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H.R. 1346, The Medical Device Safety Act of 2009 (12 comments ↓ | 4 wiki edits)
H.R. 1346 would amend the Federal Food, Drug, and Cosmetic Act with respect to liability under State and local requirements respecting devices.
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Visitor Comments
byoung
July 1, 2009, 9:25am (report abuse)This bill needs to pass, as currently medical device manufactures are free from liability
on products approved by the FDA. Even if these products have never been tested in humans or if the product was modified, their is no liability to the device manufacturer. They can take any product and as long as the FDA approves it, you can do nothing about it.
One example is the certain lead wires that recently had fracture issues and the number of people that were effected by this can only sit back and do nothing. Getting shocked at 700 volts, repeatedly, thinking that you were dying, and having your family suffer thru it. Real people died from this, and it could of all been avoided.
Medical device companies should not have blanket protection. What about consumer protection?
Laura Jones
July 31, 2009, 9:48pm (report abuse)This bill is about the quality and safety of HUMAN lives!!! The medical device manufactures have it made. Their bottom line (profits) are protected at the expense of HUMAN lives!!! PLEASE pass this bill NOW!!!
Jackie Jones
August 6, 2009, 10:22pm (report abuse)Medtronic should not have made these devices that were not tested properly--They have done not only physical harm but caused much worry and emotional harm to patients and their familys
Please pass this bill as soon as possible
Jackie JonesCTXWI
Hank
August 19, 2009, 9:51pm (report abuse)Without the ability to sue there is no way to discovery if in fact the device manufacturer was guilty of fraud in its report to the FDA. One would have to sue the FDA to force an investigation which would put them in the position of proving their own malfeasance.
hank
August 19, 2009, 9:52pm (report abuse)Without the ability to sue there is no way to discovery if in fact the device manufacturer was guilty of fraud in its report to the FDA. One would have to sue the FDA to force an investigation which would put them in the position of proving their own malfeasance.
Jud Orcutt
August 21, 2009, 12:40am (report abuse)I am one of the victims of the Charite artificial disk. I had it implanted in May of 05. Directly after the surgery I had problems. I started having bouts of paralysis and extreme pain. It broke my facet joints in my back and caused me to have to get rods to hold my back together.I than got a severe infection from the corrective surgery which required my back to have to be reopened, drained, and than sewn shut. I had to be on IV antibiotics for nearly six months.The company knew that the disk was defective before it was put on the market and hide any Dr's beliefs or data that the device was unsafe. This device has totally destroyed my life. I now have to be on countless medications everyday for pain, insomnia, depression, and anxiety. I have two young children who think that daddy doesn’t want to hold them.
Jud Orcutt
August 21, 2009, 12:43am (report abuse)if this bill does not pass these companies have no way to be held responsible for the severe physical, emotional, and financial damage that they cause. I just wish that the opponents of this bill would come see the real life consequences of this choice and explain to my family why daddy can’t afford to feed them or
send them to college. Anyone reading this PLEASE encourage your Senators and Congressmen or women to vote yes and allow all these families devastated by a defective
medical product a glimse of hope!!!
Allan Silverman
September 2, 2009, 10:13am (report abuse)I was shocked with 700 volts 35 times in a row by a faulty fractured lead wire to my heart from a definrillator. It nearly killed me, and I had to get rushed from a job I was working, to the nearest hospital, in an ambulance. I would have died had I been alone or driving at the time. I owe about $100,000.00 in medical bills for a new heart defibrillator, and surgery.
Ten days before my defective heart defibrillator gave me problems, I received a letter from the manufacturer two years ago stating that there was only 1% chance I would have a defective fractured lead wire inside of me, and not to worry. My two year statute of limitation is running out, as I am sure everyone else's is too. I was shocked on 10/31/07. Please pass the Medical Equipment Safety Act at once.
Allan Silverman
September 2, 2009, 10:20am (report abuse)Please pass the Medical Equipment Safety Act S 540 at once. So many people including myself had our lives devastated physically and emotionally by defective medical devices such as fractured lead wires to the heart from defibrillators.
Scott Cooley
October 1, 2009, 3:25am (report abuse)I am a failed recipient of the Charite Artificial disc,it has cost me my health,job,home & future.
How can we allow these companies to destroy our bodies & lives with no concern at all of repercussions.
I was a very active 40 ish dude until i got the Chaite disc in 05 put in.It nearly killed me , was very ill for over three years after.
Now on disability, it's hard for me to see my family go without cause of the lies the doctors & the Charite disc promised us we would have our natural motion back in our spine.
That the Charite Disc was better than fusion & it would last eighty years and reduce pain 75%.
Lies, Lies, Lies.
They don't care.
Please help us restore our right to have compensation for these defective life destroying Charite Discs.
Pass HR 1346 At Once
noticia
November 17, 2009, 10:36am (report abuse)please congress restore the medical device safety bill, i was a victim of medtronic faulty lead product,i was shocked twenty-two times, leaving me a wreck. i cant support myself as i did before, for fear that if i move around to much. i will get shocked and this time i might not be as bless as before. i have put my family through so much since this horrible experience, i have personally wrote three senators for help.all of us that have been injured by this device and other like it need to be compensated,i beg you congress hear our cries for they are real.
angella
November 18, 2009, 7:53pm (report abuse)My father is dead because of the synchromed II infusion device. He leaves behind 2 minor children 1 handicapped son, and myself. I am the only one that can help my father, but because of this ruling my father's death means nothing. How do I help my brothers and sister? There is no ramifications for these companies. They can make a defective product, sell it, not report adverse cases to FDA, and have the devices taken out. ONLY to have new devices made from that comapny put it. What do I do now? NOTHING will ever bring my dad back, but he deserves justice.