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Johnson & Johnson Agrees to Pay $2.2 Billion to Settle Charges involving its Drug Risperdal

In what amounts to one of largest health care fraud settlements in U.S. history, health care giant Johnson & Johnson (J&J) and its subsidiaries agreed to pay more than $2.2 billion in criminal and civil fines to resolve allegations that the company committed off-label marketing practices in connection its prescription drugs Risperdal, Invega, and Natrecor.

In order for a prescription drug to be approved by the U.S. Food and Drug Administration (FDA), the drug maker must show that the drug is safe for the proposed use through extensive clinical trials. Although many drug makers find other uses for their medications that extend beyond the use for which they are approved, federal law prohibits them from marketing their drugs for uses that extend beyond the uses for which the FDA approved the drug.

According to the government's lawsuit, J&J violated federal law by allegedly promoting Risperdal and other drugs for uses that not approved FDA and also paid kickbacks to physicians and pharmacy providers.

In a press release, Attorney General Eric Holder criticized the company for conduct that "jeopardized the health and safety of patients and damaged the public trust" and in a press conference on Monday, Nov. 4, Holder called J&Js conduct "shameful" and "unacceptable."

J&J's conduct "displayed a reckless indifference to the safety of the American people," Attorney General Holder said. "And it constituted a clear abuse of the public trust, showing a blatant disregard for systems and laws designed to protect public health."

As a Forbes article points out, the lack of oversight and guidance regarding off-label prescriptions has "left a void that drugmakers have been all to [sic] willing to fill in with clever marketing campaigns designed to evade the FDA's prohibition of off-label marketing." The article goes on to state that by some estimates, off-label prescriptions account for 20 percent of all prescriptions and total more than $40 billion in sales annually.

Since off-label uses of prescription drugs are not adequately tested and proven to be safe and effective, the use of prescription drugs for off-label uses can lead to serious health problems and medical conditions. For instance, J&J's drug Risperdal was originally approved to treat schizophrenia, but J&J began marketing the drug to doctors for the treatment of dementia and other psychological disorders - medical conditions for which the drug was not proven to safely and effectively treat. As a result, many patients were put at risk for potential medical problems.

"As patients and consumers, we have a right to rely upon the claims drug companies make about their products," said Stuart Delery, Assistant Attorney General for the DOJ's Civil Division. "That is why this Administration has continued to pursue aggressively - with all of our available law enforcement tools -- those companies that corrupt our health care system."

The Chicago medical malpractice lawyers at Steinberg, Goodman & Kalish are committed to protecting the public from dangerous medical products, including unsafe pharmaceuticals and defective medical devices. If you have been injured by an unsafe medicine or defective medical device, contact the Chicago medical malpractice lawyers at Steinberg, Goodman & Kalish to schedule a free consultation to discuss a possible product liability or medical malpractice claim.


Steinberg Goodman & Kalish  (www.sgklawyers.com) is dedicated to protecting victims and their families.  We handle medical malpractice, product liability, personal injury, wrongful death, auto accidents, professional negligence, birth trauma, and railroad law matters. Contact us at (800) 784-0150 or (312) 782-1386.