Tampa-based Meridien Research could be in some pretty hot water. A former nurse for the medical research company is seeking damages in Hillsborough court as a whistleblower after she claims she was fired for uncovering research fraud.
According to lawsuit documents, Cindy Anne Mannis worked as site director at Meridien’s Tampa location along with Dr. Cynthia Huffman, the site’s principal investigator.
Meridien conducts clinical drug trials for major pharmaceutical and biotech companies that are seeing FDA approval on new medicines. The firm also conducts human trials on exploratory drugs.
Manis claims in a lawsuit filed November 12 that she witnessed Huffman falsify trial data in order to benefit pharmaceutical companies like CoLucid, Biogen and Novartis.
Biogen is known for its production of the arthritis drug Enbrel. CoLucid has been making headlines this year with its investigational migraine reliever, lasmiditan and Novartis produces things like Ritalin and the over the counter headache medicine Excedrin. However, Mannis does not specifically mention which drugs were affected by alleged records tampering.
Mannis said she observed Huffman destroy medical records in order to qualify more people for drug-trials. That means people who may not have been appropriate for those tests may have been allowed to participate.
This potentially puts the safety of drug consumers at risk if drug trials would not have met FDA standards without falsified records and fraudulent practices.
Mannis claims she brought the information to Meridien CEO Tony Busa and was immediately placed on administrative leave for creating what the lawsuit describes as creating a toxic environment. The employee was later terminated.
According to the lawsuit, Mannis said Busa told her he didn’t know what to do with the information she gave him. He mentioned the amount of revenue Huffman brought in for the company as well as the potential for problems should the FDA catch wind of the claims.
The lawsuit only names Meridien Research in its claim and does not specifically accuse the drug companies of being a part of the fraud. Skepticism of drug companies and their practices in hiring salespeople to promote products to doctors has shown some potential kickbacks for doctors who prescribe a lot of their drugs.
The lawsuit could raise questions about whether drug companies are incentivizing research firms in order to push new pharmaceuticals through the FDA approval process.
Meridien Research has retained attorney Cheryl Loraine Wilk of the national firm Hinshaw & Culbertson. Mannis is represented by two attorneys from the Whittel & Melton law firm in St. Pete.