As 3D printing becomes more accessible, the innovative technology is finding a place in many hospitals, creating customized medical devices. As the use of these 3D printed devices grows, so do concerns about liability. If a patient is injured by a medical device that was designed and printed by their doctor or other medical personnel, who is liable for their injury?
In traditional medical devices, a failure that causes injury to the patient would be blamed on the manufacturer of the device. Medical manufacturing companies adhere to strict quality standards to ensure that their devices are safe to use. Products liability law dictates that a manufacturer is responsible for the products they sell. As hospitals begin to print devices and sell them to patients, the line between manufacturer and service provider becomes blurred, and liability becomes harder to assign.
Under current laws, patients injured by faulty printed devices are only able to sue for negligence. Negligence cases are often more difficult to prove fault in, so patients may not recover the damages they require for further procedures and medical care. The burden of proof is on the victim, who will need to demonstrate a breach of duty, causation, and damages. Victims may have difficulty locating expert witnesses to testify, due to the newness of the technology. The recent advances in 3D printing technology add obstacles when it comes to the standard of care and causation.
Medical Malpractice Claims
A patient may be able to file a medical malpractice claim if a medical professional recommended or supervised the use of a 3D printed device. If the procedure is performed incorrectly, there was improper training for the device’s use, or the medical professional failed to provide informed consent about the risks of the device, a medical malpractice claim can be filed. Physicians and other medical personnel are obligated to meet a standard of care and exercise the same level of skill and knowledge normally used in the medical field. Doctors who specialize in certain fields must demonstrate an even higher standard of care than those who do not specialize. Hospitals can be subject to corporate negligence claims if institutional policies, actions, or inactions were responsible for a patient injury.
Most traditionally manufactured medical devices are subject to FDA, and there are many liability laws to enforce the administration’s regulations. Due to the custom nature of bespoke 3D printed medical devices, the FDA may not be classified as medical devices by the FDA, and the creators of these devices might not face the same responsibilities that traditional manufacturers do. Hospitals or doctors who manufacture custom devices are typically not regulated by the FDA, and do not need to meet quality standards that other manufacturers do.
Due to the increasing popularity of 3D devices, the future of liability law is likely to require changes to protect patients. The customizable nature of 3D printed devices can mean incredible advances to the way injuries and conditions are treated. Injuries caused by faulty devices need to be addressed, and patients need a way to ensure that their pain and suffering doesn’t go without just compensation.
If you have been injured by a 3D printed medical device, you need experienced representation from our Palmyra personal injury attorneys. Our team can help you determine what your best path is to receive compensation, and can assist in filing your claim, negotiating on your behalf, and fighting for your rights in court, if necessary. We have been serving injured clients in Western and Central New York since 1974, and we believe in compassionate advocacy for our clients’ needs. Contact Foley & Foley today to schedule a consultation.