Levaquin Warnings About Tendon Problems Were Sufficient: NJ State Jury
A New Jersey jury has returned a defense verdict in the third trial out of several thousand Levaquin lawsuits that have been filed throughout the United States, finding that Johnson & Johnson provided adequate warning on the drug’s label about the risk of tendon problems with the antibiotic.
The Levaquin trial involved a complaint brought by Paul Gaffney and Robert Beare, who alleged that they each suffered a ruptured tendon after taking the medication.
An estimated 2,500 people have filed a similar Levaquin tendon rupture lawsuit against Johnson & Johnson and their Ortho-McNeil-Janssen Pharmaceuticals subsidiary, raising nearly identical allegations that the injuries could have been avoided if the drug makers had placed a stronger warning on the medication instead of downplaying the risks.
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Learn MoreLevaquin is the best selling antibiotic in the U.S., pulling in about $1.5 billion last year. It is now also available as a generic from other drug makers.
Although there has been information about the potential risk of tendon damage on the drug’s label since it was first approved by the FDA in 1996, plaintiffs alleged that those warnings were insufficient and that the drug maker actively attempted to downplay the risk for years.
In July 2008, the FDA required that a “black box” warning be added about the side effects of Levaquin and other similar antibiotics, which is the strongest warning that can be placed on a prescription medication. However, consumer advocates called for stronger Levaquin tendon rupture warnings to be added at least two years earlier, with Public Citizen filing a petition with the FDA in 2006, insisting that consumers and the medical community be provided with clearer warnings about the risk of tendon damage.
Following a five week trial, the New Jersey state court jury found that these plaintiffs failed to establish that Johnson & Johnson provided inadequate warnings, returning a defense verdict.
The decision is the second victory for Johnson & Johnson out of the three Levaquin cases that have made it to trial. In December 2010, the first trial ended in a $1.8 million award for the plaintiff, including punitive damages to punish the drug maker for their conduct. However, the drug maker successfully defended the second trial, which ended in June 2011.
The first two trials were held in federal court, where the Levaquin litigation has been consolidated in the U.S. District Court for the District of Minnesota as part of an MDL, or multidistrict litigation. This latest trial was held in New Jersey state court, where about 1,900 of the cases are currently pending.
These early trials, typically referred to as “bellwether” cases, are not binding on other lawsuits, but they are often useful in providing the parties with a gauge for how juries may respond to similar evidence that will be presented throughout other cases in the litigation. The parties often use the outcome of these bellwether trials to help facilitate potential Levaquin settlement agreements in other cases.
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3 Comments
L.S.SullivanMay 16, 2012 at 5:34 pm
On November 2, 2011, I was perscribed Levaquin to combat drug resistant pnemonia. I saw a bright orange warning label on the perscription bottle, stating that it could cause "spontaneous tendon rupter & nerve damage in adults over the age of 60, up to several months after use." I am only 39 years old and after questioning my doctor prior to taking it, I was told I had an extremely low risk of[Show More]On November 2, 2011, I was perscribed Levaquin to combat drug resistant pnemonia. I saw a bright orange warning label on the perscription bottle, stating that it could cause "spontaneous tendon rupter & nerve damage in adults over the age of 60, up to several months after use." I am only 39 years old and after questioning my doctor prior to taking it, I was told I had an extremely low risk of having a reaction. I completed the perscription and got well. However, in the end of January, 2012 I started feeling pain in my left heel. It kept getting worse even after taking advil and swtiching to flat shoes with heel pads. I finally went to see an Orthopeadic Surgeon on April 2nd and the second question out of his mouth was, "Have you ever taken Levaquin for pnemonia?" I told him I had and he then stated that "he had seen several cases recently becaise of it." I have been in a soft cast for going on 8 weeks and now have limited use of my left foot. Is this something I can get help with?
DavidOctober 26, 2011 at 12:00 am
The above comment so far is mine.
DavidOctober 18, 2011 at 10:35 pm
How many more bellwether cases will be scheduled, before potential levaquin settlement agreements like the first trial in a $1.8 million award? How long did it take for Schedin to actually recieve his award? What is the criterior for these bellwether cases in the selection process? There remains hundreds of other cases to be decided. Who's bellwether case is next? When will the parties facilita[Show More]How many more bellwether cases will be scheduled, before potential levaquin settlement agreements like the first trial in a $1.8 million award? How long did it take for Schedin to actually recieve his award? What is the criterior for these bellwether cases in the selection process? There remains hundreds of other cases to be decided. Who's bellwether case is next? When will the parties facilitate potential levaquin settlement agreements, and stop having these bellwether cases? Sincerly, Yours!