Medical devices, such as pacemakers and hip replacements, have the potential to prolong life, restore mobility, prevent illness and heal a wide variety of injuries. But when those devices malfunction or fail, they may cause injuries that are far more debilitating than the condition they were intended to cure.
To prevent dangerous or ineffective medical products from harming the public, medical device manufacturers are subject to strict rules and regulations. If a manufacturer failed in its duty to provide a safe medical device, and a person is injured as a result, it is possible to recover financial compensation (damages) from the device manufacturer.
What is a medical device?
Medical device manufacturers are governed at the federal level by the U.S. Food & Drug Administration (FDA) Center for Devices and Radiological Health. The FDA defines a medical device as something that:
- Is “intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease…”; and
- Is “intended to affect the structure or any function of the body…”; and
- “[D]oes not achieve its primary intended purposes through chemical action within or on the body…" (This last point differentiates medical devices from drugs, which are regulated by a different branch of the FDA.)
There are many types of medical devices. A medical device can be something as simple as an electric toothbrush or as complicated as a laser surgical instrument. Medical devices include things that are implanted in the body, such as hip or knee replacement, heart defibrillators, pacemakers, IVC filters, insulin pumps, heart stents, cosmetic implants and transvaginal mesh. Robotic surgical machines and diagnostic machines also fall under the category of medical devices.
Responsibilities of device manufacturers
Because of the potentially devastating consequences of poorly designed or poorly made medical devices, manufacturers are subject to strict rules and regulations. Failure to meet those strict standards could be the basis for a product liability lawsuit against the device manufacturer.
The goal of a product liability lawsuit is to hold a medical device manufacturer financially responsible (liable) for injuries or loss of life that occurred due to a defective medical device.
Manufacturers can potentially be found liable for a number of different types of medical device defects, including:
- Design. If the device was improperly designed and the design flaw resulted in injuries, the manufacturer could potentially be found liable for resulting injuries.
- Testing. Medical devices must be thoroughly tested. The FDA reviews the medical device company's test results and decides whether the potential benefits of the device outweigh any potential side effects or dangers. If a medical device company performed inadequate testing--or, worse, if it hid negative test results--it can potentially be found liable for resulting injuries.
- Manufacturing. A manufacturer can potentially be found liable for injuries resulting from a manufacturing defect. Even if the design was safe, defects may be introduced during the manufacturing process. For example, a manufacturer may try to save money by using low-quality materials that break down or degrade over time, or they may assemble device components incorrectly. Devices may also be contaminated with germs or hazardous substances during manufacturing.
- Warnings. Device manufacturers are also required to provide warnings about potential hazards, side effects or dangers associated with using their devices. If the manufacturer fails to do so and injuries occur as a result of that failure, the manufacturer could be held liable for the injuries.
An experienced defective medical device attorney will review all the facts of your case and advise you regarding the best way to hold a device manufacturer responsible for failing to produce a safe and effective product.
Proving a Medical Device is Defective
In order to successfully recover damages in a defective medical device case, generally, the injured party will need to prove that the device was defective and that the defect caused injuries.
Proving that a device was defective requires in-depth knowledge of how devices are designed, manufactured and tested. Demonstrating a link between the device defect and resulting injuries also requires detailed medical knowledge.
Damages in Defective Medical Device Cases
Patients may experience tremendous pain and suffering due to a defective medical device. They may be forced to go through multiple surgical procedures to repair or replace a defective device. They may miss work due to their injuries or become permanently unable to work due to their injuries. Defective medical devices can even result in wrongful death.
If a manufacturer is found to be responsible for injuries or loss of life, the injured person or surviving family members may be able to recover damages. Damages include compensation for financial losses such as medical expenses and lost wages. Damages also include compensation for things like pain and suffering, fear and anxiety, mental anguish, loss of enjoyment of life and reduced quality of life.
What should you do if you or a loved one have been injured by a defective medical device?
Medical product lawsuits are some of the most complex types of personal injury cases. In order to recover the compensation you are due in a medical device case, it is important that you seek experienced, knowledgeable legal advice.
You should not try to fight a medical device manufacturer on your own. Medical devices are a lucrative business. Device manufacturers will work very hard to show that they were not at fault and to prove that you don't deserve compensation for your injuries.
An experienced defective device attorney can help you navigate this complex area of law and get the compensation you deserve. Contact the Hadden Law Firm today.