NY Court Ruling Narrows Claims in Advanced Bionics Implant Case
A NY federal court dismissed most claims in Wieder v. Advanced Bionics, citing medical device preemption.
Why it matters: The decision clarifies what state-law claims are blocked by federal preemption for FDA-approved medical devices. Legal teams and manufacturers gain clearer guidance on litigation exposure and product design compliance for Class III devices.
- On March 31, 2026, the court dismissed six of nine claims in the Wieder v. Advanced Bionics lawsuit.
- Dismissed claims included design and manufacturing defect, fraud, and failure to warn, due to federal preemption under the MDA.
- Claims for negligence and loss of services were not preempted and will proceed.
- The HiRes Ultra 3D cochlear implant had FDA Pre-Market Approval and was voluntarily recalled by Advanced Bionics in 2020 due to fluid ingress issues.
The Southern District of New York issued an opinion on March 31, 2026, in Wieder v. Advanced Bionics LLC, clarifying the limits of state-law product liability claims against FDA Pre-Market Approval (PMA) medical devices.
- Plaintiffs alleged their child's Advanced Bionics HiRes Ultra 3D cochlear implant failed due to fluid ingress, causing a device short-circuit.
- The court dismissed most state-law claims—manufacturing defect, design defect, breach of implied warranty, consumer protection violations, fraud, and negligent failure to warn—citing express preemption under the Medical Device Amendments (MDA) to the FDCA.
- Judge Dale E. Ho emphasized, "To survive express preemption under the MDA, state-law tort claims must not impose requirements in addition to those imposed by federal law and they also must be 'premised on a violation of FDA regulations.'"
- The court allowed counts based on negligence and loss of services to proceed, finding they did not conflict with federal law.
- The defendant's HiRes Ultra 3D device is a Class III medical device and was voluntarily recalled in February 2020 by Advanced Bionics, following similar performance issues.
This decision provides key precedent for future suits involving federally regulated medical devices, highlighting the high bar for plaintiffs seeking to overcome FDA preemption unless they tie claims directly to FDA regulation violations.
By the numbers:
- 6 — Number of claims dismissed out of nine total claims
- 2020 — Year Advanced Bionics recalled the unimplanted HiRes Ultra 3D devices due to fluid ingress
- Class III — FDA classification for the HiRes Ultra 3D cochlear implant
Yes, but: The court allowed negligence and loss of services claims to proceed, signaling that some state-law claims may survive preemption if not based on additional requirements beyond federal law.