HOUSTON -- A legal battle between two companies that co-developed an artificial heart valve has slowed production of the valve to a trickle, forcing the postponement of surgery for many heart patients.
Some doctors believe the St. Jude Medical valve is the best on the market and have advised patients to postpone operations until the valve is available. Production of the valve has dropped from 2,000 a week to 300.
'Given Houston's position as a center for such surgery, I'm sure hundreds of patients are being affected,' Dr. Neil Foley, chief cardiac surgeon for the Veterans Administration Medical Center, told the Houston Chronicle Wednesday. 'These products were also shipped internationally, so the figure would run even higher worldwide.
'Many of these patients have to either settle for second-rate valves of other brand names or postpone surgery. This seems to be a case of human tragedy caused by corporate greed.'
St. Jude Medical Inc. of St. Paul, Minn., and Intermedics of Freeport, Texas, grudgingly are producing the valve together under a court order, but at a much lower volume, officials of both firms said. The companies also are preparing for a legal battle scheduled for July in federal court.
St. Jude Medical engineers created the valve's distinctive bileaflet design, and the valve's anti-blood clotting carbon skin was produced by CarboMedics, an Intermedics subsidiary in Austin, Texas.
But in March 1984 CarboMedics sued St. Jude Medical, claiming patent infringement because the Minnesota firm was researching carbon materials technology. St. Jude's countercharges include a barrage of antitrust and restraint-of-trade claims. Both companies allege thefts of trade secrets and breaches of contract.
Noted heart surgeon Dr. Denton Cooley of the Texas Heart Institute said in a court affidavit that he used the bileaflet valve in 90 percent of his valve replacement surgeries.
'Any interruption in the supply of St. Jude Medical heart valves would cause a significant disruption in the care and treatment of my patients,' Cooley said in the affidavit.
According to St. Jude's figures, its bileaflet valve was used in 30 percent of all heart valve surgeries worldwide, and in 80 percent of such surgery involving children.
A preliminary injunction issued in October 1984 ordered CarboMedics to continue supplying St. Jude with valve components. But St. Jude Medical spokeswoman Noreen Suntrup said the number of components sent by CarboMedics has dropped.
Attorneys for InterMedics and CarboMedics blame the slowdown on St. Jude's attempt to 'counterfeit' the carbon skin.
'It's disturbing if the press, patients or doctors blame CarboMedics for this,' said attorney Sydelle Pittas. 'The company couldn't let St. Jude's walk off with trade secrets.'
