Medtronic Infuse Bone Graft
- Lawsuits have been filed against Medtronic due to the injuries and complications experienced by patients after using an infuse graft.
- It is alleged that the company hid the risks of using Infuse bone grafts from the consumers and that it may lead to severe side effects while also increasing the risk of cancer. They have been accused of paying off researchers and doctors to promote their products despite these risks.
- Medtronic also attempted to dismiss the lawsuit on the grounds that the FDA had approved the use of Infuse. However, the company was unsuccessful in this strategy since the FDA never approved the product for off-label use
- The company has settled around 4,000 lawsuits and plans to settle thousands of pending cases as well. These settlements were projected to reach $460 million or more.
Infuse bone grafts are concentrated, synthetic proteins used for certain trauma, dental, and spine indications created by Medtronic. The FDA approved the use of these infuse bone grafts for spinal fusion in 2002. Therefore, the product was later approved for the treatment of tibial shaft fractures in 2004 and oral-maxillofacial procedures in 2007.
Although infuse bone grafts have been utilized in millions of medical procedures around the globe. But, a number of patients are now reporting of severe complications from their use. Moreover, the company has also been accused of paying off doctors to use its products and intentionally hiding their side effects, as well as using deceptive strategies for marketing. Due to the injuries and complications experienced by patients after using an infuse graft, they have filed Infuse Bone Graft lawsuits against Medtronic.Reasons for Infuse Bone Grafting
Bone grafts are bone substitutes or bone pieces that are used to replace diseased or damaged bones in different parts of the body. An increasing number of individuals experience chronic back pain caused by arthritis or other conditions. For spinal fusion, the individual damaged spinal bones are fused surgically. The bone is usually taken from a different part of the patient’s body. Doctors may even use a donated or synthetic bone.
Once the fusion procedure is done, it leads to the formation of a solid bone, which helps eliminate irritation of nerves in the patient’s spine and allows them to lead a painless lifestyle.
Using a synthetic bone graft eliminates the need to harvest bone from another part of the patient’s body. Moreover, using a donated bone increases the risk of infection. The infuse system is, therefore, more effective than these options, especially for patients with degenerative disc disease. However, keep in mind the FDA has only approved one spinal surgery method for the infuse bone graft, which is anterior lumbar interbody fusion.
Medtronic’s infuse bone graft includes the following two parts:
- RhBMP-2: It refers to a genetically engineered type of natural protein (Bone Morphogenetic Protein) that is found in the human body and aids in regulating bone healing and growth.
- Collagen Sponge: It is created from cow type 1 collagen, which works as a natural carrier for delivering the rhBMP-2 protein.
This collagen sponge gets soaked with synthetic proteins and is then injected into the patient’s spine to ease their pain. Millions of people around the globe have undergone infuse bone graft surgeries after it was approved by the FDA. Infuse bone grafts are also risky and can lead to severe side effects while also increasing the risk of cancer.
The most astonishing fact is that it is alleged that Medtronic hid this information from consumers, and paid off researchers and doctors to promote their products. The company’s sheer negligence caused injuries and pain to many patients, which is why they have filed lawsuits against Medtronic. In this regard, numerous Medtronic infuse bone graft lawsuits have been settled, but many cases are still pending today.Side Effects of Using the Medtronic Infuse Bone Graft
Many clinical studies reveal that infuse can cause inflammation of nearby bones and tissues, which can result in urinary issues and cancer growth among patients. Bone Morphogenetic Protein (BMP) products have also been linked to a 43% higher complication rate in comparison to traditional bone grafts. It wasn’t until a review was published in 2011 that the adverse side effects of BMP products came to light. The research study stated that these severe effects were 10 to 50 times higher than the original estimates published by peer-reviewed publications, which were industry-sponsored.
Some of the side effects reported by patients after a Medtronic infuse bone grafts surgery includes:
- Ectopic formation of bone (growth of unwanted bone in the spinal canal)
- Osteolysis (bone tissue degeneration)
- Male sterility
- Retrograde ejaculation
- Displacement of implant
- Radiculitis (pain spreading through spinal nerves)
- Leg and back pain
- Inflammatory reactions
In severe cases, the use of infuse led to patient death. In the review, the researchers accused Medtronic and other companies of paying off doctors to hide these complications and side effects from patients. Medtronic also marketed its product as a better option to standard bone grafts. Even after a number of people who underwent infuse bone graft surgery reported complications and increasing evidence showing that a large dose of infuse can increase the risk of cancer among patients, Medtronic still keeps denying these claims.History of Medtronic Infuse Bone Graft Lawsuits
The FDA approved restricted usage of the infuse bone graft in 2002, only for the lumbar spine to repair open fractures and specific cranial and facial drafts, as well as occasional dental and oral procedures. No other use for this product was given the FDA approval.
Medtronic was accused of encouraging physicians and hospitals to use this infuse device for off-label treatments of the cervical spine. While this product appeared to be safe for use in lumbar or lower back surgery, major complications arose after using infuse in a patient’s neck vertebrae or cervical spine.
This is the off-label use of the product, which wasn’t approved by the FDA. The company gained substantial profits from off-label usage, which boosted more than $3 billion in the company’s overall sales.
While the company enjoyed its profits, patients suffered greatly from grave health complications due to the infuse system. The affected patients started experiencing side effects, including respiratory system damage, nerve damage, airway compression, and breathing difficulties, between three to two weeks post-surgery. Some cases required additional surgeries for treating the issue, while others led to patient death.
Many claimants suffered from permanent and debilitating injuries due to this illegal use of the device. In most of the cases, the affected patients were not even aware that they would receive Medtronic infuse bone grafts during their procedures. They claimed that they found out about it once they started experiencing complications after surgery.
These allegations first emerged when two patients getting treatment at a hospital claimed that their surgeons received kickbacks from Medtronic. These two patients alleged that thousands of dollars in royalty, grants, and consulting payments to the surgeons had established a conflict of interest, resulting in a risky treatment, which they were never informed about. Aside from these patients, many more patients claimed to have suffered from grave complications after their surgical procedure and had no idea that they would receive the infuse bone graft and that it wasn’t even tested for safety.
After receiving increasing reports of these complications, the FDA warned against the off-label use of this product in 2008. After a few months, the Wall Street Journal published a report that stated around 200 patients suffered from life-threatening complications from this device. The report also stated that many surgeons and researchers might have been bought off by the company to use and publish favorable reports of using the infuse system for off-label usage.
After the negligence of the company came to light, multiple lawsuits were filed against it for numerous reasons related to the infuse system. Three former employees of the company filed a lawsuit against it for not disclosing information about the device’s side effects and complications to the people. One case was dismissed, while the other two were settled without the company admitting negligence.
Several law firms urged whistleblowers to take steps against Medtronic for negligence and fraudulent behavior. Patients who had undergone off-label surgeries with the infuse system also sued the company. By now, more and more people started reporting severe complications from the device’s off-label use, which include muscle spasms, paralysis, coma, and wrongful death. Amidst increasing patient complications and lawsuits, the U.S Senate Finance Committee launched an official investigation in 2011 against the surgeons who were accused of acting on behalf of the company.
This 16 month-long investigation revealed that Medtronic’s employees collaborated with different researchers and physician authors to alter or create misleading and inaccurate studies about the safety and benefits of the company’s infuse bone graft. It was also revealed that these authors earned more than $210 million from the company to publish biased studies and reports.
Another investigation was launched by Yale in the same year, which revealed that there were hardly any differences in the benefits of the infuse bone graft and traditional bone grafts. The latter was a much affordable surgery as compared to infuse surgery. This investigation also confirmed the findings of the U.S. Senate investigation regarding the device’s safety concerns and inaccurate and biased reports.
Dr. Eugene and other researchers published an editorial that indicated that the majority of the studies sponsored by Medtronic failed to reveal the potential life-altering complications and side effects linked with the infuse bone graft system. Rightfully so, many more patients sued the company for its negligence to recover compensation for their pain and suffering. The company has settled several cases, but there are hundreds of lawsuits still pending in courts.Who Can File a Claim for Medtronic’s Infuse Bone Graft Lawsuit?
After experiencing complications due to the use of this defective medical device in surgical procedures, patients have been filing lawsuits against Medtronic. After the research review was published, many more patients have joined mass tort lawsuits. Medtronic also attempted to dismiss the lawsuits on the grounds that the FDA had approved the use of Infuse. They also claimed they are not liable for the effects that occurred after surgeries.
However, the company wasn’t successful in getting all the cases dismissed since the FDA didn’t approve the product for off-label use, which the company had been promoting. Since Medtronic also misrepresented research related to the product they funded, the patients who experienced severe injuries and pain due to infuse bone grafts have the right to recover damages.
Many claimants have been demanding compensation for their medical bills, loss of potential wages, loss of wages, as well as pain and suffering. If you or a loved one has received Medtronic infuse bone graft and suffered from injuries, you are entitled to take part in the mass tort case against the company. After the court’s judgment, you would get a portion of the total settlement.
If you haven’t experienced any symptoms, it is still recommended that you consult your doctor or surgeon to determine whether or not you have any health problems or potential problems due to the infuse bone graft. It might be possible that the symptoms haven’t occurred yet, but you have a certain medical complications. Moreover, consult a personal injury lawyer for your case and determine if you can claim for damages against Medtronic.How Long Do I Have To File a Medtronic Infuse Bone Graft Lawsuit?
The deadline for medical device defects and complications is typically tied to when you discover you are experiencing side effects from the product or when you should have reasonably discovered the problems. The statute of limitations also varies from state to state. If you fail to file your Medtronic Infuse Bone Graft Lawsuit within the Statute of Limitations, you will be barred from pursuing your claim and your case will likely be dismissed. Therefore, it is essential to get in touch with a lawyer to determine if you can join the Medtronic Infuse Bone Graft lawsuit to recover damages.
If you or a loved one has undergone an infuse bone graft surgery and have experienced complications, you might be entitled to pursue compensation for your damages. The amount you may receive will be dependent on the unique factors involved in your case. You should consult your lawyer to determine the statute of limitations in your state and immediately file a claim against the company. Have a thorough medical examination done to determine any potential complications if you haven’t yet experienced any side effects.How Many Lawsuits Have Been Filed Against Medtronic?
Since 2008, thousands of individuals have filed cases against Medtronic over severe complications that they or their loved ones experienced due to infuse bone grafts. Claimants have even stated that Medtronic pushed their surgeons to utilize the infuse bone graft for their treatments, even though the product hadn’t been approved off.
Medtronic has been accused of marketing the infuse system for off-label uses, which led to several patients experiencing injuries and even death in some cases. The company has settled around 4,000 lawsuits and plans to settle thousands of pending cases as well. These settlements were projected to reach $460 million or more. The company set aside $300 million for all pending charged. This settlement would likely resolve all pending lawsuits and create end plans for possible future litigations.
Additionally, Medtronic also settled a shareholder lawsuit for $85 million in 2012 for not revealing that the majority of infuse sales were off-label uses. They paid another $43 million to another stockholder case in 2018 for inflating stock prices. The case accused the company of scheming and conduct to defraud the investing consumers.
Another $12.5 million was paid by the company in 2012 to settle a five states’ attorney general lawsuit for fraudulently or deceptively marketing infuse. The U.S Department of Justice also investigated the company, which resulted in a $40 million payout for settling allegations of buying off doctors to use its infuse bone graft product.Hire a Lawyer to File a Medtronic Infuse Bone Graft Lawsuit
Instead of pondering about how to file a lawsuit against Medtronic, consult with a lawyer to take immediate legal action. At Frankl & Kominsky, our attorneys have recovered more than $75 million in accident and injury settlements. If you or a loved one has experienced complications or wrongful death after having Medtronic infuse bone graft surgery, our lawyers can help you try to recover compensation for your previous and future medical bills, lost wages, and special damages.
Frankl & Kominsky offers a contingency fee agreement, where you don’t have to pay anything unless our lawyers have helped you recover damages.
Call us today at 855-955-1428 for a free consultation on your case.