Favorable Ruling for Companies Defending Off-Label Promotion Cases
By Anne K. Walsh –
Most news involving the False Claims Act reports that a company paid large sums of money to the government and relators to settle allegations of off-label promotion. Not so in this post about a recent decision dismissing a relator’s complaint. Not only did the company win, for now, but the court made some helpful statements to support dismissal of other complaints with similarly defective allegations.
The relator, Laurie Simpson, worked for seven years at Bayer Corporation, during which tenure she helped market and promote Trasylol, a prescription drug approved by FDA for patients undergoing coronary artery bypass graft using a cardiopulmonary bypass pump to prevent excess bleeding. Simpson alleged that Bayer violated the False Claims Act by “engag[ing] in a campaign of concealment and disinformation concerning Trasylol’s safety and efficacy.” At the heart of Simpson’s Eighth Amendment of the 131-page Complaint containing 30 causes of action, is the allegation that Bayer promoted Trasylol for other types of surgeries and failed to provide safety and efficacy information about those other uses, resulting in the drug being misbranded under the Federal Food, Drug, and Cosmetic Act (“FDC Act”).
continue to read here
Most news involving the False Claims Act reports that a company paid large sums of money to the government and relators to settle allegations of off-label promotion. Not so in this post about a recent decision dismissing a relator’s complaint. Not only did the company win, for now, but the court made some helpful statements to support dismissal of other complaints with similarly defective allegations.
The relator, Laurie Simpson, worked for seven years at Bayer Corporation, during which tenure she helped market and promote Trasylol, a prescription drug approved by FDA for patients undergoing coronary artery bypass graft using a cardiopulmonary bypass pump to prevent excess bleeding. Simpson alleged that Bayer violated the False Claims Act by “engag[ing] in a campaign of concealment and disinformation concerning Trasylol’s safety and efficacy.” At the heart of Simpson’s Eighth Amendment of the 131-page Complaint containing 30 causes of action, is the allegation that Bayer promoted Trasylol for other types of surgeries and failed to provide safety and efficacy information about those other uses, resulting in the drug being misbranded under the Federal Food, Drug, and Cosmetic Act (“FDC Act”).
continue to read here
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