Medical device maker Medtronic has agreed to create a multimillion-dollar settlement fund to compensate hundreds of people who say they were harmed by the company's implantable drug pump, the SynchroMed II — a pain-fighting device that was the subject of a major legal settlement in 2015 between Medtronic and the Department of Justice (DOJ).
According to legal records obtained by the Star Tribune, about 500 people represented by three law firms are in the process of obtaining individual settlements from a $35 million fund that Medtronic agreed to create as part of a master settlement agreement with the plaintiffs. The settlement notice is dated April 2019, though at least one of the plaintiffs said no money has been distributed.
Separately, a Hennepin County judge in July granted a request to file confidential settlement paperwork in a SynchroMed wrongful-death case, Patricia A. Jones vs. Medtronic. Although the Jones case was initially thrown out of court, settlement talks surfaced in the court record this summer after an appeals court reinstated part of the case and sent it back to the trial court.
Medtronic spokeswoman Michelle Claypool e-mailed a statement on behalf of the company acknowledging that settlements have been reached, without confirming details.
"Over the years, Medtronic has reached various agreements resolving certain claims related to the SynchroMed Infusion System. Terms of those agreements are confidential," the statement said. "These agreements are a compromise between the parties of disputed claims that avoids the costs and disruptions of continued litigation and is in no way an admission of liability or wrongdoing by Medtronic."
Medtronic is run from offices in Fridley.
The SynchroMed II, made by Medtronic's neuromodulation division, is a complex battery-powered drug-delivery system that is implanted under the skin to slowly deliver medication to the intrathecal space around the spine to treat chronic pain and severe muscle spasticity. Delivering medication so close to the spine allows the device to use much lower doses of drugs than would be needed otherwise.
The settlement notice disclosing the creation of the $35 million fund in April was from three law offices — Pearson, Randall & Schumacher in Minneapolis; Ashcraft & Gerel in Washington, D.C.; and Berezofsky Law Group in New Jersey, where attorneys on the SynchroMed case have since joined the firm Motley Rice. Lawyers with the firms declined to comment on the settlement talks.
Individual awards from the settlement fund will vary, depending on the individual circumstances of each case, including whether Medicare is owed part of the amount. The $35 million fund includes lawyers' fees.
The SynchroMed II device has been linked to mechanical problems over the years that have triggered many field advisories for safety issues, as well as manufacturing plant inspections by the U.S. Food and Drug Administration. In some cases, the device has stopped pumping medication unexpectedly because of problems with the battery, motor or the thin catheter tube that delivers the liquid medication, leading to withdrawal or failed therapy. In other cases, the pump has released too much of a powerful drug. The device has been linked to more than a dozen patient deaths.
In the Jones case, a Florida teen named Kaitlyn M. Jones died in 2014 from a bowel problem related to withdrawal from a drug that her SynchroMed II pump failed to deliver to treat her spastic quadriplegia from severe cerebral palsy, the lawsuit says. Other patients have had problems after being delivered the wrong dosage of powerful pain-fighting drugs, including opioid medications.
Medtronic has made design changes to the device over the years, and told doctors the pump is less reliable when used with drugs that are not listed on the product label. More than 300,000 people have been treated with the device worldwide.
"The SynchroMed Infusion System has been proven safe and effective for patients when used in accordance with instructions for use," Medtronic's statement this week said. "Medtronic continues to improve the design and performance of the system. Since 2016 several durable design and software changes have been implemented. Medtronic also continues to monitor the safety of the SynchroMed Infusion System, initiating and supporting studies involving the accuracy, safety and performance of the System."
In April 2015, the DOJ filed a legal complaint against Medtronic and CEO Omar Ishrak, and simultaneously filed a consent decree resolving the allegations if Medtronic met the conditions of the agreement. The complaint said inspections of a Medtronic plant in Columbia Heights between 2006 and 2013 found the company had failed to follow federal rules that required the device maker to address problems with the device, rendering it "adulterated" in the eyes of the DOJ.
The consent decree imposed a temporary set of restrictions that limited implants of the device to "extraordinary cases" in which the device was deemed medically necessary. It also required implanting doctors to certify in writing that they had informed patients about the consent decree. Company officials announced in late 2017 that those restrictions have since been lifted.