Digoxin is a drug product used to treat heart failure and abnormal heart rhythms. A higher than labeled dose may pose a risk of digoxin toxicity in patients with renal failure. Digoxin toxicity can cause nausea, vomiting, dizziness, low blood pressure, cardiac instability, and bradycardia. Death can also result from excessive digoxin intake. A lower than labeled dose may pose a risk of lack of efficacy potentially resulting in cardiac instability. Caraco is recalling these tablets to the consumer level to minimize any potential risk to patients.

Last year, Actavis Totowa LLC, a generic pharmaceutical company initiated a Class 1 recall on Digitek brand digoxin tablets when it was learned that some tablets were oversized and contained twice the level of active ingredient, putting consumers at risk.

Consumers of Caraco’s digoxin tablets that fall within the recall should return these products to their pharmacy or place of purchase. Patients who have medical questions should contact their healthcare provider for additional instructions or guidance.

Source: FDA

SOURCE: Digitek Recall › Caraco brand digoxin recalled; could put consumers at risk

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

Chandler’s wife Barbara Chandler deems the defendants negligent because Digitek was distributed to the public with twice the amount of the active ingredient, according to the West Virginia Record.

The paper reports, “Digitek (Digozin) has a narrow therapeutic index and has a limited margin between effectiveness and toxicity. Chandler, as administratix of the estate is seeking judgment, jointly and severly, (sic.) from all defendants, pre and post judgment interest and costs.”

SOURCE: Digitek Recall › Alabama man dies after consuming Digitek

The FDA filed an action against Actavis Dec. 23, which was signed by Actavis on Dec. 29. The FDA awaits a permanent injunction against this company. The FDA declares Actavis and its officers have been manufacturing and distributing “unapproved” drugs in the U.S. The FDA promotes pharmacists to stop dispensing unapproved Digitek drugs.  The FDA strongly encourages Digitek consumers to discuss alternative plans with their doctors.

Janet Woodcock, director of  FDA’s center for Drug Evaluation and research, stated, “The FDA will not allow manufacturers to put the public’s health at risk. These unapproved new drugs have not undergone FDA review for safety and efficacy and may pose potential health risks.”

John LaRocca, Actavis’s chief legal officer, said, “We have been working with the FDA to address compliance issues at the Totowa facilities. We have an entirely new management team in place at Little Falls, [New Jersey], and have invested significantly to reinforce systems and procedures intended to better ensure robust, sustainable compliance. This agreement with the agency is a positive step and is one we have looked forward to reaching. We will continue to work with the FDA to show that we have addressed all of the agency’s compliance and manufacturing issues.”

SOURCE: Digitek Recall › FDA awaits Actavis permanent injunction

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

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

Dingell and Stupak’s letter questions not only the FDA’s inspection of the company’s facilities, but if the FDA should have allowed this company to resume its operation, even though it has a history of recalls.

According to PharmTech, Congress wants the FDA to provide documents “on all FDA-regulated products that Acatavis received approval to sell in the United States since January 1, 2003.”

At the end of July, Actavis Totowa decided to voluntarily recall “the retail level of all drug products manufactured at its Little Falls, New Jersey, facility.” This recall took place after the FDA conducted an inspection of the company in April when Digitek was recalled because the pills were double in “the appropriate thickness.” In this third recall, the recalled pills are believed to have contained twice the correct amount of medication.

Digitek is not the only product that Actavis has recalled; in March, Actavis South Atlantic LLC recalled U.S-sold fentanyl transdermal system CII patches. They may have “a fold-over defect,” which may leak fentanyl gel.

The Actavis Group is not only the producer of Digitek but also many other products. According to Actavis’ website, Actavis is “one of the world’s leading players in first-class generic pharmaceuticals.” We will see just how much longer this statement remains to be true.

SOURCE: Digitek Recall › Congress investigates FDA inspection of Actavis

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