Amgen Whistleblowing Case
Amgen, a Thousand Oaks, California-based company, had the unenviable task of dealing with lawsuits filed by 15 states in 2009 alleging a Medicaid kickback scheme.1 To make matters worse, two additional whistleblowing lawsuits were filed against the company in Ventura County. The complaints, which don't appear related to the fraud alleged by the group of states, were brought by former employees who said they had uncovered wrongdoing at the biotech giant and were terminated after they raised red flags to superiors. One employee alleged the company violated federal law by under-reporting complaints and problems with the company's drugs after they hit the market. The facts of that lawsuit are described below.
Former Amgen employee Shawn O'Brien sued Amgen for wrongful termination on October 9, 2009, alleging he was laid off in October 2007 in retaliation for raising concerns about how the company reported complaints and problems with drugs already on the market. O'Brien worked as a senior project manager for Amgen's "Ongoing Change Program," according to the lawsuit filed in Ventura County Superior Court. His job was to improve Amgen's "compliance processes with high inherent risk to public safety, major criminal and civil liability, or both," according to the lawsuit.
The lawsuit alleged that in April 2007, Amgen's board of directors flagged the company's process for dealing with post-market complaints about drugs as a potential problem. Federal law requires drug companies to track and report to the Food and Drug Administration any problems with their drugs after they hit the market. In June 2007, O'Brien was put on the case. He soon uncovered facts that Amgen was not adequately and consistently identifying phone calls or mail related to post-marketing adverse events of product complaints. That year, O'Brien warned the company about the seriousness of the issues but, he claims, the company would not take any action or offer any support. In August 2007, O'Brien took his complaint to a senior executive/corporate officer (unnamed) and warned that Amgen's process for dealing with post-market problems wasn't adequate.
In early September of 2007, O'Brien's managers instructed him to stop all work and not discuss the issues any further with anyone. Approximately four weeks later he was informed that he was being terminated as part of Amgen's October 12, 2007, reduction in the work force.