Dangerous Drug - Digitek

The drug company Actavis Totowa LLC has initiated a Class 1 nationwide recall of Digitek (digoxin tablets, USP, all strengths) for oral use. The products, manufactured by Actavis, are distributed by Mylan Pharmaceuticals, Inc. under the "Bertek" label and by UDL Laboratories, Inc. under the "UDL" label.

The recall was issued on April 25, 2008.

Actavis realled Digitek due to the possibility that some tablets with double the appropriate thickness may have been commercially released. These tablets may contain TWICE the approved level of active ingredient than is appropriate.

Digitek is used to treat heart failure and abnormal heart rhythms. According to the FDA, the existence of DOUBLE strength tablets poses a risk of digitalis toxicity in patients with renal failure. Ditigalis toxicity can cause nausea, vomiting, dizziness, low blood pressure, blurred vision, cardiac instability and bradycardia. Death may also result from excessive Digitalis intake. Several reports of illnesses and injuries have been received by the FDA.

Digitek users who suffered serious injuries as a result of this manufacturing error may be entitled to monetary damages. Our law firm is actively investigating these claims and encourages Digitek users or their families, in the case of a death, to contact our office for a free, confidential legal consultation.

The Bernstein Law Firm has experience in pharmaceutical liability claims. Currently, our law firm is representing Vioxx patients who were injured as a result of a failure of Merck to warn patients regarding risks associated with this drug.

It is important to recognize that claims related to Digitek are not prohibited under the draconian Michigan drug shield law; often referred to as the "drug immunity" law. Digitek cases (along with another current potential cause of action involving Baxter Heparin) involve the negligent MANUFACTURE of a drug - not a failure to warn. "Failure to warn" claims involve FDA approval and therefore may be prohibited under Michigan law. These claims may also be prohibited under the expanding application of the pre-emption doctrine by the United States Supreme Court.

The negligent manufacture claim simply states that, despite FDA approval, the drug was not manufactured properly. The approval by the FDA is irrelevent. The Digitek claim will likely claim that the drug company simply did a bad job making the drug. The resulting errors/mistakes caused the double dosage and resulting injuries.

The Digitek episode raises, once again, the serious issue about the FDA and the government's ability to keep us safe.