20 suing phen-fen drugs' makers

Plaintiffs allege diet pills are linked to health problems

August 31, 1999|By Gary Dorsey | Gary Dorsey,SUN STAFF

In the wake of a trial that brought a $23 million award to a Texas woman who sued manufacturers of the diet drug "cocktail" known as phen-fen, 20 Maryland residents have filed suits in U.S. District Court in Baltimore linking the drug to their health problems.

The most serious allegation, made by Angela Borlik of Arnold, is that her husband, Michael, 48, died in May 1997 of primary pulmonary hypertension, a lung disease that she says the drugs caused.

Other plaintiffs say they have suffered from heart disease or related cardiopulmonary problems, according to the suits.

Each of the suits asks the court to award punitive and compensatory damages exceeding $1 million against 14 pharmaceutical companies, including American Home Products Corp., which was found liable in a Texas district court case Aug. 6. That case represented the first time a phen-fen complaint had reached a jury.

Companies named in the suits manufactured, promoted and sold one or more of the drugs that combined to make the diet medication.

"All these cases allege essentially the same thing," said Matt R. Ballenger, a Baltimore lawyer who filed all of the Baltimore-area suits in federal court. "Not everybody got pulmonary hypertension -- there's a broad range of injuries -- but the essence of the claims is the same."

Officials with American Home Products Inc. could not be reached to comment on the suits.

Each suit says the companies knew of health risks associated with the drug mixture as early as 1995 but failed to alert the public. The suits also refer to a study published in the New England Journal of Medicine in August 1996 reporting that phen-fen increased risk of primary pulmonary hypertension by a factor of 30.

Phen-fen became a popular prescription for dieters in the middle of the decade.

Made from a combination of phentermine, fenfluramine and dexfenfluramine, the cocktail never received approval by the Food and Drug Administration, although the individual drug components did.

After publicized studies linked the combination to heart and lung illnesses, the FDA successfully prodded pharmaceutical companies to withdraw it from the market in 1997.

Demand for the drugs had been limited before 1992, when a journal called Clinical Pharmacology Therapeutics published a study praising the combination as a successful weight-loss drug. As a result, public demand grew quickly and it was prescribed widely by doctors, diet centers and psychiatrists.

In 1997, the Mayo Clinic in Minnesota released an emergency report suggesting that phen-fen was potentially life-threatening. As evidence, the report identified thickening in the heart valves of women who took the drugs. The thickening plus leakage in the valves made it harder for the heart to pump blood through the body, the report said. Five of the 24 women in the study required heart surgery to replace the damaged valves.

Besides the heart problems, researchers also discovered evidence linking the use of phen-fen to a deadly lung disease, primary pulmonary hypertension. Although pulmonary hypertension was considered a rare disease, in the mid-1990s doctors reported seeing more patients with the illness who had used the diet drug.

Pulmonary hypertension occurs when small arteries inside the lungs thicken and constrict, raising the lung's internal pressure and causing an increased resistance to blood flow. The heart weakens as it struggles to pump blood.

One case involving phen-fen has focused on a Baltimore Internet diet doctor, Pietr Hitzig, who built a worldwide patient list using his "Fen-Phen Crisis Center" Web page. Federal agents arrested Hitzig in July and indicted him on 34 counts of illegally prescribing medicine.

Hundreds of people around the world obtained drugs such as phentermine and fenfluramine from him from 1996 to 1998, according to the indictment.

The criminal charges against him were preceded by questioning from the Maryland Board of Physician Quality Assurance about detailed allegations of sexual misconduct with patients.

Hitzig surrendered his medical license in February, left his 7-acre estate in Monkton and moved into a $700-a-month apartment in Baltimore.

More than 3,000 lawsuits have been filed against pharmaceutical companies that manufactured phen-fen drugs, Ballenger said.

In some cases, he said, companies have settled the suits. In July, for example, a 70-year-old woman from Tyler, Texas, agreed to a settlement of more than $3 million, according to the Dallas Morning News.

"Why are there so many of these suits?" Ballenger asked. "You can probably turn around and ask any slightly overweight woman if she used phen-fen and chances are she'll say, `Yes.' "

In previous cases, American Home Products has vigorously denied the allegations and argued that it had fully informed doctors and government regulators of health risks.

The company has appealed the Texas verdict.

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