Drug Safety Developments

Third Risperdal Trial in Philadelphia Begins

Quoted from http://www.law.com/sites/articles/2015/10/15/third-risperdal-trial-in-philadelphia-begins/

 

Third Risperdal Trial in Philadelphia Begins

By P.J. D'Annunzio
Published: Oct 15, 2015

Lawyers in the third Risperdal gynecomastia trial against Johnson & Johnson subsidiary Janssen Pharmaceuticals in the Philadelphia Court of Common Pleas on Thursday painted starkly different pictures to the jury on what caused a young boy to grow enlarged breasts.

Plaintiff Tim Stange’s case will be the tiebreaker in the litigation, as the first and second trials resulted in victories for the plaintiff and defendants, respectively.

On Feb. 25, a jury awarded $2.5 million to plaintiff Austin Pledger, while on March 20, the jury in plaintiff William Cirba’s case came back in favor of Janssen.

Stange, like the other plaintiffs, alleged his use of the antipsychotic drug Risperdal caused him to develop enlarged breasts. Stange took Risperdal from 2006 to 2009 to control his Tourette syndrome symptoms.

 

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Johnson & Johnson loses first Risperdal jury trial

Quoted from http://www.philly.com/philly/business/20150225_Johnson___Johnson_loses_first_Risperdal
_jury_trial.html

Johnson & Johnson loses first Risperdal jury trial

Posted: Wednesday, February 25, 2015, 1:08 AM

 

A Philadelphia jury said Tuesday that drugmaker Johnson & Johnson should pay $2.5 million to a 20-year-old autistic man from Alabama - who developed size 46 DD breasts as a young teenager - because the company failed to adequately warn of that potential side effect from his use of the antipsychotic drug Risperdal.

This was the first case related to the condition called gynecomastia that went to a jury, but thousands more lawsuits are lined up in Philadelphia, California, Missouri, and other locations.

J&J paid $2.2 billion in 2013 to settle federal and state criminal and civil charges related to illegal marketing of the drug, but that did not stop individual lawsuits related to adverse events.

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Former FDA Commissioner David Kessler might testify against J&J in Philly case

Quoted from http://www.philly.com/philly/blogs/phillypharma/Former-FDA-Commissioner-David-Kessler-might-testify-against-JJ-in-Philly-case.html

Former FDA Commissioner David Kessler might testify against J&J in Philly case

David Sell

Posted: Monday, January 26, 2015, 8:39 AM

Former Food and Drug Administration Commissioner Dr. David Kessler might testify for the plaintiff in coming days in a lawsuit against drugmaker Johnson & Johnson that is being heard in Philadelphia Court of Common Pleas.

Contrary to several media reports, this is not the first trial of a case involving the antipsychotic drug Risperdal, which was approved more than a decade ago for schizophrenia. J&J has been accused of promoting the drug for unapproved uses in a many jurisdictions and, in a federal case, eventually agreed pay a $2.2 billion penalty. J&J's pharmaceutical division, Janssen Pharmaceuticals, is the maker of Risperdal.

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Johnson & Johnson CEO will not have to testify in Risperdal drug case

Quoted from http://www.philly.com/philly/business/homepage/20120921_Johnson___Johnson_CEO_will_not_have_to_testify_in_Risperdal_drug_case.html

Johnson & Johnson CEO will not have to testify in Risperdal drug case

By David Sell, Inquirer Staff Writer

September 21, 2012

A Philadelphia judge said Thursday that Johnson & Johnson chief executive officer Alex Gorsky cannot be called as a trial witness by lawyers for a 17-year-old boy whose family sued the company because he grew breasts after taking Risperdal, an antipsychotic drug made by J&J.

In a big victory for the health-care giant, Philadelphia Common Pleas Court Judge Arnold New agreed to the request by J&J defense lawyers to quash the subpoena from the boy's attorneys.

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J&J CEO Alex Gorsky talks Risperdal, via deposition, with lawyers nearby

Quoted from http://www.philly.com/philly/blogs/phillypharma/JJ-CEO-Alex-Gorsky-talks-Risperdal-via-deposition-with-lawyers-nearby.html

J&J CEO Alex Gorsky talks Risperdal, via deposition, with lawyers nearby

Johnson & Johnson CEO Alex Gorsky

 

Johnson & Johnson Chief Executive Officer Alex Gorsky was proud enough of helping to boost Risperdal sales to include the numbers on his resume at one point, according to court filings, but he is trying to hard to avoid talking about the antipsychotic drug on the witness stand in front of a jury in a trials scheduled for the next several weeks in Philadelphia.

On Sept. 10, with a jury waiting in Philadelphia Court of Common Pleas, J&J settled a case with a man who claimed he grew breasts after being prescribed Risperdal as a child, rather than risk having a judge rule that Gorsky must testify.

The 60-page transcript of Gorsky's deposition in the individual suit filed by Aron Banks in Philadelphia was a publicly-available exhibit in the case.

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J&J CEO Should Be Forced to Testify, Teen’s Lawyers Say

Quoted from http://www.bloomberg.com/news/2012-09-18/j-j-ceo-should-be-forced-to-testify-teen-s-lawyers-say.html

J&J CEO Should Be Forced to Testify, Teen’s Lawyers Say

By Jef Feeley and Margaret Cronin Fisk - Sep 18, 2012 10:42 AM ET

Johnson & Johnson (JNJ)’s top executive should be forced to testify about claims that the company illegally marketed the antipsychotic drug Risperdal, which allegedly caused boys to grow breasts, lawyers for a teenager suing the drugmaker said in a court filing.

Alex Gorsky, J&J’s chief executive officer, once ran the unit responsible for making and selling Risperdal and has intimate knowledge of the company’s illegal marketing efforts targeting doctors who treat troubled youths, lawyers for a 15- year-old Texas teen said in a filing in a Philadelphia state court. J&J attorneys contend Gorsky will be out of the country when jurors begin hearing evidence in the trial of the boy’s claims Sept. 24.

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J&J Settles Risperdal Lawsuit on Opening Day of Trial

Quoted from http://www.businessweek.com/news/2012-09-10/j-and-j-settles-risperdal-lawsuit-on-opening-day-of-trial

J&J Settles Risperdal Lawsuit on Opening Day of Trial

By Jef Feeley and Margaret Cronin Fisk on September 10, 2012

Johnson & Johnson (JNJ) settled a lawsuit on the first day of a trial over claims by a male plaintiff that its antipsychotic drug Risperdal caused him to grow breast tissue, it was announced in court in Philadelphia.

Aron Banks, 21, claimed he sustained psychological trauma from growing breasts after taking the medication during childhood. Banks took the medicine from 2000 to 2004, when it wasn’t approved for children.

The Banks suit in state court in Philadelphia was the first to go to trial on claims that Risperdal caused boys to grow breasts. Another trial is set to begin Sept. 20 in Philadelphia.

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J&J’s Risperdal Wasn’t Factor in Man’s Diabetes, Jury Rules

Quoted from http://www.bloomberg.com/news/2012-02-16/j-j-s-risperdal-not-substantial-factor-in-diabetes-new-jersey-jury-says.html

J&J’s Risperdal Wasn’t Factor in Man’s Diabetes, Jury Rules

By David Voreacos - Feb 16, 2012 1:24 PM ET

Johnson & Johnson’s anti-psychotic drug Risperdal wasn’t a substantial factor in causing a Nebraska man’s diabetes, even though J&J failed to adequately warn his doctor about the drug’s risks, a New Jersey jury ruled.

Jurors in state court in New Brunswick, where J&J is based, today found by a 5-1 vote that the company didn’t adequately warn the doctor for Gary Skala of the risk of diabetes. Because they ruled 5-1 against Skala, 56, on the causation question, they didn’t award him any damages.

Skala’s lawsuit was the first of more than 400 personal- injury lawsuits over Risperdal to go to trial. J&J lawyers said the company properly warned of the drug’s risks after its introduction in 1994. They said Skala was an obese “couch potato” whose disease was caused by his weight, heavy drinking, sedentary lifestyle and other risks, not Risperdal.

“Doctors used the medicine because it worked,” J&J attorney Jeffrey Peck told jurors yesterday in his closing argument. “In this case, Dr. Skala’s doctors prescribed it and it saved his life.”

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J&J Hid Risperdal Studies to Boost Drug Sales, Lawyer Says

Quoted from http://www.businessweek.com/news/2012-02-02/j-j-hid-risperdal-studies-to-boost-drug-sales-lawyer-says.html

J&J Hid Risperdal Studies to Boost Drug Sales, Lawyer Says

February 02, 2012, 4:41 PM EST

By Jef Feeley

 

Feb. 2 (Bloomberg) -- Johnson & Johnson hid studies showing its Risperdal anti-psychotic drug caused diabetes to protect billions of dollars in sales, a lawyer said in the first personal-injury claim over the medication to go to trial.

Researchers at J&J’s Janssen unit knew as early as 1999 that a study found Risperdal caused diabetes at a higher rate than a competing drug and failed to hand over the results to regulators probing links between the disease and anti-psychotic medicines, Fletch Trammell, a lawyer for a former Risperdal user, told a New Jersey jury today in opening statements.

“The evidence will show Janssen buried studies for a competitive advantage,” Trammell told jurors in state court in New Brunswick, New Jersey. J&J, the world’s second-largest health-products maker, is based in the city.

The trial of Gary Skala’s claims that his 14 years’ worth of Risperdal use caused his diabetes began two weeks after J&J agreed to pay $158 million to settle Texas officials’ claims that it fraudulently marketed the drug.

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UK study links antipsychotic drugs to clot risk

Quoted from http://www.reuters.com/article/idCNLDE68K0XS20100921

UK study links antipsychotic drugs to clot risk

Tue Sep 21, 2010 7:01pm EDT

 

By Ben Hirschler

LONDON, Sept 22 (Reuters) - Modern antipsychotic drugs, especially AstraZeneca's (AZN.L) blockbuster Seroquel, may increase the risk of patients developing life-threatening blood clots, British researchers said on Wednesday.

The finding, from a trawl of tens of thousands of patient records, adds to a growing body of evidence linking so-called atypical antipsychotics to adverse side effects.

Atypicals -- which also include Eli Lilly's (LLY.N) Zyprexa, Johnson & Johnson's (JNJ.N) Risperdal and Bristol-Myers Squibb's (BMY.N) Abilify -- dominate the antipsychotic market, which had sales of $16 billion in 2009, according to Thomson Reuters data.

First introduced more than 20 years ago, such drugs cause fewer of the involuntary-movement problems associated with older medicines but have been linked to diabetes and increased mortality in people with dementia.

There has also been limited evidence linking them with dangerous blood clots, such as deep vein thrombosis and pulmonary embolism, although previous studies have been small.

The large British study, which compared 25,000 cases of patients with venous thromboembolism (VTE) against 89,000 controls, found people prescribed antipsychotics had a 32 percent greater risk of serious blood clots, after adjusting for other potential risk factors.

 

The risk was greater for people on atypical drugs, rather than older ones, and the highest risk was seen with Seroquel, which showed a nearly three times increase on an adjusted basis.

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