Many lawsuits have been filed against the manufacturer of the Medtronic INFUSE Bone Graft, alleging that the device was used off label and that it causes side effects such as uncontrolled bone growth, cancer, among others. You may be entitled to receive compensation for medical bills, lost income and pain and suffering, among other losses. We are currently working with some of the more experienced lawyers in the country and there is no fee unless you obtain a settlement or award. Call us toll-free or submit a contact form online.
It is alleged in lawsuits that in July 2002, the FDA approved the INFUSE Bone Graft for sale on the market by its manufacturer, Medtronic (i). This medical device was approved to treat degenerative disc disease (DDD) in the L2 and S1 vertebrae. These vertebrae are located in the lumbar region of the spine (lower back). In order to treat DDD, surgeons implant the device using a spinal surgery called, Anterior Lumber Interbody Fusion (ALIF). An anterior approach means that the device is inserted by making an incision in the front of the body. It is alleged in lawsuits that the FDA has only approved a label using this approach for INFUSE Bone Graft surgeries; therefore lateral (incision in the side) and posterior (incision in the back) approaches are considered off-label.
The device consists of three parts: (1) Lumbar Tapered Fusion Device (LT-Cage), (2) collagen sponge, and (3) rhBMP-2 (recombinant human Bone Morphogenetic Protein-2). The LT-Cage is a small metal case which holds the sponge and protein. It stabilizes the spine while fusion occurs. The sponge is manufactured from cow collagen. It holds and releases the protein solution over time. It is also disappears as bone growth takes place. The rhBMP-2 is a genetically engineered version of a protein that occurs naturally in the human body. This protein regulates bone building cells and promotes bone growth (ii).
When the INFUSE Bone Graft was first introduced to the market it had received several positive reviews from medical studies while its competition received negative reviews. It has been alleged that adverse events were underreported in the first 13 studies of the device. Additionally, it is alleged in lawsuits that Medtronic may have paid money to doctors, raising the concern that the benefits of the INFUSE Bone Graft may have been inflated while the risks were downplayed.
Understanding FDA Approval of the INFUSE Bone Graft
- It is alleged in lawsuits that the FDA has only approved this device for a limited number of uses. These include Anterior Lumbar Interbody Fusion (ALIF) to treat degenerative disc disease (DDD) and some dental surgeries.
- And, that other uses are off-label and may be dangerous.
- And it is alleged in lawsuits that the implantation of the device in the thoracic vertebrae (middle of the back) or in the cervical vertebrae (top of the back/neck) are off-label. And, that the FDA has even warned that implanting the device in the cervical area can be life-threatening.
- It is further alleged that lateral or posterior surgical approaches are off-label and may increase the risk of suffering an injury.
How Do I Know If I Received a Medtronic INFUSE Bone Graft?
There are two major back surgeries used to treat DDD. The traditional treatment for this disease is the iliac crest bone graft (ICBG). This procedure requires two incisions because bone is harvested bone from the hip and then fused to the spine. The INFUSE Bone Graft is the newer treatment and it was introduced to replace the ICBG. If your procedure required bone to be harvested from your body or you received bone from a cadaver or demineralized bone matrix, then you probably were not implanted with the INFUSE device. However, if your doctor talked to you about Medtronic, implantation of a device, or Bone Morphogenetic Protein (BMP), then you may have received the INFUSE device. If you are unsure of what surgery you underwent, then you should look through your medical records or contact your doctor’s office because they are required by law to give this information.
INFUSE Bone Graft Side Effects
It is alleged in lawsuits that this medical device has been linked to a wide range of serious side effects, especially when used off-label. Medtronic warns about a number of complications on the product’s website including: infection, failure to fuse, migration of the device, gastrointestinal problems, damage to the spinal cord, paralysis, and death (iii). In addition to these side effects FDA adverse event reports and clinical trials have uncovered even more dangers posed the device.
In July 2008, the FDA released a warning about the INFUSE Bone Graft. It based this warning on 38 adverse event reports from patients who experienced complications after the device was inserted in the cervical/neck region. These reports described how patients had trouble breathing, speaking, and swallowing because the device caused uncontrolled bone growth to obstruct the airways and throat (iv). Medical trials have also suggested the following side effects may result.
- Nerve damage causing chronic pain (neuritis, radiculitis, and radiopathy)
- Cauda equina syndrome
- Abnormal or uncontrolled bone growth (ecotopic bone growth)
- Male sterility, sexual problems, uro-genital injuries
- Cancer including breast, laryngeal, leukemia, lung, lymphoma, ovarian, pancreatic, prostate, skin (melanoma), and thyroid
rhBMP-2 May Increase the Risk of Cancer
Two Medtronic products use the rhBMP-2 protein solution as their active ingredient, the INFUSE Bone Graft and Amplify. Both of these products have been linked to increased rates of cancer. As early as 2002, doctors were concerned about an increased risk of cancer caused by the active ingredient in the INFUSE device. Later in 2010, the FDA Executive Summary of Amplify found 15 cancer events in 12 patients. Patients taking Amplify were 2.5 times more likely to develop cancer after one year and 5 times more likely to develop cancer after three years, than the control group (v). Most recently in May 2013, a study conducted by the University of York found 12 cases of cancer in 11 INFUSE trials and 13 cases of cancer in 5 Amplify trials (vi).
INFUSE Bone Graft Medical Studies
Early studies of the medical device were overwhelmingly positive. At the same time studies about the competing iliac crest bone graft (ICBG) were showing negative results. This set the stage for FDA approval of the INFUSE Bone Graft and its subsequent large sales numbers. By 2011, the medical device was earning the company almost $900 million in sales each year (vii). However, recent information has revealed that Medtronic paid the doctors who conducted these studies millions of dollars, which may jeopardize their legitimacy. It has also been alleged that the company encouraged off-label use of the device. A study conducted by the Cleveland Clinic found that by 2007 the INFUSE Bone Graft was used off-label 17% of the time (viii).
In April 2011, The Spine Journal published an article which questioned the accuracy of 13 INFUSE Bone Graft clinical trials. According to the article, these trials included 780 patients but did not report a single adverse event. The article suggested that the actual rate of adverse events was between 10% and 50%. The article also alleged that these trials were favorable to the device because Medtronic had paid the doctors conducting the trials. On average, the company paid doctors between $12 and $16 million per study. In one study the company paid doctors $23.5 million (ix). The negative studies continued in June 2011 when it was found that 7% of men experienced retrograde ejaculation. This condition redirects semen into the bladder causing male sterility (x).
In an effort to obtain legitimacy Medtronic paid Yale researchers to conduct a study completely independent of the company’s control. However, the study concluded that the “[INFUSE Bone Graft] has no proven clinical advantage over bone graft and may be associated with important harms (xi).
Senate Investigation of Medtronic
Recently, Medtronic was the subject of an investigation by the Senate Finance Committee. The Committee investigated the financial ties between the company and doctors who were conducting medical studies and writing journal articles. The company produced over 5,000 documents detailing its financial relationship with doctors. The investigation alleged that the company paid doctors $210 million over the course of a 15-year period. The Committee stated that “Medtronic was heavily involved in drafting, editing, and shaping the content of medical journal articles authored by its physician consultants who received significant amounts of money.” Additionally, company e-mails showed the company concealed adverse events (xii).
InFUSE Bone Graft Lawsuits
Medtronic’s INFUSE Bone Graft has caused a growing number of lawsuits to be filed against the company. For example, in December 2008, a wrongful death lawsuit was filed on behalf of a California woman. The medical device was implanted near the woman’s neck but surgery complications caused her fall into a coma and die. Additionally, Laurie DeNeui, a Noth Dakota woman, has filed a lawsuit alleging the INFUSE device caused her to become disabled. She experienced uncontrolled bone growth near her neck after the device was implanted in the cervical region. She now has trouble breathing, speaking, and swallowing. In August 2011, Jennifer English, a Florida woman, filed a lawsuit alleging that she was implanted with the device using the off-label posterior approach. The device caused uncontrolled bone growth which compressed her spine causing severe pain.
In March 2012, Medtronic settled a shareholder lawsuit $85 million settlement. Investors claimed that the company made misleading statement about the INFUSE Bone Graft. Recently, a lawsuit was filed in the Southern District of Ohio on behalf of 88 patients who received the device in experimental surgeries. One of the most recent lawsuits is: David et al. v. Medtronic Inc., et al., No. BC-510542, complaint filed (Cal. Super. Ct., L.A. County May 31, 2013). The lawsuit was filed on behalf of 37 people who were given the INFUSE device for off-label uses (xiii).
Have You Suffered Serious Injuries after Implantation with Medtronic INFUSE Bone Graft?
If you or a loved one has suffered injuries related to the INFUSE Bone Graft, then you should talk to a personal injury lawyer. Our law firm works with some of the more experienced Medtronic Infuse Bone Graft lawyers in the country, who can file a lawsuit on your behalf. And, there are no legal fees until you receive a settlement or award for your spinal fusion injuries. Feel free to contact us at 1-800-992-6878 for more information.
- (i) FDA Approval, July 2, 2002.
- (ii) Medtronic Product Website.
- (iii) Medtronic Product Website.
- (iv) FDA Safety Communication, July 1, 2008.
- (v) FDA Executive Summary of Amplify, July 27, 2010.
- (vi) Systematic review and meta-analysis of the safety and efficacy of recombinant human bone morphogenetic protein-2 (rhBMP-2) for spinal fusion, May 2013.
Reuters, November 3, 2011.
- (vii) The New York Times, May 25, 2011.
- (viii) The on- and off-label use of rhBMP-2 (Infuse) in Medicare and non-Medicare patients. Presented at the North American Spine Society 23rd Annual Meeting. Oct. 15-18, 2008.
- (ix) The Spine Journal, April 2011.
- (x) The Spine Journal, June 2011.
- (xi) Annals of Internal Medicine, Yale Study, June 2013.
- (xii) Senate Finance Committee Medtronic Report, October 2012.
- (xiii) Reuters, June 21, 2013.
- (xiv) Department of Justice Press Release, July 18, 2006.