Nebraska Failure‑to‑Warn Law Clarified: Learned Intermediary Extends to Proximate Cause and Supports Merging Negligence and Strict Liability Claims

Introduction

In Jeffrey Thelen v. Somatics, LLC, the Eleventh Circuit affirmed a defense verdict in an electroconvulsive therapy (ECT) product-liability case, resolving multiple points of law that are pivotal for failure-to-warn litigation under Nebraska law. The plaintiff, who underwent 95 ECT treatments between 2014 and 2016 and was later diagnosed with a neurocognitive disorder, alleged that Somatics’s Thymatron IV device was defectively designed and inadequately warned of “brain damage.” After the district court pared back the case (including dismissing certain claims, granting partial summary judgment, and consolidating theories), a jury found a failure to warn but no proximate cause. On appeal, Thelen challenged summary judgment on design defect, the merger of negligence and strict liability, the court’s proximate cause instruction, and several evidentiary rulings.

The Eleventh Circuit’s opinion is notable for two clarifications of Nebraska product-liability law: (1) in failure-to-warn cases involving prescription medical products, proximate cause turns on whether the prescribing physician would have altered conduct if adequately warned (i.e., the learned intermediary doctrine reaches the causation element), and (2) where negligence and strict liability claims are factually identical failure-to-warn theories, a trial court may merge them to avoid juror confusion. The decision also reinforces standards for design-defect proof under Nebraska’s consumer-expectations test and underscores rigorous gatekeeping under Federal Rules of Evidence 403 and 702.

Summary of the Opinion

Thelen sued Somatics in the Middle District of Florida, advancing negligence, strict liability, warranties, consumer-protection, and fraud claims under Nebraska law. The district court:

Dismissed the consumer-protection and fraud claims (no private right under the Nebraska statute and failure to plead fraud with particularity).
Merged implied-warranty claims into strict liability under Nebraska law.
Granted summary judgment on design and manufacturing defect, and on express warranty (for lack of reliance), but allowed failure-to-warn theories to proceed.
Preempted negligence theories premised on failure to report adverse events to the FDA (Buckman/Mink preemption).

The case went to trial solely on failure-to-warn, with the court merging negligence and strict liability warnings theories under Rule 16 to avoid confusion. The jury found that Somatics failed to provide adequate warnings to the prescribing physician, but also found that the failure did not proximately cause Thelen’s injuries. Post-trial, the court denied Thelen’s Rule 59 motion for a new trial.

On appeal, the Eleventh Circuit affirmed across the board:

Design defect (summary judgment): Thelen failed to produce objective evidence that the Thymatron IV was “unreasonably dangerous” beyond ordinary consumer expectations, and failed to show proximate cause given the jury’s causation finding on warnings.
Merger of negligence and strict liability failure-to-warn claims: Consistent with Nebraska’s “merger of doctrines” approach and Restatement (Third) of Torts, the district court acted within its discretion to submit a single warnings claim.
Proximate cause instruction: No error in instructing that Thelen had to prove the prescribing physician would have altered his conduct if adequately warned; applying the learned intermediary doctrine to causation is consistent with Nebraska authority as interpreted by federal courts.
Closing argument and curative instruction: Any complaint about defense counsel’s formulation (“would not have prescribed”) was untimely and non-prejudicial; jurors were instructed to follow the court’s statement of law.
Evidentiary rulings: Excluding a treating physician’s consent video under Rule 403 and excluding a neuropsychologist’s causation opinions under Rule 702/Daubert were within the court’s discretion.

Analysis

Precedents Cited and Their Influence

Freeman v. Hoffman-La Roche, Inc., 618 N.W.2d 827 (Neb. 2000): The Nebraska Supreme Court endorsed a Restatement (Third)–aligned “merger of doctrines,” cautioning against sending factually identical failure-to-warn or design claims to the jury under multiple doctrinal labels (strict liability, negligence, implied warranty). The Eleventh Circuit relied on Freeman to uphold the district court’s consolidation of negligence and strict liability warnings theories into a single submission.
Pitts v. Genie Indus., 921 N.W.2d 597 (Neb. 2019): Defines “unreasonably dangerous” under Nebraska law by a consumer-expectations standard (“beyond that which could be contemplated by the ordinary user”). Thelen’s design-defect proof faltered because he offered no objective evidence of ordinary consumer expectations pertinent to the Thymatron IV; instead, he relied on his own and family’s subjective understandings, and his physician’s beliefs.
Langner v. Boston Scientific Corp., 492 F. Supp. 3d 925 (D. Neb. 2020) and Ideus v. Teva Pharms. USA, Inc., 361 F. Supp. 3d 938 (D. Neb. 2019): Federal courts applying Nebraska law have articulated the learned intermediary doctrine with a causation component: the plaintiff must prove that, with adequate warnings, the prescribing physician would have behaved differently (e.g., not prescribed, or prescribed differently). The Eleventh Circuit adopted this understanding in upholding the proximate cause instruction.
King v. Burlington N. Santa Fe Ry. Co., 762 N.W.2d 24 (Neb. 2009): Establishes the general/specific causation framework in Nebraska toxic tort/product cases, including the role of epidemiology and biological plausibility (general causation) and differential diagnosis (specific causation). The trial court used this framework to filter expert evidence; the appellate opinion recounts those rulings approvingly.
Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 341 (2001) and Mink v. Smith & Nephew, Inc., 860 F.3d 1319 (11th Cir. 2017): Confirm implied preemption of private attempts to enforce duties owed to the FDA (e.g., failure to report adverse events). Thelen’s negligence theory premised on FDA reporting failures was properly preempted at summary judgment.
Goldsmith v. Bagby Elevator Co., 513 F.3d 1261 (11th Cir. 2008); Schafer v. Time, Inc., 142 F.3d 1361 (11th Cir. 1998): Standards for reviewing jury instructions: de novo for legal correctness, but broad discretion in wording. These supported affirmance of the proximate cause instruction.
United States v. Frazier, 387 F.3d 1244 (11th Cir. 2004) (en banc); Kumho Tire Co. v. Carmichael, 526 U.S. 137 (1999): Gatekeeping under Rule 702/Daubert; broad discretion to exclude expert testimony that is unqualified or methodologically unreliable. Used to affirm exclusion of neuropsychologist causation opinions.
Chapman v. Procter & Gamble Distrib., LLC, 766 F.3d 1296 (11th Cir. 2014); Hendrix ex rel. G.P. v. Evenflo Co., 609 F.3d 1183 (11th Cir. 2010); Guinn v. AstraZeneca Pharms. LP, 602 F.3d 1245 (11th Cir. 2010): Define a reliable differential diagnosis: the expert must consider and rule out plausible alternative causes. Thelen’s neuropsychologist did not adequately account for significant alternative causes (substance abuse, prior suicide attempts), justifying exclusion.
Oxford Furniture Cos. v. Drexel Heritage Furnishings, Inc., 984 F.2d 1118 (11th Cir. 1993): Need for contemporaneous objections to closing argument. Thelen’s delayed objection to defense counsel’s “would not have prescribed” formulation was deemed waived.
Proctor v. Fluor Enters., Inc., 494 F.3d 1337 (11th Cir. 2007): Evidentiary error warrants reversal only if it affects a substantial right. The district court’s exclusion of the consent video did not harm Thelen where the jury already found a failure to warn.

Legal Reasoning

1) Design Defect under Nebraska’s Consumer-Expectations Test

Nebraska measures design defect by whether a product is “unreasonably dangerous,” i.e., more dangerous than an ordinary consumer would expect. The court accepted that the “consumer” is the patient (not the physician) for medical devices. Thelen argued that the Thymatron IV was defectively designed because Somatics did not warn of “brain damage,” and because literature and experts suggested ECT can cause persistent memory loss and brain injury.

The court concluded that:

Somatics’s and the hospital’s materials warned of severe risks, including “prolonged seizures,” “temporary or permanent heart abnormalities,” and “permanent memory loss,” as well as mortality. Even if the label omitted the specific phrase “brain damage,” a reasonable patient would understand that permanent memory loss is a serious brain-related harm. Notably, plaintiff’s own experts equated persistent memory loss with brain injury.
Thelen offered no objective evidence of ordinary patient expectations for ECT devices; he relied on his personal expectations and his physician’s or parents’ beliefs. Those are insufficient under the consumer-expectations standard.
Proximate cause for design defect was independently lacking because the jury later found that any warnings inadequacy did not cause Thelen’s injuries; the design-defect theory overlapped heavily with warnings and could not succeed absent causation.

2) Merger of Negligence and Strict Liability Failure-to-Warn Theories

The district court merged negligence and strict liability warnings theories to “simplify issues” under Rule 16, citing the risk of inconsistent verdicts (e.g., negligence finding with adequate warnings under strict liability). Nebraska’s high court in Freeman endorsed a functional approach that avoids presenting factually identical claims under multiple doctrinal labels. The record confirmed that Thelen’s negligence theory depended on a failure to warn; his “failure to test/investigate” contentions were relevant (if at all) only insofar as they supported a warnings defect and had no independent causal pathway. The Eleventh Circuit held merger was well within the trial court’s discretion.

3) Proximate Cause and the Learned Intermediary Doctrine

The jury was instructed: to prove causation on a warnings claim, Thelen had to show his prescribing physician “would have altered his conduct” if adequately warned. This instruction aligns with Nebraska federal decisions (Langner; Ideus) applying the learned intermediary doctrine not only to duty but also to causation: a plaintiff must show that a different warning would have changed the prescriber’s behavior. Thelen offered no controlling Nebraska authority to the contrary and, in the charge conference, acknowledged the correctness of the court’s approach.

The appellate court emphasized two points:

The instruction accurately reflected the substantive law; the court had discretion as to wording.
Even assuming arguendo a broader formulation could have been used, Thelen failed to demonstrate prejudice—that the verdict would likely have differed under his preferred instruction.

4) Closing Argument and Curative Instruction

Defense counsel told jurors Thelen had to prove Dr. Sharma “would not have prescribed” ECT had the manual used “brain damage” instead of “permanent memory loss.” Thelen’s objection came only after the jury began deliberating. The court held the objection waived for lack of contemporaneity, and, in any event, non-prejudicial: counsel’s phrasing was a reasonable application of the court’s instruction that the prescriber must have “altered his conduct.” Jurors were instructed that the court’s legal instructions govern, not counsel’s arguments. No abuse of discretion occurred in declining to issue a curative instruction sua sponte.

5) Evidentiary Rulings

Patient consent video (Rule 403): The district court excluded a CHI Health consent video featuring Dr. Sharma, reasoning it risked confusing the issues by shifting focus to physician-to-patient disclosures instead of manufacturer-to-physician warnings, and was cumulative because Dr. Sharma testified to his understanding of ECT risks. Given the jury’s finding for Thelen on warnings adequacy, exclusion could not have affected a substantial right.
Neuropsychologist causation opinions (Rule 702/Daubert): The court excluded Dr. Mark Hannappel’s medical causation opinions because he is not a physician, expressly disclaimed expertise in ECT causation, and did not perform a reliable differential diagnosis (he failed to grapple with alternative causes such as extensive substance abuse and prior suicide attempts). Thelen’s fallback attempt to recast him as a lay witness under Rule 701 failed because his causation opinions necessarily relied on specialized knowledge and were formed while consulting, not contemporaneously treating. The exclusion was squarely within Daubert gatekeeping discretion.

Impact

Thelen v. Somatics has several practical and doctrinal implications for product-liability litigation—particularly failure-to-warn claims involving prescription medical products governed by Nebraska law:

Learned intermediary and causation: Plaintiffs must marshal admissible evidence that an adequate warning would have changed the prescriber’s conduct. Depositions and testimony from the prescribing physician are often decisive. Mere proof that warnings were inadequate will not suffice without a causation bridge to the prescriber’s decision-making.
Consolidation of duplicative theories: Trial courts may merge negligence and strict liability warnings claims when they are factually identical, curbing juror confusion and inconsistent verdicts. “Failure to test/investigate” is not a stand-alone tort; it must be tied to a cognizable defect (design or warnings) and a causal pathway.
Design-defect proof under consumer expectations: In Nebraska, plaintiffs need objective evidence of ordinary patient expectations for medical devices. Anecdotal beliefs (plaintiff, family, or individual physicians) are insufficient; product literature, consensus statements, risk communications, and empirical evidence bearing on what an ordinary patient would contemplate can be critical.
Warnings semantics: Courts may treat “permanent memory loss” warnings as encompassing serious brain-related harm even if the label omits the phrase “brain damage,” particularly where experts themselves use these concepts interchangeably. Plaintiffs should focus on material risk communication and clinical decision-making impact, not solely vocabulary.
Expert gatekeeping is exacting: Medical causation typically requires a qualified physician employing a reliable methodology. Non-physician clinicians must remain within their expertise and, if opining on causation, must conduct a rigorous differential diagnosis that addresses plausible alternative causes with reasoned analysis.
FDA-based negligence remains preempted: Claims predicated on enforcing FDA reporting or pharmacovigilance duties are impliedly preempted under Buckman and Eleventh Circuit precedent (Mink), reinforcing a strategic focus on state-law duties independent of the FDCA.
Preservation and timing matters: Objections to closing arguments must be contemporaneous to preserve error, and parties should anticipate the need for immediate corrective relief if adversaries shade the legal standard in argument.

Complex Concepts Simplified

Learned Intermediary Doctrine: For prescription drugs/devices, the manufacturer’s duty to warn runs to the prescribing clinician (the “learned intermediary”), who then advises the patient. To prove causation in a warnings case, the plaintiff must show that with an adequate warning, the clinician would have acted differently (e.g., not prescribed, prescribed differently, or monitored differently).
Consumer-Expectations Test (Design Defect): A product is defectively designed if it poses dangers beyond what an ordinary consumer would expect. In medical-device cases under Nebraska law, the “consumer” is the patient.
General vs. Specific Causation: General causation asks whether a product is capable of causing the type of harm alleged (often supported by scientific studies and biological plausibility). Specific causation asks whether it did cause this plaintiff’s injury, typically requiring a physician’s differential diagnosis that fairly considers and rules out other plausible causes.
Differential Diagnosis: A systematic process where a clinician lists all plausible causes of a patient’s condition and, using medical reasoning and data, rules them in or out. A perfunctory or incomplete effort (ignoring obvious alternative causes) is methodologically unreliable.
Rule 403 (Unfair Prejudice/Confusion): Even relevant evidence can be excluded if its probative value is substantially outweighed by risks of confusing issues, misleading jurors, undue delay, or needless cumulativeness.
Rule 702/Daubert (Expert Testimony): Expert opinions must be offered by a qualified expert, based on sufficient data and reliable methods, and help the jury. Specialized, technical, or scientific opinions from treating providers are still subject to Rule 702.
Implied Preemption (Buckman): Private plaintiffs cannot sue to enforce duties owed to the FDA (e.g., reporting adverse events). State-law claims must arise from independent state duties, not as a back-door enforcement of federal regulatory requirements.

Conclusion

The Eleventh Circuit’s decision in Thelen v. Somatics, LLC is a significant clarifier of Nebraska failure-to-warn law as applied in federal court. It endorses the view that, in learned intermediary cases, proximate cause hinges on whether adequate warnings would have changed the prescriber’s conduct; it also affirms trial courts’ discretion to merge negligence and strict liability warnings claims when they are factually identical. The opinion reinforces Nebraska’s consumer-expectations test for design defect and highlights the high bar for medical causation testimony under Rule 702. On the procedural side, it underscores the importance of timely objections and the limited appellate appetite for reversing discretionary evidentiary and instructional rulings absent demonstrated prejudice.

For practitioners, the message is clear: assemble objective evidence of ordinary patient expectations for design-defect theories; build a robust, prescriber-focused causation record for warnings claims; retain properly qualified medical experts who perform rigorous differential diagnoses; and preserve issues at trial with timely, specific objections. These steps will be decisive in navigating Nebraska product-liability claims post-Thelen.