Medical Device Litigation
Philips CPAP and Ventilator Recall Litigation: What the Record Shows
The Philips Respironics CPAP and ventilator recall litigation: the June 2021 recall, MDL 3014, the 2024 consent decree and the US settlement.
Topic
Medical Device Litigation
Information about US litigation over medical devices: FDA recalls and safety communications, premarket approval and preemption, and how consolidated device claims proceed.
2 articles
Last updated
Device cases look like drug cases from a distance and behave differently up close, for two reasons.
The regulatory pathway decides part of the legal question. Devices cleared through the 510(k) process and devices approved through premarket approval (PMA) are treated differently when a plaintiff argues that a state-law claim should survive. In Medtronic, Inc. v. Lohr (1996) the Supreme Court held that 510(k) clearance does not preempt state-law claims; in Riegel v. Medtronic, Inc. (2008) it held that claims imposing different state requirements on a PMA-approved device are preempted. Each article here states which pathway applies where it matters.
Recalls are frequent and staged. FDA recall notices and safety communications are dated, public documents. They describe a hazard and a corrective action; they are not findings that a device injured any particular patient.
Current articles
- Philips CPAP and ventilator recall litigation covers the 2021 recall of sleep and respiratory devices over sound-abatement foam, the federal consolidation, and the settlement and consent decree that followed.
- Hernia mesh litigation covers the polypropylene mesh claims, the recalls and warnings that preceded them, and the consolidated federal proceedings.
Related sections: pharmaceutical lawsuits and product liability.
Medical Device Litigation
Hernia Mesh Litigation: What the Court and FDA Records Show
A factual overview of US hernia mesh litigation: the federal MDL against Davol and Bard, FDA device data, and the 2024 BD settlement announcement.