Table of Contents
- 1 Who will need a bone graft?
- 2 Applications of Bone Grafting
- 3 Types of Bone Grafts
- 4 Bone grafting procedure: How is it done?
- 5 Purity of the Allografts: How important it is?
- 6 What is FiberCel?
- 7 FiberCel Lawsuit: The How and Why
- 8 FiberCel Surgical Bone Product Lawsuit: The Arguments
- 9 Aziyo FiberCel Case- The Response of CDC
- 10 Aziyo FiberCel Tuberculosis Lawsuit- Case Studies
- 11 Aziyo’s Stand in FiberCel Lawsuits
- 12 How to file a FiberCel lawsuit?
Starting with a stat, every year, around 2 million bone fractures are reported in the United States, including cases of osteoporosis. Bone grafting is the surgical procedure done in many fracture cases to heal bones. This procedure helps to repair both damaged and diseased bones through transplantation. Bone grafting is an integration procedure that promotes the body’s own bone to fuse with the graft, unlike just as a patch job. The transplant eventually becomes a functional, living component of the skeletal system.
In this blog, MedLegal360 is taking you for a deep dive in to FiberCel lawsuit, stemming from the harmful effects of tainted bone graft transplantation.
Let’s start with the basics of bone grafting for a better understanding, why bone grafting is done and how the procedure works?
Who will need a bone graft?
In cases of minor bone fractures, the repairing process is carried out naturally. However, in case of severe fractures, bone grafts are needed to proceed with the healing process. Let’s check out some major conditions that demands bone grafting.
Delayed union: Bone healing is naturally occurring, but in a delayed manner
Malunion: Bone healing is naturally occurring, but in a wrong position
Nonunion: Bone healing is not occurring naturally
The above-mentioned conditions may occur in individuals due to smoking, old age, suppressed immune system, diabetes etc.
Applications of Bone Grafting
Bone grafting may be required for patients who suffer from certain injuries or disease conditions as mentioned below.
- Motor vehicle accidents
- Slip and fall injuries
- Construction accidents
- Bone diseases (osteonecrosis, cancer etc.)
- Bone infections like osteomyelitis
- Congenital anomalies, such as uneven limbs or an abnormally small chin.
- Jaw reinforcement before receiving a tooth implant.
- Joint replacement surgery
- Spinal fusion surgery
Types of Bone Grafts
Bone grafts can be classified into four types, depending upon the source of the grafts. They are
Autografts are the bone tissues collected from a healthy site of the patient’s body and reimplanted into the trauma site. Though the amount of bone tissue that could be taken is limited, autografts provide better fusion results.
Allografts are the bone tissues taken from a donor (living or cadaver), which is then fused in to the patient’s body where the bone is damaged. Allografts are commonly used on spinal fusion surgeries.
- Synthetic Bone Grafts
Synthetic bone grafts are porous materials, artificially produced to support the healing of damaged bones. These materials hold bone healing proteins to trigger the repair of the damaged bone.
- Bone Marrow Aspirates
Bone marrow aspirates are collected from the hip bone, which is then mixed with the other bone grafts during allograft procedures.
Bone grafting procedure: How is it done?
Bone grafting procedure is done under anesthesia. The surgeon creates an incision in the site of the damaged bone and the bone substitute is placed with the help of additional tools like screws, wires, cables, etc. If the procedure involves an autograft, two incisions would be required, one to retrieve the bone substitute and the other in the trauma site.
Once the bone substitute is placed, the surgical site is closed with sutures and observed for bone healing. Normally, the recovery takes 2 weeks to 2 months.
Purity of the Allografts: How important it is?
Allografts, which accounts for 57% of the bone graft market, are the most commercially successful type of bone graft to date. However, the use of allografts possess high risks like disease transmission due to harmful microbes present in the allograft bone. Microbial contamination may occur anytime, right from the retrieval of the allograft bone, during transportation, storage or transplantation.
The allografts undergo several phases of processing to make them ideal and safe for bone grafting.
The steps in allograft preparation are as follows.
Cleaning phase involves a combination of physical and chemical processes like sonication, ethanol wash, agitation, etc. that eliminates any contamination in the allograft bone.
Second step is decellularisation that removes the histocompatibility antigens and DNA residues, causing immunogenic response in the recipient. Removal of these cells are carried out by chemical, enzymatic and mechanical methods using SDS, enzymes, freeze thawing etc.
Following decellularisation, sterilization of the allograft bone is done to eliminate pathogenic microorganisms that can cause fatal infections in the recipient.
Discussing about the need of maintaining the allograft bones safe from microbial contamination, we will move on to the heart of the blog, FiberCel lawsuits. FiberCel surgical bone product lawsuit revolves around FiberCel, an allograft bone product that resulted in tuberculosis infections in the recipient.
What is FiberCel?
FiberCel is an allograft bone product manufactured by Aziyo Biologics. Inc. The product is derived from donated human tissue, recovered from a single human donor. The allograft is used in orthopedic or bone grafting surgeries in a combination with autologous bone or other forms of allograft bone or independently as a bone graft.
FiberCel contains cancellous bone particles with preserved living cells from donors and demineralized cortical bone fibers, that facilitate bone repair and healing in recipients, and is used during various spine and orthopedic procedures. Since June 2019, the product is distributed in the United States by Medtronic. On September 06, 2023 Aziyo Biologics, Inc. changed the Company’s name to Elutia Inc.
FiberCel Lawsuit: The How and Why
On June 2, 2021, Aziyo Biologics, Inc. issued a notification about an urgent voluntary recall for a specific batch (NMDS210011) of its FiberCel Fiber Viable Bone Matrix product. This recall was the result of a complaint originating from one hospital, which reported post-surgical infections in 7 out of 23 patients who had received FiberCel from this particular lot. The more alarming news was that four of these patients tested positive for tuberculosis (TB).
The letter issued by Aziyo served as a call to action for all customers who had received FiberCel from this particular donor lot. The instruction was to immediately inspect the inventory and place any remaining product under quarantine.
If any of these customers had further distributed FiberCel product from this Donor lot to other locations, they were advised to take immediate action.
Aziyo also went the extra mile by offering prepaid shipping containers, ensuring a seamless and efficient return of the product.
As per the reports, around 100 patients are exposed to the recalled batch of contaminated FiberCel products. The contaminated products where mainly used for spinal surgery and fracture repair procedures. PCR analysis of the recalled batch products are found positive for Mycobacterium tuberculosis. Cell culture studies are ongoing as the next step, so that the Mycobacterium contamination of the recalled product could be confirmed.
Tuberculosis- Is it really fatal?
Not properly treated, it can be fatal. The signs and symptoms of the disease can be very severe, demanding continous medication. Treatment typically involves a long-term course of treatment with a number of antibiotics.
FiberCel Surgical Bone Product Lawsuit: The Arguments
According to the FiberCel lawsuit, the defendants had failed to
- Adequately gather and review donor medical history
- Design, manufacture, and test the product to prevent contamination
- Issue a timely recall of the product
- Warn consumers of the risk of contracting tuberculosis
Aziyo FiberCel Case- The Response of CDC
In coordination with other state health agencies, the U.S. Centers for Disease Control (CDC) has been working actively for the patients sustaining from FiberCel bone graft injury. CDC reports indicate that 136 units of the recalled FiberCel product lot were used in 113 patients in 20 states. Out of them, 72 patients are reported to exhibit diagnostic findings of tuberculosis infection and 8 of them had died.
The shocking side of this date is that, tuberculosis is relatively rare in the U.S., with only about 9,000 cases reported every year. This adds more clarity to the findings connecting the use of tainted bone grafts with tuberculosis infection.
CDC had contacted all the patients treated with recalled lot of FiberCel to help ensure they receive proper diagnosis and medical treatment if diagnosed with tuberculosis.
Aziyo FiberCel Tuberculosis Lawsuit- Case Studies
Let’s now go through some of the FiberCel tuberculosis lawsuits to know better about the injuries sustained by the victims.
The first FiberCel lawsuit was filed in a Delaware state court, where the plaintiff Richard Williams was diagnosed with tuberculosis after undergoing spinal surgery in April 2021. The lawsuit claims that the plaintiff developed a post-operative infection and tested positive for TB after the spine surgery.
Identifying the use of tainted bone graft, the plaintiff had to undergo a revision surgery on June 7, 2021 to remove the FiberCel and redo spinal fusion. Mr. Williams demands and ongoing medical care and monitoring for tuberculosis. The Aziyo Biologics FiberCel bone graft lawsuit claims that the revision surgery required a higher level fusion, resulting in decreased range of motion and permanent injury.
Another FiberCel lawsuit was filed by William Wilcox, a Virginia man. As per the lawsuit, the plaintiff was diagnosed with tuberculosis, after receiving a contaminated bone graft product in March 2021. He received the notification from the CDC in June 2021 and the tuberculosis tests were identified positive. The plaintiff filed a lawsuit in the Loudoun County Court in Virginia in March 2023.
The lawsuit was later moved to the federal court, including defendants like Aziyo Biologics, Inc., Medtronic Sofamor Danke U.S.A., SpinalGraft Technologies, LLC, DCI Donor Services, Inc. and New Mexico Donor Services.
The FiberCel lawsuit alleges that the plaintiff had to undergo two revision surgeries in order to overcome the damages caused by the tainted FiberCel. The plaintiff also requires prolonged medical assistance to return to his life.
The litigation is ongoing with discovery procedures were completed in September 2023.
Georgia Flinn is another plaintiff who had filed a FiberCel bone graft injury lawsuit for wrongful death on behalf of Gregory Flinn. The lawsuit was filed in the Marion Superior Court in Indianapolis, Indiana with the following companies as defendants: Silver Spring, Maryland-based Aziyo Biologics, Inc.; Memphis, Tennessee-based Medtronic, Sofamor Danek USA, Inc.; Memphis, Tennessee-based SpinalGraft Technologies, LLC; and Indianapolis, Indiana-based Rapp Medical Systems, LLC.
In April 2021 Gregory underwent a spine fusion surgery using the FiberCel implant. Three or four days after surgery, the victim began to experience high fevers, weakness, fatigue, back pain, etc. In May 2021, his fever spiked and later the victim developed mental status changes and hypoxia. He was rushed to the ICU and was diagnosed with TB that led to his death on May 23, 2021. The post-mortem core biopsy of Gregory’s liver by the CDC confirmed immunohistochemical and molecular evidence of Mycobacterium tuberculosis.
Aziyo’s Stand in FiberCel Lawsuits
As the FiberCel lawsuits claim, Aziyo Biologics had the responsibility to ensure that the FiberCel Bone Matrix was sterile. However, the manufacturer failed to test the product for Mycobacterium contamination, which resulted in direct transmission of the infection to the victims.
Aziyo accepts that their contaminated batch of 154 FiberCel units were distributed to 20 states. The company expects more and more injury lawsuits to boom in 2024. Foreseeing a legal battle, the company suspended its recent revenue guidance for 2021. This indicates that the manufacturer is concerned about the uncertainty in their business due to the tainted product recall and its effect on sales.
How to file a FiberCel lawsuit?
Are you suffering from tuberculosis as a result of tainted FiberCel bone grafts? Seek the help of an expert FiberCel lawyer to know the possibilities of filing a personal injury claim. Produce your medical records and exhibit the injuries you have sustained due to product contamination.
As of now there are only personal injury lawsuits being filed against Aziyo Biologics for manufacturing tainted bone graft products. Lawyers expect more and more injury lawsuits to be filed in 2024, as all the victims with the recalled lot of FiberCel are diagnosed with TB.
To sum up, the issue of tainted bone grafts and the FiberCel lawsuits that are being filed provide as a clear reminder of the risks that can arise from subpar medical supplies. These instances demonstrate the psychological and financial toll these products can have on patients in addition to the physical harm they can cause. When treatments meant to heal actually cause more damage, this becomes an alarming scenario.
To protect one’s health, it is essential to be aware of the risks, inquire about the safety and provenance of implants or grafts, and be alert to any unusual symptoms that may arise after the procedure. Furthermore, it is critical to understand your legal rights and resources.
Legal options may provide some measure of justice and compensation in situations where patients suffer as a result of faulty medical equipment. These lawsuits serve as a warning, guaranteeing greater safety standards and accountability in the medical product industry, in addition to offering relief to the impacted victims.