Lawsuit Over Medtronic Synchromed Pump Failure Allowed To Proceed

A federal judge has decided a lawsuit over problems with a Medtronic Synchromed II Infusion Pump can proceed forward, after rejecting an attempt by the manufacturer to dismiss the claim.

The lawsuit was filed by John David Brumfield, who has suffered lower back pain since 2000, because of three ruptured discs in his spine. He received the SynchroMed II in 2012, as a method of regular pain relief. However, the lawsuit indicates the Medtronic pump suffered a motor stall, leaving him with hydromorphone withdrawal and the need for a replacement device in September 2018.

The Medtronic SynchroMed II is a small, battery powered implantable pump used to deliver prescription drugs to patients through a catheter, specifically into the spinal fluid to treat chronic pain and severe muscle spasticity in patients who are not responsive to other, less invasive, forms of drug therapies or treatments.

The case is one of a growing number of lawsuits filed nationwide over Medtronic Synchromed pump failures, which plaintiffs allege are caused by design defects which allow overdoses of power pain medications, or fail to provide the critical drugs when needed.

Brumfield filed the complaint in September 2020, and Medtronic filed a motion to dismiss, arguing the claims were preempted by federal law and that the lawsuit contained no plausible claims entitling Brumfield to relief.

On March 11, U.S. District Judge Robert C. Chambers, of the Southern District of West Virginia, issued a memorandum opinion and order (PDF) rejecting Medtronic’s arguments and refusing to dismiss the lawsuit. He noted his ruling was consistent with other decisions involving similar SynchroMed II lawsuits.

In November, a judge in the Eastern District of Missouri made a similar ruling regarding a claim filed by Carissa Sullivan, whose SynchroMed II pump failed in 2015, causing her to suffer baclofen withdrawal. Again Medtronic tried to put forward the preemption theory to have the case dismissed, and again their arguments were rejected by a federal judge.

SynchroMed II Pump Problems

The Medtronic SynchroMed II Infusion Pump line has been plagued with problems over the last several of years, which have caused many users to suffer severe and potentially life-threatening health issues.

In 2016 Medtronic issued an Urgent Field Safety Notice indicating it was aware of more than 100 adverse events related to likely over-infusion events linked to the SynchroMed II.

Earlier, in February 2011, the FDA declared a Class I Medtronic Synchromed pump recall following reports doctors were accidentally injecting drugs directly into patients’ subcutaneous tissues while attempting to refill the devices. These “pocket fills” resulted in at least eight deaths and 270 injuries requiring medical intervention.

In September 2011, a Synchromed II battery recall was announced after the company received reports of batteries becoming covered with a thin film and failing. The FDA classified that as a Class I recall as well. Class I medical device recall classifications mean that the FDA believes the device has a reasonable likelihood of causing severe injury or death.

In July 2012, the FDA sent a warning letter to Medtronic over the infusion pumps, ordering the company to put in place a plan to deal with reported failure problems. The FDA had received 567 complaints about motor corrosion in the SynchroMed II pump between then and October 2007. The corrosion caused gears to lose teeth, which lead to the motor seizing up.

The FDA finally entered into a consent decree with Medtronic over the repeated errors and manufacturing problems in April 2015, which required the company to cease manufacturing, designing and distribution of new Medtronic Syncromed II infusion pumps, except in cases where a doctor determined it was medically necessary for a patient’s treatment.

Similar problems have plagued Medtronic’s MiniMed Infusion Pump, which is used to deliver insulin. A number of Medtronic infusion set lawsuits have been filed on behalf of patients who suffered serious injury or death when they received too much or too little insulin. Each of the plaintiffs raise similar claims, indicating they were prescribed and used Medtronic’s 600 series of insulin infusion pumps to automatically deliver insulin into their bodies for the treatment of diabetes.

As Medtronic pump recall lawyers continue to review and file claims, it is expected that hundreds of lawsuits may be filed in the coming months and years, as individual realize that insulin pump malfunctions may have been caused by known defects associated with the device.