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    Medical Device Failure

    Medical devices are often recommended by doctors and physicians
    to help treat underlying medical conditions and ailments.
    Medical devices are often recommended by doctors and physicians to help treat underlying medical conditions and ailments.
     

    Medical devices must be approved by the FDA prior to use by doctors, however, most people don’t realize that there are two methods of approval.

    1. Pre-market approval (PMA)
    2. 510(k) approval

    With a PMA approval, the manufacturer must submit a lengthy application which details the design and test results of the product. The PMA approval process weighs the benefits of the device with the risks of using it. The manufacturer must strictly comply with any approval including the approved design, marketing, and manufacturing process

    However, with a 510(k) clearance, the manufacturer must merely show that the device has been approved by another manufacturer and is substantially similar. Surprisingly, with a 510(k) approval, no testing is required by the manufacturer or the FDA prior to the device being implanted in patients. The FDA can set limits on marketing, however, manufacturers may skirt these rules by misleading physicians or hiring them as consultants to encourage what is known as off label use.

    PMA approval provides certain protections to a manufacturer that a 510(k) clearance does not. Our firm has successfully litigated against device manufacturers with both types of approvals. These devices include spine stimulators, neuro-monitoring devices, and spinal fusion devices. In our investigations for clients, we have also uncovered kick-back schemes which involve doctors being paid to use certain devices. Patients are never informed of this lucrative scheme which can conflict with what is best for the patient.

    Medical device litigation is complicated and dynamic with various courts around the country setting different rules and laws. With our main office in Austin, Texas, our firm currently represents injured persons from coast to coast. Various statutes of limitations apply, some as short as one year.

    We have recently litigated claims involving defective spine stimulators from Medtronic, Eclipse Spinal Spheres from Medtronic, spine stimulators by St. Jude Medical, neuromonitoring by Nuvasive, pelvic mesh failures, and hip replacements by DePuy

    If you have concerns that your medical device is defective or may have caused you injury, call us immediately for a free consultation.

    Medical devices must be approved by the FDA prior to use by doctors, however, most people don’t realize that there are two methods of approval.

    1. Pre-market approval (PMA)
    2. 510(k) approval

    With a PMA approval, the manufacturer must submit a lengthy application which details the design and test results of the product. The PMA approval process weighs the benefits of the device with the risks of using it. The manufacturer must strictly comply with any approval including the approved design, marketing, and manufacturing process

    However, with a 510(k) clearance, the manufacturer must merely show that the device has been approved by another manufacturer and is substantially similar. Surprisingly, with a 510(k) approval, no testing is required by the manufacturer or the FDA prior to the device being implanted in patients. The FDA can set limits on marketing, however, manufacturers may skirt these rules by misleading physicians or hiring them as consultants to encourage what is known as off label use.

    PMA approval provides certain protections to a manufacturer that a 510(k) clearance does not. Our firm has successfully litigated against device manufacturers with both types of approvals. These devices include spine stimulators, neuro-monitoring devices, and spinal fusion devices. In our investigations for clients, we have also uncovered kick-back schemes which involve doctors being paid to use certain devices. Patients are never informed of this lucrative scheme which can conflict with what is best for the patient.

    Medical device litigation is complicated and dynamic with various courts around the country setting different rules and laws. With our main office in Austin, Texas, our firm currently represents injured persons from coast to coast. Various statutes of limitations apply, some as short as one year.

    We have recently litigated claims involving defective spine stimulators from Medtronic, Eclipse Spinal Spheres from Medtronic, spine stimulators by St. Jude Medical, neuromonitoring by Nuvasive, pelvic mesh failures, and hip replacements by DePuy

    If you have concerns that your medical device is defective or may have caused you injury, call us immediately for a free consultation.

    Defective Medical Devices

    There are thousands of medical devices on the market today that are often recommended by doctors and other healthcare professionals to treat a host of conditions. And while these products are designed to make life easier, many malfunctions cause them to stop working or even break down with use. Sadly, these products (which exist to support people with various ailments) often harm those they are supposed to help.

    The Austin medical device lawyers at The Meyerson Law Firm have represented thousands of injured individuals and their families since 1995. We know how devastating these types of cases can be and are committed to doing everything we can in their defense. We don't sleep until our clients have justice - whether injured by a medical device or car wreck.

    Common Types of Medical Devices

    Modern medicine has provided us with innovative medical devices that aim to improve an individual's quality of life and health. Unfortunately, medical device failures are quite common and can have a life-altering effect on people of all different ages. Some of the most common medical devices include:

    • Surgical implants
    • Pacemakers
    • Prosthetics
    • Surgical instruments
    • Implantable defibrillators

    Reasons Medical Devices Fail

    When these devices do not function as intended, it can lead to added medical costs, severe injuries, trauma, emotional distress, and even death. Some products have issues because of faulty design, production, or insufficient testing, whereas others have problems during the manufacturing or marketing stages. According to the U.S. Food and Drug Administration (FDA), there have more than 5.4 million adverse events associated with medical devices throughout the last ten years.

    Let's take a closer look at some of the most common reasons medical devices fail::

    • Faulty design
    • Poor production
    • Contamination during the manufacturing process
    • Poor molding
    • Poor product design
    • Overstress during the manufacturing process
    • Incorrect material used

    These are just a handful of the most common reasons medical devices malfunction. If you or a loved one suffered injuries or were harmed by a medical device that was intended to help.

    Contact The Meyerson Law Firm today and schedule a free consultation with one of our experienced Austin medical device attorneys.

    Injuries from Malfunctioning Medical Devices

    Injuries from malfunctioning medical devices can range and will depend on the type of device. Here's a look at some of the most common injuries we see from defective medical devices:

    • Infection
    • Allergic reaction
    • Heart attack
    • Organ loss
    • Stroke
    • Tissue or bone damage
    • Chronic pain
    • Disability

    Do I need a lawyer?

    The manufacturers, marketers, and retailers of defective medical devices must be held accountable for their misaction or negligence. As consumers, we assume the products we buy are safe and well-made.

    • Added medical bills
    • Prescription costs
    • Rehabilitation or surgery
    • Lost wages
    • Pain and suffering
    • Emotional distress
    • Loss of a loved one
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