Drug Safety Developments

Takeda Failed to Properly Warn About Actos Risks, Jury Rules

Quoted from http://www.businessweek.com/news/2013-09-26/takeda-failed-to-properly-warn-about-actos-risks-jury-rules-1

 

Takeda Failed to Properly Warn About Actos Risks, Jury Rules

By Jef Feeley
Bloomberg News
September 26, 2013

A Maryland jury ruled that Takeda Pharmaceutical Co. didn’t properly warn 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. A judge immediately threw out the verdict.

Jurors in state court in Baltimore deliberated more than six hours over two days before finding Asia’s largest drugmaker liable for the cancer death of Diep An, Michael Miller, one of An’s lawyers, said in an interview. Since jurors also found that An contributed to his death by smoking for 30 years, Judge Brooke Murdock set the verdict aside based on Maryland law.

[Article continues at original source]

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Takeda Put Actos Sales Ahead of Consumer Safety, Lawyer Says

Takeda Duped Patients, Doctors on Actos Risks, Lawyer Says

Quoted from http://www.businessweek.com/news/2013-09-25/takeda-duped-patients-doctors-on-actos-risks-lawyer-says-1

Takeda Duped Patients, Doctors on Actos Risks, Lawyer Says

By Jef Feeley
September 25, 2013
Businessweek

Takeda Pharmaceutical Co. duped patients and doctors about the risks of its Actos diabetes drug and should be held liable for the cancer death of a former U.S. Army translator, a lawyer argued in the second case over the medicine to go to trial.

Officials of Osaka, Japan-based Takeda, Asia’s largest drugmaker, failed to provide any warning until 2011 that researchers had linked Actos to bladder cancer, Michael Miller, a lawyer for the family of Diep An, told a jury today in state court in Baltimore. The lack of a warning allowed the company to protect billions in sales of the drug, Miller said.

“Failure to warn is what we are here about,” Miller told the four-woman, two-man jury in closing arguments of the trial of the family’s lawsuit against Takeda. Deliberations began late today.

The case is the second of more than 3,000 suits over Actos to come to trial. A California jury ordered Takeda to pay $6.5 million in damages to a diabetic man who blamed the drug for his bladder cancer. The judge in the case later threw out the verdict and the family appealed.

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Takeda Put Actos Sales Ahead of Consumer Safety, Lawyer Says

Statins Linked to Raised Risk of Cataracts in Study

Quoted from http://www.philly.com/philly/health/topics/HealthDay680331_20130919_Statins_Linked_to_Raised_Risk_of_Cataracts_in_Study.html

Statins Linked to Raised Risk of Cataracts in Study

Steven Reinberg HealthDay Reporter

THURSDAY, Sept. 19 (HealthDay News) -- The statin medications that millions of adults take to lower their cholesterol levels may also raise their risk of developing cataracts, a new study suggests.

This is the latest of several studies looking for a link between statins such as Lipitor and Zocor and cataracts, a clouding of the lens of the eye. The results to date have been conflicting and inconclusive, the researchers note.

"Cataracts are a main cause of poor vision and blindness, specifically for the elderly," said lead investigator Dr. Ishak Mansi, of the VA North Texas Health System in Dallas.

"This study cannot identify that statins cause cataracts; rather, it identifies statin use as associated with a higher risk of being diagnosed with cataract," he added.

The report, published Sept. 19 in the online edition of JAMA Ophthalmology, involved almost 14,000 men and women, 6,972 pairs of statin users and nonusers, who were seen by the military health care system from October 2001 to March 2010.

Those taking statins had a 27 percent increased risk of developing cataracts compared with nonusers, the researchers found.

[Article continues at original source]

Class action lawsuit against anti-obesity drug Meridia can go ahead: B.C. court

Quoted from http://www.timescolonist.com/life/class-action-lawsuit-against-anti-obesity-drug-meridia-can-go-ahead-b-c-court-1.628680

Class action lawsuit against anti-obesity drug Meridia can go ahead: B.C. court

The Canadian Press
September 18, 2013

VANCOUVER - The B.C. Supreme Court has ruled a class-action lawsuit against the makers of the anti-obesity drug Meridia can go ahead.

Six people were fighting for the right to launch a class action against drug makers Abbott Laboratories and generic manufacturer Apotex, arguing the drug caused them dire health effects, including heart attacks and a stroke.

Justice Robert Johnston agreed the six met the test of whether a case should be considered a class action.

“Those who took the drug and who allege harm as a result have a rational relationship to the negligence, failure to warn, and some claims pleaded under the Business Practices and Consumer Protection Act and the Competition Act," Johnston wrote in a ruling released Tuesday.

[Article continues at original source]

Family blames birth control for woman's death

Quoted from http://www.wbng.com/news/local/Family-blames-birth-control-for-womans-death-223984901.html

Family blames birth control for woman's death

By Matt Porter

September 16, 2013

Oneonta, NY (WBNG Binghamton) When Claire Sperbeck sat down for breakfast with her 21-year-old daughter Justine on Aug. 28, she expected it to be like any other normal day.

"She came into the kitchen and she said to me my leg is bothering me, I think I pulled a muscle," Claire Sperbeck remembers.

But, her daughter suddenly passed out.

She had a pulmonary embolism, also known as a massive blood clot.

Paramedics were at the house in minutes and brought Justine to the hospital, but she never made it home.

"When I got to the hospital, they were doing CPR and she was gone," Claire Sperbeck said. "In just a matter of minutes, she was gone."

Justine Sperbeck's injury is similar to complaints across the country about a new form of birth control using a patch instead of a pill.

Justine had been using the patch called Ortho Evra made by a subsidiary of the Johnson and Johnson Company.

[Article continues at original source]

Lawsuits pile up over popular birth control pill

Quoted from http://www.chicagotribune.com/health/ct-met-birth-control-risks-20130915,0,765904,full.story

Lawsuits pile up over popular birth control pill

FDA says contraceptives containing drospirenone may pose greater blood clot risk; industry-funded studies, some physicians say drugs are very safe

 By Julie Deardorff, Chicago Tribune reporter

September 15, 2013

Peotone's Maggie Yunker had been taking birth control pills for a year when her doctor suggested switching to a brand that also could clear up acne and ease some aggravating symptoms related to her period.

Yunker was sold. But a year later, the 20-year-old suffered a life-altering stroke after multiple blood clots formed, broke free and lodged in her brain.

Though all oral contraceptives slightly increase the chance of developing blood clots in the legs and lungs, Yunker was taking Yaz, part of a newer generation of pills that the U.S. Food and Drug Administration says may pose a greater risk than similar types of birth control.

[Article continues at original source]

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YAZ / Yasmin / Ocella / Gianvi Blood Clot Lawsuits That Are Not Settled Yet: Number Increases, Indicating That These Legal Claims Continue To Be Filed In 2013

Higher Risk Of Venous Thrombosis - Blood Clot Side Effects Like DVT And PE With YAZ / Yasmin Birth Control Pills Is Confirmed By September 2013 BMJ Medical Journal Article

Beauty queen Georgie Holland claims Yasmin pill caused a stroke

Quoted from http://www.dailymail.co.uk/health/article-2416856/Beauty-queen-Georgie-Holland-claims-Yasmin-pill-caused-stroke.html

'The Pill gave me a stroke': Beauty queen, 18, claims Yasmin caused a blood clot in her brain - and damaged her vision

• Georgie Holland was picked up early from school after feeling faint
• At home her condition deteriorated quickly
  
• She became confused, her speech was slurred and she struggled to see
• She was rushed to hospital where she was diagnosed with a stroke
• She had no other risk factors so doctors think The Pill might have contributed
  

By Emma Innes

PUBLISHED: 12:57 EST, 10 September 2013

A teenager has been left partially blind after suffering a stroke linked to the contraceptive pill.

Georgie Holland, 18, collapsed after being sent home from college and spent two days in bed before her parents took her to hospital, where a scan revealed a blood clot in her brain that was affecting the flow of blood.

Doctors linked the stroke to her taking the contraceptive pill Yasmin for two years. Georgie now has limited peripheral vision in her right eye and has to take aspirin every day to thin her blood.

[Article continues at original source]

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Higher Risk Of Venous Thrombosis - Blood Clot Side Effects Like DVT And PE With YAZ / Yasmin Birth Control Pills Is Confirmed By September 2013 BMJ Medical Journal Article

YAZ / Yasmin / Ocella / Gianvi Blood Clot Lawsuits That Are Not Settled Yet: Number Increases, Indicating That These Legal Claims Continue To Be Filed In 2013

Reports of side-effects from Bayer's Xarelto grow: Spiegel

Quoted from http://www.reuters.com/article/2013/09/08/us-bayer-xarelto-idUSBRE9870AH20130908

Reports of side-effects from Bayer's Xarelto grow: Spiegel

FRANKFURT | Sun Sep 8, 2013 12:07pm EDT

FRANKFURT (Reuters) - Bayer faces a growing number of reports of suspected undesirable side-effects from its stroke prevention pill Xarelto, German magazine Der Spiegel reported, citing data from a federal authority.

There was a total of 968 cases of suspected undesirable side-effects related to Xarelto in the first eights months of 2013, including 72 cases of death, the magazine reported, citing Germany's Federal Institute for Drugs and Medical Devices (BfArM).

 

This compares to 750 cases of side-effects, including 58 cases of death, for the whole of 2012, the magazine said. BfArM said there was no clear proof of a correlation between the drug and side effects, the report said.

Jointly developed with U.S. peer Johnson & Johnson, Xarelto is one of Bayer's most important new drugs, expected to earn annual peak sales of more than 2 billion euros ($2.63 billion).

[Article continues at original source]

Takeda Put Actos Sales Ahead of Consumer Safety, Lawyer Says

Quoted from http://www.businessweek.com/news/2013-09-03/takeda-put-actos-sales-ahead-of-consumer-safety-lawyer-says-1

Takeda Put Actos Sales Ahead of Consumer Safety, Lawyer Says

By Peter Geier and Jef Feeley September 03, 2013

Takeda Pharmaceutical Co. (4502), Asia’s biggest drugmaker, put sales ahead of safety by failing to warn consumers about its Actos diabetes medicine’s cancer risks, a lawyer argued in the second case over the drug to go to trial.

Officials of Osaka, Japan-based Takeda knew by 2005 at the latest that studies had shown links between Actos and cancer, and didn’t issue a warning until six years later, Stuart Simms, a lawyer for the family of Diep An, told a jury today in state court in Baltimore. An’s family blames Actos for the Vietnamese immigrant’s bladder-cancer death last year.

Takeda executives “knew the value of the drug and they knew the risks” Actos posed and they opted not to adequately warn An or his doctors, Simms told jurors in opening arguments of the trial of the family’s suit against Takeda. The delay in issuing the warning allowed the company to push ahead with efforts to “sell, sell, sell” Actos, he said.

[Article continues at original source]

Hundreds of Fosamax lawsuits versus Merck ordered readied for trial

Quoted from http://www.chicagotribune.com/business/sns-rt-us-merck-fosamax-20130830,0,1627005.story

Hundreds of Fosamax lawsuits versus Merck ordered readied for trial

Nate Raymond Reuters

3:53 p.m. CDT, August 30, 2013

NEW YORK (Reuters) - A federal judge overseeing consolidated litigation against Merck & Co over jaw injuries allegedly caused by the osteoporosis drug Fosamax has ordered hundreds of cases be dispersed to courts across the country for trial.

The decision by U.S. District Judge John Keenan in Manhattan marks an unusual and potentially costly development for Merck.

Companies often find it easier to reach settlements in mass tort cases that are consolidated before one judge.

"It's a big deal as it changes the cost paradigm for Merck exponentially," said Timothy O'Brien, a partner at Levin, Papantonio, Thomas, Mitchell, Rafferty & Proctor and lawyer representing Fosamax plaintiffs.

The judge's order Thursday requires that 200 cases per month be sent to back to courts where they were initially filed, beginning with the oldest ones.

Lainie Keller, a spokeswoman for Merck, said the company "is committed to defending its conduct in regard to Fosamax and has confidence in its defense strategy that has had so much success in the courts."

[Article continues at original source]

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