Risperdal Trial in Texas

Texas’ 58th Judicial risperdalDistrict Court in Beaumont will host a Risperdal trial this month. Beginning June 12, 2016, Jacoby Moore vs. Ortho-McNeil-Janssen Pharmaceuticals, Inc., et al. will be presented to the first Texas judge and jury to hear a Risperdal claim.

Trial Update: A continuance has been granted; this trial will now begin Sept. 12, 2016.

Gynecomastia Injury alleged

Mr. Moore, represented by Houston law firm Matthews & Associates, is suing J&J’s Ortho-McNeil and Janssen for the case of gynecomastia he says he developed as a minor. Gynecomastia is a painful condition in which males develop female breast tissue. The petition alleges that the J&J companies illegally marketed the drug to Mr. Moore’s doctor for off-label use in minors despite knowing that the drug raised the risk of gynecomastia.

Risperdal Background

Risperdal is a powerful atypical antipsychotic developed by Janssen-Cilag, a subsidiary of Johnson & Johnson. It was approved by FDA in 1993 for the treatment of schizophrenia in adults.

Released in 1994, Risperdal became one of the most profitable drugs in history, bringing billions of dollars in profits.

In 2003, FDA approved risperidone, the chemical name for Risperdal, for the short-term treatment of the mixed and manic states associated with bipolar disorder in adults.

“But,” the petition reads, “many executives, marketing professionals, and even sales representatives were more interested in its unapproved use in children.”

Although the FDA never approved Risperdal for use in children and adults, in 2003 unapproved prescriptions accounted for most Risperdal sales.

J&J failed to Warn

The petition reads: “Johnson & Johnson and Janssen by and through its agents, servants, directors, officer(s) and employees knew, or should have known, about the devastating side effects that Risperdal could bring to children, but they failed to inform or to adequately inform physicians, including the Physician Defendant about this vital information.”

Jacoby Moore was a 7-year-old boy living in Beaumont in 2003 when he was prescribed Risperdal for Attention Deficit Hyperactiity Disorder (ADHD) and behavioral problems. Though Risperdal was not approved for use in children, Mr. Moore was prescribed it by his doctor, who had been encouraged by J&J to subscribe the drug to children.

The petition reads: “But for the Manufacturer Defendants’ off-label marketing, recommending, advertising, and promoting, the Physician Defendant would not have prescribed Risperdal to Plaintiff for off-label use. The Physician Defendant prescribed Risperdal to Plaintiff Jacoby Moore as it was recommended, promoted, and advertised to him by the Janssen Defendants.”

Risperdal Trial in Texas

The trial, the third to try J&J for Risperdal in civil court, is expected to last three weeks.

In the first Risperdal trial in February 2015, a jury hit J&J’s Janssen with a $2.5 million verdict. In the second Risperdal trial, in March 2015, a Philadelphia jury found Janssen had failed to warn that Risperdal could cause male breast growth, but awarded no damages to a young man for whom the jury found no direct link to his condition.

J&J, Janssen fined $2.2 Billion +

In 2013, Johnson & Johnson and Janssen paid more than $2.2 billion to resolve civil and criminal investigations by the U.S. Department of Justice into the marketing of Risperdal and several other drugs.

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Johnson & Johnson loses Risperdal Judgment

Big Pharma giant JJ-logoJohnson & Johnson lost a motion for summary judgment in a Risperdal case in Beaumont, Texas yesterday. J&J subsidiary Janssen pharmaceuticals had filed a motion for summary judgment that attempted to toss out of court the Risperdal-induced gynecomastia claim of 20-year-old Jacoby Moore.

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FDA fails with Risperdal

Many people assume First Risperdal Verdict $2.5 Millionthat oversight of drug development and marketing by FDA is adequate to insure  public protection from dangerous products, and that an FDA-approved product’s benefits outweigh its risks. Professional evaluations of FDA capabilities have unfortunately proven those assumptions wrong time and again. The agency’s handling of Risperdal is a perfect example of the systemic problems in the drug approval and safety surveillance processes.

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First Risperdal Verdict $2.5 Million

First Risperdal Verdict $2.5 MillionA Philadelphia jury ordered Johnson & Johnson in Feb. 2015 to pay $2.5 million to an Alabama man who developed  46 DD breasts as a teenager after taking Risperdal. The jury agreed with the 20-year-old autistic man’s attorneys that the company failed to warn of the gynecomastia “side effect” from the antipsychotic drug Risperdal.

Update: The verdict is on appeal; so no recovery has been made despite the verdict.

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Risperdal lawsuit documents could be sealed

Important Risperdal lawsuit risperdal-johnson-johnsondocuments could be sealed if the manufacturer of the drug has its way with the Philadelphia County Court of Common Pleas.

One of Johnson & Johnson’s latest moves in the company’s ongoing fight to defend its research and promotion of Risperdal is to hide its research and promotion. The company is claiming – in the Philadelphia County Court of Common Pleas where 275 Risperdal cases now sit ready for trial – that it has proprietary rights which allow it to keep its Risperdal research sealed from the public. Because this information concerns the very same public targeted by J & J to use Risperdal, this argument seems of dubious merit at best.

Johnson & Johnson has already paid billions of dollars to settle federal and state allegations that it illegally marketed its drug Risperdal. More than 420 lawsuits have been filed in state courts against Johnson & Johnson over Risperdal. The suits allege that the drug stimulates breast growth and milk production in boys and young men.

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Risperdal Lawsuits – Fraud & Settlement News

The FDA reported in a risperdal-johnson-johnsonNovember news release that Janssen Pharmaceuticals, Inc. would plead guilty and pay more than $1.6 billion to resolve charges the company misbranded Risperdal and filed false claims for its uses. Hundreds of Risperdal Lawsuits have also been filed by individuals in state courts across the country.

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Risperdal Fraud & Risperdal Lawsuits

The FDA reported in a news release last month that Janssen Pharmaceuticals, Inc. would plead guilty and pay more than $1.6 billion to resolve charges the company misbranded Risperdal and filed false claims for its uses.

On behalf of FDA, the U.S. Dept. of Justice announced a guilty plea agreement with Janssen Pharmaceuticals, Inc., (JPI) – a division of Johnson & Johnson –  of Titusville, N.J. The company agreed to pay $400 million in criminal fines for placing a misbranded drug –  Risperdal (risperidone) – in interstate commerce. JPI must also pay $1.25 billion as part of a Risperdal civil settlement. The plea and civil settlement penalties top $1.67 billion.

FDA Commissioner Margaret A. Hamburg, M.D. said, “When pharmaceutical companies ignore the FDA’s requirements, they not only risk endangering the public’s health but also damaging the trust that patients have in their doctors and their medications. . . Today’s announcement demonstrates that pharmaceutical manufacturers that ignore the FDA’s regulatory authority do so at their own peril.”

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J&J fined $2.2 Billion for Risperdal Marketing

Johnson & Johnson has agreed to pay $2.2 Billion and plead guilty to a misdemeanor in a deal to settle a U.S. Department of Justice investigation into the marketing of Risperdal and other drugs.

Prosecutors had pursued J&J for nearly ten years after a whistleblower brought evidence that the company had promoted drugs for unapproved and sometimes harmful uses in the 1990s and early 2000s.

Prosecutors allege that J&J promoted Risperdal, an anti-psychotic for boys suffering from mental disabilities, despite knowing that using Risperdal could raise levels of a hormone known to stimulate breast development.

U.S. Attorney General Eric Holder said at a news conference Monday that J&J “displayed a reckless indifference to the American people. [I]t constitutes a clear abuse of the public trust, showing a blatant disregard for systems and laws designed to protect public health.”

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Risperdal Warning for Young Males

Risperdal (risperidone)risperdal-johnson-johnson increases the risk of developing breasts and hyperprolactemia.

Recently, Risperdal maker Janssen,  a Johnson & Johnson subsidiary, has been blamed for its failure to inform the public that young males or boys taking Risperdal (or risperidone, a medication used to treat schizophrenia, bipolar disorder, and other psychological disorders) are at an increased risk of developing abnormally enlarged breast tissue (gynecomastia) and spontaneously producing breast milk (galactorrhea).

The manufacturer of Risperdal has known about this risk since at least 1999 but has done little to warn patients. Young boys or males who developed gynecomastia or galactorrhea after using Risperdal, may have a legal claim against the manufacturer and may be entitled to compensation.

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J&J fined $1.1 Billion in Risperdal Case

Johnson & Johnson .1 Billion in Risperdal Case">First Risperdal Verdict $2.5 Millionand its subsidiary, Janssen Pharmaceuticals, received a $1.1 billion fine by an Arkansas judge for allegedly lowering the profile of the risk of certain side effects in off-label uses and hiding risks associated with Risperdal, an antipsychotic drug.  The ruling could affect dozens of pending lawsuits concerning the drug.  This verdict is one of many brought against the pharmaceutical giants by state governments.  Additional lawsuits are pending in other states.

Circuit Judge Tim Fox ruled Janssen Pharmaceuticals Inc. and Johnson & Johnson must pay $5,000 each for 240,000 Risperdal prescriptions paid for by the state Medicaid program during a three and one half year span.  He also fined the companies an additional $2,500 for more than 4,500 letters Janssen sent to Arkansas doctors, totaling more than $11 million.

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