Nine lawsuits have been filed against drug companies who mistakenly released several lots of the heart drug, Digitek, which contained double the normal dosage. Several injuries and at least one death are being blamed on the mistake.

What happened?

The heart drug, Digitek, used to treat heart failure and abnormal heart rhythm, was recalled by its manufacturer, Actavis Totowa LLC, earlier this year. The company accidentally produced pills that were double the ordinary thickness and strength and didn’t catch the mistake until the pills were already released into the market. The double strength dosage poses a serious risk of digitalis toxicity, which can cause nausea, vomiting, dizziness, low blood pressure, cardiac instability, bradycardia and death. Nine lawsuits have reportedly been filed against the company and its distributors.

Who’s involved?

There are three companies that may be involved in the litigation: Actavis Totowa LLC, a division of Actavis Group located in Iceland, who manufacturers Digitek in its New Jersey plant; Mylan Laboratories Inc of Pennsylvania who distributes Digitek, but under the name Bertek and UDL Laboratories Inc. of Illinois who distributes Digitek, but under its own name. Actavis Totowa was sent a warning by the U.S. Food and Drug Administration (FDA) two years ago about lax safety procedures.

Details of the FDA warnings

The FDA sent Actavis Totowa a letter in 2006 warning it about safety procedures that included:

• Six potentially serious and unexpected adverse drug events dating back to 1999 for products such as Digoxin [Digitek] … that were not reported to the FDA.
• Two cases where the patients’ adverse experiences had not [been] resolved when your firm received the initial reports, and in one case where only minimal case information concerning a fatal adverse event had been initially reported to your firm, there were no follow-up investigations.

It is unknown if the FDA has taken any further steps to investigate the company’s procedures. To view the letter, go to: http://www.usrecallnews.com/FDA-Letter-Digitek.pdf

If you’ve been injured by Digitek, contact an attorney whose practice focuses in this area of the law. Consultations are free, without obligation and strictly confidential. To contact an experienced attorney to discuss your situation, please click here. We may be able to help.