Profession
Company discussed telling physicians about defibrillator problem earlier
NEWS IN BRIEF — Posted Feb. 13, 2006
Guidant Corp. considered warning physicians about malfunctions of some its heart defibrillators sooner than the July 2005 recall of more than 100,000 devices, according to internal company documents released Jan. 19 in a Texas product liability lawsuit.
The documents show that some officials recommended telling doctors about the failures in January 2005, while others opposed the suggestion. Judge Jack Hunter of the 94th District ordered that the records be disclosed after The New York Times and plaintiff attorney Bob Hilliard requested access to them. Hilliard, representing two patients in the first trial against Guidant, said in a statement that the documents "directly affect the public health and safety and Guidant has wrongfully attempted to hide them from the public's view." The recalled defibrillators have been linked to seven deaths.
An independent panel of medical experts established by Guidant in August 2005 is expected to release a report in March with recommendations for how and when to communicate with doctors and patients about device malfunctions. The Heart Rhythm Assn. said it also plans to issue a similar report in May.
Indianapolis-based Guidant did not comment on the suit. The trial, in Nueces County, Ind., is set for Feb. 20.
Note: This item originally appeared at http://www.ama-assn.org/amednews/2006/02/13/prbf0213.htm.
