Medtronic Infuse Side Effects Lawsuit
Medtronic Inc.'s Infuse bone graft product has been associated with serious injuries in many patients, especially when it is used in off-label procedures. The Medtronic Infuse injury lawyers at Parker Waichman LLP are currently investigating potential lawsuits on behalf of people who have suffered life-threatening injuries following surgery with Infuse, including:
- 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;
Medtronic has been accused in lawsuits of downplaying Infuse side effects, and promoting its use in procedures not approved by the U.S. Food & Drug Administration (FDA). If you suffered a serious Medtronic Infuse injury, including any described above, you may be eligible to obtain compensation through a lawsuit. Our Medtronic Infuse lawyers are currently offering free lawsuit evaluations to anyone injured by Infuse. To learn more about filing a Medtronic Infuse lawsuit, we urge you to contact us today.
Medtronic’s Infuse bone graft system
Medtronic’s Infuse bone graft system consists of the LT-Cage Device, a small, hollow metal cylinder, which is filled with a genetically engineered material that stimulates bone growth, known as rhBMP-2 (recombinant human Bone Morphogenetic Protein-2). In 2002, the FDA approved the Infuse system for use in one type of spine surgery, anterior approach lumbar fusion. While Infuse was later approved for use in two types of dental surgeries, it was never approved for any other spine surgery. The FDA first issued a warning about Medtronic Infuse in 2008, after 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. According to a 2008 report from The Wall Street Journal, at least 280 reports of side effects involving Infuse had been made to the FDA since Medtronic Infuse was first brought to market, with most of those involving off-label spine surgeries. Research indicates that at least 85% of Infuse use is now off-label.
Medtronic currently faces several investigations, including one launched by the U.S. Justice Department in 2008, which seek to determine whether or not the company illegally promoted unapproved Infuse uses. Lawsuits allege that surgeons with financial ties to Medtronic promoted the use of Infuse for unapproved procedues. It has also been alleged that Medtronic downplayed many of the side effects associated with off-label use of Infuse.
In June 2011, a study published in The Spine Journal 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.)
Legal Help for Victims of Medtronic Infuse Injuries
Parker Waichman LLP is one of the preeminent personal injury law firms in the US. Parker Waichman LLP is listed in Best Lawyers, the oldest and most respected peer-review publication in the legal profession. The attorneys of Parker Waichman LLP are also the authors of "Personal Injury Law for Dummies,” an easy-to-understand guide to all aspects of personal injury law.
If you or a love one suffered a serious injury following treatment with the Medtronic Infuse bone graft, you may be entitled to receive compensation for medical bills, lost wages, pain and suffering, and other damages by filing a Medtronic Infuse lawsuit. To discuss your case with one of our Medtronic Infuse injury lawyers, please fill out our online form or call 1-800 LAW INFO (1-800-529-4636) today.