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› $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.
Caraco Pharmaceutical Laboratories has alerted the Food and Drug Administration (FDA) and is issuing a consumer-level recall of all tablets of the generic medication Caraco brand Digoxin, USP, 0.125 mg, and Digoxin, USP, 0.25 mg, distributed prior to March 31, 2009, which are not expired and are within the expiration date of September, 2011. The drugs are being voluntarily recalled. The tablets may differ in size and could contain more or less of the active ingredient, digoxin.
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.
Actavis Inc. has signed a proposed consent decree agreeing to fix the manufacturing problems at its New Jersey plant where it produced and sold the heart drug, Digitek, a brand of digoxin, according to the Canadian Medical Association Journal.
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.
Two subsidiaries of KV Pharmaceutical, ETHEX Corporation and Ther-Rx Corporation, have issued an update to an announcement issued just days earlier, expanding even more on a long list of generic drug products recalled at the wholesale or retail levels. This new release includes the nationwide recall at the wholesale level of prescription prenatal and iron supplements.
ETHEX Corporation has expanded two previous voluntary recalls initially issued in 2008 to include more than 60 generic drug products at either the wholesale level or retail level as a safety precaution. The generic products may have been manufactured under conditions that “did not sufficiently comply with current Good Manufacturing Practices,” according to a press release issued by the FDA.
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.
Nicholas Chandler, a 23-year-old resident of Alabama, died after consuming Digitek (Digozin) on Jan. 9, 2009. His doctor prescribed Digitek (Digozin) in order to correct his heart condition that could not be corrected by other medications. Chandler suffered toxicity after taking the medication.
Chandler’s wife Barbara Chandler deems the defendants negligent because Digitek was distributed to the public with twice the amount of the active ingredient, according to the West Virginia Record.
The paper reports, “Digitek (Digozin) has a narrow therapeutic index and has a limited margin between effectiveness and toxicity. Chandler, as administratix of the estate is seeking judgment, jointly and severly, (sic.) from all defendants, pre and post judgment interest and costs.”
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