Medtronic warned that the initial settlement of $22 million is likely be the tip of the settlement iceberg. The medical device manufacturing giant plans to record a fourth-quarter charge of up to $140 million to cover its initial settlement and the estimated cost of additional settlements.
What is BMP Infuse?
Infuse is a genetically modified bio-engineered bone graft product, a version of a naturally occurring protein that promotes bone growth. The U.S. Food and Drug Administration in 2002 approved the product for spinal fusion involving the anterior approach for back spinal surgery.
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.
BMP Infuse Side Effects
Infuse side effects can cause unwanted bone growth, leading to severe pain, reduced mobility and nerve damage in some patients. In 2011, The Spine Journal, a medical publication, reported that the Infuse’s side effects were not reported in clinical research.
Medtronic Infuse has been touted as a cutting edge alternative to traditional spinal fusions. In the older procedure, bone is harvested from another area of the body usually the pelvis or used from a cadaver.
Medtronic Lawsuit Allegations
Medtronic has been accused of manipulating Infuse studies and using deceptive marketing practices to promote off label use by physicians in other types of orthopedic procedures not approved by the FDA. According to the Medtronic Infuse bone graft lawsuits, plaintiffs have suffered severe nerve damage, airway compression and other complications associated with uncontrollable bone growth after the device was used off-label, such as in the cervical spine, at multiple levels or through a non-anterior approach.
Medtronic: No admission of Liability or Wrongdoing
Medtronic reported that, “subject to certain conditions,” to pay roughly $22 million to resolve the claims of about 950 claimants. The company described the settlement as “a compromise of disputed claims” and said it is “not in any way an admission of liability or validity of any defense in the litigation by Medtronic.”
The product remains on the market, and Medtronic said it will “vigorously defend the product and company actions in the remaining cases.”
Still pending, however, are roughly 750 cases filed by about 1,200 individuals. Medtronic noted that the pending cases are “still in the early procedural stages and none have resulted in a finding of liability against Medtronic.”
Medtronic expects to record a charge of between $120 million and $140 million in its recently completed fourth quarter—a charge that accounts for not only the latest $22 million settlement but also the estimated costs of settling the 1,200 pending claims and the 2,600 that have yet to be filed.