The first Guidant defective defibrillator trial has been postponed because one of the witnesses is unavailable due to the Passover holiday. The judge has said that the case will most likely resume in July.
An expert panel commissioned by Guidant Corporation to assess its handling of problems with cardiac medical devices cited the company for failure to properly assess patient safety. The commission noted that Guidant’s decisions were guided by statistical projections provided by engineers rather than medical data provided by doctors. The group urged Guidant to create an outside panel of physicians and others who would regularly monitor the safety of its devices and advise the company about when and how to notify doctors and patients about problems.
According to a report published in the NY Times, Guidant Corporation has issued a warning to doctors about possible battery defects in two of its implantable defibrillator devices. The devices in question, the Contak Renewal 3 RF and Renewal 4 RF cardiac defibrillators, have not been implanted in any patients thus far. Guidant said the FDA may classify the warning as a product recall.
Senate Judiciary Committee Chairman Arlen Specter (R-PA) has introduced legislation that would toughen penalties for companies and their executives who sold products that cause injury or death. Presently, there are only civil penalties for such behavior. In announcing the legislation, Specter singled out Guidant Corp. and their defective defibrillators as an example of actions that would be targeted by the legislation.
A Guidant Corporationconsultant told the medical device company that it had an ethical obligation to inform doctors of defects in its defibrillator device. Dr. Richard N. Fogoros, also told company executives that their decision to withhold such data, while statistically defensible, was questionable. In one of two lengthy memos to Guidant executives, Fogoros wrote that the company violated a “sacred obligation” it had to doctors by interposing its medical judgment for theirs. He also noted that Guidant had a clear conflict of interest that would naturally lead it to disclose product failures only when “absolutely necessary.”
When Guidant Corp. came under fire last year for not revealing to doctors it’s problems with its medical device, it remained positive in its public announcements. But newly released documents show that, inside Indianapolis-based Guidant, executives were struggling to contain a mounting crisis.
The records illustrate how a series of miscalculations by Guidant, like its misreading of doctors’ tolerance for being kept in the dark, as well as its initial decision not to recall devices, put the company on the defensive. As a result, company executives repeatedly changed course.
According to an article in the NY Times, “A top federal medical official overruled the unanimous opinion of his scientific staff when he decided last year to approve a pacemaker-like device to treat persistent depression, a Senate committee reported Thursday.
The device, the surgically implanted vagus nerve stimulator, had not proved effective against depression in its only clinical trial for treatment of that illness. As a result, scientists at the Food and Drug Administration repeatedly and unanimously recommended rejecting the application of its maker, Cyberonics Inc., to sell it as such a treatment, said the report, written by the staff of the Senate Finance Committee.”
Guidant Corp.’s program to pay $2,500 to patients to replace a heart device that has had malfunctions is nowhere near sufficient to cover costs of the procedure. The offer covers only about 10% of the cost of the replacement procedure. How is this fair? How is this the right thing to do?
New limits imposed by the FDA on Guidant, maker of an implantable heart defibrillator found to be defective, will make it difficult for new products made by the company to be approved for commercial sale, as the agency applies pressure to the company to improve its manufacturing procedures.