When pain becomes unbearable and a patient does not respond well to oral medications, options can be limited. That’s why more than 200,000 people have opted to receive implants of a device called the Medtronic SynchroMed II.
The device was initially promoted as a safe and reliable way to treat chronic pain and severe muscle spasms using advanced technology. But, in the years since it was first approved, the device has been associated with dozens of failures and defects that have led to hundreds of severe injuries and a handful of deaths.
Now, patients are fighting back with lawsuits against Medtronic over claims that the medical device company made a defective device and failed to warn consumers of the risks.
The Medtronic SynchroMed pump has a long and rocky history. The SychroMed I pump was approved by the U.S. Food and Drug Administration in 1998, but the SynchroMed II wasn’t approved until June 2004.
The SynchroMed II is a programmable pump system that is implanted in patients to store and deliver pain medication to specific parts of the body. Also known as pain pumps, drug infusion pumps like SynchroMed II have been used for years to treat chronic pain related to cancer as well as muscle spasticity associated with disorders like cerebral palsy and multiple sclerosis.
The device is implanted under the skin where a pump and catheter deliver medication to targeted spots. It is commonly used when a patient does not respond to oral pain medications or suffers reactions.
When the second iteration of the SynchroMed was approved, it was touted as a smaller and more comfortable version of the previous generation. It was also said to have the benefit of targeting specific sites and thereby limiting dose requirements and side effects.
“With the convergence of pharmacology and electrical, mechanical and software engineering, the SynchroMed II programmable pump is an incredible advance in medical technology,” the president of Medtronic said in a statement 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.”
It didn’t take long for patients implanted with the SynchroMed II pump to begin experiencing problems and unexpected side effects.
The very first class II recall came in July 20042 after serial numbers were mixed up, causing confusion related to the size of the infusion pump. By 2013, the device had been the subject of dozens of recalls, including 30 class I recalls, according to the FDA database3.
Problems were found in the SynchroMed EL that could result in overinfusion or underinfusion, potentially causing serious side effects in 2006.
In January 2009, a warning letter was sent to physicians about possible battery failures in SynchroMed II devices. They were warned that a defect in the battery could lead to device failure or the release of improper amounts of medication. In July 2011, Medtronic sent out an urgent medical device correction4 for the reduced battery performance in some devices. The company said there were 55 confirmed cases of battery issues at that time.
Healthcare professionals were also warned in a January 2011 letter5 that drugs might be accidentally injected at the site of the pump implant rather than the desired location — a phenomenon known as pocket fill. The side effect of a pocket fill could be the overdose or underdose or medication. Both may result in severe injury or death.
Additional fatal flaws — such as issues with the priming bolus function that could lead to high and then low doses of medication — were also discovered. Medtronic also warned physicians in 2013 that 14 deaths6 were associated with SynchroMed.
Between 2006 and 2013, the FDA conducted five inspections at the Medtronic facilities in Minnesota. The agency uncovered several significant violations of quality regulations and issued three warning letters to Medtronic.
In 2015, the FDA in conjunction with the Justice Department filed a consent decree7 with a legal complaint against Medtronic and two executives over claims that they distributed faulty devices. Medtronic was cited for failing to address the problems in manufacturing brought up by the FDA. The company was barred from making and distributing SynchroMed II pumps until the issues were addressed.
Since then, there have been additional updates to recalls of defects that put patients at risk.
After all the SynchroMed device failures, patients started filing lawsuits.
In one case, plaintiff Richard Stengel said he was implanted with a SynchroMed EL pain pump in 2000. Five years later, he started developing symptoms of paralysis due to inflammation in his spine near the tip of the catheter. The device was removed “but not in time to prevent the granuloma from rendering Stengel permanently paraplegic,” according to MassDevice8.
His case was eventually dismissed under the preemption doctrine adopted by the Supreme Court in 2008. The dismissal was reluctantly upheld by an appeals court.
“We recognize that it may seem harsh to deny compensation to a person who alleges serious injury from a medical device,” Judge J. Clifford Wallace wrote9 in 2012. “But such is the direction from the Supreme Court for cases like the one before us. We are required to follow the Court.”
Another case was filed in 2016 by plaintiff Jason Silver. Silver was implanted with the SynchroMed II device in 2012 but a malfunction led to an overdose of medication that required hospitalization. He sued Medtronic on seven counts, including negligence, manufacturing defects, a failure to warn, and more.
In 2017, a district court judge granted in part and denied10 in part a motion to dismiss.
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