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For years, infusion pumps have assisted with treating pain related to cancer and other long-term disorders by delivering medication directly to the spinal cord. Also referred to as pain pumps, these devices provide far quicker relief than oral and patch solutions and are prescribed when a patient doesn’t respond well to or experiences side effects from traditional treatments.
In terms of its use and operation, a trained medical professional must insert the pump and then program its rate and duration via an integrated software system. Doing so eliminates manually injecting the fluids for every treatment, but several recalls across multiple models have involved this feature.
Of all infusion pumps on the market, the Medtronic SynchroMed models have received the most attention. Since their introduction in the mid-1990s, these pumps have created deadly “pocket fills” – when the medication gets injected into the skin, instead of the spine – and experience battery failure related to film buildup. This latter scenario directly affects the dosage: Patients either get too much and overdose, or too little and start to experience pain and severe withdrawal symptoms. Along with these factors, studies find the SynchroMed’s design responsible for granuloma development. To date, the FDA’s reports associate this series of infusion pumps with 14 patient deaths.
The FDA gave the Medtronic SynchroMed Pump & Infusion System pre-market approval in 1988 and, by 1996, it was commercially available. By 1999, a second device, the SynchroMed EL Pump and Catheter, arrived. These devices, plus the SynchroMed II, get implanted with or without a catheter to treat pain or muscle spasms. When a catheter is involved, the pump uses an infusion system and a suture-less connector to hold onto and inject the drugs. Generally, doctors program these devices to deliver the medication to a specific spot within the body.
However, a few years after the SynchroMed’s introduction, Medtronic allegedly knew these infusion pumps could potentially cause granulomas at the injection site. This occurrence could create spinal fluid blockage, which may then compress the spinal cord and potentially lead to paralysis. Patients require surgery to get this condition corrected, and because the procedure isn’t always successful, they’re often left partially paralyzed.
Along with this concern, reports found that, when the SynchoMed is used to deliver Lioresal (baclofen) for treating severe muscle spasms, the system may break and interrupt treatment. As a result, patients begin to develop baclofen withdrawal symptoms, such as mental disturbances, a high fever, muscle stiffness, organ failure and death.
Attention to the SynchoMed’s defects goes back to 2007, when Medtronic reported its high stall rates, which prevent patients from receiving the dosage needed and can lead to accidental overdose or withdrawal symptoms. In response, the FDA inspected Medtronic’s facility, during which they uncovered the company had been underreporting the device’s adverse events. A recall followed in 2008, citing poor catheter connection as the reason for life-threatening blockages.
Four years later, the FDA sent another warning letter, this time concerning 270 reports of serious injuries and eight deaths involving the infusion pump. To resolve the issue, Medtronic alerted consumers with its own letter, which touched on high device failure rates involving unauthorized drugs. That same year, the FDA issued a second warning concerning the SynchroMed II’s corrosion issues.
In 2013, the FDA recalled the SynchroMed devices over software failure. Reports indicated that, during a priming bolus procedure, the SynchroMed may unintentionally deliver large doses of a medication to the spine.
By 2015, the FDA outright banned Medtronic from manufacturing and distributing the SynchroMed II, except in certain limited cases. According to the FDA, Medtronic failed to respond to and correct 30 total warnings related to quality regulations.
Other SynchroMed devices remained on the market, and in 2017, the FDA put out a recall for the SynchroMed Implantable Infusion Pump’s software which, as with past cases, could inject a higher-than-recommended dose of the medication into the spine and lead to overdosing, a coma, respiratory depression or death.
By 2010, the FDA Center for Devices and Radiological Health (CDRH) had received 710 reports of deaths related to infusion pumps and, from 2005 through 2009, cataloged 10,000 complaints per year involving these devices. Many, according to a New York Times investigation, go back to high failure rates, which stem from the simulated tests conducted for approval.
Because manufacturers had conducted few real-world tests, the pumps experienced data errors when programmed for an actual patient. However, after reading this assessment, the FDA disagreed, instead associating the high number with design problems.
Along with the Medtronic SynchroMed models, other recalled infusion pumps include:
- GemStar Infusion Pump: The FDA recalled this device in 2014 after reports of a faulty power supply.
- CareFusion Alaris Infusion Pump: The FDA put out a Class I recall in 2014 concerning a software defect that administered drugs earlier or later than scheduled.
- Acclaim Infusion Pump: A defective door resulted in over-infusion or delayed drug therapy and prompted a 2014 recall.
- Sigma Spectrum Infusion Pump: Manufacturer Baxter put out its own recall in 2014, after a design malfunction halted drug delivery.
- MedStream Programmable Infusion Pump: Air in the pump’s reservoir led to accidental overdoses or under-dosing of morphine or baclofen, leading to recalls in 2013 and 2014.
Patients who have ended up paralyzed or who lived through a dangerous overdose or withdrawal have started holding manufacturers responsible. These individual claims allege:
- Defective and negligent manufacturing practices
- Negligent misrepresentation
- Breach of warranty
- Violation of state trade practices and consumer protection laws
- Failure to warn medical professionals and patients. For instance, plaintiffs claim that Medtronic knew of its pumps’ defects as far back as 2001, but concealing its adverse reports resulted in doctors prescribing the device to more patients.
No patient should start a drug treatment program, only to end up partially paralyzed or dead. If you or a loved one experienced this scenario after using an infusion pump, get Trantolo & Trantolo’s product liability lawyers involved. If you think you have a claim, contact us today to learn more.