Legal Information and Resources

The Justice Department filed a civil complaint against pharmaceutical company, Forest Laboratories, on February 25, 2009, charging that the company “concealed for several years a clinical study that showed that Celexa and Lexapro were not effective in children and might even pose risks to them, including causing some to become suicidal.” The company was accused of defrauding the government of millions of dollars. It did so, says the Justice Department, by marketing the anti-depressant drugs for unapproved uses in children and teenagers. Forest Laboratories allegedly promoted another clinical trial’s results (that the company financed) showing the drugs were effective. Indeed, Forest Laboratories is accused of paying “kickbacks” to doctors, disguised as grants and consulting fees. The government is seeking triple money damages under the federal False Claims Act.

Two lots of Duragesic pain patches were recalled on December 31, 2008 by the Pri-Cara division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., which is a unit of Johnson & Johnson. The reason given was that cuts in the product might allow direct exposure to the fentanyl gel, which is a very powerful opioid. That exposure can cause a potentially fatal overdose.

There is a long history of recalls and of Public Health Advisories from the FDA regarding fentanyl pain patches. Millions of pain patches have been recalled. Manufacturers include Alza, Sandoz, Janssen, Mylan, Watson and Actavis. Actavis patches also involve the names of Corium International and Abrika Pharmaceuticals. The FDA has received hundreds of reports of fatalities associated with fentanyl patch use. Millions of dollars in jury verdicts have been awarded.

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