Takeda Consultant Loses Two Whistleblower Suits

Helen Ge is now 0-for-2. Earlier this month, a federal judge tossed two different whistleblower lawsuits that the former drug safety consultant had filed against Takeda Pharmaceuticals. She alleged the drugmaker misrepresented or altered descriptions of adverse events for the Uloric gout treatment and failed to report instances of bladder cancer and congestive heart failure concerning the Actos diabetes pill to the FDA.

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has failed to provide the specific factual allegations necessary to support the inference that the FDA would have withdrawn approval from all four drugs immediately upon receiving the proper adverse reports," he wrote.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

11 Comments

Nov 20, 2012 - 12:06pm
............. I read this a week or two ago in several good pubs... What are you gonna publish next??? Pres Obama won the election?
Nov 20, 2012 - 12:24pm
@ ramsey - may I observe that such an incident (which was actually news to me) should be grounds for an immediate refund of the price of your paid subscription to this site.
Thanks Ed you are always on the ball.

Actos is produced by Takeda Industries and co-marketed by Eli Lilly.

Eli Lilly Zyprexa can *cause* diabetes. I took Zyprexa olanzapine a powerful Lilly schizophrenic drug for 4 years it was prescribed to me off-label for post traumatic stress disorder was ineffective costly and gave me diabetes. Eli Lilly's #1 cash cow Zyprexa drug sale $67 billion dollars so far,has a ten times greater risk of causing type 2 diabetes over the non-user of Zyprexa. So,here we have a conflict of interest that this same company Eli Lilly also is a big profiteer of diabetes treatment.

(Actos works as an insulin *sensitizer*)

Sooooo,Eli Lilly pushes a drug (Zyprexa) that can cause diabetes.... then turn around sell you the drugs (Actos) to treat the diabetes that in turn can cause cancer! What a terrible conflict of interest! -- Daniel Haszard FMI http://www.zyprexa-victims.com

Hi Not-The-Real-Ramsey,

Thanks, as always, for stopping by. To answer your question, as the only person in the Pharmalot newsroom, I am spread thin most days and, therefore, cannot see or get to everything as quickly as I would like.

Candidly, I missed this ruling, but since I twice wrote earlier this year about the lawsuits filed by Ge, I thought I owed to the audience -as well as Takeda and Ge - to close the loop and go on record with a piece about the ruling.

It is not as timely as I would like, but I did not feel it was best to ignore this development. However, if you are unhappy with my attempt to play catch up and offer readers some consistency in coverage, then you are free to not visit.

Regards ed

Nov 20, 2012 - 2:27pm
Ed, Just for the record I am a former Takeda employee and am very disappointed that Ge's lawsuits were dismissed. There is a lot more to this story, as indicated by Mr. Haszard's comments. Your website is terrific and I'm grateful to be able to read your knowledgeable comments and/or articles every day.
Nov 20, 2012 - 2:35pm
Really Catpower? Lilly stopped promoting Actos in 2004. Now they are being sued for breach of contract by what was Amalyn. They promote diabetes products for decades and now because of some silly Zyprexa story there is a giant Takeda/Lilly conspiracy to give everyone diabetes and cancer? The judge threw out both suits because they are from an unhappy employee. Where is the boxed warning for cancer from the FDA? They have had 5 years to comb through the data...take your grievance and conspiratorial subplots up with them.
Nov 20, 2012 - 3:01pm
Ge and her husband are frauds, as I have repeatedly said. The court has vindicated my expert judgement.
Nov 20, 2012 - 7:01pm
The fact that a federal judge dismissed these cases because they did not meet the requirements of rule 9b, does not mean the company did not avoid reporting fewer side effects than actually occurred.

False claim suits are one thing, deliberately misleading the FDA on adverse events is something else.

Everyone can make their own judgement.

Nov 20, 2012 - 9:52pm
Compare this to Roche, who failed to report 15000 adverse events and they were warned by the EU regulatory authorities!!! Still action is pending!!
Nov 21, 2012 - 10:47am
Ed, Thanks for closing the loop. While I may have seen in passing that both suits were thrown out, I don't recall for sure...or even care. The reason I read Pharmalot is for your unique perspective and slant on situations as well as the often intriguing and frequently ascerbic comments...not for current events. I like this community you have formed. I even relish that little thrill of indignation when someone takes a dig at our fearless leader or one of our eclectic band of followers. I can laugh or growl, but I always appreciate the dialogue and the humor. Have a wonderful Thanksgiving, and thank you all for being a part of my information highway.
Nov 21, 2012 - 6:45pm
I have more reason to give thanks this year: another grifter and ambulance chaser stopped in their tracks. Helen Ge(aka Huilen Ge)and her husband Bing Du have a history of suing the unfortunate corporations who hire them. It didn't take the amazing Kreskin to foresee that this suit would be thrown out. How incompetent is the former federal prosecutor, Mr Sullivan, who filed this scam? Catpower: That you are a former employee does not make you uniquely qualified to opine on the merits of the charges. I, too, worked at TGRD and completely reject Helen/Huilen Ge's story. I would suspect you are a disgruntled terminated employee just as Ms.Ge was (sorry Helen; I don't consider you a doctor)