Guidant never sent letter warning about devices


- NY Times
06/07/2006 - - Newly released records show that Guidant Corp. drafted a letter last year to tell doctors about significant defects in the company's heart devices but never sent it, a report said on Wednesday.

Heart patients apparently kept getting the devices, advanced defibrillators known as Contak Renewal and Contak Renewal 2, which Guidant said in the proposed letter had electrical flaws, The New York Times said.

The "dear doctor" letter dated January 2005 also told physicians that it had withdrawn all devices that had not yet been implanted into patients, the Times said.

The letter and other Guidant records released this week by a Texas state judge suggest that the legal and financial consequences from an inquiry into Guidant may be significant for the company and Boston Scientific Corp. <BSX.N>, which bought Guidant in April.

A call to Boston Scientific was not immediately returned. The Times cited a company spokesman who said Boston Scientific would not comment on specific Guidant documents.

Spokesman Paul Donovan told the newspaper, however, that Boston Scientific understands and acknowledges the need for more timely and transparent communication.

"We are committed to doing a better job of communication with patients and physicians," Donovan said.

The U.S. Justice Department and the Food and Drug Administration have been conducting an inquiry into Guidant's handling of safety issues related to several of its defibrillators, which have been recalled.

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