Sunday, April 23, 2000
Drug firm faces suit by diabetic
By Ben L. Kaufman
The Cincinnati Enquirer
Oxford restaurateur Alan Weisman has sued the maker of the diabetes drug Rezulin, saying side effects put him on the list for an emergency liver transplant.
Mr. Weisman's suit was filed Thursday in U.S. District Court in Cincinnati by West Chester lawyer Janet G. Abaray.
The complaint seeks unspecified damages from Warner-Lambert Co.
Rezulin was prescribed for Type II (adult onset) diabetes. The company took it off the market last month at federal request after Rezulin was linked to at least 61 deaths.
“I've always taken my health for granted,” Mr. Weisman, 62, said Sunday. “I'd give anything in the world to live a normal life.”
Ms. Abaray, a litigator in the medical products liability field, accused Warner-Lambert of hiding dangerous side effects and the Food and Drug Administration (FDA) of an unseemly rush to approve Rezulin's use.
Moreover, she and FDA officials agreed, safer drugs are available for the more than 15 million Americans with adult diabetes.
Mr. Weisman's suit accuses Warner-Lambert of negligence, failure to warn patients of all possible side effects, defective design or manufacture, breach of warranty, and misrepresentation/concealment.
Mr. Weisman said he took more than 300 doses of Rezulin after his physician prescribed it in September 1997.
He quit in May 1998 “after I read something that alerted me to the fact that it could be dangerous to my liver.”
His physician returned him to a drug with fewer side effects, Mr. Weisman said. Even so, “I have continually gotten worse.”
Pervasive fatigue and balance problems mean that Mr. Weisman's wife, Sally, and brother Les must run the family's two restaurant/bars on Oxford's Main Street, First Run and Attractions, without him.
Last month, Cincinnati lawyer Stanley M. Chesley, another medical products liability litigator, sued on behalf of three Rezulin patients and asked a federal judge in Cleveland to certify his complaint as a class action.
Rezulin was taken off the market previously in Great Britain. FDA intervention followed re-evaluation of Rezulin side effects data and efforts by at least one FDA physician to get it banned.
FDA approved Rezulin with uncommon speed under a “fast track” process that gives drug makers more time to sell drugs before patents expire.
That process was not without problems, Ms. Abaray said. “The FDA's chief medical officer was highly critical of Rezulin and recommended it not be approved by FDA based on Rezulin's potential danger to the liver.” However, she said, “the medical officer was removed” after Warner-Lambert executives complained.
More recently, an FDA physician used office e-mail to make a similar argument and FDA acted after the intra-agency feud reached Congress.
The Los Angeles Times reported that Warner-Lambert sold $1.8 billion of Rezulin. It was introduced in March, 1997; initial fatalities were acknowledged a few months later.
Warner-Lambert officials could not be reached on Sunday, but they have said Rezulin is safe if used as directed.
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