Patients who have suffered complications from Medtronic Infuse problems after undergoing surgery may be able to seek compensation for their injuries. Several individual lawsuits, as well as larger class actions suits, have been filed against Medtronic after patients reported serious and potential life threatening complications.
Medtronic Infuse Bone Graft Complications
The FDA has received hundreds of complaints that allege Medtronic Infuse bone grafts caused serious complications that can be life threatening when untreated. Difficult swallowing, breathing, and speaking are the three most common side effects as well as swelling in the neck and throat. However, more serious Medtronic Infuse side effects have been reported which include:
- Infertility in men
- Cyst Formation
In a few reported cases, death has even followed Medtronic Infuse bone graft surgery after symptoms went untreated. Other patients had to undergo revisionary surgery to remove additional growths from the Infuse bone graft product.
FDA Warns Consumers About Risk
After receiving over 280 reports of severe complications, the FDA warned that Infuse bone graft and other similar products had caused serious complications when used off-label in spine surgeries. The FDA announced that swelling of the neck and throat was the most common issue, which often required emergency surgery and other treatment.
Justice Department and U.S. Senate Investigates Medtronic
The FDA warning along with the complaints from consumers led to an official U.S. Justice Department investigation after reports surfaced that up to 80% of surgeries using Medtronic Infuse were off label. Although the investigation was eventually closed without action, it exposed several immoral and unethical practices committed by Medtronic.
This investigation also came less than a decade after Medtronic agreed to pay close to $10 million dollars in a whistleblower suit that alleged kickbacks and gifts were given to doctors who actively used other Medtronic products as well.
The Unites States Senate has also gotten involved. After a two yearlong investigation, the U.S. Senate Finance Committee found that Medtronic paid study authors more than $200 million dollars in consulting fees, when they were supposed to be examining the effectiveness of Infuse. Senator Max Baucus stated: “Patients are at serious risk when companies distort the facts the way Medtronic has.” He later went on to add that Medtronic took actions to promote Infuse that “violate the trust patients have in their medical care.”
Medtronic Infuse Lawsuits
Due to the dangerous side effects and possible unethical and illegal behavior of Medtronic, many people who have suffered complications from Medtronic Infuse bone grafts are now filing lawsuits against the company. These lawsuits include claims that:
- Medtronic-paid researchers failed to report serious complications from Infuse.
- Medtronic failed to warn about the risk for serious complications.
- Medtronic bribed doctors and surgeons to use Medtronic Infuse more often.
- Infuse was often performed for off-label uses, increasing the risk for complications.
- Advertisements for Medtronic Infuse claimed the procedure was safe and little to no side effects.
The two main issues however are the off-label use for Medtronic Infuse along with the kickbacks to doctors and surgeons. Medtronic is only approved for tibia repairs, a few dental procedures, and specific spinal procedures. However, some estimations report that up to 85% of Infuse sales were for off-label purposes, which increased the risk for complications significantly.
To make matters worse, there are many allegations in lawsuit documents that Infuse was only being used in many surgeries because Medtronic was giving kickbacks, direct cash payments, and lavish gifts to doctors and surgeons who performed Infuse bone grafts more often.
Do You Have a Claim?
If you or a loved one has been injured by Medtronic Infuse bone graft surgery, or if you have had a loved one pass away, then you need to contact an attorney to receive a free no-obligation case evaluation. The experienced attorneys of the Infinity Law Center will evaluate your case and determine the best course of action going forward.
You do not deserve to been injured or deserve to suffer from Medtronic Infuse bone graft complications. If you have been injured by Medtronic Infuse bone graft surgery, please contact an attorney to discuss your rights. Experienced Infuse attorneys will fight for you to get you the compensation you rightfully deserve for your injuries.