Category: Manufacturing Defect

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

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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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Plaintiff’s Half-Baked Attempt to Prove Defect and Causation With Photographs of Moldy Bread Shows the Knead for Expert Testimony

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A picture may be worth a thousand words, but that doesn’t make the camera an expert witness. Product liability actions usually require expert testimony to prove defect and causation. Pictures, like other documents, can be central to an expert’s opinion on those points. But as a plaintiff in the Eastern District of Pennsylvania recently learned, pictures alone are insufficient. Defect and causation still require an expert’s testimony — even in cases involving products as simple as a loaf of bread.

In Kovalev v. Lidl US, LLC, 2024 WL 4642982 (E.D. Pa. Oct. 31, 2024), the plaintiff alleged that he became ill after consuming bread sold and/or baked by the defendants. He claimed to have bought eight loaves initially and experienced abdominal pain and difficulty breathing after spending two days eating the first loaf. He claimed to have thereafter discovered that the loaf was “extensively contaminated with dangerous disease-causing toxic mold.” He took pictures. Later, the plaintiff ate from a second loaf and developed nausea, vomiting, abdominal pain/cramps, general malaise, and respiratory issues “for days.” Once again, he allegedly inspected the bread after eating it and “discovered various-colored mold.” And once again, he took pictures. (As an aside, if we became ill after eating a loaf of bread and then discovered “extensive” mold on it, we would spend the foreseeable future carefully checking all our bread for mold before digging in. We might do so simply because we have read this case. But we digress.) Three months later, the plaintiff purchased four more loaves of bread from another of defendants’ stores. He claimed that while eating that bread he discovered “a large piece of black substance” inside it. Once again, he took pictures. Because he did not know what the substance was or whether he had consumed part of it, he claimed to be “severely traumatized” and afraid of developing future “cancer or damage to his organs,” “suffer[ing] a physical impact,” and losing his “enjoyment of life.”

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Third Circuit Confirms That Alleged Defect in “Simple” Component of More Complex System Must Be Proven by Expert Testimony When Facts Surrounding Defect Claim Are Beyond Common Knowledge

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A plaintiff who alleges that a product is defective usually has to offer expert testimony in support of that allegation.  This should come as no surprise for complex products – if it took a team of scientists and engineers to bring the product to market, then a lay jury should not be asked to evaluate an alleged defect in that product without the aid of expert testimony.  But what if a plaintiff alleges a defect in the design of a relatively simple, more familiar component of a complex product?  The Third Circuit recently addressed that question in an opinion that, although nonprecedential and in some respects peculiar to New Jersey law, illustrates how a court should approach the issue.

In Kuhar v. Petzl Co., 2022 WL 1101580 (3d Cir. Apr. 13, 2022), Plaintiff fell and injured himself while using a safety harness that he had purchased as part of a kit seven years earlier.  He alleged that the fall occurred because a bolt attached to the carabiner of the safety harness had snapped due to a design and/or “indeterminate” or manufacturing defect.  In support of his claims, Plaintiff proffered a metallurgical and materials sciences expert who identified two alleged design defects – a “sharp profile change” and “sharp threads on the bolt” – and machining grooves that the expert deemed a manufacturing defect, some combination of which he claimed had caused the accident.  But some of the expert’s defect and causation opinions were “net opinions” – New Jersey parlance for “ipse dixit” opinions – and were excluded for lack of supporting data.  Other opinions were excluded because the expert failed to define his terms or explain his reasoning.  The Third Circuit agreed with the district court that the expert’s opinions lacked both reliability and fit, and affirmed its exclusion of all of the expert’s opinions.

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A Bridge Too Far: Reliance on Malfunction Theory Rejected When the Alleged Failure is a Known Risk of the Product

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In some circumstances, a plaintiff lacking direct evidence of an identifiable, specific defect may be permitted to use circumstantial evidence to prove that a product malfunctioned and create a triable inference of a product defect. Some courts may treat proof of a product malfunction as circumstantial evidence of a product defect because a product will not ordinarily malfunction (or perform outside the reasonable safety expectation of the consumer) in the absence of a defect. This circumstantial evidence doctrine, commonly known as the “malfunction theory,” may provide plaintiffs with a pathway to establish a prima facie case of a product defect.

While the malfunction theory sometimes allows plaintiffs to bring a claim for a product defect where the product is no longer available or a specific defect cannot be identified, plaintiffs often attempt to stretch the theory beyond its logical bounds. In a recent case from Idaho, Black v. DJO Global, Inc., the Idaho Supreme Court rejected use of the malfunction theory when the alleged product “failure” (or malfunction) was the occurrence of a known risk, i.e., one that could occur even when the product performs as intended. Black v. DJO Glob., Inc., 488 P.3d 1283, 1288 (Idaho 2021).

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Pennsylvania Medical Device Strict Liability Claims: Relentless Repetition, Clamoring for Review

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A Pennsylvania federal court has again asked that the state’s Supreme Court clarify whether, and to what extent, medical device manufacturers are immune from strict liability claims by virtue of the “unavoidably unsafe products” exemption recognized in Restatement (Second) of Torts Sec. 402A cmt. k (“Comment k”)—only this time with a direct certification.

On Thursday, the Third Circuit Court of Appeals certified that question to the Pennsylvania Supreme Court, along with a question about which negligent design defect theory—or theories—a Pennsylvania plaintiff may assert against a medical device manufacturer.  Pet. for Certification of Questions of State Law, ECF No. 50, Ebert v. C.R. Bard, Inc., et al., No. 20-2139 (3d Cir. June 24, 2021) (“Ebert Pet.”).   Last spring, Judge Pappert of the Eastern District of Pennsylvania dismissed Ms. Ebert’s strict liability claim, finding her IVC filter “an ‘unavoidably unsafe product’” under Hahn v. Richter, 673 A.3d 888 (Pa. 1996), and she appealed that order granting summary judgment to the Third Circuit.

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Ninth Circuit Affirms Dismissal of Breast Implant Cases on Preemption Grounds

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The Ninth Circuit has confirmed in quadrophonic sound that plaintiffs cannot avoid preemption by relying on vague and speculative allegations to establish a parallel claim.  The court affirmed the dismissal of four lawsuits by plaintiffs claiming they were injured by breast implants on the grounds that their claims are barred by the 1976 Medical Device Amendment to the Food, Drug and Cosmetic Act (MDA).  Sewell v. Mentor Worldwide, LLC, et al., no. 19-56393; Vieira v. Mentor Worldwide, LLC, et al., no. 19-56394; Billetts v. Mentor Worldwide, LLC, et al., no. 19-56398; Nunn v. Mentor Worldwide, LLC, et al., no. 19-56391.

In each case, California plaintiffs alleged their breast implants were defective and caused them to experience fatigue, muscle pain, and migraines.  The district courts dismissed the complaints for failure to state a claim on grounds of preemption, and plaintiffs appealed.

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