Product News and Recalls

J&J to pay $181 million in illegal marketing settlement

Johnson & Johnson will pay 36 states and the District of Columbia $181 million as a settlement for allegations that the company inappropriately marketed its antipsychotic drug Risperdal, the Philadelphia Inquirer reports.

Federal and state investigators have been examining the company’s Risperdal marketing practices for almost a decade, according to the Inquirer. The $181 million agreement is separate from a continuing federal investigation that could lead to criminal charges against Johnson & Johnson, and according to some reports could cost the company more than $2 billion.

Johnson & Johnson also faces ongoing legal action over allegations that it improperly marketed dangerous medical devices.

Up to 10 percent of patients who received transvaginal mesh implants, used to treat urinary incontinence and pelvic organ prolapse, had the devices fail within a year. The most common reported problem is the vaginal mesh eroding and sticking through the walls of the bladder and vagina, causing debilitating pain and infection.

Although Johnson & Johnson’s Ethicon unit recently announced it would stop selling four lines of vaginal mesh devices, the company marketed them despite thousands of reports of device failure, and despite being ordered by the U.S. Food and Drug Administration to stop.

The FDA is also investigating metal-on-metal hip implants manufactured by Johnson & Johnson subsidiary DePuy Orthopaedics in response to thousands of reports that the devices fail prematurely and leave toxic metal debris in patients’ bodies.

The hip implants were recalled in 2010. But an investigation by British medical journal The Lancet found internal company documents indicating that Johnson & Johnson officials were aware as early as 2005 of the device’s high early failure rate, yet continued to market it.

J&J has said it will appeal big-money losses from Risperdal settlements in separate state cases in South Carolina, Louisiana, and Arkansas. An Arkansas judge penalized the company $1.2 billion, but Janssen prevailed in a case brought by Pennsylvania through the Governor’s Office.

It’s legal for physicians to prescribe drugs for purposes beyond the parameters of their FDA approval, called “off-label” uses. But it’s illegal for pharmaceutical companies to market drugs for those uses.

If you’ve received a DePuy hip or transvaginal mesh implant, you should consult with a doctor if you have any ongoing symptoms or health concerns. If you have significant injuries from either device, you should also consult with a lawyer familiar with the DePuy hip implant or transvaginal mesh case to discuss your legal rights.

See the story here:

http://www.philly.com/philly/business/20120831_Johnson___Johnson_settles_Risperdal_case_for__181_million.html