Manufacturing practices of Eprex were unsafe, says fired worker

SAN JUAN, Puerto Rico -- A lawyer for a fired Johnson & Johnson employee says manufacturing practices were unsafe at one of the company's Puerto Rican plants and may be causing health risks.

The plant in Manati manufactures Eprex, used in Europe and Canada to raise levels of red blood cells in people undergoing kidney dialysis or suffering from anemia caused by chemotherapy.

Hector Arce, a boiler operator for 12 years at the plant, alleges in his lawsuit that he was unjustly fired in 1999 when he refused to falsify documents before an inspection as requested by supervisors at the Ortho Biologics plant, which is a subsidiary of Johnson & Johnson. Johnson & Johnson denies the charge.

"Reproducing a biological product is like reproducing a snowflake," said Arce's lawyer, Juan Saavedra Castro, by telephone Friday. "This drug is so sensitive, you need to be completely accurate" in maintaining equilibrium in the production process. He argued that evidence in his client's case shows otherwise.

Johnson & Johnson insisted the product is safe. "We have conducted our investigations and confirmed that the integrity of the product has not been compromised," the New Brunswick, N.J.-based company said in a statement Friday.

A report in the New York Times Friday said health officials have recently found an increasing number of Eprex users have developed pure red cell aplasia, a rare condition in which the body can lose its ability to produce red blood cells, leaving patients dependent on blood transfusions to survive.

Arce was responsible for monitoring the boiler and recording levels of saline, oxygen and other elements in the water, the lawsuit says.

He claims supervisors told him more than 100 times between 1996 and 1999 to falsify records documenting those levels and to sign on behalf of other employees. Arce said he was fired in 1999 before an FDA inspection because he refused his supervisor's commands to lie to FDA agents.

Johnson & Johnson said Arce was a utilities worker with no involvement in the making of Eprex, and said he was fired in 1999 for dishonesty and violations of company procedures.

"Our investigation of the employee's allegations confirm that the integrity of our product has never been compromised and there is no connection between the allegations and the occurrence of (pure red cell aplasia)," the company said.