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Settlement Good News for Medtronic Infuse Bone Graft Victims

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Los Angeles, CALast week Medtronic agreed to settle its Infuse bone graft lawsuit for $22 million that involves 950 people. A further $140 million is estimated to also settle about 3,800 additional claims, 1,200 of which have been filed and the remainder (2,600) unfiled.

Despite FDA reports of complications over the past four years resulting from the off-label use of Medtronic Inc.’s Infuse Bone Graft, Medtronic is not admitting liability in the settlement, and the company “continues to stand behind INFUSE Bone Graft,” according to a Medtronic statement.

Medtronic must have deep pockets: it paid $210 million in payments and royalties to 13 doctors and two corporations linked to doctors. Then again, its Infuse product, which is also known as BMP-2, has been used in more than one million patients since the FDA approved it more than 10 years ago. The product generated sales of $800 million a year, though the amount has declined since 2011 - when the lawsuits started pouring in.

One cynical attorney believes this settlement is simply the “cost of doing business.” Up to 85 percent of those million people had the bone graft surgery off-label.

Dr. Dan Spengler, a Vanderbilt University orthopedic surgeon, said that with many off-label surgeries, there are going to be problems. He suspected that many of the lawsuits involved patients who experienced excess bone growth that occurred after their off-label surgery.

Many of the lawsuits claim that Medtronic illegally promoted Infuse off-label, i.e., for uses that were not approved by the FDA, through its payments to the spine surgeons. One spine surgeon, Dr. Jeffrey Wang, received an undisclosed $459,500 between 2004 and 2007 from Medtronic, Bone Biologics, FzioMed and the DePuy unit of Johnson & Johnson, according to The Los Angeles Times. Wang is currently being sued for fraud and malpractice for surgeries using the Infuse bone graft. And Dr. Mark Ipsen has a number of lawsuits filed against him, again for using the Medtronic product off-label during surgery. He has been accused of medical malpractice, failure to obtain informed consent and fraud. An estimated 2,300 surgeons have used Medtronic products in the US before any serious side effects were reported.

More lawsuits filed in both federal and state courts are still to be settled, according to Medtronic’s recent financial reports. Attorneys general in California, Illinois, Massachusetts, Oregon and Washington have subpoenaed documents regarding Medtronic's sales and marketing of the product.

READ ABOUT MEDTRONIC INFUSE BONE GRAFT LAWSUITS

Medtronic Infuse Bone Graft Legal Help

If you or a loved one have suffered losses in this case, please click the link below and your complaint will be sent to a defective products lawyer who may evaluate your Medtronic Infuse Bone Graft claim at no cost or obligation.

READER COMMENTS

Posted by

on
I filed with the class action suit back in 2008 when I first heard about it. My five fusions with two metal bars and 26 2 1/2 in screws are still bored into my spine to keep everything together. I continue daily with pain, receive myofascial release, weekly, medications and try to get into every swimming and walking class that they have available. I stick to a Paleo Diet so that sugar and processed foods will not directly get into my system and cause swelling in my joints and legs. I work very hard to keep my ears open for any new and/or experimental treatment that would be of further help. It is dreadful pain that can be grueling at times with a few small breaks between the seasons. However, I have begun to notice more problems with neuropathy in both my legs and feet and bone on bone in my left hip. Not looking forward to a hip operation. Would be nice to be compensated since the operation caused the loss of my job and having to apply for social security benefits along with pleading with my disability company to keep me on file. I wish more than anything that I could return to my former company which was a great place to work, had many,many friends and loved the actual work i did. Thank you for listening.

Posted by

on
All of this information is Vague at best. I hear about the total revenues earned by Medtronic... but I left guessing as to what it means... I would LOVE a specific report as to the affects of each item (infused device) ... Thank You.

Posted by

on
I had emergency spine surgery after being paralyzed by a myelogram. During this surgery 4 large kits of Infuse were placed in my spine during open posterior surgery which this product was not approved for. I had no idea what was being done to me because after I became paralyzed I was sedated until they got me into the operating room. My wife was with me and they shoved papers in front of her and she signed them. When I woke up I had at least four spinal fusions with instrumentation. These were located in the lumbar and thoracic spine. Since then I have experienced nerve damage, bone growth in the spinal canal, and chronic pain. I was examined by a neurosurgeon and was told there was nothing that could be done because my spine was a wreck and anything they attempted might either paralyze me from the waist down or even possibly kill me. I filed a lawsuit about three years ago and recently received a settlement offer of $6800.00. You haven't been embarrassed until you have crapped all over yourself in Walmart because the nerves to your anal sphincter have been damaged and losing you ability to have sex because you have nerve damage to those nerves as well makes for some marital problems that aren't easily resolved either. Plus the nerves in my right leg are continuing to degrade and I am losing my ability to even walk with crutches. I have no health insurance only the VA which is mostly useless for anything above a cold and sniffles. I have fought for years undergoing many hours of exercise therapy and doing everything I could to keep walking but the battle is nearly over now and there is a big wheel chair sitting in my living room and it won't be much longer before I'm stuck in it for the rest of my days. I certainly never thought this would be my end and I am most certainly disappointed in a legal system that allows attorneys to make millions while the people who were injured get crumbs.

Posted by

on
I waited 3 years to be told the 3.7 million I lost in past and future wages is worth 55,000 in damages before the 40% for the law firm. Been in bed 20 plus hours a day for 12 years. 6 surgeries. Infuse put in me 4 times. What a joke.

Posted by

on
I submitted all my records with a very strong case to a law firm. After obtaining my records they sent me a letter stating I no longer qualified?
Dirty!
I wonder how many women verses men were actually compensated for their injuries?

I think there needs to be an investigation into the settlement itself?

Posted by

on
I have had 3 lumbar and two cervical surgeries. Infuse Medtronic used in four of those. I've had a national firm handling it but its been FIVE years! I've been told we are settling in Nov-Dec this year. I'm not holding my breath. No one can tell me even a ballpark amount of what I am entitled to. I have chronic pain, nerve damage, bone spur growth in my neck, and radiatng pain and cramps in my arms and legs. I'm so sick of the continual "putting off" by the attorneys and courts. Enough already.

Posted by

on
I made a deal with my lawyer he only gets 30 percent. It was my second surgery that she used the bmp2 from c5-6 and c6-7 which also failed my husband said my neck was bigger than my head when they brought me to my room where I preceded to throw up every five minutes for five days. They were giving me toradol in my IV ,shots in the back of my head and I remember seeing an ambulance and begging my husband to call the other hospital before they killed me. I wanted her to use my own bone marrow and she said but if it's soft we will be in a bad position then she said they have come out with a great new medicine for this surgery it makes it fuse faster.well she bullied me and I let her and six months later I was at a different hospital with a different surgeon having the surgery through the back of my head

Posted by

on
Its about time!!! I hired an attorney 3 years ago to file suit against Medtronic. Two more fusion surgeries and three revision surgeries later finally some good news. Now if our own attornies dont sell us out for the fast buck, we might get some justice. 140 million divided by 3,800 is no where enough money for the pain, suffering and life changes I have suffered. Im sure the law firms will be all over this settlement. They get 40% of the amount (140mill divided 3,800); they get that amount 3,800 times. Who is getting justice?? The only people who will benfit are the lawyers.

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