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Doubting Off-Label Use May Have Led to Firing

HOUSTON (CN) - A saleswoman can pursue her claim that she was fired for questioning off-label promotion of a heart device, a federal judge ruled.

Elaine George says she has been blacklisted from the medical device industry after Guidant Corp. fired her just three months into the job in 2006.

Boston Scientific had just acquired Guidant in July 2006 when they hired George as a territory manager for the Midwest region of the cardiac surgery division.

George said tension arose immediately in a training session when she questioned the legality of promoting off-label use of the FlexView Microwave Surgical Ablation System. Though the Food and Drug Administration approved the FlexView device for the removal of soft cardiac tissue during surgery, Guidant allegedly wanted sales reps to market the device for an off-label use, the treatment of atrial fibrillation, a condition in which the heart's atria beats rapidly or irregularly.

After George questioned whether such promotion was legal, her managers and trainers repeatedly reprimanded and criticized her, according to the complaint. George claims the companies then invented several pretexts to fire her.

Earlier versions of George's 2006 lawsuit have not made it to trial, but U.S. District Judge Lee Rosenthal last week refused to dismiss the second amended complaint, which alleges retaliatory discharge under the False Claims Act.

After concluding that the statute of limitations does not bar George's claim, the Houston court found that the lawsuit properly states a claim.

"George's twice-repeated questions about the legality of Boston Scientific's off-label marketing practices raised a 'distinct possibility' that she, or other employees attending the presentation, might bring False Claims Act litigation against Boston Scientific for those practices," Rosenthal wrote. "George alleged that both times, she was immediately reprimanded for questioning the legality of Boston Scientific's off-label marketing and warned that her job could be at risk. George has plausibly alleged that her actions were aimed at matters that reasonably could lead to False Claims Act litigation against Boston Scientific."

The 22-page order sets a scheduling and status conference for April 16.

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