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Whistleblower Lawsuit Alleges Medical Device Makers Over Off-Label Marketing

An industry whistleblower has filed lawsuits against Boston Scientific Corporation, Medtronic, Inc., St. Jude Medical, Inc. and three other medical-device makers, the Associated Press reported. Lawsuits allege that companies have marketed their surgical ablation devices for off-label uses, according to documents unsealed in Houston federal court. Surgical ablation devices use focused energy to create controlled lesions or scar tissue on a patient’s heart or other organs.

The lawsuits were filed under the federal False Claims Act on behalf of the government, alleging the marketing caused excessive Medicare reimbursements.

The complaints allege that manufacturers have struggled to sell their surgical ablation devices because the devices have not been specifically approved by US Food and Drug Administration (FDA) for use in the treatment of a common heart rhythm problem called atrial fibrillation.

The lawsuits, originally filed in 2007 and 2008 in the southern district of Texas, were made public July 10, 2009 by a judge’s order. The allegations against the companies were made by a former Boston Scientific employee.

A spokesman for Boston Scientific declined to comment on the issue.