San Diego, CA (PRWEB) March 20, 2014
Resource4thePeople announced today that its national network of attorneys is now investigating claims over allegations that the antipsychotic medication Risperdal may cause a breast-growth condition known as gynecomastia or other side effects.
Free consultations are being offered to consumers who may have been affected by non-approved uses of the medication as recently outlined* by the U.S. Justice Department and the Food and Drug Administration involving multimillion dollar criminal and civil penalties.
“The revelation of the illegal activities that federal officials resolved against the manufacturer of this drug and its parent company has generated a large number of inquiries from consumers about their rights to file claims,” said Resource4thePeople.
“As a result we are announcing that our national network of attorneys will offer free consultations to those who inquire about their legal rights to seek compensation over allegations involving gynecomastia and other serious side effects.”
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 in connection with Risperdal and other medications:
“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) in teens or adolescents.
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.
“’When companies put profit over patients’ health and misuse taxpayer dollars, we demand accountability,’ said Associate Attorney General Tony West. ‘In addition to significant monetary sanctions, we will ensure that non-monetary measures are in place to facilitate change in corporate behavior and help ensure the playing field is level for all market participants.’”
The Justice Department in its press release 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 in the press release 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.”