Antipsychotic Drugs Are the Target of Numerous Lawsuits

October 2010

Antipsychotics are the top-selling class of drugs in the country. More than a half-million young people take the medications and one-quarter of nursing home residents have used them. They are also the biggest target for lawsuits in the pharmaceutical world, with every major manufacturer either settling recent government cases or under investigation for possible healthcare fraud.

Recent settlements include the following:

• In 2010, AstraZeneca paid $520 million for "illegal promotions" of antipsychotics for children, the elderly, veterans, and prisoners.
• In 2009, Eli Lilly paid a $515 million criminal fine as part of a broader, $1.4 billion settlement with the government for the illegal marketing of Zyprexa.
• In 2009, Pfizer paid a $1.3 billion criminal fine as part of a broader, $2.3 billion settlement. This included $301 million related to Geodon along with the marketing of other drugs.
• In 2007, Bristol-Myers Squibb paid $515 million to settle federal and state investigations into the marketing of Abilify to child psychiatrists and nursing homes.

In addition, Johnson & Johnson is currently under investigation for allegedly paying kickbacks to encourage Omnicare, the nation’s largest nursing home pharmacy, to recommend Risperdal.

The manufacturers say their drugs are safe and effective in treating the conditions for which they’re approved, namely bipolar mania and schizophrenia. The companies also say they adhere to ethical sales guidelines and that all possible side effects are fully disclosed to the Food and Drug Administration (FDA).

However, documents have come to light showing that some company officials knew they were using questionable tactics when marketing their drugs. These included gifts, payments, meals, and trips for doctors as well as biased studies, ghostwritten medical journal articles, promotional conference appearances, and payments for postgraduate education to encourage a pro-drug mentality among physicians. Investigators say that together, these tactics allowed drug makers to exaggerate the medications’ benefits while minimizing their risks and encouraging off-label uses.

Over the next year, the government will add at least 15 prosecutors and 100 investigators to probe healthcare fraud. The Pharmaceutical Research and Manufacturers of America strengthened its marketing code of conduct two years ago, and some companies are disclosing their speaking and consulting payments. There are still over 1,000 False Claims Act lawsuits underway, however, and many of them are focused on healthcare and antipsychotic drugs. Critics say this is proof that the pharmaceutical industry hasn’t done enough to change its practices.