CMS Regulation -
District Court Strikes Down Rule Mandating Price Disclosure in DTC Pharmaceutical Advertisements -
The U.S. Department of Health and Human Services (HHS), together with the Centers for Medicare &...more
7/10/2019
/ Advertising ,
Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Commercial Speech ,
Department of Health and Human Services (HHS) ,
Direct to Consumer Sales ,
Drug Pricing ,
False Claims Act (FCA) ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Final Rules ,
First Amendment ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Medicare ,
Pharmaceutical Industry ,
Prescription Drugs ,
Price Transparency ,
Social Security Act ,
Unduly Burdensome
Holland & Knight invites you to read our China Practice Newsletter, in which our authors discuss pertinent Sino-American topics. The firm provides legal assistance to Chinese investors and companies doing business or making...more
The equitable defense of "unclean hands" is often raised but rarely proven. Sometimes stated as "he who comes into equity must come with clean hands," it is based on the maxim that "he that hath committed iniquity shall not...more
3/1/2019
/ Abuse of Discretion ,
Appeals ,
Document Retention Policies ,
Duty of Loyalty ,
Electronically Stored Information ,
Employee Misconduct ,
Equitable Relief ,
Misappropriation ,
Preliminary Injunctions ,
Tortious Interference ,
Trade Secrets ,
Unclean Hands
Five years after the U.S. Supreme Court found in FTC v. Actavis, 570 U.S. 136 (2013), that large and unjustified payments from a brand pharmaceutical manufacturer to prevent generic entry can provide a basis for an antitrust...more
Mrs. Skounakis died of a coronary artery occlusion after being prescribed an unusual combination of drugs (phendimetrazine and liothyronine) by Dr. Sotillo for weight loss. Her husband sued Dr. Sotillo for malpractice. What...more
As post-Actavis antitrust litigation over so-called “reverse payment” patent settlements proceeds, courts continue to provide further illumination about what evidence a private plaintiff would need to offer to survive summary...more
2/1/2018
/ Antitrust Litigation ,
Causation ,
Claim Construction ,
Damages ,
Generic Drugs ,
Manufacturers ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Patents ,
Preponderance of the Evidence ,
Reverse Payment Settlement Agreements ,
Settlement Agreements ,
Summary Judgment
We pointed out in a recent article that, based on recent decisions by the Courts of Appeals for the First and Third Circuits, private antitrust plaintiffs seeking damages from so-called “reverse-payment” settlement agreements...more
11/8/2017
/ Anticompetitive Agreements ,
Antitrust Litigation ,
Appeals ,
Claim Construction ,
Damages ,
Generic Drugs ,
Manufacturers ,
Motion for Summary Judgment ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Preponderance of the Evidence ,
Reverse Payment Settlement Agreements
The Supreme Court of Texas recently ruled that a trial court erred in a hearing on a misappropriation of trade secrets claim. The lower court had summarily refused the plaintiff's request to exclude the designated corporate...more