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Medtronic Infuse Bone Growth Cancer

Medtronic Infuse Bone-Growth Cancer Side Effects Lawsuit

Medtronic Infuse Bone-Growth Lawsuit, Side Effects Cancer Risk

Medtronic Infuse Bone-Growth | rhBMP-2, Bio-Engineered Bone GrowthProtein | Lawsuits, Lawyer | Side Effects : Cancer, Stomach Cancer, Thyroid Cancer, Breast Cancer, Skin Cancer (melanoma), Ovarian Cancer, Lung Cancer, Leukemia Cancer, Prostate Cancer, Laryngeal Cancer, Lymphoma Cancer, Pancreatic Cancer, Sterility in Men, Infections, Bone Dissolution, Worsened Back, Leg Pain | Spinal Fusion Procedures, Bone Growth Product, Medtronic Amplify

Medtronic Infuse Bone-Growth Lawsuit, Side Effects Cancer Risk

An unprecedented medical journal review of Infuse found unreported complications and undisclosed financial conflicts among doctors. The complications range from sterilization in men to unwanted bone growth.

Medtronic Inc's Infuse bone graft, a bioengineered bone-growth product used in spinal surgery, has been linked to a greater cancer risk than previously thought in patients treated with high doses of Medtronic's controversial protein. People who received Infuse, especially in off-label procedures, may be at higher risk for stomach, thyroid, breast, skin (melanoma), ovarian, lung, leukemia, prostate, laryngeal, lymphoma, and pancreatic cancers. Amplify, another Medtronic product that contained a higher dose of rhBMP-2, the bio-engineered bone growth protein found in Infuse, was rejected by U.S. regulators because of its association with cancer. However, it is known that off-label Infuse procedures often require doses of rhBMP-2 that are even higher than what was present in Amplify.

Parker Waichman LLP's defective drug lawyers are actively investigating potential lawsuits on behalf of anyone who developed cancer after treatment with Medtronic Infuse. If you or someone you love was diagnosed with stomach, thyroid, breast, skin (melanoma), ovarian, lung, leukemia, prostate, laryngeal, lymphoma, or pancreatic cancer following surgery with Medtronic Infuse, you may be entitled to compensation through a lawsuit. Parker Waichman LLP offers free lawsuit evaluations to possible Medtronic Infuse cancer victims. We urge you to contact one of our experienced attorneys today to discuss your potential Medtronic Infuse cancer lawsuit by completing the form at right or calling us at 1-800-YOURLAWYER (1-800-968-7529) for a FREE Lawsuit evaluation.

Medtronic Infuse, Amplify Bone Growth Products and Cancer

Medtronic Infuse, Amplify Bone Growth Products and Cancer

Linked to a greater risk of cancer than previously thought

In March 2011, the U.S. Food & Drug Administration (FDA) rejected Medtronic's approval application for the Amplify bone graft product because of concerns it could increase cancer risks among patients who received it. The FDA Amplify decision came after Medtronic trial results showed a significantly higher number of cancers in the study group that received Amplify when compared to a control group that received a bone graft as part of a spinal fusion.

In November 2011, during a meeting of the North American Spine Society (NASS), Dr. Eugene J. Carragee of Stanford University revealed that not all the findings of that Medtronic-sponsored clinical trial had been made public. In an interview with The New York Times, Dr. Carragee said the Amplify study findings had potential implications for patients who received Infuse, as doctors often administered Infuse off-label at doses equal to or higher than Amplify.

According to Dr. Carragee, his research reflected a 2.5 times greater risk of developing cancer one year after rhBMP-2 was used and a five times greater risk after three years. He said Infuse was linked to a cancer diagnosis more often than when the product was not used at all. Amplify was tied to more cancer risk than Infuse.

Dr. Carragee was also the author of a June 2011 Spine Journal article that found that Medtronic-paid surgeons had failed to report serious complications from Infuse, including cancer, sterility in men, infections, bone dissolution and worsened back and leg pain. The article said complications occurred in 10 to 50 percent of patients who got the product in 13 Medtronic-funded clinical trials between 2000 and 2010.

Medtronic Infuse Off-Label Use

Medtronic Infuse Off-Label Use

Medtronic Bone Graft Device

Medtronic's Infuse product is approved for use in a type of spine surgery called anterior approach lumbar fusion, and two types of dental procedures. However, Infuse is widely 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. In July 2008, the FDA warned that Infuse bone graft and similar products had caused serious problems when they were used off-label in cervical spine (neck) surgeries. Patients reported difficulty swallowing, breathing and speaking. Several required emergency treatment, including tracheotomies and the insertion of feeding tubes, as well as second surgeries.

While doctors are not prohibited from using an approved medical product in any way they see fit, manufacturers are not legally permitted to promote or market products based on off-label uses. Even before Dr. Carragee revealed his cancer findings, the U.S. Department of Justice was investigating whether Medtronic had promoted off-label use of Infuse. The investigation was launched in November 2008, when at least 280 reports of side effects involving Infuse had been made to the FDA when the investigation. At least three quarters of those reports involved off-label use of Infuse.

Medtronic Infuse Cancer Victims - Legal Help

If you or a loved one were diagnosed with cancer following treatment with the Medtronic Infuse bone growth product, you may have valuable legal rights and may be entitled to compensation through a lawsuit. Parker Waichman LLP offers free lawsuit evaluations to possible Medtronic Infuse cancer victims. To discuss your potential Medtronic Infuse cancer lawsuit, please fill out our online lawsuit evaluation form, or call 1-800-YOURLAWYER (1-800-968-7529)  today for a FREE lawsuit evaluation.


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Three Medtronic Infuse Personal Injury Cases Remanded to Circuit Court

Nov 11, 2014
Three lawsuits filed against Medtronic, Inc. over injuries associated with its Infuse bone graft device will be remanded to the Circuit Court of the City of St. Louis for further proceedings, according to the law firms Parker Waichman LLP, Neblett Beard & Arsenault, and The Drakulich Firm, which are collaborating on the cases. The three cases have been sent back to the 22nd Judicial Circuit (St. Louis City) Court under Judge John F. Garvey. Allegations in the cases include that Medtronic...

Class Action Lawsuit over Infuse may Affect Medtronic Acquisition of Covidien

Oct 16, 2014
Medtronic's $43 billion acquisition of Covidien, which is already controversial, may be influenced by a class action lawsuit over its Infuse bone growth product. According to Star Tribune, if a jury rules in favor of the plaintiff, many patients may be able to sue over injuries. Medtronic has used the strategy of pre-emption to avoid numerous lawsuits over Infuse; pre-emption generally prevents consumers from suing over an FDA-approved product without allegations of fraud. U.S. District...

Medtronic Infuse Injury Lawsuit Not Preempted, Maryland Appeals Court Rules

Oct 9, 2014
The Court of Special Appeals in Maryland ruled that a lawsuit over the off-label use of Medtronic Infuse bone graft is not preempted by federal law, according to Law360. When faced with allegations of injury due to Infuse, Medtronic has often relied on preemption as a legal strategy. The court decided that although preemption applies to cases that focus on approved uses of Infuse, allegations of off-label marketing are not preempted by the Medical Device Amendments to the Federal Food Drug and...

Humana Files Lawsuit Against Medtronic Over InFuse

Jun 3, 2014
Managed care company Humana Inc. has filed a lawsuit against medical device maker Medtronic, alleging the company misrepresented its Infuse bone growth product as safe and effective in spinal fusion surgeries. The suit was filed on Friday in federal court in Tennessee, and alleges that Medtronic paid for academic studies that fraudulently portrayed the product as safe and effective for uses not approved by the Food and Drug Administration (FDA), Reuters reports. Humana said it paid for...

Senate investigation details Medtronic's influence on clinical data

Dec 10, 2012
A Senate investigation has confirmed that medical device maker Medtronic Inc. paid hundreds of millions of dollars to influence clinical data on its INFUSE bone growth product. According to a Milwaukee Journal Sentinel report, the Senate Committee on Finance determined that Medtronic paid at least $210 million to a group of 13 doctors over the course of 15 years. This money and other rewards were given in exchange for favorable data used to get INFUSE approved by the Food and Drug...

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