The Chicago Tribune reports on the story of pharmaceutical sales representative turned whistleblower, Allison Zayas. Zayas worked for pharmaceutical company AstraZeneca marketing and selling the antipsychotic drug Seroquel to doctors and nursing homes. In the winter of 2009, one of Zayas’ clients, a doctor, described to her how a patient died while taking a combination of Seroquel and methadone and the possible link between the two and the death. Subsequently, two other doctors told Zayas that as many as 10 patients in methadone clinics in New York had died while taking Seroquel and methadone together. Zayas reported her concerns to AstraZeneca but claims that the company continued to aggressively market the successful drug even to methadone clinics.
In response, Zayas quit her job at AstraZeneca and filed a whistleblower lawsuit against the company in 2010. This lawsuit was a rare example in the pharmaceutical industry of a current or former employee brining suit about dangerous drug combinations. The lawsuit claimed that AstraZeneca withheld safety information from FDA advisory panels and did not alert patients, doctors, or pharmacists about the risks of taking Seroquel in combination with methadone. The suit also claims that AstraZeneca directed and incentivized its sales representative to sell Seroquel to doctors that were known to prescribe methadone and other drugs that could trigger harmful reactions.
AstraZeneca disputes the claims in the lawsuit but declined to comment further on the allegations. In court documents AstraZeneca argued that the whistleblower lawsuit is “long on words, paragraphs and pages, but falls far short of stating a claim.” Later in 2010, AstraZeneca changed prescribing information on Seroquel to “caution” use with other medications and in 2011 the FDA required AstraZeneca to revise this to say Seroquel “should be avoided” with those drugs where harmful effects may occur.
The case reportedly settled last month for an as of yet undisclosed amount with a status report expected sometime today. This is not the first time AstraZeneca has faced suit over Seroquel. In 2010, AstraZeneca paid $520 million to settle allegations that the company had marketed Seroquel for unapproved uses. The status report today should give some clarity on the reported settlement in this matter and may shed further light on AstraZeneca’s response and game plan moving forward.
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