The first Levaquin bellwether trial, which involved a lawsuit brought
by John Schedin, resulted in a finding that the drug makers were liable for
recklessly failing to warn consumers and doctors earlier about the risk of Levaquin tendon ruptures. The jury awarded $700,000 in
compensatory damages and another $1.1 million in punitive damages as a penalty
against pharmaceutical company. In December, a federal jury ordered Johnson
& Johnson’s Ortho-McNeil-Jansen Pharmaceuticals to pay Schedin $700,000 in
actual damages and $1.1 million in punitive damages. Actual damages will be
reduced by $70,000 under the jury’s finding of 75 percent liability for the
company. Ortho-McNeil’s lawyer argued that
some of the closing statements made by Schedin’s lawyer were incendiary in
persuading the Jury’s passions to award a large settlement. Judge Tunheim sided
against this deeming all the statements “suitable for consideration.”
Levaquin Lawsuits Ensue
Levaquin Lawsuits Ensue
All federal Levaquin tendon rupture lawsuits have been consolidated and centralized in Minnesota as part of
an MDL, or multidistrict
litigation, under US District Judge John R. Tunheim. Plaintiffs claim
the tendon injury warning should have been added to the Levaquin label earlier
and remains inadequate. They also say Levaquin’s maker, Johnson & Johnson’s
Ortho-McNeil-Janssen unit, downplayed the drug’s risk to boost sales. The FDA
has received reports of hundreds of individuals who experienced a tendon
rupture after using Levaquin, Cipro or one of the other fluoroquinolones. As a
result of the inadequate warnings currently provided, the consumer advocacy
group, Public Citizen, filed a Levaquin lawsuit in January 2008 as a result of the FDA's
failure to act on a petition they filed in 2006, calling for more detailed
information about the risk of Levaquin tendon ruptures to be added to
the warning label.
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 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.
