A federal judge in the U.S. District Court Western District of Kentucky Louisville Division has dismissed a lawsuit against Abbott and St. Jude Medical.
District Judge Rebecca Grady Jennings granted the Abbott and St. Jude motion to dismiss a case brought forward by plaintiff Nathan Jackson. Jackson sued Abbott and St. Jude in August 2023, alleging that the Gallant implantable cardioverter defibrillator (ICD) manufactured by St. Jude (acquired by Abbott in 2016 for $25 billion) is defective.
The plaintiff had an ICD implanted in August 2022 and claimed that, shortly after implantation, he experienced serious heart pain. He was admitted to the hospital, according to the complaint, and alleged that pain resulted from electric shocks to his heart. Jackson said he was told that the shocks resulted from a device malfunction before he was discharged from the hospital. He claimed worsened heart conditions, pain and anxiety, leading to harm, damages and economic loss as a result.
According to the judge’s decision, the FDA never revoked or withdrew approval for the device in question. Jackson claimed that St. Jude recalled the device on three occasions. First, in 2015, the company recalled certain ICDs due to exposed aluminum. In October 2016, the FDA issued a Class I recall due to exposed aluminum wires preventing defibrillation. Finally, in 2021, Abbott issued a recall due to another issue with premature battery depletion.
The decision notes that the final recall occurred approximately 17 months before Jackson received his implant.
Why the judge granted the Abbott and St. Jude motion to dismiss
The court had to determine if Jackson’s claims relied on Kentucky law requirements that differ from federal laws, as the ICD went through the FDA’s premarket approval (PMA) pathway and satisfies federal regulations.
Grady Jennings found that Jackson’s complaint did not refer to the PMA process or FDA regulations, let alone a violation of them.
“Even under the more lenient approach taken in some decisions, the court can find no parallel claim that would justify discovery,” the judge wrote.
Jackson responded by alleging that his state law claims qualify as parallel claims consistent with the concept that Abbott and St. Jude violated the Federal protocols. The judge said it remains uncertain whether Abbott and St. Jude committed violations of FDA regulations by deviating from FDA-approved processes.
The judge said Jackson correctly indicated that previous decisions ruled against dismissal at this stage to provide the opportunity for discovery. However, Grady Jennings said those prior cases are distinct from Jackson’s complaint as they all have some reference to FDA regulations that could indicate a parallel claim.
Finally, the judge said the alleged device recalls occurred between 17 months and seven years before Jackson’s implant. Thus, it remains uncertain what impact those recalls have on the current device. That meant the mere reference to past recalls was insufficient to properly plead a parallel claim.
“For the foregoing reasons, and being otherwise sufficiently advised, it is ordered that request for judicial notice is granted, and the motion to dismiss filed by Abbott and St. Jude is granted,” the judge concluded.
