Suit Alleges Genentech Cover-Up
Matthew B. Stannard / San Francisco Chronicle 27feb01
A former ranking employee at Genentech has sued the biotech giant, saying she was forced out of the company because she knew too much about an alleged cover-up of problems with the company's manufacturing process.
The problems alleged in the suit are similar to problems pointed out by U.S.
Food and Drug Administration inspectors in a Dec. 14 warning letter that followed an August inspection at the company's South San Francisco plant.
Among other discrepancies, the inspectors said they found two lots of Pulmozyme, a cystic fibrosis medication, contaminated with traces of cellulose and stray bits of stainless steel. Instead of trashing the batches, Genentech refiltered the Pulmozyme to remove the particles and shipped out the product, the FDA found.
The company said after receiving the letter that, while the remedies involved were still safe, it was concerned and was addressing the FDA's issues.
A Genentech spokeswoman said yesterday that the company had a Feb. 7 letter from the FDA finding those corrective actions acceptable, without a need for reinspection.
"We acted quickly, we had very good discussions with the FDA, and we thoroughly addressed all their concerns," said Sabrina Johnson, director of corporate communications.
However, a lawsuit filed in San Mateo County Superior Court on Feb. 22 alleges that problems with particulate matter in Pulmozyme and other products were called to company officials' attention years before the FDA letter, and that the company hid the problem instead of correcting it.
The lawsuit identifies plaintiff Juliana Monroe as an executive assistant to Genentech's director of pharmaceutical research and development. Monroe was hired in 1988, left on disability early in 2000 and was terminated effective Feb. 24.
In her suit, Monroe alleges she was close to several highly placed individuals in Genentech -- referred to in-house as the "seven samurai," according to the suit -- who were in charge of "reviewing the shortcomings and problems with how certain drugs were being manufactured."
Monroe's relationship with the seven samurai became an issue after the 1995 hiring of Tue Nguyen as director of the department of pharmaceutical research and development, according to the suit. It alleges that Nguyen was "uncomfortable" with Monroe's knowledge of the team's "cover-up" work.
"The cover-up work referred to herein is Genentech's unethical and illegal suppression of information revealing that Genentech was manufacturing drugs with vials that contained particulates," the suit alleges.
Monroe claims that she spoke with Nguyen about her concerns and disappointment that Genentech "did not use its vast financial resources to take steps to remedy these types of problems instead of covering them up." Pulmozyme was one of the drugs Monroe's suit specifically alleges she discussed with Nguyen -- as early as 1995.
The suit alleges that Nguyen tried to discredit Monroe and push her to leave Genentech because he was worried she would discuss the alleged manufacturing problems with state or federal authorities. The relationship became increasingly hostile until early 2000, when Monroe left the company on disability, the suit said.
FDA officials did not return a call late yesterday asking whether they had ever spoken with Monroe before the August inspection.
Genentech officials declined to comment on the pending litigation. Monroe's San Francisco attorney, Sanford M. Cipinko, did not return a call seeking comment.
The suit seeks general, special and punitive damages. It is scheduled for a case management conference June 29.
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