The maker of <"http://www.yourlawyer.com/topics/overview/digitek_recall">Digitek will pay $13 million to settle lawsuits over the defective heart drug. Actavis Totowa, a division of Iceland-based Actavis Group hf, recalled Digitek tablets in 2008, because of concerns they might have been oversized, and could expose patients to a dangerously high level of the drugâ€™s active ingredient, digitalis.
According to a Bloomberg News report, Actavis agreed in September to create a $10 million settlement fund as a base and add as much as $3 million more if 98 percent of people with Digitek claims participate in the settlement. Enough consumers already have taken part to push the settlement amount to $12 million, the report said.
The settlement would resolve as many as 3,000 lawsuits stemming from the Digitek recall. The lawsuits claim Actavis failed to warn consumers that Digitek was defective. The settlement, which also settles claims against drug maker Mylan Inc. over its marketing of Digitek, provides an average recovery of at least $4,000 each for consumers who took the defective drugs, Bloomberg said.
Digitalis medicines strengthen the force of the heartbeat by increasing the amount of calcium in the heartâ€™s cells. When the medicine reaches the heart muscle, it binds to sodium and potassium receptors. These receptors control the amount of calcium in the heart muscle by stopping the calcium from leaving the cells. As calcium builds up in the cells, it causes a stronger heartbeat. Digitalis medicines also control irregular heart rhythms (called arrhythmias) by slowing the signals that start in the sinoatrial (SA) node. This, in turn, reduces the number of signals that travel through the atrioventricular (AV node). Fewer signals mean fewer arrhythmias.
The US Food & Drug Administration (FDA) deemed the 2008 Digitek recall a Class I recall, meaning that the defective Digitek tables could cause serious health problems or death. A double-strength Digitek tablet poses a serious risk of digitalis toxicity in those patients suffering from renal failure. Digitalis toxicity can cause nausea; vomiting; diarrhea; dizziness; confusion; loss of appetite; low blood pressure; cardiac instability and irregular pulse; heart palpitations; and bradycardia, a slower than normal heartbeat rate.