Pharmaceutical Drug Litigation Updates

Takeda’s Actos Diabetes Drug Tied to Cancer, Jury Is Told

Quoted from http://www.businessweek.com/news/2013-04-15/takedas-actos-diabetes-drug-tied-to-cancer-jury-is-told

Takeda’s Actos Diabetes Drug Tied to Cancer, Jury Is Told

By Valerie Reitman, Phil Milford and Jef Feeley on April 16, 2013

Takeda Pharmaceutical Co. (4502), Asia’s biggest drugmaker, hid the cancer risks of its Actos drug to protect billions in sales, a jury was told in the first of more than 3,000 lawsuits over the diabetes medication to go to trial.

While Takeda’s internal Actos studies uncovered links to bladder cancer as early as 2004, the company didn’t alert U.S. regulators until seven years later, Michael Miller, a lawyer for plaintiff Jack Cooper, told a state court jury in Los Angeles yesterday. The company kept quiet to protect more than $1.6 billion in annual Actos sales, he added.

“Selling diabetes drugs is big business in America,” Miller said in closing arguments in the trial of Cooper’s suit against Takeda. “There’s a lot of money to be made. But companies are not allowed to downplay the risk. Patient safety is the No. 1 thing.”

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Takeda Put Actos Sales Ahead of User Safety, Witness Says

Quoted from http://www.bloomberg.com/news/2013-03-05/takeda-put-actos-sales-ahead-of-user-safety-witness-says.html

Takeda Put Actos Sales Ahead of User Safety, Witness Says

By Jef Feeley - Mar 6, 2013 12:01 AM ET

Takeda Pharmaceutical Co., Asia’s biggest drugmaker, put sales of its Actos diabetes drug ahead of concerns about consumer safety, a witness testified in the first trial over claims the medicine caused cancer.

In 2005 e-mails discussing whether regulators in the U.S. and Europe might seek warning labels about Actos’s potential links to bladder cancer, Takeda officials emphasized protecting the product rather than its users, Howard Greenberg, a clinical pharmacologist, said in state court in Los Angeles yesterday.

“There are multiple e-mails from different levels of Takeda management that indicate the product came first,” Greenberg told jurors in the first day of testimony about Jack Cooper’s claims over Actos.

[Article continues at original source]

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Takeda Didn’t Warn of Actos Cancer Risk, Lawyer Says

Quoted from http://www.businessweek.com/news/2013-02-28/takeda-didn-t-warn-of-actos-cancer-risk-lawyer-says

Takeda Didn’t Warn of Actos Cancer Risk, Lawyer Says

By Sophia Pearson and Jef Feeley on February 28, 2013

Takeda Pharmaceutical Co. (4502), Asia’s biggest drugmaker, failed to warn doctors of the cancer risk associated with its Actos diabetes treatment, a lawyer said as the first of more than 3,000 lawsuits over the drug goes to trial.

Takeda sales representatives never warned a doctor for California resident Jack Cooper in more than 195 visits, Cooper’s lawyer Michael J. Miller said today in opening statements in state court in Los Angeles. The doctor prescribed the drug to Cooper in 2006.

The Osaka-based company is facing thousands of lawsuits alleging Actos caused bladder cancer or other ailments among patients, according to court records.

“Jack Cooper will be dead in the next seven months from bladder cancer,” Miller told jurors. “There is no cure.”

Cooper’s suit is among the cases that have been gathered before Judge Kenneth Freeman in California. The drugmaker is also facing cases in state court in Illinois and more than 1,200 lawsuits consolidated before a federal judge in Louisiana. The first federal trial is scheduled for November 2014, according to court filings.

Takeda officials have defended the company’s handling of Actos by noting the U.S. Food and Drug Administration found it safe and effective. There is no proof that it causes bladder cancer, the company has said. Lawyers for the company are set to present their opening statements in the trial later today.

[Article continues at original source]

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FMC says U.S. wrongful death lawsuits to be consolidated

Quoted from http://www.reuters.com/article/2012/12/13/fmc-lawsuits-idUSWEB171120121213

FMC says U.S. wrongful death lawsuits to be consolidate

FRANKFURT | Thu Dec 13, 2012 1:57am EST

FRANKFURT Dec 13 (Reuters) - Fresenius Medical Care, the world's largest dialysis group, said a group of plaintiffs in the United States had moved to consolidate wrongful death lawsuits against the company over its NaturaLyte and GranuFlo products.

The suits generally allege that the two products carried inadequate labeling and warnings, causing harm to patients, FMC said, adding that it considered the suits to be without merit and was vigorously defending against them.

The company's chief executive Ben Lipps said in a statement that FMC's actions related to the products were appropriate and responsible.

[Article continues at original source]

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In Re: Actos -- Does New Federal Litigation Clarify Predictive Coding In eDiscovery?

Quoted from http://www.forbes.com/sites/benkerschberg/2012/08/27/in-re-actos-does-new-federal-litigation-clarify-predictive-coding-in-ediscovery/

Litigation Clarify Predictive Coding In eDiscovery?

Guest Post by Matthew Nelson

In Re: Actos (Pioglitazone) Products Liability Litigation recently surfaced as the newest case to fuel the continuing debate about the use of predictive coding technology in litigation. The plaintiffs allege a prescription drug for the treatment of type 2 diabetes called Actos increases the risk of bladder cancer in patients.

On July 27, 2012, United States Magistrate Judge Hanna Doherty of the Western District of Louisiana entered a Case Management Order outlining the electronically stored information (ESI) protocol the parties must follow during discovery.

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Diabetes Drugs Avandia, Actos Linked to Vision Woes

Quoted from http://health.usnews.com/health-news/news/articles/2012/06/11/diabetes-drugs-avandia-actos-linked-to-vision-woes

Diabetes Drugs Avandia, Actos Linked to Vision Woes

They may raise risk of macular edema, researchers report

June 11, 2012

By Steven Reinberg
HealthDay Reporter

MONDAY, June 11 (HealthDay News) -- British researchers report that thiazolidinediones, diabetes medications that are used to help control blood sugar levels, may cause eye problems in those who take them.

The drugs that fall into this group include Avandia and Actos, which have been tied to increased risk of heart attack in the case of Avandia and bladder cancer in the case of Actos. Now it is possible that these drugs may also cause diabetic macular edema, the study authors said.

"Patients who received a thiazolidinedione were at two- to three-fold increased risk of developing macular edema," said lead researcher Dr. Iskandar Idris, an associate professor in diabetes medicine at the University of Nottingham.

However, the risk of macular edema is very small, about 0.2 percent, so the increased relative risk translates into an absolute risk of less than 1 percent.

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Study details cancer risk of Takeda diabetes pill

Quoted from http://www.reuters.com/article/2012/05/31/takeda-actos-idUSL5E8GVEEO20120531

Study details cancer risk of Takeda diabetes pill

Thu May 31, 2012 6:30pm EDT

* Two years use of Actos doubles risk of bladder cancer

* Absolute risk still low, study finds

LONDON May 31 (Reuters) - Taking Takeda Pharmaceutical's diabetes drug Actos for more than two years doubles the risk of bladder cancer, although in absolute terms the risk is still low, researchers said on Thursday.

A study by Canadian researchers, published online by the British Medical Journal, quantified the risk by analysing the records of more than 115,000 British patients newly treated with diabetes drugs between 1988 and 2009.

They found that Actos use of two years or more was associated with 88 extra cases of bladder cancer per 100,000 person years. This rose to 137 extra cases among patients who had taken more than 28,000 milligrams of the drug.

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Fertility Methods Raise Risk of Birth Defects, Study Finds

Quoted from http://abcnews.go.com/Health/w_ParentingResource/fertility-methods-raise-risk-birth-defects-study-finds/story?id=16280515

Fertility Methods Raise Risk of Birth Defects

By LARA SALAHI  May 5, 2012

Babies conceived with infertility treatment methods are more likely to have certain birth defects than babies who are conceived naturally, according to a study published today in the New England Journal of Medicine.

Australian researchers looked at medical records nearly 300,000 babies born in Australia -- more than 4,000 of whom were conceived through an assisted fertility method -- to see if babies born using the various assisting methods were more likely to have birth defects than babies who were conceived naturally.

Eight percent of the babies conceived through assistance were born with birth defects such as heart, genital, kidney, lung and muscle problems, compared to nearly 6 percent of babies who were conceived naturally, the study found. Those conceived through fertility assistance were also more likely to have cerebral palsy.

More than 6 million women of childbearing age in the U.S. have difficulty getting pregnant or staying pregnant, according to the U.S. Centers for Disease Control and Prevention.

Intracytoplasmic sperm injection (ISI), a so-called assisted reproductive technology in which a single sperm is injected into a removed egg and then transferred back to the uterus was the most common type of method associated with birth defects, the study found. The oral hormone pill commonly known as Clomid also increased the risk for defects.

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Takeda Actos Judge Names Lead Attorneys in Cancer Suits

Quoted from http://www.bloomberg.com/news/2012-03-13/takeda-actos-judge-names-lead-attorneys-in-u-s-bladder-cancer-lawsuits.html

Takeda Actos Judge Names Lead Attorneys in Cancer Suits

By Jef Feeley and Margaret Cronin Fisk - Mar 13, 2012 4:24 PM E

The judge overseeing lawsuits alleging Takeda Pharmaceutical Co. (4502)’s Actos diabetes medicine causes cancer appointed 19 plaintiffs’ lawyers to manage litigation involving U.S. claims.

Takeda, Asia’s biggest drugmaker, may face as many as 10,000 claims that Actos causes bladder cancer after U.S. regulators found last year the drug was linked to the disease. Federal lawsuits against the drugmaker were consolidated before U.S. District Judge Rebecca Doherty in Lafayette, Louisiana, in December. The first hearing on the cases is set for March 22, according to court filings.

“The court has determined to effect the selection of lead counsel, liaison counsel and plaintiffs’ executive and steering committees before the March 22nd-23rd status conference,” Doherty said in a March 12 note posted on the court’s website.

The lawsuits claim patients who use Actos, a prescription drug approved to treat type 2 diabetes, face increased risks of developing bladder cancer. The plaintiffs also claim that Takeda and co-defendant Eli Lilly & Co., based in Indianapolis, withheld information about the risk and failed to provide adequate warnings.

Takeda pulled Actos, its top-selling drug, off the market in Germany and France last year after it was linked to an increased cancer risk. The medication had sales of 387.9 billion yen ($4.8 billion) last fiscal year, 27 percent of the Osaka, Japan-based company’s revenue.

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Takeda Hid Actos-Linked Heart Failure Cases, Whistle-Blower Claims in Suit

Quoted from http://www.bloomberg.com/news/2012-03-07/takeda-hid-actos-linked-heart-failure-cases-whistle-blower-claims-in-suit.html

Takeda Hid Actos-Linked Heart Failure Cases, Whistle-Blower Claims in Suit

By David Voreacos - Mar 6, 2012 7:28 PM ET

A U.S. unit of Takeda Pharmaceutical Co. (4502) failed to give accurate reports to regulators about hundreds of congestive heart failure cases associated with its diabetes drug Actos, a whistle-blower claimed in a lawsuit.

The company failed to classify “non-hospitalized or non- fatal” congestive heart failure cases as serious from late 2007 to January 2010, former Takeda medical reviewer Helen Ge said in the complaint in federal court in Boston. Takeda, like other drugmakers, is required to update the U.S. Food and Drug Administration’s Adverse Event Reporting System.

“These events were not properly identified or reported in the FDA’s safety database,” Ge claimed in the complaint, filed in June 2010 and recently unsealed. “Takeda’s motivation to fraudulently report and under-report the serious adverse events was driven by an economic desire to falsely enhance Actos’s safety profile and to increase sales.”

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