(Editorial Content)
The Supreme Court finally gave medical device makers their one true wish – Immunity from Lawsuits. Companies that produce medical devices like breast implants and implantable defibrillators now have federal protection against lawsuits arising from deaths or injuries associated with their products as long as the product has been approved for use by the FDA.
From the New York Times:
“Makers of medical devices like implantable defibrillators or breast implants are immune from liability for personal injuries as long as the Food and Drug Administration approved the device before it was marketed and it meets the agency’s specifications, the Supreme Court ruled on Wednesday. The 8-to-1 decision was a victory for the Bush administration, which for years has sought broad authority to pre-empt tougher state regulation. In 2004, the administration reversed longstanding federal policy and began arguing that “premarket approval” of a new medical device by the F.D.A. overrides most claims for damages under state law. Because federal law makes no provision for damage suits against device makers, injured patients have turned to state law and have won substantial awards.“
This is an absolute outrage! First the phone companies get immunity from lawsuits in which they illegally tapped the phone lines of American citizens. Now companies like Medtronic get immunity as long as the device was approved by the FDA. You might think this is as far as the Bush Administration’s hand-picked Supreme Joke… I mean Supreme Court Justices would take it. You would be wrong. The Supreme Court has accepted another FDA case for its next term. This one is on whether the FDA’s approval of a drug, as opposed to a device, pre-empts personal injury suits. In other words, as long as a drug gained FDA approval, it won’t matter how many people have died or been injured by the drug – pharmaceutical companies will get off without having to pay a dime to the victims and suffering families of the deceased, who in many cases may have lost their primary bread-winner.
This is what the United States of America is coming to. Corporate lobbyists have “convinced” our government that the interests of Big Business are more important than the safety of the American people. It makes me sick.
When Americans talk about reforming the legal system to do away with “frivolous lawsuits” they mean throwing cases out of court in which someone is suing a restaurant chain for millions because they found a hair in their soup, or burnt their tongue on the hot coffee. But the Bush Administration has used this legitimate call for reform as an excuse to grant immunity to their corporate pals. After all, if they have do go to court for killing thousands of people they won’t be able to make it to the BBQ down at the Crawford Ranch on Tuesday.
Well the next time you need a pacemaker to keep you from death…
make your own.
Nothing in this world is perfect when “man-made”. Hopefully, these companies can focus their profits into making even better equipment instead of having to put billions of dollars into reserves so they can pay for law suits.
Get over it, man!!
I counter your claim that Americans are clamoring for tort reform over hair in soup issues. In fact, Americans are just parroting misinformation spread by corporate interests. In reality, Americans by and large have no idea what the pertinent details are in most cases.
The McDonalds coffee lawsuit, which people often point to as an outrageous miscarriage of justice, was in fact a far more complex case that, when examined, yielded a lenient result.
Lawsuits are what private citizens have in their arsenal to protect themselves against the abuses against them by corporate power. Now that the Fortune 500 is firmly entrenched as the fourth branch of government, they seek to take that power away from us. It won’t be too hard since as a nation we, by and large, lack critical thinking skills and tend to get our “informed” views from the very media sources owned by the same corporations.
It would seem that the FDA is going to have to pick up the tab from now on. I don’t know how much good it would do to sue the organization itself, though. I guess the good news is that they will be taking the brunt of the social stigma for this absolutely ludicrous piece of legislation – or at least they would in a sane world.
To the First Guy:
So you’re saying that because a product helps some people live it’s ok if it causes other people to die? The only thing this law does is take away the incentive for a company to do its best to ensure the safety of the medical devices they produce.
When someone dies because a heart defibrillator goes haywire and shocks them to death, you don’t think the family should be allowed to sue the company who made it? What the hell is wrong with you?
I write as a person with an ICD who is 100% dependent. In other words without the pacemaker I die. I also have the defective Medtronic leads. I underwent a septal myectomy 16 years ago for HCM. I am always somewhat taken aback by the “tort reformers” who have little or no real life experience with what it is like to live ones life dependent upon a medical device. I have witnessed 1st hand Medtronics response to the lead recall. It has been too little too late and is characterized by deception and an all consuming attention to their bottom line, share price, executive compensation and NOT THE USERS OF THEIR DEVICES. I am disgusted by Medtronic, the Supreme Court and the Bush administration. Their behavior is appalling. My only hope is that one day they all have to live with a device or drug upon which their life depends, perhaps then they will wake up.
Of course. Next it will be drug immunity. Big Pharma is bigger than we can even imagine. And we basically subsidize the world’s health care. My doctor says a tetanus shot costs him $12. The same exact drug company gets to sell it to Canada for $6, but my doctor can’t buy it from there. And that same drug costs 12 cents in India. Who exactly is paying for all of that? We are. Out of our pockets with deductibles and ridiculous copayments if we have coverage at all.
If only someone had the balls to stand up to them. Not very likely.
Bah. This is just an extension of “Good Samaritan” laws. If you give someone CPR on the street and, in the process, crack some of his ribs (which often happens even for the “pros”), should the victim or the family of the victim be allowed to sue you? The answer has been overwhelmingly “No” in the past.
But if the drug companies or medical device companies try to help you, AND you willingly accept their help, if that attempt at helping actually harms you, SUE THEM?
Bah. Only in cases of negligence (like, say, you know studies suggest your drug harms more than it helps and you willfully ignore and hide that and market it anyway) should such lawsuits be entertained.
But finding out years later that the drug that helped your condition also caused some bad side-effect? I should sue you for soaking up my tax money in the court system. 😛
What it really comes down to, is whether or not you have one of the devices inside your body. I have a stimulation system that was supposed to curb the pain in my back and legs. Medtronic should be held liable for presenting itself as a reputable, while using sub-standard products.
Tell me why it’s right for them to enjoy themselves, when I am in constant pain, my life and quality of life reduced to an inkling. Oh yeah you don’t have the problem , so you sure as hell CAN’T GET IT.
My husband had a defib put in in Dec 2006. Medtronics and FDA knew in March 2006 that there were defected leads, yet they still, instead of recalling back in March 06, placed it in my husbands heart. Yet we have no recourse. They got their money and we live on pins and needles everyday…..Just look at the Meditronic equipment that has been recalled and yet they continue to allow the (censored) higher ups to put things in people that they know is something wrong or could cause death. I hope they all and I am a Christian, have to go thru this some day…..
I have a pacemaker on my left side put in 2002. the they put in 2 ….35 inch electrical wires screw in to my left chest.. theyare now shocking me terribly andhave for 2 years….no body wants to put me in anew pacemaker, so I ma stuck suffering..
2005 they put in a defribulator….. so if the pacemaker fails because of all this voltage it will shock my heart………….the promlem is it on recall defective wiring…………so its shocking me so bad the finally just shut it down….bit it just turned off,, no body will remove it either……so if these 2 medical devices dont kill me..I have to Kill my self……………. medtronic is saying dont remove these.. i dont what tosue any body I just want help tostop shocking me……….I think they had by one get one free
some body help me
In 2 days, they will implant me an ICD. I’m scare beyond belief. But they insist the technology is so much better and I shouldn’t worry. Can I hear from someone that has a recent implant and give me some advice or comment or just tell me how is everything going?