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Did Mylan Employees Knowingly Release Defective Fentanyl Patches?

Posted in Duragesic / Fentanyl

When I read the following article this morning, the first question I had was whether these Mylan employees overrode quality control guidelines for the Mylan fentanyl patch:

MORGANTOWN, W.Va. — Late this spring, Mylan Inc. took the unusual step of halting production at its sprawling generic drug manufacturing plant in Morgantown for an emergency meeting. Hundreds of employees, gathered in the cafeteria, were about to hear a bombshell.

Days earlier, Mylan learned two production workers had violated government-mandated quality control procedures intended to ensure the safety and effectiveness of prescription drugs. The company was launching a probe.

Publicly, Mylan officials have refused to discuss or even acknowledge the matter.

But according to a confidential internal report obtained by the Pittsburgh Post-Gazette, the company discovered that workers were routinely overriding computer-generated warnings about potential problems with the medications they were producing.

Source: http://www.post-gazette.com/pg/09207/986516-28.stm#ixzz0MT8ZvQJB

The article doesn't specifically mention the Mylan fentanyl patch, but it doesn't exclude it, either.  I'm glad that Mylan management took the initiative to launch an investigation, but I'm disturbed that overriding the quality control mechanisms was apparently as simple as "right-clicking" the red screen.

Many people refer to Windows crashes as "The Blue Screen of Death." If Mylan employees knowingly released defective fentanyl patches, perhaps we should start talking about "The Red Screen of Death," as a defective patch can certainly kill someone.  In fact, many lawsuits have been filed over deaths attributed to Mylan fentanyl patches already.