Pharmaceutical Giant Refutes Claims of Falsified Maintence Documents

Johnson & Johnson says it investigated allegations maintenance records at its Ortho Biologics facility in Manati, Puerto Rico were falsified to cover up unsafe manufacturing practices and determined the claims are unfounded.

A former boiler operator at the facility, Hector Arce, filed a lawsuit against the company claiming he was unfairly fired in 1999 for refusing to lie to Food and Drug Administration (FDA) officials about maintenance issues.

In the lawsuit, Arce, who worked at the facility for 12 years, contend that supervisors asked him more than 100 times to falsify records documenting levels of conductivity, PH, oxygen, salinity and alkalinity content of the water used in the company's manufacturing process for Eprex, a drug used to increase red blood cells in patients undergoing kidney dialysis or who suffer from anemia.

The drug has come under fire recently, with medical professionals reporting an increasing number of Eprex users developing pure red cell aplasia (PRCA), a rare condition in which the body loses its ability to produce red blood cells.

According to the lawsuit, Arce was asked to lie so that FDA officials would believe that the process "was done in accordance with current good manufacturing practices, when in fact it was not."

Arce's attorney, Juan Saavedra Castro, said the FDA began a criminal investigation when if found out about the civil lawsuit.

Johnson & Johnson, headquartered in New Brunswick, N.J., released a statement saying the FDA's Office of Criminal Investigations sought a stay of Arce's civil lawsuit "in order to investigate the employee's allegations regarding false documentation."

The company says it is complying fully with the FDA investigation. It maintains its investigation into Arce's allegations found "the integrity of our product has never been compromised and there is no connection between the allegations and the occurrence of PRCA. We have dealt with this matter with the utmost urgency since we first became aware of it."

According to Johnson & Johnson, Arce was a utilities worker with no responsibility for manufacturing who was terminated for failing to properly complete equipment records.

After a thorough investigation of all the allegations, Johnson & Johnson found "no connection between the allegations of [Arce] and the occurrence of PRCA."

Johnson & Johnson "intends to vigorously defend against the lawsuit," and claims its attorneys conducted interviews with the individuals identified in Arce's complaint and reviewed related records. "Employees with knowledge of the facts refuted the plaintiff's allegations," the company noted in the statement, adding, "A review of documents disclosed no suspect patterns for falsification (e.g., penmanship, consistent passing results)."

A stay has been granted in Arce's case until Aug. 28.

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