As we anticipated in our October 17, 2024, blog, both the Government and the Relator have appealed the district court’s decision in U.S. ex rel. Zafirov v. Florida Medical Associates, LLC, et al. (Zafirov), the first case to...more
Mifepristone is safe for now. On June 13, 2024, the Supreme Court unanimously held that the plaintiffs — doctors and medical associations alike — lacked standing to challenge 2000 and 2019 FDA approvals of mifepristone (brand...more
6/18/2024
/ Abortion ,
Alliance for Hippocratic Medicine v Food and Drug Administration ,
Article III ,
Dobbs v. Jackson Women’s Health Organization ,
EMTALA ,
Equal Protection ,
Food & Drug Regulations ,
Food and Drug Administration (FDA) ,
Healthcare ,
Human Rights ,
Life Sciences ,
Medical Necessity ,
Patient Access ,
Pregnancy ,
Prescription Drugs ,
Reproductive Healthcare Issues ,
Roe v Wade ,
SCOTUS ,
Standing ,
Women's Rights
For the second time this month, the United States Supreme Court addressed a circuit split involving the False Claims Act (FCA, 31 U.S.C. §§ 3729 – 3733). Earlier, in the SuperValu decision (discussed in a recent Health Law Rx...more
Yesterday, the United States Supreme Court held that a False Claims Act (FCA) defendant cannot rely on an objectively reasonable interpretation of a law, regulation, or rule to negate the scienter element of the FCA. In...more
6/2/2023
/ Drug Pricing ,
False Claims Act (FCA) ,
Healthcare ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Reasonable Interpretations ,
Safeco ,
Safeco Insurance Co of America v Burr ,
Scienter ,
SCOTUS ,
US ex rel Thomas Proctor v Safeway Inc ,
US ex rel Tracy Schutte et al v SuperValu Inc et al
What does it mean to “knowingly” or “recklessly” violate the law when that law consists of highly complex and ever-changing regulations, which may be open to interpretation? The U.S. Supreme Court recently agreed to review...more
2/1/2023
/ Case Consolidation ,
False Claims Act (FCA) ,
Health Care Providers ,
Healthcare ,
Healthcare Fraud ,
Relators ,
Scienter ,
SCOTUS ,
US ex rel Thomas Proctor v Safeway Inc ,
US ex rel Tracy Schutte et al v SuperValu Inc et al ,
Whistleblowers
Ruling on the State of Georgia’s November 18, 2022 Emergency Petition for Supersedeas, this past Wednesday (November 23, 2022) the Georgia Supreme Court enjoined the lower court’s decision thereby reinstating the prohibitions...more
11/30/2022
/ Abortion ,
Dobbs v. Jackson Women’s Health Organization ,
Equal Protection ,
GA Supreme Court ,
Georgia ,
Healthcare ,
Motion To Enjoin ,
Patient Access ,
Pregnancy ,
Reproductive Healthcare Issues ,
Roe v Wade ,
SCOTUS ,
State Constitutions
The Supreme Court’s landmark decision in Dobbs v. Jackson Women’s Health Organization represents a sea-change in Constitutional law that has already impacted our country in multiple ways. By overruling Roe v. Wade (1973)...more
8/19/2022
/ Abortion ,
Dobbs v. Jackson Women’s Health Organization ,
EMTALA ,
Health Care Providers ,
Healthcare ,
New Guidance ,
Patient Access ,
Popular ,
Pregnancy ,
Reproductive Healthcare Issues ,
Roe v Wade ,
SCOTUS