OTHER NEWS - Sept. 13, 1991

Shiley Accused of Deception in Heart Valve Approval: The Shiley division of Pfizer Inc. won approval for its Convexo-Concave heart valve by misleading the Food and Drug Administration, according to an FDA document released at a congressional hearing. “Shiley has engaged in a continuing scheme to interrupt, deflect and misdirect FDA’s regulation,” said the report released by Rep. John D. Dingell (D-Mich.) at a House Energy and Commerce Committee oversight hearing. The valve was “defective from the time of its approval,” the report said. The valve, which has been implanted in more than 80,000 people, was recalled by the FDA in 1986. In about 400 known cases, a defect has caused the valve to fracture while implanted. Pfizer had no immediate comment. Pfizer is the subject of hundreds of lawsuits alleging that potential problems with the device have caused emotional stress in those with implants.