Wednesday, June 15, 2011

Bellwether Trails Set Precedent in Levquin Side Effect Cases

Since Levaquin was introduced in 1997, Johnson & Johnson has failed, according to the Levaquin lawsuits filed against Johnson & Johnson, to adequately warn about the risk of tendon ruptures side effects associated with the antibiotic, particularly involving the Achilles tendon. Although a “black box” warning was announced in July 2008 for all antibiotics in the same class, Johnson & Johnson still does not indicate that Levaquin is more tendon toxic than the other drugs in the class. A handful of cases, known as bellwether lawsuits, were selected for early trials in the Multidistrict Litigation to help the parties gauge the relative strengths and weaknesses of their cases, by determining how juries respond to evidence that is likely to be similar throughout many cases in the litigation. The results of the bellwether trials may h
elp facilitate a potential Levaquin settlement agreement.

The Judicial Panel on Multidistrict Litigation determined that centralizing the Levaquin Tendon Rupture cases was appropriate. All Levaquin Tendon Rupture federal cases have been ordered transferred to the District of Minnesota, brought before U.S. District Judge John Tunheim. Recently a jury returned a verdict of $1.8 million in the first bellwether trial over side effects of the popular antibiotic, which occurred late last year.

Levaquin belongs to a group of antibiotics known as fluoroquinolones. It is manufactured by Ortho-McNeil-Janssen Pharmaceuticals, Inc., a subsidiary of Johnson & Johnson, for treatment of prostatis and bacterial infections of the upper respiratory and urinary tracts. Other anti-microbial drugs in this class include Cipro, Tequin, Floxin, Penetrex, Factive, Maxaquin and Avelox . Floxin was Levaquin’s predecessor, and the two drugs were so pharmacologically similar that the drug’s makers even indicated when they filed their New Drug Application with the FDA that Levaquin side effects would mirror those of Floxin. Therefore, it is being argued that Ortho-McNeil knew or should have known over 10 years ago that Levaquin would be as tendon toxic as Floxin, with an increased risk for people over 60 and those using corticosteroids at the same time.

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