C&M Health Law

SEPTEMBER 11, 2023

Interestingly, both the proposed standard and the evaluated range of standards are below the standard that this same outside consultant recommended in 2001 of 4.1 HPRD, which is often cited in False Claims Act cases and enforcement actions by the Department of Justice and state Medicaid Fraud Control Units. HPRD consisted of 0.75

Nursing Homes 98

Nursing Homes Nurses Medicaid Medicaid 98

Drug & Device Law

JANUARY 4, 2024

Finally, while PREP Act preemption is the focus of today’s post, to the extent that the Texas Complaint can be read to allege – and we think it can – either: (1) direct fraud on the FDA or (2) that the FDA’s approvals (both emergency and/or final) of the defendant’s vaccine should not have been granted, Buckman Co. 247d-6d(b)(8).

COVID-19 Vaccine 59

COVID-19 Vaccine COVID-19 FDA Public Health 59

Drug & Device Law

SEPTEMBER 29, 2022

Before a biologic may be marketed, the manufacturer must obtain a license from the FDA. Plaintiff received the biologic just months after it had been licensed by the FDA. 341 (2001). Regardless of its underpinnings, Buckman clearly proscribes as preempted state-law fraud-on-the-FDA claims. See 42 U.S.C. § See 21 C.F.R.

FDA 59

FDA Licensing Fraud 59