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Rezulin Drug

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NEWS
June 4, 2000 | DAVID WILLMAN, TIMES STAFF WRITER
The suffering persisted for more than two years. Initially, there were four known victims. Then 21. Then 33. Finally, 63 confirmed fatalities. All the while, federal authorities watched, waited and hoped the deaths would stop. It was not until a disparate collection of physicians inside the U.S. Food and Drug Administration waged a remarkable revolt that the agency was forced to reverse course.
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BUSINESS
October 6, 2006 | From Bloomberg News
Pfizer Inc. must defend a lawsuit in which people claim its diabetes drug Rezulin damaged their livers. A federal appeals court in New York reinstated a case dismissed last year in a lower court. The appeals court said New York-based Pfizer wasn't shielded from the suit by state law in Michigan, as the lower-court judge had found. Plaintiffs in the case live in Michigan. Pfizer did not immediately comment.
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BUSINESS
July 9, 2003 | From Bloomberg News
Pfizer Inc. must face a class-action suit in West Virginia over its Rezulin diabetes drug's role in destroying some patients' livers, a state appeals court ruled. The West Virginia Supreme Court reversed a lower court ruling denying 5,000 former Rezulin users the right to join together to sue the drug maker over the costs of monitoring their health in the future. Pfizer's shares fell 9 cents to $34.31 on the NYSE.
BUSINESS
July 9, 2003 | From Bloomberg News
Pfizer Inc. must face a class-action suit in West Virginia over its Rezulin diabetes drug's role in destroying some patients' livers, a state appeals court ruled. The West Virginia Supreme Court reversed a lower court ruling denying 5,000 former Rezulin users the right to join together to sue the drug maker over the costs of monitoring their health in the future. Pfizer's shares fell 9 cents to $34.31 on the NYSE.
NATIONAL
September 13, 2002 | From Times Wire Reports
Pfizer Inc. won't have to face a nationwide class-action suit over its Rezulin diabetes drug that's been linked to liver problems, a federal judge ruled. U.S. District Judge Lewis A. Kaplan rejected a bid by plaintiffs to combine claims from more than 2 million former Rezulin users into a single case in federal court in New York. Kaplan said consumers' problems with the drug were too individualized to warrant treatment as a class.
BUSINESS
April 1, 2003 | From Bloomberg News
Pfizer Inc. said a California appeals court upheld denial of class-action status to a lawsuit by consumers who claim they were misled by advertising for the Rezulin diabetes drug. The state Court of Appeal in Los Angeles backed the ruling by a trial judge last year that there aren't enough common claims among more than 200,000 Rezulin users in the state to let them pursue the false-advertising suit as a group.
NEWS
March 22, 2000 | DAVID WILLMAN, TIMES STAFF WRITER
The Food and Drug Administration said Tuesday that the popular diabetes pill Rezulin--a drug that won "fast-track" government approval but was linked to scores of liver failures and deaths--will be withdrawn promptly from the U.S. market. Compared to alternative diabetes treatments, "continued use of Rezulin now poses an unacceptable risk to patients," said Dr. Janet Woodcock, director of the FDA's drug evaluation center.
NEWS
December 18, 1998 | DAVID WILLMAN, TIMES STAFF WRITER
A Food and Drug Administration advisory committee that recommended approving the diabetes pill Rezulin was never told that 11 research patients had suffered potentially life-threatening liver injuries or that an agency medical officer opposed the drug, according to three experts who served on the panel.
NEWS
June 4, 2000 | DAVID WILLMAN, TIMES STAFF WRITER
Dr. Janet Woodcock delivers a mixed post-mortem of the diabetes pill Rezulin. She faults many practicing physicians who failed to monitor Rezulin patients for signs of liver damage, as recommended by the Food and Drug Administration. But Woodcock concedes that strict adherence to the recommended monitoring could not have reliably shielded patients from liver failure.
NEWS
September 4, 1999 | DAVID WILLMAN, TIMES STAFF WRITER
Federal investigators examining whether the top diabetes researcher at the National Institutes of Health had a conflict of interest while overseeing a $150-million government study of diabetes will be asked to review a second scientist's financial ties to the drug Rezulin. A spokeswoman for NIH Director Harold E. Varmus said that officials want to determine whether proper procedures were followed in the government study of Rezulin concerning the role of Dr. Jerrold M.
BUSINESS
April 1, 2003 | From Bloomberg News
Pfizer Inc. said a California appeals court upheld denial of class-action status to a lawsuit by consumers who claim they were misled by advertising for the Rezulin diabetes drug. The state Court of Appeal in Los Angeles backed the ruling by a trial judge last year that there aren't enough common claims among more than 200,000 Rezulin users in the state to let them pursue the false-advertising suit as a group.
NATIONAL
September 13, 2002 | From Times Wire Reports
Pfizer Inc. won't have to face a nationwide class-action suit over its Rezulin diabetes drug that's been linked to liver problems, a federal judge ruled. U.S. District Judge Lewis A. Kaplan rejected a bid by plaintiffs to combine claims from more than 2 million former Rezulin users into a single case in federal court in New York. Kaplan said consumers' problems with the drug were too individualized to warrant treatment as a class.
BUSINESS
December 18, 2001 | Reuters
A jury in Houston found that the prescription drug Rezulin, made by Pfizer Inc.'s subsidiary Warner-Lambert, did not contribute to the death of a diabetic woman who died in January 2000. The verdict was the first jury decision in litigation involving thousands of claims against the diabetes drug. The drug, now withdrawn, has been blamed in 63 liver failure deaths worldwide for the period from 1997 to 2000 during which it was sold.
NEWS
March 11, 2001 | DAVID WILLMAN, TIMES STAFF WRITER
Executives of the Warner-Lambert Co. brimmed with confidence as they marched the now-discredited diabetes pill Rezulin toward government approval in the mid-1990s. And with good reason, according to newly obtained company and government documents. As portrayed in the records, officials of the Food and Drug Administration provided Warner-Lambert with inside information and favors at critical moments throughout the development and marketing of Rezulin.
NEWS
November 16, 2000 | DAVID WILLMAN, TIMES STAFF WRITER
Key aspects of the Food and Drug Administration's regulation of prescription drugs should be reevaluated in the wake of the safety withdrawal of the diabetes pill Rezulin, according to a newly issued agency report. The new report is the first FDA acknowledgment of possible missteps in the agency's handling of Rezulin, including officials' decision to examine the safety and effectiveness of the drug within a "fast-track" review of just six months.
NEWS
October 19, 2000 | DAVID WILLMAN, TIMES STAFF WRITER
A senior Food and Drug Administration official who played a pivotal role in the agency's controversial handling of the diabetes pill Rezulin has resigned his post and temporarily assumed a lesser position. The resignation and reassignment of Dr. Murray M. "Mac" Lumpkin was announced in an internal e-mail last Friday by his boss, Dr. Janet Woodcock, director of the FDA's drug review center.
NEWS
April 23, 1999 | DAVID WILLMAN and HEIDI SHERMAN, TIMES STAFF WRITERS
A Food and Drug Administration advisory committee Thursday unanimously recommended approval of a new pill to treat adult-onset diabetes that would compete with the controversial compound Rezulin. The action by the FDA panel is a victory for Britain-based SmithKline Beecham, maker of the new pill, called Avandia. The drug still must be approved by senior FDA officials before SmithKline can market Avandia in the United States.
NEWS
March 18, 1999 | DAVID WILLMAN, TIMES STAFF WRITER
The government death reports provide the barest of details. Like all other adverse reaction notices filed at the Food and Drug Administration, "Individual Safety Report No. 3174412-0" provided no name or address. In this case, The Times learned the victim's identity from other documents and interviews: Her name was Rosa Delia Valenzuela. She was 63 and lived in a ranch-style house in Arcadia, at the foot of the San Gabriel Mountains.
NEWS
June 4, 2000 | SUNNY KAPLAN, TIMES STAFF WRITER
Dr. Lisa McCoy embraced the arrival of Rezulin in mid-1997 as a "new hope" for her patients who struggled with adult-onset diabetes. She enthusiastically prescribed the drug for about a dozen diabetics in her Ashland, Ky., family practice but not before warning them about potential side effects, such as nausea, dizziness and headaches. "Rezulin worked and it worked great," McCoy said.
NEWS
June 4, 2000 | DAVID WILLMAN, TIMES STAFF WRITER
The suffering persisted for more than two years. Initially, there were four known victims. Then 21. Then 33. Finally, 63 confirmed fatalities. All the while, federal authorities watched, waited and hoped the deaths would stop. It was not until a disparate collection of physicians inside the U.S. Food and Drug Administration waged a remarkable revolt that the agency was forced to reverse course.
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