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Yesterday was a big win for our client, who helped the government recover a whopping $885 million from AmeriSourceBergen Corporation under the False Claims Act. Mike Mullen, former CEO of an Amerisource subsidiary, had the courage to stop serious health care fraud.
Mr. Mullen played an instrumental role in a landmark $625 million civil settlement. This settlement announced between his former company and federal and state prosecutors covered false claims submitted for unapproved and adulterated drugs, double-billing from exploiting overfill, and kickbacks to physicians. His whistleblowing was also critical in the government’s criminal investigation of the company. Importantly, that investigation led to convictions for violations of the Food, Drug and Cosmetic Act and criminal fines totaling $260 million.
The combined $885 million settlement is one of the largest pharmaceutical settlements in history.
The drugs at issue in the case were used to treat cancer or the side effects of cancer treatments. The defendants illegally harvested overfill by repackaging manufacturer-produced vials into unapproved pre-filled syringes at an unlicensed facility operating outside the regulatory oversight of the U.S. Food and Drug Administration (FDA). The defendants then offered the syringes to physicians at a discount. Subsequently, patients received drugs that had been manipulated in ways that resulted in adulteration and contamination.
Mr. Mullen drew the government’s attention to the fact that the Amerisource subsidiary was putting cancer patients at risk. Certainly, the facility ignored safety protocols required by the FDA. These rules are called “current good manufacturing practices” or “cGMPs.”
Drug manufacturers and repackagers have a duty to ensure the safety and proper handling of the drugs they distribute. However, by bypassing the FDA’s requirements and falsely holding itself out as a mere “pharmacy,” the subsidiary shipped unapproved drug forms. This also compromised critical information for doctors and patients. Above all, the unlicensed facility is now closed, a direct result of the investigation that our client’s complaint launched.
Mr. Mullen’s complaint details AmerisourceBergen’s overfill laundering scheme. Above all, it provides the first-hand, operational knowledge necessary to detect AmerisourceBergen’s crimes. It also identifies executives who knew about the oncology business model and regulatory issues. These include the former and current AmerisourceBergen CEOs.
In conclusion, As the founders of the Whistleblower Law Collaborative, we could not be more proud of our client. It has been a privilege to represent him as he fought to protect patient safety and the public fisc. Mr. Mullen exposed the insidious ways in which drug wholesalers can extract profits from manufacturers, doctors, and patients.
Mr. Mullen could have remained silent and continued to accept the lavish compensation packages and perks of corporate life. However, he instead chose to do the right thing. He spoke up to his superiors about the problems he saw. But, this cost him his job. He then alerted law enforcement of his concerns after vetting his claims with whistleblower attorneys.
We salute him today.
If you wish to learn more about this case we have additional information here.