The National Law Journal
April 12, 2002
Oklahoma Jury Awards $11.5M in Rezulin Case
An FDA medical officer's testimony on drug trials was key
by Dee McAree
A Tulsa, Okla., jury has ordered Pfizer Inc. to pay $11.55 million to the family of a diabetic man whose death was allegedly caused by taking Rezulin.
Michael Wakefield, 41, a diabetic since the 1980s, was first administered the drug by his doctor on Feb. 3, 1999. A month later, he was admitted to St. John's Medical Center, where he died in a week. His widow sued the drug company.
At trial, the plaintiffs alleged that Wakefield developed a blood disorder from Rezulin and that he had died of liver failure. The defense countered that his liver was good enough to be used as a transplant and theorized that an antibiotic administered intravenously at the hospital caused his death. Wakefield v. Warner-Lambert, No. CJ 2000-4654 (Tulsa, Okla., Dist. Ct.).
Rezulin, produced by the Warner-Lambert Co., broke ground as the first oral medication for diabetics when it went on the market in the late 1990s. More than 1.9 million diabetics are reported to have taken it. Three years after it was introduced, the U.S. Food and Drug Administration ordered it pulled from pharmacy shelves after it gave rise to liver problems.
The FDA linked 63 deaths and incidents of severe liver damage to Rezulin. In 2000, Pfizer purchased Warner-Lambert and inherited the liability over the drug. Thousands of lawsuits have been filed.
For plaintiff's attorney Zoe Littlepage of Houston's Littlepage & Booth, the Wakefield trial was the third Rezulin suit against Pfizer. She has won two and lost one.
Littlepage said that she and her partner, Rainey Booth, have spent 18 months laying the groundwork to litigate Rezulin cases. They attended 100 days of depositions, and spent 17 weeks examining five million documents that they catalogued into a Rezulin database.
"No one case could support that kind of expansive preparation," Littlepage said.
Pfizer was represented at trial by Pierce O'Donnell of Los Angeles' O'Donnell & Shaeffer. O'Donnell was traveling and did not return calls.
DOCTORS' TESTIMONY
According to plaintiff's counsel, Wakefield's treating physicians all testified on behalf of the drug company. Despite that, Littlepage said, the jury was won over by the "whole atmosphere of compelling evidence" that the drug could cause liver damage.
"Treaters can only have opinions based on what they are told," she added, suggesting that there was much about the history of the drug that the physicians did not know.
One of the most compelling bits of evidence, according to the plaintiffs, was the testimony of Dr. John Gueriguian, the FDA medical officer assigned to Rezulin, who has worked with the drug since 1989. Gueriguian, now retired from the FDA, talked about the defendant's conduct and expressed the opinion that the drug was rushed through trials and pushed onto the market.
After 10 hours of deliberations, the jury found that Warner-Lambert had marketed a defective drug and had shown malice and reckless disregard for the rights of others. It awarded $1.55 million in actual damages and $10 million in punitives. Ten jurors voted for the family on the initial award. Nine -- the minimum required -- voted for the punitive award.
The National Law Journal