By Russ Banham
While the benefits of 3D bioprinting are clear and valuable, the risks created by the novel technology for researchers, manufacturers, software programmers and health care providers are uncertain. Among the hornet’s nest of liabilities that may arise are product liability, professional liability, medical malpractice, and intellectual property infringement.
Such risks should create pause for consideration, but they in no way should impede the extraordinary progress of ongoing research and development into the medical use of 3D bioprinting. The technology involves the manufacture or growth of human tissues and organs printed layer-by-layer into a three-dimensional structure. In many cases, the structures are made from a patient’s genetic matter to accurately match the diseased organ or bone they replace—kidneys, livers, skin, windpipes, bladders, and even more complex structures like hearts.
The Great Promise of 3D Bioprinting
The import for humankind is incalculable: Since the 3D bioprinted organ or tissue is made from the patient’s DNA cell matter, the risk of an immune response causing rejection is greatly reduced, if not eliminated. This is the great promise of 3D bioprinting. But, like any new technology or product, its singularity also creates risk.
“3D bioprinting is vital, fascinating and evolving, but when there is the inevitable litigation, most every party up and down through the supply chain will be named in a lawsuit,” said Matthew L. Cohn, senior vice president and global head of the life sciences insurance practice at Newport Beach, Calif.-based insurance broker Alliant Insurance Services.
These parties run the gamut from the scientists who have created the technology; the software programmers, manufacturers and distributors of the 3D bioprinting systems; the health care facilities that buy these medical devices; the physicians and other health care providers who advise patients to consider using bioprinted organs and tissues and/or deliver these options surgically; and even the insurance agents and brokers counseling the life sciences space about the assumed risks.
“Not only will insurance agents need to do a tremendous amount of research to stay ahead of the curve, they must be prepared to impart this insight proactively to their clients,” Cohn explained. “Otherwise they can be hit with a professional liability lawsuit for failing to do proper due diligence.”
A Gradual Progression
Some time will pass before 3D bioprinting is as routine as CAT scans and colonoscopies. For now, only bones, teeth and prostheses have been made through 3d printing, i.e., without living human tissue. In the case of dental fabrication, a digitized, intra-oral scan is made of a patient’s teeth to manufacture a set of dentures. The image is uploaded into a computer and emailed to a dental lab that prints out the dentures three-dimensionally, which fit the patient much like his or her actual teeth.
A similar process is pursued to make bones like hip and jaw replacements. Last year, doctors and engineers in the Netherlands printed a three-dimensional prosthetic lower jaw that was implanted into an 83-year old woman suffering from chronic bone infections. The prosthetic jaw was printed from 33 layers of titanium powder that were heated, fused and coated with bioceramic artificial bone.
“These early developments will eventually give way to 3D bioprinted living tissues and organs,” said Joseph Coray, Vice President for the Technology and Life Science Practice at insurer The Hartford. “For now, much of this activity is ongoing and, in some cases, in the early stages of clinical trials. Assuming they pass the rigorous testing and are introduced into the marketplace, a range of different liabilities may arise.”
As an example, he cited a hip replacement made from 3D printed materials. “The orthopedic surgeon who buys the system to make the hip and then implants it in a patient could be liable for medical malpractice, if the hip has to be removed for medical reasons,” Coray said. “The manufacturer of the printer, as well as third party software suppliers, also could be named in a product liability lawsuit. The original developers of this intellectual property—the scientists that came up with the technology—are similarly vulnerable to litigation. It all depends on how the contracts indemnifying these parties were developed.”
Corporate Risk Managers Need to Identify Vulnerabilities
The potential liabilities require corporate risk managers within these organizations to identify respective pockets of vulnerability. It also behooves insurance agents and brokers serving the life sciences industry to assess the exposures from a risk management standpoint, and for insurance companies to create broad policy coverages at adequate limits of financial protection to absorb the risks. “All of this begins with a deep understanding of what the 3D bioprinting technology does and who is using it,” said Coray.
Cohn agreed. “There are a plethora of issues that come to light when one considers where this is headed,” he said. “For it to work best across the spectrum of entities involved, there has to be a high degree of collaboration among these entities with insurance underwriting, broking and risk management experts.”
He added, “Nobody wants the benefits of these extraordinary technologies to be impeded or postponed. Now is the time to consider the risk-related obstacles and overcome them.”