The Minnesota Court of Appeals is reviving a lawsuit against Medtronic from the mother of a deceased patient, despite the medical device maker’s insistence in court filings that it is all but immune from personal liability in such cases.
The mother of Florida teen Kaitlyn M. Jones sued Medtronic in 2016, arguing that the company’s SynchroMed II implantable drug pump became clogged and failed to deliver required doses of a powerful drug to treat Jones’ spastic quadriplegia from severe cerebral palsy. Jones died in 2014 from a bowel problem related to her withdrawal from the drug that her pump was supposed to deliver, the lawsuit alleges.
A Hennepin County District judge granted Medtronic’s motion to dismiss the case, finding most of its claims “pre-empted” by the federal law that gives the Food and Drug Administration the exclusive authority to regulate the safety of the riskiest devices. This week, a three-judge panel of the state appeals court disagreed, and reinstated many of Patricia Jones’ claims against the Minnesota-operated device maker.
The underlying allegations — that Medtronic knowingly sold a bad device that harmed Kaitlyn Jones — have yet to go to trial, which means her mother’s legal team would still need to prove that Medtronic was liable for her death in order to win the case.
“We were dismayed to learn of the death in this case and our thoughts are with the patient’s family,” Medtronic spokesman Eric Epperson said via e-mail. “While we are disappointed that the appellate court has allowed certain claims to move forward, the ruling addresses preliminary issues and is not a decision on the merits of the case. We continue to have strong defenses to the remaining claims and will pursue those defenses vigorously.”
Similar patient lawsuits are pending, though it’s not clear how many. Medtronic has not disclosed the total to investors in securities filings.
A Medtronic filing with the Minnesota appeals court on Nov. 17 cited seven other SynchroMed II lawsuits that were dismissed in recent years by courts in Ohio, Tennessee, Texas, Louisiana, New York and Illinois because judges found the claims were pre-empted by federal law.
In the medical device litigation context, “pre-emption” refers to Congress’ decision to give the FDA exclusive authority to regulate risky Class III medical devices. That means consumer-protection laws in the 50 states cannot impose additional requirements on Class III medical devices, and they cannot be used to enforce federal law in cases where plaintiffs disagree with the FDA’s enforcement decisions.
“Although the pre-emption of state tort claims may leave some injured individuals ‘without … judicial recourse,’ Congress determined that the loss to those comparatively few individuals was outweighed by the benefit to the far greater number ‘who would suffer without new medical devices if juries were allowed to apply the tort law of 50 states to all innovations,’ ” Medtronic’s attorneys wrote, quoting from the 2008 U.S. Supreme Court decision in Riegel vs. Medtronic.
In the Kaitlyn Jones case, the Minnesota appeals court found a harmed patient may have judicial recourse.
Jones’ attorneys threaded their arguments through a narrow exception to medical-device pre-emption law that says lawsuits based on state consumer-protection laws can escape FDA pre-emption if the state laws only impose the same kinds of requirements — known as “parallel” requirements to the federal rules — but no additional rules.
“It is only when a lawsuit says that the manufacturer should have done more than the FDA required of it that it is pre-empted,” wrote Robert Peck, a lawyer representing the Jones estate from the Center for Constitutional Litigation. “Here, we were careful to say that Medtronic violated federal regulations and that the FDA itself identified the violations. The same infractions were also prohibited under Minnesota law. For that reason, these were parallel state claims.”
The SynchroMed II is approved to pump drugs like baclofen into the spinal canal, where they can be effective at small doses for patients with cancer, chronic pain and severe spasticity. But the widely used pump has been a source of headaches for Medtronic over the years.
In 2015, the Justice Department said Medtronic had repeatedly failed to correct violations identified by FDA inspectors at the SynchroMed II plant in Columbia Heights. DOJ filed a complaint against Medtronic and CEO Omar Ishrak for failing to correct problems related to design controls, complaint handling and corrective actions that could lead to a pump delivering too much or too little medication.
The complaint was settled the same day it was filed with a legal agreement that limited who could be prescribed a SynchroMed II pump. Neither Medtronic nor Ishrak admitted wrongdoing as part of the agreement. Last fall, the FDA lifted the special rules on pump distribution and the warning letter on the manufacturing operation, Medtronic has told investors.