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Jury finds Rezulin manufacturer acted with `malice'.

In what is believed to be the first pro-plaintiff verdict in a case involving the diabetes drug Rezulin, a jury in Corpus Christi, Texas, awarded Margarita Sanchez and her family $43 million in actual damages. Pfizer, Inc., settled the case for a confidential sum while the jury was deliberating on punitive damages. (Sanchez v. Parke-Davis, No. 006523-F (Tex., Nueces County Dist. Ct. Dec. 21, 2001).)

The plaintiffs' attorneys said jurors later told them that the panel had decided on but not yet announced a $100 million punitive damages award. Pfizer purchased the drug's manufacturer, Warner-Lambert, in 2000.

"I believe the Sanchez case is very significant, as the jury specifically found by clear and convincing evidence that Warner-Lambert was guilty of criminal conduct," said plaintiff attorney Chris Pinedo, of Corpus Christi. "The jury found that Warner-Lambert had actual subjective awareness that Rezulin involved an extreme degree of risk, yet despite this knowledge, Warner-Lambert proceeded to market Rezulin. This in itself is a very significant finding."

Margarita Sanchez was diagnosed with Type 2, or adult-onset, diabetes, and in 1998 her physician prescribed Rezulin to treat the disease. In March 1999, she stopped taking the drug because diagnostic studies revealed liver damage due to Rezulin. At the time of trial, she was awaiting a liver transplant. Sanchez, joined by her husband and two sons, sued Warner-Lambert, and several corporate subdivisions including Parke-Davis.

Pinedo said he polled jurors and found that they believed the company had concealed documents from the FDA regarding the number of liver failures among users and the severity of the elevated liver-enzyme levels in their blood, an indication of liver damage. Jurors also concluded that Warner-Lambert had used "fluffy" and technical language and altered the information in the product inserts so that it was not understandable to laypeople and even to some doctors, and had "impaired" the truthfulness of the documents it submitted to the FDA.

This finding of criminal conduct and "malice" under Texas law eliminated the application of the state's exemplary damages cap, exposing the company to unlimited punitive damages.

Attorney Mikal Watts, of Corpus Christi, also a member of the plaintiffs' legal team, said the Sanchez case is a harbinger of verdicts to come.

"Warner-Lambert's documents reveal that it knew its product would kill people, yet the company continued to sell it," he said. "Jury after jury is going to hit them with punitive damages."

Watts also expects that most of the liver-damage cases will settle, because the parent company has seen the damages that juries are willing to award for these injuries.

On January 29, 1997, the FDA approved troglitazone, under the brand name Rezulin, for the treatment of Type 2 diabetes. Because it was the first in a new class of diabetes drugs, the agency agreed to a six-month "priority" review instead of the usual approval process, which averages 14 months. Before the approval, some scientists were already documenting concerns about the drug's potential to cause heart and liver damage.

Within several months of the drug's launch in March 1997, reports of liver damage cases began. Over the next three years, Warner-Lambert made four changes to the drug's warning label, each recommending more stringent liver-enzyme testing for users.

In March 2000, the FDA asked Warner-Lambert to withdraw Rezulin from the market. The agency has now established that the drug can cause liver failure, liver damage, and elevated liver enzymes in the blood. (See Robert K. Jenner, Rezulin: Fast Track to Failure, TRIAL, July 2000, at 39.)

Thousands of cases have been filed across the country, and more are expected before the two-year statute of limitations expires this month, Watts said. Two other cases have gone to trial so far. One was settled for a confidential amount while being tried in Liberty, Missouri. (Griggs v. Warner-Lambert Co., No. CV1003957 (Mo., Clay County Cir. Ct. Dec. 27, 2001).)

In a Houston case, the jury returned a verdict for the defendant. (Mercado v. Warner Lambert Co., Parke-Davis, No. 2000-42692 (Tex., Harris County Dist. Ct. Dec. 17, 2001).) Watts said the death certificate in that case stated that the patient had died of causes other than Rezulin. "We did not face the causation hurdles that they did," he said.
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Title Annotation:Texas
Author:Jurand, Sara Hoffman
Publication:Trial
Geographic Code:1U7TX
Date:Mar 1, 2002
Words:700
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