A man who received 95 electroconvulsive therapy treatments and later suffered severe memory loss could not collect damages from the device manufacturer — even after a jury found its warnings were deficient. That is the bottom line of a September 2025 decision from the United States Court of Appeals for the Eleventh Circuit in Thelen v. Somatics, LLC, No. 23-13892.
The ruling is a reminder that in product liability cases involving prescription medical devices, identifying a warning defect is only half the battle. A plaintiff must also prove that the inadequate warning was the reason the patient was harmed — and that burden proved insurmountable here.
Although juries rarely find a medical device manufacturer’s warnings inadequate and still return a defense verdict, that unusual combination is exactly what happened here. The decision illustrates how causation—not merely proof of a defective warning—often determines the outcome in pharmaceutical and medical device litigation.
Background: 95 Treatments, a Neurocognitive Diagnosis, and a Lawsuit
Jeffrey Thelen suffered from severe depression and a long history of mental health crises, including multiple suicide attempts. Beginning in 2014, his psychiatrist recommended electroconvulsive therapy. Over roughly two years, Thelen underwent 95 ECT sessions at a CHI Health hospital in Omaha, Nebraska, using a Thymatron IV device manufactured by Somatics, LLC.
In 2017, Thelen was diagnosed with a neurocognitive disorder. According to his mother’s trial testimony, he could not recognize family members, forgot how to do basic household tasks, and — by his own account — even forgot where his childhood home was located. In 2020, Thelen filed suit in the Middle District of Florida, alleging that Somatics failed to adequately warn him of the risks associated with ECT.
His complaint raised seven claims, including negligence, strict product liability, breach of warranty, violation of Nebraska’s Consumer Protection Act, and fraudulent misrepresentation. Before the case reached the jury, the district court dismissed or resolved most of those claims. What survived was a narrow failure-to-warn theory under negligence and strict liability.
At trial, the jury concluded that Somatics had placed its device on the market without adequate warnings to Thelen’s prescribing physician. But the jury also found that the inadequate warnings were not the proximate cause of Thelen’s injuries. He received no damages. The district court denied his motion for a new trial, and the appeal followed.
The Eleventh Circuit’s Analysis
Writing for a three-judge panel, Circuit Judge Marcus addressed each of Thelen’s appellate arguments and rejected them all, affirming the district court on every point.
Design Defect. Thelen argued the district court wrongly dismissed his design defect claim at summary judgment. Under Nebraska law, a design defect requires showing the product is “dangerous to an extent beyond that which would be contemplated by the ordinary consumer.” The court found Thelen had failed to present objective evidence of what an ordinary ECT patient would expect — he offered only his own subjective expectations and the views of his treating physician and parents.
The court noted that Thelen’s own experts testified at trial that “brain damage” and “permanent memory loss” are used interchangeably, making it difficult to argue the warnings were so deficient as to constitute an unreasonably dangerous design. And critically, the jury’s finding that inadequate warnings did not cause Thelen’s injuries made any error on the design defect claim harmless.
Claim Merger. The district court combined Thelen’s negligence and strict liability claims on the first day of trial, reasoning they were both rooted in the same alleged warning defect. Thelen objected, arguing his negligence claim also encompassed failures to test and investigate. The Eleventh Circuit disagreed. Nebraska’s “merger of doctrines” allows a court to submit factually identical claims under a single theory. And as Thelen’s own counsel conceded during trial, the failure-to-test and failure-to-investigate theories only mattered insofar as they resulted in a failure to warn. There was no independent theory of liability that the merger extinguished.
Jury Instructions on Proximate Cause. The district court instructed the jury that to prevail, Thelen had to prove “his prescribing physician would have altered his conduct had adequate warnings and instructions been provided.” Thelen claimed this improperly embedded the learned intermediary doctrine into the causation analysis. The Eleventh Circuit was unpersuaded. Several federal district courts applying Nebraska law have reached the same conclusion: when a manufacturer’s duty runs through a prescribing physician, the failure to warn must be shown to have changed what that physician would have done. The court also noted that Thelen’s own counsel had told the trial court the instruction was “accurate as written” — a difficult position to walk back on appeal.
Closing Argument and Curative Instruction. During summation, defense counsel told the jury Thelen had to show Dr. Sharma “would not have prescribed ECT” if the device manual had used the words “brain damage” instead of “permanent memory loss.” Thelen argued this was a narrower — and incorrect — statement of the law. But his counsel had not objected contemporaneously; the objection came only after the jury had already begun deliberating. The court found the objection waived and, in any event, found no prejudice — the jury was instructed to follow the court’s instructions, not the lawyers’ arguments.
Exclusion of Consent Video. Thelen sought to introduce a 2009 patient consent video featuring his treating physician, Dr. Arun Sharma. The trial court excluded it under Federal Rule of Evidence 403, finding that the video — which concerned disclosures from the doctor to the patient — would confuse the jury in a case where the central issue was the manufacturer’s disclosures to the physician. The Eleventh Circuit agreed. Dr. Sharma had already testified at trial about his understanding of ECT’s risks, making the video largely cumulative. And since the jury ultimately found that the warnings were inadequate — a finding in Thelen’s favor on that issue — any error in excluding the video could not have affected his substantial rights.
Expert Testimony. The district court had barred neuropsychologist Dr. Mark Hannappel from offering a medical causation opinion, finding he lacked the qualifications and that his methodology was unreliable under Daubert standards. Hannappel had admitted at his deposition that he was “not qualified to offer medical causation opinions” and that ECT treatment was “outside of [his] scope of expertise.” His analysis also failed to account for Thelen’s documented history of severe substance abuse — a significant alternative explanation for cognitive decline. The Eleventh Circuit affirmed the exclusion and rejected Thelen’s argument that Hannappel should have been allowed to testify as a lay witness under Rule 701, noting that his opinions on cognitive causation required precisely the kind of scientific and technical reasoning that Rule 702 and Daubert are designed to regulate.
What This Case Means
Thelen v. Somatics illustrates a defect warning and causation are separate elements, each requiring its own proof. A jury agreed that Somatics’s warnings were inadequate. Thelen still lost.
For plaintiffs’ lawyers, the case underscores the importance of ensuring that causation experts have the credentials and methodology to survive Daubert scrutiny.
– The Trial Attorneys Editorial Staff
Thelen v. Somatics US Appeals for the Eleventh Circuit
*This article is for informational purposes only and does not constitute legal advice. Readers with questions about a specific legal matter should consult a licensed attorney.
