› $4.85 Billion settlement in drug case
According to reports filed to the FDA and consumers, the Center for Public Integrity has found that Digitek is responsible for 667 consumers’ deaths from April through June 2008. Pharma Live says health experts believe the FDA should have made more “aggressive warnings” to the public. The number of deaths associated with Digitek consumers have increased since the last reporting period.
U.S. District Judge Joseph Goodwin, who is striving to resolve the national litigation over Digitek, wants separate complaints from separate plaintiffs. On December 2, he signed an order stating that all Digitek attorneys who have numerous plaintiffs in single suits must separate the claims.
John Anthony Conte of Madison County, Kentucky, filed a Digitek lawsuit against a West Virginia pharmaceutical company, Mylan Pharmaceuticals, for his wife’s estate. His wife is believed to have died after taking Digitek. This suit was filed on October 9, 2008.
U.S. Attorneys in New Jersey are moving to close three Actavis Inc. plants, the company that manufactures Digitek, until they comply with FDA regulations.
On October 8, John Dingell (D-MI), chairman of the U.S. House Committee on Energy and Commerce, and Bart Stupak (D-MI), chairman of that committee’s Subcommittee on Oversight and Investigations, wrote a letter to the U.S. Food and Drug Administration Commissioner Andrew C. von Eschenbach to request more information concerning the FDA’s procedure for examining manufacturing facilities of the generic drug manufacturer Actavis after several of the company’s products were recalled.
Many previous Digitek consumers have steered away from Digitek after the recall. However, as Digitek has lost consumers, Lannett Company has only reaped the benefits.
Sales for Lannett’s digoxin, a generic form of Digitek, still have been strong since the recall of Digitek in April of this year.
According to Huntington News, the United States Judicial Panel on Multidistrict Litigation (MDL) has ordered that all federal lawsuits about the double strength, defected Digitek be transferred to the U.S. District Court for the Southern District of West Virginia. This development in the lawsuit is taken as a result of the April 2008 recall on Digitek. Some tablets were twice as thick as usual, made with the double amount of medication.
Actavis Totowa, the drug manufacturer of Digitek, just announced a voluntary recall, to the retail level, of more than 65 generic drug products manufactured at its Little Falls, New Jersey, facility, according to a release on the company web site. This recall follows an inspection conducted by the Food & Drug Administration, earlier this year, which revealed that operations at the New Jersey facility did not meet FDA standards.
In 2006, Actavis, the manufacturer of Digitek, was reprimanded by the U.S. Food & Drug Administration (FDA), which says that an inspection between January and February 2006 revealed six potentially serious and unexpected adverse side effects dating back to 1999 for drugs including digoxin (Digitek), phentermine and phenazopyridine that were not reported to the FDA.
According to a report on In-Pharma Techologist.com, the FDA sent a warning letter to Actavis in August 2006, alerting the company that its manufacturing facility in New Jersey had failed to file periodic safety reports, and had failed to report adverse drug events. Actavis was reprimanded for marketing drugs without proper clearance by not submitting the safety reports.
The report also noted that Actavis was cited for manufacturing several medications without approved applications.
The company insists it has since complied with all medical event reporting obligations that were overdue, and that it had revised its procedures for reporting such events to ensure continuous compliance with FDA regulations.
In April 2008, Actavis issued a Class I recall of Digitek (digoxin) tablets, which were manufactured at twice the proper thickness, which could result in digitalis toxicity. However, subsequent news reports indicate that the product may still have been in distribution up to a year after the initial recall, relying on pharmacists to alert patients prescribed the medication about the possible danger.
Most recently, on August 1, 2008, Actavis announced a voluntary recall, to the retail level, of more than 65 generic drug products manufactured at its Little Falls, New Jersey, facility, according to a release on the company web site. This recall follows an inspection conducted by the Food & Drug Administration, earlier this year, which revealed that operations at the New Jersey facility did not meet FDA standards.
For a list of the most recently recalled drugs, and more information, visit Actavis online.
Actavis was founded in 1956 and today is one of the leading companies worldwide involved in the development, manufacture and sale of generic pharmaceuticals. According to the company’s web site, there currently are more than 400 products in development. Headquartered in Iceland, Actavis has operations in about 40 countries and employs more than 11,000 people.
![[ Beasley Allen Law Firm Logo ]](/wp-content/themes/system-unity/images/logo.png){kind=logo}