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Strategies & Market Trends : John Pitera's Market Laboratory -- Ignore unavailable to you. Want to Upgrade?


To: John Pitera who wrote (9310)5/9/2008 9:03:42 PM
From: John Pitera  Read Replies (1) | Respond to of 33421
 
MYL--Update--- Down 8.35% today and about 15% since I recommended shorting it a week ago. More downside left it this one... imo...... the scale of this problem is most likely going to increase some more...Drop the Hammer on this irresponsible company, they came very close to killing my father in front of my very eyes.

(Be sure to read post I am responding too!!!!)

John

__________________________________

Check out huge Volume in MYL and

May 9, 2008, 2:41 pm
Patients Sue Icelandic Drugmaker Over Recalled Heart Drug
Posted by Heather Won Tesoriero
Out goes the drug, in come the lawsuits.

On April 25, Icelandic generic drug maker Actavis recalled its heart drug Digitek, or digoxin, over concerns that some batches of the medicine may have contained tablets that were twice the normal thickness and strength.


Today, two weeks since the recall, a lawsuit seeking class action status was filed against privately-held Actavis, as well as Mylan and its UDL Laboratories unit, which distributed the meds. Plaintiffs are seeking damages over alleged injuries and to cover medical monitoring in case of future health trouble.

There’s been very little information about the scope of the problem with the drug. At the time of the recall, Actavis spokeswoman Hjördís Árnadóttir said the company didn’t know how many bad lots or batches were in distribution. The company learned of the problem when one double-strength tablet was found. “The only information we have from the drug companies is from the recall notice,” said Michael Weinkowitz, a plaintiffs’ attorney with Levin, Fishbein, Sedran & Berman, which filed the suit in U.S. District Court in New Jersey. “It fails to advise the public to the real extent” of the problem, the lawyer said.

In announcing the recall, Actavis said the double-strength tablets pose a risk of toxicity in patients with renal failure. The right amount of digoxin can strengthen a weak heart and calm fluttering heart beats. Too much digoxin can make you nauseous, depress your blood pressure, slow down your heart rate or kill you.

Actavis said it has received several reports of illnesses and injuries. The plaintiffs include a woman who alleges she experienced “changed cardiac symptom episodes of nausea, and dizziness” from her Digitek consumption. Another plaintiff alleges he may have suffered serious personal injuries, including kidney damage.

According to the lawsuit, the FDA issued a warning letter back in August 2006 for failing to provide periodic safety reports at its oral dose manufacturing plant in Little Falls, N.J. The suit alleges that some of the faulty generic Digitek came out of that plant. The suit also claims that an FDA inspection in early 2006 revealed six potentially serious and unexpected adverse drug events dating back to 1999 for products that included generic Digitek, that weren’t reported to the agency. A Mylan spokesman said, “Since Actavis is the manufacturer and they initiated the recall, we believe they will be responsible for all costs associated with it, including the litigation.” The Health Blog contacted Actavis’s Árnadóttir today, and she declined to comment on the suit.

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