弁護士谷直樹/医療事件のみを取り扱う法律事務所のブログ

カリフォルニア州地裁評決,アクトスの膀胱癌リスクを警告しなかった武田薬品に650万ドルの賠償を認める

カリフォルニア州地裁の陪審は,武田薬品工業株式会社に対し,糖尿病薬アクトスの膀胱癌リスクについて十分な警告を行わなかったとして,650万ドル(約6億3600万円)の損害賠償を認める評決を下しました.陪審の評決ですので,未だ最終結論ではないのですが.

同社が2003年,医師12人に対し,密かにアンケート調査を実施し,命にかかわる病気(がん)の発症リスクについて警告が書かれた糖尿病薬を患者に処方するかどうかを調査し,ぼうこうがんの警告を表記した場合,アクトスの売り上げに壊滅的な影響が及ぶことを同社は認識した,という証拠が提出されていました.

Bloomberg「Japan drug maker Takeda loses US lawsuit  Takeda Pharmaceutical is ordered to pay a patient US$6.5 million for failure to warn of cancer risk from diabetes medicine Actos」(28 April, 2013) は,次のとおり伝えています.

「Takeda Pharmaceutical of Japan must pay US$6.5 million in damages to a California man who said Asia's largest drug-maker failed to warn consumers that its Actos diabetes drug could cause cancer, a jury ruled in the first of more than 3,000 lawsuits over the medication to go to trial.

Jurors in state court in Los Angeles found that Osaka-based Takeda did not provide adequate bladder-cancer warnings to Jack Cooper and his doctors about Actos. Cooper, now 79, took the drug for more than four years before being diagnosed with the disease in 2011.

Takeda officials said they had filed motions seeking to have the verdict and the entire case thrown out and that Judge Kenneth Freeman review those requests this week.

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 played down concerns about the drug's cancer-causing potential before it went on sale in the US in 1999, and misled US regulators about the medicine's risks.

Cooper's case was heard on an expedited basis after Freeman found he 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 did not tell regulators about the findings for seven years.

Michael Miller, one of Cooper's lawyers, produced internal Takeda e-mails in which executives urged colleagues to persuade the US Food and Drug Administration not to demand increased warnings about bladder cancer on Actos' label.

Even after FDA officials asked the drug-maker in 2005 and 2006 to update warnings about Actos' health risks, Takeda executives "stalled and delayed" because the company "was making [US]$1.6 billion a year" on the drug, Miller argued.

The company contends Cooper was more likely to develop bladder cancer because he was an elderly male former smoker who suffered from diabetes.

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 harm, according to court filings.

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


ちなみに,インターナショナル・アライアンス社による企業イメージ調査「日本における最も賞賛される製薬企業」では,武田薬品工業株式会社が調査開始以来14年連続首位なのですが.

【追記】

ブルームバーグ「武田薬:アクトスでの陪審評決退ける判断勝ち取る-立証不十分」(2013年5月1日)は,次のとおり報じました.

「武田薬品工業 の糖尿病治療薬「アクトス」でがんを発症したとして米カリフォルニア州の男性が同社を訴え、陪審が650万ドル(約6億3200万円)の損害賠償を認める評決を下したことについて担当判事は1日、男性側が同薬服用とがんとの因果関係を十分に立証できていないとして同評決を退けた。

ロサンゼルスにあるカリフォルニア州地裁のケネス・フリーマン判事は、この男性ジャック・クーパー氏(79)の弁護士は同氏のぼうこうがんとアクトス服用との関係を立証できておらず、評決を下す機会を陪審に与えるべきではなかったとの判断を示した。

同判事は27ページに及ぶ文書で、クーパー氏がアクトス服用でぼうこうがんを発症したとしていた医師の証言が「本質的に信頼を置けない」ことが分かったとし、訴えを退けることが正当化されると指摘した。

武田の米国部門のケネス・グリースマン法務顧問は同日の電話取材に対し、「クーパー氏の主張には裏付けがないとの裁判所の判断に同意する」と述べた。

クーパー氏の弁護士の1人マイケル・ミラー氏はフリーマン判事の判断を不服とし、上訴する意向を明らかにした。 」



Bloomberg「Takeda Gets $6.5 Million Diabetes-Drug Verdict Thrown Out」( May 2, 2013)は,次のとおり報じました.

「Takeda Pharmaceutical Co. (4502) persuaded a judge to throw out a $6.5 million jury verdict over its Actos diabetes drug because lawyers for a California man didn’t produce sufficient evidence to show his cancer was caused by the medication.

Judge Kenneth Freeman in state court in Los Angeles ruled today Jack Cooper’s attorneys weren’t able to properly link the former telephone-company worker’s bladder cancer to his Actos use and jurors shouldn’t have had a chance to return their verdict against Asia’s largest drugmaker. It was the first of more than 3,000 lawsuits over the medication to go to trial.

Testimony from a doctor who concluded Cooper’s Actos use caused his bladder cancer turned out to be “inherently unreliable” and that justified throwing the case out, Freedman said in a 27-page ruling.

The verdict came 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.

“We agree with the court’s finding that Mr. Cooper’s allegations were not supported by the evidence,” Kenneth Greisman, general counsel for Takeda’s U.S. unit, said in a telephone interview today.

Law Misinterpreted?

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.

Michael Miller, one of Cooper’s lawyers, said he would appeal Freeman’s post-verdict ruling throwing out the case.

“We believe the court has misinterpreted the law and feel confident the decision will be reversed,” Miller said in a telephone interview.

Former Actos users contend in court filings 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, 79, took the drug for more than four years before being diagnosed with bladder cancer in 2011. He worked as a cable splicer for Pacific Bell telephone, according to court filings.

January Trial
Takeda’s lawyers argued during the almost two-month trial that 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, the company’s attorneys told jurors.

Takeda is scheduled to face an Actos trial in January that is part of the consolidation of cases before a federal judge in Louisiana, according to court filings.

Mark Lanier, who won a $253 million verdict against Merck in 2005 in the first trial over the company’s withdrawn Vioxx painkiller, is slated to try the case for plaintiff Ida St. John.

The Los Angeles case is Cooper v. Takeda Pharmaceuticals America Inc., CGC-12-518535, California Superior Court (Los Angeles). 」



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by medical-law | 2013-04-30 06:08 | 医療事故・医療裁判