Failure to Warn Standards Archives - Faegre Drinker on Products

Subject: Failure to Warn Standards

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.

5 Major Drug and Device Developments of 2022

As we ring in the new year, it is time once again to reflect on some of the most significant legal developments for drug and device companies this year. The list below is by no means exhaustive (who could forget the Rule 702 updates that took place this year, which will carry over into 2023?), but provides a brief recap and assessment of five of the most interesting and consequential developments affecting drug and device law in 2022.

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“Alternative Avenues” Argument in Failure-to-Warn Cases Adding an Additional Wrinkle to Medical Device Litigation

A developing line of cases across the nation may have large implications for medical device manufacturers defending against failure-to-warn claims. While a treating physician’s failure to read or rely on the manufacturer’s warnings has historically been fatal to a failure-to-warn claim in many jurisdictions (at least those without a “read and heed” presumption), plaintiffs have tried novel “alternative avenues” arguments to make summary disposition of the claim more difficult.

There are two theories under which a failure-to-warn claim may be brought in the products liability context: a manufacturer with a duty to warn may breach its duty by either (1) failing to provide an adequate warning of the product’s potential risks (the “content theory”) or (2) failing to adequately communicate the warning to the ultimate consumer (the “communication theory”). Plaintiffs have traditionally pursued failure-to-warn claims in prescription medical device cases under the content theory, with most courts holding that a treating physician’s failure to read or rely on the manufacturer’s warnings in the product’s instruction for use (“IFU”) is fatal to the claim. See, e.g., Foster v. Ethicon, Inc., 2021 WL 1169473, at *7 (D.S.D. Mar. 26, 2021).

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Blurry Vision in Two Courts Leads to Denial of Preemption in Intraocular Lens Implant Case

A recent Second Circuit preemption decision illustrates the importance of a clear-eyed approach to medical device preemption issues.

In Glover v. Bausch & Lomb, Inc., 6 F.4th 229 (2d Cir. 2021), the district court dismissed as preempted a complaint concerning vision loss from defective intraocular lenses implanted during cataract surgery. Plaintiff developed “Z syndrome,” permanently impairing her vision, and sued the manufacturer under the Connecticut Product Liability Act (CPLA) for failing to warn. She alleged the defendant had failed to report prior Z Syndrome cases to the FDA, as required by the Federal Food, Drug, and Cosmetic Act (FDCA).

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Expert’s Failure to Identify Product Defect in Pressure Cooker or Inadequacy in Warnings Leads to Summary Judgment

It is axiomatic that a plaintiff must offer evidentiary support for each element of her claim in order to survive summary judgment. And a ubiquitous feature of product liability actions is the use of expert witnesses by both sides. These principles are, of course, related – the plaintiff usually must offer expert testimony in order to make a prima facie case, and the defense then attacks that prima facie case through expert testimony. But sometimes a plaintiff loses sight of the connection and, despite retaining an expert, fails to elicit the opinions she needs to make her case. As a recent decision from the Western District of Wisconsin illustrates, it pays for a defendant to carefully evaluate whether a plaintiff has checked all of the necessary boxes.

In Moore v. National Presto Industries, Inc., 2022 WL 1555875 (W.D. Wis. May 17, 2022), Plaintiff alleged that she was injured when she opened her pressure cooker while it was still pressurized, ejecting its contents onto her arm, causing burns. Plaintiff sued the cooker’s manufacturer, asserting strict liability claims for design defect and failure to warn as well as a claim for negligence. Defendant moved for summary judgment on each of these claims.

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Ninth Circuit Asks California Supreme Court to Clarify the Causation Standard Applicable When the Learned Intermediary Doctrine Applies

How demanding is the causation standard in a California failure to warn claim when a learned intermediary testifies that he would have read and incorporated more stringent warnings if they had been available? Is the plaintiff required to show that the stronger warning would have altered the physician’s decision to prescribe the product? Or may the plaintiff establish causation by showing that the physician would have communicated the stronger warnings to the patient and that a prudent person in the patient’s position would have declined the treatment as a result?

The Ninth Circuit isolated this undefined causation standard in Himes v. Somatics, LLC, and certified the question to the California Supreme Court. After confirming that the learned intermediary doctrine is alive and well in California and that a failure to warn claim cannot survive when the learned intermediary does not read the warnings at all, the Ninth Circuit stopped short of defining the causation standard that applies when a learned intermediary does read the warnings.

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