Employee Says FDA Seeks Resignation in Settlement

Published on April 27, 2009

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Employee Says FDA Seeks Resignation in Settlement

A Food and Drug Administration employee who accused her boss of sex discrimination and won a judgment said the agency has asked her to resign as part of a settlement.

An administrative law judge at the Equal Employment Opportunity Commission found in August 2008 that the FDA promoted a hostile work environment in the case of Cindy Demian, a bioengineer in the medical-device division. The judge said the FDA failed to act when Ms. Demian’s supervisor made derogatory sexual comments.

The supervisor, Elias Mallis, is chief of the agency’s cardiac electrophysiology branch. The FDA declined to comment and said Mr. Mallis wasn’t available. He didn’t return messages.

Sen. Chuck Grassley (R., Iowa) is taking issue with the FDA’s handling of the matter and has asked the agency for information on the outcomes of sexual-harassment cases over the past three years.

“It is alleged that this is not the first time that FDA has taken action against a victim of harassment while insulating and perhaps even rewarding the wrongdoer,” Sen. Grassley said in a letter to the FDA last week. The FDA declined to comment on Sen. Grassley’s inquiry.

The administrative judge ruled that Mr. Mallis changed Ms. Demian’s employment status and demanded specific work from her that he didn’t require of male employees. The judge called the boss’s behavior “unconscionable” and said the agency “failed to exercise any reasonable care.”

David Colapinto, a Washington lawyer who represents whistle-blowers, said it’s uncommon in such cases for an employer to seek the resignation of someone like Ms. Demian who wants to stay and isn’t accused of wrongdoing.

“Resigning should not be the price for winning a discrimination claim,” said Mr. Colapinto. But, he added, “I’ve seen this happen at federal agencies.”

The case, which covers the period 2002 through 2005, is part of larger turmoil at the FDA’s device division. A group of officials in the division has sent letters to Congress and the Obama administration accusing the FDA of bowing to industry in approving products deemed unsafe or ineffective by some of the agency’s scientists. They have also said that the agency has retaliated against some of those reviewers.

Ms. Demian was the lead reviewer for a part of the FDA’s “Reuse Project”  between 2002 and 2004, evaluating the safety of nearly 1,500 cardiac catheter models that companies wanted retroactive approval to sell. The catheters had originally been intended and approved for one-time use.

Ms. Demian said in an interview that she warned the frequent resterilization of the devices could result in electrodes on the catheters falling off during heart surgery. She was removed from her reviewer role in the fall of 2004, according to the judge’s decision, and later took an administrative job at the FDA.

The administrative judge said a separate hearing on damages would be held unless the parties could reach a settlement. Ms. Demian said the FDA has offered her a financial settlement — she declined to say how big — but  made it contingent on her resigning this month. She said she doesn’t know why the agency wants her to leave.

By: Alicia Mundy
Wall Street Journal
April 27, 2009

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