Medtronic Meddling Leads to Class-Action Lawsuit

Kingston, GAAllen, a Medtronic Infuse bone graft victim, is reading with great interest a Medtronic class-action lawsuit filed by its investors, claiming that Medtronic intentionally misled them and charging the CEO in a cover-up.

The outcome of this lawsuit may be good news for Allen and thousands of other Medtronic claimants. If a jury decides that Medtronic officials were fraudulent about Infuse’s problems, more people suffering from Medtronic injuries could sue the company. However, shareholders who sued Medtronic over Infuse in 2008 received an $85 million settlement in 2012, but Medtronic admitted no wrongdoing. According to the Star Tribune (October 12, 2014), if Medtronic settles this current class action without admitting wrongdoing, experts say the chances of injured Infuse patients proving fraud diminish.

Allen, age 46, underwent two surgeries, one five years ago and the other three years ago, involving a Medtronic Infuse bone graft, for the same problem. Now he has bone growing outside of the graft in his neck.

“I feel worse now than I did before this Medtronic fusion,” says Allen. ”The surgeon cut through the front of my neck and I can’t see the new bone growth but inside it constantly hurts. It’s like I have a constant spasm in my neck and sometimes when I try to swallow, my throat forgets how to swallow. If I drink or eat, it is stuck in my throat and finally I get it down, but that is really scary because I can’t breathe. I am scared to have this Medtronic device taken out because it might be even more dangerous.”

Allen hasn’t told his surgeon about the swallowing issue because he is afraid that his surgeon will advise yet another fusion. Meanwhile, Allen’s Medtronic attorney is getting all of his medical records from the surgeon. “My attorney said that I might have to wait up to six weeks to determine whether my claim will go forward, so this latest lawsuit against Medtronic might have some bearing…”

Allen had no idea that Medtronic had been sued by thousands of people like him until he saw a commercial on television. “The commercial said time may be running out to make a claim so I called an attorney, and then I read online about people’s complaints that sound just like me,” he says. “I have been in and out of hospital with staph infections from these surgeries and that pretty much messed up my life. If this Medtronic claim is all I have left, then I won’t let it pass me by. I also want to add that my neck surgeon is a great doctor. I read that these complaints are not against the doctor, they are against Medtronic.”

A federal judge in Minneapolis will let lawyers for Medtronic investors investigate the purported cover-up of Infuse’s dangerous side effects by Medtronic officials and doctors the company paid to do research, reported the Star Tribune. As for the former Medtronic CEO William Hawkins, he has been accused of manipulating scientific research to cover up Infuse problems. Further, he allegedly made misstatements to stock analysts to hide the fact that the FDA had refused to approve the next iteration of Infuse, a product called Amplify.

The shareholders’ class-action suit claims that Medtronic intentionally misled investors by shaping Infuse research done by doctors to whom the company paid $210 million from 1996 to 2010. And in some instances, Medtronic edited results of studies to overstate the usefulness of Infuse in patients recovering from spinal surgery while downplaying harmful side effects, including abnormal bone growth into nerves, male impotence and risks of cancer.