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.

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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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Defining the Limits of Lay Testimony in Complicated Products Cases

“So when is a question too complicated for the jury?” That is the question the Third Circuit sought to answer recently in Slatowski v. Sig Sauer, Inc., ___ F. 4th ___, 2025 WL 2178533 (3d Cir. 2025), reversing a district court’s grant of summary judgment despite affirming its exclusion of the plaintiff’s causation experts. Ironically, the Third Circuit’s analysis of when an expert opinion is required is itself so nuanced that it may require expert interpretation. Upon close inspection, the Slatowski panel’s holding is not nearly as broad as the headings might suggest.

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Message Received – Delaware Follows Federal Rule of Evidence 702

The Delaware Superior Court took the mass tort world by surprise with its May 31, 2024, refusal to exclude the plaintiffs’ experts’ causation opinions in the Zantac litigation, breaking with the federal MDL court’s prior exclusionary order and applying Delaware Rule of Evidence 702 “with a liberal thrust favoring admission.” The ruling was so unexpected that some outlets questioned whether Delaware courts would become a new preferred venue for mass tort plaintiffs. But, in a rare move, the Delaware Supreme Court granted the defendants’ request for interlocutory appeal — despite the Superior Court’s refusal to certify the order — and has now restored order, reversing the Superior Court’s decision and remanding for further proceedings. In re Zantac (Ranitidine) Litig., — A.3d —, 2025 WL 1903760 (Del. July 10, 2025).

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