The Cochran Firm Legal Blog

Boston Scientific's Guidant division was charged on Thursday by the US Department of Justice for reportedly not fully disclosing problems with implantable heart defibrillators. These misdemeanor charges come three months after Boston Scientific and the Department of Justice reached a nearly $300 million agreement to settle an investigation into the Guidant defibrillators. Both the DoJ and Boston Scientific claim the latest charges are part of the settlement and that a plea agreement has already been signed, and will be filed later on.

Guidant discovered in 2002 that one of its models, the Ventak Prizm 2 DR, was defective. The device arced, keeping it from responding correctly when a patient suffered an irregular heart rhythm. Though the design was changed, Guidant admitted that the safety and effectiveness of the device was not affected. In 2004, there were problems with two other Guidant devices. The DoJ says that a patient's death that year was the result of a short circuit in their heart device.

Guidant allegedly knew that the instructions responding to a short circuit were misleading and false. They sent out a product update after this, but Guidant broke the law by not notifying the FDA about the change within ten days.

Class I recalls were then issued for all three Guidant devices in June 2005. This is the most serious type of recall since there is a reasonable chance that the defective device can cause serious injury or death.

Boston Scientific acquired Guidant in 2006, beating out Johnson & Johnson.

If you or a loved one has been seriously injured by a defective medical device, please contact the experienced personal injury attorneys at the Cochran Firm for an initial case consultation. We serve clients nationwide.