Atypical antipsychotic drug Zyprexa, after an 18-month drug injury investigation into manufacturer Eli Lilly’s unsafe off-label marketing to vulnerable elderly and young patients, is expected pay a $1.42 billion settlement, $362M of which will go to 32 states, including Tennessee, and the District of Columbia.
Zyprexa was FDA approved in 1996 for treatment of bipolar disorder and schizophrenia in adults but the company has since marketed the drug for off-label (unapproved, often untested) uses. These include Zyprexa for treatment lesser psychological problems, such as behavioral problems, and prescription to children and the elderly patients. (More details on Zyprexa side effects and dangerous drugs at my law firm’s Defective and Potentially Dangerous Drugs site). An estimated 26 million patients worldwide have taken Eli Lilly’s “wonder drug” Zyprexa.
Zyprexa was marketed as the next generation of anti-psychotic drugs called atypicals. Creators of atypicals claimed that severe psychological disorders like schizophrenia could be treated with drugs like Zyprexa with few, minor side-effects. Yet not all these new drugs developed accurate testing for long-term side effects, such as Zyprexa’s side effect of rapid weight gain and diabetes in select populations. In one tragic case in Atlanta, Georgia (previously covered in Tennessee Law Blog’s “Southern Man’s Death Linked to Zyprexa”), a middle-aged bipolar man died after significant weight gain during his five years of taking Zyprexa. Eli Lilly has already spent $1.6 billion to settle over 30,000 product-liability lawsuits from people who developed diabetes or suffered from other unintended side effects of Zyprexa. And yet Zyprexa not only remains on the market but remains the company’s best selling drug.
The present Zyprexa settlement developed out of two qui tam whistleblower cases against Eli Lilly. As Medicare, Medicaid, and other government-funded hearth care programs were involved in the targeting of sales to the elderly, the federal government accepted the False Claims lawsuits against Zyprexa, which resulted in the then largest qui tam settlement in False Claims Act history.
Though the drug was not approved for geriatric patients, in at least one case, Eli Lilly urged medical staff to use Zyprexa to zonk unruly nursing home residents. According to court documents, Zyprexa’s salespeople suggested doing so would reduce “nursing time and effort”. Doctors were also urged to prescribe Zyprexa to patients with dementia, including Alzheimer’s, even though the drug is not FDA approved for such patients.
Zyprexa remains available to Medicaid patients, and most of Zyprexa’s sales are to the federal government. If the announced settlement does not go through, Eli Lilly may be barred from Medicaid and Medicare programs.
While Zyprexa has been subject of lawsuits, other drug makers such as Cephalon Inc. (read Tennessee Law Blog’s entry on the Cephalon qui tam lawsuit settlement) have been subject to criminal and injury lawsuits and others such as AstraZeneca (Seroquel) and Johnson & Johnson (Risperdal) are under government investigations related to alleged off-label promotion of antipsychotics.
If you’ve suffered injury from a prescription drug, my drug injury attorneys and I can help. Initial contact can be made by completing our drug injury attorney form for Tennessee, Georgia, and Kentucky, or by calling our Nashville law offices toll-free at 800.705.2121.