CHARLESTON – Three West Virginians say they suffered serious tendon-related injuries after taking a popular antibiotic used to treat bacterial infections.

Pheoba M. Bostic, Keith E. Morgan and Rebecca J. Cook filed three separate lawsuits on Nov. 10 in U.S. District Court for West Virginia against Johnson and Johnson, Ortho-McNeil Pharmaceutical and Johnson and Johnson Pharmaceutical Research and Development.

Bostic says she began taking Levaquin to treat a persistent cough and asthma, not knowing the antibiotic would cause her to suffer severe tendinitis. Morgan says he developed bilateral Achilles tendon ruptures after taking the antibiotic to prevent a potential infection. And Cook says she took Levaquin to treat an infection, but developed severe tendinitis soon after.

When they took the antibiotic, the plaintiffs say they did not know that it causes a higher incidence of tendon injuries, including tendon rupture, especially in people older than 60 and those who take corticosteroids.

Levaquin, the antibiotic the plaintiffs say they took, belongs to a group of antibiotics known as fluoroquinolones that studies have revealed cause tendon injuries.

"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.

Normally, patients use Levaquin to treat a wide array of bacterial infections, such as upper respiratory infections, urinary tract infections and prostatitis. Many of the people who take the antibiotic belong to the 60 and older age group, who are more at risk for tendon injuries, according to the complaint.

And if a person over the age of 60 does develop an Achilles tendon rupture, the injury usually remains with the person for the remainder of his life, the plaintiffs claim.

"Treatment may include a corticosteroid to decrease inflammation -– the very drug that, when combined with a fluoroquinolones, can dramatically increase the risk of a tendon rupture," the suit states. "In the event of a tendon rupture, the leg is often immobilized with a boot or other casting for anywhere between six weeks and six months, and physical therapy is ordered thereafter. Surgery is frequently not recommended in the elderly population due to poor recovery rates."

But the plaintiffs say they remained unaware of Levaquin's dangers when they took the antibiotic because the defendants did not highlight the possibility of tendon ruptures when marketing the drug. Instead, a warning about the ruptures remained buried inside a long list of possible side effects, according to the complaint.

And in the promotion of Levaquin, the defendants boasted about its safety record, saying only diarrhea and nausea had shown up as adverse effects, the complaint says.

"Clearly, the promotional literature only reported on adverse events in U.S. clinical trials where only a very small sampling of patients took their drug, and where many adverse events do not necessarily reveal themselves," the complaint says. "So, Defendants claimed 'proven performance' on the 63,000,000 people that had used Levaquin outside the United States, but chose not to disclose the adverse events that were being reported in this same population."

In fact, Levaquin more frequently caused tendon injuries than any of its fellow fluoroquinolones on the market, the plaintiffs claim.

Regulatory authorities in countries other than the United States were so concerned about the dangers of Levaquin that they issued "Dear Doctor" letters, advising physicians of the frequent tendon ruptures people experienced when taking the antiobiotic, according to the complaint.

And in 2001, countries such as France, Belgium, Italy and the United Kingdom convened before the European Agency for the Evaluation of Medicinal Products to discuss a heightened warning for Levaquin, proposing that the antibiotic would be singled out as being the most tendon toxic of flurooquinolones.

Aventis, the largest manufacturer of levofloxacin in Europe, agreed to two epidemiological studies in Europe regarding the antibiotic's tenotoxic effects. But before releasing the results of the studies, Aventis contacted Johnson and Johnson Pharmaceutical Research, promising to fund and co-author a study in the United States on tendon rupture and fluoroquinolones, the plaintiffs say.

"Advocating that the U.S. study would be the largest epidemiological study to date and therefore provide the most definitive evidence of the relative risk of levofloxacin and tendon injury, and that the European studies to date were too small from which to base a label change, Aventis convinced the European regulatory authorities to forestall the proposed warning change until the preliminary data from the U.S. study was released," the suit states.

Still, in April 2002 – about six months before the scheduled completion of the U.S. study -- Aventis released its European studies, finding a significantly increased chance of tendon rupture in levofloxacin as compared to other fluoroquinolones.

But the U.S. study revealed different findings -– people taking Levaquin faced no increased risk of tendon rupture, the study found.

"Unlike the healthcare databases in Europe, which contain computerized medical records, Johnson and Johnson PRD used data from the Ingenix Research database which consisted of U.S. health insurance claims from 1997 to 2001," the complaint says. "The study analyzed only Achilles tendon ruptures and sought to examine whether fluoroquinolone exposure was a risk factor for this injury. It did not assess the risk of Levaquin tendon toxicity, as had been requested by the United Kingdom.

"Under the guise of data validation, Defendant Johnson and Johnson PRD created an algorithm that conveniently excluded nearly 70 percent of health claims for elderly persons who suffered Achilles tendon rupture. The algorithm used CPT procedure codes that only related to surgical repair which thereby excluded all those Achilles tendon rupture cases where the patient was casted or booted, as is the case in the elderly population."

Because of the U.S. study, the defendants and the MHRA decided not to revise levofloxacin warning labels, the plaintiffs claim.

But Levaquin-related injuries were on the rise, the complaint says.
"Corresponding with Levaquin's increased popularity, the number of adverse events reported to the FDA reported soared," the suit states. "143 tendon related injuries were reported in 2006, and in just the first quarter of 2007, 107 tendon-related injuries were reported where Levaquin was the primary suspect."

In 2002, the defendants decided to revise their label on Levaquin products to say, "Post-marketing surveillance reports indicate that this risk may be increased in patients receiving concomitant corticosteroids, especially in the elderly."

And the defendants made another label change in April 2007, stating that the elderly face an increased risk of tendon injury.

By Feb. 8, 2008, the FDA mandated that the defendants provide a black box warning that indicates the risk of tendonitis and tendon rupture is increased in patients who are older than 60, the suit states.
Still, the labels aren't enough for the plaintiffs.

"It does not warn healthcare providers that Levaquin is much more tenotoxic than other fluoroquinolones and therefore physicians will interpret the relative risk of a Levaquin-induced tendon injury inappropriately," the suit states. "Defendants continue to market Levaquin as a first line therapy for the common bronchitis and sinusitis infections, and for which many other, safer, antibiotics are available."

The plaintiffs allege strict products liability, design defect, inadequate warning, negligence, breach of express warranty, breach of implied warranty, negligent misrepresentation, fraud, violation of West Virginia's Consumer and Credit Protection Act, unfair or deceptive acts, false advertising and unjust enrichment.

In each of their 12-count suits, the plaintiffs are seeking compensatory and non-economic damages of more than $75,000, punitive damages, attorney's fees, costs, pre-judgment interest and other relief the court deems just.

Troy N. Giatras of The Giatras Law Firm in Charleston will be representing each of them.

U.S. District Court case numbers: 5:09-1232, 2:09-cv-1233, 5:09-1234

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