Drug & Device Law

SEPTEMBER 11, 2023

FDA litigation, back in April, the United States Supreme Court had just stayed what we described as “a truly ridiculous decision purporting to invalidate a number of actions taken by FDA with regard to mifepristone, the only currently marketed approved medication for medical abortion.” FDA , 727 F. That’s why Buckman Co.

FDA 59

FDA Doctors Malpractice COVID-19 59

Drug & Device Law

AUGUST 28, 2023

FDA litigation, back in April, the United States Supreme Court had just stayed what we described as “a truly ridiculous decision purporting to invalidate a number of actions taken by FDA with regard to mifepristone, the only currently marketed approved medication for medical abortion.” FDA , 727 F. That’s why Buckman Co.

FDA 52

FDA Doctors Malpractice COVID-19 52

Drug & Device Law

DECEMBER 4, 2023

2002). “[I]t is not the role of a federal court to expand state law in ways not foreshadowed by state precedent.” Taking the good doctor first, In re Philips Recalled CPAP, Bi-Level Pap, & Mechanical Ventilator Products Litigation , 2023 WL 7019667 (Sp. Ford Motor Co. , 3d 661, 680 (3d Cir. City of Philadelphia v. Beretta U.S.A.

Fraud 52

Fraud FDA Hospitals Doctors 52

Drug & Device Law

JUNE 6, 2022

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

FDA Doctors Malpractice Medical Personnel 59

Drug & Device Law

NOVEMBER 10, 2022

3, 2002) (to be published), the California Court of Appeal held that federal law preempts state law failure-to-warn claims alleging that branded and generic drug manufacturers did not ensure that patients received FDA-approved Medication Guides for amiodarone, a heart medicine. In Amiodarone Cases , No. A161023, 2022 WL 16646728 (Cal.

FDA 52

FDA Doctors Fraud Governance 52

Drug & Device Law

JUNE 13, 2022

But in the device area – we looked, but did not find an analogous FDA regulatory exception for drugs – the FDA has itself recognized this common-sense, and common-law, exception to the duty to warn. Somewhat surprisingly, at least until recently, there hasn’t been much case law addressing the FDA’s “commonly known” hazard exception.

FDA 59

FDA Licensing Doctors Nurses 59

Drug & Device Law

NOVEMBER 9, 2023

In addition to its recent revamp of its “§510(k)” substantial equivalence clearance process for medical devices, (see our post here ), the FDA has also been active with respect to off-label communications – another regulatory area of continuing interest to this Blog. 357 (2002); United States v. FDA , 119 F. E.g. , Sorrell v.

FDA 64

FDA Health Insurance Nurses Medicare 64