Medical equipment maker forgets 'first, do no harm'

Washington Post: All remedies to treat serious diseases are subject to some degree of failure. But the conduct of medical device maker Guidant Corp., as revealed in its guilty plea to 10 federal felonies last week, was despicable. The company, through its subsidiary EndoVascular Technologies, failed to report serious complications, up to and including deaths, following the use of one of its devices. The fines imposed thus far are insufficient to punish this reckless behavior or, more important, to deter future misconduct in the medical world.
The Ancure Endograft System was designed to treat abdominal aortic aneurysms, the weakening in the wall of a major blood vessel, without major surgery. Guidant put Ancure on the market knowing doctors had concerns about the delivery of the device into the body, according to the plea agreement. After the device was approved by the Food and Drug Administration, doctors frequently found that the system to insert it, through a small incision, became lodged in a patient, sometimes requiring abdominal surgery -- the drastic measure the product was supposed to prevent.
Percentages high
Altogether more than a third of patients receiving the device suffered problems -- including serious injury, device malfunction and death -- that by law should have been disclosed to the FDA. Between Sept. 30, 1999, and March 23, 2001, the company disclosed 172 such incidents to the FDA. But another 2,628 incidents were not disclosed. The company failed to report 12 of 28 deaths that followed insertion of the device.
The company has now agreed to pay more than $92 million in criminal and civil penalties and to implement a batch of "corporate integrity agreements." On Monday Guidant announced that it was discontinuing its Ancure device. The company assured investors and analysts that its financial position remains strong. The company had more than $3 billion in sales and a net income last year of $612 million. Although more than a dozen lawsuits relating to the device are on the horizon, Guidant expects insurance to cover much of its liability.
The FDA, which began investigating only after hearing from seven anonymous whistleblowers, should re-examine its monitoring procedures and resources to see whether they are sufficient. In the end, though, the agency will always depend on voluntary disclosure of problems -- which is why Guidant's confidence that it will skate away from this without much damage is disconcerting.
Guidant will not be banned from lucrative government programs such as Medicare and Medicaid. With that punitive measure ruled out, the best solution is to hold criminally liable those executives who failed to ensure that problems were promptly reported. No company should be able to calculate that the potential benefits of ignoring malfunctions outweigh the penalties.