Guidant has just had to recall yet more devices, this time, older pacemakers. (See story here.)
Furthermore, the New York Times reported that documents possibly related to charges that Guidant withheld negative information about its products were just subpoenaed by a US Attorney. The Times reported:
Among other things, the records indicate that company executives debated whether to warn doctors that some heart defibrillators could short-circuit. The records suggest that Guidant might have sold potentially flawed devices.
The documents include a hand-written annotated chronology related to the Contak Renewal that was apparently composed by the head of Guidant's cardiac unit, J. Frederick McCoy Jr. It suggested that Guidant executives debated in January 2005 whether to alert doctors to the Contak Renewal problem.
At the time of the debate, one entry also states "Informed Ron Dollens: Guido Neels of the development," an apparent reference to Guidant's chief executive and chief operating officer at the time; both men have since retired. Mr. Dollens declined, through a company spokesman, to comment. Mr. Neels, reached by telephone, also declined to comment.
The released documents, hand-dated Oct. 20, 2004, apparently projected that existing inventories of Contak Renewals would run out in mid-November 2004. The company did not disclose the Contak Renewal problem until June 2005, after the F.D.A. had opened an inquiry.
Furthermore, Boston Scientific, which apparently won the bidding war for Guidant, has quality problems of their own. The Boston Globe just reported that the company
has been slapped with a rare federal warning letter that could prevent the Natick company from introducing new products until it fixes 'continuing serious deficiencies' in quality control, the Food and Drug Administration said last night.
The FDA warning letter focused on the Natick company's top management, saying executives failed to fix numerous problems the agency had already outlined at particular plants and offices. Such emphasis is unusual for the FDA. This week's 'corporate warning letter' was only the third issued in a decade by the agency's medical device division, officials said.
'The problems we identified in this letter we consider very serious,' said Daniel G. Schultz, the director of the FDA's medical device division, in a phone conference last night.
Boston Scientific received three FDA warnings last year about shipping errors and lapses in keeping track of doctors' reports of device problems. In one case, workers were able to override a computer system and ship devices to a hospital even though the products had failed an inspection.
This letter also detailed problems in three other plants, including one facility in Indiana where managers were unaware that one of their products, the Leveen needle electrode, had been recalled.
As we have noted many times before, physicians and patients cannot make good decisions about whether to implant medical devices in the absence of unbiased information about the devices benefits and harms.
Furthermore, such devices are now so expensive that physicians and patients should expect that the devices will be manufactured to exceptional quality standards.