Medical Devices Archives - Faegre Drinker on Products

Subject: Medical Devices

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.

In Case You Missed It – Winter 2024

Catch up on the latest developments of interest for product manufacturers. Here’s a quarterly compilation of the most popular blog posts on Faegre Drinker on Products.

Michigan Repeals Pharma Immunity Provision

By Jacqueline E. McDonnell

Michigan recently signed into law a repeal of the immunity provision under its Product Liability Act, presenting a new litigation risk in Michigan for pharmaceutical companies. The provision had granted near-complete immunity to pharma for the past 30 years, as the only of its kind nationwide. Michigan’s new law — Senate Bill 410 — removes this immunity, leaving intact a rebuttable presumption of nonliability and caps on noneconomic damages.

Pennsylvania Stays in a Minority of Two States in Prohibiting Evidence of Compliance With Government and Industry Standards in Product Liability Design Defect Cases

By David F. Abernethy

Just before Christmas, the Pennsylvania Supreme Court delivered a lump of coal to product liability defendants: Sullivan v. Werner Co., 2023 WL 8859656 (Pa. Dec. 22, 2023), affirming a lower court ruling that barred evidence of a product manufacturer’s compliance with government and industry standards in a strict liability design-defect case. The lower courts held that such evidence goes to due care and is relevant only to negligence, not strict liability. The affirmance appears to support the exclusion of such evidence in design-defect cases based on a risk-utility theory, but leaves uncertainty for the future because only three justices joined the principal opinion; a fourth justice concurred with the result but concluded the record was inadequate to resolve the legal issue, while two others dissented.

EPA’s Final EtO Rule Has Landed: What Now?

By Adrienne Franco Busby

The U.S. Environmental Protection Agency recently released their long-awaited final rule regulating ethylene oxide (EtO) emissions from commercial sterilizers. The final rule comes after five years of development, over 1,000 comments, and with estimated compliance costs for industry of up to $900 million.

FDA Publishes New Artificial Intelligence & Medical Products White Paper

On March 15, the United States Food & Drug Administration published a white paper entitled “Artificial Intelligence & Medical Products: How CBER, CDER, CDRH, and OCP are Working Together.” FDA announced the paper by sharing a short letter from Commissioner Califf, where he reaffirmed the Agency’s commitment to “promoting the responsible and ethical development, deployment, use, and maintenance of safe and effective medical products that incorporate or are developed with AI.” The white paper does not contain any new pronouncements of FDA position, but refers to existing guidance and serves as a reinforcement for existing FDA policy regarding AI.

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California Appellate Court Upholds Federal Preemption of Negligent Undertaking Claim Under the Medical Device Amendments of 1976

Federal preemption can be a very powerful defense. For example, claims concerning Class III medical devices requiring pre-market approval are generally preempted by the Medical Device Amendments of 1976, 21 U.S.C. § 360c, et seq. (“MDA”). In Regwan v. Abbott Laboratories, Case No. B319606, 2023 WL 8818748 (Cal. App. 2d Dec. 21, 2023), the California Court of Appeal relied on that principle in holding preempted a negligent failure to warn claim premised on a sales representative’s intraoperative communications and presented as a “negligent undertaking” claim. This holding continues a California trend that federal law may preempt negligence-based claims regarding Class III PMA medical devices even if they are not presented as traditional design defect or failure to warn claims.

In Regwan, the plaintiff alleged she suffered serious injuries following implantation of a MitraClip that the defendant manufactured. During the procedure, the saline bag ran dry, causing the plaintiff to allegedly suffer an air embolism and brain injuries. The plaintiff asserted negligence and products liability causes of action against the defendant after discovering a defendant representative attended the surgery and was allegedly “responsible for the flow of saline.” The defendant demurred, arguing federal law preempted the plaintiff’s products liability claims.

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The Omnibus Appropriations Act Grants FDA Formal Authority to Require Cybersecurity Action by Medical Device Manufacturers

Cyberattacks affecting internet-connected medical devices like insulin pumps, intracardiac defibrillators, mobile cardiac telemetry, pacemakers and intrathecal pain pumps have increased in recent years. And such attacks show no sign of slowing, as the number and type of medical device products that are connected to the cloud increase (thereby increasing the attack surface for hackers), and as hackers become more sophisticated. Indeed, in a September 2022 FBI Private Industry Notification, the FBI noted that around 53% of connected medical devices and other internet of things (IoT) devices in hospitals had known critical vulnerabilities. These vulnerabilities could allow hackers to direct medical devices to give inaccurate readings, administer drug overdoses, or otherwise endanger patient health.

In the past, the U.S. Food & Drug Administration (FDA) has urged manufacturers to take measures to ensure the cybersecurity of their products through non-binding guidance. On December 29, 2022, President Biden signed into law the $1.7 trillion Omnibus Appropriations Act, which provided the FDA with authority to require manufacturers to take cybersecurity protection measures as to medical devices that are brought to market through future pre-market submissions. See H.R. 2617 (117th Congress, 2021-2022), text available here.

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