The Medtronic pain pump recall lawsuits center on the SynchroMed II, an implantable drug pump that has been tied to at least 14 patient deaths, multiple Class 1 FDA recalls, a 2015 federal consent decree, and a $35 million settlement fund resolving claims from roughly 500 injured patients in 2019. Some additional cases remain active in state courts, though a federal preemption defense continues to make these claims difficult to bring.
What Went Wrong With the SynchroMed II
The SynchroMed II is a battery-powered pump implanted in the abdomen that delivers medication (most often morphine for pain or baclofen for severe spasticity) directly into the fluid around the spinal cord. Because the drug bypasses the digestive system, doses are tiny. That precision is also the danger: if the pump stops working, delivers too much, or delivers too little, patients can go into overdose or acute withdrawal within hours. Baclofen withdrawal in particular can escalate from returning spasticity to high fever, organ failure, and death.
Between 1996 and 2013, Medtronic linked 14 patient deaths to four distinct device flaws: 11 from improper infusion, two from catheter blockages, and one from an electrical short. Two more deaths tied to overinfusion had been reported by July 2016.
The recalls piled up. The most serious, classified Class 1 by the FDA, included:
- A January 2011 recall over “pocket fills,” in which a clinician refilling the pump injected medication into the patient’s tissue instead of the reservoir, causing both a missed dose and an unintended absorption of drug.
- An August 2011 recall for reduced battery performance leading to “sudden loss of therapy.” A filmy substance forming inside the battery could shut the pump down without warning. Batteries made between January and June 2011 had a cumulative failure probability of 3.17% at 72 months, roughly 24 times the rate of batteries made in the preceding five years. At least one death from baclofen withdrawal was attributed to this failure.
- A June 2013 recall over the priming bolus function, which could deliver an initial overdose of medication into the cerebrospinal fluid followed by a period of underdelivery. By July 2016, 103 overinfusion adverse events had been reported across more than 238,000 implanted pumps.
- An October 2019 recall of 11,299 pumps manufactured between May 2018 and April 2019, after foreign particles from the manufacturing process were found to stall the motor. Five patients experienced early permanent motor stall; three had the pump surgically removed and one was hospitalized for withdrawal.
Motor stalls, electrical shorting from ions permeating the internal tubing, and catheter problems (fracture, kinking, migration, occlusion) rounded out the picture. An analysis of FDA adverse event reports found 82 reports of catheter damage or fracture, 53 of kinking, 37 of migration, and 51 of occlusion, with worsening pain or withdrawal symptoms the most common outcome.
The 2015 Federal Consent Decree
On April 27, 2015, the U.S. Department of Justice filed a complaint and consent decree against Medtronic, CEO Omar Ishrak, and Neuromodulation unit president Thomas Tefft in the U.S. District Court for the District of Minnesota. The government alleged that Medtronic had distributed “adulterated” SynchroMed II pumps from its Columbia Heights, Minnesota facility in violation of the Federal Food, Drug, and Cosmetic Act.
The allegations rested on five FDA inspections conducted between 2006 and 2013, which had already produced three warning letters. Inspectors documented failures in design controls, complaint handling, and corrective and preventive action. In plain terms, the FDA found that Medtronic was not adequately identifying, investigating, or fixing known quality problems.
The decree ordered Medtronic to stop the manufacture, design, and distribution of new SynchroMed II systems. Pumps could be distributed only if a treating physician certified the device was medically necessary for a specific patient. Medtronic had to hire an independent expert to develop corrective plans and could not resume full distribution without FDA permission. The certificate-of-medical-necessity requirement was lifted in late 2017 after Medtronic reported “substantial compliance,” but the consent decree itself remained in effect, with at least two additional years of continued FDA oversight.
The government’s findings, and the detailed recall record behind them, later became key evidence in civil suits.
The $35 Million Settlement Fund
In April 2019, Medtronic established a $35 million settlement fund to resolve claims brought by approximately 500 individuals who alleged they were harmed by the SynchroMed II pump. The fund was negotiated with three plaintiff-side firms: Pearson, Randall & Schumacher of Minneapolis; Ashcraft & Gerel of Washington, D.C.; and Berezofsky Law Group of New Jersey.
This was not a class action. Each claimant negotiated individually, and the terms were confidential. Medtronic characterized the agreement as “a compromise between the parties of disputed claims” and “in no way an admission of liability or wrongdoing.”
One of the higher-profile cases resolved during this period was Patricia A. Jones v. Medtronic, a wrongful-death suit filed after Kaitlyn M. Jones, a Florida teenager with severe cerebral palsy, died in 2014 from a bowel problem linked to withdrawal when her SynchroMed II failed to deliver medication. The case was initially dismissed but reinstated by a Hennepin County appeals court. In July 2019, a Hennepin County judge granted a request to file confidential settlement paperwork, and Medtronic confirmed that related claims had been resolved.
Why These Lawsuits Are Hard: Federal Preemption
The biggest obstacle for anyone suing over the SynchroMed II is federal preemption. Because the pump went through the FDA’s pre-market approval process (original PMA number P860004 in 1988, with the SynchroMed II approved through a supplement in September 2003), Medtronic has argued that federal law bars state-law tort claims.
The defense traces to the Supreme Court’s 2008 decision in Riegel v. Medtronic, Inc., which held that the Medical Device Amendments expressly preempt state-law claims imposing requirements “different from, or in addition to” the federal requirements established through PMA. It has worked in some courts. In Benyak v. Medtronic, an Illinois appellate court affirmed dismissal of all claims in June 2018, finding that design-defect and manufacturing-defect claims were preempted.
The Parallel Claims Opening
The door plaintiffs use is the “parallel claims” exception. In Stengel v. Medtronic, brought by a patient who alleged a SynchroMed EL pump caused permanent paraplegia from a granuloma at the catheter tip, the Ninth Circuit reheard the case en banc and ruled in January 2013 that a state-law failure-to-warn claim was not preempted when it paralleled a federal duty, specifically Medtronic’s obligation under federal regulations to report known adverse events to the FDA. Medtronic asked the Supreme Court to review the ruling. In June 2014 the Court declined, leaving the decision in place.
Federal circuits have since split on how specifically a plaintiff must plead the underlying federal violation. Courts in the Eighth and Eleventh Circuits require plaintiffs to identify the precise FDA regulation violated. Courts in the Fifth, Sixth, Seventh, and Ninth Circuits allow claims to proceed based on broader context such as FDA warning letters, recall notices, or inspection reports. Given Medtronic’s extensive recall record and the consent decree findings, plaintiffs in the more permissive circuits have had substantial material to work with.
Where Cases Stand Now
The 2019 settlement fund closed out most of the pending litigation, but it did not end it. As of 2023, additional SynchroMed II lawsuits were reported to be moving forward in state courts in California and Pennsylvania after surviving preemption challenges.
Recall activity has continued as well. Between 2023 and 2026, the FDA posted multiple Class 2 recalls affecting SynchroMed II and the newer SynchroMed III pumps, along with associated software and catheter components. None have reached the Class 1 severity of the earlier actions.
If you or a family member was injured, the practical questions are whether the injury can be tied to a specific documented defect (a recalled battery lot, a pocket fill, a motor stall, a catheter failure), whether the treating clinicians followed the approved drug list (Medtronic noted that 99 of 103 overinfusion events involved drug formulations not specifically approved for the pump), and which court’s preemption rules apply. Those variables, more than the underlying facts of what the pump did, tend to decide whether a claim survives.