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Medtronic Infuse Bone Growth Use

Medtronic Infuse Side Effects Lawsuits | Medtronic Infuse Bone Graft | Lawyers, Lawsuits | Side Effects: Acute Severe Swelling, Severe Neck Swelling, Inflammed Tissue Difficulty Swallowing, Difficulty Breathing, Difficulty Speaking, Speech Impaired, Uncon

Medtronic Infuse Side Effects Lawsuits

Medtronic Infuse Bone Graft | Lawyers, Lawsuits | Side Effects: Acute Severe Swelling, Severe Neck Swelling, Inflammed Tissue Difficulty Swallowing, Difficulty Breathing, Difficulty Speaking, Speech Impaired, Uncontrolled Bone Growth, Ectopic Bone Growth, Nerve Injuries, Severe Pain, Chronic Pain, Chronic Radiating Pain, Chronic Radiating Leg Pain, Chronic Radiating Arm Pain, Neuritis, Radiculopathy,  Radiculitis, Male Sterility, Retrograde Ejaculation, Uro-Genital Injuries Swelling, Cauda Equina Syndrome (CES)

Medtronic Infuse Off-Label Use Lawsuit

Medtronic Infuse Off-Label Use Lawsuit

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.

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, 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 defective medical device lawyers are aggressively 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 procedure, you may be eligible for compensation for your medical bills, lost wages, and pain and suffering. We are currently offering free legal consultations to anyone interested in filing a Medtronic Infuse lawsuit. If you or a loved one were injured due to a procedure where this product was used inappropriately, it is vital you contact our Medtronic Infuse lawyers as soon as possible to protect your legal rights.

Medtronic Infuse Off-Label Use Complications

Medtronic Infuse Off-Label Use Complications

What is the Infuse® Bone Graft Used For?

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.

Injures linked to off-label use of Infuse bone graft include:

Acute severe swelling of the neck several days after surgery, resulting in death or permanent injury;

Cancer – may types including stomach, thyroid, breast, skin (melanoma), ovarian, lung, leukemia, prostate, laryngeal, lymphoma, pancreatic;

Difficulty swallowing;

Difficulty breathing

Difficulty speaking

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)

Nerve injuries causing severe and chronic pain;

Ongoing or chronic radiating pain in the legs or arms (i.e., neuritis, radiculopathy, or radiculitis);

Male sterility (Independent researchers at Stanford University found evidence that Infuse was linked to a complication that causes sterility in men)

Retrograde ejaculation, or other uro-genital injuries in male patients

Cauda Equina Syndrome (CES).

Injures linked to off-label use of Infuse bone graft

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.

Did Medtronic Downplay Infuse Side Effects?

Plaintiffs in Infuse bone graft lawsuits allege that Medtronic either negligently or fraudulently misrepresented the risks and benefits of Infuse. In June 2011, such allegations were given credence by a study published in The Spine Journal which disclosed that Medtronic-paid researchers 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 these complications occurred in 10 to 50 percent of patients who got the product in 13 Medtronic-funded clinical trials conducted between 2000 and 2010. The Spine Journal review also examined payment data from Medtronic to the doctors who co-authored the Infuse studies, and found that the median amount the company paid to doctors was at least $12 million to $16 million per study (though it should be noted that none of the royalty payments related to Infuse.)

Medtronic’s Motion to Dismiss Infuse Lawsuit Denied

A Motion to Dismiss a consolidated class action lawsuit recently brought over Medtronic’s Infuse and being tried in the U.S. District Court for the District of Minnesota was denied on September 29, 2014 by the judge overseeing the case. The lawsuit was brought on behalf of a class group represented by the West Virginia Pipe Trades Health & Welfare Fund, Employees’ Retirement System of the State of Hawaii, and Union Asset Management Holding AG.

Medtronic and some former and current Medtronic officers, consultants, and executives were involved in an arrangement created to mislead investors regarding Medtronic’s financial position, specifically concerning the safety and efficacy of Infuse, according to the allegations. The allegations also include that early research showing the product’s safety and efficacy were revealed to be inaccurate based on later studies published in May and June 2011 in The Spine Journal. The journal articles revealed that the incidence of adverse events associated with Infuse were 10-50 times greater than previously published rates.

Medtronic, in collaboration with physician consultants, was also allegedly involved in a scheme to defraud investors by manipulating the early research. The scheme led to Medtronic’s stock trading at falsely inflated prices during the Class Period, then plummeting about 25 percent from its highest level once the truth was exposed, according to lawsuit allegations.

The lawsuit cited violations of the Securities and Exchange Act; a scheme and course of conduct intended to mislead; and violations of the Exchange Act.

Legal Help for Victims of Medtronic Infuse Off-Label Complications

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 our Medtronic Infuse lawyers can help you, please fill out our online form, or call 1-800-YOURLAWYER (1-800-968-7529) to discuss your case with one of our experienced Medtronic Infuse Bone Graft lawyers.

Latest Medtronic Infuse Bone Graft News:

June 28, 2011: Medtronic Clinical Trials showed Infuse Bone Graft Issues

June 22, 2011: Medtronic Infuse Bone Graft Studies under Congressional investigation for possible payments to Orthopaedic Surgeons to hide serious side effects


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FDA Warns against Use of Medtronic Infuse Bone Graft in Patients Under Age 18

Jan 22, 2015
In a safety alert issued Jan. 21, the U.S. Food and Drug Administration (FDA) warned that bone graft substitutes containing recombinant proteins or synthetic peptides, such as Medtronic Infuse, should not be used in patients younger than 18. The agency said it was aware of reports of serious injuries, such as excess bone growth, fluid accumulation, inhibited bone healing and swelling, linked to using the bone graft substitutes in patients under the age of 18. Bone graft substitutes containing...

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...

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