"Levaquin is administered in infants as young as six months, but is usually used in adults 18 or over," Stewart says. "People who have had an organ transplant are more at risk of experiencing side effects than people who have not. People who have kidney or liver disease are more at risk of experiencing side effects than people who do not. But, even people who are otherwise healthy may be at risk of experiencing side effects."
Those side effects Stewart speaks of include tendon ruptures, for which Levaquin now carries a black box warning label.
"Levaquin has been affirmatively linked to an increased risk of ruptures, tears and disorders that lead to permanent damage to the tendon," Stewart says. "The most commonly affected tendon is the Achilles, which runs from the heel to the calf, but there are also confirmed reports of tendon ruptures in the shoulders, biceps, hands and thumb."
Currently, according to Stewart, there are approximately 750 lawsuits regarding Levaquin in federal court and approximately 570 lawsuits pending in state court. Those federal lawsuits have now been consolidated into a multi-district litigation (MDL). The first bellwether case—a case from the MDL to be tried individually to give attorneys on both sides an indication of how juries will view the evidence presented and what damages could be awarded—is expected to go to trial in early November 2010. The results of the bellwether case can help determine whether a settlement will occur, although a settlement could occur at any time.
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Patients who suffered serious injuries may consider opting out of the MDL and bringing their case in state court, where the laws of their state would allow such an action, Stewart says.
Although there are other side effects linked to Levaquin, it is the increased risk of tendon ruptures that is the focus of the lawsuits.
"Tendon rupture was an undisclosed risk of the drug," Stewart says. "Patients should be able to make an informed consent about using the drug. The manufacturer didn't tell patients tendon rupture could occur, so they couldn't properly evaluate the cost-benefit of the drug. Patients were denied informed consent and meaningful choice."