The
Gaffney-Beare lawsuit is the first to go to trial in the New Jersey Levaquin
mass tort litigation. The trial, which is being presided over by Judge Carol
Higbee, is expected to last about four weeks. It is compiled of various Levaquin lawsuits filed by individuals whom have sustained unwanted Levaquin side effects. In
his opening statement, Andres F. Alonso alleged that Paul Gaffney, 67, and
Robert Beare, 72, both of New Jersey, suffered Achilles-tendon injuries because
of Levaquin that left them unable to walk and required surgery. He said both
men
took the drug to treat sinus infections. In his opening statement,
Johnson & Johnson’s attorney asserted the drug maker repeatedly warned
doctors and patients about reports linking tendon ruptures to Levaquin,
starting when the drug was approved for sale in the U.S., Bloomberg said.
Johnson & Johnson contends that are not liable for the men’s
injuries because there were warnings on Levaquin labels about the risk of
tendon damage since the antibiotic was first approved by the FDA in 1996. The
company’s attorneys also contend that Gaffney and Beare had other symptoms that
could have cause their tendon ruptures and claims the men did not follow their
doctors’ advice, which may have prevented the ruptures. In June a jury sided with
Johnson & Johnson, saying that the label warnings were adequate
enough to reject 84-year-old Calvin Christensen’s Levaquin tendon rupture
claim. When the FDA mandated the Black Box warning it reported that its
database showed the majority of tendon ruptures – 61 percent – were related to Levaquin.
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. According
to the agency, injuries were more likely to occur in people who are over 60
years of age, taking steroids (corticosteroids), or who have undergone a
kidney, heart, or lung transplant.
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