Quality control allegations against Mylan put Post-Gazette in hot water

PITTSBURGH A newspaper story alleging employee misconduct at the West Virginia manufacturing plant of a generic drug maker has earned a Pittsburgh newspaper a lawsuit.

Mylan announced Wednesday that it had filed suit against the Pittsburgh Post-Gazette, reporters Len Boselovic and Patricia Sabatini and others in the Circuit Court of Monongalia County, W. Va., over the Post-Gazette’s publication of a series of articles alleging serious quality-control problems at Mylan’s plant in Morgantown, W.Va.

The articles – based on confidential internal documents, anonymous sources and third-party commentary – reported that employees at the plant had ignored and deleted computerized warnings of product quality problems with the plant’s manufacturing equipment. A subsequent investigation by the Food and Drug Administration found “minor” deviations in standard operating procedures, but found that the problem had been corrected, and there was no evidence of widespread misconduct.

Mylan said the lawsuit seeks “compensatory, exemplary and other appropriate relief” from the defendants and the return of the documents, which Mylan said the Post-Gazette obtained improperly and without Mylan’s knowledge or consent. The company said the documents were distributed to third parties who reviewed them without a complete set of facts, leading to “mischaracterizations” and “misleading allegations.”

“We are very disappointed that this situation occurred and reached this level, however, we have no other alternative but to address this type of misconduct,” Mylan chairman and CEO Robert Coury said in a statement.

Representatives of the Pittsburgh Post-Gazette could not be reached for comment.