The Washington Post
Jan 4, 2002

Lawyer Alleges Cover-Up in Drug Case

Firm Accused of Concealing the Effects of Diabetes Medication

By Phuong Ly
Washington Post Staff Writer
Friday, January 4, 2002; Page B02

A lawyer for the family of a Rockville woman who died after taking the diabetes drug Rezulin charged in Montgomery County Circuit Court yesterday that the maker of the drug was intent on producing a blockbuster and covered up information about serious side effects when it sought speedy approval from the federal Food and Drug Administration.

Rainey Booth, representing the family of Monica T. George, said in opening statements that an e-mail from an FDA official to Warner-Lambert Co. said the drug should never have been approved for people like George, whose mild form of diabetes could be controlled by other medications.

George, 67, a retired nurse, began taking Rezulin in November 1997 and died less than a year later, while awaiting a liver transplant. She was one of 63 people who died after taking Rezulin, and the lawsuit filed by her three daughters is the fourth of more than 4,200 claims filed against Rezulin to go to trial.

Rezulin was pulled from the market in March 2000 by the FDA, which cited the drug's toxicity to the liver and noted that alternative drugs were available.

The Montgomery County case is the only Rezulin lawsuit in the Washington region. Pfizer Inc., which bought Warner-Lambert in June 2000, has won one lawsuit and settled two others after trial testimony was completed.

A lawyer for Pfizer told jurors that Rezulin, also known as troglitazone, was a major medical advance for the treatment of Type 2, or adult onset, diabetes and the first of its type on the market.

Attorney Charles Goodell said Rezulin did more good than harm for George and 2 million other diabetics who were prescribed the drug. He said that George, like other diabetics, was beset with other health problems that contributed to her death, including autoimmune hepatitis, which he said attacked her liver.

Pointing to a large copy of a warning label placed on the drug, Goodell said that Warner-Lambert adequately informed doctors and consumers about the possible risks and side effects, including deaths in rare cases.

"When you look at the dangers of diabetes . . . the risk disclosed about this drug are mild in comparison," Goodell said. "Doctors wanted it. Many doctors were sorry it ever left the market. This was a very effective drug."

In the packed courtroom yesterday, George's three daughters -- Elaine Shaw, Andrea Shaw and Donna Storey -- sat on the first bench, behind the jury box.

Both sides said they would present testimony from doctors who treated George. Attorneys for George's family said doctors at the University of Virginia Medical Center will testify that George did not suffer from autoimmune hepatitis and that the drug caused her death.

Pfizer attorneys said a Johns Hopkins Hospital liver specialist will testify that George had autoimmune hepatitis -- which quickly degrades the liver -- and will exonerate Rezulin in George's death.

Most of the opening statements focused on how drugs are tested and approved.

Booth accused Warner-Lambert of negligence and failing to adequately warn the FDA. He said that the company told FDA officials that the effect of the drug was "comparable to a placebo pill," even though clinical trials on animals and humans had found toxicity to the liver.

Shortly after Rezulin was approved, reports of liver problems began to emerge, Booth said. That fall, Glaxo Wellcome, a pharmaceutical company that was marketing the drug in England for Warner-Lambert, voluntarily pulled Rezulin off the shelves.

Within nine months, the FDA had received 47 reports of liver problems, including one death -- all before George began taking Rezulin, Booth said.

Booth quoted an e-mail from an FDA medical officer to Warner-Lambert as saying that the agency was being "very liberal" to allow the drugmaker to market Rezulin to people with mild diabetes and that if it had known of the safety problems beforehand, "we would have definitely turned it down."

Warner-Lambert, Booth said, "had reckless disregard for the patients who took this drug."

But Goodell said that Glaxo withdrew Rezulin to take a "wait-and-see approach." He said Glaxo had just 5,000 patients on Rezulin, while Warner-Lambert had more than 600,000 and knew more about the drug.

Goodell said that despite much debate and publicity over Rezulin, the FDA decided to keep the drug on the market, saying the benefits outweighed the risks. When the FDA pulled Rezulin from the market, it noted that two newer drugs of the same type -- Avandia and Actos, made by other companies -- were not causing the same kind of liver toxicity in patients.

"Medicine does not avoid all risks," Goodell said. "There is no drug anywhere that is risk-free."

In its two settlements, Pfizer admitted no liability. The Montgomery County case is expected to take more than two weeks. Two other Rezulin cases are scheduled for trial later this month in Texas.

© 2002 The Washington Post Company