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Suit Against Drug Maker Goes To Jury

Feb 19, 2003 | Fort Worth Star Telegram

When Doris Brown got her first dose of Rezulin in April 1998, it was hailed as a blockbuster drug for treating diabetes. Eight months later, with her stomach distended and her liver shrunken, the 63-year-old woman died.

Suspicious that Rezulin (pronounced REZ-uh-lun) might have caused her death, the Brown family was outraged when the drug was yanked from the market about a year later when the federal government said it had been linked to about 60 deaths.

Carroll Brown and his family are now suing the drug company for millions of dollars in one of the biggest product liability lawsuits in Tarrant County and only the seventh trial in the nation concerning Rezulin.

"I feel like they killed my wife," said Carroll Brown, Doris Brown's high school sweetheart and husband for 45 years. "And the way they did it, a few deaths didn't matter to them. They were driven by profit."

The jury began deliberations Tuesday after a six-week trial that turned Judge Dana Womack's sixth-floor courtroom into a storage room for documents, poster boards and high-tech slide shows.

The testimony in person and on video resembled biology lessons on enzymes, cell damage and tissue death with terms such as mitochondrial damage, necrosis and cholestic injury.

"We want to send a message that this type of conduct will not be tolerated in Fort Worth, Texas," said Zoe Littlepage, a Houston lawyer who is one of the attorneys representing the Brown family.

About 8,000 Rezulin users have filed lawsuits against the drug manufacturer in state and federal courts across the country. In June 2000, Pfizer Inc. bought Warner-Lambert, the pharmaceutical company that originally produced Rezulin.

Attorneys for Pfizer have argued that Rezulin was carefully studied before and after it went on the market and repeatedly won approval from the Food and Drug Administration.

Pfizer's attorneys presented evidence that the drug was effective in controlling patients' blood sugar, and say only a fraction of the nearly 2 million people who took the drug were harmed by it.

They've also questioned whether Doris Brown's doctors carefully read the warning labels that came with Rezulin before prescribing the drug to the Hurst woman.

"We believe that the threats of Rezulin's toxicity are extremely rare and unpredictable," said Jack Urquhart, lead attorney for Pfizer in the Brown trial.

Diabetes is a difficult disease to treat and is a leading cause of death, blindness, heart disease, nerve disease, stroke and amputation.

Dr. Eric Orzeck, a Houston diabetes specialist hired by Pfizer, said that before Rezulin became available in 1997, doctors had been "twisting in the wind" to treat the disease.

"Rezulin was an absolute godsend to physicians," Orzeck said. "A lot of patients heard about it, they took it, and they liked it. I really feel it was the right drug at the right time."

A wife and friend

When the Browns retired in 1995, they planned to see the world.

It seemed a fitting and typical reward for a couple who had been together for nearly half a century and who had known each other since they were teen-agers in Lake Worth in the 1940s.

"We had a great life," said Carroll Brown, a former Bell Helicopter employee. "She was not only my wife but my best friend."

But in 1998, as Carroll and Doris Brown were planning a trip to Alaska, problems with her diabetes flared.

Doris Brown, a former day-care worker and floral designer, had Type 2, or adult-onset, diabetes. Short and overweight, Doris Brown's blood sugar levels were fluctuating when her Fort Worth doctor prescribed Rezulin, Carroll Brown said.

On the market for about a year, Rezulin had been introduced with great fanfare as the new hope for diabetes patients who feared other treatments. Rezulin helped the body use its own insulin.

In a recent interview with the Star-Telegram, Carroll Brown said his wife began feeling nauseated and fatigued within two weeks of starting the medicine.

By the end of June, she had dementia because her liver was unable to filter the ammonia in her blood, Carroll Brown said.

In and out of hospitals and specialists' offices after that, Doris Brown was sent home each time. She stopped taking Rezulin in June of that year, and by August a CT scan revealed that her liver was shrinking.

Eventually, a gastroenterologist discovered that she had "acute cirrhosis of the liver," a disease that typically plagues alcoholics. Doris Brown did not drink.

She died less than a week later.

"She suffered," said her daughter, Janice Daniel, who lives in Hurst. "She died at the hospital saying she didn't understand why this happened."

Carroll Brown, 71, said he immediately suspected Rezulin contributed to his wife's death.

Last year, the Los Angeles Times reported that internal documents indicated Warner-Lambert masked early indications of the drug's danger to the liver and its lethal toxicity in information provided to the FDA and to doctors.

"I believe that the FDA was misled," Carroll Brown said. "They were not furnished all of the information or they never would have approved that drug."

Pfizer revealed in recent annual reports that it is cooperating in a federal grand jury investigation in Maryland concerning Rezulin.

Questions raised

The FDA approved Rezulin for U.S. patients in early 1997, giving it a "priority review" because it was viewed as the first in a new class of drugs believed to be a significant improvement to the treatment of diabetes.

Warner-Lambert said the drug was thoroughly tested under strict medical protocols monitored by the federal government.

No cases of liver failure occurred in clinical trials involving 2,500 patients, Pfizer's attorneys said. Roughly 2 percent experienced some difficulties, but the problems were resolved without permanent injury, they said.

"The FDA knew there was a potential problem with liver damage, and they approved it," Urquhart said. "We feel very confident the information was provided and understood by the FDA and its advisory committee."

Six months after Rezulin went on the market, after reports of patients developing liver problems, the first of several revised FDA-sanctioned warning labels were issued, Pfizer attorneys said. Doctors also got warning letters.

Mounting evidence that Rezulin could injure a patient's liver, and the availability of two newer drugs that were not as risky, led Warner-Lambert and the FDA to discontinue Rezulin's distribution.

But before Rezulin was voluntarily taken off the market in March 2000, it had provided Warner-Lambert nearly $2.1 billion in sales.

"They were celebrating making a billion dollars as she [Doris Brown] laid in the hospital here, dying," said Rainey C. Booth, a Florida lawyer who also is representing the Brown family. "They called it their 'billion dollar bash.' "

In the Brown lawsuit and in others, Pfizer has vigorously argued that the drug helped thousands of people afflicted with diabetes.

"We don't deny it's tragic that [Doris] Brown died," said Robert Fauteux, a spokesman for Pfizer. "It's just not Rezulin-induced."

Doris Brown's medical records indicate that she was clinically obese, had a history of hypothyroidism and an irregular heartbeat, and had apparently been exposed to something toxic in the 1980s that caused her to develop a liver condition.

She also had developed NASH non alcoholic steato-hepatitis or a cirrhosis of the liver whose cause was unknown, Urquhart said.

"Everyone agrees there was liver trouble," Urquhart said. "They [the Browns] say Rezulin did it. But they don't present any evidence to support that."

Urquhart said the pharmaceutical industry, which is among the most regulated in the nation, is targeted for such lawsuits because the companies are big, wealthy and impersonal.

Pfizer fights each case. It has lost a few, including a $43 million verdict in a Corpus Christi case that led to an undisclosed out-of-court settlement.

Judges in California, New York and West Virginia, however, have refused to grant class-action status in Rezulin lawsuits, in some cases questioning whether Rezulin could be linked to the injuries.

Ultimately, Pfizer attorneys say, such lawsuits could inhibit pharmaceutical companies from testing new drugs.

"Rezulin clearly saved many more lives and the patients lived better lives than if it was not available," said Orzeck, a physician paid by Pfizer to talk to the media about Rezulin. "It was a huge plus for me."

But Doris Brown's daughter Janice Daniel says the case has made her question the safety of the nation's drug supply.

"I am terrified now when I take my 6-year-old to get a prescription," Daniel said. "I wonder what I'm putting into that child's mouth."

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