Montgomery McCracken’s Life Sciences Industry Group offers a depth of experience in related legal and business disciplines, ranging from compliance, intellectual property, manufacturing, labeling and distribution issues, to environmental, employment, labor and immigration, to the defense of governmental and complex product liability or consumer protection claims.
Our attorneys provide legal guidance on general business counseling, licensing, manufacturing arrangements, distribution arrangements, administration of employee benefit programs, compensation packages, immigration issues, preventive practical advice on workplace problems, including arbitration and other alternative dispute programs and a variety of broader human resource matters, and preventive risk management.
- Represented pharmaceutical companies in criminal and civil investigations relating to False Claims Act claims, anti-kickback allegations, challenges to nominal pricing and “best price” issues, and AWP challenges.
- Represented a drug wholesaler in a national price-fixing case.
- Designed and helped implement compliance programs for a major pharmaceutical company to detect sales and distribution issues and problems before they result in regulatory violations or litigation.
- Advised a major drug wholesaler on antitrust concerns, including price restrictions and price discrimination, related to the client’s distribution network and contracts.
- Represented a drug manufacturer in an antitrust case involving FDA approval of generic substitutes for a branded drug.
- Represented a manufacturer of products for drug delivery systems with respect to environmental and worker safety issues.
- Represented pharmaceutical and medical device companies in significant product liability cases.
- Structured consulting agreements between medical device and pharmaceutical companies and physicians and medical researchers.
- Assisted a major pharmaceutical company with all immigration issues related to the hiring and movement of its multi-national work force.
Richard M. Simins Rejoins Montgomery McCracken
Firm adds partner and associate to its Litigation Department PHILADELPHIA – Montgomery McCracken is pleased to announce the additions of Richard M. Simins and Jackson E. Warren to its Litigation […]
Pharmaceutical Promotion Compliance: Avoiding the Common Mistakes
There are certain key questions to keep in mind when creating promotional materials for prescription drugs and reviewing these materials for regulatory compliance: Is the content truthful and not misleading? […]