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Medtronic will have to face a lawsuit concerning its allegedly defective SynchroMed EL implantable pain pump, according to a Missouri federal judge. Medtronic had tried to get the lawsuit dismissed on the grounds of preemption, but the court denied the motion, allowing the lawsuit to move forward.

Plaintiff Suffers from Permanent Injuries After Medtronic SynchroMed Fails

The plaintiff lives with cerebral palsy and spastic quadriplegia. In 2005, she had the Medtronic SynchroMed II infusion pump implanted in her abdomen to regularly deliver medication that would reduce her muscle spasticity. The device administers a programmed amount of medication via a catheter into the spinal fluid to treat patients who do not experience good results with other forms of treatment.

According to the plaintiff, her first device functioned normally until the end of its lifecycle in 2011. She then had her original SynchroMed replaced with a new SynchroMed while retaining the original catheter. The new device failed in 2015, sounding an alarm while the motor stalled, seized, or otherwise failed to deliver the medication as programmed.

The plaintiff suffered from withdrawal and had to go to the emergency room with symptoms of tremors, shortness of breath, tachycardia, elevated blood pressure, and hypothermia. The surgeon performed pump replacement surgery, noting that there was evidence of a catastrophic pump failure with a rotor stall that could not be remedied by cycling the pump off and on. The plaintiff alleged that she suffered from permanent injuries because of the ordeal and blamed the failure on manufacturing defects.

In her lawsuit, the plaintiff brought claims of strict liability, negligence, and breach of warranties, and sought punitive damages.

Judge Denies Medtronic’s Motion to Dismiss

Medtronic filed a motion to dismiss based on federal preemption, a move it has made in other similar lawsuits. The manufacturer argued that the claims were preempted by the 1976 Medical Device Amendments (MDA) to the Food, Drug, and Cosmetic Act. That act authorized the FDA to regulate the safety and effectiveness of medical devices and separated medical devices into three groups based on the degree of risk they pose.

In general, Class III devices are the most dangerous and are subject to the highest level of scrutiny by the FDA. The Medtronic SynchroMed is a member of this class and had to go through the rigorous premarket approval (PMA) process before being allowed on the market in 1988.

The MDA expressly preempts certain state laws. That means the court must examine the federal laws applicable to the device in question and compare them to the state claims the plaintiff wishes to bring.

In this case, Missouri District Court Judge Catherine D. Perry ruled that the plaintiff’s claims of manufacturing defects survive preemption. The plaintiff refers to several FDA warnings given to Medtronic because the company was violating current good manufacturing processes. Since receiving PMA approval, the SynchroMed has been subject to at least 72 recalls.

The July 17, 2012, FDA warning letter, for instance, states that Medtronic failed to establish adequate procedures to correct issues relating to motor corrosion resulting in a motor stall. On April 17, 2015, the U.S. Department of Justice and the U.S. Department of Health and Human Services filed a complaint in the District of Minnesota for a permanent injunction against Medtronic concerning its manufacture of SynchroMed, alleging that the company continued to introduce adulterated devices into commerce.

Medtronic subsequently agreed to halt the production of the devices in April 2015.

Medtronic also complained that the plaintiff’s allegations were not specific enough and that she failed to allege a plausible claim for relief. The judge rejected that argument as well, ruling that the plaintiff “is entitled to conduct discovery to support her claims.”

Medtronic has had a similar problem with its MiniMed Infusion Pump, which is used to deliver insulin. The company has had to defend lawsuits filed by patients injured by this device, and in February 2020, recalled over 320,000 of the MiniMed 600 Series Insulin Pumps because they could over or under deliver insulin, resulting in hypoglycemia or hyperglycemia. At the time, the company had received over 26,000 complaints of the device malfunctioning and was aware of over 2,100 injuries and one death.

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