The last thing that diabetics need is a drug that causes liver failure, yet that is precisely the kind of drug the FDA approved for diabetes patients.
"According to the FDA, an estimated 1.9 million patients with diabetes were prescribed Rezulin, with fewer than 100 reported acute liver failures leading to death or transplant as of the drug's withdrawal in March 2000 following the introduction of two newer medicines of the same class."
This case against this drug demonstrates that the public is unprotected from deadly, FDA-approved drugs. The FDA is no longer rigorous in its new speedy drug evaluation an approval process. As was revealed in the Pulitzer Prize winning series by David Willman in The Los Angeles Times, [1998-2001], the FDA has been approving harmful, even deadly drugs in rapid succession.
The case demonstrates how difficult it is for individuals to successfully sue the Goliath pharmaceutical industry. Is this the best service our government can provide to the citizens of this country?
ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP) Contact: Vera Hassner Sharav Tel: 212-595-8974 firstname.lastname@example.org
A jury on Monday found that the prescription drug Rezulin did not contribute to the death of a diabetic woman who died in January 2000, Pfizer Inc., whose subsidiary Warner-Lambert made the drug, said.
The verdict, in District Court in Harris County, was the first jury decision in litigation involving thousands of claims against the diabetes drug Rezulin, including current trials in Liberty, Missouri, and Corpus Christi, Texas.
The drug, now withdrawn, has been blamed in 63 liver failure deaths worldwide for the period from 1997 to 2000 during which it was sold.
Norma Culberson, 58, had diabetes and took Rezulin, approved by the Food and Drug Administration in 1997 for the treatment of Type II diabetes, which affects about 15 million Americans, starting in late 1997 for a period of about two years, according to trial testimony.
Lawyers for Culberson's daughters, who were seeking $25 million in damages, argued that the drug damaged her liver, leading to a coma and her eventual death in January 2000.
But Pfizer, the world's largest drugmaker, argued that the risks from a drug like Rezulin had to be weighed against the threat posed by a disease like diabetes.
"Insulin has 395 deaths in every 100,000 patients," attorney Jack Urquhart he told jurors. "Why do we tolerate 395 deaths in every 100,000 with insulin? There is no replacement right now," he said.
Culberson's death certificate listed kidney or renal failure due to diabetes as cause of death, with liver damage as a secondary factor.
Paul Miller, executive vice president and general counsel for Pfizer said in a statement "We are pleased ... that the jury in Houston differentiated between the kidney failure which was the immediate cause of Norma Culberson's death and the positive role Rezulin played in treating her diabetes."
Pfizer, which affirmed on Monday it expects earnings to grow at least 20 percent next year, closed up $0.89 or 2.26 percent to $40.33.
"From June 2000, when Pfizer acquired Warner-Lambert," Miller added, "we have clearly stated that Pfizer is committed to the fair and reasonable resolution, without litigation, of claims arising from those very rare injuries experienced by Rezulin patients.
"We have also said that, in cases where the alleged harm has not been demonstrably caused by Rezulin or where the plaintiff makes excessive demands, Pfizer will go to trial." Other cases have been settled out of court with undisclosed terms.
The trial began on Nov. 27.
According to the FDA, an estimated 1.9 million patients with diabetes were prescribed Rezulin, with fewer than 100 reported acute liver failures leading to death or transplant as of the drug's withdrawal in March 2000 following the introduction of two newer medicines of the same class.