President take them down a few pegs by overturning their worst decisions and appointing judges and justices who will faithfully enforce laws that protect ordinary Americans.
Lets not forget Clinton-Feinstein and the fake Democrats.
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