The New York Times is reporting on the results of Guidant‘s independent investigation panel into the company’s shortcomings in the wake of their recall fiasco. According to the report, Guidant needs to completely overhaul their disclosure practices.
The toughness of the report may reflect the person Guidant appointed to head the effort, Dr. Robert J. Myerburg, a professor of medicine at the University of Miami. In their 135-page report, Dr. Myerburg and the cardiologists and other experts on the panel were sharply critical of the company’s decision to withhold device safety information from doctors, and they rebuffed its arguments for doing so.
Dr. Myerburg said that he and other physicians on the panel had an immediate realization when they began work: for years, device makers had not provided them with detailed data on defibrillator failure, and they, as doctors, had been so taken with the life-saving technology that they had never asked for that data.
The result, Dr. Myerburg said, was that information about the potential of devices to fail, even in small numbers, had never been communicated to patients.
“The light went on,” he said, “and one of the things that we realized is that industry had to be transparent with physicians about these devices so that physicians could be transparent with patients.”
Over months, the Guidant panel interviewed company officials and requested and reviewed documents. In the process, Dr. Myerburg said he realized that engineers at Guidant were deciding medical issues without hearing from doctors.
In a new spirit of disclosure, the report can be found on Guidant’s site. Unfortunately for them, insomniac medgadgeteers might not be the only parties reading the 135 page tome:
Its findings were also cited in a lawsuit filed yesterday against Guidant in a Minnesota state court on behalf of a heart patient who died in July. The suit contends that his death occurred because his defibrillator short-circuited and failed.
Tara D. Sutton, a plaintiffs’ lawyer in Minneapolis, said yesterday that she thought that the panel’s report would help establish punitive damages in the case because it provided further evidence that Guidant disregarded the safety and rights of patients.
A spokesman for Guidant, Steven Tragash, said yesterday that the company did not comment on litigation. Guidant has previously said that it did nothing wrong.
Regulatory and Bioethics classes will have that report as assigned reading from here to eternity. The lawsuits that go along with it might set interesting precedent for future product failures. An interesting question is the investigation into wrongdoing Vs negligence; did they screw up, or did they willingly deceive the public?