Levaquin Tendon Rupture Year in Review

Edina, MNThe beginning of a new year is often a reason to reflect on the year passed—and this past year has witnessed the unfolding of some significant events with regard to Levaquin, the fluoroquinolone antibiotic now under fire for triggering Levaquin tendon ruptures. A landmark lawsuit, together with the ascension of a Levaquin poster boy from an obscure homemade video to a seat advising government regulators, marked a landmark year for Levaquin.

The "poster boy" to whom we refer is John Fratti, who first emerged three years ago by way of YouTube. Sitting in a cluttered room, a box fan whirring in the background, an exasperated Fratti—in obvious pain—first told how he had been devastated by Levaquin after taking the antibiotic for an infection.

The irony to this story is that the 45-year-old Fratti (41 at the time of his initial injury) had been working as a pharmaceutical rep. And yet here he was, decrying the risks of a drug which that even he, as a drug rep, remained unaware until it was too late.

Fratti did a YouTube update two years ago—but by then he was in training as a Levaquin side effects spokesperson to whom local, and then national media paid attention.

And then in July of 2010, Fratti earned an audience with Karen Weiss, MD, the lead for the Safe Use Initiative that works under the auspices of the US Food and Drug Administration's (FDA) Center for Drug Evaluation and Research. Fratti returned to White Oaks, at Silver Spring, Maryland, on November 17 as a private citizen advising the participants in a public workshop on safe safe-use challenges inherent with fluoroquinolones.

Last year finished with the ink still wet on the $1.8 million jury award to John Schedin of Edina, whose lawsuit and subsequent trial is considered by many as the bellwether for more than 2,600 similar lawsuits nationwide alleging Levaquin tendon problems. In spite of the plaintiff becoming saddled with ten 10 percent of the liability for making the decision to exercise in response to his tendon ruptures, the 82-year-old Schedin was awarded $700,000 in compensatory damages and $1.1 million in punitive damages for his suffering.

Schedin, according to an Associated Press (AP) summary of the case, ruptured both his Achilles tendons three days after starting a Levaquin prescription, in 2005. The FDA mandated Johnson & Johnson, as well as manufacturers of other drugs in the fluoroquinolone class to update warning labels with regard to Levaquin torn tendons in 2008—three years after Schedin's injury.

Ortho-McNeil-Jansen Pharmaceuticals, the unit of New Brunswick, New Jersey-based Johnson & Johnson that markets Levaquin, was the defendant in the Levaquin and Achilles tendon lawsuit.