In 2023, we wrote about the Supreme Court’s decision in United States ex. rel. Schutte v. SuperValu Inc. interpreting the False Claims Act’s (FCA) scienter standard to require inquiry into a defendant’s subjective knowledge....more
6/26/2025
/ Breach of Contract ,
Centers for Medicare & Medicaid Services (CMS) ,
Damages ,
Expert Testimony ,
False Claims Act (FCA) ,
Healthcare ,
Healthcare Fraud ,
Jury Trial ,
Liability ,
Litigation Strategies ,
Medicaid ,
Medicare ,
Motion to Dismiss ,
Pharmaceutical Industry ,
Scienter ,
SCOTUS ,
Statutory Interpretation ,
Subjective Standard ,
US ex rel Tracy Schutte et al v SuperValu Inc et al
Texas Attorney General Ken Paxton recently announced that his office is investigating some of the country’s most ubiquitous home brands — including Colgate-Palmolive, Proctor & Gamble, and General Mills — for allegedly...more
6/17/2025
/ Civil Investigation Demand ,
Consumer Protection Laws ,
Department of Health and Human Services (HHS) ,
Enforcement Actions ,
False Advertising ,
FDA Approval ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Food Labeling ,
Food Safety ,
Health and Safety ,
Manufacturers ,
NLEA ,
Preemption ,
Secretary of HHS ,
State Attorneys General ,
Texas ,
Trump Administration ,
Unfair or Deceptive Trade Practices
With companies constantly developing new therapies and technologies, the biotech industry is a hotbed of innovation. This dynamic environment often leads to mergers and acquisitions (M&A) as a vehicle for larger companies to...more
After years of FDA discussion and failed congressional efforts to assert greater oversight of laboratory developed tests (LDTs), FDA has proposed a rule that would require many LDTs to comply with FDA’s requirements for in...more
The COVID-19 pandemic highlighted both the incredible promise and challenges for life science companies developing and manufacturing drugs, biological products, and devices that enhance our lives....more
9/25/2023
/ Biologics ,
Coronavirus/COVID-19 ,
False Statements ,
Food and Drug Administration (FDA) ,
Fraud ,
Inspections ,
Life Sciences ,
Manufacturers ,
Pharmaceutical Industry ,
Public Health ,
Warning Letters
As companies begin planning for the upcoming year, attorneys who sit on promotional review committees should consider the significant guidance published by the U.S. Food and Drug Administration (“FDA”) and update process aids...more