As a pharmaceutical liability attorney, I’ve written about illegal “off-label” marketing for several drugs, including drugs that turned out to have dangerous and serious side effects. A drug is used “off label” when doctors prescribe it for uses other than the use approved by the FDA. This is permissible for doctors, but the pharmaceutical companies that make the drugs are not legally allowed to market the drugs for those purposes. That rule has led to several large settlements between the drug companies and state and federal governments over the past few years, including cases in which the drug at issue carried serious potential risks that the drug maker did not warn about. The latest such settlement appears to be one announced by Abbott Laboratories, the maker of seizure drug Depakote.
Depakote (valproic acid) was approved in the United States to treat seizures, prevent migraine headaches and stabilize the moods of those with bipolar disorder. However, it’s also used off-label in a variety of applications, some experimental. According to the Chicago Tribune, a former saleswoman for Abbott sued in 2007, charging the company with asking her and other salespeople to market the drug for schizophrenia, autism and symptoms of dementia. Even more disturbingly, the Depakote whistleblower lawsuits accused Abbott of paying illegal kickbacks to doctors and pharmacists to talk up these off-label uses. A statement from Abbott said it had been under investigation for at least four years, for behavior stretching as far back as 1998.
The off-label marketing was particularly damaging to the federal and state governments because it took advantage of publicly funded Medicare and Medicaid programs, which have funds readily available for drugs doctors deem necessary for covered patients. Nursing homes in particular provided many potential patients for the off-label use to control agitation in dementia patients – but no science backed up that claim, the Justice Department said. No clinical trials showed benefits to using Depakote in schizophrenia patients, either. The settlement from Abbott totaled $1.6 billion, which included $700 million to settle criminal charges, $800 million to settle civil lawsuits brought by various governments and $100 million to resolve state consumer protection matters. Illinois will receive $20 million and Missouri $15 million.
This settlement continues a trend that I, as a dangerous drug lawyer, think is promising. As the article notes, the federal government and many states have aggressively pursued drug companies accused of defrauding Medicare and Medicaid with off-label marketing, kickbacks and similar illegal marketing practices. These drugs include several with concerning side effects, such as the diabetes drug Avandia – associated with an increased risk of stroke and heart disease – and atypical antipsychotics such as Risperdal and Zyprexa, all of which are federally required to carry a warning about the increased risk of death in elderly dementia patients. That’s why off-label marketing is concerning to me as a defective drug attorney: drug companies are not just breaking the law, but also using the drug in populations that haven’t been studied and may carry unknown risks.
If you or someone you love took a drug that was supposed to help and ended up sick, injured or worse, your family may have a claim against the drug’s manufacturer. To tell your story to an experienced drug injury lawyer, call Carey, Danis & Lowe today at 1-877-678-3400 or send us a message through our website.
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