Suit alleges Digitek contained double dose of active ingredient

Michelle Massey, East Texas Bureau Nov. 25, 2008, 4:23am

MARSHALL – Already at risk for heart problems from pre-existing health conditions, several East Texas patients allege they began to experience new symptoms after they began taking the prescription drug Digitek.

Plaintiffs Peggy Byassee, Davetta Clark, Aaron Clark, Thomas Clark Jr., Melissa Clark, Altie Clark, Dannie Webster and Opal Horton filed suit against Actavis Totowa LLC and Mylan Pharmaceutical Inc. on Nov 21, 2008, in the Marshall Division of the Eastern District of Texas.

The plaintiffs allege the drug caused symptoms that include shortness of breath, low or irregular heartbeat and low blood pressure.

Manufactured by Actavis and distributed by Mylan Pharmaceuticals, Digitek is prescribed to treat heart failure and abnormal heart rhythm. 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, digoxin.

According to the complaint, "an excessive amount of digoxin can produce dizziness, cardiac instability, low blood pressure and other immediate as well as long-term health problems."

Plaintiff Peggy Byassee took Digitek for approximately eight days before she began experiencing adverse health effects and was hospitalized for two days.

Thomas Clark began taking the drug shortly after being diagnosed with cancer and suffering a heart attack. His family claims the drug caused adverse effects on Clark's heart and blood pressure which limited his doctors from providing certain cancer treatments such as chemotherapy.

Clark died in June 2008, three months after his cancer diagnosis. Although his immediate cause of death was lung cancer, the death certificate also states that "poor condition of his heart had contributed significantly to his demise."

Plaintiff Dannie Webster was prescribed the drug for a heart condition in March 2008 and began experiencing dizziness and chest pain. He was admitted to the hospital for chest pains in April. In May, Webster's doctor changed his drug.

Plaintiff Opal Horton took Digitek for a heart condition for more than a year. In May, her pharmacy informed her of the recall. Horton believes the deterioration of her heart condition is due "wholly or partially to her ingestion of Digitek."

The plaintiffs believe the drug's manufacturers should have known the drug was defective but they 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 negligence, negligence per se, strict liability, breach of express and implied warranty, fraud, and unjust enrichment.

The plaintiffs allege that the defendants are liable for fraud by nondisclosure, for failing to disclose some of the Digitek's post-marketing complaints.

The complaint argues the defendants were aware that their conduct posed a high risk of harm but "proceeded anyway with conscious indifference to the safety of Plaintiffs and others similarly situated."

The plaintiffs are seeking damages for physical pain, mental anguish, physical impairment, medical expenses, including future medical monitoring, loss of earning capacity, loss of consortium, loss of household services, pecuniary loss, loss of companionship, loss of inheritance, funeral expenses and pre- and post-judgment interest.

Marshall attorney Paul W. Turner of The Carlile Law Firm LLP is representing the plaintiffs.

Jury trial requested.

U.S. District Judge T. John Ward will preside over the litigation.

Case No: 2:08cv451

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