Three drug companies involved with the manufacturing and
distribution of the recalled heart drug, Digitek, will soon face lawsuits
stemming from alleged injuries associated with the medication. A voluntary
recall was issued for Digitek on April 25 because some tablets contained twice
the appropriate level of the active ingredient. Plaintiffs’ attorneys claim
that the flawed medications led to serious injury and even death in some cases.
Digitek is used to treat heart failure and irregular heatbeats, but an overdose
of the medication can lead to cardiac arrest.
“It was supposed to treat the symptoms of congestive
heart failure, and the tragic thing is that it turned around and caused
congestive heart failure in some cases,” said Charleston lawyer James
Peterson, one of the attorneys involved in the case.
Digitek, is manufactured by New Jersey based Actavis Totowa,
and is distributed by Mylan Pharmaceuticals and UDL Laboratories. A class
action lawsuit has been filed in the U.S. District Court in New Jersey against
the three companies.
At the time of recall Actavis was aware of 11 cases of
illness involving patients that took the erroneously manufactured medication,
but was not aware of any deaths. A 2007 letter from the FDA to Actavis, based
2006 inspections, stated that “significant deficiencies were found in the
operations of your firm’s quality control unit.”
Plaintiffs’ attorneys will argue that the company had been
made aware of quality control issues and chose not to address them adequately,
and in turn placed the lives of the consumers of their medications at risk.