1. How long were you at the company and/or in the industry?
I was in the industry for almost 25 years. I worked for Amgen for over 15 years, and before that, for Merck for over 9 years.
2. When and how did you discover the fraud and the scope of the fraud? How did it work?
There were various schemes that I had observed at Amgen over 15 years, some of them definitely company sponsored, and some that were "home grown." The particular fraud that I ultimately reported was a rather flagrant violation of stated company policy, but one that was obviously supported by the management. I really did not "uncover" the fraud at all, in that it was a full "in your face" violation. Just months before the start of the off-label promotion schemes, we had been required to sign documents that stated that if we were ever found to engage in off-label promotion, we would lose our jobs. Then when our product launch did not produce the anticipated avalanche of prescriptions, we were asked to memorize a script that was carefully worded to do just exactly that--promote an off-label dosing scheme. Of course we were not provided with hard copies of the script, but we were asked to memorize it from a PowerPoint slide, and then we were asked to demonstrate our proficiency in a role-playing situation. No paper trail! How tidy! One of the reasons that I liked working for Amgen was that they had never asked me or required me to do something that I knew was either illegal or unethical. The new management group that had been hired from the top Pharma companies were teaching Amgen to compete all right, but with the same questionable ethics that had caused many of us to flee to Biotech a decade or more earlier.
3. Did you report internally? If so, what was the company response? What was the response of co-workers and others when you started talking about “the problems”?
I did report internally, but I waited until I had already gone to the government. Why you might ask? I had already seen what had happened to other employees who had asked questions about ethics and illegality. I had a high level of suspicion that the internal compliance department was there to protect the company, not to protect a potential whistleblower. I had the advice of my attorneys and the government investigators when I ultimately did report the activity. I wanted to make sure that the evidence was squarely in the government's hands before I gave the company the opportunity to destroy or alter the evidence that I brought to their attention. In the end, I didn't really have anything to fear about them attempting to change evidence--they promptly fired me without attempting to perform any significant internal investigation. The behavior continued unabated for several years after I was fired, so obviously, there was no serious attempt to use the information to curtail the illegal activity.
4. Were you employed by the company that was committing the fraud? If so, did the company take any retaliatory action against you as a result of your whistleblowing? Did you sue the company under the FCA’s anti-retaliation provision?”
I was employed by the company that was committing the fraud. I believe that the company did in fact retaliate against me, but on several levels. There was a coworker who was actively retaliating against me for cooperating with an internal investigation conducted by the HR department. I did not initiate the HR investigation, but I told the truth when asked, allowing the company to mitigate their legal risk in a discrimination matter. I reported the retaliation by my coworker, and my supervisor directly witnessed the retaliation, but refused to take meaningful actions to stop it. I therefore filed a claim first in my state, and then in Federal Court. Because I already had a case filed regarding retaliation, it would only be confusing to claim another basis of retaliation under the FCA.
5. When did you become aware there was a law called the False Claims Act? What were you told about the process of filing a False Claims Act case, and how did that compare to the reality?
I knew about the False Claims Act due to the compliance guidance that was provided to us by the Amgen Legal Department. They warned the sales department of what had happened to other companies under the False Claims Act. They were especially concerned about the fine that had been assessed in the TAP case, and their main fear seemed to be the potential exposure for "Selling on the Spread" which was a pervasive practice in the Oncology market. They did of course also caution against "Off-Label Marketing," but there had not been any huge fines assessed on that basis at the time that I was working for them. The cases in off-label marketing began to be settled after I had taken my case to the government, and after as had left the company.
I was not told anything about the process of filing a false claims act case. I went to the government to report the illegal activities before I filed a False Claim Case. After wearing a wire for the government, I became aware that the evidence was powerful, and that it could potentially be used in a False Claims case. I then consulted an attorney and learned about the First to File provisions of the False Claims Act and decided to file a case in the unlikely event that I was in fact the first to report this illegal activity. I was shocked to learn that I was the first to file with the required specificity regarding the various illegal activities that I reported.
After reporting the illegal activities to the government, there was an ongoing learning process about the reality of participating in an investigation and bringing forward a legal action. It is so different from what we are led to expect from the TV and news reports. I did not realize that I would be asked to wear a wire versus the government using electronic surveillance. I assumed that wiring our meeting room would be easier than having someone wear a wire. I also assumed that a recorded conversation might not be permissible in court. I learned a lot of legal terms like "single party consent" which means that a single party in a conversation has the legal right to record a conversation in which they are a involved. I did not know that most states are single party consent states. I also did not realize the extent to which the investigators for the government would actively protect the rights of the company and i did not anticipate the high level of proof that was required to convince the government of wrongdoing. Even though this was a civil case, the government wanted a virtually bullet proof case to proceed against the company. They were, in my opinion, unbelievably willing to listen to the defenses offered, even though I knew the defenses to be absolutely false. I was not prepared for the number of times that I had to present the same evidence over and over again during various phases of the investigation. I certainly did not anticipate that this case would take 8 years to come to its conclusion. which means that their resources are spread very thin.
6. Relationships change during FCA cases – relationships with the company, friends, former co-workers, the government, the family, other co-relators, and even your lawyers. Were you prepared for both the daily grind and the emotional volatility of that?
I guess that I had already suffered so much under the retaliation that I was subjected to before I ever went to the government, what occurred afterwards was just more of the same. I had come to the conclusion before I ever went to the government that I was a survivor, and I was a fighter, and that if I did what was right, the good Lord would watch over me. I relied upon my family and my faith to bring me through. I had already gone through an internal battle over going to the government. I knew that what had happened to my company was repeated over and over again in the Pharma world. I knew that it was what I hated about my job and about the industry. I had to reconcile myself to the fact that I was admitting to participating in the activities myself, and that I would have to tell the truth about myself and about my friends. Thankfully, the government is not really interested in prosecuting the "little guys" like me and my immediate co-workers. But I also knew that I had a unique ability to financially survive the loss of my job as well as the loss of any possible future employment in Pharma. And I knew that I was already targeted by my coworker and my boss, so what did I have to lose anyway?
But I knew that I could not do this all alone. There were many, many things that had to be done and done right for this case to ever have an impact on Amgen or on the industry. Therefore, I could not fret every day about what was happening. I had to leave it to a higher authority for justice to prevail. So every day I just did what I could do, even if that was just to remain calm and trust that the wheels of justice were turning.
7. If you lost your job as a result of the company’s fraud, how did you support yourself financially while the case was going on?”
My father had a small manufacturing firm that he had started many years before. While I had not anticipated going to work at the family firm, shortly after I lost my job, we found that a key employee had embezzled money, and my father asked me to come in and help get things straightened out. I didn't plan to stay, but I found that my business experiences were helpful, and so I continued to work for the family business. It turned out to be a blessing for me and for the company.
8. What about your family? Did they know about the case? How did you cope emotionally with the wait, the uncertainty, and the financial stress?
My family knew that I had gone to the government to report illegal activities, and they knew that I had worn a wire. When I filed the False Claims Case, it was difficult because the case was placed under seal, and now I couldn't say anything to my family at all. I had to come up with a lot of different ways to tell them that I couldn't say anything. They knew that there was a case or investigation of some sort, but they did not know any details, and they didn't know that it was a False Claims Case. They knew that I had to take time off to go and talk to the government agents, and that I spent a lot of time talking to, and working with my attorneys, but they were helpful, and respected the fact that I could not share the full story with them. They believed in my integrity and knew that I was trying to do what was right.
9. Do you think justice was done? What outcome would you like to have seen?
I believe that some justice was done. But I also know that justice is often not counted in monetary terms, and I don't know the personal consequences that this case had on involved individuals. I know that everyone who participated knew exactly what they were doing, and did it for their own personal enrichment.
I would have liked to see hard criminal punishments for the top brass that pushed these schemes and permanent sanctions from these people working its any government contractor as an employee or a consultant. As a society we need to see the practices of the Pharma industry reigned in so that costs can go down and safety of the consumer can be more assured.
10. Looking back, what do you wish you knew at the beginning? What three bits of advice would you pass on to others?
Be careful of your motives and your expectations. If you are seeking revenge, you will end up tearing yourself up. Work as hard as you can, but accept the results such as they are. In the end, you have to continue your own life and you can't let your case destroy you.
Prepare to be patient, recognizing that there is only so much you can control.
Don't exaggerate or inflate your evidence. Your own integrity is key to the case, so don't send the government off chasing sketchy claims.
Plan ahead for what might happen. Don't wait till you have been fired to decide to go to the government. Get good counsel from an attorney and from the appropriate investigators before you challenge the company (my personal opinion).