At About Same Time, Drug Company Accepts FDA Consent Decree In Connection With Justice Department's Injunction Complaint
(Posted by Tom Lamb at DrugInjuryWatch.com)
In late December 2008 investigative reporter Jeanne Lenzer's hard-hitting article about the Digitek fiasco, "Did the FDA Miss Signals on a Troubled Heart Drug?", was published by The Center for Public Integrity (the Center, for short).
The most surprising part of that article, to me, was this contention by the drug company:
Actavis maintains that none of the improperly manufactured Digitek pills ever reached the public, telling the Center that it recalled the drug simply out of an “abundance of caution.”
I suppose this is a predictable corporate position to take in light of the increasing number of lawsuits being filed by people who allege that they ingested the so-called "double-dose" Digitek pills and were subsequently harmed. The validity of this Actavis contention, however, will certainly be tested in the federal and state court Digitek litigations.
About a week after the Digitek article by Jeanne Lenzer was published, on December 29, 2008, Actavis issued a press release to announce a Consent Decree that the drug company had agreed to enter into with the FDA:
Actavis Inc. today announced that it has reached agreement on a Consent Decree of Permanent Injunction with the Food and Drug Administration (FDA) regarding the company's Actavis Totowa LLC subsidiary. This agreement, in effect, settles the issues identified by the Department of Justice in its previously filed complaint against Actavis Inc., Actavis Totowa, and officers Sigurdur Oli Olafsson and Douglas Boothe.
The Consent Decree only affects operations at Actavis Totowa in New Jersey. [Editor's Note: Two of these facilities ("Little Falls" and "Riverview") are oral-dose manufacturing sites, and one ("Taft") is a packaging facility.] Pursuant to the Consent Decree, Actavis has agreed to not distribute any products from the Actavis Totowa facilities until it has certified completion of certain enumerated requirements that demonstrate compliance with FDA's current good manufacturing practice (cGMP) and has passed follow-up FDA inspections of the facilities. The company anticipates that commercial production in the Actavis Totowa facilities will resume shortly.
As you may recall, the FDA had filed an Injunction Complaint through the U.S. Department of Justice (DOJ) in November 2008.
According to a DOJ press release regarding that Complaint, "U.S. Files Suit Against New Jersey Generic Drug Manufacturer That Distributed Adulterated and Misbranded Products":
...The Food and Drug Administration (FDA) conducted five inspections of Actavis Totowa's facilities over the last three years. Despite written warnings to the company, during its last inspection this year, the FDA continued to find numerous and recurring violations of Good Manufacturing Practice requirements. FDA also found that the company continued to manufacturer and distribute unapproved new drug products.
If you read the December 2008 Digitek article by Jeanne Lenzer as well as the November 14, 2008 COMPLAINT FOR PERMANENT INJUNCTION document filed by the DOJ, it seems that a more realistic position for Actavis to have taken on the issue of whether or not any defective Digitek pills were ever dispensed and used by a patients would have been that -- given the very nature of those numerous problems found at this Little Falls, NJ facility -- "we don't know", rather than its apparent position of denial.
Of course, as the the Digitek lawsuits progress we will find out whether, in fact, there are any double-dose Digitek pills that were used by and harmed patients.