Health (Pharmaceuticals - Litigation)

 

• Litigation involving antitrust and trade regulation issues under the Sherman Antitrust Act, the Clayton Act and the Federal Trade Commission (FTC) Act, such as brand restrictions, distribution practices, exclusion of pharmacy chains from managed care networks, generic competition restraints, incentives to providers, interdependence, monopolistic mergers and purchases, parallel pricing, parens patriae, price-fixing, qui tam, unfair competition and whistleblower.

 

• Responses to audits and investigations alleging defective pricing and fraud.

 

• Participation in patent enforcement cases involving non-practicing entities (NPEs, or colloquially, "patent trolls"), which seek to force the holder of a patent to pay the troll for what the troll claims to be an infringement of the troll’s patent by the holder’s patent, even though the troll’s claim may be grossly exaggerated and overreaching.

 

• Experience with Paragraph IV actions pursuant to the Drug Price Competition and Patent Term Restoration Act (a/k/a “Hatch-Waxman Act”), requesting Food and Drug Administration (FDA) approval to market a generic drug before the expiration of the patent governing a branded drug, through the submission of an Abbreviated New Drug Application (ANDA).

 

• Consultation for enforcement actions by state and federal regulators.

 

• Consultation for class actions and multidistrict proceedings.

 

• Domestic and international litigation management.

 

• Use of Six Sigma-certified subject matter experts (SMEs) as consultants, both for product safety issues during product development, and as expert witnesses for product liability litigations.

 

• Consultation for issues involving Federal regulatory agencies, such as the Centers for Medicare and Medicaid Services (CMS), Drug Enforcement Administration (DEA), Food and Drug Administration (FDA), FDA Office of Criminal Investigations, Office of Inspector General (OIG), Department of Health and Human Services (HHS), the U.S. Department of Justice (DOJ).

 

• Representation for regulatory enforcement actions, such as for anti-kickback, Controlled Substances Act (CSA), diversion, False Claims Act (FCA), Federal and state audits, Food, Drug, and Cosmetic Act (FD&C Act), fraud & abuse, internal investigations, off-label promotion, pharmacy compounding, reimbursement, third-party-payer audits.

 

• Representation for drug companies in litigation involving price reporting claims.

 

• Representation for manufacturers of biologics, branded, diagnostics equipment, dietary supplements, devices, generics and specialty pharmaceuticals. 

 

• Representation for administrative proceedings of Federal agencies, such as the Consumer Product Safety Commission (CPSC), Customs and Border Protection (CBP), Environmental Protection Agency (EPA), Federal Trade Commission (FTC), the Food and Drug Administration (FDA), the National Highway Traffic Safety Administration (NHTSA), Occupational Safety and Health Safety Administration (OSHA).

 

• Representation for issues involving state administrative agencies, state Attorneys General, state boards of health and human services, state boards of pharmacy, state pharmacy associations.

 

    Last Updated 210509_1529