by
Heather Mayer, DOTmed News Reporter | September 28, 2010
Boston Scientific Corp. asked a federal court to dismiss a false claims lawsuit against its Guidant Corp. subsidiary over an allegedly defective defibrillator. The company is arguing that the case is based on "parasitic claims" based on media reports, according to a MassDevice post.
The lawsuit was filed after James Allen, a patient using the company's Ventak Prizm model 1861, reported two incidents in August and December 2002 in which the device allegedly caused him harm. In the first incident, the device allegedly delivered seven unnecessary 750-volt shocks, knocking Allen unconscious. The second alleged failure caused Allen to fall down a flight of stairs.
Prior to the incidents, in February 2002, Guidant had discovered a design flaw in one of its defibrillators, the Ventak Prizm. According to court documents, in April 2002, the company reported fixing the flaws and producing a corrected version without recalling the defective products.
In July 2008, Allen sued Guidant and Boston Scientific under the False Claims Act, claiming that the company knew of the device problems but did not disclose them.
The Natick, Mass.-based company argued that the suit doesn't hold water because it is based on public information gleaned from the media, according to court documents, reported by MassDevice.
Courts do not have power over suits brought under the False Claims Act if they are "based upon the public disclosure of allegations or transactions [1] in a criminal, civil or administrative hearing; [2] in a congressional, administrative, or Government Accounting Office report, hearing, audit or investigation; or [3] from the news media, unless the action is brought by the attorney general or the person bringing the action is an original source of the information."
Just last November, Boston Scientific
settled a case with the U.S. Justice Department, agreeing to pay $296 million. As part of the agreement, Guidant also pleaded guilty to two misdemeanor charges of failing to supply certain information to U.S. regulators.
