A recent lawsuit alleges that Takeda Pharmaceuticals, the maker of the diabetes drug Actos, paid Cleveland Clinic Dr. Steven Nissen between $8 and $10 million to downplay the drug’s health risks in reports to the U.S. Food and Drug Administration (FDA).
The lawsuit, filed by a former Takeda employee, asserts that Nissen authored a meta-analysis claiming Actos’ main rival, Avandia, increased the risk of heart attack by up to 40 percent. Dr. Nissen’s paper led the FDA to require safety labels on Avandia and restricted domestic Avandia sales. With Dr. Nissen touting Actos as a safer alternative to Avandia, it became the top Type-2 diabetes drug in the world.
Whistleblower Claims Involving Drug Companies
The current federal administration is using health care fraud prosecution as one of its main tools to tackle rising health care costs. While the government does use auditors to root out fraud, it usually learns of misconduct through insiders coming forward with information. These “whistleblowers” are a critical part of the fight against health care fraud crimes and in protecting consumers from predatory companies.
The U.S. False Claims Act allows private citizens to file “qui tam” lawsuits on behalf of the federal government against private corporations for illegal behavior. The law allows the private citizen to share in any settlement amount. Between 1996 and 2005, the federal government recovered more than $9 billion in qui tam cases involving health care fraud. A recent study found whistleblower informants received a median of $3 million because of their lawsuits.
In the pharmaceutical industry, whistleblowers may report crimes ranging from bribery to securities fraud. There is strong competition in emerging global markets for pharmaceutical contracts. However, the U.S. Foreign Corrupt Practices Act (FCPA) prohibits bribery of foreign officials.
While research has found that most whistleblowers are motivated by morals more than money, it is unfortunate that it takes concerned citizens to call out a company’s criminal acts. This is especially true when people trust a company, like a drug manufacturer, to potentially save their lives by giving them the best products available.
If you have witnessed or been a victim of health care fraud, consult with an experienced medical malpractice attorney as you may be entitled to compensation.