San Diego, CA (PRWEB) April 24, 2014
Resource4thePeople announced today that it is encouraged by the overwhelming response to its offer of free consultations to consumers over allegations that the antipsychotic medication Risperdal may cause a breast-growth condition known as gynecomastia or other side effects.
As a result of a larger-than-expected number of inquiries these consultations from its national network of attorneys will continue to be offered on a permanent basis in the future, said Resource4thePeople.
“It is obvious that there are far more consumers who have been affected by the allegations* admitted to by the manufacturers of this medication in their guilty plea to charges filed by the U.S. Justice Department than first anticipated,” said Resource4thePeople.
“Therefore, we have decided to continue to offer these free consultations for any boy or man who has been affected by off-label or other uses of Risperdal in which gynecomastia or other serious side effects have occurred.”
These non-approved uses of Risperdal were recently outlined* by the U.S. Justice Department and the Food and Drug Administration in the resolution of charges involving multimillion dollar criminal and civil penalties.
The Justice Department and FDA issued a joint Nov. 4, 2013 press release* in which they explained the resolution of charges against pharmaceutical giant Johnson & Johnson and its subsidiaries:
“Global health care giant Johnson & Johnson (J&J) and its subsidiaries will pay more than $2.2 billion to resolve criminal and civil liability arising from allegations relating to the prescription drugs Risperdal, Invega and Natrecor, including promotion for uses not approved as safe and effective by the Food and Drug Administration (FDA) and payment of kickbacks to physicians and to the nation’s largest long-term care pharmacy provider. The global resolution is one of the largest health care fraud settlements in U.S. history, including criminal fines and forfeiture totaling $485 million and civil settlements with the federal government and states totaling $1.72 billion.
“’The conduct at issue in this case jeopardized the health and safety of patients and damaged the public trust,’ said Attorney General Eric Holder. ‘This multibillion-dollar resolution demonstrates the Justice Department’s firm commitment to preventing and combating all forms of health care fraud. And it proves our determination to hold accountable any corporation that breaks the law and enriches its bottom line at the expense of the American people.’”
The resolution includes criminal fines and forfeiture for violations of the law and civil settlements based on the False Claims Act arising out of multiple investigations of the company and its subsidiaries.
Resource4thePeople said its attorneys are investigating cases in which off-label uses of Risperdal resulted in a diagnosis of diabetes or tardive dyskinesia and gynecomastia (male breast development).
The Food and Drug Administration originally approved Risperdal in 1993 for the treatment of schizophrenia, although that approval later was expanded to also address bi-polar disorder.
Risperdal works by blocking dopamine, which releases prolactin from the pituitary gland. Thus, Risperdal creates a sedating effect on the patient, typical in antipsychotics of its class. It can be administered orally in the form of tablets or via a bi-weekly injection.
The Justice Department said that from March 3, 2002, through Dec. 31, 2003, Janssen Pharmaceuticals Inc., a J&J subsidiary, introduced the antipsychotic drug Risperdal into interstate commerce for an unapproved use, rendering the product misbranded.
For most of this time period, Risperdal was approved only to treat schizophrenia, the Justice Department said.
Justice officials said that Janssen’s sales representatives promoted Risperdal to physicians and other prescribers who treated elderly dementia patients by urging the prescribers to use Risperdal to treat symptoms such as anxiety, agitation, depression, hostility and confusion.
The Justice Department said the company created written sales aids for use by Janssen’s ElderCare sales force that emphasized symptoms and minimized any mention of the FDA-approved use, treatment of schizophrenia.
The company also provided incentives for off-label promotion and intended use by basing sales representatives’ bonuses on total sales of Risperdal in their sales areas, not just sales for FDA-approved uses, Justice Department officials said in the release.
“When pharmaceutical companies interfere with the FDA’s mission of ensuring that drugs are safe and effective for the American public, they undermine the doctor-patient relationship and put the health and safety of patients at risk,” Director of the FDA’s Office of Criminal Investigations John Roth said in the press release.
“Today’s settlement demonstrates the government’s continued focus on pharmaceutical companies that put profits ahead of the public’s health. The FDA will continue to devote resources to criminal investigations targeting pharmaceutical companies that disregard the drug approval process and recklessly promote drugs for uses that have not been proven to be safe and effective.”
“The charges in this case were filed under the Federal Food, Drug, and Cosmetic Act (FDCA), which protects the health and safety of the public by ensuring, among other things, that drugs intended for use in humans are safe and effective for their intended uses and that the labeling of such drugs bear true, complete and accurate information,” said Resource4thePeople.
The federal officials outlined the following procedures in their press release:
“Under the FDCA, a pharmaceutical company must specify the intended uses of a drug in its new drug application to the FDA. Before approval, the FDA must determine that the drug is safe and effective for those specified uses.
“Once the drug is approved, if the company intends a different use and then introduces the drug into interstate commerce for that new, unapproved use, the drug becomes misbranded. The unapproved use is also known as an “off-label” use because it is not included in the drug’s FDA-approved labeling.