A whistleblower lawsuit against the makers of the diabetes drug Actos could make it easier for consumers harmed by the medication to seek relief in civil suits against the manufacturer.
- Lawsuit claims drugmaker Takeda failed to disclose cancer and heart failure related to usage of Actos medication
- Employee brought up underdisclosure and was promptly fired
- Users of Actos who suffered side effects could have personal injury claim
Dr. Helen Ge, a medical doctor and experienced drug safety consultant, was hired by the pharmaceutical company Takeda in 2008 to help ensure product safety as well as proper review and testing of negative reactions to the company’s drugs. At the time, Takeda’s crown jewel was a diabetes medicine known as Actos.
Actos was supposed to be a miracle drug, hailed as a safer alternative to Avandia, which had recently seen its market share plummet after being linked to heart attack, heart failure and stroke. Actos was bringing in billions in sales, and accounting for half of Takeda’s revenue.
However, during Ge’s tenure at the drug company, she noticed a disturbing trend. Of more than 100 reports of bladder cancer reported to the company by Actos users, only 72 were relayed to the FDA. Ge also claimed that hundreds of congestive heart failure events went unreported.
However, when she went to her superiors with her concerns, Ge was fired, in January 2010. She filed a lawsuit later that year, which was unsealed last month.
Culture of Fraud
In an 111 page complaint, Ge lambastes Takeda’s “culture of fraud,” alleging, among other things, that the company suppressed reports of bladder and other cancers, suicidal ideation, renal failure, strokes and various heart problems. Actos, the lawsuit contends, is actually more dangerous than Avandia, despite its marketing campaign to position itself as a safer alternative.
Daniel C. Burke
“What the lawsuit does is essentially says that these things were happening in their clinical testing, within their knowledge, to patients and they weren’t reporting those adverse events properly,” says Daniel Burke, senior litigation counsel at national personal injury firm Parker Waichman, which is taking on cases for individuals who were harmed by Actos. “It essentially alleges that the Actos drug was more dangerous than some of the other drugs that were in the same class. Although Actos was being advertised as safer than other drugs, there was evidence it may have been as or more dangerous.”
Not only were an unknown number of consumers harmed by taking a drug without all the information about its side effects, Medicare, Medicaid and other government health programs paid out for tens of thousands of prescriptions it never would have approved had the manufacturer been honest about the dangers of the drug, the lawsuit alleges.
The federal government’s interest allows Ge to bring her complaints to them and be protected as a whistleblower under the False Claims Act. The lawsuit is filed on behalf of the federal government and 23 states to recover payments made to Takeda based on the company’s allegedly fraudulent claims.
Individual Claims to Follow
Actos is just one of numerous prescription drugs currently the subject of active or potential litigation. The stories become repetitive: Drugmaker downplays or fails to disclose harmful and deadly side effects of their product, consumers seeking medical treatment come away more ill than they started and the lawsuits start to pile up.
For consumers who think they could have been harmed by using Actos, the Helen Ge lawsuit could help make their case more clear. “They weren’t reporting things. Unsealing the whistleblower complaint certainly brought that to light,” Burke says.
Actors users who think they have a case should consult with a law firm experienced in handling drug cases and review their history with an attorney to see if a lawsuit is a possibility. “Go over when you took the drug, how long you took the drug, when you were diagnosed,” Burke explains. “Folks who developed congestive heart failure, or had heart attacks or strokes are folks we’d like to talk to as potential plaintiffs.”