Five Illinois residents have filed suit against Johnson and Johnson, Ortho-McNeil Pharmaceutical, Johnson and Johnson Pharmaceutical Research and Development and Walgreens after they say an antibiotic caused them severe tendon problems.
Plaintiffs Susan Price, Jerry Mahlandt, Johnna Woosley, David Force and Rachel Speiser say they took the antibiotic Levaquin, which is normally prescribed for upper respiratory infection, urinary tract infections, prostatitis and other bacterial infections.
They are represented by David W. Bauman, Joseph P. Danis, John J. Carey and Corey D. Sullivan of Carey and Danis in St. Louis and by Jeffrey J. Lowe of The Lowe Law Firm in St. Louis.
What the plaintiffs claim they did not know at the time they took Levaquin is that it causes a higher incidence of tendon injuries, including tendon rupture, in people who are older than 60 or who are on corticosteroid therapy, according to the complaint filed Sept. 2 in St. Clair County Circuit Court.
"Levaquin-induced tendon injury involves the degradation of the tendon tissue, leading to severe and permanent injuries," the suit states.
As a result of their taking the antibiotic, all the plaintiffs say they suffered severe and permanent tendon injuries.
Levaquin is part of a class of antibiotics known as fluoroquinolones and was originally introduced into the U.S. in 1997, the complaint says.
When Levaquin entered the market, warnings about tendon side effects were required on all fluoroquinolone labels, but were buried in a long list of potential adverse reactions, the plaintiffs claim. In addition, the warnings did not advise that tendon injury was tripled with fluoroquinolone use in people older than 60 and in those who are on corticosteroid therapy, according to the complaint.
In fact, Levaquin manufacturers marketed the drug toward the elderly, especially those with upper respiratory infections who were likely to be chronic corticosteroid users, the suit states.
"More disturbingly, Defendants' promotional campaign was themed on Levaquin's excellent safety profile and failed to disclose the risks of tendon injury," the complaint says.
After world-wide studies revealed the tendon risks to Levaquin users, the defendants updated their label for the antibiotic, the plaintiffs claim. However, the new warning only included information about the risks to people who were on corticosteroid therapy and contained no warnings about risks to the elderly, according to the complaint.
"Accordingly, despite the 2002 label change, Levaquin prescriptions only increased and tendon injuries mounted," the suit states.
Other European countries began discussing the requirement of heightened label change as early as 2001, and collaborated with Johnson and Johnson PRD to perform a study on the antibiotic's effects, the complaint says.
The plaintiffs claim that Johnson and Johnson PRD, however, only analyzed achilles tendon ruptures in its study and did not assess the risk of Levaquin tendon toxicity. In addition, Johnson and Johnson PRD created an algorithm that excluded nearly 70 percent of health claims for the elderly who suffered Achilles tendon rupture, according to the complaint.
"The algorithm used CPT procedure codes that only related to surgical repair," the suit states. "This algorithm thereby excluded all those Achilles tendon rupture cases where the patient was casted or booted, as is the case in the elderly population. By manipulating the data, Defendant Johnson and Johnson PRD was able to exclude the very group that was prone to tendon rupture."
As a result, the Johnson and Johnson PRD study found no increased risk of achilles tendon rupture and found neither age nor corticosteroid use altered the findings, the complaint says.
As a result, the Levaquin label was not changed as had been recommended.
Because the defendants issued no warnings to doctors, physicians continued to prescribe the antibiotic, the plaintiffs claim.
However, Levaquin was responsible for 1,044 reports of tendon injuries and 282 reports of tendon ruptures from 1997 through 2005, according to the complaint.
Injuries continued to soar as Levaquin's popularity increased, the suit states.
Even the Illinois attorney general took notice and in 2005 submitted a petition to the FDA requesting that a black box warning be placed on the antibiotic's label, the complaint says.
Although the black box warning was not been placed on Levaquin's packaging, a revised label was placed on the antibiotic in April 2007. However, the plaintiffs say the label continued to bury warning about tendon risks and did not contain a warning about Levaquin's greater association with tendon toxicity as compared to other fluoroquinlones.
Finally, in July 2008, a revised Levaquin label contained a black box warning, but still fails to warn about its higher risk of tendon toxicity compared to other similar antibiotics, according to the complaint.
In the 10-count suit, the plaintiffs allege strict liability, negligence, breach of implied warranties, breach of express warranty, common law fraud, violation of the Illinois Consumer Fraud Act, unjust enrichment, breach of warranty and failure to warn.
Johnson and Johnson and its subsidiary, Ortho-McNeil, are named as defendants because they test and manufacture Levaquin. Walgreens sold the plaintiffs the drug, the suit states.
The plaintiffs are seeking actual and compensatory damages, plus costs, pre- and post-judgment interest and other relief the court deems just.
St. Clair County Circuit Court case number: 09-L-468.