Actavis Inc.

Digitek was cited by the Center for Public Integrity as the “primary suspect” in 667 deaths reported between April 1, 2008 and June 30, 2008. Digitek is prescribed for various heart conditions such as atrial fibrillation, atrial flutter and sometimes heart failure. An incorrect dosage or overdosage can be dangerous and even fatal to heart patients taking the medication, causing even more cardiac instability and compounding existing problems.

Last April, it was discovered that some tablets produced in the Actavis New Jersey plant were oversized and contained as much as twice than the marked dosage of the active ingredient. A massive recall was ordered and Actavis contends that none of the oversized pills reached consumers. The New Jersey plant was officially closed in August to correct its shoddy manufacturing practices, and in November the U.S. Justice Department ordered the plan remain closed until it could prove it has met the FDA’s “Good Manufacturing Practice.”

In January, the FDA announced that it would allow Actavis to resume its production of Digitek provided it proves it has cleaned up its act. Actavis signed the proposed consent decree but whether it will start making Digitek again is anyone’s guess.

A division of the Icelandic Actavis Group, Actavis is among of the world’s five largest drug makers.

SOURCE: Digitek Recall › Actavis signs consent decree to resume making Digitek

The complaint further states the FDA letter, written in Aug. 2006, advised defendants they were promoting drugs “without proper clearance” and possibly more than 26 adverse drug experiences went unreported.

The updated FDA letter in February 2007 states, “Significant deficiencies were found in the operations of your firm’s quality control unit, and as a result there is no assurance that many drug products manufactured and released into interstate commerce by your firm have the identity, strength, quality and purity that they purport to possess.”

In April of 2008, Digitek’s manufactures issued a recall because the pills contained twice the amount of the active ingredient.  In response to recall, the plaintiff argues, “Defendants placed tens of thousands of patients, including Decedent, unnecessarily at risk of serious injury and/or death and may have caused them to suffer personal injuries and harm, including medical expenses, anxiety and fear induced from ingesting the defective and misbranded drug.”

In the Digitek lawsuit, Butts filed the following charges: “violation of the Texas Deceptive Trade Practices Act, strict product liability including design and manufacturing defects, failure to warn, breach of express and implied warranty, negligence, fraud, negligence per se, and negligent misrepresentation.”

Butts is also desiring “damages for pecuniary losses, all hospital, medical and funeral expenses, loss of advice and counsel, loss of spouse’s services and parent’s services, mental anguish, loss of companionship and society, and loss of inheritance.”

SOURCE: Digitek Recall › Texas woman sues Digitek manufacturer for husband’s death

According to the Philadelphia Inquirer, the agreement says Actavis cannot resume its practices until it conforms to “the agency’s good manufacturing practice.” Actavis must improve its labs, facilities, and equipment.

Actavis has faced numerous lawsuits over the recalled drug Digitek. One such lawsuit includes the death of a patient and claims that Digitek is an unsafe and flawed drug.

Actavis would not comment if the FDA agreement had influenced the Digitek lawsuits or not.

SOURCE: Digitek Recall › Actavis N.J. plant agrees with FDA

In April of this year, Digitek pills were recalled due to a suspicion of Digitek pills containing twice the active ingredient. Actavis Inc., the drug manufacturer, believes none of these pills made it to the public and that the recall was only out of “an abundance of caution.”

Unfortunately, many Digitek consumers are still unaware of the Digitek recall and the number of reported deaths associated with Digitek consumers. The FDA posted a Med Watch Alert for Digitek on April 28, 2008 due to the possibility of some of the pills containing double the active ingredient.

Health experts believe the FDA should have further investigated Digitek’s manufacturers and the FDA should have warned doctors, pharmacists, and consumers of the potential dangers associated with this drug. The FDA believes their actions in informing the public were consistent when compared to other drugs that have caused issues.

SOURCE: Digitek Recall › Digitek believed responsible for 667 deaths

Actavis claims that it has been dedicated to ensuring the value and integrity of its manufacturing since May 2008, which is after the FDA inspected Actavis because the company manufactured Digitek pills that were twice as thick as they ought to have been.

According to Market Watch, “The company views the filing of this complaint as one step in a long regulatory process, and is fully committed to working collaboratively and openly with the FDA in a timely manner.”

John LaRocca, Actavis Inc.’s Chief Legal Officer, says in response to the claim, “We have taken a comprehensive approach to correcting all deficiencies within the Totowa business, and we’ve communicated regularly and candidly with the FDA, the public, our employees and our customers. Last month, we asked FDA to return to the Totowa facilities, conduct an inspection, and observe the substantial progress we have made. To this point, the FDA has not acted. Our company takes these matters very seriously, and we remain focused on quality, innovation, and product safety. We look forward to a quick and satisfactory resolution to these issues for the benefit of consumers, the agency, and ourselves.”

SOURCE: Digitek Recall › Actavis comments on lawsuit

According to the Associated Press, the suit requests the court to not allow Actavis Inc. and Actavis Totowa to manufacture drugs until the company complies with FDA regulations for testing, quality control, and test response. The company must also stop selling unapproved and misbranded drugs.

Filed by U.S. Attorney Christopher Cristie and the Department of Justice’s Officer of Customer Ligation, the suit states Actavis’ facilities in Totowa and Little Falls, N.J., have not only continued to fail FDA examinations, but Actavis has not made the required changes.

Between January 2006 and May 2008, the FDA examined the two facilities in Totowa and the one in Little Falls five times overall.

In April of 2008, Actavis recalled its heart drug Digitek due to pills being twice as thick as the original form. Due to the doses being doubled, Digitek posed a threat to its consumers.

The FDA discovered in the inspections that Actavis did not have complete lab records of its testing information, and did not verify that its testing methods “matched up with actual conditions under which the products would be used.”

These are just a few of many violations that continued throughout FDA inspections of Actavis.

SOURCE: Digitek Recall › U.S. attorneys sue makers of Digitek, seek to close facilities