What If a Medical Device Malfunctions?

Jul 26, 2021
by Becki Andrus

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    What If a Medical Device Malfunctions?

    You probably know or have heard about a friend having a procedure done only for the implant or medical device to malfunction. This can make their original problems worse after a period of time. Or maybe an unfortunate event like this has happened to you.

    A medical device malfunction is described by the FDA as a medical device that caused or contributed to death or a serious injury. This could be a result of device failure, malfunction, improper or inadequate design, manufacturing, labeling or user error.

    Have you seen the commercials on television or the radio talking about the current lawsuits going on for a medical device malfunction and asking for others to join the suit? Malfunctioning products like a hip or knee replacement implant that has failed, birth control that causes medical device injury and dangerous problems for their user, and of course there is always the Transvaginal mesh that has been used as a sort of sling for bladder surgery that begins to grow into other organs.

    Medical Device Malfunction

    When a trusted medical device malfunctions, it can be serious and possibly even life changing. When we undergo surgery or other medical procedure, we are putting our body at risk. Not to mention our time and money. We rely on our doctors and the hospitals and health care centers to keep us safe in every way.

    This trust can often be misplaced and “too trusting”. When a malfunctioning device is used, our confidence in the health care system in general can be sadly compromised. You’re not sure who or what you can depend on to keep you safe and healthy.

    Have you ever wondered about medical device malfunction lawsuits? It seems we always hear about the huge settlements that can be won when going up against large companies but who is involved in these lawsuits? What is required to win a claim like this? Let’s explore more…

    Medical Device Monitoring and Reporting

    Once a device has been approved to use for the general public, the FDA doesn’t just let it go out into the medical world with no other observation. Medical devices are continually monitored for any problems, especially safety concerns. This is called Medical Device Reporting and it transpires when the FDA needs to look closer due to an injury claim that is made. There are actually many reporting requirements for manufacturers, hospitals and doctors to abide by when reporting a medical device malfunction.

    When a medical device malfunction claim is made, the FDA takes a close look at the medical device manufacturer. Serious injury can occur and companies are really scrutinized when claims start coming through. The physician technique can also be looked into as well as hospital use and implementation.

    The FDA has hundreds of thousands of medical device malfunction cases come across their desks. There are reports of injury and suspected deaths associated with medical devices and manufacturers. Facilities and medical providers are required to submit certain documents for harmful product issues to the FDA.

    The FDA also strongly encourages other groups like patients, caregivers and other health care providers to voluntarily submit reports about concerning medical device malfunctions. These can include product issues, product quality concerns and healing failure. These reports can provide important information to the FDA that will improve the safety of patients throughout the country.

    What Happens When the FDA Finds a Substantial Problem?

    Once all reports are gathered and the FDA decides there is a substantial problem with a certain device, they issue a recall. These recalls can be issued as Class I, II or III, with Class I being the harshest and most dangerous. Class II and III are not quite as serious but are still considered harmful.

    At this point a lawyer can access all the reports and data that has been gathered by the FDA. They will then be able to make a case against the manufacturer and others. Maybe the manufacturer knew a device safety issue was possible and went ahead with the distribution of their product anyway. There can be a variety of other cases brought against a manufacturer, physician or facility depending on the device and reports made.

    Throughout the medical device life, the FDA works hard to oversee medical devices that are meant to help us. Through this type of supervision, we are protected from several device malfunctions and issues. The FDA continues to work to improve available medical device safety every day for the American people.

    Who Is Liable for Medical Device Malfunctions?

    When you have a medical device malfunction is it your doctor’s fault, the hospital or the company that made the medical device? Maybe it’s all three? This can be a very grey area in your lawsuit and can depend on a couple of scenarios.

    First, it’s important to know that most medical devices don’t have a lifetime guarantee. They will wear out over time. If your doctor has not warned you about this risk or the nature of the device, then your doctor can be held liable too. The doctor could also be liable if they knew that a certain device or product had a history of problems but didn’t tell the patient.

    If the medical device was poorly manufactured, the company that made it can be held responsible.

    An attorney can help you sort through all the “what ifs” and “who’s responsible” scenarios. AMA Law is experienced in these types of lawsuits. We can give you personalized advice and dedication to your needs and case.

    Do You Have a Medical Device Malfunction Lawsuit?

    If you suspect you could have a medical device malfunction claim on your hands, the first thing to do is call a lawyer. Your experienced Oklahoma attorney can help you down the road of a medical device malfunction claim and get you the results you deserve and need. Our goal is to encourage quality, safe medical devices and decrease the safety risks and injuries to patients all over. Reach out to our team for more information on the services we provide.

    Request a free consultation

    (405) 607-8757