If you or a loved one have been harmed by a defective medical device, you know how devastating the consequences can be. Defective medical devices can cause serious injuries, complications, and even death. In such cases, you may be entitled to compensation for your damages.
However, pursuing a legal claim against a medical device manufacturer can be complex and challenging. That's why it's important to work with our experienced Louisville defective medical device lawyers who can help you navigate the legal process and fight for your rights. At Gray and White Law, we use our knowledge, skill, and dedication to pursue justice on your behalf and hold those responsible accountable for their actions. Contact us today for your free consultation.
What is a Defective Medical Device?
A defective medical device is a device that is intended to be used for medical purposes but is flawed or has a defect that causes it to fail to perform as intended, or causes harm to patients. This can include devices such as pacemakers, artificial joints, surgical mesh, and other medical implants. Defects can arise from design flaws, manufacturing defects, or inadequate warnings or instructions for use. When a medical device is defective, it can cause serious harm to patients, including infections, organ damage, or even death. As a result, victims of defective medical devices may be entitled to compensation for their injuries and losses through a legal claim against the manufacturer or distributor of the device.
Common Causes of Defective Medical Devices
- Design defects: Medical devices may be designed with flaws or defects that can cause harm to patients.
- Manufacturing defects: Even if a device is properly designed, errors can occur during the manufacturing process that can cause the device to malfunction or fail.
- Failure to warn: Manufacturers have a duty to provide adequate warnings about the potential risks and side effects of their devices. If they fail to do so, patients may be at risk of harm.
- Off-label use: Some medical devices may be approved for use in certain situations or for certain patient populations, but not for others. If a device is used in an off-label manner and causes harm, it can lead to legal claims.
- Improper installation or maintenance: Medical devices must be installed and maintained properly to ensure they function as intended. Failure to do so can cause harm to patients.
Laws on Defective Medical Devices
The Food and Drug Administration (FDA) regulates medical devices in the United States under the Federal Food, Drug, and Cosmetic Act (FD&C Act). Under this law, medical devices are classified into one of three categories based on the level of risk they pose to patients: Class I (low risk), Class II (moderate risk), or Class III (high risk).
Medical device manufacturers are required to submit a premarket notification (510(k)) or a premarket approval (PMA) application to the FDA before they can market a device in the United States. The 510(k) process is used for Class I and Class II devices and requires manufacturers to demonstrate that their device is substantially equivalent to a device already on the market (known as a predicate device). The PMA process is used for Class III devices and requires manufacturers to provide extensive data on the safety and effectiveness of their device.
Even with FDA approval, medical devices can still be defective if they have design flaws, manufacturing defects, or inadequate warnings. In such cases, the FDA may issue a recall or require the manufacturer to take other corrective actions. The FDA can also issue warnings and safety communications to alert patients and healthcare providers to potential risks associated with a device.
Contact our Louisville Defective Medical Device Lawyer Today
If you or a loved one have been harmed by a defective medical device, it's important to seek legal help as soon as possible. Pursuing a legal claim against a medical device manufacturer can be complex and challenging, but with the help of our Louisville defective medical device lawyer, you can protect your legal rights and seek justice for your injuries and losses.
At Gray and White Law, our team of dedicated lawyers has extensive experience representing clients in defective medical device cases. We understand the impact that a defective medical device can have on your life, and we're committed to helping you obtain the compensation you deserve.
Don't wait any longer to take action. Contact our Louisville defective medical device lawyers today to schedule a free consultation and learn more about your legal options. We're here to help you navigate the legal process and fight for your rights.