Medtronic SynchroMed II Pump Lawsuit
The Medtronic SynchroMed II System is an implantable device that delivers medications to specific parts of the body. These devices have been used by more than 200,000 patients around the world to treat those diagnosed with cancer, severe muscle spasticity, chronic pain, and many other disorders.
While the device has helped thousands of people get the medications they need, countless others have suffered adverse effects from problems with the pumps.
Since the Medtronic SynchroMed II device was first approved by the U.S. Food and Drug Administration in 2004, dozens of recalls have been issued over defects and issues with the devices. These range from battery power issues that have resulted in device failure to software problems that could cause the incorrect administration of doses.
After countless injuries and more than a dozen deaths, patients have started filing lawsuits against Medtronic.
What is the Medtronic SynchroMed II Pump?
The Medtronic SynchroMed II is an implantable fusion system that stores and delivers pain medication directly to the patient via a catheter. Also known as a pain pump, the surgically implanted device delivers the medication near the spinal cord.
The FDA first approved the device for use in the United States in 2004 to treat chronic pain and severe muscle spasticity, which is commonly associated with multiple sclerosis, cerebral palsy, and other serious disorders.
The device is touted for its ability to target specific parts of the body while minimizing side effects associated with oral medications.
“With the convergence of pharmacology and electrical, mechanical and software engineering, the SynchroMed II programmable pump is an incredible advance in medical technology,” Jon Tremmel, president of Medtronic, said at the time1. “The marriage of these technologies creates a new drug delivery platform that will improve patient care today while enabling the development of new therapeutic solutions for neurologic diseases and chronic pain in the future.”
Issues with Medtronic SynchroMed II Arise Immediately
Within two years of approval, the FDA started noticing issues with the manufacturing of the SynchroMed II.
Between 2006 and 2013, the regulatory agency inspected Medtronic’s facilities in Minnesota five times. During that time, it sent three warning letters to notify the company of major violations.
“The violations included inadequate processes for identifying, investigating, and correcting quality problems with the Synchromed II Implantable Infusion Pump Systems; failure to document design changes; and failure to ensure that finished products meet design specifications,” the FDA said2.
This culminated in the filing of a consent decree against Medtronic and two company leaders for failing to fix the issues in 2015. Medtronic was forced to stop making SynchroMed II devices until it corrected violations pointed out by the FDA.
“The FDA expects that all patients will be treated with safe, effective and high-quality medical devices,” Jan Welch, acting director of the Office of Compliance in the FDA’s Center for Devices and Radiological Health, said at the time. “We will continue to stop distribution of devices made by firms that fall short of regulatory requirements.”
History of Medtronic SynchroMed II Recalls
The FDA’s consent decree was just one incident in a long string of recalls and problems with Medtronic and SynchroMed II dating back years.
The SynchroMed II has been the subject of dozens of recalls for sometimes deadly issues.
For example, in 2009, Medtronic sent out a letter to physicians warning that defective batteries in the device could result in sudden failure. By 2011, a class I recall was issued for SynchroMed II pumps over the defect. The company reported that there were at least 55 confirmed cases3 of device failure related to battery troubles.
That same year, another class I recall — the most serious recall — was issued for the device over the potential of “pocket fills.” Pocket fills occur when drugs are injected near the implant site of the device rather than the intended target. The company reported4 that pocket fills could cause life-threatening injuries or death.
In 2013, Medtronic again notified physicians of four possible defects with the pump. It said 14 deaths were associated with SynchroMed, according to The Wall Street Journal5.
Patients File Medtronic SynchroMed Lawsuits
It didn’t take long for patients to start filing lawsuits against Medtronic over defective SynchroMed devices. One of the first lawsuits related to a SynchroMed device was filed by plaintiff Richard Stengel.
He claimed that he started using the SynchroMed EL pain pump in 2000 but developed symptoms of paralysis in 2005. The device had caused inflammation in his spine that ultimately led Stengel to become permanently paralyzed. His case6 was dismissed under the federal preemption doctrine.
In 2016, another patient named Jason Silver filed a lawsuit against Medtronic over claims that the company designed a defect product. He had a SynchroMed II pump implanted in his stomach to treat chronic pain in 2012. About two years later, the device malfunctioned and gave him too much medication. He suffered severe pain and had to be hospitalized.
A year after the lawsuit was filed, Medtronic attempted to get the seven counts Silver brought against the company dismissed on the basis of federal preemption established in a previous Supreme Court ruling7. Judge John Jones III of the U.S. District Court for the Middle District of Pennsylvania granted in part8 and denied in part the motion.
Attorneys around the country are currently determining whether victims of unexpected device failure related to SynchroMed II pumps have a case.