article thumbnail

A Health-Heavy State of the Union

Kaiser Health News

The FDA is at the center of the abortion pill case, which challenges its approval of the drug decades ago and could set a precedent for legal challenges to the approval of other drugs. While they do plan to appeal the ruling should the FDA lose, the upheaval that could happen in the meantime can’t really be overstated.

article thumbnail

CPAP MDL Overinflates Plaintiffs’ Claims

Drug & Device Law

Taking the good doctor first, In re Philips Recalled CPAP, Bi-Level Pap, & Mechanical Ventilator Products Litigation , 2023 WL 7019667 (Sp. CPAP II shrugs off plaintiffs’ repeated allegations that defendants “failed to apprise the FDA” of this or that, with the excuse that plaintiffs don’t really “rely” on them. 341 (2001).

Fraud 52
article thumbnail

Confident Learned Intermediaries Defeat Warning Causation

Drug & Device Law

Further, “both doctors testified that they still prescribe [the drug] for patients with conditions similar to plaintiff’s condition.” The prescriber] provided explicit, uncontroverted testimony that, even when provided with the most current research and FDA mandated warnings, as well as the information found in [defendant’s] updated. . .

FDA 59