Digitek Double-Trouble: Getting to the Heart of the Matter

Talladega, ALAs heart patients continue to reel over the reality that they may have been unwittingly poisoning themselves, and putting their lives at risk by taking Digitek tablets, the lawsuits continue to roll in.

One of the latest involves a couple from Talladega, Alabama—home of the famous Talladega Motor Speedway—who, in late July, filed what became the first federal lawsuit in the State of Alabama over the alleged failure of Actavis Totowa, the manufacturer of the Digoxin tablets, to provide a safe product with consistent dosing levels.

Bobbie Dyal, who together with her husband Robert filed a lawsuit July 17th in Birmingham Federal court, claims to have suffered permanent heart damage after taking a series of Digitek tablets that contained more digoxin than the labels suggested.

The situation serves as an invitation to digitalis toxicity, a serious and potentially lethal condition that results from too much digoxin in the bloodstream—and the margins can be very narrow. In other words, it is possible for a patient to progress from an unnecessarily high level of digoxin in the bloodstream, to a situation that could be potentially lethal, as quickly as a week.

Symptoms of digitalis toxicity include nausea, vomiting, diarrhea, dizziness, confusion, loss of appetite, low blood pressure, cardiac instability and irregular pulse, heart palpitations, and vision changes such as halos or light rings around objects. Patients suffering digitalis toxicity can also experience excessive nighttime urination, or difficulty breathing when lying down.

According to documents filed with the court, Dyal began having symptoms March 21st and was airlifted to hospital, where she remained until May 5th. The resulting damage to her heart, which the Dyals attribute to Digitek, required surgery for the installation of a pacemaker.

Digoxin helps to strengthen the heart and is commonly prescribed for a host of heart conditions including atrial fibrillation, atrial flutter and heart failure. The US Food and Drug Administration (FDA) strictly regulates how much digoxin is allowed in a single tablet for reasons of safety, not the least of which is the aforementioned narrow therapeutic index, which suggests a limited margin between effectiveness of digoxin, and digitalis toxicity.

Needless to say, doctors were alarmed to hear about the Class 1 recall triggered by Actavis Totowa earlier this year due to a possible manufacturing defect inherent with the tablets. Digitek tablets were found to be double in size, and contained a corresponding double dose of digoxin—a situation that would result if two single tablets containing the correct dose of digoxin were mashed together in the manufacturing process.

The result would have been tablets which not only contained a larger dose of digoxin than was reflected on the product labeling, but would have contained levels of digoxin considered unsafe for human consumption.

Actavis Totowa LLC, the manufacturer of Digitek, issued a voluntary recall of all lots of Digitek digoxin tablets sold under the commercial names Bertek and UDL Laboratories on April 25th after "the possibility tablets with double the appropriate thickness may have been commercially released."

That recall came too late for Dyal, who was injured several weeks prior. And there have since been a host of horrifying stories of parents arriving to see their loved ones on the bathroom floor, having been felled by digoxin toxicity in short order. It should be noted that not every senior, or client of Digitek due to a heart condition, lives in a nursing home or chronic care facility. Many seniors are fiercely independent and value that freedom. So long as they are in good health and are taking their meds, many seniors are allowed to enjoy the independence they crave—with, of course, regular contact with friends or loved ones.

Digoxin is such a common medication used to aid the heart, that most would not give a passing thought to the possibility that something might be wrong with the medication.
Additionally, due to the rapid ascension to digitalis toxicity, Digitek consumers could be forgiven for assuming that painstaking checks and balances would be locked into place at the manufacturing level.

However, that does not appear to be the case at Actavis Totowa, which has been cited in the past for manufacturing deficiencies. Previous inspections by the FDA have uncovered lapses in so-called good manufacturing practices, which the manufacturer promised it would rectify in short order.

It has been alleged that these deficiencies may not have been properly addressed, given the circumstances that led to the Class 1 recall of double-strength, double-size Digitek tablets which can, and allegedly has, resulted in injury and premature death.

The Dyal suit blames Actavis for failing to heed FDA warnings in July and August of 2006 and February of 2007, that many of the drug products that were manufactured and released to the public by Actavis were compromised and as a result the drugs were not "the identity, strength, quality and purity they purport to possess," according documents filed with the court.

The suit charges the drug maker knew, or should have known about the manufacturing defects and that the recalled Digitek was adulterated, misbranded, defective, unreasonably dangerous and unfit for its intended uses. The lawsuit claims that "Despite the undeniable knowledge, Actavis placed tens of thousands of patients, including our client, unnecessarily at risk of catastrophic injury and death."

Those close to the situation expect the flood of lawsuits to continue.