Representative Experience

  • Represents major pharmaceutical company in qui tam lawsuit alleging concealment of adverse clinical trial results, off-label promotion and kickbacks
  • Represents medical device distributor in qui tam lawsuit alleging violations of FDA regulations and whistleblower retaliation
  • Represents major pharmaceutical company in government investigation involving patient assistance programs
  • Represents major pharmaceutical company in government investigations involving prescription drug marketing and potential violations of state consumer protection laws
  • Represented major pharmaceutical company in qui tam litigation alleging underpayment of Medicaid rebates; all claims dismissed following close of discovery
  • Represented major pharmaceutical company in Department of Justice inquiry relating to alleged kickbacks paid to long-term care pharmacies; government declined to intervene in underlying whistleblower complaint
  • Represented major pharmaceutical company in US Attorney's Office investigation relating to alleged kickbacks paid to KOLs and prescribers; government declined to intervene in underlying whistleblower complaint
  • Represented major pharmaceutical company in State Attorney General inquiries into patent litigation settlement raising potential pay for delay issues
  • Conducted internal investigations into potential violations of Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP) guidelines
  • Conducted internal investigation into potential violations of regulations and corporate policies governing adverse event reporting
  • Conducted internal investigations into alleged failure to disclose safety risks allegedly associated with prescription medications 
  • Conducted proactive assessments of litigation and compliance risks presented by the promotion of various prescription medications and other critical business functions