Digitek is a medication widely used to treat heart conditions that cannot be controlled by other medications. Incorrect dosing of the medication can be dangerous, and sometimes fatal. In April 2008, Digitek’s manufacturers issued a nationwide recall because the pills contained twice the amount of the active ingredient. The oversized pills posed a serious risk of digoxin toxicity especially in patients with renal failure.

On behalf of her husband, Rosina Michna has filed a lawsuit alleging medical negligence against the doctor who initially prescribed Digitek but didn’t monitor his blood levels. She also is suing the numerous pharmaceutical companies involved in the manufacture, marketing and distributing of Digitek for negligence, according to the Marin Independent Journal.

An initial hearing of the lawsuit is set for April 27, 2009.

SOURCE: Digitek Recall › Widow files suit against doctor, pharmaceutical companies

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