Judge Rules 'No Reliable Scientific Evidence' Exists Linking Phentermine to Cardiovascular Disease

Business Wire, June 29, 2000

Business Editors, Health/Medical Writers

NEW YORK--(BUSINESS WIRE)--June 29, 2000

In a ruling that affects potentially hundreds of diet drug cases pending in the federal courts, U.S. District Judge Louis C. Bechtle yesterday excluded as "scientifically unreliable" testimony by plaintiffs' experts Drs. Paul Wellman and Timothy Maher that phentermine caused or contributed to the development of cardiovascular disease in people who took the "fen-phen" diet drug combination.

Ruling on a motion made by the manufacturers of phentermine, Judge Bechtle, who oversees all of the federal court litigation involving the diet drugs, found that "the opinions of Drs. Maher and Wellman do not amount to scientific knowledge." The Court continued, "Drs. Maher and Wellman have not demonstrated reliable data to support their hypothesis." Drs. Wellman and Maher are the two principal experts identified by plaintiffs to support their cases against the manufacturers of phentermine.

Judge Bechtle's 35-page written opinion follows a two-day evidentiary hearing at which the Court heard from plaintiffs' witnesses, Drs. Wellman and Maher, as well as from experts offered by the phentermine manufacturers. Dr. Maher is a pharmacologist affiliated with the Massachusetts Institute of Technology in Boston. Dr. Wellman is a behavioral psychologist affiliated with Texas A&M University. Judge Bechtle found that the two witnesses' testimony was not reliable enough to present to a jury, both because it was not supported by scientific data and because neither witness is a medical doctor nor had ever treated patients.

The Court's decision also follows rulings in several state courts dismissing cases against the phentermine manufacturers upon the ground that there is no reliable scientific evidence showing that phentermine causes or contributes to primary pulmonary hypertension or valvular heart disease. Last December, a Massachusetts State Court judge granted a phentermine manufacturer's motion to preclude Dr. Wellman from testifying in a case in that court, also because he found Dr. Wellman's theories scientifically unreliable.

"We are very pleased that Judge Bechtle found that there is no scientific evidence that phentermine causes or contributes to development of cardiovascular disease," said Terrance C. Coyne, M.D., Medical Director of Medeva Pharmaceuticals, Inc., the manufacturer of Ionamin(R) (phentermine resin) Capsules C-IV. "Moreover," said Dr. Coyne, "Judge Bechtle's thoughtful opinion will likely be instructive to courts around the country which face similar issues regarding the non-existence of reliable science implicating phentermine in these cases."

The combination anti-obesity therapy known as "fen-phen" has received considerable media and scientific attention since mid-1997, when the Mayo Clinic reported in the New England Journal of Medicine on a number of patients with valvular heart disease who had a history of taking "fen-phen." Fenfluramine and phentermine, the two components of the "fen-phen" combination, are separate and distinct pharmaceutical products. Fenfluramine and dexfenfluramine, a related product, were withdrawn from the market in September 1997 at the request of the FDA. Phentermine has been on the market since 1959 and remains on the market today as short-term treatment of exogenous obesity, in conjunction with caloric reduction and lifestyle changes.