Close, But Not Quite: Eastern District of North Carolina Excludes Experts Whose General Expertise Does Not Enable Specific Opinions Offered

Even “[a] supremely qualified expert cannot waltz into the courtroom and render opinions” unless those opinions pass muster under Federal Rule of Evidence 702. Clark v. Takata Corp., 192 F.3d 750, 759 n.5 (7th Cir. 1999). As a recent case from the Eastern District of North Carolina illustrates, this principle is at play not only when critiquing an expert’s methodology, but also the expert’s expertise.

In Williams v. Sig Sauer, Inc., — F. Supp. 3d —, 2025 WL 2643400 (E.D.N.C. Sept. 8, 2025), the plaintiff was an “enforcer” for his motorcycle club who “protect[ed]” and “monitor[ed]” the club members. He alleged that his pistol discharged and injured him while he was adjusting his position on his motorcycle. In support of his product liability claims against the manufacturer of the pistol, he proffered two expert witnesses: a gunsmith and a mechanical engineer. The defendant moved to exclude both experts and filed a motion for summary judgment.

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Nothing Shocking Here – Eleventh Circuit Affirms Defense Win in Electroconvulsive Therapy Case

When a case involves electroconvulsive therapy (ECT), one might think it originated out of the Twilight Zone. Despite the misrepresentation of such therapies in popular media, modern ECT serves as a valuable option for patients with certain severe mental health conditions who have tried other therapies without success. Although ECT is far safer today than it was when the stigma attached to it was formed, it still carries risks such as confusion, memory loss, and some physical side effects. One need not enter another dimension to envision why a plaintiff might claim damages arising from those risks. Much like Rod Serling’s anthology, the Eleventh Circuit recently closed the door on one such episode.

In Thelen v. Somatics, LLC, — F.4th —, 2025 WL 2749888 (11th Cir.), the plaintiff suffered from depression and mental health issues so severe that he attempted to take his life numerous times in numerous ways. During a two-year span, he received 95 ECT treatments to address his conditions. He was later diagnosed with a neurocognitive disorder that caused severe memory loss.

The plaintiff sued the manufacturer of the device used to administer the ECT treatments, asserting the typical slew of product liability claims premised on the defendant’s alleged failure to warn. The district court dismissed some claims, merged others, and granted summary judgment on some. By the time the case reached trial, all that survived were claims for negligent and strict liability failure to warn. The district court, again, merged those claims into one for the jury’s benefit. While the jury found the ECT devices lacked adequate warning, they also concluded that the inadequate warnings did not proximately cause the plaintiff’s injuries.

The plaintiff appealed, citing six alleged errors by the district court and bringing to mind the Sixth Circuit’s reminder that “[w]hen a party comes to us with nine grounds for reversing the district court, that usually means there are none.” Fifth Third Mortg. Co. v. Chicago Title Ins. Co., 692 F.3d 507, 509 (6th Cir. 2012). The Eleventh Circuit affirmed the district court’s decision on each of the six issues.

  • Design Defect Claim

    The plaintiff first argued that the district court erred in granting summary judgment for Defendant on the design defect claim. Nebraska supplied the substantive law and, for a claim of design defect, requires a plaintiff to show the product is dangerous “beyond that which could be contemplated by the ordinary user or consumer.” The plaintiff’s argument was that the defendant failed to warn consumers that the product might cause “brain damage,” and that it therefore fell short of his own subjective expectations and those of his physician.  But the warnings expressly noted that ECT could cause “short term memory loss;” “permanent memory loss;” “prolonged seizures;” “heart abnormalities;” and even “mortality.” The plaintiff had to come forward with “objective evidence of ‘ordinary knowledge common to the community’” about ECT’s risks. Because the plaintiff’s evidence at most supported a subjective view of the warnings, his design defect claim failed.

  • Merger of Strict Liability and Negligence Claims

    The district court merged the plaintiff’s strict liability and negligence claims because both were based on an alleged failure to warn. Despite the plaintiff’s challenge to the practice, the Eleventh Circuit panel noted Nebraska’s recognition of “merger of doctrines” and a “single theory approach.” Because the claims arose from the same alleged warning defect, either legal theory would require proof of the same “failure to warn” to succeed.

  • Jury Instructions and Closing Argument

    The plaintiff next challenged the district court’s jury instruction on proximate cause, which stated that he “must prove his prescribing physician would have altered his conduct had adequate instructions been provided.” Id. The plaintiff contended that the learned intermediary doctrine applied only to duty, whereas this instruction applied it to causation.  However, he cited no authority to support that argument, and cases interpreting Nebraska law supported the opposite conclusion.

    The plaintiff’s challenge based on opposing counsel’s remarks in closing argument fared no better. Defense counsel suggested that, to succeed, the plaintiff must prove his doctor “would not have prescribed ECT” if the warning had used the words “brain damage” and not just “permanent memory loss.” But the closing argument “largely mirrored” the jury instruction, and in any event the plaintiff had waived the objection.

  • Exclusion of Evidence

    Lastly, the plaintiff argued that the district court erred by excluding (1) a patient consent video featuring the plaintiff’s treating physician and (2) the plaintiff’s treating neuropsychologist’s opinion on medical causation. The district court had excluded the patient consent video under Rule 403 out of concern that it would confuse the jury over application of the learned intermediary rule, and the Eleventh Circuit declined to find an abuse of discretion. As for the neuropsychologist, the expert was not a medical doctor and admitted he was unqualified to opine on medical causation, as ECT was outside his scope of expertise. Moreover, his opinions were unreliable because he failed to rule out alternative causes of the plaintiff’s memory loss. Because medical causation required expert opinion, and because the neuropsychologist’s opinion did not pass muster under Rule 702, the Eleventh Circuit affirmed its exclusion.

The plaintiff’s story is a sad one, to be sure. However, when a case involving a plaintiff who experienced a specific labeled adverse event makes it to a jury simply because the label did not also warn of a broader category of adverse event, we feel like we have entered the Twilight Zone. Fortunately, the Eleventh Circuit waded through the smorgasbord of issues brought on appeal and affirmed the defense win.

No Defect, No Negligence: Lessons from Rudzinskas v. Retractable Technologies, Inc.

A recent summary judgment decision out of the Southern District of Georgia illustrates the critical role of defect evidence (or lack thereof) in negligence claims involving medical devices. As the plaintiff in Rudzinskas v. Retractable Technologies, Inc., No. 4:24-cv-009, 2025 WL 22772490 (S.D. Ga. Sep. 29, 2025) recently learned, allegations that a medical device malfunctioned are not sufficient evidence to survive summary judgment on negligent manufacturing and failure to warn claims.

In Rudzinskas, the plaintiff alleged that on two different occasions, when her husband injected her with vitamin B12 at home, the needles shot off their syringes and became dislodged inside her body (first in her buttock, and a few months later, in her arm). Plaintiff asserted that the syringes were marketed as containing needles that automatically retract from a patient into the barrel of the syringe when the plunger handle is fully depressed. Plaintiff sought medical attention following the alleged incidents. Plaintiff’s physicians confirmed the presence of the first needle and attempted to surgically extract it, but the surgery was unsuccessful. After the second incident two months later, the same surgeon attempted to confirm the presence of the second needle, but did not see it and did not perform surgery. Arising from these allegations, the plaintiff asserted two claims against the defendant for (1) negligent manufacture and (2) negligent failure to warn.

During discovery, plaintiff produced syringes that she claimed had dislodged needles into her body, but the produced syringes still contained their needles. Upon this discovery, the plaintiff claimed she produced them inadvertently and could not locate the syringes in question for production. The plaintiff identified her surgeon as an expert witness, who opined that both needles were lodged in plaintiff’s body and admitted that he had never had a similar instance in which the needle lodged into a patient rather than retracting back into the syringe.

The defendant’s corporate witness testified that based on the syringes’ manufacture, it would “defy physics” for the needle to shoot forward into a patient’s body as plaintiff alleged. He also testified that aside from the plaintiff’s allegations, he was not aware of other similar incidents, and that without examining the specific syringes allegedly at issue, it was “impossible” to determine if those syringes contained a manufacturing defect.

On the defendant’s motion for summary judgment, applying Georgia law, the district court granted summary judgment in favor of the defendant on both claims. It agreed with the defendant that expert testimony was needed to establish that the device contained a manufacturing defect, i.e., a deviation from the manufacturer’s specifications. Because the plaintiff’s expert opinions on this topic were not admissible, the record contained no expert evidence suggesting the syringes were defectively manufactured.

The court went on to find that even if expert manufacturing testimony were not required, the record evidence would still be insufficient to establish a claim based on circumstantial evidence of defect in the absence of the subject devices. Taking plaintiff’s allegations that the needles shot off the syringes and lodged under her skin, the court noted this only described the condition of the syringes at the time they were used to administer her shots, not their condition at the time of manufacture, and therefore the plaintiff had not met her burden of producing sufficient evidence for a reasonable jury to infer that the syringes were defective when they left the defendant’s control. The court also held that a Food and Drug Administration recall that plaintiff relied on, which involved a different syringe model, did not establish a defect in the syringes at issue. Finding no issue of material fact, the court granted the defendant’s motion as to the negligent manufacturing claim. It also granted summary judgment in favor of the defendant on the negligent failure to warn claim, finding that it was derivative of the failed manufacturing claim insofar as it was predicated on the allegation that the syringes contained a manufacturing defect.

The Rudzinskas decision reinforces both the challenges that plaintiffs face (and sometimes fail to appreciate) in proving their manufacturing defect claims in the absence of the device at issue, and the opportunities that a defendant has in defeating a claim in those circumstances. Because the defendant was able to provide competent expert testimony about its own manufacturing processes and device history, including the lack of other reports of similar incidents, and because the plaintiff could not point to any substantive evidence to contradict the circumstantial evidence in the defendant’s favor, the court had no trouble dismissing the plaintiff’s claims on summary judgment.

Standing on Shaky Ground: Product Recalls Alone Do Not Constitute an Injury in Fact

Cynics have long said that no good deed goes unpunished. Such can be the case with voluntary product recalls, which often engender litigation even by plaintiffs who have suffered no real injury and merely see an opportunity for a windfall. As we recently noted, recalls do not equate with product defects. However, plaintiffs — or their attorneys — act as though purchasing a recalled product is in itself a cause of action that justifies a lawsuit. A recent opinion from the Sixth Circuit offers yet another illustration why that reasoning is unsound and highlights how defendants can attack it early in a case. Specifically, because an allegation that the product a plaintiff purchased was recalled does not raise a plausible inference of injury in fact, a plaintiff lacks standing to assert a claim premised on a recall alone.

The named plaintiffs in Ward v. J.M. Smucker Co., No. 24-3387, 2025 WL 2613489 (6th Cir. Sept. 10, 2025), filed a putative class action in Ohio federal court alleging that they purchased peanut butter products from lots that the defendant had voluntarily recalled following a salmonella outbreak that had affected 16 people across 12 states. The plaintiffs did not, however, allege that any sampling or testing had revealed the presence of salmonella in the products they purchased. The defendant moved to dismiss the complaint for lack of Article III standing, arguing that the plaintiffs lacked an injury in fact, and the district court granted the motion.

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ChatGPT As Your New Testifying Expert Under Proposed Federal Rule of Evidence 707? Maybe Not.

Artificial intelligence is taking the world by storm, and the legal community is no exception. Tools that can reduce the time and cost of litigation have long been in high demand by both clients and counsel. But the tool must be fit for its purpose, and tools that generate evidence or other outputs that will be submitted to the court must pass judicial scrutiny. As video cameras became smaller and less expensive, there were fights over the admissibility of deposition videos that attorneys had recorded themselves to avoid videographer fees. Practitioners who focus on e-discovery can tell stories of hotly litigated technology-assisted review protocols. One of the newer fights concerns the admissibility of machine-generated “expert” opinions.

The U.S. Courts Advisory Committee on the Federal Rules of Evidence (the “Committee”) proposes to address the issue by adding a new rule, Federal Rule of Evidence 707. The prospect of adding a new rule to regulate the admissibility of machine-generated evidence was first raised at the Committee’s November 2024 meeting. Since then, the Committee has proposed the following language for Rule 707:

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Clearing the Weeds: The Ninth Circuit Confirms that There is Not (And Never Has Been) a Presumption of Admissibility in Its Case Law Addressing Rule 702

The judge overseeing the In re Roundup Products Liability Litigation MDL once remarked that “When you [consider] Ninth Circuit law, you come away with a pretty strong feeling that the Ninth Circuit is more tolerant of shaky expert opinions than other circuits.”  But that was before the 2023 amendments to Federal Rule of Evidence 702, and appellate courts around the country have gradually been addressing how the amendments impact pre-amendment case law. The Ninth Circuit recently joined the ranks in a way, affirming that same judge’s exclusion of an expert’s causation opinion while harmonizing Ninth Circuit case law with the purposes of the 2023 amendments. The opinion is Engilis v. Monsanto Company, — F.4th —, 2025 WL 2315898 (9th Cir. 2025), and the headlines may come as a surprise to some.

The case-specific underpinnings of the holding are relatively straightforward. The plaintiff alleged that he developed cancer due to exposure to a product manufactured by the defendant. His expert, however, had failed to consider the plaintiff’s obesity as a potential cause of the cancer when conducting the differential etiology that formed his specific causation opinion. He tried to get around this omission by claiming that the plaintiff was not obese, and the plaintiff argued that this was a disputed fact because his plaintiff’s fact sheet was marked “negative” for obesity.  However, the expert failed to cite any medical records indicating that the plaintiff was not obese and did not engage with records that showed he was obese. Translated to Rule 702 terms, any opinion that the plaintiff was not obese was not “based on sufficient facts or data.”  So, the expert argued that obesity is not a risk factor for the kind of cancer at issue and thus did not need to be considered. But his report cited no support for that proposition, which he manufactured at the hearing on the defendant’s Rule 702 motion. The Ninth Circuit agreed with the district court that these issues rendered the expert’s specific causation opinion inadmissible.

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