New cases are no longer being accepted. 2 comments Christene October 18, 2019 at 9:46 pm Reply. The Medtronic Infuse Bone Graft is used to stimulate bone growth. Product Liability Attorney, Walter Kelley, explains related the dangerous and sometimes fatal side affects caused by Medtronic Infuse Bone Graft. Nearly 1000 Infuse bone graft injury lawsuits filed for financial compensation will be settled using the $22 million that Medtronic set aside to cover complaints that their medical device produces serious injuries. If you have used Medtronic Infuse for bone growth and have had any injuries, including additional surgeries, sterility, cancer or swelling, contact our team at 1.800.553.8082, or online. Infuse side effects can cause unwanted bone growth, leading to severe pain, reduced mobility and nerve damage in some patients. is a law firm with lawyers licensed to practice law in Maryland, Washington, D.C., Pennsylvania and Virginia. In "Company News". Bones grafts are pieces of bone or bone substitute that can replace damaged or diseased bone in a number of joints and bones in the body. For more information. Off-label use of the Medtronic Infuse Bone Graft in the cervical spine has been associated with a number of serious and life-threatening complications. Medtronic Bone Graft Lawsuit Update. Lawsuits have been filed against Medtronic due to the injuries and complications experienced by patients after using an infuse graft. Medtronic has already paid over $40-million to settle lawsuits associated with the manufacturer’s illegal promotion of off-label use of the Infuse bone graft. According to allegations raised in Medtronic Infuse lawsuits, the manufacturer: The Medtronic Infuse lawyers at Saiontz & Kirk, P.A. Bone Graft Class Action Lawsuit – Medtronic InFuse Defect Claim According to several scientific studies the use of the Infuse Bone Graft manufactured in cervical spine surgeries has been linked to several severe and life threatening medical health complications. About 85% of Infuse use is off-label according to MedPage Today. Suite 900 In May 2014, Medtronic agreed to settle 950 lawsuits for $22 million. Saiontz & Kirk, P.A. 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. The product liability lawyers at Saiontz & Kirk, P.A. Email Alerts. Bone grafts traditionally have come from the patient’s own jaw, skull, hip or chin, requiring a second surgery to harvest the bone. Medtronic Infuse Bone Graft Defined. Medtronic: No admission of Liability or Wrongdoing, Medtronic reported that, “subject to certain conditions,” to pay roughly $22 million to resolve the claims of about 950 claimants. Two of these lawsuits have been settled with the company admitting no wrong doing. Through use of co-counsel and local attorneys, cases are reviewed nationwide, but are not accepted in every state. The portions of The Legal Examiner Affiliate Network maintained and operated by law firms are Legal Advertising. May 6, 2014. Another lawsuit alleges improper usage of the bone graft. New cases are no longer being accepted. I have their hardware in my back and I’m have issues with it. In reaction many injured victims have sought compensation through the filing of class action and single party lawsuit against the manufacturers of the defective medical devices. Press Releases. Using this site or communicating with our law firm affiliates through this site does not form an attorney/client relationship. Call us now 1-877-690-7373 2 talking about this. Although the medical device was approved for only one purpose, analysts estimate that as much as 85.2 percent of Infuse use was for off-label purposes. How Will Maritime Laws Apply to the Seacor Boat Accident? The company described the settlement as “a compromise of disputed claims” and said it is “not in any way an admission of liability or validity of any defense in the litigation by Medtronic.”, The product remains on the market, and Medtronic said it will “vigorously defend the product and company actions in the remaining cases.”, Still pending, however, are roughly 750 cases filed by about 1,200 individuals. And 80% of all bone grafts in the United States are performed to support the spine during vertebrae fusion surgery. In addition, our attorneys provide each client with personalized attention and passionate representation. A Motion to Remand Has Been Granted by a Federal Court in A Case Brought Against Medtronic, Inc. and Medtronic Sofamor Danek USA, Inc. Over its InFUSE™ Bone Graft Product. Medtronic is facing over 3,000 lawsuits involving complications of the Infuse bone graft. The U.S. Food and Drug Administration in 2002 approved the product for spinal fusion involving the anterior approach for back spinal surgery. This page is maintained for informational purposes only. This is in addition to the $140 million that will be used to settle future claims. Infuse contains a synthesized human hormone that causes bone to grow. Medtronic Announces New Clinical Trial to Study Infuse Bone Graft in TLIF Spine Procedures. Some shareholders have lawsuits pending concerning illegal advertising of the product. Spinal fixation devices use pedicle screws and rods to hold the vertebrae in place. Instead, they are individual lawsuits filed by plaintiffs with severe injuries. The U.S. Department of … Medical device company Medtronic plc has agreed to pay institutional investors $43 million in a proposed class-action settlement of a lawsuit related to its bone-growth product, Infuse. Sep 26, 2019. Medtronic Settles Investor Lawsuit for $43M. Medtronic Continues to Invest in Scientific Evidence for Expansion of Indications and Greater Clinical Understanding of Infuse™ Bone Graft. Dr. Shezad Malik Law Firm has offices based in Fort Worth and Dallas and represents people who have suffered catastrophic and serious personal injuries including wrongful death, caused by the negligence or recklessness of others. The two-part device is implanted on the lumbar section of … previously reviewed cases for individuals throughout the United States who have experienced side effects or complications following surgery. Although it was only tested and approved for use during anterior lumbar fusion, involving single level fusion, it has been widely used off-label in other spinal surgery, including cervical fusion, thoracic fusion, posterior lumbar fusion (where the lumbar spine is approached from the back instead of through an incision in the abdomen, as is done during an anterior lumbar fusion), as well as during multi-level fusions. These have not been consolidated into a class action lawsuit. DUBLIN and CHICAGO, Sept. 26, 2019 (GLOBE NEWSWIRE) -- Medtronic plc (NYSE:MDT) today announced U.S. FDA approval of a prospective, randomized pivotal clinical trial for the use of Infuse™ Bone Graft in Transforaminal Lumbar Interbody Fusion (TLIF) spine procedures. Medtronic, the company that manufactures the INFUSE bone graft, has come under scrutiny by physicians, the FDA and even the federal government in recent years.Some patients have chosen to file an INFUSE bone graft lawsuit, claiming Medtronic failed to provide proper warning about the risks associated with their medical product. Alternatives to Infuse Bone Grafts. Medtronic has been accused of manipulating Infuse studies and using deceptive marketing practices to promote off label use by physicians in other types of orthopedic procedures not approved by the FDA. The number of lawsuits continues to grow, even as Medtronic … Medtronic warned that the initial settlement of $22 million is likely be the tip of the settlement iceberg. previously reviewed claims for individuals who experienced problems following neck or back surgery where the Medtronic Infuse bone graft was used off-label, which has been linked to a risk of serious and potentially life-threatening side effects. The Medtronic Infuse is a new type of bone graft, which uses recombinant human Bone Morphogenetic Protein (rhBMP-2) to stimulate bone growth. Patients were not told of the risk of serious complications linked to Infuse. Medtronic, Inc., announced today that it has agreed to settle 950 of its BMP Infuse Bone Graft product liability injury cases. How Did 3M Fail 230,000+ Military Members? Baltimore, Maryland 21202. New cases are no longer being accepted. Medtronic InFuse Bone Growth Side Effects, Medtronic Infuse Lawyers Reviewing Lawsuits for Bone Graft Problems, Medtronic Infuse Bone Graft Class Action Lawsuit, 3 South Frederick Street During oral surgery with Infuse Bone Graft, the rhBMP-2 protein is mixed with sterile water. Filing a Lawsuit after Suffering Complications from Medtronic Infuse Bone Graft The Medtronic Infuse Bone Graft has been implanted into thousands of patients for spinal fusion surgery. Copyright © 2021 Saiontz & Kirk, P.A. This page is maintained for informational purposes only. Parker Waichman LLP, continues to evaluate cases of spinal surgery patients suffering from serious injuries allegedly caused by Medtronic Infuse. Medtronic has been under scrutiny for years now concerning allegations of illegal off-label promotion and use of Infuse Bone Graft Device, financial conflicts of interest by researchers, under-reporting of complications and overblown reports of superior clinical results. Saiontz & Kirk, P.A. Medtronic Infuse Bone Graft Lawyers. Shezad Malik is an Internal Medicine and Cardiology specialist, a Texas Medical Doctor (retired) and Defective Medical Device and Dangerous Drug Attorney. When used during these unapproved procedures, Medtronic Infuse side effects may cause bone growth in areas where it is not wanted, which may cause: Research has also suggested that use of Medtronic Infuse BMP may increase the risk of cancer, as well as cause some men to become sterile. The Medtronic Infuse BMP bone graft was promoted as a superior alternative, because it helps avoid pain and problems associated with harvesting bone and removes the risk of the cadaver bone being rejected by the body. The product liability lawyers at Saiontz & Kirk, P.A. One of the primary advantages of Infuse Bone Graft is that it is an alternative to autograft—the use of autogenous bone (from the hip, rib, leg, jaw or chin) for implantation into a void or defect elsewhere in the body, such as the bones of the jaw. It was approved in 2002 for limited use in the lumbar spine, but not for the cervical or thoracic spine. | Privacy Policy | Terms of Use and Disclaimers | ATTORNEY ADVERTISING MATERIALS. But, many Legal Examiner Network Affiliates are. Please do not act or refrain from acting based on anything you read on this site. Medtronic, Inc., announced today that it has agreed to settle 950 of its BMP Infuse Bone Graft product liability injury cases. Medtronic Infuse has been touted as a cutting edge alternative to traditional spinal fusions. ... 2019… More Information on Bone Infuse Claims; Medtronic’s Infuse Bone Graft fact sheet Former employees of Medtronic also began lawsuits against the company. In spinal fusion, doctors surgically fuse together individual vertebrae, which is meant to eliminate the irritation of nerves in the spine. previously reviewed claims for individuals who experienced problems following neck or back surgery where the Medtronic Infuse bone graft was used off-label, which has been linked to a risk of serious and potentially life-threatening side effects. About the Lawsuit The securities lawsuit alleges that Medtronic artificially inflated stock price through ‘off-label’ promotional schemes, including promoting Infuse for use in the cervical spine. The Medtronic Infuse Bone Graft is not approved for any other uses but it has been used off-label in cervical spine (neck) procedures. Stryker Biotech manufactures a similar product, called OP-1, which was approved by the FDA in 2001 for limited use. Court Says Children Given For Adoption May Pursue Louisiana Wrongful Death Claims. This page is maintained for informational purposes only. This allows doctors to implant a synthetic bone graft instead of using bone from a cadaver or harvesting a graft from a patient’s hip, which can be painful. It was approved by the FDA in 2002 for the limited use during single-level anterior lumbar fusion surgery, as well treatment of tibia fractures and some oral or dental procedures. Infuse contains recombinant human Bone Morphogenetic Protein, which triggers bone growth. Medtronic warned that the initial settlement of $22 million is likely be the tip of the settlement iceberg. Roundup Lymphoma Cancer Claim California Trial Underway, Cook IVC Filter Lawsuit results in $3M Trial Verdict, Injectafer Iron Medication under fire for severe side effects. Spinal surgery is one of the most common orthopedic procedures performed today. Medtronic has been accused in lawsuits of aggressively promoting unapproved uses of Infuse, and it has also been alleged that research sponsored by the device maker downplayed many serious Infuse bone graft side effects. Infuse Lawsuit. It was developed as an alternative to traditional bone graft procedures, which involve either the use of bone harvested from the hip or another part of the body, or bone extracted from dead bodies. Medtronic recklessly promoted and encouraged use of their Infuse BMP (Bone Morphogenic Protein) for a number of surgical procedures that have not been properly tested and which may increase the risk of inflammatory reactions, breathing problems, severe nerve damage, sterility in men, cancer and wrongful death. Medtronic noted that the pending cases are “still in the early procedural stages and none have resulted in a finding of liability against Medtronic.”. The Legal Examiner is not a law firm. According to the Medtronic Infuse bone graft lawsuits, plaintiffs have suffered severe nerve damage, airway compression and other complications associated with uncontrollable bone growth after the device was used off-label, such as in the cervical spine, at multiple levels or through a non-anterior approach. What is a Medtronic Infuse Bone Graft and why is it used? If you are in need of a Wisconsin Medtronic Infuse Bone Graft attorney, contact PKSD today for your free consultation at 877-877-2228. The medical device manufacturing giant plans to record a fourth-quarter charge of up to $140 million to cover its initial settlement and the estimated cost of additional settlements. Medtronic is now facing several lawsuits over injuries and deaths linked to the use of Infuse in cervical spine surgeries. The product is applied to an absorbable collagen sponge that is placed within an “LT-Cage” that is implanted to encourage bone growth and fuse the gaps between the vertebrae. We are investigating Medtronic Infuse lawsuits nationwide. Although Medtronic was aware risks associated with off-label use, the company engaged in widespread over-prmotion of the Infuse bone graft, encouraging use during fusion surgery that was never properly studies and was known to cause serious side effects. The Infuse® Bone Graft/LT-Cage® Lumbar Tapered Fusion Device (“Infuse”), developed by Medtronic, was created to assist patients with degenerative disk disease (DDD). During spine surgery, the Medtronic Infuse bone graft consists of an absorbable collagen sponge that is treated with rhBMP-2, and then placed in a small “cage”, known as the LT-CAGE, to keep the two vertebrae in place and provide the frame for the Infuse BMP. Financial compensation was pursued through Medtronic Infuse lawsuits as a result of the manufacturers failure to adequately warn consumers and the medical community about the side effects associated with use of the bone graft. Hyundai Recalls Another 390,000 Vehicles Because of Potential Engine Fires. Infuse is a genetically modified bio-engineered bone graft product, a  version of a naturally occurring protein that promotes bone growth. In 2017, Medtronic announced the FDA approval of a separate clinical trial to study Infuse Bone Graft in Posterolateral Fusion (PLF) procedures. Medtronic has initiated site recruitment for the TLIF clinical trial with the potential to enroll up to 50 sites with over 1,000 patients. The Medtronic InFuse Bone Graft medical device implant has been linked to a series of serious side effects. The vast majority of InFUSE bone graft operations involve the spine. Medtronic has also stated that it paid a physician nearly $800,000 to conduct a study promoting the off-label use of Infuse. I’m looking for a lawyer to help me in the Medtronic infuse bone graft. In 2011, The Spine Journal, a medical publication, reported that the Infuse’s side effects were not reported in clinical research. Medtronic expects to record a charge of between $120 million and $140 million in its recently completed fourth quarter—a charge that accounts for not only the latest $22 million settlement but also the estimated costs of settling the 1,200 pending claims and the 2,600 that have yet to be filed. Medtronic Infuse Bone Graft Litigation. This website is for informational purposes only and does not provide legal advice. This field is for validation purposes and should be left unchanged. Lawyers Reviewing Medtronic Infuse Lawsuits Nationwide, Medtronic Infuse Bone Growth Side Effects, Holding Corporations Accountable for Dangerous Products, Nerve Impingement Resulting in Severe Back or Neck Pain, Additional Surgery to Remove Excessive Bone from the Spinal Canal, Failed to adequately study the side effects of Medtronic Infuse Bone Morphogenic Protein, Concealed their knowledge about the potential Medtronic Infuse risks when used off-label, Failed to report Medtronic Infuse side effects that occurred when used during back or neck surgery, Failed to adequately warn about the risk that Medtronic Infuse may result in severe damage to the nerves and spinal cord, *No Fees or Expenses Unless a Recovery is Obtained*. may associate with outside attorneys to serve as lead counsel, at no additional cost to the client. In the older procedure, bone is harvested from another area of the body usually the pelvis or used from a cadaver.

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