› $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.
Another prescription heart medication has been pulled from the market because some pills have been found to be oversized. Those oversized pills may contain slightly higher levels of the active ingredient than specified, according to the Food and Drug Administration (FDA), which issued the alert.
Watson Pharmaceuticals, Inc., announced the voluntary recall of Propafenone HCL 225 mg tablets sold in 100-count bottles in the United States. The affected tablets were sold to customers between October 15, 2008 and November 26, 2008. No other strengths or lots were affected and the company does not anticipate any product shortages as a result of this recall.
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.
John Anthony Conte of Madison County, Kentucky, filed a Digitek lawsuit against a West Virginia pharmaceutical company, Mylan Pharmaceuticals, for his wife’s estate. His wife is believed to have died after taking Digitek. This suit was filed on October 9, 2008.
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.
A generic form of digitalis – a heart drug – has been recalled in an unusual action that requires pharmacists to personally notify all customers who have purchased it.
Doctors prescribe the drug, Digitek, to treat heart failure and abnormal heart rhythms.
Actavis Totowa, a Totowa, N.J., manufacturer, recalled Digitek after consulting with the Food and Drug Administration. Actavis makes Digitek for Mylan Pharmaceuticals of Pittsburg, Pa.
Actavis counsel John LaRocca said the company recalled Digitek after at least one pill emerged from the manufacturing process at double the appropriate thickness. An FDA statement said: “These tablets may contain twice the approved level of active ingredient than is appropriate.”
Double-strength tablets could lead to toxic levels of digitalis in patients with renal failure.
“We had some concerns about the process,” LaRocca said. He said the company knew of no deaths linked to Digitek use but Actavis and the FDA had received 11 complaints about side effects since 2006.
Actavis has asked pharmacists to instruct consumers to return all unused Digitek pills and to consult their physicians. While recalls often result in the removal of drugs from pharmacy shelves, consumers seldom receive personal notification.
At North Shore Pharmacy in Huntington, supervising pharmacist Ron Wood said, “We never keep the generic [Digitek] in stock, so it [the recall] doesn’t apply.”
Joel Bassuk, pharmacist at Raindew Pharmacy in Manhasset, said he received the recall notice yesterday but he only has about five customers who use the drug.
“They said to immediately examine your inventory and discontinue all lots,” Bassuk said, noting he has had no reports of adverse side effects.
CVS spokesman Mike DeAngelis said the chain had removed all Digitek from its stores. “We went back to see which patients had prescriptions over the past 12 months and contacted them,” DeAngelis said.
SOURCE: Newsday
