By Joe Winebrenner and Andrew Jackson
Over the last decade, 3D printing (also known as “additive manufacturing”) has revolutionized the medical industry. The FDA has reviewed hundreds of medical devices made with 3D printers, including orthopedic and cranial implants, surgical instruments, dental restorations, and prosthetic devices. With greater frequency, 3D printing technology is being incorporated at the point of care. Healthcare providers, alone or in conjunction with third-party manufacturers, utilize 3D printing to manufacture patient-specific models, implants, prosthetics, external fixators, splints, surgical instrumentation, and surgical cutting guides. And this technology has allowed providers to save lives: Already, healthcare providers have implanted a 3D-printed trachea into a six-week-old infant, replaced 75 percent of a patient’s skull plates with 3D-printed material, and have used 3D-printed anatomical models to facilitate the separation of conjoined twins, correction of spinal deformities, and removal of tumors.
While 3D printing provides undeniable benefits in healthcare, its use at the point of care raises questions as to liability exposure that remain unanswered, and it is incumbent upon hospitals and healthcare providers to consider and protect against these risks as they incorporate the technology into their practices.
Product User or Manufacturer?
The use of 3D printing at the point of care blurs the lines between product user and manufacturer. Traditionally, healthcare systems have been viewed as service providers, not as sellers or manufacturers of a product for use or consumption, and their actions and liability exposure have been subject to the relevant “standard of care”—as opposed to the product liability doctrines of strict liability and warranty that control liability in the context of product manufacturers and sellers. Under the traditional chain-of-sale, a third-party medical device manufacturer may design, manufacture, and sell a medical product to hospitals; the hospital then uses the product to provide care to its patients. In this context, where user and manufacturer are distinct, it is relatively straightforward to assign responsibility if a product is later determined to be defective.
When a healthcare provider uses 3D printing to create the medical product at the point of care, however, this distinction is blurred. The “user” becomes the “manufacturer” in some respects. A doctor or technician may use technology to scan a patient’s body, to “specify” the size and shape of an implant, and to “print” that implant using a 3D printer, all in-house. In this way, many of the roles that were once the responsibility of the traditional device manufacturer are now embraced by healthcare providers around the country.
New Liability Exposure?
The liability impact of this change in roles has not yet been tested in the courts and is not yet clear. However, if the courts determine that a healthcare provider that 3D prints a medical device in their facility becomes a “manufacturer” or “seller” of that device under the law, it could potentially implicate product liability exposure—an area of law that was previously shut off from the profession.
There are a variety of legal theories that could apply to healthcare providers that make and sell their own products. Under the theory of strict liability, product suppliers owe a special responsibility to ensure their products are safe and may be found liable for defects determined to be to be unreasonably dangerous to consumers, regardless of the care taken in creating the products. Similarly, under theories of implied warranty, product sellers may be liable if the product is found to be “unmerchantable” or if it is not “fit” for the particular purpose for which it was intended to be used. These theories have not yet been tested, and they may or may not ultimately apply to healthcare providers in the context of 3D printing at the point of care. Indeed, the exposure to liability may even vary across states. Regardless, it is certain that, as 3D printing technology becomes more prevalent in the healthcare industry at the point of care, new theories of liability will be pushed by the plaintiffs’ bar and tested in the courts, and healthcare providers utilizing the technology will want to be prepared.
Accordingly, it is incumbent upon healthcare providers considering the use of 3D printing technology in their practices to consider and protect against these liability risks. Among other measures, risk managers should review applicable insurance policies to understand the scope of protection and whether additional insurance may be needed. Institutions should consider indemnification agreements with the relevant third-party suppliers or service providers, if appropriate. Such third parties may include the seller of the printer itself, the supplier of the 3D printing materials used with the printer, or the supplier or sponsor of the computer technology or design files that are employed to take patient measurements or to “specify” the size or shape of a customized medical product.
As healthcare providers embrace the benefits of 3D printing at the point of care, they may also be embracing a new risk of liability. Providers seeking to benefit from 3D printing at the point of care should consider these risks, incorporate risk mitigation measures that are aimed to rein them in, and follow the developments in the law as they emerge.
For more information, please contact Joe Winebrenner or Andrew Jackson.
