Medtronic, a worldwide medical technology company with executive headquarters in Dublin, Ireland and operational headquarters in Minneapolis, Minn., became a leader in the spinal surgery industry with the manufacture of its Infuse Bone Graft.
The product was released into the market following its FDA approval in 2002. Just four years later, the popularity of spinal-fusion surgeries involving a genetically engineered human bone-growth protein (such as Infuse Bone Graft) grew to cover 25 percent of all such surgeries.
Infuse Bone Popularity
The popularity of spinal-fusion surgeries grew to cover 25 percent of all such surgeries.
With back pain reportedly ranking as a leading cause of disability in the United States, the company’s sales for devices used in spinal surgeries reached billions in annual revenues. But a study published by the Journal of the American Medical Association (JAMA) also revealed that these types of surgeries were associated with increased hospital costs and a greater risk of complications, some serious, if used in ways not approved by the FDA.
While FDA approval for the product existed for its use in a patient’s back only in the lumbar (lower) spine, the JAMA publication found that complications followed its use in both lumbar and cervical (relating to the neck) fusion procedures. And a 2008 FDA public-health notification issued in 2008 said that using Infuse Bone Grafts in non-approved ways, such as for cervical spine surgeries, heightened the risk of complications, including swelling of the neck and throat.
A 2008 lawsuit filed in California claimed that the off-label use of Infuse for a neck surgery is what killed a 74-year-old woman. Thousands of more lawsuits have been filed, including one by Medtronic’s shareholders, which settled for $85 million in 2012.
Medtronic has since been accused of marketing its Infuse product for off-label uses that have allegedly contributed to patient injuries, and in some cases, death.
Medtronic’s handling of adverse-event reports has also been scrutinized, with over 1,000 reports, including four patient deaths, not appropriately and timely relayed to the FDA until approximately five years past the deadline. A spokesperson for the federal agency was reported to have said that the records provided were not deemed to be of any new public benefit due to the dated information contained in each report.
Medtronic’s chief scientific, regulatory and medical officer, Richard Kuntz, said in a 2016 news report, “We’ve sent it to the FDA… and there has been no action. It’s just kind of a no-issue.”
Medtronic was also investigated by the U.S. Department of Justice, ending in a $40 million payout to settle allegations of illegal kickbacks to doctors as incentive to use its Infuse product.
Meet Some Infuse Plaintiffs
The majority of plaintiffs (85 percent) who filed lawsuits against Medtronic, the hospitals where their spinal surgeries were performed and/or the surgeons who performed them, alleged that the Infuse Bone Graft was used in their surgeries in an off-label way that does not meet the requirements for FDA approval.
Allegations: Off-label/improper use of Infuse Bone Graft in cervical spine surgery; undisclosed financial relationship between the doctor performing his surgery and Medtronic; not receiving consent to operate in an off-label manner
Injuries: Excessive bony overgrowth; additional surgery; chronic nerve damage
Allegations: Off-label/improper use of Infuse Bone Graft in spinal fusion surgery; negligence; fraud; loss of consortium (refers to the loss of benefits of a familial relationship)
Injuries: Severe, continuous pain; bony overgrowth; economic losses
Allegations: Off-label/improper use of Infuse Bone Graft in cervical spine surgery; undisclosed financial relationship between the doctor performing his surgery and Medtronic
Allegations: Promoting Infuse for non FDA-approved uses; Medtronic sales representative recommended off-label use to surgeon
Injuries: Spine injuries requiring additional surgeries; drop foot condition in right leg that led to torn ligament in right knee; bone overgrowth
Allegations: Off-label/improper use of Infuse Bone Graft in cervical spine surgery
Injuries: Bony overgrowth; additional surgeries; pain and suffering
Patients who underwent spinal surgeries utilizing the Infuse product alleged injuries including:
- Bone overgrowth
- Destruction/loss of bone tissue
- Fluid build-up under the skin or pooling of blood within the tissues
- Difficulty swallowing (off-label use in cervical spine surgery)
- Neurological (having to do with the nervous system, includes the spinal cord) disorders
- Retrograde ejaculation (semen is redirected to the bladder)
Infuse Patient: Medtronic Advised Surgeon
An Oklahoma woman allegedly injured by Medtronic’s Infuse Bone Graft lost her ability to sue the manufacturer when the U.S. Supreme Court declined to hear her petition challenging an appeals court decision.
Patricia Caplinger claimed that a sales representative from Medtronic was in the operating room during her spinal surgery and advised the surgeon to use Infuse in a way not approved by the FDA.
Inproper Use of Infuse
Caplinger argued that the company was aware of an FDA public health notification that warned physicians of life-threatening complications that could be associated with off-label uses of Infuse.
Not only was it not an approved use of the product, but Caplinger further argued that the company was aware of an FDA public health notification distributed in 2008 that warned physicians of life-threatening complications that could be associated with off-label uses.
Caplinger sued Medtronic for injuries she incurred following her surgery including a condition called drop foot, due to bone overgrowth, and accused the company in the lawsuit of promoting its Infuse product for uses never determined to be safe or effective by the FDA.
However, an earlier case in 2008, Reigel v. Medtronic, established a precedent that medical device companies were given broad immunity from liability when the FDA has approved the product for any use, and not specific to what it is actually used for. An attorney for Caplinger said it doesn’t make sense to bar a patient from suing a company when it is promoting a product for a use not tested by the FDA because it may be unsafe.
The company argued that all patients filing lawsuits against it alleging similar claims of liability, which equates to about 85 percent of pending litigation, are barred from suing the manufacturer based on a legal decree of preemption. Preemption means that federal laws overrule state laws having to do with consumer/patient protection, essentially siding with Medtronic in its alleged efforts to “develop new patient treatments.”
First Jury Trial – Keim v. Medtronic
In December 2016, a Missouri judge refused to dismiss a lawsuit filed against Medtronic for injuries to the plaintiff allegedly caused by the Infuse Bone Graft. Judge Mark H. Neill did not entertain Medtronic’s preemption argument in plaintiff Trisha Keim’s personal injury suit, and instead set the case for trial.
Product liability expert David Prince of Mitchell Hamline School of Law said in a news report that the ruling was “a very big deal” for the thousands of plaintiffs still waiting on the sidelines. The outcome can also make a difference in potential settlement negotiations and the amount of payouts.
Medtronic Paid $22 Million in Settlements
In 2014, Medtronic paid a total of $22 million to settle about 950 claims from plaintiffs allegedly injured after Infuse was used in their spinal surgeries. The settled lawsuits accused the company of manipulating studies and engaging in misleading marketing tactics.
The company said that the settlement was rendered to “disputed claims” and confirmed that that the compromise was in no way an admission of liability. Medtronic said it stood by its product, which has been used in more than 1 million patients since FDA approval in 2002.
The company projected spending $120 million to $140 million on settlements — including the $22 million one — in the fourth quarter that year.
Infuse Patients, UCLA Settle
Two patients who received Infuse Bone Grafts at the University of California Los Angeles (UCLA) later sued the teaching hospital, surgeon Jeffrey Wang and Medtronic for alleged injuries resulting from the off-label, or improper, use of the product. The plaintiffs, Ralph Weiss and Jerome Lew, alleged that in both surgeries Medtronic’s Infuse product was used in ways not approved by the FDA.
UCLA settled with Weiss and Lew for a combined $8.45 million.
The patients further alleged that Wang failed to inform them of a financial relationship between him and the product manufacturer. The lawsuits claimed that Wang received hundreds of thousands of dollars in grants and royalties from Medtronic.
UCLA settled with Weiss and Lew for a combined $8.45 million, with Weiss receiving a little more than $4.25 million. Medtronic also settled with Lew for an undisclosed amount.
UCLA said it only settled so the school and its medical program could “move forward,” but it did not respond to any of the allegations made by the plaintiffs.
Medtronic Settles DOJ Case
Medtronic paid $40 million to the U.S. Department of Justice (DOJ) to settle charges that it had violated the Anti-Kickback Statute (AKS). The AKS is a part of the federal False Claims Act (FCA) and was designed to ensure a physician’s independent medical judgment in making decisions affecting a patient’s health, free from enticement by companies such as Medtronic.
The governmental alleged that between 1998 and 2003 Medtronic paid kickbacks to physicians in various forms, including sham consulting agreements, royalties and lavish trips.