Three Jefferson County residents have filed separate suits against Mylan Pharmaceuticals, alleging they suffered physical pain after they took the prescription drug Digitek, which they claim contained twice the approved level of its active ingredient.
The drug, which is normally prescribed to treat various heart conditions, including atrial fibrillation, atrial flutter and congestive heart failure, was recalled on April 25, according to the complaints filed Feb. 4 in Jefferson County District Court.
The plaintiffs are Herman Barnes, Charles Bond and Imogene McGann.
The suits name Mylan Pharmaceuticals Inc., Mylan Bertek Pharmaceuticals Inc., UDL Laboratories Inc., Actavis Totowa LLC and Actavis Group hf as defendants.
Digitek (Digoxin) has a narrow therapeutic index, and thus has a limited margin between effectiveness and toxicity, according to the suits.
On Aug. 15, 2006, the Food and Drug Administration issued a warning label to defendants for failing to file periodic safety reports at its solid oral dose manufacturing facility in Little Falls, N.J., marketed drugs without proper clearance and causing at least 26 adverse drug experiences by not submitting proper safety reports.
According to the suits, in February 2007 the FDA issued a second warning letter citing "significant deviations from the current Good Manufacturing Practice regulations."
In April 2008, the FDA announced a recall of all lots of Bertek and UDL Laboratoriees Digitek. Class I Recalls are instituted only when there exists a reasonable probability that use of the product will cause serious injury or death. The complaints state that "as of this date, defendants have released little additional information about the recalled drugs."
"Apparently the drug Digitek (Digoxin) contained twice the approved level of the active ingredient," the complaints state. "The existence of double strength poses a risk of digitalis toxicity."
Plaintiffs McGann, Bond and Barnes were prescribed the drug and had been taking it for a period of time, the lawsuits claim.
Because of their extended use of the drug, all three suffered mental anguish, physical impairment and incurred medical expenses, according to the complaints.
They also experienced a loss of earning capacity, the suits state.
Causes of action in the lawsuits include strict products liability, negligence and breach of warranty.
Digitek was placed into the stream of commerce in a condition that was defective and unreasonably dangerous, which is a breach of Mylan's warranty, according to the complaint.
"Defendants placed into the stream of commerce the drug Digitek and recommended its use to physicians, the FDA and consumers without adequately warning physicians, the FDA and consumers including Plaintiff, of the risks associated with the use of the drug and that it contained an amount of digoxin exceeding the labeled dose and sometimes exceeding the approved dose for ingestion," the suits state.
Mylan placed the drug into the stream of commerce when it knew the drug posed a significant risk to the health, well-being and safety of McGann, Bond and Barnes, the suits state.
McGann, Bond and Barnes are seeking actual and exemplary damages, pre- and post-judgment interest, costs and other damages to which he may be entitled.
They are represented by Barry Bennett of Eddins and Bennett in Beaumont and by Michael R. McGown of Benckenstein, Norvell and Nathan of Beaumont.
Bond vs. Mylan Pharmaceuticals, Case No. D183-217
McGann vs. Mylan Pharmaceuticals, E183-218
Barnes vs. Mylan Pharmaceuticals, Case No. B183-219