Distributors Pharmaceutical Industry

News & Analysis as of

Antitrust Matters - September 2015

Antitrust investigations are no longer limited to a nation’s borders, or even to a region. Enforcers are more and more sharing information and coordinating their investigative efforts as they strive to uniformly enforce the...more

EPA Proposes New Rules for Pharmaceutical Wastes That Qualify as RCRA Hazardous Wastes

On August 31, 2015, the Administrator of the U.S. Environmental Protection Agency (“EPA” or the “Agency”) signed a proposed rule that would establish special management standards for pharmaceutical wastes that are classified...more

Drug Disposal Ordinance: Supreme Court Writ Filed

On December 29, 2014, the Pharmaceutical Research and Manufacturers of America (“PhRMA”), the Biotechnology Industry Organization (“BIO”), and the Generic Pharmaceutical Association (“GPhA”) jointly filed a Petition for a...more

Damages in “Aggravated Breach” Cases

We have written before about the “aggravated breach of contract” theory under N.C. Gen. Stat. § 75-1.1. This theory can make a breach of contract a springboard to treble damages....more

GPhA Issues Statement Regarding Proposed IP Provisions of Trans-Pacific Partnership Agreement

The Generic Pharmaceutical Association (GPhA) issued a statement today regarding ongoing talks between major Pacific Rim countries (including the U.S.) related to the proposed Trans-Pacific Partnership Agreement. This trade...more

False Claims Act Update: GSA Contractor Reasonably Relied Upon Distributor Certifications Of Product Origin And Trade Agreements...

The United States Court of Appeals for the District of Columbia Circuit recently upheld a District Court’s dismissal of a False Claims Act (FCA) complaint against a federal government contractor in a case that will be of...more

Drug Distributor and Pharmacies Obtain Partial Dismissal of State and Federal FCA Claims

On June 10, 2014, a New York federal court dismissed, in part, state and federal False Claims Act (FCA) claims brought against Novartis Pharmaceuticals Corporation and pharmacies to which it distributed (CVS Caremark Corp.,...more

Commission-Based Sales Agreements for Medical Supplies and Equipment: More Whistleblower Activity on the Horizon? - A Wide Range...

The common industry practice of compensating independent contractor sales representatives on a "percentage of sales" commission basis may be creating an enhanced risk of False Claims Act liability for illegal kickbacks in...more

No Standing for Illegal Drugs: Third Circuit Limits Antitrust Standing for Foreign Drug Manufacturers Absent FDA Approval

A Third Circuit panel recently ruled that a foreign drug manufacturer lacks antitrust standing when it could only sell its product in the United States through a distributor....more

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