Medtronic Infuse Bone Graft Lawsuits Continue to Mount
A growing number of individuals throughout the United States are pursuing product liability lawsuits over problems following Medtronic Infuse bone graft procedures, with one recent complaint filed on behalf of nearly 100 plaintiffs who all allege they suffered severe injuries and complications from excessive growth of bone around the spine.
Medtronic Infuse is a newer type of bio-engineered bone graft product that has been promoted as an alternative to traditional spinal fusions, where bone is harvested from another area of the body or used from a cadaver.
The FDA approved Infuse recombinant human bone morphogenetic protein (rhBMP-2) for limited use during spinal fusion procedures where the lumbar spine is approached through the front and the product is applied to an absorbable collagen sponge that is placed within an “LT-Cage” that is implanted to encourage bone growth and fuse the gaps between the vertebrae. However, Medtronic has been accused of illegally promoting the device for non-approved uses, with a vast majority of sales for Infuse involving applications that were never approved by the FDA.
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According to allegations raised in the mounting number of Medtronic Infuse bone graft lawsuits filed nationwide, off-label use of the device in the cervical spine, such as through a non-anterior approach or involving fusions at multiple levels, increases the risk of severe and potentially life-threatening complications associated with the bone overgrowth, which may damage nerves or compress the airway.
One of the latest Medtronic Infuse complaints was filed in the 22nd Circuit Court in St. Louis, Missouri on October 1. The lawsuit involves 98 different plaintiffs who claim they suffered a number of different injuries, including uncontrolled bone growth, nerve damage, airway compression and breathing difficulties. The lawsuit claims that the injuries occurred because Medtronic failed to tell doctors and patients of the risks and then encouraged the use of Infuse in ways that were dangerous and against the recommendations of the FDA.
Preemption Challenges Over Off-Label Use
Medtronic has attempted to defend the cases filed in courts nationwide by arguing that the product liability lawsuits should be preempted by federal law, since the FDA approved Infuse BMP as safe and effective.
The manufacturer argues that the controversial Supreme Court decision in Riegel v. Medtronic, which involved another medical device, should protect them from liability for design defects because such claims would conflict with federal regulations regarding the approval of medical devices in the United States.
Plaintiffs in most of the cases allege that they suffered Infuse-related complications because Medtronic illegally promoted the bone graft product for uses that were not specifically approved by FDA or determined to be safe and effective. Medtronic has been accused of withholding important safety information about the risks associated with off-label uses, resulting in an argument by plaintiffs that the claims should therefore not be subject to the Supreme Court decision that state-law product liability claims involving approved medical devices are preempted by federal law.
A federal judge rejected the company’s pre-emption argument in August, allowing a cases to proceed. However, unlike many similar litigation, the Medtronic Infuse lawsuits have not been centralized in federal court, which means each case is going through pretrial proceedings individually, increasing the chances of contradictory rulings by different judges.
In late August, Illinois state court Judge Eileen Mary Brewer rejected an attempt by Medtronic to have a lawsuit pending in Cook County Circuit Court dismissed, finding that the FDA did not apply device-specific requirements on Medtronic for the off-label use and that state court claims are not prevented from providing damages for claims based on a violation of FDA regulations.
In contrast, a Minnesota state court judge granted Medtronic’s motion to dismiss dozens of cases early last month, finding that the plaintiffs could not sue the device maker over injuries caused by Medtronic Infuse because the FDA had approved the product. Judge Laurie Miller found that Medtronic was not under legal obligation to warn of adverse effects involving off-label usage, but has allowed plaintiffs to refile their cases with more specific allegations of fraud involving the promotion of the device for non-approved uses.
Last year, a congressional investigation determined that Medtronic paid $210 million to study authors that failed to include data on Infuse complications in their reports. Those authors not only failed to disclose links to Medtronic, but the investigation also determined that Medtronic employees secretly edited and sometimes wrote parts of the studies before they were published, which encouraged the off-label use of Infuse.
kevinFebruary 14, 2016 at 9:57 pm
10 years, 3 surgeries and at the point of not being able to walk at times, pain keeps me up nearly all night and take 5 pain meds schedule 2 plus the other nerve meds to help with that pain, nothing doing, at the time did not know doctors were to give you something when putting parts in your body, part numbers and the company who made them, I got nothing except emergency surgery due to loosing spi[Show More]10 years, 3 surgeries and at the point of not being able to walk at times, pain keeps me up nearly all night and take 5 pain meds schedule 2 plus the other nerve meds to help with that pain, nothing doing, at the time did not know doctors were to give you something when putting parts in your body, part numbers and the company who made them, I got nothing except emergency surgery due to loosing spinal fluid one week after the first time he cut me..............the doc also blamed me for not getting better as it was workers comp and yet he use 3 of these in a row when only allowed to use 1 and had to go thru the stomach, he went thru my back, now at 59 years old no retirement to look for ward to as he retired me with all the pain and lack of life he took from me.....a total disgrace of this company and the doctor's they paid to use bad parts, we all should get a million and more for all they took from us..........not to mention not one doc will even touch my back as it is that messed up so no chance of getting any relief........6thank you dr and Medtronic.....thank GOD I have a great law firm on them, at least a shot of loosing stress for not being able to make money
MaudineJuly 11, 2015 at 5:07 am
I have had four back surgeries two to fix the damage to my spine and nerves done by the surgeries that put the in-fuse bone graft cage with sponge a Medtronics manufactured device in my entire lumbar area S-1 thru L-5 and then the second one was to remove it. The last two surgeries were to clean out all the bone fragments that looked like a snow blizzard in my entire abdomen which accounted for th[Show More]I have had four back surgeries two to fix the damage to my spine and nerves done by the surgeries that put the in-fuse bone graft cage with sponge a Medtronics manufactured device in my entire lumbar area S-1 thru L-5 and then the second one was to remove it. The last two surgeries were to clean out all the bone fragments that looked like a snow blizzard in my entire abdomen which accounted for the unbearable pain from the bone fragments touching nerves. The last two surgeries were twelve hours and my spine was repaired but I can't dress myself, drive, clean my house ...I have a caregiver every day. What I don't understand is why are they allowed to keep operating on people using the same technique which was not FDA approved ....other companies have to recall their devices when they cause so many people to be disabled by their products. So what is exempting Medtronics...MONEY.
KeddieApril 14, 2014 at 12:25 pm
This has really Shocked Me. I No Longer Trust Doctors. My Life Is Destroyed. I Stay In Pain All The Time. I Can't Do Things With My Family, I Was In Process Of Adoption Of Two Children Before Back Surgery. What About Them? I Stay So Damn Depressed. I'm Trying To Give Them A Better Life. Now Over This Medtronic Fusion Company. They Have Took That From Them And Me. I'm So Tired Of Pain. I Can't Do [Show More]This has really Shocked Me. I No Longer Trust Doctors. My Life Is Destroyed. I Stay In Pain All The Time. I Can't Do Things With My Family, I Was In Process Of Adoption Of Two Children Before Back Surgery. What About Them? I Stay So Damn Depressed. I'm Trying To Give Them A Better Life. Now Over This Medtronic Fusion Company. They Have Took That From Them And Me. I'm So Tired Of Pain. I Can't Do Anything Unless I Have Pain Meds. In Me. There Was A Time That I Wouldn't Touch pain Meds After Surgery. Now I Can't Go Without It. What A Mess. Medtronic Used The Old Mighty Dollar To Get Profits At Anybody Cost. No Only Destroying People Lives That Had To Have Back Surgery. But Destroying The Lives Around Them. It Puts So Much On My Husband. I Just Don't Understand Why They Would Do This.
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