December 18, 2001 - Drug Company Wins First Jury Trial Over Rezulin
It's a decision certain to set plaintiffs' attorneys across the country scrambling for new strategies: A Houston jury ruled in favor of drug maker Warner-Lambert on Monday, in the first Rezulin lawsuit to go to trial in the nation.
Rezulin, a drug taken by nearly 2 million Type 2 diabetics before being ordered off the market in March 2000, has been linked to hundreds of cases of liver injury and 63 deaths.
The family of Norma Culberson, a 58-year-old diabetic who took the drug, developed jaundice and later died, sought $25 million in damages from Warner-Lambert, a division of Pfizer Inc.
The jury, which heard testimony for three weeks was asked to determine whether Warner-Lambert caused the death of Culberson through misleading marketing of the drug, disregard for safety concerns, or a defect in the design of the drug itself.
After less than eight hours of deliberation, the jury voted no.
``It was a good drug. It helped a lot of people,'' said one juror, who asked not to be identified. ``There just wasn't enough evidence to show the drug was defective.''
The trial was widely viewed as a test case for Warner-Lambert, which is facing thousands of liver-injury lawsuits. Last month in Mississippi, a settlement for an undisclosed amount was reached in a $175 million lawsuit against the company.
Shares of Pfizer rose 89 cents to $40.33 in midafternoon trading. Pfizer market analyst Bob Kirby said, ``It's obviously a positive. But we need to be cautious. There's going to be more (lawsuits) to come.''
When Rezulin hit the U.S. market in 1997, it was an immediate blockbuster, hailed as a pioneering medication that treated the root cause of Type 2, or adult-onset, diabetes, a disease that afflicts 15 million people. Doctors wrote about 10,000 prescriptions in its first month; later, there were nearly 2 million users.
Rezulin, known chemically as troglitizone, was thought to resensitize the body to insulin, a hormone that converts sugar into energy. High blood sugar over time leads to kidney failure, blindness, heart disease and other life-threatening conditions.
Rezulin was seen as a breakthrough for diabetics who didn't respond to other drugs.
Problems, however, emerged after Rezulin became widely available. Side effects too rare to be detected during clinical trials often become apparent once a medication goes on sale and is taken by thousands of patients. The U.S. Food and Drug Administration says drug-induced liver disease is the single leading cause of drugs running afoul after hitting the market.
That was the case with Rezulin. When reports of serious liver injury in Rezulin users - including deaths from liver failure - began trickling in to Warner-Lambert and the FDA, Warner-Lambert responded by warning doctors about ``rare and idiosyncratic'' drug reactions, including liver failure and death. The company recommended frequent testing to watch for elevated liver enzymes, an early indicator of trouble. The FDA oversaw and approved the warnings which were made both by letter and changes on the drug's labeling.
But the human toll continued to climb. In March 2000, the FDA announced the drug would immediately be withdrawn. By that time, the drug had been linked to 90 cases of liver failure, 63 deaths and 10 liver transplants.
Critics contended the FDA had a too-cozy relationship with the drug maker, ignored warnings voiced by its own medical officers and failed to force Warner-Lambert to include the rising number of deaths on the revised Rezulin label. Consumer advocates accused Warner-Lambert of putting profits before patient safety, and pointed out that the company made $1.8 billion in the 36 months that Rezulin was sold.
The FDA defended its decision to keep Rezulin on the market until two more similar, and presumably safer, drugs became available to treat Type 2 diabetes.
Culberson, who was diagnosed with diabetes in 1989, was suffering from numerous other ailments at the time of her death. In 1992 she lost a kidney to cancer. Her remaining kidney was failing, forcing her to be on dialysis. She was overweight and had high blood pressure.
She started taking Rezulin in 1998. In November 1999, after her skin turned yellow from jaundice, and liver tests showed elevated enzymes, her doctor took her off the drug.
After several hospitalizations, doctors sent her home to hospice care with end-stage renal failure. Elevated ammonia levels and a change in mental status pointed to ``end-stage liver disease,'' said an expert witness hired by the family to review Culberson's medical records.
She died Jan. 7, 2000. Cause of death on her death certificate was listed as kidney failure, with liver failure as a secondary cause.
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