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.