Medtronic Synchromed II Lawsuit Over Infusion Pump Malfunction Survives Motion to Dismiss

A federal judge has cleared the way for a product liability lawsuit to move forward over a Medtronic Synchromed II Infusion Pump malfunction, rejecting the manufacturer’s effort to have the case dismissed.

The complaint (PDF) was filed last year by Regina Barnes, on behalf of Tiana Gibson, who is an incapacitated adult who experienced severe injuries after a Medtronic Synchromed II pump failed.

Gibson was implanted with the infusion pump in 2011, after an automobile accident left her with spasticity of the bilateral upper extremities, lower extremity weakness and seizures due to a traumatic brain injury.

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.

According to allegations raised in the lawsuit, the pump made Gibson’s spasticity worse, and the original pump was removed and replaced with another SynchroMed II device in June 2017. However, that pump eventually eroded through her skin and also had to be removed and replaced with yet another Synchromed II device, which malfunctioned and failed.

The case joins a number of similar Medtronic Synchromed II lawsuits filed in recent years over problems with the infusion pump, which plaintiffs allege are caused by design defects that allow overdoses of power pain medications, or fail to provide the critical drugs when needed.

Barnes presented claims of strict liability manufacturing defect, negligent manufacturing defect, breach of warranty and negligence per se, seeking both compensatory and punitive damages.

Medtronic filed a motion to dismiss the lawsuit, arguing that the claims were preempted by federal law, and that the allegations in the complaint were inadequately pled. However, U.S. District Judge J.P. Boulee, of the Northern District of Georgia, disagreed and cleared the case to proceed in a court order (PDF) issued on August 24.

“In sum, this Court finds that Plaintiff’s allegations sufficiently state a claim for strict liability manufacturing defect, negligent manufacturing defect and breach of implied warranty of merchantability,” Judge Boulee ruled. “This Court also finds that the claims are sufficiently pled to avoid express and implied preemption. The remaining claims are subject to dismissal.”

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 are used to deliver insulin and have been linked to a number of lawsuits involving malfunctions and failures, which caused plaintiffs to suffer severe insulin overdoses.


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