Medtronic Infuse Settlement Agreement Reached For $22M

  • Written by: Irvin Jackson

Medtronic has agreed to pay about $22 million to settle about 950 Infuse BMP lawsuits filed on behalf of individuals nationwide who have experienced problems after receiving the bone graft product.  

The settlement was announced in a press release issued on May 6, but does not include an admission of guilt and still leaves an estimated 750 cases unresolved.

Estimates suggest that litigation costs, including all Medtronic Infuse settlements, will ultimately cost the company between $120 and $140 million. Whether those remaining cases will proceed to trial or be settled later is unknown.

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.

In March 2014, Medtronic indicated that the number of lawsuits over Infuse are likely to continue to grow significantly, and the manufacturer has indicated that it intends to defend its product in court.

The settlement announcement came just days after the California Supreme Court granted the company’s petition to review a decision by a lower court that determined that Medtronic Infuse lawsuits were not preempted by federal law.

“This agreement is a compromise of disputed claims and is not in any way an admission of liability or validity of any defense in the litigation by Medtronic,” the company stated. “The company continues to stand behind INFUSE Bone Graft, which has been utilized in more than one million patients since it was approved more than ten years ago, and will vigorously defend the product and company actions in the remaining cases.”

Medtronic has tried repeatedly to have the cases dismissed, arguing that the product liability lawsuits should be pre-empted by federal law because the Infuse device was approved by the FDA. The manufacturer has argued that the controversial Supreme Court decision in Riegel v. Medtronic should be applied to protect them from design defect claims, but plaintiffs claim that the company loses that protection because it illegally marketed Infuse for uses not approved by the FDA.

According to allegations raised by plaintiffs in the Medtronic Infuse lawsuits, since the manufacturer has withheld important safety information about the risks associated with off-label uses, 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.

federal judge rejected the company’s pre-emption argument in August, allowing some 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.

The company has appealed that decision to the U.S. Supreme Court. The California Supreme Court says it will not make a decision on Medtronic Infuse cases until the federal high court does. However, it is unclear at this time whether those appeals will continue if settlements are reached to resolve the cases.

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  1. Kathleen Reply

    I have had 3 neck surgeries, first one was to get bone spurs off C-6 and got better for a short time, then about a year later had 2 discs replaced on C-5 and C-6, saying they used my own bone and put in a titanium brace from the front of my neck, wearing a hard brace for 2 months and never got better, then the surgeon said she had to go back in and remove bone spurs on C-7 and T-1 and didn’t have any brace. But now it has been almost 2 years and I still live in chronic pain. I have not worked for over 4 years. Bee going from one doctor to the next and no help. Only thing they do is give me pain meds, but I can not live without them as they help me function.

  2. Martha Reply

    I had first cervical fusion in 1994. In 2010 had cervical fusion done (using I believe either actifuse or infuse). Had lumbar fusion March 2010 and was unable to walk for 2 weeks post surgically (put in rehab 11 days). Also actiifuse or infuse. Found out April that cervical fusion fails (pseudoarthroses-I am non smoker), and again fails in June 2010 needing yet another revision. During and after this time my left leg and low back pain comes back with vengeance and new symptoms on opposite side. Multiple injections, nerves finally burnt and finally go to new neurosurgeons in 2013 both who agree have failed back syndrome and adhesive arachnoiditis from lumbar fusion in 2010. Since then new neurosurgeon has had to go in anteriorly and posteriorly to fuse c3-t3 posteriorly. 4 weeks ago I had my neurosurgeon remove all hardware from 2010 surgery, and replace it both anteriorly and posteriorly from l2-s1. My life has been completely turned upside down because of the errors made and or products utilized in 2010

  3. Martha Reply

    I had to have all the hardware removed tin lumbar region anterior and posterior revised with l4–s1 added . My second neurosurgeon looked at ct (finally I guess cuz it was in last years report too-) that “someone must have been asleep at the wheel during cervical surgery as the rod is not cut off and is I bedding itself in c2 vertebrae. I gave told him of excruciating pain up there since right after surgery and it is mentioned that rod is making contact with c2 vertebrae in radiology report last year. He is revising meaning cutting rod off November 25 and fixing facial dehescince that he did acknowledge last year was there. My podiatrist says this is malpractice and is ready to give me his attorneys number. Ps still not sure if second lumbar fusion failed cuz can’t seem to get Cigna to cover mri at this point. I think actifuse or infuse may have factored into arachnoiditis as well. Thanks Martha 7202443556

  4. Kelly Reply

    I had a 3 level cervical fusion in July 2007 by neurosurgeon who used BMP. Immediately after the surgery while still in hospital my pain worsened each day instead of getting better. My throat was swollen, and I was released from the hospital after 5 days with no explanation of why my pain was increasing. I developed nerve damage which I didn’t have before the surgery. The surgeon kept asking if I smoke. I had quit smoking before the surgery and never resumed it. He said the fusion was incomplete. He had put 3 spacers in and used the BMP and no metal. Then he retired and I had a 2nd surgery in March 2008by his assistant surgeon. Just before I was to be released from the hospital, this surgeon came and told me I was going to need another surgery where he would go in thru the back of my neck. The metal failed immediately and it destroyed a good disc. I could feel my neck wasn’t stable and could feel the metal moving around. I went to a 2nd opinion at a 3rd Neurosurgeon who practiced at the same hospital and he showed me an x-ray of someones neck and said that is hormone should look. Mine looked nothing like that. The small piece of metal in the front of my neck and punctured a good disc. In January of 2010 I had a 3rd surgery by an orthopedic surgeon at a different hospital and he had to reconstruct my neck doing surgery on the front and back at the same time. I have approximately 18 pieces of metal in my neck now and have bad shoulder cramps and nerve pain on both sides. This 3rd surgeon did a good job repairing the damage the first two neurosurgeons caused but I now have a 4level fusion and have to be very careful to adjust my neck when I sleep using a cervical pillow. I felt like I was going to die after the first surgery because of the swelling and daily increasing pain that kept increasing for about a month. I have to be careful now while eating certinan things so that I don’t choke. I didn’t find out that I was “having a bad reaction to the BMP” until the 2nd surgeon told me.

  5. Martha Reply

    Status of suits for adhesive arachnoiditis caused by surgeons error and or epidural steroid injections . If have infuse ( remember actifuse in one record but given had three revisions can’t imagine didn’t have infuse in one of them. How to proceed 7202443558 . Also second surgeon destroyed my trapezius muscles doing unnecessary posterior fusion (12+ screws that were not needed) . He later removed hardware where my arachnoiditis was diagnosed which exacerbated condition.

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