Contact Us

Medtronic Infuse Bone-Growth
*    Denotes required field.

   * First Name 

   * Last Name 

   * Email 


Cell Phone 

Street Address 

Zip Code 



Date when device was implanted :

Please describe any problems or injuries caused by the product:

For verification purposes, please answer the below question:

No Yes, I agree to the Parker Waichman LLP disclaimers. Click here to review.

Yes, I would like to receive the Parker Waichman LLP monthly newsletter, InjuryAlert.

please do not fill out the field below.

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


Medtronic Infuse Bone Growth UseRSS Feed

After Tax Inversion Deal, Medtronic to Pay $500 Million to U.S. Treasury To Move $9.8 Billion To United States

Oct 1, 2015
In a restructuring that is part of its $49.9 billion merger with Dublin-based Covidien, Medtronic will pay a one-time tax charge of $500 million to the U.S. Treasury so that it can bring $9.8 billion in overseas cash to the United States. Earlier this year, Medtronic completed a tax inversion deal that relocated the company headquarters from Minnesota to Ireland, a company with much lower corporate taxes than those in the U.S. The extra cash could help Medtronic fund more acquisitions, Med...

Medtronic's Payments to Doctors Raises Questions about the Role of Money in Medicine

Jul 14, 2015
Federal data show that Medtronic still makes payments to doctors over InFuse, a controversial spine product that has prompted questions about industry-funded research. Star Tribune reports that 79 doctors and their affiliates received a total of $60.7 million from Medtronic Sofamor Danek, the company's spine division, in 2014. Some of the money went to doctors who authored disputed studies promoting InFuse. InFuse is an artificial bone growth product that is used to stimulate bone growth in...

Lawsuit Filed over Medtronic Infuse Bone Graft Product

Jun 9, 2015
A recently filed lawsuit alleges that the Medtronic InFuse Bone Graft and LT Cage product caused serious injuries, including excessive bone growth. The suit, which represents numerous individuals implanted with the device, was filed by Jerrold S. Parker of Parker Waichman LLP; Richard J. Arsenault of Neblett Beard & Arsenault; Nicholas Drakulich of The Drakulich Firm; Eric Holland of The Holland Law Firm; and Mark Lanier of The Lanier Law Firm. Infuse was approved in 2002 for very specific...

Medtronic Agrees to $4.4 Million Settlement in False Claims Act Case

Apr 7, 2015
The U.S. Department of Justice announced last week that it reached an agreement for a $4.4 million settlement with medical device maker Medtronic, Inc. for violations of the False Claims Act. The violation stems from false statements Medtronic made about the sale of medical equipment to the U.S. Department of Defense and the U.S. Department of Veteran Affairs during an eight-year period from January 2007 until September 2014. During that time, Medtronic claimed the equipment sold to the...

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...

More Medtronic Infuse Bone Growth Use News

Parker Waichman Accolades And Reviews Best Lawyers Find Us On Avvo