Who is Liable for a Defective 3D Printed Medical Device?
Printing custom medical devices and tools while you waited seemed like something we’d achieve in the distant future, but thanks to the additive process, doctors and hospitals can now make that a reality. 3D printing, using the additive process, can build 3-dimensional objects by layering successive layers of a material on top of one another, creating a solid figure. This process has been used to create surgical tools, prosthetics, hearing aids, braces, and casts. Researchers hope that it may even be able to one day create functioning organs. These devices can use metal, plastics, medication, and even human tissue to create devices and figures.
Like most cutting-edge technologies, the law has yet to completely catch up and provide comprehensive solutions to potential issues. As 3D printing is becoming more accessible and hospitals are turning to this method to custom print medical devices, patients are at risk. Defective medical devices are a significant cause of injuries, but the non-traditional manufacturing method may mean that there is little that injured patients can do to hold responsible parties reliable. Determining liability for an injury caused by a defective 3D printed medical device requires a careful evaluation to determine which theory of liability applies.
Theories of Liability & Medical Malpractice
When a patient is injured due to neglect, incompetence, or defective medical devices, they should be able to receive compensation for their injuries. But when a 3D printed medical device is involved, liability can grow hazy. Here are some of the potential theories of liability, and how they may apply to your case.
Currently, it is difficult to apply products liability towards hospitals or doctors who are printing their own custom medical devices. This is because a manufacturer of a device can only be held liable if they create the device to be sold. Under current laws, you cannot hold a doctor or hospital strictly liable as a supplier of medical products, since they are actually considered to be consumers and users themselves.
As the law currently exists, patients may be relegated to a simple negligence claim if they want to hold a doctor or hospital responsible for their injuries. While strict liability holds manufacturers liable for defective devices regardless of fault, negligence is a fault-based doctrine. As an injured patient, it will be on you to prove that your doctor or hospital was somehow negligent when creating and utilizing your 3D printed medical device.
Medical Malpractice Claims
If a hospital or medical professional supervises the use of a defective 3D printed device, it may be possible for an injured patient to file a medical malpractice claim. Medical negligence can be asserted when a procedure is performed incorrectly with the device or if there is a failure to provide informed consent about the use and risks of the device. It will also fall to the patient to find evidence that proves the negligence of the medical staff in charge of the procedure.
In order to prove a medical malpractice claim, you must demonstrate that your doctor or hospital had a duty of care to you, and that a similarly skilled and knowledgeable medical professional wouldn’t have made the same mistakes in similar circumstances. If the physician is a specialist, these standards of care are even higher. Hospitals may be held liable under corporate negligence theory, which can arise from policies, actions, and inactions of the hospital itself.
If you or a loved one has been injured by a defective 3D printed medical device, our team at Williams DeClark Tuschman Co., L.P.A. can help. Our Toledo medical malpractice attorneys have more than 100 years of collective legal experience, so you can trust that we have the knowledge and skill to fight for you. Don’t wait to reach out for the help you need.
Schedule a free consultation to discuss your case with our team. Contact our firm by calling (419) 318-0772.