Business, Government Legal News from throughout WVCalifornia family appeals federal court Digitek ruling in W.Va.

Plaintiffs claiming a double-dosed Digitek pill caused the death of a family member will bring their case to the 4th Circuit Court of Appeals, following a West Virginia federal court order granting pharmaceutical manufacturers summary judgment.

California residents, Kathy McCornack and sons Daniel McCornack Jr. and Ralph J. McCornack filed the suit in June 2009 against Actavis Inc., Actavis Elizabeth Inc., Mylan Inc., Mylan Pharmaceuticals Inc., Mylan Bertek Pharmaceuticals Inc., and UDL Laboratories.

The McCornacks allege Daniel McCornack Sr., obtained a double thick pill that contributed to his death.

However, the pharmaceutical companies argue the pills would have had to make it past internal processes of the plant, slip by the repackaging process at the distributor's facilities and additionally would have caused machine failure at one of the plants.

Digitek, or Digoxin, is used to control various heart conditions such as atrial fibrillation, atrial flutter and heart failure. According to court documents, Digitek was made in 2003 and recalled tablets were produced in 2006.

"Digoxin itself is tricky to manage, even without other drugs in the mix," U.S. District Judge Joseph Goodwin wrote in an order. "Taking too little has no effect. Taking too much can kill you."

At its peak, 1,053 civil actions were brought against the pharmaceutical manufacturers alleging the double thick tablets hit the market and caused damage to consumers. However, all of those cases except for the McCornacks and one other case either have been settled or dismissed.

The McCornacks say the Food and Drug Administration issued a warning letter to defendants in 2006 for failing to file periodic safety reports at its New Jersey manufacturing facility. 

"According to the FDA's August 2006 warning letter, an FDA inspection in early 2006 revealed that there were six potentially serious unexpected adverse drug events relating back to 1999 for products including Digoxin, that were not properly reported to the agency," the suit stated.

According to the suit, the FDA announced a recall of tablets because of the possibility that tablets contained twice the approved level of active ingredient. For people with renal failure, this means a risk of digitalis toxicity.

In the order, Goodwin noted that McCornack had a long history of atrial fibrillation and had taken Digoxin and Diltizam. However, McCornack did not experience problems with renal functions.

The order additionally stated six of McCornack's Digitek tablets were tested but were all within specifications.

Goodwin entered judgment in favor of defendants in a Nov. 3 judgment order. The family appealed the case Dec. 7.

"There has been no evidence that either of the decedents in those two cases, or their loved ones, ever saw a double-thick Digitek," the order granting summary judgment states. "That is true as well of the pharmacists, nurses and doctors. Some of the plaintiffs still have many untested pills in their possession. The ones they have tested were fine."