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Takeda loses cancer suit over Actos

Drugmaker told to pay dying U.S. man $6.5 million for slack risk warnings

Bloomberg

Takeda Pharmaceutical Co. owes $6.5 million in damages to a California man who said Asia’s largest drugmaker failed to warn consumers its Actos diabetes drug could cause cancer, a jury said in the first of more than 3,000 lawsuits over the medication to go to trial.

Jurors in state court in Los Angeles deliberated for more than five days before finding Osaka-based Takeda didn’t provide adequate bladder-cancer warnings to Jack Cooper and his doctors about Actos.

Cooper, 79, took the drug for more than four years before being diagnosed with the disease in 2011.

“I hope this verdict makes Takeda realize it’s time to solve the problems with Actos that they’ve known about for years,” Michael Miller, one of Cooper’s lawyers, said after the jury’s ruling was announced.

The verdict comes almost three months after Takeda won U.S. regulatory approval for Nesina, a diabetes drug to replace Actos, which lost patent protection last year.

Actos sales peaked in the year ended March 2011 at $4.5 billion, or 27 percent of Takeda’s revenue at the time, according to data compiled by Bloomberg.

Takeda officials said Friday they’ve filed motions seeking to have the verdict and the entire case thrown out and to have Judge Kenneth Freeman review those requests next week.

“We respectfully disagree with the jury’s verdict and believe we showed in this trial Takeda acted responsibly” in its handling of Actos, Kenneth Greisman, general counsel for Takeda’s U.S. unit, said in a telephone interview.

Takeda faces more than 3,000 suits alleging Actos caused bladder cancer or other ailments, according to court records. Cooper’s suit was among those gathered before Freeman in Los Angeles. Other cases are in state court in Illinois.

More than 1,200 suits have been consolidated before a federal judge in Louisiana for pretrial information exchanges. The first federal case is set for trial in January, according to court filings.

Lawyers for former Actos users contend in court filings that Takeda researchers ignored or downplayed concerns about the drug’s cancer-causing potential before it went on sale in the U.S. in 1999, and misled U.S. regulators about the medicine’s risks.

Cooper’s case was heard on an expedited basis after Freeman found the former Pacific Bell Telephone Co. cable splicer was “gravely ill,” according to court filings.

During the almost two-month trial, Cooper’s lawyers told jurors that while Takeda’s own research found links between Actos and bladder cancer as early as 2004, company officials didn’t tell regulators about the findings for seven years.

Miller, Cooper’s lawyer, produced internal Takeda email messages in which executives urged colleagues to persuade the U.S. Food and Drug Administration not to demand increased warnings about bladder cancer on Actos’ label.

“Actos is the most important product for Takeda and therefore we need to manage this issue very carefully and successfully not to cause any damage for this product globally,” Takeda executive Kiyoshi Kitazawa said.

Even after FDA officials asked the drugmaker in 2005 and 2006 to update warnings about Actos’ health risks, Takeda executives “stalled and delayed” because the company “was making $1.6 billion a year” on the drug, Miller argued.Sara Gourley, one of Takeda’s lawyers, countered FDA researchers hadn’t concluded Actos caused bladder cancer. The drug didn’t cause Cooper to contract the illness, she said.

The company contends Cooper was more likely to develop bladder cancer because he was an elderly male former smoker who suffered from diabetes. That placed him in high-risk categories for the disease regardless of his Actos use, she said.

“The evidence is not only clear, it is overwhelming, that Mr. Cooper is in the highest-risk groups, and that his bladder cancer had nothing to do with Actos,” Gourley told jurors.

Still, jurors found Takeda officials “failed to adequately warn” Cooper’s doctors about Actos’ cancer risk and that failure was “a substantial factor” in causing Cooper harm, according to court filings.

Jurors awarded $5 million in compensatory damages to Cooper and $1.5 million to his wife. The panel rejected the couple’s request that Takeda face a punitive-damage award, according to the filings.

Losing the first of more than 3,000 Actos suits that are slated for trial is “a disaster for Takeda,” Hunter Shkolnik, a New York-based lawyer for former Actos users, said in an interview Friday.

“They will be facing back-to-back trials of stronger cases next year,” Shkolnik said. “This loss is devastating to the company.”

Greisman countered that the company will continue to “vigorously defend” against Actos suits and will evaluate cases individually as they come up for trial.

  • Wayne

    Big Pharma needs to be regulated more severely all the way around the board.

  • Spudator

    Here we go again: another example of the ancient Japanese art of hiding inconvenient truths. Unfortunately, as this example shows, these truths have an even more inconvenient habit of resurfacing sooner or later, and then the damage they do to Japan or the Japanese institutions involved is far greater than it would have been had the truth been admitted and dealt with sincerely in the first place.

    I know it’s only human to resort to lying and deceit to escape blame and protect one’s interests when faced with exposure of one’s wrongdoings. So it’s probably unfair to single out Japan for criticism in this regard. But what I’ve always found incomprehensible about the predisposition of Japanese institutions to try to pull the wool over everyone’s eyes is how they’ll do it even when the truth is glaringly obvious. They really must think people are idiots. We’ve seen this kind of contempt for people’s intelligence in, for example, nationalist denials of wartime acts such as forced prostitution and the Nanking Massacre and, more recently, in Tepco’s denials of responsibility for the Fukushima disaster. Now we find that Takeda Pharmaceuticals believed that, if they could keep a lid on the issue long enough, the truth that one of their drugs was potentially carcinogenic would never come to light. How cluelessly naive can you get?

    When Apple suffered global embarrassment because of the Mapplegate fiasco, CEO Tim Cook did the only logical and decent thing: he publicly admitted Apple had screwed up, apologised, and promised to fix the problem. I bet if Apple were a Japanese company, that would never have happened.

    • blahblahblah

      Spudator, honestly your comment is ridiculous. There a lot of big companies has something they try to cover up or shoulder the blame to others (ie BP with the oil spill, Apple with the Antennagate, etc). To single out Japanese companies as the only ones that do this is ridiculous. Seriously, if you have an issue with Japan, then just leave and go somewhere else.

      • Spudator

        Well, well; talk about synchronicity. It was only yesterday that I was wondering how long it would be before somebody responded to one of my posts with the old “if you don’t like it here, go home” line. And right on cue, blahblahblah, you deliver the goods. Way to go! You deserve a prize for being so fearlessly predictable.

        You know, you really should read things more carefully. My point, which I think I expressed quite clearly in the second paragraph of my post, wasn’t that Japanese institutions are more prone to whitewashing and covering up their wrongdoings than their counterparts in other countries, but that they use such tactics when nobody else would even contemplate using them because the truth has become incontrovertible public knowledge. Were it not so insulting to the intelligence, it would be laughable that they continue to try to deceive everyone when their deceptions no longer have a hope in hell of fooling anyone.

        As an example, I gave right-wing denials that Japan was the aggressor in World War II, this being quite pertinent in view of Prime Minister Abe’s recent pronouncements on what constitutes aggression. It’s beyond belief that the LDP has the effrontery to continue to trot out these offensive lies about Japan’s wartime culpability when the whole world is in no doubt whatsoever about (1) the acts committed by Japan during the war, such as the Nanking Massacre, forced prostitution, and human experimentation by the Imperial Japanese Army’s Unit 731; and (2) how Japan, along with its pals—and authors of the Holocaust—Adolf Hitler’s Nazis, was one of the bad guys in the conflict.

        It’s because of the way Japan, in the face of the undeniable truth, has continued to lie shamelessly about its wartime behaviour in Asia that the country is now despised by its Asian neighbours, especially China, and doesn’t have any friends in the region. The current imbroglio with China over the Senkakus would probably never have happened if Japan had, like Germany, honestly confronted, owned up to, and shown contrition for its past misdeeds. Instead, with the Senkakus problem going from bad to worse and relations with China deteriorating alarmingly, Prime Minister Abe decides that the answer is to throw another can of petrol on the fire by yet again denying Japanese wartime aggression. This is the behaviour of a complete imbecile. I cannot for the life of me imagine the head of government of any other country acting in such a grossly dishonest, confrontational and tactless manner—well, apart from North Korea’s Kim Jong-un.

        Yes, you’re right about Apple and BP trying to avoid the truth about their respective Antennagate and Deepwater Horizon fiascos. As I said in my original post, “it’s only human to resort to lying and deceit to escape blame and protect one’s interests when faced with exposure of one’s wrongdoings.” Regrettably, companies and governments the world over do this. What you have to bear in mind, though, is that once Apple and BP saw that the truth had become indisputable, they stopped trying to hide it and took the blame fairly and squarely. That’s the only logical option once the truth is out, and Apple and BP are run by logical, rational people. Only an imbecile or a madman continues to lie once they’ve been found out. In fact, Apple has clearly learned its lesson from Antennagate because, when Mapplegate struck, Tim Cook didn’t even attempt a whitewash. I’ve no doubt that BP has also learned its lesson.

        Now compare Apple’s and BP’s ultimate acceptance of the truth and their ability to learn from past mistakes with the LDP’s continued whitewashing of Japan’s war record and, to take another current issue, the Japanese whaling industry’s unceasing yet futile attempts to misrepresent commercial whaling as scientific research. In both cases—war and whaling—the truth is out, the game is up, and the lies no longer have any power to deceive. The logical response, were the government and the whaling industry run by rational people, would be to stop lying and come clean. Instead, these two institutions keep churning out the lies. What was it Einstein said about insanity consisting of doing the same thing over and over again and expecting different results? How can such insanity serve the interests of Japan?

        As a result of this insanity, Asia already hates Japan; and now, because of the Antarctic whale slaughter and the lies Japan tells to justify it, Australia and New Zealand are beginning to hate Japan, too. This is the kind of thing I meant when I explained, in the first paragraph of my original post, how hiding inconvenient truths can backfire because those truths eventually resurface and cause greater damage than they would have had they been owned up to and handled properly in the first place.

        Finally, let me deal with the underlying message of your post. You seem to be saying that I shouldn’t pick on Japanese companies for their dishonesty because companies the world over are dishonest. Sorry, but I don’t see the logic of that. I agree with you that many foreign firms are dishonest, even to the point of criminality; just look at the terrible damage done to ordinary people around the world by U.S. and U.K. banksters. But how foreign companies behave has no bearing whatsoever on how Japanese companies should behave. The only question that matters is whether or not it’s acceptable for Japanese companies to practise deceit. I say it’s not. Deceiving people is immoral. It’s plain wrong. Surely you don’t disagree with that.

        Also, you obviously feel I have no right to criticise anything to do with Japan because I’m not Japanese myself. Again, your logic escapes me. I have every right in a country that allows free speech to speak my mind about any aspect of that country I disapprove of so long as I’m not forcing my opinions down anyone’s throat. How is my nationality important? If you don’t like my opinions, feel free to use your own right to free speech to tear them to shreds; but please don’t demand I practise self-censorship.