The human tissue industry is a rapidly growing part of the medical landscape but recent issues have brought to light certain flaws in the industry.
In 2021 in America, over 100 patients went to their local hospitals for orthopedic surgery but got much more than they bargained for—a case of tuberculosis from a contaminated human tissue product used in their surgeries. The human tissue industry is a rapidly growing part of the medical landscape but recent issues have brought to light certain flaws in the industry.
Human tissue is taken from donor cadavers and turned into a wide variety of medical products, many of which are life-saving. Last year, one donor lot of a human tissue product used primarily in spinal fusion surgeries, FiberCel Viable Bone Matrix (FiberCel), was sold to 37 medical facilities across the country even though it was contaminated with deadly tuberculosis (TB) bacteria. The 113 victims that received the contaminated bone graft are all believed to have developed active TB as a result. The litigation around this catastrophe has focused a microscope on this emerging industry and the safety and potential uses of human tissue and bone products harvested from donor cadavers for use in medical procedures.
Prior Human Tissue Litigation
You may remember the now infamous case of the “body snatchers,” which involved the illegal “harvesting” of cadavers in funeral homes in Philadelphia, New Jersey and New York. In that case, from 2000 to 2005, a properly registered human tissue company by the name of Biomedical Tissue Services, Ltd., led by criminal mastermind Michael Mastromarino, illegally “harvested” over 1,000 cadavers supplied by funeral homes without proper consent or medical screening. As a result, more than 25,000 human tissue products were sold across the country for surgical implantation into unsuspecting, innocent victim patients. Many of those human tissue products contained communicable diseases that were not adequately screened for.
Thousands of patients, complaining of everything from fear to the development of specific diseases, filed suit against not only the harvesting company, but also the manufacturers and distributors of the potentially tainted human tissue products. On June 21, 2006, those cases were consolidated into a federal Multi-District Litigation (MDL), In re Human Tissue Products Liability Litigation, MDL 1763, assigned to the U.S. District Court for the District of New Jersey. The victims’ claims were litigated for six years, and ultimately the civil claims were resolved in 2012. Mastromarino faced both civil claims and criminal charges and was ultimately sentenced to 56 years in federal prison in New York, where he expired just a few years later.
The Human Tissue Industry
The “body snatchers” litigation informed an entire industry, and was a wakeup call for the legal, medical and scientific community. Over the past several decades, the use of human tissue products for surgeries of all types has grown exponentially. “Human tissue,” per FDA regulations, includes bone, skin, corneas, cells, ligaments, tendons, as well as other types of tissue harvested from human donor cadavers. Cadaver skin can be used for burn patients, skin graphs and breast reconstruction. Human bone can be used both whole or ground into paste for any surgery requiring repair to damaged bone, particularly spinal fusion surgeries. Because of their broad range of uses and incredible benefits, patients today welcome and accept the use of human tissue products.
Human tissue intended for implantation or transfer into a human recipient is generally regulated by the FDA’s Center for Biologics Evaluation and Research (CBER) under 21 CFR Parts 1270 and 1271. The regulations require manufacturers of human tissue products to create donor eligibility criteria and to establish procedures to prevent the spread of communicable diseases. The FDA regulates human tissue products under a completely different framework than its regulations for drugs and medical devices.
As of 2019, the human tissue market totaled nearly $10 billion and is continuing to grow. The lesson learned from the earlier fiasco is that harvested cadavers that are contaminated with communicable disease can lead to the spread of that disease to innocent recipients. The industry pledged to make certain that harvesting, processing and distribution procedures would be scrutinized and that contaminated human tissue would not find its way into surgical suites around the country. Unfortunately, the resulting changes to the FDA’s regulations fell short of protecting patients from these risks.
The FiberCel Recall
On June 2, 2021, Aziyo Biologics Inc. (Aziyo) issued a voluntary recall of a single lot of FiberCel that was sold to 37 hospitals across 20 states. The product was recalled after a number of patients tested positive for TB after undergoing orthopedic surgery utilizing FiberCel. FiberCel is a human tissue product made from cryopreserved bone. It is primarily used in orthopedic and reconstructive bone grafting procedures and is intended to maintain characteristics of natural human tissue. FiberCel is manufactured by Aziyo and had been distributed by Medtronic, Inc., through its subsidiaries, Medtronic Sofamor Danek USA, Inc., and Spinalgraft Technologies, LLC.
One hundred and thirteen innocent patients who underwent complex spinal fusion surgery in early 2021 had FiberCel from the contaminated lot used in their surgeries. All of these patients are believed to have subsequently tested positive for TB or died prior to being tested for TB.
Early reports suggest that the harvesting company, New Mexico Donor Services, Inc., harvested a cadaver that was infected with TB and then sold that cadaver’s infected human tissue to Aziyo. Aziyo then used the infected human tissue in the production of FiberCel and that infection was transferred to the surgical patients intraoperatively by the placement of the FiberCel product at the site of the spinal fusion. The plaintiffs allege that none of the parties involved in the harvesting, processing, manufacturing, sale, or distribution of the contaminated FiberCel product adequately tested the product or the human tissue used in the product to ensure that it was free from TB contamination.
The horror faced by each of these patients should never have come to pass. Tuberculosis in the bone, and eventually spreading to plates, rods, screws, and then to other parts of the body, presents a rare and almost insurmountable challenge to the infectious disease doctors treating these victims. Most people who have TB are originally exposed to TB through aerosol transmission. TB bacterium are inhaled into the lungs and then spread to highly oxygenated parts of the body where there is good blood flow. Only about 5% of people exposed to TB actually develop active disease. For most, the TB stays latent and does not cause harm.
The situation these patients are in is extraordinarily unusual because their TB came from bone fiber material and the TB went directly into their bone. Because these patients received FiberCel as part of their spinal fusion surgeries, the risk of TB entering their spinal cord is greatly heightened. Once TB enters the spinal cord, it can result in significant neurological effects, the formation of abscesses up and down the spinal cord, as well as other severe complications. The TB can also spread to the hardware used in these patients’ spinal fusion surgeries which makes the infection much more difficult to treat effectively, as antibiotics cannot reach the hardware through the bloodstream.
Many of the victims have been compelled to undergo painful revision surgeries, having rods, plates, and screws removed, in an attempt to better fight the TB infections, and some will likely have to undergo additional surgeries in the future. These victims must all take four to six different medications for upwards of a year or more in order to fight their TB infection. Numerous victims have been admitted to hospitals for prolonged hospitalizations, some of them by court order and against their will, to receive aggressive inpatient treatment to fight their TB. Local departments of health are involved in almost every case and are monitoring these TB-infected patients on a daily basis to ensure they are taking their TB medication. These innocent victims have lost their ability to work, remain homebound, and have daily unrelenting pain associated with virulent TB infections. Many are suffering from additional complications as a result of their TB, including loss of memory, lesions on the lungs, brain, and on other organs, spreading infections, large abscesses and other devastating complications.
The FiberCel litigation is still in its infancy. The first case in the country was filed in Delaware Superior Court in June 2021, Williams v. Aziyo, C.A. No. N21C-06-166 EMD, and additional cases have been filed in both federal and state courts in Delaware, Florida, Ohio, Indiana, Michigan, Kentucky, and Oregon. Since the contaminated product was used in 20 different states and impacted up to 113 individuals, additional filings in other jurisdictions are expected.
The lawsuits primarily allege that the defendants failed to adequately screen the donor cadaver’s medical history, failed to adequately test the product, failed to manufacture the product in a way that ensured it was free from contamination, and failed to warn patients of the risk of contracting TB. Lawsuits have been filed against the harvesting company, the manufacturer and the distributor of FiberCel. Due to the number of victims and the long and uncertain road to recovery that many of them face, this litigation will likely be ongoing across the country for years to come. While these cases are being fought in court, it is imperative that the defendants involved do everything in their power to ensure that a tragedy like this never happens again.
The questions raised by this tragic situation include: how could this possibly have occurred, what is the standard for selecting a donor cadaver, and what has been done to ensure that this industry, so critical to our modern and evolving medical world, has taken the necessary steps to assure the safety of its products. We have to encourage the FDA, the human tissue industry, and the medical community to have a high and demanding standard. Simply put, there should be no opportunity for diseased human tissue to reach operating rooms.
This case should be the final lesson to make sure the industry is properly regulated, and that exhaustive testing is performed so doctors can feel safe when using human tissue products, and so patients can knowingly consent to their use without fear or uncertainty.
Larry Cohan and Joshua Cohan lead the Saltz Mongeluzzi & Bendesky mass tort and toxic tort practice. They are co-counsel with the Morris James firm in the first FiberCel case filing and Larry was co-lead counsel in the In re Human Tissue MDL. Their practice includes chemical exposure cases, products liability and pharmaceutical mass torts, and asbestos- and vaccine-related injury claims. They can be contacted at email@example.com and firstname.lastname@example.org.