The San Diego Union-Tribune
June 18, 2003

Guidant switches strategy in lawsuits

SAN FRANCISCO - Guidant Corp., which already has agreed to pay a record criminal fine for hoodwinking federal regulators about the safety of one of its medical devices, is altering its defense strategy in civil lawsuits that blame the same device for deaths and injuries.

The Indianapolis-based company has abruptly withdrawn a motion in which it argued that it was immune to injury and wrongful death lawsuits under California product liability laws. The company claimed it was shielded because the Food and Drug Administration approved its blood-vessel-patching device in 1999.

The Associated Press outlined Guidant's initial defense to the suits in a Monday report that noted the legal argument's inconsistency with the guilty plea the company recently entered in criminal court, where it admitted hiding data about its Ancure system from the FDA.

Guidant now says it is rethinking its strategy on the civil side as it addresses "issues raised by the plea," according to court documents filed electronically after the close of business Monday.

Company spokesman Steve Tragash declined comment yesterday,

As part of its guilty plea last week, Guidant acknowledged it pulled the wool over the FDA's eyes by not disclosing that the Ancure system was linked to 12 deaths and thousands of injuries. Guidant also agreed to pay the nation's largest criminal and civil find of its kind -- $92 million - as punishment.

In the documents filed Monday, Guidant said it would refrain from asserting the immunity defense at a scheduled June 30 hearing in federal court in San Jose. The company is defending nine civil lawsuits there alleging the device led to two deaths and seven major injuries.

In its new motion, Guidant said it "may refile" that defense "in one or more of the cases."