AstraZeneca Plc is in talks to settle a Texas lawsuit claiming that the company fleeced the state’s Medicaid program by fraudulently marketing one of its top drugs, according to court filings.
Texas sued the drugmaker in 2013, saying AstraZeneca had targeted the state’s Medicaid program by urging doctors to prescribe the powerful antipsychotic Seroquel for unauthorized treatments -- particularly for children -- over six years.
While doctors have wide discretion to prescribe drugs beyond what they’ve been approved to treat, drugmakers are forbidden from marketing them for off-label uses. By 2013, AstraZeneca had already agreed to pay almost $600 million in a pair of settlements over claims related to Seroquel’s marketing.
While the company pledged to prevent off-label marketing as part of those deals, the Texas suit claimed it never did, and seeks $5 billion in civil fines.
Texas says emails and testimony by sales representatives and managers reveal that AstraZeneca had its sales force pitch Seroquel to child psychiatrists and as a treatment for nonbipolar depression even though the U.S. Food and Drug Administration hadn’t approved the drug for either purpose.
“AstraZeneca believes that all applicable laws were followed and that the allegations are without merit,” company spokeswoman Abigail Bozarth said in an email. “Beyond that, we cannot discuss the specifics of ongoing litigation.”
The Cambridge, England-based drugmaker’s shares were down 0.9 percent to 4,967 pence at 2:13 p.m. in London.
AstraZeneca is in negotiations to resolve both the Texas case and a lawsuit in Brooklyn brought by a whistleblower claiming the company downplayed the drug’s risks. Talks on a “potential resolution” aim to settle both suits, according to a Nov. 10 filing in federal court in Brooklyn.
Kayleigh Lovvorn, spokeswoman for Texas Attorney General Ken Paxton, declined to comment on settlement discussions or the lawsuit.
James Pepper, attorney for Allison Zayas, a whistleblower in the Brooklyn and Texas cases, also declined to comment on settlement prospects. AstraZeneca has “reached a settlement in principle’’ with Zayas, according to a Nov. 14 filing.
First approved in 1997 to treat schizophrenia, Seroquel sales totaled $28 billion between 2007 and 2013, according to data compiled by Bloomberg, and the drug was AstraZeneca’s second-biggest seller from 2007 to 2011. By 2016, sales fell to $737 million amid generic competition.
The company’s zeal in promoting the drug was targeted by the U.S. Justice Department, and in 2010, AstraZeneca signed a $520 million civil pact without admitting wrongdoing but agreeing to market Seroquel “in a manner that complies with all applicable federal health care program and FDA requirements,” including on how doctors are told about off-label uses, through 2015.
But Texas claims that even after securing the settlement AstraZeneca salespeople were still pushing doctors to prescribe Seroquel for unapproved uses.
According to internal company documents filed in the Texas lawsuit, the state’s sprawling Medicaid program was AstraZeneca’s “number one payer and an ABSOLUTE MUST WIN.” The May 2010 memo reminded the sales team that “it’s not going to sell itself” and pressed them to “do a better job of selling this win.”
Meanwhile, the company was the target of an investigation by 37 states -- including Texas -- over allegedly deceptive marketing practices through 2006. In 2011, AstraZeneca agreed to pay $68.5 million to settle those claims without admitting wrongdoing, and separately paid $647 million to patients who claimed the drugmaker hadn’t disclosed Seroquel’s side effects.
Texas, which brought the 2013 suit with the cooperation of two former AstraZeneca salespeople, says the drugmaker breached the federal settlement by promoting Seroquel to psychiatrists and others who treated children. If found to be true, that could be costly, the state argued in filings, because “repeated or flagrant violation” could lead the U.S. to exclude AstraZeneca drugs from federal programs such as Medicare and Medicaid.
Lauren Ehrsam, a Justice Department spokeswoman, declined to comment.
AstraZeneca has argued that Texas didn’t sustain any harm or damages due to the drug’s marketing, and submitted a statement from former FDA chief counsel Ralph Tyler saying “off-label use of approved medications is expected and, indeed, may constitute the standard of medical care.”
The company’s lawyer, Steve McConnico, also pointed out that Seroquel -- in its generic form -- remains on the state’s list of drugs approved for Medicaid and prescriptions for it are still being reimbursed by the state. He also said it’s still being prescribed to children and adolescents.
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