Pansy Mae Christian, who suffered from a cardiac condition, died on November 8, 2007 after taking Digitek prescribed by her doctor. On May 2008, Christian’s estate administrator James R. Christian received notice of the drug’s recall and complaints about significant adverse side effects.

On January 15, 2008, Gary Lucineo suffered toxicity and died after taking Digitek prescribed by his physician for congestive heart failure. His estate administrator, Jeanette Lucineo, is suing the companies, claiming they failed to warn users of the drug that the medication was provided for use by the public with twice the approved level of active ingredient. That overdose caused toxicity that the suit claims contributed to Mr. Lucineo’s death.

In April 2005, Actavis Totowa LLC, initiated a nationwide Class I recall of Digitek after it learned that oversized tablets had been distributed, which likely contained twice the level of active ingredient. Taking more than the FDA-approved level of Digitek can lead to Digitek toxicity, also known as digitalis toxicity, a serious and life-threatening complication. Symptoms of digitalis toxicity include unusual visual changes, confusion, loss of appetite, nausea, vomiting or diarrhea, palpitations or irregular pulse.

If you are taking digitalis medications and symptoms of digitalis toxicity develop, contact your healthcare provider immediately.

SOURCE: Digitek Recall › Two lawsuits filed against makers of Digitek heart medication

The fact sheets will be used in court to determine whether Mylan Pharmaceuticals of West Virginia, Actavis US and DUL Laboratories misrepresented Digitek as safe and whether physicians and patients relied on those “misrepresentations and deceptions” in choosing to use the heart medicine.

Digitek is used in the treatment of various heart conditions such as atrial fibrillation, atrial flutter and heart failure. In 2008, the FDA issued an alert to the public of a recall of Digitek, after it was found that some tablets had been released at double the thickness, which were thought to contain double the active ingredient. As a result, some patients experienced digoxin toxicity, which can result in life-threatening complications.

The lawsuit argues that, “Plaintiffs have sustained severe physical injuries and/or death, severe emotional distress, mental anguish, economic losses and other damages for which they are entitled to compensatory and equitable damages.”

The fact sheets require plaintiffs to detail 10 years of medical history including the names of every doctor who saw them, every hospital that admitted them and every pharmacy that dispensed medications to them, as well as providing full disclosure for psychological disorders, substances abuse and acquired immune deficiency syndrome. They also are required to list all drugs they have taken and list possible side effects, complete a chart of diagnoses of family members, and state how much they smoke, how long they have smoked, and how much and how often they drink alcohol. They must complete charts of Digitek or Lanoxin pills usage. And, plaintiffs must submit job records including pensions and insurance and disclose all workers compensation claims, disability claims and personal injury lawsuits.

To date, more than 100 Digitek lawsuits have been transferred to U.S. District Judge Joseph Goodwin, and more are expected to be added.

SOURCE: Digitek Recall › Those suing for Digitek injury must fill out lengthy fact sheets

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

According to the West Virginia Record, Goodwin wrote, “Some complaints in this MDL action join multiple plaintiffs whose only apparent connection with one another is that they ingested the drug at issue.”

Goodwin gave all plaintiff lawyers a Dec. 31 deadline “to identify all multi-plaintiff actions subject to his order and propose a severance order.”

After the 30 days of separation, the plaintiff must file a revised complaint. Goodwin wrote, “The severed and amended complaint must contain the specific claims asserted by the plaintiffs named in it.”

In cases of husbands and wives as plaintiffs, Goodwin won’t sever the cases.

For deaths and illnesses associated with Digitek, plaintiffs seek compensation from the Digitek drug companies Mylan Pharmaceuticals of West Virginia and Actavis Group.

SOURCE: Digitek Recall › Goodwin to seperate federal digitek complaints

According to the West Virginia Record, the suit claims, “Digitek contains twice the approved level of active ingredient and a narrow therapeutic index, which means the medication has a limited margin between effectiveness and toxicity.”

Digitek has a negative history.  Since 2006, 11 or more complaints have been recorded about the dangerous side effects of the drug, which include injuries and diseases.

At this time, Digitek is the only heart medication that is supposed to correct atrial fibrillation, atrial flutter and heart failure. Instead of correcting these problems, Digitek has unfortunately lead some consumers to their deaths and has also affected numerous loved ones in the process.

Being filled with mental agony and grief are just a few ways John Anthony Conte has suffered in losing his wife to Digitek ingestion. Though John Anthony Conte seeks compensatory and punitive damages for his wife’s estate, his wife cannot be replaced.

SOURCE: Digitek Recall › Kentucky man files digitek suit after losing wife

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