LEGAL ENFORCEMENT AGAINST ALLEGED MARKETING ABUSES

Despite these obstacles, the lure of a wider market was too much for the manufacturers of atypical antipsychotics to resist. A number of lawsuits filed over the past several years have alleged that the drugs were marketed in ways that violated the law. Specifically, the suits claim that manufacturers hid or downplayed known risks and that they actively promoted uses beyond those that the FDA had approved. Some of the promotions were also alleged to have involved paying indirect bribes to prescribing physicians.

Legal actions over pharmaceutical marketing practices can take several forms. Among the most common, the federal government can sue under the False Claims Act for deceptive practices that lead to payment for a product or service under a government program, such as Medicare or Medicaid.3 Private whistleblowers can report perceived abuses to the government and can sue on their own if the government decides not to pursue the case. These are known as qui tam actions.4 Individual patients can bring product liability claims for harm caused by undisclosed side effects.

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Manufacturers of the atypical anti-psychotic medications have been the targets of all of these kinds of lawsuits, resulting in some of the largest settlements ever seen in pharmaceutical litigation. Pfizer holds the dubious record, paying $2.3 billion in 2009 to settle an enforcement action involving Geodon as well as other drugs. Of this total, $1.3 billion was assessed as a criminal fine, an unusually severe penalty in a case of corporate misconduct.5

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The same year, Eli Lilly paid a $1.4-billion settlement for a suit involving Zyprexa, including a $515 million criminal assessment. Beyond these block-buster settlements, Bristol-Myers Squibb paid $515 million in 2007 to settle charges concerning the promotion of Abilify. More recently, Novartis agreed in 2010 to pay $422.5 million in an enforcement action involving the epilepsy drug oxcarbazepine (Trileptal, Novartis).6 Also in 2010, AstraZeneca paid $520 million to settle charges related to the marketing of Seroquel.

In addition to these federal actions, several states have sued makers of atypical antipsychotic agents. Some of these suits claim that undisclosed side effects imposed costs on their Medicaid programs; other suits allege violations of consumer protection laws.7 Patients have also sued claiming harm from the drugs.8 These proceedings have resulted in numerous additional settlements, although not as large as those in the federal prosecutions.

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