Tuesday, November 10, 2015

UPDATED: J&J Slapped With $1.75 Million Verdict In Risperdal Male Breast Growth Case

fiercepharma
November 10, 2015 | By 


[Ed; "Contains No Active Drug". The Doctors pushing Risperdal are so paranoid themselves - and with good reason considering the drug maker they're dealing with - that they need a written disclaimer because despite what they tell the consumer about Risperdal, they know better than to be made 'Mentally Healthy' themselves with the stuff.]

 On to the Fierce Pharma article:

Johnson & Johnson ($JNJ) lost another courtroom battle over claims that the company failed to warn doctors and patients that its antipsychotic drug Risperdal could cause breast growth in boys, a blow for the company as it continues to deal with related cases.
A state court jury in Philadelphia ordered J&J to pony up $1.75 million, including damages for disfigurement and mental anguish, to a young man who developed gynecomastia, or abnormal breast development, while taking the drug as a teen, Bloomberg reports. The company and its Janssen unit still face about 1,500 cases in the same court that were filed by men who grew breasts after taking Risperdal.
"We will consider our options going forward," J&J spokeswoman Robyn Frenze told FiercePharma in an emailed statement. "Risperdal has helped and is still helping millions of patients with debilitating mental illnesses and neurodevelopmental conditions as part of a comprehensive treatment plan."
The verdict marks a dark point for J&J as it deals with breast growth claims over the drug. Earlier this year, former FDA chief David Kessler testified in the Philadelphia court that the company knew as early as 2001 that Risperdal could cause boys to grow breasts, about 5 years before adding a warning about the side effect to the drug's official label. J&J also got flak for allegedly marketing the drug off-label for pediatric patients before the breast growth side effect went on the label.

 [Ed: more on and from David Kessler below:
Ex FDA Chief Says J&J Broke The Law In Promoting Risperdal
"Kessler's report was posted to the Court of Common Pleas electronic docket system late Wednesday in four pieces, as part of the J&J motion to preclude him from testifying. The pieces are all PDFs and links are here, here, here and here." ]
J&J struck back, saying that Kessler was a "hired gun" known for testifying against drugmakers and that he cherry-picked information to support his claims against the company. J&J lawyer Diane Sullivan also said that Janssen requested to add information about safe dosing in children to Risperdal's label before the breast-development warning was added in 2006.
Former FDA commissioner David Kessler
But a Philadelphia jury didn't buy those arguments and shot down J&J/Janssen in the first court battle over breast growth claims, ordering the company in February to pay $2.5 million to a young man who grew 46DD breasts while taking Risperdal. None too pleased with the ruling, J&J said it would consider all of its legal options including a potential appeal. "We firmly believe this verdict should be overturned," Frenze said at the time.
J&J has traveled a long legal road with Risperdal. In 2013, the company agreed to shell out $2.2 billion to settle off-label marketing allegations by the Justice Department and several U.S. states over claims that J&J pushed the drug for use in children and teens before the FDA approved pediatric indications.
The drugmaker also settled marketing claims with 36 states and the District of Columbia over Risperdal marketing for more than $180 million, plus another settlement in Texas for $158 million. In October, J&J and Janssen revealed that they set up a reserve to deal with 5,400 pending Risperdal cases, Bloombergreports.
Still, J&J has chalked up some victories along the way in state courts. The company fended off a $257 million award in Louisiana after convincing the state's Supreme Court that its marketing practices did not violate state law. J&J also escaped a $1.2 billion verdict in Arkansas after the Arkansas Supreme Court ruled that the state filed the case under a statute that did not apply to pharma companies.
In July, South Carolina's Supreme Court further reduced the penalty against J&J from a Risperdal marketing lawsuit. The court originally ordered the company to pay $327 million but shaved the judgment down to $124 million.
- read the Bloomberg story
Editor's note: This story was updated with a comment from Johnson & Johnson.

Thank You Ms Wasserman and Fierce Pharma.



Psychiatry's Ethics.
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