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Have you or someone you love been injured due to Medtronic Infuse Off-Label product? This means that the Medtronic Infuse Bone Growth product was used “off label” or in a neck surgery or a back surgery using posterior entry.
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By HGSS Law on
10/31/2012 2:45 PM
(AP)–October 25, 2012
WASHINGTON (AP) — Medical device maker Medtronic Inc. helped write and edit medical journal articles attributed to outside physicians, which downplayed the risks of the company's best-selling bone graft, according to a report by Senate investigators.
The Senate Finance Committee said Thursday that the world's largest device maker did not disclose its role in shaping 13 key studies of InFuse, which helped turn the bone graft into an $800-million a year product. The studies, funded by Medtronic, failed to mention serious risks of InFuse including male sterility, infection and increased back and leg pain.
Senate investigators also reported that Medtronic paid the study authors $210 million in consulting fees for unrelated work over 15 years.
"Medtronic's actions violate the trust patients have in their medical care," said Sen. Max Baucus, D-Mont, in a statement. "Medical journal articles should convey an accurate picture of the risks and benefits of drugs and medical devices, but patients...
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By HGSS Law on
8/27/2012 3:20 PM
On August 20, 2012, Plaintiffs were given an important victory in the fight against Medtronic when a Los Angeles Superior Court Judge denied the drug company’s motion to dismiss a Southern California woman’s complaint arising out of the use of an INFUSE Bone Graft during surgery. Medtronic argued that the case was preempted by the Medical Device Act, meaning that the plaintiff could not file a lawsuit against device companies when its products were approved by the FDA because the approval supercedes state law claims challenging safety, efficacy, or labeling.
As background, the plaintiff claimed an INFUSE Bone Graft that was used off-label in her back surgery not only failed to cure her pain, but exacerbated her back condition and caused debilitating and permanent injuries. She alleged that Medtronic illegally promoted the INFUSE Bone Graft for a number of off label procedures and that it was only approved for a limited surgical procedure.
The Court stated that “plaintiff’s claim is not based...
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By HGSS Law on
6/13/2012 3:19 PM
 The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) has completed its review of your premarket approval application (PMA) for the Infuse Bone Graft. This device is indicated as an alternative to autogenous bone graft for sinus augmentations, and for localized alveolar ridge augmentations for defects associated with extraction sockets. We are pleased to inform you that the PMA is approved. You may begin commercial distribution of the device in accordance with the conditions described below and in the "Conditions of Approval" (enclosed).
Click here to download the full letter
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By HGSS Law on
6/13/2012 1:28 PM
As Chairman of the Senate Special Committee on Aging, Ranking Member of the Senate Judiciary Committee, and a member of the Senate Helth. Education, Labor and Pensions Committee, we take seriously our responsibility to protect the interests of our nation's health care consumers. We are writing today to request information on how your company handles recalls, and post-marketing surveillance of your products, two important tools for ensuring that only safe and effective medical devices remain in the marketplace.
View the entire letter
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By HGSS Law on
6/13/2012 12:30 PM
December 2011
Medtronic Inc. is taking more heat over its controversial Infuse bone graft product. Now, three U.S. Senators are asking questions about Infuse, and want to know if research for the bone growth protein downplayed serious side effects, including cancer, associated with it.
Infuse is a recombinant human Bone Morphogenetic Protein (rhBMP-2) that is widely used in spinal fusion surgery. However, it has only been approved by the U.S. Food & Drug Administration (FDA) for use in anterior-approach lumbar fusion. The FDA issued a safety alert for rhBMP products in 2008, after their off-label use in cervical spine (neck) surgeries had been associated with serious, and sometimes life-threatening complication.
In their letter, Senators Charles Grassley, R-Iowa, Herb Kohl, D-Wis., and Richard Blumenthal, D-Conn. inquire about Medtronic's tracking of safety information for devices once they have been released to the market. But the Senators also ask specifically about side effects linked...
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By HGSS Law on
6/13/2012 11:32 AM
Increasingly, reports of frequent and occasionally catastrophic complications associated with use of recombinant human bone morphogenetic protein-2 (rhBMP-2) in spinal fusion surgeries are being published. In the original peer review, industrysponsored publications describing the use of rhBMP-2 in spinal fusion, adverse events of these types and frequency were either not reported at all or not reported to be associated with rhBMP- 2 use. Some authors and investigators have suggested that these discrepancies were related to inadequate peer review and editorial oversight.
Read the entire article
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By HGSS Law on
6/13/2012 10:37 AM
June 2012
Serious questions were raised about side effects associated with Medtronic Inc’s Infuse bone graft product by a study published in The Spine Journal last summer. The study found that published reports for 13 Medtronic-fund Infuse clinical trials downplayed serious adverse events. The authors of The Spine Journal report, led by prominent spine surgeon, Dr. Eugene Carragee, also raised questions about the financial relationships some of the researchers who conducted those studies had with Medtronic.
According to a report from MedPage Today, the 13 Medtronic-sponsored studies reviewed by Carragee and his colleagues purportedly found no adverse events attributed to Infuse. But Food & Drug Administration (FDA) documents and other data sources the team reviewed suggested otherwise, and they found that as many as half of those receiving Infuse could experience serious adverse events, including:
implant displacement
subsidence
infection
ectopic bone formation
osteolysis...
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By HGSS Law on
6/13/2012 9:38 AM
April 2012
A study presented this past November raised serious concerns about cancer risks that could be associated with Medtronic Inc.'s Infuse Bone Growth product. The study was conducted by long-time Infuse critic, Dr. Eugene Carragee, and found that within a year of implantation, cancer risks more than doubled in Infuse patients. At three years after implantation, the increased cancer risk grew to nearly five-fold.
Carragee's cancer study, presented at the annual North American Spine Society meeting in Chicago, isn't the first time the Stanford University professor and Spine Journal editor has raised concerns about Infuse. This past summer, he edited an entire issue of The Spine Journal dedicated to rhBMP-2 products which raised serious questions about the validity of the research that was used to gain regulatory approval of Infuse. One of the articles included in the journal, co-authored by Carragee, found that Medtronic-paid surgeons had failed to report serious complications from Infuse, including:...
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By HGSS Law on
6/13/2012 8:39 AM
February 2012
Medtronic Inc.'s sales of its Infuse (rhBMP-2) product have taken a hit in recent months, thanks to concerns that the bone growth protein may be associated with cancer and other serious side effects. Now one analyst is raising doubts as to whether Medtronic can salvage Infuse and convince doctors to start to start using it again.
"Someone who is a very poor healer, someone who is in a revisional surgery, someone who is older and not in child-bearing age … some doctors still see an (Infuse) application in treating these hard -to-treat people,” Caroline Corner, an analyst with investment bank MLV & Co, told MedCityNews.com. “But doctors in general are definitely shying away from using Infuse (most of the time).”
Medtronic's Infuse sales are certainly showing evidence of this. According to a press release issued by the company in November, its core spinal revenue declined by 3 percent in the second quarter compared to last year. At the same time, the biologics portion of Medtronic’s spine...
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By HGSS Law on
6/13/2012 5:42 AM
February 2012
A study published last year by Dr. Eugene Carragee, a prominent spinal surgeon and researcher with Stanford University, linked Medtronic Inc.’s Infuse bone growth product with retrograde ejaculation, a condition that causes male sterility. Dr. Carragee's study, published on The Spine Journal’s website last May, found that men who underwent anterior lumbar fusion with Infuse developed retrograde ejaculation at a much higher rate than those who received a traditional bone graft.
According to a report from The New York Times, Infuse is used in about half of such procedures, and men make up about half of the patients who undergo spinal fusions.
“It is important that men who are considering having children have the opportunity to weigh the risks of the various available procedures,” said Dr. Carragee, according to The Times.
Dr. Carragee's study involved 240 men who had undergone anterior lumbar fusion some years prior. Sixty-nine patients had received Infuse, while 174 had received...
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“Off-label” use of Medtronic Inc.’s Infuse bone graft product in cervical spine surgeries, as well as lateral approach or posterior approach spinal procedures, has been linked to serious, and even life threatening side-effects. Some of these Medtronic Infuse injuries include ectopic or uncontrolled bone growth at or near the site of the surgery; ongoing or chronic radiating pain in the legs or arms; male sterility, retrograde ejaculation, or other uro-genital injuries; nerve injuries causing severe and chronic pain; and even cancer. In cervical spine surgeries, which is an off-label use of Infuse, some patients experience acute severe neck swelling several days after surgery resulting in death or permanent injury. 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.
Our lawyers are investigating these allegations, and would like to hear from anyone who suffered a serious Infuse bone graft complication. If you sustained a serious injury after undergoing an off-label Medtronic Infuse surgery, you could be eligible for compensation for your medical bills, lost wages, and pain and suffering. If you or a loved one were injured due to a procedure where this product was used inappropriately, it is vital you contact Holland, Groves, Schneller & Stolze, LLC as soon as possible to protect your legal rights.
INJURIES LINKED TO OFF-LABLE USE OF INFUSE BONE GRAFT INCLUDE:
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Acute severe swelling of the neck several days after surgery, resulting in death or permanent injury;
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Cancer – may types including stomach, thyroid, breast, skin (melanoma), ovarian, lung, leukemia, prostate, laryngeal, lymphoma, pancreatic;
- Difficulty swallowing;
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Difficulty breathing
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Difficulty speaking
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Ectopic or uncontrolled bone growth at or near the site of the surgery (a study found that 75% of Infuse patients experienced ectopic bone growth)
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Nerve injuries causing severe and chronic pain;
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Ongoing or chronic radiating pain in the legs or arms (i.e., neuritis, radiculopathy, or radiculitis);
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Male sterility (Independent researchers at Stanford University found evidence that Infuse was linked to a complication that causes sterility in men)
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Retrograde ejaculation, or other uro-genital injuries in male patients.
In 2008, the FDA warned Infuse bone graft and similar products had caused serious problems when they were used off-label in cervical spine surgeries. At the time, the agency said that it had received dozens of reports of side effects linked to off-label Infuse procedures, mainly swelling of neck and throat tissue, which resulted in compression of the airway and other structures in the neck. Patients reported difficulty swallowing, breathing and speaking. Several required emergency treatment, including tracheotomies and the insertion of feeding tubes, as well as second surgeries.
In November 2008, Medtronic disclosed that the U.S. Department of Justice (DOJ) was investigating the off-label use of a Medtronic's Infuse bone graft. According to a report from The Wall Street Journal, at least 280 reports of side effects involving Infuse had been made to the FDA when the investigation was announced. About three-quarters of those reports involved off-label use. While doctors are permitted to use approved medical devices in any way they see fit, it is illegal for manufacturers to market products based on such uses.
MEDTRONIC INFUSE OFF-LABLE USE COMPLICATIONS:
Medtronic Infuse, which contains rhBMP-2 (recombinant human Bone Morphogenetic Protein-2, a protein that stimulates bone growth), was approved by the U.S. Food & Drug Administration (FDA) for use in a type of spine surgery called anterior approach lumbar fusion. This is the ONLY type of spine surgery for which Infuse is approved, though the FDA did later grant clearance for its use in two types of dental surgeries. Despite its limited approval, it has become clear that Infuse bone graft is frequently used off-label in other spine procedures, especially cervical (neck) spine surgery, as well as in lateral approach (through the side of the body) or posterior approach (through the back of the body) spinal procedures. Unfortunately, it has also become apparent that such off-label use puts patients at risk for serious, and even life-threatening, injuries.
If you or someone you know sustained an injury due to off-label use of the Medtronic Infuse bone graft, you have valuable legal rights. To learn how Holland, Groves, Schneller & Stolze, LLC can help you, please fill out our online form, or call 1-877-255-3352 to discuss your case.
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