This case involves the alleged improper marketing of a particular opioid pain medication by a defendant pharmaceutical company. The allegations claimed that the defendant fraudulently marketed the drug in question for off-label uses and that the defendant was negligent in their warning practices. The suit further alleged that the pharmaceutical company was involved in a wide-spread kickback scheme in which they were paying physicians to prescribe the drug.
Question(s) For Expert Witness
- 1. Please briefly describe your experience in fraud investigation as it pertains to pharmaceutical companies.
- 2. Are you able to opine on the alleged fraud committed by the defending pharmacy company?
Expert Witness Response E-007290
As an FDA official, I work to identify and prevent fraudulent promotional campaigns and targeted marketing. I have a great deal of experience reviewing promotional materials, professional publications, as well as print and TV media ads related to FDA-regulated products. As a federal investigator, I also participated in joint investigations (with the FBI and Postal Service) of fraud cases related to illegal manufacture and distribution of steroids, contraception and erectile-dysfunction medications. I have also worked undercover to capture illegal marketing of silicone filler and collagen by dermatologists and plastic surgeons. I am familiar with the many ways that drugs are detailed off-label by reps, and have intercepted such sales campaigns related to Retin-A, steroids, NSAIDS, and a few other drugs. Lastly, I am very familiar with the manufacturing process and patch delivery system as well.