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.

5 Comments

  • KeithMarch 2, 2022 at 4:07 pm

    12 back surgeries. I've got a pain pump.but.get a bs excuse why no adjustments. Don't get the pump. Pain drs are a pain

  • AmeliaJanuary 19, 2022 at 7:35 pm

    Same except death

  • PamelaSeptember 25, 2021 at 12:50 pm

    My pain management office drug tested me and said I was positive for cocaine! I don't use cocaine! I had never failed a drug screen but they refused to retest me and refused to refill my pump. My pump was empty and alarming for at least 3 months before I found a new pain management doctor which is almost 2 hours away. I went through extreme withdrawals, depression, anxiety, stress and excruciating[Show More]My pain management office drug tested me and said I was positive for cocaine! I don't use cocaine! I had never failed a drug screen but they refused to retest me and refused to refill my pump. My pump was empty and alarming for at least 3 months before I found a new pain management doctor which is almost 2 hours away. I went through extreme withdrawals, depression, anxiety, stress and excruciating pain for months. I also had a neurostimulator implanted and six weeks after surgery the battery died and I had to have another surgery. After my very first surgery which was a spinal fusion, screw fixation and bone graft I got a really bad staph infection and they had to open me back up and redo everything. I have had a total of 11 spunal surgeries from December 2001 through January 2019. I shouldn't have had to have at least 8 of them. I was rear-ended ended in a car accident in May 2000 and received around $80k. They could have given me $80m and it wouldn't have been enough! These doctors and companies are getting paid to terrorize, demoralize and treat us like we are addicts for seeking some pain relief! I have been in pain every day for over 21 years!

  • KristieSeptember 7, 2021 at 8:08 pm

    I had a Medtronic intrathecal pain pump for 12 years. When they replaced the device 2 years ago due to battery dying, they left the mesh in my pocket, replaced the device a week later I had to go back for I&D surgery. The pocket wad cultured and grew two colonies of bacteria. I was never told by my pain m doctor this. He told me to Finnish the antibiotics to be safe. For two years I’ve been on ant[Show More]I had a Medtronic intrathecal pain pump for 12 years. When they replaced the device 2 years ago due to battery dying, they left the mesh in my pocket, replaced the device a week later I had to go back for I&D surgery. The pocket wad cultured and grew two colonies of bacteria. I was never told by my pain m doctor this. He told me to Finnish the antibiotics to be safe. For two years I’ve been on antibiotics non stop, prednisone, blood pressure medications, thyroid medications, diagnosed with so many different things. I finally insisted on being weaned off the pump and had it removed. The mesh in my device pocket was infected. I have been in the hospital for a month over this. My pain doctor lied to me and when I insisted on being weaned off the pump abandoned me and all of a sudden I tested positive for illegal drugs. I always did my urine drug screenings through quest and when I all of sudden did the test at their office it was positive? The lab result does not even have a collection time to the drug screen report. The pain doctor let my pain pump empty and did not refill it and left it alarming for over a month. I went through severe withdrawals. I finally called Medtronic and the rep came to my house to turn the alarm device off after now 6 weeks of it alarming and my pain doctor said he could not turn it off. The Medtronic rep said he could and should have. I just got out of the hospital, they removed the pain pump. I was on three iv antibiotics. They neurosurgeon had to dissect the mesh out of my tissue and said it was “gunky and a mess”. The mesh, Medtronic pump and tubing were all sent off to the lab. I’m still on antibiotics because of this. My pain doctor did nothing. I kept complaining to him that something was wrong. I was treated horribly. I could of died from this infection, and it’s still not gone. I would really like to speak to a lawyer. As a registered nurse, I’ve never felt so helpless and I do not want this to happen to anyone else.

  • BrendaJune 18, 2021 at 1:10 am

    I had (2) of the Medtronic pain pumps modal # 8637-40,Nearly died.got so plugged and the pain clinic would not believe me when I would tell them the alarm was going off every hour.even the nurse who filled the pump knew there was problems.there was so much fluid in the pouch she could not find the port.even when she drain the pump there was extra meds coming out.after I was not getting any pain re[Show More]I had (2) of the Medtronic pain pumps modal # 8637-40,Nearly died.got so plugged and the pain clinic would not believe me when I would tell them the alarm was going off every hour.even the nurse who filled the pump knew there was problems.there was so much fluid in the pouch she could not find the port.even when she drain the pump there was extra meds coming out.after I was not getting any pain relief I kept telling them they only kept upping my meds in put and break though meds.i got so sick and ended up with meningitis.after that the pump had to come out because it was the cause.Even the surgeon that took out the pump said it was so plugged and messed up it took him over a hour to get it out.after that the pain clinic acted like they didn’t know me and yet I was going there for 10 years.How was it that Medtronics did not inform us of the recall?and why don’t we have any recourse to get compensation for what we went though?

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