Two Maryland women have filed a class-action suit against the makers and distributors of controversial weight-loss drugs and two doctors who prescribed them, alleging the drugs caused health problems that endanger the women's lives along with thousands of others.
Denise Ratajczak, 43, of Baltimore and Joanne Dignan, 41, of Cumberland are the plaintiffs in the suit filed Thursday in Baltimore Circuit Court against nine drug companies and two physicians.
The most well known of the drugs, fenfluramine and phentermine, have been sold widely across the country in recent years, with 18 million prescriptions having been written in the past year. Those pills are often used in a combination known as fen-phen. The third drug, dexfenfluramine, was recently approved for sale in the United States.
The suit alleges the defendants were negligent in portraying the drugs as safe and prescribing them when medical experts had documented evidence about their harmful effects.
"Defendants actually knew of the defective nature of their products . . . and continued to design, manufacture, market and sell their products so as to maximize sales and profits at the expense of the public's health and safety," the suit alleges.
The suit was filed three weeks after the U.S. Food and Drug Administration sent a letter to the nation's doctors asking them to report instances in which patients developed heart-valve defects after taking the fen-phen combination.
That request was sparked by a report documenting 33 cases of valvular heart disease among fen-phen patients in North Dakota and Minnesota. Within two weeks, the FDA had heard of 17 additional
cases from states stretching from Maryland to California.
The suit seeks $2 million in compensatory damages for each plaintiff and an unspecified amount of punitive damages.
H. Russell Smouse, the women's lawyer, said that a circuit judge must decide whether to certify the suit as a class action before it can go to trial. Class-action certification would would allow other Maryland residents hurt by the drug to join as plaintiffs and win damages, he said.
Smouse said that Dignan has a lung disease, primary pulmonary hypertension, as a result of taking the diet pills beginning in 1983. He said Ratajczak has experienced breathing problems because she took them from 1993 to 1995.
Smouse said he didn't know how many patients in Maryland had experienced similar problems that would qualify them as plaintiffs. But the suit alleges that there may be "thousands" of them.
The women are also asking the court to set up a "monitoring fund" to pay for treating plaintiffs hurt by the drug.
The first cases of valvular heart disease were reported by the Mayo Clinic of Rochester, Minn., and the MeritCare Health Center of Fargo, N.D. It remains unclear whether the pills caused the heart damage or were a coincidence.
Critics find the reports disturbing, especially in light of the way the use of the diet pills has taken off as a national fad.
Smouse said he knows of a similar lawsuit in federal court in San Francisco.
Named as defendants in the Baltimore suit were Dr. Dana Simpler of Baltimore and Dr. Arvind K. Pathak of McLean, Va., and nine drug companies: Gate Pharmaceuticals of Sellersville, Pa.; Smithkline Beecham Corp. of Philadelphia; Zenith Goldline Pharmaceuticals of Fort Lauderdale, Fla.; Abana Pharmaceuticals Inc. of Birmingham, Ala.; Richwood Pharmaceutical Co. of Florence, Ky.; Ion Laboratories Inc. of Fort Worth, Texas.; Medeva Pharmaceuticals Inc. of Fort Worth; A. H. Robins Co. Inc. of Richmond, Va.; and Wyeth-Ayerst Laboratories Co. of Wayne, Pa.
Dr. Pathak yesterday denied ever prescribing the drug.
Dr. Simpler said she has always been aware of the medications' side effects and has been very careful when prescribing it.
"One thing I felt assured about with all the warnings that have come out was that I was always so cautious with it," she said.
Many doctors have defended the pills as a safe approach to obesity.
Pub Date: 8/02/97