Denver, CO (PRWEB) August 4, 2008
A lawsuit filed in United States District Court in Denver, Colorado on August 1, 2008 charges pharmaceutical company Actavis Totowa LLC with manufacturing and distributing defective Digitek heart drug pills that contained dangerously excessive doses of the drug's active ingredient, digoxin, causing life-threatening adverse drug reactions. Digitek is typically prescribed to treat irregular heartbeat or heart failure. The Federal suit, filed in the wake of an FDA Digitek recall, alleges defective Digitek contained amounts of digoxin exceeding the dose set forth on the label and in some cases exceeding the dose approved for medical treatment in humans.
The litigation, brought by a Denver woman on behalf of her deceased husband, alleges defective Digitek pills containing a lethal dose of the active ingredient caused the death of her husband. The case was filed by Digitek Attorney Beth Klein.
The death occurred in August 2007 over a year after FDA inspections of the manufacturing
operations of Actavis Totowa, LLC revealed the manufacturers failure to comply with federal regulations to ensure the safety of its medications.
The FDA issued a Revised Warning Letter to Actavis Totowa, LLC on February 1, 2007 finding that the inspection of the company's 101 East Main Street, Little Falls, New Jersey facility that took place July 10, 2006 through August 10, 2006 revealed that drug products manufactured at that facility were adulterated under the meaning of the Federal Food, Drug and Cosmetic Act.
A year later on April 25, 2008 the FDA announced a nationwide recall of all Digitek tablets because of the potential that the tablets were double the appropriate thickness and contained up to twice the approved level of the active ingredient. The suit claims the victim was prescribed Digitek and innocently ingested defective tablets that contained lethal levels of the active ingredient.
The suit blames Actavis for failing to heed FDA warnings in July and August of 2006 and February of 2007, that many of the drug products that were produced, manufactured and released to the public by Actavis were adulterated and as a result the drugs were not safe for patients to ingest.
"What makes this so tragic is that Actavis chose not to take appropriate measures in response to the FDA warnings in 2006 and 2007. Scores of people have unnecessarily lost their lives," said Beth Klein, Digitek lawyer with the law firm Klein | Frank, P.C. in Denver, Colorado. Klein and Carrie Frank of Klein | Frank, P.C. are representing the family of the deceased.
The suit charges the drug maker knew or should have known about the manufacturing and production defects and that the recalled Digitek was adulterated, misbranded, defective, unreasonably dangerous and unfit for its intended uses. "Despite the undeniable knowledge, Actavis placed tens of thousands of patients, including our client, unnecessarily at risk of
catastrophic injury and death," said Klein.
Klein | Frank, P.C. is recognized nationally for its practice in mass torts litigation, multidistrict litigation and complex litigation including class actions, serious personal injuries, wrongful death, products liability, defective medical devices and pharmaceuticals. The firm is currently accepting Digitek lawsuits.
Beth Klein, Lead Counsel
Klein | Frank, P.C.