Suit over Digitek alleges heart drug contained too much digoxin

Michelle Massey, East Texas Bureau Jan. 27, 2009, 3:45am

TEXARKANA, Texas – A Texas woman claims her husband's heart medication Digitek contained more than a double dose of the active ingredient, causing his death in January 2007.

Vickie Butts, individually and as estate representative of Donnie Butts, filed the product liability lawsuit against drug manufacturer Actavis and distributor Mylan on Jan. 23 in the Texarkana Division of the Eastern District of Texas.

Digitek, generically known as digoxin, is used to treat various heart conditions, including atrial fibrillation, atrial flutter and congestive heart failure.

According to the original complaint, just a year after acquiring the business of manufacturing Digitek, the defendants received a warning from the U.S. Food and Drug Administration that they had failed to provide periodic safety reports from its solid oral dose manufacturing facility. Failure to provide these safety reports violated its adverse medical event reporting obligations.

The August 2006 FDA letter also warned defendants they were marketing drugs without proper clearance and that there had been at least 26 adverse drug experiences that went unreported, the complaint states.

The FDA sent a revised letter in February 2007 that stated, "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."

On April 25, 2008, the drug's manufacturers issued a voluntary recall of all lots of Digitek, due to a possibility that the drug was released with more than the approved level of the active ingredient.

The complaint states that an excessive amount of digoxin can produce dizziness, cardiac instability, low blood pressure, and other immediate as well as long-term health problems.

According to the complaint, "The Recalled Digitek was adulterated, misbranded, defective, unreasonably dangerous and unfit for its intended use."

Further the plaintiff argues that the "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."

The plaintiff claims the drug's manufacturers should have known and warned that the drug was defective but instead failed to timely warn of this defect and misrepresented the drug as "a safe and effective treatment for certain heart problems."

Causes of action filed against Actavis and Mylan Pharmaceutical include 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.

The plaintiff claims the defendants are liable for fraud by nondisclosure, specifically for failing to disclose some of the Digitek's post-marketing complaints.

The complaint alleges the defendants were aware that their conduct posed a high risk of harm but "negligently, recklessly, gross negligently, wantonly and willfully displayed a morally culpable and conscious disregard of the rights of others."

On behalf of the deceased, the plaintiff is seeking damages for conscious pain and suffering, physical injury, pain and suffering, loss of income, loss of opportunity, loss of family and social relationships, and medical, hospital, and surgical expenses.

The plaintiff is also seeking 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.

The plaintiff is seeking a jury trial.

Texarkana attorney Jack N. Boyd Jr of the law firm Boyd, Poff and Burgess LLP is representing the plaintiff.

U.S. District Judge David Folsom is assigned to the litigation.

In August 2008, all Digitek lawsuits were consolidated into a multi-district litigation (MDL- 1968) in the U.S. District Court of the Southern District of West Virginia for pre-trial proceedings.

Case No 5:2009cv00007

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