Digitek® (Digoxin) Lawsuit | 2025 Latest Updates

Digitek® Lawsuit Overview

Digitek® lawsuits stemmed from manufacturing defects that resulted in double-thickness tablets containing twice the approved level of active ingredient. These defective Digitek® tablets, manufactured by Actavis Totowa LLC, posed serious health risks to patients, particularly those with renal failure. The FDA classified this as a Class I recall, the most serious type of recall, as the defective medication could cause serious health consequences or death. Hundreds of patients reported adverse events related to digitalis toxicity after taking the medication.

Latest Digitek® Lawsuit Updates

March 27, 2025 – In 2008, Actavis Totowa recalled Digitek tablets after discovering that some contained double the intended dosage, leading to concerns over digitalis toxicity, particularly among patients with kidney issues.

November 7, 2024 – A legal judgment related to Digitek lawsuits addressed product liability concerns, marking an important development in the ongoing litigation over defective tablets.

FDA Reports and Statistics

The FDA classified the Digitek® recall as a Class I recall, indicating a situation where there is a reasonable probability that the use of the product will cause serious adverse health consequences or death. According to FDA data:

• Multiple adverse event reports were filed through the MAUDE database in 2008
• Reports included cases of digitalis toxicity, requiring hospitalization
• The FDA issued safety communications warning patients and healthcare providers about the potential for double-strength tablets
• 100% of distributed Digitek® lots were subject to the recall action

Digitek® Injuries & Side Effects

Patients who took double-strength Digitek® tablets reported a range of serious side effects related to digitalis toxicity:

• Cardiovascular Effects: Cardiac instability, bradycardia (slow heart rate), and abnormal heart rhythms
• Gastrointestinal Effects: Severe nausea, persistent vomiting, and abdominal pain
• Neurological Effects: Dizziness, confusion, blurred vision, and headaches
• Systemic Effects: Low blood pressure, fatigue, and in severe cases, death

Do You Qualify for a Digitek® Lawsuit?

You may qualify for a Digitek® lawsuit if:

• You used Digitek® (digoxin tablets) prior to the 2008 recall
• You experienced symptoms of digitalis toxicity including nausea, vomiting, dizziness, low blood pressure, cardiac instability, or bradycardia
• Your symptoms required medical treatment or hospitalization
• You can provide medical documentation linking your injuries to Digitek® use

Evidence Required for a Digitek® Lawsuit

To strengthen your Digitek® lawsuit, you'll need to provide:

• Medical records documenting your Digitek® prescription and subsequent health complications
• Pharmacy records confirming you received medication from the affected lots
• Documentation of any communication from your pharmacy regarding the recall
• Medical opinions linking your health issues to digitalis toxicity

Damages You Can Recover

Successful Digitek® lawsuits may provide compensation for:

• Medical expenses related to treatment of digitalis toxicity
• Lost wages due to inability to work during recovery
• Pain and suffering caused by medication side effects
• Punitive damages against the manufacturer (in cases of gross negligence)

Digitek® Recall Information

The Digitek® recall involved:

• Recall Date: The recall was initiated in April 2008, with the official notification to healthcare professionals on April 28, 2008
• Classification: The recall was classified as a Class I recall, which is the most serious type, indicating that the product defect could cause substantial injury or death
• Products Affected: All lots of Digitek (digoxin tablets, USP, all strengths) were affected by the recall
• Manufacturers: The manufacturer involved was Actavis Totowa LLC
• Distributors: The products were distributed by Mylan Pharmaceuticals Inc. under a "Bertek" label and by UDL Laboratories, Inc. under a "UDL" label
• Reason for Recall: The recall was initiated because some tablets may have been twice the usual thickness, potentially containing twice the approved level of active ingredient, which posed a risk of digitalis toxicity

Statute of Limitations for Digitek® Lawsuits

Most Digitek® lawsuits were subject to state-specific statutes of limitations ranging from 1-3 years from the date of injury or discovery of injury. With the 2010 settlement, the litigation has largely concluded for affected patients who took action during the appropriate time frame.

FAQs

1. What specific manufacturing defect led to the Digitek® recall?

The manufacturing defect involved tablets with double the appropriate thickness that contained twice the approved level of active ingredient (digoxin), putting patients at risk for digitalis toxicity and other serious complications.

2. How did patients discover they received defective Digitek® medication?

Patients typically received phone calls from their pharmacist and/or letters from their pharmacy advising them of the recall. Some patients discovered the issue after experiencing unexpected side effects and seeking medical attention.

3. What was the outcome of the Digitek® multidistrict litigation?

The Digitek® multidistrict litigation (MDL) was resolved in September 2010 with a comprehensive settlement that addressed all outstanding state and federal lawsuits related to the defective medication.

4. Who manufactured the defective Digitek® tablets?

Actavis Totowa LLC, a United States manufacturing division of the international generic pharmaceutical company Actavis Group, manufactured the defective Digitek® tablets.

5. What is digitalis toxicity and what are its symptoms?

Digitalis toxicity occurs when there is too much digoxin in the body. Symptoms include nausea, vomiting, dizziness, low blood pressure, cardiac instability, bradycardia (slow heart rate), and in severe cases, death.

6. Were there any deaths attributed to defective Digitek® tablets?

While the exact number is not specified in the provided information, the FDA classified the recall as Class I, indicating potential for serious health consequences or death, suggesting that fatalities may have occurred.

7. How did the Digitek® settlement compensate affected patients?

The settlement provided compensation based on the severity of injuries sustained, medical expenses incurred, and other damages. The specific terms and amounts of the settlement were not publicly disclosed.

Take Action Now: Time-Sensitive Legal Claims

Time is limited to pursue legal action related to Digitek® injuries. While the main litigation was resolved in 2010, some patients may still have legal options depending on their specific circumstances and state laws.

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