In Brief: A Digest of Pharmaceuticals Projects

Client Success

Serve as national litigation counsel for one of the largest pharmacy benefit managers in the world for more than twenty years. In addition to serving as national litigation, also provide counsel on healthcare regulatory, intellectual property and government contract issues, including licensure requirements in various states, pharmacy licensure, third party administrator licensure and utilization review agent licenses.
Regularly provide compliance advice regarding Medicare Part B and Part D rules and manual guidance as well as state Medicaid guidance in all 50 states.
Advised clients on all legal and regulatory issues of starting new pharmacies and purchasing existing pharmacies. As well as assisted pharmacists with land use entitlement issues, business entity formation, zoning as well as simple tax and business planning.
Generic Pharmaceuticals, FDA
Handled numerous major Abbreviated New Drug Administration (ANDA) litigations, including cases involving Norvasc, Antara, Floxin Otic, Boniva, Ultracet, Wellbutrin XL, Strattera, Adderall XR, Clarinex, Amrix, Enablex, Luvox CR, and Cymbalta.
Design and implement defense strategies in Hatch-Waxman litigations, preparing Hatch-Waxman Paragraph IV letters as well as patentability and freedom to operate letters of opinion.
Provide counsel regarding Food and Drug Administration (FDA) patent infringement litigation and litigated such matters in the U.S. District Court, District of Columbia, and the U.S. Court of Appeals and District of Columbia Circuit.
Assist clients with a wide-range of FDA regulatory issues including; post-market reporting obligations for manufacturers, product recalls, product labeling, establishment registration, investigation and compliance plans and product sales and distribution requirements.
In Fenofibrate Patent Litigation (S.D.N.Y. Dec. 28, 2012), we obtained summary judgment of noninfringement on Lupin’s Orange Book listed patents on behalf of our client Apotex. We avoided prolonged discovery and prevented Lupin’s counsel from engaging in a fishing expedition, while limiting our client’s overall expenses in demonstrating that our client’s formulation did not infringe
Product Liability
Trial lawyers have handled a variety of product liability litigation involving numerous drugs, vaccines and various antidepressants.
Defended pharmaceutical, biotechnology and medical device companies in cases involving product liability claims, pricing issues, False Claims Act matters, contract and fraud allegations, consumer and third-party class action cases. These cases involved multidistrict litigation, whistleblower claims, advertising lawsuits, marketing disputes with regulatory bodies, off-label promotions and failure-to-adequately-warn claims.
Regulatory, Labor and Employment
Represented pharmaceutical companies in a wide range of civil and criminal healthcare matters, including class action cases and government investigations.
Secured numerous summary judgments for pharmaceuticals client in all types of employment discrimination claims.