Infuse Bone Grafting Device Lawsuit Survives Preemption Motions

An Oregon district judge ruled that the bulk of the claims in an Infuse bone grafting device lawsuit will survive preemption motions filed by Medtronic, in regards to the manufacturer’s duties under federal law. The suit in question was filed by Richard D. Alton, who brought claims against Medtronic Inc. and Medtronic Sofamor Danek USA Inc. based on allegations that he sustained complications following an April 2010 Infuse bone graft surgery, in which the device was implanted in his spine.

Alton sued on charges of fraud, strict products liability (failure to warn, defective design, misrepresentation), negligence, and breach of express warranty.

In a judicial order issued on September 6, Magistrate Judge Paul Papak of the District of Oregon found that Alton’s claims of failure-to-warn, fraud, negligence and breach of warranty are not preempted since they did not intend to impose device-specific duty that deviates from those under federal law.

As reported by Harris Martin, Medtronic attempted to have the claims dismissed, stating they were preempted under Section 360k of the MDA, which denies states from imposing “any requirement which is different from, or in addition to, any requirement which relates to the safety or effectiveness of a Class III Pre-Market Approved medical device intended for human use.”

Infuse bone grafting device lawsuit design defect claim dismissed

While the majority of Alton’s Infuse bone graft claims remain intact, Judge Paul Papak ruled to dismiss the plaintiff’s count of design defect because it sought to impose additional requirements to those issued by the Food and Drug Administration (FDA) in regards to its Pre-Market Approval process.

After receiving clearance for its Infuse bone grafting device, Medtronic heavily promoted the product for non-approved uses in spinal fusion procedures, such as posterior lumbar interbody fusion (PLIF) surgeries. Richard Alton underwent the PLIF procedure, where the synthetic bone graft was implanted in his spine without the interbody cage. In his lawsuit, he argues that his surgeon was unaware of the procedure’s inherent risks due to the defendant’s concealment of complications with off-label procedures. Alton alleges that after receiving the device, he suffered Medtronic Infuse device problems, including excessive bone growth in his lumbar spine that required another operation and left him with substantial pain and suffering.

This isn’t the first Infuse bone grafting lawsuit leveled at Medtronic involving off-label use of its billion-dollar product. The company faces escalating products liability litigation over its aggressive promotion for unapproved spinal fusion surgeries. Despite limitations on its FDA-cleared uses, Medtronic marketed its device for posterior lumbar interbody fusion surgery (PLIF), cervical spine (upper back) surgery, and multi-level spine surgery. Lawsuits filed by injured patients say the company employed unethical tactics and misled physicians with its misleading and deceptive marketing.

Mounting reports of Medtronic Infuse device problems

Alternately known as ectopic bone growth or overgrowth, this is just one of many serious complications linked to off-label spinal fusion surgery with the Infuse bone graft. Problems from uncontrolled bone growth can lead to damaged nerves around the spinal column, causing pain, spasms and potential paralysis.

Potential dangers with Infuse bone graft surgery also include an increased risk of cancer, according to a September Stanford University study. The team of researchers analyzed data from patients who underwent spinal fusion with either a traditional bone graft or a high-dose of rhBMP-2 – like that in the Infuse device. The results were dramatic, as the team found 15 new cancer reports in the rhBMP-2 group, compared with only two incidents of cancer in patients who had received traditional bone grafts.

Since its approval in 2002, the Infuse bone graft has been the topic of nearly 40 FDA adverse event reports regarding painful and potentially life-threatening complications.