Johnson & Johnson will pay more than $2.2 billion to settle a lawsuit alleging that it marketed off-label uses of its antipsychotic and anti-seizure drugs and that it paid kickbacks to doctors and pharmacists who prescribed the drugs. Those alleged actions were illegal because, although physicians may prescribe FDA-approved drugs for off-label uses, drug manufactures may not market the drugs for such uses. The lawsuit began several years ago when a group of whistleblowers brought a qui tam action under the False Claims Act.
After initially fighting the case, Johnson & Johnson agreed to pay $2.2 billion in criminal and civil fines to settle the case in early November of this year. Part of the settlement will reward the whistleblowers, as permitted by the False Claims Act. The Johnson & Johnson settlement is the latest in a string of massive settlements involving pharmaceutical companies. In recent years, GlaxoSmithKline and Pfizer agreed to pay settlements in the billions of dollars to end lawsuits alleging improper marketing. Since the beginning of 2009, the Department of Justice has recovered $11.9 billion through False Claims Act cases involving allegations of defrauding federal healthcare programs. These lawsuits highlight the need for robust compliance programs at healthcare-related companies to reduce the risk of costly whistleblower lawsuits.
See the press release from the Department of Justice here: http://www.justice.gov/opa/pr/2013/November/13-ag-1170.html
David Dirr is an attorney at the Northern Kentucky office of Dressman Benzinger LaVelle and is a member of the firm’s healthcare and litigation practice groups. He is licensed to practice in Ohio, Kentucky, and Indiana. David concentrates his practice on the areas of Medicare and Medicaid reimbursement, anti-kickback law, the Stark law, and HIPAA.
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