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Originally published March 10 2015

FDA involved in case after approving psych meds that cause boys to grow breasts

by PF Louis

(NaturalNews) It's not often that the FDA gets sued for anything, but a powerful Philadelphia legal firm that handles whistleblower and class action cases throughout the nation, Sheller, P.C., has petitioned the Federal Court to demand the FDA follow through with black box warnings for Johnson & Johnson's drug Risperdal or remove its pediatric approval.

The FDA had ignored Sheller's requests to allow the legal firm to release documents held by drug company Johnson & Johnson and its subsidiary Janssen that would prove the necessity of withdrawing the FDA's 2006 approval of Risperdal for pediatric prescriptions or at least demand black box warnings.

By November 2014, the FDA simply denied all legal actions from Sheller and dismissed their motions to proceed toward a black box warning or remove the drug's pediatric prescription classification. So Sheller has filed a suit which would insist that a federal judge issue an injunction to the FDA for either issuing a black box warning or removing the drugs from pediatric use.

The law under which Sheller is suing the FDA is the Administrative Procedures Act (APA). According to "The APA serves to police improper agency behavior, protect public safety, and secure proper entitlements. The APA governs all three main agency functions: rulemakings, adjudications, and licensing."

Sheller piling on after the U.S. Justice Department collected the largest financial penalties from Big Pharma ever

Sheller is representing hundreds of adolescent boys whose use of prescribed Risperdal caused breast enlargement and other gender development issues. Risperdal had been prescribed for bipolar and schizophrenic behavior and was approved by the FDA for use among adolescents and children in 2006.

Sheller has managed to do well for its class action clients, garnering settlements for each client in a class action suit.

But prior to Sheller's actions, the U.S. Justice Department did some real justice for a change. In a November 2013 guilty plea, a total of $2.2 billion was paid to the Justice Department for J&J and Janssen's promotion of Risperdal, Invega and Natrecor. A portion was distributed to federal Medicaid as well as to Texas and South Carolina Medicaid.

Sheller's demands to the FDA also includes obtaining documents that show the drug's dangers.

The sealed documents, currently subject to confidentiality, "describe the risks associated with the Risperdal Drugs and contradict, complicate, and/or substantially call into question safety data provided by J&J and/or Janssen to the FDA," Sheller says. "The documents are in J&J and/or Janssen's possession and control, and in many instances were generated by J&J, Janssen and/or J&J's predecessor or subsidiary companies."

The Justice Department also caught Janssen and J&J offering kickbacks to physicians for prescribing Risperdal. In addition to the lawsuit settlements, the drug makers were fined $400 million for criminal charges of selling their drugs for off-label use not allowed by the FDA.

The total of $2.2 billion dollars is the Justice Department's biggest dollar coup against Big Pharma thus far. What's amazing is how well Big Pharma holds up regardless of the fines levied and vast lawsuits settled.

It's apparent that these financial setbacks are accepted as part of business-making decisions based solely on the bottom line. For example, a drug company boardroom meeting may discuss going off-label with a dangerous drug and weigh it against the probable costs of penalties and lawsuit settlements. If they calculate that the profits outweigh the sum of possible fines and lawsuits, they go for it.

That's what our healthcare system is all about, money. Not medical science, not finding real safe cures, but profits.


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