Background - Practices (Details)

Pharmaceuticals & Life Sciences

CONTACTS +

Representative Engagements

  • Coumadin® antitrust and consumer fraud cases. Represented a pharmaceutical manufacturer in Federal Trade Commission (FTC) proceedings and as national coordinating trial and appellate counsel in a series of antitrust and consumer fraud class actions directed at alleged misrepresentations regarding a pharmaceutical product and its generic competition.
  • Brand name prescription drug antitrust litigation. Defended a major pharmaceutical company against a nationwide class of retail pharmacies and thousands of individual opt-out pharmacies alleging antitrust claims in federal court. We also represented the company in numerous parallel state court class actions brought by retail pharmacies and consumers alleging state law antitrust and consumer fraud violations.
  • Acquittal of criminal charges. Obtained acquittal of the vice president for quality assurance of a major pharmaceutical company, accused of conspiracy, obstruction and other charges, in federal court in Maryland after the company itself had pleaded guilty and paid a $10 million fine for the same.
  • Grand jury investigations. Represented of the leading blood bank in the New York metropolitan area, and one of the largest in the country, in two grand jury investigations of alleged falsification of viral testing. Despite the conviction of two lab supervisors, no criminal changes were brought against our client.
  • New Drug Application (NDA) approval process assistance. Blocked the Food and Drug Administration (FDA) from giving a competitor's product an unfair advantage in the NDA approval process. On behalf of a drug manufacturer, we petitioned the agency to treat similar products similarly, and successfully sued in federal court when FDA failed to do so.
  • Product seizures. Represented an over-the-counter (OTC) drug manufacturer in federal court and in negotiations with FDA to resolve the agency's seizure of a large quantity of product at a distributor's warehouse. The settlement permitted the company to continue distributing the product.
  • Investigator disqualification hearings. Defended a clinical investigator in the first disqualification hearing held in years, the result of FDA's increasingly aggressive enforcement activities aimed at clinical investigators and their institutions.
  • Trade matters. Defended the boycott and restraint of trade charges against a health plan for maintenance of a limited pharmacy network.
  • Antitrust litigation. Served successfully as defense counsel in antitrust litigation in Alabama arising out of the pricing system that pharmaceutical manufacturers have implemented that differentiates between "retail" pharmacies and managed care payers/providers of prescription drug products.
  • Junk science cases. Prepared successful Amici briefs in Daubert v. Merrell Dow Pharmaceuticals, Inc., and Carmichael v. Kumho Tire Co., two Supreme Court junk science cases.