C&M Health Law

JANUARY 25, 2023

trillion spending package, which consists of all 12 fiscal year (FY) 2023 appropriations bills and funds the federal government through September 30, 2023, provides additional assistance to Ukraine, and makes numerous health care policy changes. 117-164 ) (the “Act”)—an approximately $1.7

Medicaid 104

Medicaid Medicaid Medicare Medicare 104

Drug & Device Law

DECEMBER 12, 2022

223, 231-33 (2011), holding that the Vaccine Act preempted all design defect claims asserted by claimants who rejected Vaccine Act awards and sought to litigate their claims instead. The Supreme Court did its part in Bruesewitz v. Wyeth LLC , 562 U.S. Now comes DeCostanzo v. at 226 (footnote and quotation marks omitted). 300aa-11(a)(2)(a).

FDA 115

FDA Public Health Fraud Hospitals 115

Drug & Device Law

DECEMBER 29, 2023

Executive Health Resources, Inc. , 2023) (federal government may unilaterally obtain dismissal of FCA claims, and calling the constitutionality of the FCA’s private enforcement mechanism into question) ( here ); Quishenberry v. 2023) ( Buckman preemption barred MDL asserting fraud on EPA), cert. Polansky v. 3d 239 (Cal.

FDA 105

FDA US Department of Health and Human Services COVID-19 Informed Consent 105

Drug & Device Law

OCTOBER 7, 2022

While most contraceptives are short-acting, in part to allow for the possibility of conception when desired, there is clearly a role from public health perspective—among other perspectives—for long-acting and permanent contraception. Obviously, under Buckman direct fraud-on-the-FDA claims, however titled, are impliedly preempted.

FDA 59

FDA Fraud Doctors Public Health 59