Digitek Lawsuit

What is Digitek?

Digitek, which is the brand name of Digoxin Oral, is used to treat heart failure and abnormal heart rhythms. Digitek works by helping bolster the heart’s strength to maintain a healthy heart rate. Digitek, because of its side effects, was recalled by the United States Food and Drug Administration in 2008.

Digitek Side Effects:

Digitek side effects may form regardless of your adherence to intake instructions, dosage strengths or frequency of use. Please tell your doctor if any of these Digitek side effects are persistent or severe:

· Common Digitek Side Effects Include: lightheadedness or dizziness; drowsiness; vision changes; rash; irregular heartbeat.

Some Digitek Side Effects are regarded as severe. If you experience any of the following Digitek side effects, please contact your doctor immediately:

· Serious Digitek Side Effects Include: vomiting; diarrhea; loss of appetite; upset stomach; swelling of the hands or feet; unusual weight gain; difficulty breathing.

If you experience serious Digitek Side Effects, you or your doctor may file a report with the United States Food and Drug Administration’s MedWatch Adverse Event Reporting program online at http:www.fda.gov/Safety/MedWatch or via phone at 1-800-332-1088.

Another Digitek side effect—one that prompts the bulk of Digitek lawsuits—is Stevens - Johnson syndrome. This Digitek side effect is regarded as a severe, potentially fatal medical condition caused by allergic reactions to Digitek and other pharmaceutical drugs. Stevens-Johnson Syndrome affects the skin and mucus membranes; early symptoms of the condition include flu-like symptoms and the presence of painful rashes and blisters.

Digitek FDA Regulations:

The United States Food and Drug Administration issued a class I recall on Digitek—the most stringent FDA regulation—in April 2008. This Digitek FDA regulation was formalized in response to reports of severe Digitek side effects linked with faulty manufacturing –the Digitek regulation was instituted because the FDA discovered that a significant amount of Digitek pills were manufactured with twice the recommended strength.

The Digitek FDA regulation (recall) was issued in response to reports of Digitek toxicity affecting users taking the prescribed or normal dosage. The recalled Digitek pills contained twice the amount of digoxin, yielding the potential for overdose and the presence of the aforementioned Digitek side effects.

The Digitek FDA regulation was put into effect on April 28th of 2008. The FDA, on this day, notified healthcare professionals of a Class nationwide FDA recall of all forms of Digitek. The products, which were created by Actavis and distributed by Mayan Pharmaceuticals, were recalled because the tablets contained twice the approved level of the active ingredient. The existence of double-strength Digitek tablets poses significant risks of digitalis toxicity in patients with renal failure. Digitalis toxicity may cause vomiting, nausea, dizziness, cardiac instability, bradycardia and low blood pressure.

Digitek Lawsuits:

The bulk of Digitek lawsuits seek remuneration for the above Digitek FDA regulation. If you or a loved one has developed an illness or injury because of the increased strength tablet, you may file a Digitek lawsuit. Digitek lawsuits are initiated by patients who sustain an injury or illness as a result of treatment with Digitek. To file a successful Digitek lawsuit these individuals must prove that they were not adequately warned by their doctor, pharmacist or manufacturer of said risks. Additionally, to file a successful Digitek lawsuit, the patient must prove that Digitek-use was the primary factor in causing the injury or illness.

Drug manufacturers, before marketing to the public, are responsible for ensuring the efficacy and safety of their products. Failure to affirm safe use is considered negligent and grounds for Digitek lawsuits.

Prominent Digitek Lawsuits:

· A class-action Digitek lawsuit was filed in the St. Clair County Circuit Court in April of 2009 on behalf of 97 people who alleged damage and injuries caused by the aforementioned recalled tablets. This Digitek lawsuit alleges that Actavis failed to properly test the product or protect the public from consuming the extra-dose tablets. The Digitek lawsuits further claim that the company mishandled the Digitek FDA regulation and attempting to conceal the manufacturing mishap. According to reports released by the non-profit Center for Public Justice, roughly 700 Digitek overdose deaths were reported to the FDA between April 2008 and June 2008.

· Nine Digitek lawsuits were filed in the federal court in Newark, New Jersey in July of 2008. These Digitek lawsuits were also filed because of the adverse reactions experienced by patients who took the extra-dose strength Digitek tablets.

· On December 7th of 2010, Actavis was forced to pay at least $12 million in Digitek settlements after a court ruled that the company failed to adequately warn consumers of its defective drug. Actavis, to honor the verdict, agreed to establish a Digitek settlement fund to resolve the 3,000 Digitek lawsuits that comprised the case. The Digitek settlement provided an average recovery of at least $4,000 to each consumer who took the defective drug.

· All pending Digitek lawsuits and future claims filed in the federal court system will be consolidated for discovery purposes in the Southern District of West Virginia before Judge Joseph Goodwin.

Because the Digitek FDA regulation was instituted almost five years ago, the likelihood of filing a new Digitek lawsuit is remote. Securing Digitek settlements, at this time, is only probable if your Digitek lawsuit is pending. This pessimistic outlook derives from the statute of limitations instituted by the local court system.

Claims for Digitek settlements as a result of Digitek side effects or deaths are best made by filing individual Digitek lawsuits. Building on what was previously stated, the applicable statute of limitations will vary from state to state and personal injury statute of limitations is dependent on the type of Digitek lawsuit you are filing. That said, if you feel that you have a legitimate claim for a Digitek settlement, you should contact a pharmaceutical or personal injury lawyer in your area to help facilitate your Digitek lawsuit.

Sources:

1. United States National Library of Medicine “Digoxin Oral” retrieved from: http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0000643/

2. http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm084304.htm