Allegations Cite “Complex and Fraudulent” Seroquel Scheme

False Claims Act cases often prove tough to shake, as AstraZeneca is finding out this month. Following up on an oral explanation released earlier this month, a federal judge in New York released a written explanation for preserving a whistleblower’s lawsuit Seroquel scheme.

Seroquel is an antipsychotic drug used to treat schizophrenia, bipolar disorder, and depression. AstraZeneca stands accused of failing to disclose the risks associated with taking the drug when patients were also using QT prolonging drugs.

The allegations come from sales contractor-turned-whistleblower Allison Zayas. She says that her former employer knowingly misrepresented the dangers posed by Seroquel when prescribed in conjunction with QT drugs, including the serious potential for cardiac arrest.

This isn’t the first time AstraZeneca has experienced legal action related to a Seroquel scheme. The company paid $520 million to settle an unrelated False Claims Act allegation back in 2010, which related to off-label promotion of the drug.

In this case, AstraZeneca argues that the risks cited by Zayas are widely available for public scrutiny, including patients, medical professionals, and government officials. District Judge Frederick Block declined to throw out the lawsuit on this basis, however, writing in his ruling that the plaintiff “appropriately alleges a complex fraudulent scheme” that he considers plausible and worthy of further examination.

However, there was a glimmer of hope for the drug manufacturer.

Allegations of off-label marketing were also included in the lawsuit. Such unapproved usage has cost the company dearly in the past, but Judge Block opted to dismiss the claims in this case.  Similarities to the 2010 settlement appear to have saved the drug maker on this particular charge.

In broader terms, the alleged Seroquel scheme is the least of AstraZeneca’s worries. The British firm’s earnings have been hit by two patent expirations in recent years, with its star drugs Crestor and Nexium now facing generic competition. AstraZeneca has been in belt-tightening mode ever since, slashing more than 800 positions from its North American operation as 2016 came to a close.

Even so, the Seroquel scheme allegations provide another ongoing headache that the drug maker could live without. Transparency continues to be a concept where actions speak louder than words in the pharmaceutical sector.

Unfortunately, even after years of huge lawsuit settlements and patients suffering, it appears that the only language some pharma companies understand is legal action.