The executives at Takeda Pharmaceuticals may be gloating over their recent victory in which a California judge overturned a $6.5 million judgment in favor of the plaintiff - but they shouldn't get too smug about it. Currently, some 3,000 lawsuits have been filed in U.S. federal courts against the Japanese-based pharmaceutical company, and according to some estimates, there could be as many as 7,000 more yet to come.
Actos (pioglitazone) is a medication designed for the treatment of Type-2 (“adult onset”) diabetes. It differs from Type 1 (“childhood onset”) diabetes. The latter is a genetic condition that runs in families, skipping generations; the pancreas in these patients simply does not produce insulin, the hormone that regulates glucose in the blood.
Type 2 diabetics may also be genetically predisposed to the condition; however, these patients have a much different problem. The pancreas is functioning, however, the body's cells have developed resistance to insulin. While the result is the same, the mechanism is much different.
Drugs such as Actos, Avandia, Byetta and Januvia are intended to “open up” cell receptors, making them more responsive to insulin (to read a more detailed explanation of how these drugs work, go here). For some reason, Actos and other glitazone drugs appear to trigger the formation of cancerous tumors in some patients (it now seems that Byetta and Januvia may be suspect as well, and law firms around the country are preparing to pursue litigation against the manufacturers).
Judge Kenneth Freeman's decision to nullify the jury's verdict in the first Actos case is a setback – but those in the legal community as well as plaintiffs are viewing it as a temporary one. The fact that the jury in the case did find in favor of the plaintiff is seen as “encouraging.” The fact is that the verdict was overturned on a technicality based on the judge's opinion of the medical expert's testimony and a precedent (known as the “Daubert Standard”) that allowed him such latitude – despite the fact that Judge Freeman has no medical training. Currently, the plaintiff's attorney in the case are seeking to have the jury's verdict reinstated.
Another bizarre piece of information has also recently come to light. According to a story in the Wall Street Journal, new research on Avandia – a drug manufactured by Glaxo-Smith-Kline (GSK) – does not raise the risk of cardiac arrest as was once believed. Avandia, which was Actos' major competitor, was taken off the market for three years because of this perceived risk. However, recent research at Duke University now indications that Avandia is safe, at least in respect to cardiac events.
The troubling aspect here is that the cardiologist who did the original study indicating patients taking Avandia were more than 40% more likely to suffer heart attacks had received his funding from (surprise, surprise) Takeda Phamraceuticals.
Add to this compelling evidence that Takeda executives were aware of the risks of its flagship product, yet pressured sales people to downplay those concerns and use aggressive tactics with potential customers – and it appears that while the Japanese pharmaceutical giant may have won the opening battle, they may very likely wind up losing the war.
Finken, Tracy. “First Actos Lawsuit Verdict Overturned.” The Legal Examiner, 30 May 2013.
Gott-Roth, Diana. “Avandia win a Pyrrhic Victory for Consumers.” Wall Street Journal, 14 June 2013.