Fen-Phen e-Resource

The dismissal follows a ruling by Judge Raymond Brassard of the Massachusetts Superior Court that the plaintiffs' expert witnesses failed to present sufficient evidence that phentermine causes or contributes to pulmonary hypertension, the alleged cause of the their daughter's death.

"Fen-phen," popularly prescribed in the early and mid 1990's to aid in weight loss, is actually two drugs -- fenfluramine and phentermine. Fenfluramine was taken off the market in 1997 after reports that it increased the risk of valvular heart disease and pulmonary hypertension, an often-deadly disease. Since then, a number of lawsuits have been filed against the manufacturers of both fenfluramine and phentermine, despite the lack of scientific evidence showing that use of phentermine is associated with increased risk of pulmonary hypertension.

"This is an important victory for phentermine manufacturers," said attorney Peter Resnik of McDermott, Will & Emery's Boston office and co-lead national counsel for the manufacturers of phentermine. "It supports our longstanding position that there is no reliable scientific evidence that phentermine causes or contributes to pulmonary hypertension."

The order excluding the experts' testimony was written by Judge Raymond Brassard, Justice of the Massachusetts Superior Court. In this case, plaintiffs Thomas and Mary Linnen allege that the 1996 death of their 30-year old daughter from pulmonary hypertension was caused by short-term ingestion of the two drugs, fenfluramine and phentermine.

Thousands of fen-phen cases are pending in federal and state courts throughout the country. American Home Products Corporation, the maker of fenfluramine, has entered into a Settlement Agreement that, if approved by the court, could settle many of the claims against it alleging that fenfluramine caused valvular heart disease. The Massachusetts case was not subject to the Settlement Agreement because it involves a claim of pulmonary hypertension. Phentermine manufacturers are not participating in the settlement.

Using the standards established in the federal case of Daubert v. Merrell Dow Pharmaceuticals, Inc., and the Massachusetts case of Commonwealth v. Lanigan, the phentermine defendant moved to exclude as scientifically unreliable the testimony of plaintiffs' expert witnesses that phentermine, alone or in combination with fenfluramine, causes or contributes to the development of pulmonary hypertension. The Massachusetts decision represents the first time a court has ruled on the admissibility of the testimony of a plaintiff's key expert against phentermine after an evidentiary hearing in which experts for both sides were subject to cross-examination.

In his decision, Judge Brassard pointed to several key reasons for his decision: no testing of the experts' hypotheses, no known error rate, lack of acceptance among the scientific community for the hypotheses proposed by the experts, and an insufficient degree of scientific certainty by the experts themselves regarding their key theories.

"We are hopeful that this decision will mark a turning point in all of the fen-phen litigation. Judge Brassard's thorough and thoughtful decision pointing out the lack of reliable scientific evidence against phentermine is likely to influence the court's approach to this issue nationwide," remarked Resnik's partner, Donald R. Frederico. Frederico, together with David Cohen, a partner in the New York law firm of Richards & O'Neil, conducted the hearing on behalf of phentermine manufacturers.

Businesswire