Health Law Daily Wrap Up, PREEMPTION OF STATE LAW—D. Md.: Woman injured by degraded brain implant has no state law cause of action, (May 26, 2026)

By Molly Platnick

All of the product user’s claims were dismissed without prejudice because she did not identify how the manufacturer violated the FDA.

The federal district court for Maryland granted a medical device manufacturer’s motion to dismiss in a case brought by product user who faced complications from a brain implant. The product user’s complaint and supplement raised 18 products liability causes of action, all related to the manufacturer’s misrepresentation of the implant’s safety and failure to warn about its risks. In its motion to dismiss, the manufacturer countered the product user’s claims were preempted by the Federal Food Drug and Cosmetic Act (FDCA) and supreme court holdings limiting plaintiffs from challenging medical devices under state law. The court ruled the product user’s claims were preempted because she did not introduce sufficient evidence the manufacturer violated the FDA (Merkle v. Medtronic, No. SAG-25-3737 (D. Md. May 15, 2026)).

Background. The defendant manufactures and sells an implant that delivers electrical stimulation to the brain. The manufacturer marketed the implant as a “reversible and removable alternative to surgical treatment.” However, since the 1980s, the manufacturer was aware the device’s cardiac pacing leads were a safety risk because they had a polyurethane body. Products in the “same family” of polyurethane were prone to failure, and polyurethane “degradation” can release carcinogens, toxicants, endocrine disrupters, and neurotoxicants. According to internal documents, the manufacturer was aware other materials used in the leads, including platinum-iridium, could degenerate into neurotoxins and carcinogens. Despite the known risks, there was no “documented regulatory request” for a neurotoxicity or carcinogenicity study until 2008.

The product user has diagnosed Myoclonus Dystonia, a non-degenerative genetic condition caused by dysfunction within the brain’s basal ganglia. The product user was implanted in 2005, the year the device was approved by the FDA. Beginning in 2011, the product user experienced “unexplained side effects” from using the manufacturer’s implant, including an “acute neurological episode consistent with cortical insult” during her pregnancy in 2014. Because of the side effects, the product user stopped using the implant’s stimulator in 2017, and, around 2019, was approved for elective removal of the device. Surgeons who performed the explant discovered the device’s “lead” had completely disintegrated. The lead fractured further during removal, leaving platinum-iridium embedded in the product user’s cortical tissue and bone and making it unsafe for her to undergo MRIs.

When the product user had the device implanted, the risk of degradation was “buried in fine print” in the patient manual. The manual was sealed in a kit with the implant, “meaning [product user] had no opportunity to review the manual before… implantation.” Physicians were given only “general reassurances” about the implant’s safety, without a “plain acknowledgment” about the probability of degradation.

The product user brought this 12-count products liability suit against the manufacturer pro se and filed a lengthy “supplement” adding six more claims. The manufacturer filed the instant motion to dismiss based on preemption and failure to state a claim.

Preemption under the FDCA. The implant was FDA-approved to treat Myoclonus Dystonia under a Humanitarian Device Exemption (HDE). HDEs are available for devices to treat/diagnose conditions that affect less than 8,000 people in the United States per year. They are subject to a less stringent form of pre-market approval (PMA) than other medical devices and manufacturers do not need to demonstrate the device’s effectiveness through clinical trials. HDE devices are treated the same as non-exempt devices for preemption purposes.

The FDCA: (1) mandates all FDCA actions be brought “by and in the name of the United States;” and (2) its Medical Devices Amendments prohibit states from imposing requirements for a medical device different from the requirements under federal law. In Buckman v. Plaintiffs’ Legal Committee, the Supreme Court held plaintiffs cannot bring private claims “amount to an assertion of Fraud on the FDA.” In Riegel v. Meditronic (2008), the court decided plaintiffs can sue device manufacturers if and only if their state-law claims are “parallel” to federal law. A plaintiff states a parallel claim if she alleges (1) the manufacturer did not comply with applicable federal rules, and (2) manufacturer’s failure to comply also violated state law.

Failure to state a claim. The issue was the allegations in the product user’s complaint did not support her “core theory” of the case. The product user argued the manufacturer did not adequately communicate the risks associated with the implant but did not specify when/how she relied on those communications to her detriment. She pointed to a 2025 phone call with a representative for the manufacturer and attached information taken from the manufacturer’s website between 2008 and 2025. However, she had the implant removed in 2022 and did not clarify when she relied on the representations on the website. The court rejected “chronicling all publicly available representations made about the…device” as counter to Rule 12(b)(6)’s requirement for a “short and plain” statement of a claim.

The court was not persuaded by the product users’ argument. The manufacturer’s public statements violated FDA-approved labeling requirements. The product user contended that while the manufacturer complied with the FDA in its “formal” labeling, it omitted warnings in its marketing to present the implant as safer. The court acknowledged these allegations could be enough to state a misrepresentation claim under Maryland law and defeat preemption, but the product user did not “identify a fact-based violation” of FDA requirements. The court held the product user must offer specific statements the manufacturer made that deviated from FDA-approved requirements.

Misrepresentation and failure to warn. The product user asserted the FDA should not have approved and permitted the manufacturer’s labeling because of medical studies showing the risk of degradation. As discussed above, under Riegel, a plaintiff can only bring a state-law case against a medical device if it runs “parallel” to a federal law claim. Here, the product user did not introduce sufficient facts to plead the manufacturer violated the FDA’s labeling rules, nor did she show how the “informal” marketing deviated from the FDA-approved label. The court dismissed I, II, III, V, VII, VIII, IX, XI, XIII, XIV.

Reporting requirements. The product user accused the manufacturer of not reporting information to the FDA. Because, as discussed above, Buckman bars plaintiffs from brining private FDA claims, the product user cannot enforce reporting requirements against Manufacturer. The court dismissed Counts X, XVII, XVIII.

Negligent training/failure to educate physicians (Count XII). The court found the product user’s claim physicians were not adequately trained on the risk of degradation did not include specific enough allegations to satisfy Rule 12(b)(6). The court also determined the negligent training claim was a disguised failure to warn claim, which, for the reasons described above, was preempted.

Lack of safety testing. The product user argued the implant should not have received PMA because publicly available information shows no record the FDA reviewed long-term risks, which resulted in misleading labeling and made the implant not fit for permanent intracranial use. The court concluded these arguments would be preempted under Buckman’s fraud-on-the-FDA theory.

The case is No. SAG-25-3737.

Judge: Gallagher, S.

Attorneys: Katie Merkle, pro se. Sydney Fairchild Williamson (Greenberg Traurig, P.A) for Medtronic, Inc.

Companies: Medtronic, Inc.

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