Surgically implanted medical devices, or medical implants, are man-made devices or biological tissues that are placed either on the surface of the body or inside of the body. Surgically implanted medical devices can be used as prosthetics to replace body parts that are missing. Other devices are used to deliver medication, monitor the functions of major bodily systems, or provide needed support to particular organs.
Some common examples of surgically implanted medical devices include:
- Cochlear implants
- Breast implants
- Eye implants
- Surgical mesh
- Transvaginal mesh
- Inferior Vena Cava (IVC) filters to stop blood clots from traveling to the lungs
- Artificial joints, such as those used in knee replacements and hip replacements
- Insulin pumps
What Are the Dangers Associated with Surgically Implanted Medical Devices?
There are always risks associated with any surgery. However, there are specific dangers and potential complications associated with surgically implanted medical devices. Some complications might lead to serious injuries or even death.
Devices that are defective or not implanted properly can lead to major complications. Patients might experience inflammation, infection, or rejection of the implant. Depending on the type of material used to make the device, there might be corrosion or other breakdown of the material causing it to get into a person’s tissues, blood, or bones.
In some cases the devices simply fail or do not work as intended, requiring patients to undergo an additional surgical procedure to remove the device.
What Are Some Common Surgically Implanted Medical Devices Liability Claims?
Some common surgically implanted medical device liability claims include:
- Defective Design: Here, the claim is that the device was properly implanted, but the device does not work as intended. It might cause discomfort or exacerbate the existing injury or illness.
- Manufacturing Defects: A manufacturing defect is the result of an error or failure in the manufacturing process. The device was designed properly and when manufactured according to its specification works as intended. However, when there is a problem in the manufacturing process resulting in errors or flaws that are not visible to the naked eye, those devices might be defective or dangerous.
- Failure to Warn or Marketing Defects: It is essential that when a medical device is sold to medical professionals that the sales representatives are able to explain the device’s intended use. Providers must be supplied with complete and accurate descriptions of any medical devices they plan to use. When medical professionals do not fully understand the device their patients are at risk.
- Medical malpractice by the surgeon who implanted the medical device: Medical devices that are not defective and work properly can still cause harm if the surgeon who implanted them made a mistake. A patient might have a claim for medical malpractice if their doctor did not implant the device correctly.
Are There Any Legal Surgically Implanted Medical Devices Liability Cases?
In some cases a medical device was implanted properly, but was defective in some way. Design defects do not always mean that the device is dangerous, but might mean that the device does not work the way it was intended. For example, an artificial joint such as those used in knee or hip replacements may not fit as many people as it was designed to fit.
A patient must be able to show that the defective design caused an injury or made an existing injury or illness worse. In that case a patient can pursue a product liability lawsuit. A patient will have a design defect claim if the medical device was:
- Unreasonable dangerous as designed; or
- Not safe for its intended use or any reasonably foreseeable uses.
For example, one medical device that has been the subject of liability claims is surgical mesh. Courts have found manufacturers of the surgical mesh liable for injuries caused by its negligent and defective design.
What is the Duty of Health Care Facilities when a Medical Device Malfunctions?
Health care facilities owe their patients a duty of care, meaning that they must act in a reasonably prudent way based on the circumstances. Failure to meet that duty of care might result in a claim of negligence against the health care facility. In the case of surgically implanted medical devices, that means that health care facilities who know that a device is likely to cause harm must report it to the appropriate people or agency.
The Safe Medical Devices Act requires health care facilities to report instances where there is a “probability that a medical device has caused or contributed to a death, illness, or injury.” Hospitals, ambulatory surgical facilities, nursing homes, and outpatient treatment facilities must report these cases to the Secretary of Health and Human Services and/or the manufacturer of the device.
Who Is Liable for a Surgical Implanted Medical Device Injury?
A patient injured by a surgically implanted medical device might have liability claims against one or more parties. Those parties generally include:
- Hospitals or other health facilities
- Manufacturers of medical devices
The most common defendants in a lawsuit involving a surgically implanted medical device are the manufacturer of the device and the surgeon who implanted it.
A surgeon who made a mistake during the surgery might be liable under a theory of negligence or medical malpractice. An injured patient must prove:
- The surgeon owed them a duty of care to act as a reasonable surgeon performing the same or similar procedure,
- The surgeon breached that duty or failed to meet the applicable standard of care when implanting the device, and
- The patient’s injuries were caused by the surgeon’s failure to meet the standard of care.
A patient pursuing a lawsuit against the manufacturer of an alleged defective medical device will have a strict liability claim. For an injured person to be successful in a lawsuit against a manufacturer they must prove:
- The manufacturer sold surgically implanted medical devices,
- The device was in a defective condition that made it unreasonably dangerous,
- The manufacturer introduced the medical device into the marketplace in its defective condition, and
- The defect caused the patient’s injury.
What Are Class Action Lawsuits Involving Medical Device Injury?
A class action lawsuit, or mass tort lawsuit, is a lawsuit filed by one or more plaintiffs on behalf of a “similarly situated” larger group. In the context of surgically implanted medical devices, class action lawsuits are common when there has been a defective product introduced into the marketplace. Often many patients have the same device implanted before it is discovered that the device is defective.
Rather than each plaintiff injured by the device bringing their own lawsuit, one large lawsuit is brought against the manufacturer and all of the injured plaintiffs share the damages that are awarded.
Some examples of class action lawsuits involving medical device injury include:
- Women who have all been injured by defective contraceptive devices;
- Women who have been injured by transvaginal mesh;
- Women who have been injured by defective breast implants;
- Patients injured by defective hip implants;
- Patients injured by Inferior vena cava filters.
What Are the Damages for a Medical Device Injury Lawsuit?
Plaintiffs, or their family members, who are successful in a lawsuit for injuries caused by a surgically implanted medical device can usually recover the following damages:
- Compensatory damages for lost wages or lost earning capacity
- Damages for physical and emotional pain and suffering
- Past and future medical expenses
- Wrongful death
- Loss of consortium
- Punitive damages meant to punish the defendant
Do I Need a Personal Injury Lawyer?
If you have been injured because of a surgically implanted medical device, you should contact a personal injury lawyer. An attorney experienced in medical malpractice cases can evaluate your claim, explain the likelihood of success in a lawsuit, and help you collect the evidence you need to pursue a claim and receive the compensation you deserve.