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Abbott Wins $1 Billion Stent Lawsuit

Abbott Laboratories emerged victorious in a lawsuit that alleged the company had encouraged medical providers to submit false payments for stents to Medicare.

Qmed Staff

A federal jury in Dallas this week sided with Abbott Laboratories in a False Claims Act lawsuit that carried a potential $1 billion in damages for the company.

A whistleblower named Kevin Colquitt, a former regional sales director for Guidant, had alleged that the company was promoting bile duct stents for treating digestive tract cancers for unrelated vascular applications. Colquitt had maintained that the stents should not have been reimbursed by Medicare because FDA had not approved them for vascular applications. He also argued that multiple patients were injured from complications related to off-label use of the product, including fracture, stroke, migration. Abbott had countered that the use was the standard of care.

Filing the lawsuit in the Federal District Court in Dallas in April 2006, the case had been in litigation for just under a decade. Colquitt had been seeking $219.4 million in damages, which would have been tripled under the False Claims Act. Colquitt stood to receive 25 to 30% of the settlement. Now that the claims have been dismissed with prejudice, Colquitt is on the hook for all court costs in the case. He plans on appealing the ruling.

Abbott acquired Guidant's stent unit in 2006. Experts claimed during case testimony that some 99% of the company's bile-duct stents sold from 2004 to 2006 were used for off-label purposes. Guidant was estimated to have controlled some 15 to 20% of the market during this time frame, according to an earlier Bloomberg article.

The Dallas trial covered some of the same devices described in the $5.48 million settlement Abbott made with the federal government in 2013 over alleged kickbacks to physicians, according to a Bloomberg report.

Abbott's attorney James Hurst had maintained that there was no Medicare fraud because Medicare was aware that the biliary stents were used for vascular applications.  Medicare had studied the matter in 2008, two years after the lawsuit was filed, and decided not to make changes to its coverage, according to Hurst.

In that same year, however, FDA released a special communication warning physicians about the risk of using biliary stents for off-label use.

Colquitt filed the lawsuit after going to law school and learning about the U.S. False Claims Act.

Colquitt's attorney's had contended that the off-label use was an "experiment on senior citizens."

AARP Foundation attorneys joined the lawsuit in 2010.

AARP released a statement that it was disappointed with the ruling.

Learn more about cutting-edge medical devices at BIOMEDevice Boston, April 13-14, 2016.

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