› $4.85 Billion settlement in drug case
Two lawsuits were recently filed against Mylan Pharmaceuticals Inc., Actavis Group, Actavis Totowa LLC, Mylan Bertek Pharmaceuticals Inc., and UDL Laboratories Inc., makers and distributors of the heart medication Digitek, also known as digoxin, on behalf of patients who took Digitek prescribed by their physicians and as a result suffered complications and died, according to the West Virginia The Record.
Linda Weadock, on behalf of her deceased husband George Weadock, and Willie Criss and Frank Heppel, have filed a $5 million product liability lawsuit against drug maker Actavis and drug distributor Mylan Pharmaceuticals, claiming their heart medication Digitek contained more than twice the active ingredient and caused serious injury or death.
Individuals suing manufacturers of Digitek heart medicine must fill out lengthy and detailed fact sheets on their medical history and allow no secrets from their past, according to The West Virginia Record.
The fact sheets will be used in court to determine whether Mylan Pharmaceuticals of West Virginia, Actavis US and DUL Laboratories misrepresented Digitek as safe and whether physicians and patients relied on those “misrepresentations and deceptions” in choosing to use the heart medicine.
Wim Michna understood the power of medicine. He was a physician in Marin County, California. In the early 2000s, he received an arterial bypass and shortly thereafter was prescribed Digitek, also known as digoxin, by his personal doctor to strengthen and regulate his heartbeat. He remained on the medication for two years until another doctor advised him to stop. While taking the medication, Dr. Michna’s kidneys failed and he suffered from heart palpitations, dizziness, weakness and other symptoms that made another physician order a blood test. The test revealed what the symptoms were alluding to – that Dr. Michna was suffering from the ill effects of digoxin poisoning. The level of digoxin in his body was several times higher than the maximum allowable. It was too late to save him. Dr. Michna died just months after the toxicity was identified. He was 80.
A woman from Texas claims that her husband died in January 2007 as a result of his Digitek medication containing twice the active ingredient. On Jan. 23, 2008, Vickie Butts, representing the estate of her deceased husband, Donnie Butts, filed a product liability lawsuit against Actavis, the drug manufacturer, and Mylan, the distributor.
Actavis Inc. has made an agreement with the FDA not to issue any drugs from its Totowa facilities in Morristown, N.J., where Digitek is produced.
According to the Philadelphia Inquirer, the agreement says Actavis cannot resume its practices until it conforms to “the agency’s good manufacturing practice.” Actavis must improve its labs, facilities, and equipment.
Actavis has faced numerous lawsuits over the recalled drug Digitek. One such lawsuit includes the death of a patient and claims that Digitek is an unsafe and flawed drug.
Actavis would not comment if the FDA agreement had influenced the Digitek lawsuits or not.
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According to Huntington News, the United States Judicial Panel on Multidistrict Litigation (MDL) has ordered that all federal lawsuits about the double strength, defected Digitek be transferred to the U.S. District Court for the Southern District of West Virginia. This development in the lawsuit is taken as a result of the April 2008 recall on Digitek. Some tablets were twice as thick as usual, made with the double amount of medication.
Attorneys who take on the pharmaceutical industry as a voice for consumers injured by medications found an unlikely ally this week, in doctors. Noting that the U.S. Food & Drug Administration is often “overwhelmed” by drug safety problems ranging from serious side effects to unsafe manufacturing facilities, editors of the New England Journal of Medicine said patients benefit from information uncovered by attorneys during liability investigations, according to an Associated Press report released Friday.
Journal editor Dr. Jeffrey M. Drazen says the litigation process and the court system is a “key defense mechanism” to insure drug safety and to obtain justice if drug manufacturers have not made the risks involved with its product clear.
The doctors say the FDA is incapable of being the sole guardian of drug safety and that without the information supplied by liability litigation, “the American public would be deprived of a vital deterrent against pharmaceutical company misconduct.”
The opinion was submitted to the Supreme Court as a friend-of-the-court brief in the matter of Wyeth v. Levine, a case expected to be heard later this year. According to the AP story, the case involves Diana Levine, a guitarist who lost her right arm below the elbow after an injection of Phenergan. She sued the drug’s manufacturer, Wyeth, alleging the company had not adequately warned consumers of the risks associated with its product. The case was tried in Vermont, and the court agreed, awarding Levine $7 million.
Wyeth is appealing the case, saying the FDA had approved the drug, and that the state court could not overrule the FDA’s judgment.
However, the editors of the New England Journal of Medicine sided with 47 state attorneys general and two former FDA commissioners in supporting Levine’s position, the AP report states.
