Local: (502) 749-5700
Cell: (502) 649-1234 Home: (502) 228-5112
In 2002 the Food and Drug Administration (FDA) approved the use of INFUSE® (rhBMP or rhBMP-2). However, it was approved for only one type of spine surgery. The surgery for which INFUSE® was approved was a single level lumbar spine fusion. More restrictive, the INFUSE® approval was only for one "approach" to the lumbar spinal fusion. The anterior approach (as opposed to the posterior approach, for example) was the only approach the FDA approved. INFUSE® or rhBMP or rhBMP-2 has not been approved for several other orthopedic surgeries such as multi-level spinal surgeries or fusion surgeries or fusion in the cervical (or neck) area.
Infuse® Bone Graft, also known as rhBMP-2, is a bioengineered liquid bone protein that promotes bone growth. It is used by doctors as an alternative to more traditional bone grafts in spinal fusion surgery. Historically, bone grafts have been from bone harvested from the patient's hip, a cadaver, etc.
Since its initial release, Infuse® Bone Graft has enjoyed tremendous growth in use among doctors, primarily in cervical neck fusion procedures. But with this growth in use, rhBMP-2 (Infuse® Bone Graft) was subsequently tied to medical complications in many patients. These medical complications primarily arose from off-label use of INFUSE®. Off-label use of INFUSE® resulting in the complications addressed by this article include use in spine surgery other than single-level lumbar fusions and, further, anterior approach, single level lumbar fusions. INFUSE® (rhBMP-2) complications resulted in the FDA issuing a warning in 2008 that INFUSE® (rhBMP-2) should not be used for off-label purposes, especially cervical (neck) spinal fusions.
The maker of Infuse®, Medtronic, has been named in lawsuits alleging that Medtronic illegally promoted off-label use of Infuse. Former employees have claimed Medtronic financially incented doctors to use Infuse® and other Medtronic products. In June of 2011, Congress began looking into allegations that orthopedic surgeons with financial links to Medtronic may not have reported complications during their clinical trials of INFUSE® Bone Graft. More specifically, there were 13 trials funded by Medtronic which now appear to have under-reported complications. The Spine Journal released its July 2011 edition that detailed the complications associated with the use of Infusion Bone Graft as well as the questionable tactics used by Medtronics to promote the use of INFUSE®.
The off label use of INFUSE® Bone Graft/rhBMP-2 can cause a patient to have swelling in the neck and throat tissue. This swelling can cause blockage and compression of the patient's airways, leading to labored swallowing, breathing and speaking. These symptoms usually arise within a 2 to 14 day window of surgery. The risks may require patients to endure further surgery, mandate respiratory aid, require use of a feeding tube, or undergo a tracheotomy. Other complications from the use of INFUSE® (rhBMP-2), many of which stem from excessive bone growth, may include:
The off-label use of a drug or medical device by a doctor is not illegal. However, it is illegal for a drug company to promote off-label use. It also may be inappropriate for doctors to promote off-label use if they are financially incented by a drug company. Furthermore, doctors must make patients aware of any and all risks associated with off-label use of a drug or medical device.
In certain cases the doctors and surgeons using the INFUSE®/rhBMP-2 may not be responsible for the patients complications. Assuming the doctor did not know of the mis-information and under-reporting of complications, the doctor may have a legitimate defense that he or she was unaware of the risks. However, if the surgeon knew of the risks of the off label use and failed to adequately advise the patient, the surgeon may share responsibility.
If you or a loved one has had serious health problems that you believe arose from the use of Infuse® Bone Graft (rhBMP-2) then you should consider contacting a Kentucky attorney to evaluate your case. Cases such as these carry a statute of limitations (a time limit for filing a law suit), so it is important to have an attorney help you to determine if your case merits investigation as soon as possible. Please contact Brett H. Oppenheimer, PLLC a Kentucky attorney, who can help to guide you through the legal process. Email firstname.lastname@example.org or call toll free 866-935-5729 for a consultation on your Infuse® Bone Graft (rhBMP-2) claim.
Attorney Brett H. Oppenheimer explains the purpose of the phone call blog. He believes it is an opportunity to share some of the stories and inquiries that come to him by email and telephone so you can learn about the types of cases he and his staff consider. The phone call blog is a compilation of stories that come to him from people just like you. To learn more about the phone call blog, please view this short video.
I received a call from the father of an adolescent male. His son had been diagnosed with ADHD and, among other medications, was prescribed Risperdal. His son had recently been diagnosed with Gynecomastia (male breast growth). The father had learned through an internet search that Gynecomastia is a complication of Risperdal. Unfortunately,... read more
We received an inquiry from a contractor who had had two fingers severed and one injured substantially when he was injured by a table saw. Injuries from table saws can certainly be significant. We explained that where there are serious injuries we are interested in investigating claims associated with recently manufactured table... read more
We received a call from a 58 year old gentleman that had been using testosterone replacement therapy ("Low-T" gel) for approximately 60 days when he suffered a heart attack. He had seen something online about dangers associated testosterone replacement therapy and increased incidences of heart attack and stroke, and, therefore, called. I... read more
A man in his twenties contacted our office to discuss a significant injury he suffered while using a table saw. Every year, tens of thousands of injuries are suffered by table saw users. Many injuries occur as a result of kick-back, and that is exactly what happened to this man. Kick-back can... read more
A woman in her mid-fifties contacted our office to discuss her recent diagnosis of Type II Diabetes. She had been prescribed Lipitor to help lower her cholesterol. In fact, results from a recent study showed a drastic increase in Type II Diabetes in menopausal women using Lipitor. One of the criteria as... read more
We were contacted by a middle aged woman who had recently undergone surgery. She and her family were told that her surgery was anticipated to last approximately an hour and a half. Concerns arose during the surgery and, ultimately, the surgery lasted almost six hours. When the patient awoke, she had pain,... read more
By Rebekah Kearn SAN JOSE, Calif. (CN) - Stock prices for Intuitive Surgical dropped from $573 to $393 per share when it was found that the company had grossly underreported injuries and deaths caused by its da Vinci robotic surgery device, shareholders claim in a federal derivative complaint. The City of Birmingham (Ala.) Relief... read more
Drug prescriptions for testosterone therapy have nearly tripled since 2001 for American men suffering from "Low T," a condition that is more frequently the natural result of aging rather than any disease. Testosterone therapy in these men has been found to significantly increase the risk of heart disease and cardiovascular disease,... read more
A recent large study has found additional evidence of significantly increased risk of cardiovascular disease in middle aged men and older who are prescribed testosterone for "low T." Click here to read the original New York Times article... read more
By Christopher Jensenmarch 2, 2014 For Laura Christian, July 29, 2005, was the worst kind of anniversary. One year earlier, Ms. Christian had been reunited with Amber Marie Rose, the daughter she gave up for adoption at birth. But Ms. Christian did not get to call her daughter a year later. In the predawn... read more
By Christopher Jensen Feb. 13, 2014 UPDATED: Feb. 14, 2014, 10:47 a.m. General Motors is recalling about 619,000 small cars in the United States because either a heavy key ring or a "jarring event" such as running off the road could cause the ignition to shut off and possibly prevent the air bags from... read more