Medical devices that are printed using 3D technology are referred to as 3D printing medical products or 3D-printed medical devices. 3D printing technology is also known as “additive printing”. The term “3D printing” is used for a variety of processes in which layers of a material, such as plastic, are joined together under computer control to create a three-dimensional object.

Unlike traditional product manufacturing, 3D printing manufacturing does not make use of molds or multiple pieces of specialized equipment, and the designs can be modified quickly. So, 3D printing can be used for creating medical devices that are matched to an individual patient based on the patient’s unique anatomy. Joint replacements, cranial implants, and dental restorations are some examples of medical products that can be customized for use with each individual patient.

Some large-scale manufacturers create and market these products, however customization is also done at the facilities where patients receive their medical care. This is referred to as point-of-care manufacturing. Using imaging of the patient, hospitals and doctors create what is called “on-demand” 3D-printed medical products.

Examples of the kind of medical devices that can be printed at the point of care include anatomical models matched exactly to the patient, prosthetics, and surgical guides. Surgical guides are tools that help guide surgeons in their cutting during an operation. The number of hospitals in the U.S. that have their own 3D printing capability has grown in the past decade, from just a few in 2010 to well over 100 by 2019. As the technology evolves, this point-of-care model is likely to become even more widespread.

In the medical field, 3D-printed medical devices can include:

  • Orthopedic implants, such as hip and knee joint replacements;
  • Cranial implants;
  • Surgical instruments;
  • Dental restorations (such as crowns);
  • External prosthetics;
  • Other applications.

3D printing may also be applied to the production of some pharmaceuticals and drugs. As applied to the manufacture of pharmaceuticals, 3D printing has the potential to allow for dosage forms or formulations that are unique to one patient, including those that could make slower or faster absorption possible, for example.

3D printing as applied to medical devices is a relatively new technology. It can be associated with various unintended consequences and risks of injury, especially those associated with product failure. Injuries can arise when devices break, or when defective or inappropriate materials are used in the printing process, and from other causes as well.

Who Can be Held Liable for Injuries Caused by 3D Printing Medical Devices?

One of the issues associated with 3D-printed medical devices is that it may be difficult to determine who is liable for the injuries they might cause. As the technology becomes less expensive and more accessible, various different parties may begin producing such devices using the technology.

In many cases, commercial manufacturers might be held legally responsible for injuries caused by such products if the product is defective. Defects can include warning label defects, manufacturing defects, and design defects. In the event of such defects, a strict product liability theory of law might apply.

In a product liability lawsuit, the injured party does not have to prove actual negligence. Rather, they must only prove that the product had a defect and that it caused injury. So, an injured patient would not have to show that the defect was attributable to some specific act of negligence on the part of a person involved in designing, manufacturing, or labeling the product. They would only have to show that the defect was present and caused injury to the patient.

In other cases, people and companies can be held liable for injuries caused by 3D-printed medical devices if they are negligent in some way with respect to the manufacture or distribution of the devices. For instance, if a person produces 3D-printed medical devices in a way that does not conform with the standards in regulations set forth by the Food and Drug Administration (FDA) or other agencies that might regulate the devices, they can be held liable for injuries. This may also apply to doctors and other hospital personnel who are found to have produced 3D-printed items in a negligent manner.

Of course, through medical malpractice lawsuits, doctors and hospital personnel can also be liable for negligence in their use of 3D-printed devices in medical procedures. A medical malpractice claim would be the recommended course of action if a doctor or hospital negligently recommends or supervises the use of a defective 3D product. A medical malpractice lawsuit might be advisable if evidence discloses that a doctor or hospital did any of the following:

  • Improper Use: Improperly used a 3D-printed device;
  • Inadequate Training: Was inadequately trained for the use of the device;
  • Failure to Inform: Failed to inform a person of the risks associated with the 3D device.

Of course, an injured patient would have to discover evidence that clearly shows any of these forms of negligence. Success with a claim of negligence requires proving the following: l

  • Duty of Care: The person or entity owed a duty of care to the patient;
  • Breach of the Duty: The person or hospital breached the duty through some specific negligent act;
  • Cause of Injury: The breach caused injury to the patient;
  • Damages: The injured patient suffered economic and possibly psychological damage as a result.

Of course, each element of negligence must be proven by evidence.

What are the Legal Remedies for a 3D-Printed Medical Device Injury?

Injuries from 3D-printed medical devices can be severe, and legal action may be needed to provide remedies for the injured party. In such cases, money damages may be awarded to the injured person to compensate them for losses caused by the injury. The damages can cover expenses such as the cost of medical care, hospital bills, the cost of surgery needed to correct a physical problem, wages lost due to an inability to work, emotional distress and other related losses.

Other remedies may apply also, such as a recall of the product. In cases involving negligence or malpractice, in addition to having to pay damages, a medical professional may lose their ability to practice or may face other disciplinary measures.

Do I Need a Lawyer for Help with a 3D-Printed Medical Device Injury?

The laws governing 3D-printed medical devices can be complex and may be in a state of flux as the technology and the uses for it in medical treatment continue to evolve. You may need to hire a products and services lawyer near you if you have been injured in the course of medical treatment that involved 3D-printed devices. Or, you may wish to consult an experienced attorney who specializes in medical malpractice as the fault for your injury may involve your doctor and not the device.

In any event, your attorney can provide you with legal advice and can help you file a lawsuit, if that becomes necessary. Application of the law to specific situations may be novel, and you are most likely to get the best possible result if you are represented by an experienced products and services lawyer. Your attorney can provide you with legal direction and will be able to represent you in court if a conflict should arise.