Posts Tagged Diep An v. Takeda

Takeda Held Responsible in First Federal Actos Bellwether Trial

Takeda

After 34 days of trial, a Lafayette, Louisiana jury returned its verdict against Takeda and Lilly and ordered the PHARMA giants to pay $1.475 million in compensatory damages and $8 billion in punitive damages for injuries including bladder cancer to Terrance Allen, a hardware store manager, who took Actos for his diabetes treatment from 2004 to 2011. (In Re: Actos Products Liability Litigation Case No. 6:11-md-2299.). The jury felt that Takeda concealed the risks of cancer associated with Actos. Lilly, which co-promoted Actos from 1999 to 2006, said in a press release it will be indemnified by Takeda for its losses and expenses around the litigation based on the terms of its agreement with Takeda.

Actos entered the US market in 1999 and its peak sales were in 2008 at well over $3 billion. The patent expired in 2011 and sales declined.

Medical Studies Linking Actos to Bladder Cancer

Plaintiff contended that Takeda failed to warn Allen and other users of Actos of the link between Actos and bladder cancer, and that if Takeda properly advised of the risks associated with Actos, Allen never would have used it.

In September 2010, the FDA ordered a safety review of Actos.  The FDA is continuously reviewing the results of an ongoing ten-year study of the long-term risk of bladder cancer in approximately 193,000 diabetic patients taking Actos.  A significantly increased risk of bladder cancer has been seen among patients from this group who take the highest doses of Actos (more than 28,000 mg) and who take Actos for longer than one year.  Compared to patients never having taken Actos, taking Actos for longer than one year was associated with a forty percent higher risk of bladder cancer.

A European study by the French Medicines Agency found a 22 percent higher risk of bladder cancer in approximately 155,000 patients taking Actos from 2006 to 2009, compared to 1.3 million patients not taking the drug.  The risk was highest in patients taking a cumulative Actos dose of 28,000 mg or more during the study period. Authorities responded to the evidence of bladder cancer risk by recalling Actos in France and Germany.

A May 2011 study of a half million diabetes drug Adverse Event reports to the FDA between 2004 and 2009 suggested a “disproportionate risk” of bladder cancer in Actos patients, finding that of patients reporting bladder cancer, one-fifth of these were taking Actos.

In August 2011, a report by eHealthMe based on FDA reports and the user community stated that of 22,512 people reporting side effects, 50 (0.22%) had bladder cancer.

FDA Updates Warnings on Actos

On August 4, 2011, the U.S. Food and Drug Administration (FDA) issued updated warning information concerning Actos and the increased risk of bladder cancer.  The warning states that it should not be used in patients with active bladder cancer or in those with a history of the condition.  Results of a 10-year study suggest that taking Actos for periods longer than 12 months may increase the relative risk of developing bladder cancer in any given year by as much as 40 percent.  A study published in the May 2012 issue of the British Medical Journal puts the increased risk at 83 percent.

Actos Lawsuits

The Allen lawsuit was the fourth Actos trial litigated to verdict.  There have been two prior verdicts for plaintiffs in California  and Maryland (though those results were later overturned) and defense verdict in Las Vegas.  The Allen case in Louisiana was the first federal bellwether case to be tried.  There remain about 3,000 Actos lawsuits pending in the federal MDL in the Western District of Louisiana and a number of cases pending in the coordinated California cases JCCP, where the Brandi Law firm represents a number of Plaintiffs. (Case No. JCCP 4696 Assigned to Hon. Kenneth Freeman).

If you or a loved one has had a problem with Actos or has been diagnosed with bladder cancer and took the diabetes drug Actos, you may have a claim for your injuries.  The Brandi Law Firm is a leader in nationwide pharmaceutical litigation for decades and is now representing clients who have suffered bladder cancer related to Actos use and filed suits on their behalf.  For a free consultation call us at 1-800-481-1615 or email us.

Trademark Notice

Actos is a registered trademark of Takeda Pharmaceutical Company, Ltd.  The use of this trademark is solely for product identification and informational purposes. Takeda Pharmaceutical Company, Ltd. is not affiliated with this website, and Takeda Pharmaceutical Company, Ltd. has no affiliation with the Brandi Law Firm.  Nothing on this site has been authorized or approved by Takeda Pharmaceutical Company, Ltd.

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Another Plaintiffs Actos verdict, Another Verdict Thrown Out by Trial Judge

On September 26, 2013, a jury in Baltimore, Maryland, found that Takeda Pharmaceutical Co. did not properly warn Diep An, an ex-U.S. Army translator, and his doctor about the risks of its Actos diabetes drug and ordered the company to pay more than $1.7 million in damages.  Jurors also found that An, a thirty year smoker was contributorily negligent, and under Maryland Law, the Judge immediately threw out the verdict.  The case is An v. Nieberlein, 24-C12003565, Circuit Court for the City of Baltimore, State of Maryland.

For Actos users and for Takeda, this means two juries have found Actos to be defective, have inadequate warnings, and be the contributing factor to its user’s cancers.  However, for reasons unrelated to the conduct of Takeda, but solely due to legal issues, two trial judges overturned the verdicts allowing Takeda to temporarily dodge the Juries inevitable findings of fault.

In An, the case was overturned due to the vagaries of Maryland law as it relates to contributory negligence of the user, where if a Plaintiff is even one percent at fault , the Plaintiff cannot recover.  This issue was most recently upheld by the Maryland Court of Appeal in a 5-2 vote on July 9, 2013.  Only Maryland, Virginia, Alabama, North Carolina and the District of Columbia still have the law while 46 states use a comparative negligence system that reduces the damages an injured person can receive in proportion to his or her degree of fault.

On April 26, 2013, a Los Angeles jury heard similar evidence and found against Takeda and assessed damages at $6.5 million (Cooper v. Takeda Pharmaceuticals America Inc., CGC-12-518535, California Superior Court, Los Angeles), but Judge Kenneth Freeman granted a post trial motion to overturn the verdict.  First, Judge Freeman granted Takeda’s motion to exclude the opinions of Plaintiff’s causation expert Dr. Norm Smith that Actos was a substantial factor in specifically causing Mr. Cooper’s bladder cancer.  With no opinion to support that finding remaining in the case, the Court then granted Takeda’s motion for non-suit, throwing out the verdict.

In September 2010, the FDA ordered a safety review of Actos.  The FDA is continuously reviewing the results of an ongoing ten-year study of the long-term risk of bladder cancer in approximately 193,000 diabetic patients taking Actos.  Takeda officials previously said that the study FDA officials reviewed are continuing and final results are expected in 2014.  A significantly increased risk of bladder cancer has been seen among patients from this group who take the highest doses of Actos (more than 28,000 mg) and who take Actos for longer than one year.  Compared to patients never having taken Actos, taking Actos for longer than one year was associated with a forty percent higher risk of bladder cancer.

A European study by the French Medicines Agency found a 22 percent higher risk of bladder cancer in approximately 155,000 patients taking Actos from 2006 to 2009, compared to 1.3 million patients not taking the drug.  The risk was highest in patients taking a cumulative Actos dose of 28,000 mg or more during the study period.  Authorities responded to the evidence of bladder cancer risk by recalling Actos in France and Germany.

We continue to believe that Actos is a likely cause and substantial factor in the bladder cancer patients we represent and that ultimately Takeda will be held responsible.  If you or a loved one has been diagnosed with bladder cancer and took the diabetes drug Actos, you may have a claim for your injuriesThomas J. Brandi and the Brandi Law Firm are leaders in nationwide pharmaceutical litigation for decades and are now representing clients who have suffered bladder cancer related to Actos use and filed suits on their behalf. For a free consultation call us at 1-800-481-1615 or email us or go to our website for further information about Actos.

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Second Actos Trial Begins

Lawyers for the family of Diep An told a Baltimore jury that drug giant Takeda’s failure to tell the whole truth about Actos role in the increased risk of cancer was the cause of death, as opening statements got under way. This case will provide further insight into how a jury views Takeda’s role in the Actos controversy as more than 3,000 cases await trial in the United States.

Plaintiffs are expected to claim as did the Plaintiffs in Cooper vs. Takeda, that the drug giant knew of the increased risk of bladder cancer long before it provided warnings, and that Actos is the cause of death of Diep An, who began taking Actos in 2007 and was diagnosed with bladder cancer in September 2011.  On April 26, 2013, a Los Angeles jury heard similar evidence and found against Takeda and assessed damages at $6.5 million (Cooper v. Takeda Pharmaceuticals America Inc., CGC-12-518535, California Superior Court, Los Angeles).  However, trial Judge Kenneth Freeman overturned the verdict and the case is on its way through the appeal process.

Judge Freeman granted Takeda’s motion to exclude the opinions of Plaintiff’s causation expert Dr. Norm Smith, a professor of surgery and urology at the University of Chicago Medical Center,  that Actos was a substantial factor in specifically causing Mr. Cooper’s bladder cancer. With no opinion to support that finding remaining in the case, the Court then granted Takeda’s motion for non-suit, throwing out the verdict.  The basis of this ruling will be a crucial focus on appeal.

Takeda denies any role of Actos in causation and maintains the warnings were adequate.  Before it went off patent in 2012, Actos was Takeda’s top-selling drug with sales peaking at $4.3 billion.

Studies Demonstrate Dangers of Actos

A European study by the French Medicines Agency found a 22 percent higher risk of bladder cancer in approximately 155,000 patients taking Actos from 2006 to 2009, compared to 1.3 million patients not taking the drug.  The risk was highest in patients taking a cumulative Actos dose of 28,000 mg or more during the study period.  Authorities responded to the evidence of bladder cancer risk by recalling Actos in France and Germany.

In September 2010, the FDA ordered a safety review of Actos.  In June 2011, the U.S. Food and Drug Administration issued a drug safety alert warning that the use of Actos for more than one year may be associated with an increased risk of bladder cancer.  In August 2011, a report by eHealthMe based on FDA reports and the user community stated that of 22,512 people reporting side effects, 50 (0.22%) had bladder cancer.  A May 2011 study of a half million diabetes drug Adverse Event reports to the FDA between 2004 and 2009 suggested a “disproportionate risk” of bladder cancer in Actos patients, finding that of patients reporting bladder cancer, one-fifth of these were taking Actos.  In April 2012, Health Canada, the government drug safety agency for Canada, issued a safety warning on Actos.

If you or a loved one has been diagnosed with bladder cancer and took the diabetes drug Actos, you may have a claim for your injuries.  The Thomas J. Brandi and the Brandi Law Firm are leaders in nationwide pharmaceutical litigation for decades and is now representing clients who have suffered bladder cancer related to Actos use and filed suits on their behalf. For a free consultation call us at 1-800-481-1615 or email us.

Trademark Notice

Actos is a registered trademark of Takeda Pharmaceutical Company, Ltd.  The use of this trademark is solely for product identification and informational purposes. Takeda Pharmaceutical Company, Ltd. is not affiliated with this website, and Takeda Pharmaceutical Company, Ltd. has no affiliation with the Brandi Law Firm.  Nothing on this site has been authorized or approved by Takeda Pharmaceutical Company, Ltd.

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