A compelling article published in The New York Times (04/23/10) set the backdrop for the FDA concern. The FDA Center for Devices and Radiological Health (CDRH) had, by 2010 received no fewer than 710 reports of deaths associated with use of infusion pumps. The New York Times reported the Center had also received more than 10,000 complaints annually about infusion pumps from 2005 to 2009, during which time manufacturers issued 79 recalls, among the highest for any medical device.
At the time, according to The New York Times report, manufacturers would conduct ‘simulated’ tests on their devices, rather than real-world tests. Manufacturers acknowledged at the time that most problems with infusion pumps could be traced to data errors when the infusion pump is programmed for the individual patient. The FDA, however disagreed with that assessment, indicating that many deaths and injuries related to infusion pumps had more to do with design and engineering problems inherent with the devices, rather than user error.
The FDA itself at the time was not beyond culpability. The New York Times report in 2010 referenced letters sent by top scientists at the CDRH to lawmakers about two years prior, around 2008, that their superiors at the Center had “ignored both their recommendations and policy guidelines in approving the sale of devices,” The New York Times reported.
The Obama Administration installed, in August of 2010, a new director for the CDRH. Dr. Jeffrey Shuren, The New York Times reported, noted that in his view infusion pumps could be made far safer and added that pump manufacturers would soon be required to provide more data before infusion pumps could be cleared for the market.
That message would resonate too late for plaintiffs Richard and Mary Lou Stengel, in their Medtronic SynchroMed lawsuit filed that same year, in 2010. According to the Medtronic SynchroMed lawsuit, the Medtronic SynchroMed Pump & Infusion System received premarket approval (PMA) from the FDA in 1988, and its SynchroMed EL Pump and Catheter received approval through a ‘supplemental’ PMA in 1999. “The device is a system for infusing pain medication into the spine,” Court documents said.
“Over the next few years, Medtronic became aware that a granuloma (a nodule of inflammatory cells) could form at the tip of the catheter, which had the potential to paralyze the patient.
“Medtronic did not report this problem to the FDA,” the lawsuit says. “Meanwhile, in October 2000, in Tucson, Arizona, Richard Stengel had the Medtronic infusion pump and catheter system surgically implanted. The catheter was implanted inside the membrane surrounding his spinal cord. The pump delivered pain medication through the catheter tip directly to his spinal cord.”
Court heard that Stengel suffered a fall in 2005 after experiencing decreased sensation in his right leg, and difficulty with urination. An initial consultation with a neurosurgeon failed to diagnose the problem, as the doctor was unaware, according to Court records, that the “Medtronic infusion pump could cause a granuloma to form at the catheter tip.”
Stengel was seen by a second physician a few days later, who noted in a subsequent evaluation that Stengel was continuing to experience “ascending paralysis in both legs.” The second consulting physician suspected a granuloma based on prior experience with a previous patient, and ordered tests which confirmed a granuloma caused by the Medtronic pump catheter tip had caused a complete blockage of the spinal fluid, “and compressed the spinal cord at the T12 level in his spine,” the lawsuit said.
Surgery to remove the catheter and most of the granuloma in the plaintiff’s spine was only partly successful, and “as a result of the granuloma caused by Medtronic’s device, [the plaintiff] is permanently paralyzed below the T12 level, including in both legs.
“More than a year later, between November 2006 and January 2007, during inspections of a Medtronic manufacturing facility, the FDA discovered the problem caused by the infusion pump and catheter system and Medtronic’s extensive under-reporting of adverse events.”
Medtronic, Inc. submitted a Petition for a Writ of Certiorari to the US Court of Appeals for the Ninth Circuit, which subsequently went to the Supreme Court (Medtronic, Inc. v. Richard Stengel and Mary Lou Stengel, Case No. 12-1351, in the Supreme Court of the United States).
The lawsuit went on to allege that Medtronic knew as early as 2001 with regard to the possibility of an inflammatory mass developing at the catheter tip.
“Mr. Stengel and his wife filed suit against Medtronic in an Arizona state trial court,” stated documents issued by the plaintiffs in the Medtronic lawsuit. “The complaint alleged state-law claims of strict liability, breach of warranty, and negligence, including negligent design and negligent failure to provide adequate warnings. Medtronic removed the case to federal court on diversity grounds and moved to dismiss based on preemption.”
Meanwhile, the heightened oversight led, in part to the Medtronic SynchroMed recall in 2013. To wit, the FDA recalled the SynchroMed II Implantable Drug Infusion Pump and SynchroMed EL Implantable Drug Infusion Pump and tagged it as a Class 1 recall, characterized by the regulator as “the most serious type of recall. Use of these devices may cause serious injuries or death.
READ MORE MEDTRONIC SYNCHROMED LEGAL NEWS
The manufacturing and distribution dates of the devices represented by the Medtronic insulin pump recall were identified as September, 2013 through October 3, 2016.
The FDA subsequently updated the recall on October 7 of last year to reflect “a software change to the Synchromed [sic] II application contained on the Model 8870 software application card,” the FDA said. “This change will correct the priming volume associated with the priming bolus function. They also updated the labeling related to the software change and priming bolus function.”