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

Digitek, a brand of digoxin, is a widely used treatment for various heart conditions such as atrial fibrillation, atrial flutter and heart failure.

According to the complaint, the companies received a warning from the Food and Drug Administration (FDA) that they failed to provide periodic safety reports for the facility where the medication was manufactured. By failing to provide the safety reports, the companies violated their adverse medical event reporting obligations. The FDA also warned that the drugs were being marketed without proper clearance and that at least 26 adverse events with the drug had not been reported.

In 2008, the FDA issued an alert to the public of a recall of Digitek, after it was found that some tablets had been distributed at double the thickness. Those oversized pills were thought to contain double the active ingredient. As a result, some patients experienced digoxin toxicity, which can result in life-threatening complications.

The complaint states, “The recalled Digitek was adulterated, misbranded, defective, unreasonably dangerous and unfit for its intended use.” Plaintiffs also contend that Actavis and Mylan Pharmaceuticals “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.” The plaintiffs are asking for a trial by jury.

Source: The Southeast Texas Record

SOURCE: Digitek Recall › Product liability lawsuit filed against Digitek manufacturer, distributor

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

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

Across the United States, around sixty Digitek recall law suits have been filed in federal courts. The defendants include the following: Actavis Totowa, LLC, Actavis, Inc., Actavis Elizabeth, LLC, Actavis US, Mylan, Inc., Mylan Pharmaceuticals, Inc., Mylan Laboratories, Inc., Mylan Bertek Pharmaceuticals and UDL Laboratories, Inc.

Collective cases will be transferred to Judge Joseph R. Goodwin.

According to the news report, under federal court procedures, the purposes of transferring all cases to one judge for pretrial rulings eliminates duplicative discovery and inconsistent pretrial rulings. Unlike a “class action,” where all suit are tried together, the MDL relates to pre-trial actions only. If a resolution or settlement is not reached, the cases go back to their respective districts for trial.

SOURCE: Digitek Recall › MDL consolidates Digitek recall cases

Doctors prescribe the drug, Digitek, to treat heart failure and abnormal heart rhythms.

Actavis Totowa, a Totowa, N.J., manufacturer, recalled Digitek after consulting with the Food and Drug Administration. Actavis makes Digitek for Mylan Pharmaceuticals of Pittsburg, Pa.

Actavis counsel John LaRocca said the company recalled Digitek after at least one pill emerged from the manufacturing process at double the appropriate thickness. An FDA statement said: “These tablets may contain twice the approved level of active ingredient than is appropriate.”

Double-strength tablets could lead to toxic levels of digitalis in patients with renal failure.

“We had some concerns about the process,” LaRocca said. He said the company knew of no deaths linked to Digitek use but Actavis and the FDA had received 11 complaints about side effects since 2006.

Actavis has asked pharmacists to instruct consumers to return all unused Digitek pills and to consult their physicians. While recalls often result in the removal of drugs from pharmacy shelves, consumers seldom receive personal notification.

At North Shore Pharmacy in Huntington, supervising pharmacist Ron Wood said, “We never keep the generic [Digitek] in stock, so it [the recall] doesn’t apply.”

Joel Bassuk, pharmacist at Raindew Pharmacy in Manhasset, said he received the recall notice yesterday but he only has about five customers who use the drug.

“They said to immediately examine your inventory and discontinue all lots,” Bassuk said, noting he has had no reports of adverse side effects.

CVS spokesman Mike DeAngelis said the chain had removed all Digitek from its stores. “We went back to see which patients had prescriptions over the past 12 months and contacted them,” DeAngelis said.

SOURCE: Newsday

SOURCE: Digitek Recall › Pharmacists will call: Digitek recalled