A former associate medical director at Harvard Clinical Research Institute, Ge was hired as a medical reviewer in the Takeda pharmacovigilance division. As we reported previously, she repeatedly lodged complaints about alleged discrepancies and shortcomings in reporting assorted and sordid adverse events, but was shown the door for her trouble. The separate whisteblower lawsuits were subsequently filed earlier this year.
In the lawsuit concerning Uloric, Ge charged that Takeda avoided reporting adverse events caused by the drug, such as bone marrow failure, or that occurred after patients took the pill and one of several other medications. Interactions caused some patients to experience fatal reactions, severe bleeding or renal failure. She also claims Takeda failed to properly amend the labeling to reflect the alleged harm that could be caused by interactions (back stories here and here).
In the lawsuit filed over Actos adverse event reporting, Ge alleged that an internal database recorded 100 cases of bladder cancer, but the number reported to the FDA was 72, which she termed a “serious discrepancy.” The US Department of Justice, by the way, failed to intervene, or join, the lawsuits, which cited violations of the False Claims Act.
However, US District Court Judge dismissed both lawsuits. In his 12-page ruling, he wrote that Ge failed to allege specific details of any claims that were false and, therefore, prompted overpayment by federal or state healthcare programs. Specific evidence, such as is required under rule 9b of the federal law to prove a violation occurred (here is the ruling).
"Instead of providing details of allegedly false claims, (Ge) apparently suggests that all of the claims for these particular drugs in the relevant years were rendered false by Takeda’s failure to properly report adverse events. (Ge), however, has failed to provide the specific factual allegations necessary to support the inference that the FDA would have withdrawn approval from all four drugs immediately upon receiving the proper adverse reports," he wrote.
We asked Ge's attorney for comment and will update you accordingly.
gavel pic thx to walknboston on flickr