Federal Judge Refuses To Dismiss Medtronic SynchroMed II Infusion Pump Lawsuit

In a ruling which may impact a number of similar product liability claims, a federal judge has cleared the way for a Medtronic Synchromed II infusion pump lawsuit to proceed, after rejecting the manufacturer’s attempts to dismiss the case.

Medtronic faces a number of lawsuits filed in over problems with Synchromed II infusion pump, which plaintiffs say is defectively designed and can cause overdoses of powerful pain killers.

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.

Over-infusion from Medtronic Synchromed II pumps occur when more of the drug is delivered than programmed, which may or may not result in symptoms of a drug overdose, and could result in withdrawal symptoms if the drug reservoir is emptied prematurely due to overinfusion events. However, patients are often unaware their device is giving them too much of a drug until they go to refill the pump reservoir and find it lower than expected.

In a claim filed by Carissa Sullivan in the U.S. District Court for the Eastern District of Missouri, Medtronic filed a motion to dismiss based on federal preemption, which is a defense the manufacturer may have used to escape liability in all of the claims.

Sullivan had a Medtronic SynchroMed pump fail in 2015, causing her to suffer baclofen withdrawal and undergo additional surgery to have the pump replaced. She alleged the pump failure was caused by manufacturing defects and brought Missouri state law claims for strict liability, negligence and breach of implied warranty of merchantability.

In a Memorandum and Order (PDF) issued on October 30, U.S. District Judge Catherine Perry found the state law claims were not preempted by federal law, indicating the federal requirements were not different from or in addition to requirements which would satisfy the state law claims.

“Because I find that the claims are not preempted and that they meet federal pleading requirements, I will deny Medtronic’s motion,” Judge Perry wrote.

The Court also denied Medtronics attempt to prevent Sullivan from pursuing punitive damages, which could allow a jury to award substantially higher damages that are intended to punish gross negligence or reckless behavior, finding that the allegations raised in the complaint are sufficient to support such damages, indicating that the issue of whether Sullivan will ultimately prevail on such claims will be addressed in the future.

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 Minimed 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.