Remove Court Decisions Remove Healthcare Remove Manufacturing
article thumbnail

Second Circuit Decision A Reminder that Alleged FDCA violations don’t always equal FCA violations

FDA Law Blog

Last month the United States Court of Appeals for the Second Circuit affirmed the district court’s decision to dismiss a False Claims Act (FCA) ( 21 U.S.C 3729) quit tam suit, alleging that Grifols USA, Grifols Biologicals, Grifols, S.A.,

article thumbnail

Supreme Court Finds CMS’ Reduction of Medicare Hospital Outpatient Payment Rates for 340B Hospitals was Not Authorized by Statute

FDA Law Blog

The hospitals argued that the profits helped them offset the considerable costs of providing healthcare to the uninsured and underinsured in low-income and rural communities, something that Congress was well aware of and intended when it passed the Medicare Prescription Drug, Im­provement, and Modernization Act in 2003.

Statute 52
Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Federal appeals court denies New York healthcare workers religious exemption to COVID-19 vaccine mandate

JURIST

A Second Circuit decision vacated two lower court rulings which allowed healthcare workers to claim religious exemptions to New York’s COVID-19 vaccine mandate. The decision also vacated an injunction from the Northern District of New York and a prior Second Circuit ruling on an Eastern District of New York case.

article thumbnail

FDA-Approved Labeling: Is Enough Enough?

FDA Law Blog

Thus, Defendants argued that FDA already required the warning for pregnancy, rendering the decision to use it during pregnancy to a healthcare professional, and that FDA had considered the risks of in utero exposure and rejected the addition of those risks to the labeling. billion in damages were brought between 1980 and 1986.

article thumbnail

SCOTUS dispatch: in oral arguments, several justices lean against giving mifepristone opponents standing to sue FDA

JURIST

The court heard arguments from the Food and Drug Administration (FDA), Danco (a drug manufacturer that only makes mifepristone) and the Alliance for Hippocratic Medicine (AHM). The questions focused on whether the AHM had standing to bring the case to court. Pro-choice pro testers held signs that said “Abortion is our right.

article thumbnail

Divided By Principle: How Justices Barrett And Jackson Are Shaping The Future Of Constitutional Law

Above The Law

Justice Barrett : 929 words Justice Barretts questioning primarily sought to clarify legal nuances surrounding the conscience protections for healthcare workers, the standing of associations in legal challenges, and the implications of regulations related to abortion and its associated medical procedures. Reynolds Vapor Co.

article thumbnail

Will You Survive? How Trump’s Upheaval is Reshaping Your Legal Career”

The Estrin Report

Some of the most significant areas include: Regulatory Changes The deregulatory agenda in healthcare, finance, and environmental law has introduced significant uncertainty. Furthermore, recent Supreme Court decisions curbing the power of regulatory agencies set the stage for an additional litigation surge.

Legal 176