Late last month, a Los Angeles jury decided that Takeda executives were in fact aware of the cancer risk from its flagship product, Actos – and ordered the Japanese pharmaceutical giant to pay $6.5 million to plaintiff Jack Cooper and his wife. Cooper's lawyers presented the court with evidence demonstrating that Takeda executives were aware of the risks associated with Actos as far back as 2004 – yet spent the next seven years hiding this information from regulators. Ironically, this is essentially what whistleblower Helen Ge, a former Takeda medical reviewer, told to a judge several months ago when she filed a qui tam case. The judge threw her case out because her allegations had been insufficiently specific.
To put the amount of the award in perspective, sales of Actos totaled $4.5 billion between April 2010 and March 2011 – accounting for 27% of the company's revenue. The court-ordered award in the present case amounts to .0014% of that figure. It's the equivalent of fourteen cents out of every hundred dollars – probably less than their executives and major stockholders spend on lunch every day.
Of course, need we say that legally, there has been no criminal wrongdoing and not one executive will do any prison time?
It should also come as no surprise that Takeda executives are whining about the verdict, which one plaintiff's lawyer agrees is “devastating to the company” - particularly as this ruling is certain to have a profound effect on the 3,000 or so lawsuits lined up right behind it. Takeda executive Kenneth Griesman “respectfully disagrees with the jury's verdict,” adding that the company “empathizes with patients like Mr. Cooper,” but insists that the “acted responsibly.” Griesman told PR Newswire that Takeda officials “...promptly disclosed ACTOS safety data to the U.S. Food & Drug Administration and other regulatory authorities and provided updated product information to health care professionals and patients.”
That statement seems to fly in the face of internal company emails produced by plaintiff's attorney Michael Miller during the two-month trial, in which executives pressured their colleagues to “persuade the US Food and Drug Administration not to demand increased warnings about bladder cancer on Actos' label.”
In the meantime, despite the company's “empathy” for Mr. Cooper, paying .14¢ out of every hundred dollars for Mr. Cooper's pain, suffering and medical expenses seems to be too much of a burden for the multi-billion dollar pharmaceutical corporation. They have asked the judge in the case, the Honorable Judge Kenneth Freeman, to throw the case out and reverse the jury's decision. In the event that Judge Freeman lets the jury's decision stand (and there is no way to predict how he will rule), Takeda attorneys are considering their options for appealing the case to a higher court – which is not unusual in these types of cases.
Nonetheless, as the first such trial in the matter of Actos and Takeda's liability, it is a “bellwether” trial – and the L.A. jury's verdict does not bode well for the corporate defendant's impending legal battles.
Hofilena, John. “Japanese Pharmaceutical Company Takeda Loses US Cancer Lawsuit.” Japan Times, 29 April 2013.
N/A. “Takeda Responds to Verdict in Diabetes Drug Case.” Sacramento Bee, 26 April 2013.
Staton, Tracy. “Jury Hits Takeda With $6.5M Judgment in First Actos Liability Case.” Fierce Pharma, 29 April 2013. Available at http://www.fiercepharma.com/story/jury-hits-takeda-65m-judgment-first-actos-liability-case/2013-04-29 .
Learn more about Actos Lawsuits