Report: Medtronic establishes $35m settlement fund for Synchromed pumps

September 30, 2019 By Sean Whooley

Medtronic (NYSE:MDT) last week reportedly agreed to create a settlement fund worth some $35 million to compensate those who say they were harmed by the SynchroMed II intrathecal drug pump.

The settlement involves about 500 people who claimed harm came from use of the pain-fighting pump, represented by three law firms that are negotiating individual settlements. A master settlement was dated in April of this year, but the Minneapolis Star Tribune reported that at least one plaintiff has not yet received funds.

“Over the years, Medtronic has reached various agreements resolving certain claims related to the SynchroMed infusion system. Terms of those agreements are confidential,” Medtronic spokeswoman Michelle Claypool told the newspaper. “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.”

The implantable pain-fighting pumps are used primarily to treat chronic pain or severe spinal or cerebral spasticity. The initial issue with the device, reported in July 2009, relates to the formation of a filmy substance within the pump battery that can lead the device to shut down suddenly, causing a patient’s pain and symptoms to return or triggering withdrawal symptoms. Returned product analysis proved the failed devices’ alarms functioned as designed, Medtronic said at the time.

There were 55 confirmed cases of the devices failing as of May 32, 2011, Medtronic said back then, including one death attributed to baclofen withdrawal syndrome.

In 2015, after the U.S. Justice Dept. filed a legal complaint against Medtronic in relation to the issues with the SynchroMed II pump, Medtronic agreed to halt production of the devices after the FDA reported that the company failed to correct violations found by the agency.

In a letter dated April 2017 sent to European doctors, Medtronic updated the numbers for pumps with batteries made from March 2005 through December 2010. The company said there was a 0.13% cumulative probability for pump failure at 72 months due to the issue.

Shares of MDT were up +0.2% at $107.56 per share in mid-morning trading today.

Mass General researchers tout low-cost, portable brain imaging scanner
Researchers at Massachusetts General Hospital are touting a low-cost, portable “head only” MRI scanner that could be used in multiple settings. As opposed to standard costly, immobile MRI scanners that require special infrastructure, the MGH researchers developed a low-cost, compact, portable and low-power scanner that could be mounted in an ambulance, wheeled into a patient’s… […]
HHS confirms involvement in presidential transition process
U.S. Health and Human Services Dept. Secretary Alex Azar confirmed that HHS is working with president-elect Joe Biden on a presidential transition. Speaking during a press briefing, Azar said HHS is in contact with the transition team after the General Services Administration formally recognized Biden as the president-elect, having previously sidestepped questions regarding the potential… […]
Swiss scientists make ‘micromachines’ for self-deploying stents and more
Researchers in Zurich reported today that they have invented a manufacturing technique to build “micromachines” out of metal and plastic in which these two materials are interlocked as closely as links in a chain. These robots are so tiny that they can maneuver through blood vessels and deliver medications to certain points in the body… […]
This AI algorithm could detect COVID-19 in chest X-rays
Northwestern University researchers are touting a new AI platform that can detect COVID-19 in X-ray images of the lungs. DeepCOVID-XR, a machine-learning algorithm, performed better than a team of specialized thoracic radiologists by spotting COVID-19 in X-rays about 10 times faster and 1%-6% more accurately, according to a news release. Researchers involved think physicians could… […]
Aspen Surgical acquires Protek Medical Products
Disposable products maker Aspen Surgical Products today announced the acquisition of Protek Medical Products (Coralville, Iowa). Protek manufactures single-use ultrasonic probe covers and needle guides used in tissue biopsies, fluid aspiration, and vascular access procedures as well as protective covers for medical instruments and equipment. The acquisition of Protek strengthens Aspen’s portfolio of medical, patient… […]
Puritan Medical lands $11.6M to boost swab production
Puritan Medical Products (Guilford, Maine) has been awarded $11.6 million to expand its COVID-19 testing swab production by 3 million swabs per month, according to U.S. Sen. Susan Collins (R-Maine). The award was funded through the Paycheck Protection Program and Health Care Enhancement Act enacted in April. It will help fund modifications to Puritan’s newest… […]
PTI Engineered Plastics wins ‘best workplace’ award
PTI Engineered Plastics has been awarded a Top Workplaces 2020 honor by The Detroit Free Press. The list is based solely on employee feedback gathered through a third-party survey administered by research partner Energage, according to the Macomb, Mich.-based company. An anonymous employee survey measured 15 drivers of engaged workplace cultures, including alignment, execution, and… […]
SyBridge enters medtech market with acquisition of X-Cell Tool & Mold
SyBridge Technologies announced that it has completed the acquisition of X-Cell Tool & Mold, marking its first acquisition in the medical tooling industry. Fairview, Pa.-based X-Cell manufactures close-tolerance and multi-cavity plastic injection molds primarily for the medical industry. Its acquisition expands SyBridge’s tooling capabilities to include highly complex precision tooling solutions necessary for medical devices.… […]
Why making a lot of ventilators may not be enough to prevent COVID-19 deaths
Medical device companies and even manufacturers outside the industry answered the call to make ventilators needed to treat people with severe COVID-19 cases. But as a newer and larger wave of the novel coronavirus hits the U.S., the equipment may not be enough, The New York Times reported yesterday. The problem, according to the Times,… […]
Demand, flexible financing fuel strong Mako sales for Stryker
Stryker’s (NYSE:SYK) Mako surgical system remains a strong seller, even as hospitals grapple with pandemic-induced cuts to revenue. The orthopedics giant announced the placement of its 1,000th system in September. Those results stem not only from demand but also from financing options Stryker has extended to some hospitals, according to Spencer Stiles, group president of the… […]
MedTech Europe gives proposed European Health Union a partial nod
MedTech Europe has endorsed a new plan to strengthen the EU’s response to future pandemics and public health emergencies, with a few caveats. European Commission President Ursula von der Leyen outlined the plan to create a European Health Union in her state of the union speech on Nov. 11. The plan is a response to… […]