Another plaintiff has added a complaint to the growing list of lawsuits filed in St. Clair County Circuit Court against Johnson and Johnson, Ortho-McNeil Pharmaceutical and Johnson and Johnson Pharmaceutical Research and Development over an antibiotic that he says caused him severe tendon problems.
The plaintiff says he took the antibiotic Levaquin, which is normally prescribed for upper respiratory infection, urinary tract infections, prostatitis and other bacterial infections.
Plaintiff Timothy Gilley, who is from Ohio, will be represented by David W. Bauman of The Padberg and Corrigan Law Firm in St. Louis.
Gilley claims he did not know at the time he took Levaquin 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 June 3 in St. Clair County Circuit Court.
"Although the exact mechanism of how fluoroquinolones cause tendon injury is still being investigated, studies have suggested that fluoroquinolones can degrade tendon cells by causing apoptosis, or a programmable cell death, and therefore lose their integrity, and easily tear and/or rupture," the suit states.
As a result of ingesting the antibiotic, Gilley says he 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, Gilley claims. 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.
"A look at Defendants' sales materials could explain why the very group that Levaquin was most toxic to was the very market Defendants were after," the complaint says. "Defendants' target market for Levaquin was the elderly -- especially those with upper respiratory infections who were likely to be chronic corticosteroid users."
After world-wide studies revealed the tendon risks to Levaquin users, the defendants updated their label for the antibiotic, Gilley claims. 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.
Gilley claims 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, the suit says.
Because the defendants issued no warnings to doctors, physicians continued to prescribe the antibiotic, the plaintiff claims.
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.
According to the complaint, 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.
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, Gilley says 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 his seven-count suit, the plaintiff alleges strict liability, negligence, breach of implied warranties, breach of express warranty, common law fraud, violation of the Ohio Consumer Sales Practices Statute and unjust enrichment.
Johnson and Johnson and its subsidiary, Ortho-McNeil, are named as defendants because they test and manufacture Levaquin.
Gilley is 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 numbers: 11-L-296.