Surgically implanted medical devices are man made devices or instruments that surgeons use to replace a missing biological structure inside a patient’s body. Some examples of surgically implanted medical devices include:
- Cochlear Implants
- Breast implants
- Eye implants
- Transvaginal mesh
- Blood clot filters such as IVC filters
- Artificial joints, such as hip replacements and knee implants
What Are the Dangers Associated with Surgically Implanted Medical Devices?
There are many dangers and complications that are associated with surgical implanted medical devices that could lead to injury and even death. If a surgically implanted medical device is defective or is implanted in a wrong way it can cause major complications such as: inflammation, rejection of the implant, blood infection, and infections. Many cannot even recover from a defectively implanted medical device that can lead to long term or lifetime of injuries and body complications.
What is the Duty of Health Care Facilities when a Medical Device Malfunctions?
Under the Safe Medical Devices Act requires health care facilities to report to the manufacturers such as Stryker any injuries or illnesses in patients or employees caused by the use of the manufacturers' medical devices such as an IVC filter. If a patient or employee happens to die as a result of the device being used, then the FDA should be contacted as well. This ensures that a manufacturer is aware of the defect.
Who Is Liable for a Surgical Implanted Medical Device Injury?
If a patient is injured because of a surgically implanted medical device, there may be several people who are liable for their injuries. Generally, that can include:
- Professional associates;
- Hospitals; or
- Manufacturers of surgically implanted medical devices.
The two most common defendants in a lawsuit involving a surgically implanted medical device are the surgeon who performed the operation and the manufacturer of the device.
1) Surgeon Liability
If the surgeon made a mistake during surgery, then the surgeon who performs the operation that implants a medical device is liable under a theory of medical malpractice or negligence. In order to be successful in a lawsuit against a surgeon, an injured patient has to prove:
- The surgeon owed them a duty in implanting a medical device,
- The surgeon did not meet the applicable standard of care when implanting the medical device, and
- The surgeon's actions caused the injuries to the patient.
Lawsuits of this type are very difficult. Largely because determining what the standard of care should be for a surgeon is extremely to demonstrate. However, if there is a national standard and steps to the surgery then it can be easier to prove that your surgeon made a mistake.
2) Manufacturer Liability
If the product itself was defective after it was planted, the manufacturer of a surgically implanted medical device can be liable to an injured patient under a theory of strict liability for a defective product. As such, for an injured patient to be successful in a lawsuit against a manufacturer, they must show:
- The manufacturer engaged in the sale of surgically implanted medical devices;
- The surgically implanted medical device was in a defective condition which made it unreasonably dangerous;
- The manufacturer placed the surgically introduced the medical device into the marketplace in its defective condition; and
- The defective condition of the surgically implanted medical device was the cause of the patient's injury.
What Are Class Action Lawsuits a Medical Device Injury?
Class action lawsuits, also known as mass tort lawsuits, is a lawsuit that includes hundreds or thousands of injured plaintiffs who were injured by the same device that was defective. Instead of each plaintiff bringing separate lawsuits against the medical device manufacturer, one large lawsuit is brought against the company and a single plaintiff represents all the plaintiffs that have a claim against the company. The compensation of the lawsuit is then equally divided among the plaintiffs injured or brought under the claim.
What Are the Defenses to a Medical Device Injury Lawsuit?
In a lawsuit against a surgeon or manufacturer for injuries associated with a surgically implanted medical device, several defenses exist. Common defenses include:
- Protection from the Medical Device Amendments of 1967 to the Federal Food, Drug, and Cosmetic Act
- Manufacturer was not engaged in the sale of surgically implanted medical devices
- The defect of the surgically implanted medical device was caused by an outside force
- The patient was negligent themselves and did not take the necessary precautions
What Are the Damages for a Medical Device Injury Lawsuit?
If a surgeon or manufacturer is successfully sued for an injury associated with a surgically implanted medical device, and depending on the circumstances, a patient or their family can usually recover the following:
- Damages for physical and emotional pain and suffering
- Loss of earnings
- Loss of earning capacity
- Emotional distress or trauma
- Medical expenses, both present and future
- Wrongful death
- Loss of consortium
- Punitive damages
Do I Need a Personal Injury Lawyer?
If you have been injured because of a surgically implanted medical device, it is highly recommended for you to contact an experienced personal injury attorney who specializes in medical malpractice. Only a lawyer will be able to thoroughly explain any issues, help defend your rights, and assist in getting you any compensation you deserve.