
                         Roanoke Times
                 Copyright (c) 1995, Landmark Communications, Inc.

DATE: SUNDAY, June 25, 1995                   TAG: 9506260111
SECTION: NATL/INTL                    PAGE: A-6   EDITION: METRO 
SOURCE: Associated Press
DATELINE: CHEYENNE, WYO.                                LENGTH: Medium

DRUG SUIT TARGETS GENERIC

Dorothy Blair kept complaining that she felt worse after using Copley's albuterol, an inhaled drug designed to make breathing easier for people with respiratory diseases.

An avid bicyclist from Cincinnati who loved to travel despite her chronic lung disease, Blair, 73, was prescribed the drug, one of several generic versions of a popular anti-asthma inhalant.

She had switched to another drug before she was hospitalized in 1993 for shortness of breath. However, doctors at the hospital gave her Copley's albuterol again, her lawyers say. A month later, an infection in her lungs spread to her bloodstream and killed her.

The same month, Copley Pharmaceutical Inc. recalled all of the albuterol it had made since beginning production in 1990 - nearly 4 million inhalers. It said about 118,000 of the vials contained bacteria, and it was recalling the rest as a precaution.

Copley is now fighting a federal class-action lawsuit accusing it of negligence in at least 14 deaths and 100 injuries. The case consolidates 79 lawsuits.

Lawyers for the plaintiffs maintain that severe breathing problems, vomiting, pneumonia and death arose because millions of vials, not just thousands, were contaminated, and by a more harmful strain of the bacteria than the company acknowledges.

The trial, which opened last week, raises questions about how well makers of lower-priced generics are able to maintain the standards of makers of brand-name medicines.

Copley's albuterol is one of several generic versions of a drug originally sold by Schering-Plough Corp. as Proventil. Copley, based in Canton, Mass., is one of the largest U.S. generic-drug makers.

An investigation by the Food and Drug Administration found Copley had no written procedures for monitoring bacteria in the manufacturing area or for ensuring sanitation in the purified water systems used to make the drug.

FDA investigators found six leaks in the water purification system and a system of drain lines that allowed for possible contamination. It also found inaccurate records of bacteria levels and other record-keeping problems.

by CNB