Ex-Allergan Manager’s Suit Over Product Safety Claim Is Rejected

SANTA ANA â€”  An Orange County Superior Court jury Friday denied a claim by a former Allergan Inc. employee that she was forced out after allegedly being pressured to hide concerns involving product safety from regulators.

After an 18-day trial and more than two days of deliberations, jurors ruled 9 to 3 against Patricia Amtower, a former manager who had alleged that she was “wrongfully terminated� two years ago after she questioned why the drug company had not informed regulators of changes in the manufacture and marketing of its UltraCare kit for disinfecting contact lenses.

In a statement issued after the verdict, Francis R. Tunney Jr., the company’s general counsel, said, “While we are pleased with the verdict, this suit has resulted in an unwarranted attack upon the safety of one of our products. The product is safe and effective, and proper regulatory procedures were followed.�

Amtower and her lawyers refused to comment.

Greg Slanaker, a sales manager from Huntington Beach who served as jury foreman, said that it was unclear whether any omissions in regulatory reporting were the fault of Amtower or others.

He wouldn’t say whether the jury believes any omissions violated the law. An Allergan spokesman said that, after Amtower’s resignation, a federal inspector made a surprise visit to the company, investigated the matters she had raised and issued no citations against the company.

In her lawsuit filed in January, Amtower, who served as a liaison between the company and federal regulators, had alleged that, beginning in 1992, Allergan knowingly sold a product intended for disinfecting contact lenses that was itself contaminated with potentially harmful microorganisms that could cause eye infections.

During the trial, the company acknowledged receiving complaints from consumers of lens cases that were contaminated with mold. But it denied that consumer safety was ever at stake, maintained that the product posed no safety concerns, and contended that changes made in the product didn’t have to be reported to regulators.

Amtower testified that at the time she had feared possible criminal prosecution for lying to regulators. “The FDA takes fraud very seriously,� she said. “They can imprison you, enforce fines on you . . . and basically terminate your career.�

However, Allergan maintained that her fears of prosecution were unrealistic.

Amtower, who is 53, alleged that a stroke she suffered shortly after she quit in August 1994 resulted from work-related stress.

A company lawyer attributed her complaints about working conditions to a personal conflict Amtower had with her boss, saying the two were like “oil and water.� The company insisted the stroke wasn’t stress-related and presented evidence that when she resigned, it offered her job back.

Slanaker agreed with Allergan lawyers who cast doubt on Amtower’s reason for resigning. “I don’t think to this minute that any of us know why she left,� he said.