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H.R. 1346, The Medical Device Safety Act of 2009 (58 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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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.
RICHARD WILSSENS
December 4, 2009, 6:40am (report abuse)MEDTRONICS SENDS MILLONS TOO WASHINGTON TO THESE PEOPLE WE PUT IN OFFICE SO THEY OWE THIS AND ALL THE OTHER COMPANIES PAY BACK WE HAVE TOO VOTE OUT THESE CROOKS IT IS ALL ABOUT MONEY MONEY THE PEOPLE DO NOT STAND A CHNCE RIGHT IS RIGHT BUT NOT WITH THESE GUYS AND GIRLS WE HAVE UP THERE I DO NOT KNOW HOW THEY SLEEP AT NIGHT
brent
December 10, 2009, 4:49pm (report abuse)just like congress people dying and they vote on a college palyoff,wow what a bunch of bums
Bill Simpson
February 17, 2010, 4:28pm (report abuse)I too have been shocked by the Medtronic device twice in the same day so I had them shut it off and scheduled surgery to remove it. I do not wish this on anyone. Just sitting at my desk tapping away on the computer and the next thing I remember I am picking myself off the floor wondering why my foot hurt so bad. Come to find out i kicked a whole in the back of my desk. I am so happy that thing is out of me but they could not remove the leads themselves so I now feel the plug under my skin. My problem with it is they knew about it before it was ever implanted and continued to sell them. Please pass the Medical Device Safety Act.
JamesH
February 21, 2010, 12:13pm (report abuse)Another victim here. I wish we would get some updates on this... If this doesnt pass its time to find a better country to be a part of.
CrystalP
March 2, 2010, 4:57pm (report abuse)We need to pass the Medical Device Safety Act. People's lives are being damaged and manufacturers need to be held accountable. Put yourself in the victims shoes. Wouldn't you want some type of compensation for your trouble or atleast the feeling that they will accept responsibility for it?
Jeaneane Jones
March 4, 2010, 12:08pm (report abuse)I am very concerned about the passing of this bill. If passed it will give consumers the chance to be made whole when unfortunate circumstances involving these devices have altered the life of individuals. If we do not pass this bill the corporations that produce these devices do not feel any reprecutions on delivering falthy equipment. These devices are an asset to those who need them but not if they are causing more damage to the consumers. By passing this bill it will make the manufactures of these devices take more care before putting them up for distribution and there will be less inferior products and this will benefit all concerns.
Vicki Kimmick
March 4, 2010, 11:42pm (report abuse)I am in support of the proposed Medical Device Safety Act of 2009:S. 540. Quality in health care, especially medical devices, is very important in today's society. If there is a defect in a medical device such as the Medtronic sprint Fidelis heart lead, a person should be able to take legal action at the state and local level. The public needs to have its rights restored in case of any issues with medical devices intended for human use. Our poulation of people are living longer and their rights need to be protected if a faulty medical device is used to correct their medical issue. Manufacturers of these devices need to be held responsible and correct the problem for any person affected and need to do so in a timely manner.
Barbara Geisthardt
March 5, 2010, 3:35am (report abuse)I am in support of the Medical Device Safety Act of 2009, S. 540 and H.R. 1346. I believe manufactures should acknowledge all and accurate warnings of their medical devices. Patients should be allowed to make an informed decision before implanting the devices. If they are willing to take the risk, that should be their choice. If a manufacturer is aware of a defect before FDA approval, patients or family members should be allowed to take legal action against them. Why would you manufacture a defective medical device that you know is going to be implanted in a human being, knowing it has the potential to cause serious bodily harm, if not death? The legal actions maybe the only way the public will become aware of the defect and require the manufacturer to take steps to correct the defect or discontinue the manufacturering of the device. I believe we have the right to hold manufacturers responsible for their negligence.
Cheri
March 5, 2010, 10:10am (report abuse)I didn't even know this bill or the reason behind it existed until last week. I learned of it in a class. Unfortunatey many people have to learn about it the hard way in that they've been injured by one of these defective devices and now have no recourse. The government is supposed to be "for the people" and that alone is reason enough to pass this bill. Add to that that when people hear "FDA approved" about a device, they expect that to mean it's been found to be safe and effective for humans. This compromises the reputation of the FDA and you'd think that they would want to be reputable in every way they can be, but when they are essentially siding with shoddy practices and turning their backs on quality that is a disservice to the very people they exist to protect. The FDA should put their muscle behind this bill, as well.
Donyele
March 5, 2010, 12:07pm (report abuse)I am all for this bill due to the simple fact I think everyone should fit into the same guidelines. These companies need to be very careful and ensure their devices are working properly do they don't cost anyone their life. If they do malfunction each company involved should get the same punishment instead of it varying from state to state.
James Owens
March 5, 2010, 12:55pm (report abuse)My minimal education on this bill is from an assignment and not any personal expierence, but I was suprised that an american citizen could actually be barred from what would seem to be the basic right to the pursuit of happiness and to pursue financial damages the medical device manufacturers whose faulty and flawed products take that right away.
Ashly Becthold
March 5, 2010, 8:08pm (report abuse)If this bill is passed it will bring a restored faith to the FDA. We should be able to trust what the FDA is approving to be safe, when in turn, some cases it generates serious health problems at times resulting in death. The FDA shouldn’t be promoting something that’s not safe or properly tested for human usage. Although I am for this bill passing to help protect those who have been seriously affected by the malfunctions thus far, I do believe that if this bill were passed it should certainly be considered that no matter how many times a product has been tested, or for how many years a product has been tested there is still no 100% guarantee that every single consumer will have absolutely no harmful side effects associated to said product. Each person has a different body and reactions to products; it would be ultimately impossible to test all products on all body types and guarantee its safety. If they could even do that, the cost would be detrimental.
Katie K
March 6, 2010, 10:21am (report abuse)I feel that it would be very beneficial to pass this bill. Medical device companies would take extreme caution when developing new products because of the potential lawsuits that may arise. I also feel that there should be some sort of cap as to how much people should be able to collect. People also need to understand that prices of these new devices will increase drastically because companies will have to collect enough to cover any lawsuits that rise.
Ian Oundo
March 6, 2010, 11:35am (report abuse)Lets think about this for a second, when an individual in this country causes damage to another as a result of their carelessness, they are held liable for these damages, which could range from something as simple as taking one's car and causing them to miss work, to engaging in activities that might cause harm to one's body. Then you have these medical companies, that on a daily basis keep assuring us that their medical devices are built and developed to save our lives, not being held liable for any flaws and mistakes that sometimes go as far as causing death because a medical device they built and certified as being functional just killed someone. Where is the justice and fairness in this? I support this bill because I believe not only will it ensure that these companies take a serious approach when testing these products before they enter the market, they will have it in the back of their heads,that if not done right,there's a hefty price to pay the same across the board nationwide.
Lindsey Madsen
March 6, 2010, 10:02pm (report abuse)I am in support of this bill. How, in America, can a patient be barred from suing the one(s) who is/are responsible for their injuries? The current law as it stands is unconstitutional. It is imperative that Congress pass the Medical Device Safety Act of 2009. Medical device manufacturers should not be free from liability for damages caused by their dangerous or defective medical devices. Patients are being hurt and medical device manufacturers need to be held accountable.
Sandy K
March 7, 2010, 2:01pm (report abuse)I am in support of this bill. I think that Medical Device Manufactures owe it to their consumers to let them know of all of the possible risks associated with their product. This is something that affects people lives and well being, not something that is a minor inconvenience. People have the right to know what they are getting into before getting into it, it is their body and their well being that is at stake and I don't think that manufacturers have the right to hold pertinent information from their consumer. I also believe that if the manufacture does not want to disclose all of the information that they have on the product then they should be held responsible for anything that goes wrong the the victim did not knowingly agree to.
eheitner
March 7, 2010, 3:38pm (report abuse)Please support the passing of The Medical Device Safety Act of 2009.
Individuals in our society are held responsible in a court of law for their actions and the same should be said about the medical device companies.
The public’s health should be our priority and not the best interest of the organizations manufacturing the devices that are hurting patients.
Alemon
March 7, 2010, 3:46pm (report abuse)This bill needs to pass, there are too many stories about other peoples physical and emotional pains because of a defective medical device. The manufacturers need to be held responsible for the damages they are causing the victims and their families. Please pass this bill.
Nicole Dack
March 7, 2010, 7:56pm (report abuse)I feel that passing this bill would benefit the American people. The companies producing the medical devises should be held liable for malfunctions in their products. People are losing loved ones and if a car accident had taken a loved one from them, why should they not be held liable if a medical devise is the cause of pain and suffering, or death.
Mollie
March 8, 2010, 12:07am (report abuse)Personally, I think that this law needs to be passed. You hear everyday about people's pain and suffering because of a faulty medical device. They should be able to collect for their damages because of it. The companies need to start taking responsibilty for it, esp if they know that their devices could very well be defective. I also believe that the well-being of all of us needs to be a high priority, instead of the medical device companies. If you think about it, everyday people are being sued or put in jail for causing harm to someone else. They are held liable for THEIR actions, so why cant the companies that cause harm to someone else be held responsible for their actions? Without a doubt, this law needs to be passed.
MARY E
March 13, 2010, 11:28am (report abuse)I TOO, AS MANY ARE A VICTIM OF THE CHARITE DISC. I LOST MY JOB, MY HOME, MY BUBBLY LIFE. I HAVE FACET JOINTS ARE ALL CRACK, MY LEGS ARE HEAVY, LOST 40 POUNDS, AND I HAVE TO TAKE A SLEEPING PILL EVERYNIGHT SO I CAN SLEEP 5-6HOURS.PLEASE THINK OF US HUMANS........
Jack00
March 24, 2010, 5:59pm (report abuse)Does anyone know if this Bill was included in the Health Reform Law just passed? I have heard varrying statements by lobbyists and congressional representatives.
Robert Mason
March 25, 2010, 1:34pm (report abuse)The 2nd day I had the Medtronic I.C.D device implanted, I was back at the hospital Complaining of being shocked- that was Sept 06, they told me it was all in my mind-this was B4 the recall or any public or legal outcry which no one has heard- My life is a mess behind this, there will b justice in this world or the next- These corrupt judges that rule in favor of b"Big Business" are no better than criminals- I hope they get something put in their chest that they have to worry about 24/7.
norm howe
April 1, 2010, 4:45pm (report abuse)This is a bad bill. If unsafe devices are getting approved by FDA, then the corrective action is to tell congress to make FDA upgrade their standards for approval. IF you allow the courts to judge medical device safety, we'll have chaos. The device companies companies will never be able to predict what standards a court might apply.
The real problem is that FDA is underfunded for their assigned role.
NickiS
April 1, 2010, 10:25pm (report abuse)The courts have been allowed to judge medical device safety until 2008. There was not chaos before the word preemption came into play. Just because a medical device gets approval does not mean something can't go wrong in manufacturing practices. When companies lie to the FDA and/or withhold information, do not follow QC/QA control practices, how will we ever know without the courts? The FDA has asked for info from companies and they have refused to comply. Why? How many people will have to die from a medical device before the companies will have to answer to the public? What percentage of failure is acceptable, 5%, 15%, 30%, 50%? Are you willing to pay more taxes to fund the FDA so these companies can make thier billion dollar profits without having to answer to anyone once they have approval? If you are against this bill, I would like you to talk to my mom about what happens when your lead breaks. I will take you to her grave site and let her tell you her story.
JonS
April 6, 2010, 12:48am (report abuse)Does anyone know if the language of the Medical Device Safety Act was included in the recently passed Health Care Reform Legislation? I have heard varrying accounts.
robert jackson
May 10, 2010, 12:40pm (report abuse)congress just do what is right its not rocket science pass the freakin bill
Jackie Jones
May 20, 2010, 12:03pm (report abuse)I think this bill needs to be passed--My husband is very anxious because he has # 6949 defibulater -Sprint Fidelis leads and constantly feels he will get Hit again -My emotional state is not good because I am the caregiver annd He is afraid to to move much because of the information he has read-When he was zapped-It knocked him to the floor ,he was inthe tile bathroom and could have been hurt more.Please It has wrecked Hacoc on our lives
JackieJones
May 20, 2010, 12:05pm (report abuse)How can I create an accountOZYDW
Mark Baird
May 24, 2010, 6:15am (report abuse)If we do not pass the bill then the politically controlled FDA will have have complete control over our lives.
robertsfight.com
kad
May 31, 2010, 12:46pm (report abuse)I can see the points in support for this act, but I believe in considering both sides of a topic are best to get all of the information out there. The FDA goes through extensive investigation and research in the process of approving medical devices and warnings. The manufacturers have to get approval from the FDA in every aspect of the manufacturing. I think it’s ultimately up to the person/professional using the product to take into consideration the risks and to administer the product properly. If this act were to go into effect it would deter new devices from being put on the market due to its possible risks, even though it could provide great benefits for a patient in receiving the most advanced technology. It would just create more lawsuits in being able to sue the manufacturers at the state level.
Ashley
May 31, 2010, 8:26pm (report abuse)I think this bill is very important. People with faulty medical devices should be able to seek damages for these products and the companies should be held liable. Please support this bill!
CSmith
June 3, 2010, 9:58pm (report abuse)The Federal Drug Administration already has safety standards set for pharmaceutical companies that manufacture drugs. Safety standards are also already in place for most products that are manufactured and/or sold in the United States. To assume that medical device manufacturers are above making electronic mistakes or hardware defects is a serious blunder. Why shouldn’t we hold the manufacturer of medical devices, for example, liable for possible injuries that may occur, like we do for any other manufacturer? I personally support the Medical Device Safety Act of 2009.
I would like to add a response to byoung: I agree completely with you regarding the leads that can cause electrical shock. My step-mother had to suffer with that issue when the unit she had surgically placed in her back malfunctioned. She was fortunate, in that, she was able to turn the unit “off” so the leads could not induce more damage to her already fragile spine. It had only made her suffering worse.
JessW
June 4, 2010, 11:13am (report abuse)Please pass this bill soon for the reason that medical device manufacturers need to be held liable for defective equipment. They are playing around with human lives and that is not OK! Everyother manufacturer is liable for mistakes or injuries caused by their product why should medical device manufacturers not be held liable?! People who get these devices need to have the comfort of knowing it will help them survive not kill them! We need this bill passed and soon! It has gone on long enough already.
KNeary
June 5, 2010, 11:51am (report abuse)This bill needs to be passed!! Why should the manufacturer's of medical devices be free from liability and lawsuits for products that were inaccurately made? These items are going into human beings that have every right to make sure that the products they are receiving are made to the highest standard possible, and if not they should be able to seek damages from the manufacturer, much like all Americans can do with any product we get. This bill affects so many people, most Americans will have some sort of medical device used in their body at some point, be it a pacemaker, or permanent port, or even a knee replacement. This has been going on for way too long pass this bill now!
LindaV
June 5, 2010, 8:38pm (report abuse)I support this bill because if there is a defect in any product whether it has been approved by the FDA or not, the company should be held liable. The companies are for profit and the risk of harm from these defective devices outweighs the benefit to society. A high standard needs to be maintained. It's unreasonable to believe because the FDA says so, consumers are protected from serious harm from these devices.
Jane
June 5, 2010, 11:17pm (report abuse)This bill should pass. Manufacturers of medical devices need to held responsible for any defective material! It will give people a chance to receive a compensation for either being damaged, or for the unfortunate people who lost a family member because of some defect in a product. I realize that this could create a large amount of cases, but it's only fair that these manufacturers be held liable for defective material that could have devastating results!
Bill Estrem
June 6, 2010, 7:51am (report abuse)I am for any legislative bill that rights a wrong done to the community at large. My problem is that there needs to be better Quality control measures before it goes to market. Currently the companies that manufacture these products do a huge amount of training and in-services for the doctors that implant them and for the nurses that may use them too. The training is also done for the patients. Typically what may occur with a bill like this is more regulation in turn causes more expenses for these companies which in turn will shut down business' in the industry. These companies are usually smaller companies that this can cause death of an industry. But we have to be careful in how we just pass a bill that might only have a short term effect on individuals and a larger effect needs to be taken into consideration. I feel terrible for people that have suffered due to defects but we cannot let certain cases run the outcome of a very important bill that effects the whole community.
Barbara Jones
June 6, 2010, 1:46pm (report abuse)I think we should support this bill because it will restore injured patients’ ability to bring claims for injuries caused by defective medical devices. The bill will also patch up the legal system used for device manufacturers with the one used for drug manufacturers.
JohannahK
June 6, 2010, 6:38pm (report abuse)Although I have not had any personal experience with one of these devices, nor has anyone I know, I am completely for the passing of this bill. Aren't medical devices used to prolong and enhance human life? Instead they are endangering and in some cases, ending lives. Not to mention how it affects the victim's family. Why should the company of these faulty devices be protected and the consumer shouldn't?
AaricaC
June 6, 2010, 6:47pm (report abuse)I think this is very serious and the bill should be passed. The things that are happening, trauma, injury and possible death are completely avoidable. I think that it is only right for the bill to pass so that those who have been wronged by defective medical devices can bring action against the manufacturer as well as stop any future malfunctions
william m.
June 23, 2010, 9:59am (report abuse)I have been effected by one of these so called miricle devices. It is documented fact in my hospital records that it caused my 2 almost fatal heartattacks. It is fact that over 2 thousand 5 hundred people have died and that is just the ones that were documented. It is also documented that the company who made this device put 6 billion dollare in reserve to cover potential lawsuits. This should tell you something. Congress and the President and his staff were sent documents from employees at the FDA showing were they recomended that these devices not be approved but their boss approved them anyway. In years gone by if something was passed by the FDA you could relie on it but today just look at all of the things they have passed and in a short time you see lawsuits against them. Today to me FDA approval is nothing but a joke. They say this will effect 5% of the people but 5% of a thousand is 50. Now figure on the millions of people who could be effected.
kni
July 5, 2010, 6:05pm (report abuse)The bill needs to pass. I'm the victim of a bad medical device that was not medically necessary. It caused me great physical & emotional pain. I would like to also see a bill that would make the drug/device companys criminally liable should they make defective products, overstate the products effects and minimize the risks to the patient. It should also apply to those companys who do shoddy clinical trials and knowingly misrepresent the risks associated with that product.
Richard Feist
July 13, 2010, 1:35pm (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. How long does this inefficent congress need to do its job already.
Teresa Fultz
August 14, 2010, 10:20am (report abuse)Since the FDA says we can't do anything to Medtronic why can't we hold the FDA responsible for our defective devices that they protect?
Margie Arlt
September 5, 2010, 7:11pm (report abuse)I cannot believe the Supreme Court ruled as it did in Riegel v. Medtronics, Inc. in February of 2008. Clearly some type of lobbying must have occurred for this decision to come out as it did. The Court through their decision has now immunized the device companies from lawsuits being brought by patients. This bill will turn this around and without any thought needs to be passed by our legislators. The consumer (and their family) needs to and must be protected from any defective medical devices. The 2008 ruling basically has given the medical device companies the ability to slack off with quality and safety standards. By the passing of this bill it will hold medical device companies to a higher standard for quality and safety.