Say a deaf woman gets a cochlear implant, and when tested, it is found to be defective. She has just spent $30,000 on something that will not benefit her in the long run at all. They do endanger patients rights because they allow these to be sold, and therefore, the right to be able to sue should be allowed on products such as these.
Makers of medical devices should be held responsible for the products they manufacture.
In this matter of the Sprint Fidelis Leads, they were aware of the problem because
Medtronics sent letters to inform the patients that there is a small chance of lead fracture. So
Medtronics knew.....Why does someone have to die to prove something???? This statement admits
there is fault in the product...Therefore, it should have been removed from the market.
Test studies should have been done prior to the FDA approval. How can the FDA approve
something with no testing. So are we protecting the government?
Yes there are some people who take advantage of the situation...And their attorneys
should be aware of frivolous lawsuit cases But to take a life, or put someone
through hell is ridiculous. So the point is persons need to be protected from future
life threatening situations and the circumstances surrounding the event need to be
investigated. If we the people, are not afforded this opportunity to protect ourselves then we lose many lives due to manufacturers looking to make a buck. So we should have the right to
sue when a product if found to cause serious harm or death! Now it seems we have lost
that right, many law firms are not taking on new cases. Therefore, medical companies see the
green light and eventually will do less testing or none and we the consumer become
the guinea pigs.
I totally believe that it is protecting these companies to the point of where there is no punishment to the companies so they don't worry as much of the outcome. My son had the Advanced Bionics Auria cochlear implant and received a recalled device and within 8 months was having serious affects of a shocking sensation going on. He was explanted and the device was checked for moisture which stated his failure was not due to moisture but I don't believe that to be true. Anyway, lawyers tell me that we can't sue because of this decision to protect the company from lawsuits and I say that is so wrong because regardless of the integrity report results my son received a recalled unit which they knowingly allowed to implanted in his head. So they should at least compensate him for a little pain and suffering which that was his second device to fail. He now doesn't trust the new one that he has so is not benefiting from it.
If you look on the internet, so many people have died due to faulty equipment made by this company. Some have been even recalled but do they notify their patients about these recalls? The answer to that question is no. We were told by the company the doctor that put the device in should have notified us about the defected pump. Makes me sick they cannot be held accountable for their faulty merchandise.
This ruling makes me so angry. I am a mother of 3 and a pacemaker/defibrillator was implanted in my husband when he was 37 years old and now because of the faulty device and the faulty leads my family will lose my husband. Taking away our rights to sue this company for his damages and the loss of my husband is infuriating! This company is getting away with killing good people. If this was a private citizen they would be called a serial killer! Why is the government letting them make over 12 billion dollars a year while I won't even have the money to bury my husband because we can not get life insurance because of this heart issue? The company and the government should be ashamed of themselves!
When the Supreme Court protects companies and allows patients to suffer it is as if companies have more rights than people. This country was founded on the Bill of Rights that protected citizens, not corporations or other entities. If a person has been harmed by a piece of medical equipment they should be able to sue that company for damages.
The Riegel v. Medtronic Supreme Court ruling has hampered patients' rights and goes against the tenets of the Constitution. In this country, if an individual felt they were wronged, they were once allowed to sue for damages they felt entitled to. This recent ruling shows that business lobbyists have infiltrated our most hallowed institutions, and the rule of law is now up for sale.
I agree that the patient's right to take action on a medical device has been reduced a great deal. I also understand why it had to be done and that is this country is sue happy. We want to sue everyone for everything. If the person can not use the device according to how the company designed it then it is their fault if they are injured.
The only way to keep any manufacturer from providing unsafe products is to allow the right to sue. This is especially important for medical devices where the potential for harm is greatest. If a patient is prevented from suing a company whose product was faulty, simply because it is a medical device, there will be no protection for those who are afflicted by the device.
The issue is not whether the current list of companies are dangerous to patient rights, the issue is if they are allowed to be protected from any damages their products may cause, then it opens the door for more medical devices to be added later. Medical malpractice is never a fun thing to go through, and it can even be potentially deadly. To deny the victim the right to sue for damages is wrong, and such a practice removes any incentive the company has to ensure that their product is free from defects.
In the ruling of Riegel v. Medtronic, the Supreme Court stated that patients may not sue a manufacturer of medical devices which have been approved for patient use by the Food and Drug Administration. Without a ruling like this in place, lawsuits against manufacturers could become prevalent and cost prohibitive, leading to less funding for research and development and resulting in inferior products.
The Supreme Court did not endanger patients' rights by protecting makers of medical devices from being sued, because they always tell you of the risks of using the said item. The makers of medical devices protect themselves of lawsuits by telling prospective patients about the side effects and risks of using the device.
The ruling does not completely abridge patients' rights, because it is fairly limited in scope. Only certain medical devices are covered by the ruling, and it would be unfair in many cases to hold those manufacturers liable to be sued frivolously. If it were full-scale immunity, then it would be a problem. But that is not the case here.
The FDA puts many regulations in place to secure the health and well-being of patients. Since FDA spends an average of 1200 hours affirming/approving medical devices, the Supreme Court made a good judgment when analyzing Medtronic's fault. Medtronic clearly labeled its product with proper proposed usage. In this particular case, although the results were tragic, all reasonable efforts were used to save this gentleman's life. It is wise for the Supreme Court to protect makers of medical devices that have subjected their products to the FDA approval process. This will encourage all companies to submit their products for approval, and affirm the intrinsic value and customer belief that is associated with the FDA.
Patients have an awful lot of rights in this country, and it is to be expected. When we receive medical care or medication, we want certain assurance that we will get better. We want a doctor who has gone to medical school. We want medication that has undergone years of study before being released to the public. With medical devices, such as the one's made by Medtronic, there are just too many ways that a PATIENT can damage the device, buy not using it correctly, to not using it at all. If the device works properly, and the patient messes things up, the makers of the device should not be held liable.
People undergoing medical device implantation understand there is a risk associated with this. While the device may be sound and operate properly, no one can predict with 100% certainty the reaction of the device with the person's body. The manufacturer of a product is responsible for the performance of that product, not how it is used. Do we punish Smith and Wesson when someone is murdered with a handgun? Do we sue Ford when a teenager dies in a car crash?