Overview of Medical Device Injuries
Millions of Americans rely on medical devices every day, from hip and knee implants to pacemakers and surgical mesh. While these devices are designed to improve quality of life, defective or poorly designed medical devices can cause devastating injuries, chronic pain, and even death. When a medical device fails, patients often face additional surgeries, prolonged recovery periods, and significant financial hardship.
Medical device injuries may result from defects in the design or manufacturing of the device, inadequate warnings or instructions provided to physicians and patients, or the failure of the manufacturer to properly test the device before bringing it to market. In some cases, devices are approved through expedited FDA processes that do not require the same rigorous clinical testing as full premarket approval.
At Roselli & McNelis, we represent patients throughout Florida who have been harmed by dangerous medical devices. Our attorneys understand the complex intersection of product liability law, medical science, and federal regulatory frameworks that these cases require.
Types of Dangerous Medical Devices
Medical device injuries span a wide range of products and specialties. Some of the most common categories of dangerous devices include:
- Joint Implants: Hip replacements, knee replacements, and shoulder implants that fail prematurely, cause metallosis (metal poisoning), loosen, or fracture within the body, requiring painful revision surgeries.
- Surgical Mesh: Hernia mesh and transvaginal mesh products that erode, migrate, or cause chronic infections and severe pain after implantation.
- Cardiac Devices: Pacemakers, defibrillators, and heart valves that malfunction, deliver inappropriate shocks, or fail to function when needed, placing patients at risk of cardiac events or death.
- Surgical Instruments: Robotic surgical systems and power morcellators that malfunction during procedures, causing burns, perforations, or the spread of undetected cancer cells.
- Diagnostic Equipment: Imaging devices or testing equipment that produce inaccurate results, leading to misdiagnosis or delayed treatment.
- Prosthetics and Orthopedic Devices: Spinal cord stimulators, bone screws, and plates that break, migrate, or cause nerve damage after implantation.
The FDA Recall Process
The U.S. Food and Drug Administration (FDA) is responsible for overseeing the safety of medical devices sold in the United States. When a device is found to be defective or dangerous, the FDA may issue a recall or safety alert. Recalls are classified into three categories based on the severity of the risk to patients.
A Class I recall indicates a situation where there is a reasonable probability that the use of the device will cause serious health consequences or death. Class II recalls involve situations where the device may cause temporary or medically reversible adverse health consequences. Class III recalls involve devices that are unlikely to cause adverse health consequences but still violate FDA regulations.
It is important to understand that an FDA recall does not automatically mean the device has been removed from the market. In many cases, a recall simply means the manufacturer is required to correct or remove the product. Patients who have already received a recalled device may still be at risk and should consult with both their physician and an attorney to understand their options.
Pursuing a Medical Device Claim
Medical device claims can be pursued under several legal theories, including strict product liability, negligence, and breach of warranty. These cases often involve multiple parties, including the device manufacturer, the distributor, and in some cases the healthcare provider who selected or implanted the device.
Successfully litigating a medical device case requires a thorough understanding of engineering, medical science, and regulatory law. At Roselli & McNelis, our attorneys work with biomedical engineers, medical specialists, and regulatory experts to build comprehensive cases that demonstrate how a defective device caused our client's injuries.
If you or a loved one has been injured by a medical device, contact Roselli & McNelis for a free consultation. We will evaluate your case, identify the responsible parties, and fight for the full compensation you deserve.