Takeda and Eli Lilly fall foul of jury in Actos trial

For Mark Lanier, it was the biggest victory of his career as a plaintiff's lawyer: a $9bn award for punitive damages against Takeda of Japan and Eli Lilly of the US for concealing possible health risks linked to their blockbuster diabetes drug Actos.

"It's a bright day for justice," he told the Financial Times on Tuesday. "The jury sent a clear message ringing down the telephone lines to Osaka that there is a right way to do business and a wrong way to do business."

A federal jury in Lafayette, Louisiana, decided late on Monday that Takeda and Eli Lilly had hidden evidence suggesting that their Actos diabetes medicine might expose patients to a heightened risk of bladder cancer.

As punishment, they meted out the biggest damages award yet levied against big pharma and one of the largest against companies of any kind.

Even Mr Lanier acknowledges that these sums - $6bn to be paid by Takeda, the drug developer, and $3bn by Eli Lilly, its former US marketing partner - are almost certain to be reduced by a judge.

But the ruling will offer encouragement to thousands of other Actos patients queuing up to sue, and will increase pressure on the drugmakers to settle.

"Takeda and Lilly thought they could sweat these cases out," says Mr Lanier. "Instead, it is the plaintiffs who are making the companies rue their decision to take this to court because it has exposed behaviour which is simply unacceptable."

That behaviour, jurors heard, included destroying documents that showed Takeda executives were aware of safety concerns surrounding Actos early in its development.

Takeda has vowed to "vigorously challenge" the Louisiana ruling - the first federal court case involving Actos - and insists the drug is safe.

However, the case has highlighted both the temptation for drugmakers to conceal potential health risks surrounding new medicines, and the legal and reputational danger they face when such practices are exposed.

"The cover up is often worse than the problem itself," says Ben Goldacre, a British doctor who has campaigned for greater transparency in the drugs industry.

"It is very common for doctors to prescribe treatments that have very problematic side effects but they do it with their eyes open to the trade off between risks and benefits. When industry withholds data about those risks medics and patients are not able to make those informed decisions."

Big pharma has faced a series of controversies over drugs, such as Vioxx, a pain reliever marketed by Merck of the US, which was withdrawn in 2004 because of concern about an increased risk of heart attack and stroke after being prescribed to more than 80m people.

Others drugs, such as Tamiflu, an antiviral flu treatment developed by Roche of Switzerland, have provoked questions over whether the trial data supports the claims made about their health benefits.

In response to mounting pressure for greater transparency, several big pharma companies including Roche, GlaxoSmithKline of the UK and Johnson & Johnson of the US have made commitments over the past year to open their trial data to greater scrutiny.

Dr Goldacre says that, while the industry is moving in the right direction, there is much further to go. Pharma companies remain wary of jeopardising their intellectual property by giving away too many secrets from the development process. But Dr Goldacre says it is crucial that independent scientists and doctors - not just regulators - have access to all the data surrounding new drugs.

"In many cases such as Vioxx the problem was missed by regulators and only spotted later by doctors and academics," he says. "Assessing the risks and benefits in drug trial data is an extremely complex business and benefits from having many eyes."

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Carl Tobias, law professor at the University of Richmond, says lessons from the Takeda case are not limited to big pharma. Toyota of Japan last month agreed a $1.2bn fine with US prosecutors for misleading regulators and consumers over vehicle safety.

"Both these cases show that companies need to become more transparent about the data they hold about risks to consumers," said Prof Tobias.

Mr Lanier praised GSK for being more open about the risks surrounding its Avandia diabetes drug when evidence emerged of links to heart attacks and strokes. These concerns led to a near-blanket ban on the drug by US and European regulators in 2010 - a decision that cleared the path for Takeda's success with Actos.

"I feel sorry for GSK," says Mr Lanier. "Avandia got run off the road by Actos because Takeda hid the possible link with cancer."

The US Food and Drug Administration warned in 2011 that taking Actos for more than a year might increase the risk of bladder cancer. Takeda disputes that there is any proven link between its drug and the plaintiffs' cancers and says the health benefits of Actos outweigh the risks.

Dr Goldacre says the industry's record has left medics and patients sceptical of such assurances. "There are still some pharma CEOs that seem to think they can continue behaving as if it's the 1980s. They need to recognise that society's expectations have changed."

. . .

Ruling highlights 'disturbing' tactics of drug groups

"The breadth of Takeda leadership whose files have been lost, deleted or destroyed is, in and of itself, disturbing."

That was the damning ruling from US district Judge Rebecca Doherty in Louisiana as she ordered Japan's Takeda Pharmaceutical and Eli Lilly of the US to pay a combined $9bn in punitive damages after a federal court jury found the two drug companies knew and covered up the risks associated with Actos, a drug used to treat diabetes, writes John Aglionby. Takeda and Lilly have said they will challenge the ruling vigorously.

Among some of the other findings:

? "Documents were being destroyed as late as 2011, in the face of an actual bladder cancercase having been made known to Takeda, and unquestionably, after the "general Actos products liability" litigation hold of 2002 [on documents and electronic data related to Actos].

? The judge ruled that it is "undisputed" there are a total of 46 custodial files that cannot be located - or have not been produced - by Takeda. The court alleged 38 of these custodial files were deleted from the active Takeda servers after 2002.

? One more troubling of these missing files was that of Masahiro Miyazaki, who rose to be pharmaceutical research associate director after working for Takeda for 30 years and left the company in April 2011. While Mr Miyazaki's email account was deleted on July 1, 2011, his personal computer data were deleted on March 22, 2011, before he left the company.

? The ruling stated that Takeda first told plaintiffs' lawyers in May 2013 that a so-called litigation hold order not to destroy data related to Actos had been issued in February 2011. It later emerged that the first litigation hold order had been issued nine years earlier.

? The judge highlighted that when Takeda was asked to give evidence in a deposition, "only one witness was presented and that witness had no personal or first hand corporate knowledge of any kind of any of the topics about which he was questioned" [judge's emphasis]. She added that the testimony of that witness, Daniel Regard, an external consultant, "does not illustrate a strong grasp of the IT procedures and their interplay with litigation hold policy at the company".

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