A former employee of Shire Pharmaceuticals is suing the drug company in a Pennsylvania federal court, alleging she was fired in retaliation for voicing concerns over Shire’s inappropriate, off-label marketing of Firazyr, a costly drug approved for the treatment of hereditary angioedema, a rare and potentially life-threatening immune disorder that causes swelling of the face, airway, and other parts of the body.
Mary Catherin Barry, who worked in Shire’s accounting department from 2006 to 2014, monitored Medicare and Medicaid reimbursements of Firayr. She states in her lawsuit that she noticed a number of patients were using unusually high amounts of the drug, which is self-injected and costs about $8,000 per dose.
By 2014, Ms. Barry concluded that the abnormally high usage could be attributed to off-label marketing, an illegal practice some drug companies engage in to boost sales of certain drugs by promoting them for purposes unapproved by the U.S. Food and Drug Administration (FDA), thus resulting in the submission of false claims to Medicare, Medicaid, and other federal health care programs.
In April 2014, Ms. Barry sent Shire’s chief compliance and risk officer a letter expressing her concerns about the company’s marketing of Firazyr and asking the company for an independent investigation of the matter. Shire did launch an investigation, but Ms. Barry lost her job soon after.
“Despite having had nothing but sterling performance evaluations in eight years as a Shire employee … Ms. Barry was (according to Shire) the least-qualified applicant in a universe of 21 applicants for 20 positions,” the complaint stated. “She was also the only applicant who had blown the whistle on Shire’s off-label marketing of Firazyr.”
According to Law 360, before writing the letter, Ms. Barry was “asked to reapply for her position at the company, as Shire said that it was replacing its government accounts directors with a new title, government accounts field leads.”
However, Law 360 reports, Ms. Barry “was the only one of the eight applicants for the seven new (government accounts field lead) positions to not be rehired.” She was also the only applicant to fail to get one of 13 commercial accounts field lead positions.
According to the complaint, Ms. Barry said a co-worker had confided that the re-application and hiring process had been rigged to result in her termination, which she contends is a violation of the Sarbanes-Oxley Act and Pennsylvania’s whistleblower protection laws.
Law 360 reports that she seeks reinstatement to her position, twice the back pay owed to her plus interest, and other costs.
Source: Law 360