Two new lawsuits allege that one patient died and another was injured after they consumed a heart drug distributed by Mylan Pharmaceuticals that contained twice the approved amount of the drug.
Two new lawsuits allege that one patient died and another was injured after they consumed a heart drug distributed by Mylan Pharmaceuticals that contained twice the approved amount of the drug.
The lawsuits were filed last week in West Virginia for alleged injuries suffered by patients who took Digitek, also known as Digoxin.
The drug is used to treat various heart conditions, including atrial fibrillation, atrial flutter and heart failure. The drug is designed to help the heart beat and contract more efficiently.
But Digitek "has a narrow therapeutic index, and thus, has a limited margin between effectiveness and toxicity," the lawsuits state.
The damages to patients were caused, the lawsuits allege, because the pills they recently consumed contained "twice the approved level of active ingredient."
The United States Food and Drug Administration set that "approved level."
Tony L. O'Dell, partner in the Charleston firm of Berthold, Tiano & O'Dell, represents both clients. O'Dell said on Friday that the pills they consumed contained twice the federally approved levels of Digoxin.
The suits include:
Bobbi J. Myers, who administers the estate of Elizabeth J. Starr, filed a suit in Kanawha County Circuit Court on Tuesday. Starr died May 5, after "she was prescribed, purchased and ingested Digitek (Digoxin)," the suit states.Melvin L. and Sharon R. Pennington filed a lawsuit in Putnam County Circuit Court on Wednesday, after Melvin "suffered bodily injuries and other damages as a result of his ingestion of recalled Digitek."
Pennington, the suit states, suffered from "dizziness, low blood pressure, cardiac instability, bradycardia and other damages" after taking the drug.
"This risk of death ... will require future diagnostic medical examinations and medical testing," the suits state.
The lawsuits target Mylan Pharmaceuticals, Actavis Totowa LLC, Mylan Bertek Pharmaceuticals and UDL Laboratories Inc.
Two new lawsuits allege that one patient died and another was injured after they consumed a heart drug distributed by Mylan Pharmaceuticals that contained twice the approved amount of the drug.
The lawsuits were filed last week in West Virginia for alleged injuries suffered by patients who took Digitek, also known as Digoxin.
The drug is used to treat various heart conditions, including atrial fibrillation, atrial flutter and heart failure. The drug is designed to help the heart beat and contract more efficiently.
But Digitek "has a narrow therapeutic index, and thus, has a limited margin between effectiveness and toxicity," the lawsuits state.
The damages to patients were caused, the lawsuits allege, because the pills they recently consumed contained "twice the approved level of active ingredient."
The United States Food and Drug Administration set that "approved level."
Tony L. O'Dell, partner in the Charleston firm of Berthold, Tiano & O'Dell, represents both clients. O'Dell said on Friday that the pills they consumed contained twice the federally approved levels of Digoxin.
The suits include:
Bobbi J. Myers, who administers the estate of Elizabeth J. Starr, filed a suit in Kanawha County Circuit Court on Tuesday. Starr died May 5, after "she was prescribed, purchased and ingested Digitek (Digoxin)," the suit states.Melvin L. and Sharon R. Pennington filed a lawsuit in Putnam County Circuit Court on Wednesday, after Melvin "suffered bodily injuries and other damages as a result of his ingestion of recalled Digitek."Pennington, the suit states, suffered from "dizziness, low blood pressure, cardiac instability, bradycardia and other damages" after taking the drug.
"This risk of death ... will require future diagnostic medical examinations and medical testing," the suits state.
The lawsuits target Mylan Pharmaceuticals, Actavis Totowa LLC, Mylan Bertek Pharmaceuticals and UDL Laboratories Inc.
Actavis Totowa manufactured, tested and marketed Digitek pills sold in West Virginia. That company is a New Jersey-based division of the Actavis Group, an international generic pharmaceutical company based in Reykjavik, Iceland.
In West Virginia, Digitek was distributed by: Mylan Bertek, a Texas-based subsidiary of Mylan Pharmaceuticals whose principal place of business is Morgantown, and by UDL Laboratories, based in Illinois.
Actavis Totowa initiated a nationwide recall of Digitek after discovering recently produced tablets, with double the "appropriate thickness," were being sold throughout the country.
Actavis issued a press release on April 24 that stated: "Several reports of illness and injuries have been received.... Retailers who have this product are urged to return the product to their place of purchase. If consumers have medical questions, they should contact their health-care providers."
The extent of medical problems, and deaths, that may have been caused by the Digitek tablets is not yet known.
O'Dell said his law firm received 70 telephone calls after the firm ran public advertisements warning people about the dangers of taking the recently made Digitek tablets.
The pharmaceutical companies being sued, the lawsuits also allege, "have a history of failing to reliably establish the identity, strength, quality and purity of drug products they release for public consumption."
The companies have not yet filed any responses to the lawsuits. Messages left at Mylan offices in Morgantown and at the company's headquarters in Canonsburg, Pa., were not immediately returned Saturday afternoon.
Similar lawsuits have been filed in other states, but they are not related to the two lawsuits in West Virginia.
The lawsuits seek an unspecified amount of compensatory and punitive damages.
To contact staff writer Paul J. Nyden, use e-mail or call 348-5164.
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