SEC and Other Investigations of Illegal Trading: Johnson & Johnson Confirms FDA Probe

» Kirk - Johnson & Johnson Confirms FDA Probe

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7:16AM Johnson & Johnson under investigation for Eprex illnesses (JNJ) 49.73: The New York Times reports that the govt is conducting a criminal investigation into a JNJ factory in Puerto Rico that makes its anemia drug Eprex that has been linked to a number of serious illnesses in Europe and Canada; the FDA and Justice Dept investigation is tied to a whistle-blower lawsuit filed against JNJ by a former employee at the factory who contends he was pressed to falsify data to cover up manufacturing lapses and then was suspended a few days before an expected interview with FDA inspectors.

http://finance.yahoo.com/mp#jnj

and

http://biz.yahoo.com/djus/020719/2002071...

Jeepers... now it seems the big companies are literally making people sick.

Friday July 19, 9:25 am Eastern Time
Johnson & Johnson Confirms FDA Probe Related to Ex-Employee Lawsuit
By: Hollister H. Hovey

Dow Jones Newswires

NEW YORK -- Johnson & Johnson confirmed that the U.S. Food and Drug Administration is investigating the company, related to a lawsuit filed by an ex-employee about his termination in 1999.

"There is a lawsuit filed by an ex employee about his termination in 1999; it involves allegations involving record keeping," spokesman Marc Monseau said. " The employee was a utilities worker with no manufacturing responsibility. We are also aware of an FDA investigation, presumably related to the lawsuit."

The New York Times reported Friday that both the FDA and the Justice Department are conducting a criminal investigation into a factory that makes an anemia drug that has been linked to a serious spate of illnesses in Europe and Canada . Mr. Monseau wouldn't confirm the Department of Justice's involvement in the matter.

The factory, in Puerto Rico , manufactures Eprex, a drug use to increase levels of red blood cells in people undergoing kidney dialysis or suffering from anemia caused by chemotherapy.

Health authorities in Europe and North America have become increasingly concerned over the last few months about a mysterious rise in the number of Eprex users who have developed pure red cell aplasia, a condition in which the body can lose its ability to produce red blood cells, leaving the patient dependent on blood transfusions to survive, the Times reported.

The investigation is tied to a whistle-blower lawsuit by Hector Arce, a former employee at the factory in Puerto Rico . Arce, who was fired in March 1999 , contends he was pressed to falsify data to cover manufacturing lapses, and then was suspended a few days before an expected interview with FDA inspectors, the paper said.

"After investing the allegations, we found no support for them," Mr. Monseau said. The company maintains the alleged matters would not affect product integrity, he said, adding, "The company intends to vigorously defend against this employee's lawsuit."

While Johnson & Johnson is "unaware of the precise nature of the FDA's investigation, the company has offered its cooperation to all parties concerned, " Mr. Monseau said.

-Hollister H. Hovey, Dow Jones Newswires; 201-938-5287; hollister.hovey@ dowjones.com

-- posted by Kirk