Ortho-McNeil, manufacturer of Levaquin, has lost one major legal battle and may lose more. Levaquin, a synthetic chemotherapeutic antibiotic prescribed to treat life-threatening or drug-resistant bacteria, is also known to cause serious side effects. The most common, Levaquin tendon rupture prompted courts to hold them responsible.
John Schedin was the first plaintiff to win a Levaquin lawsuit – this one to the tune of $1.8 million in damages. In February 2008, Schedin took Levaquin to treat an upper respiratory infection. After just eight days of treatment, the plaintiff experienced bilateral Achilles tendon ruptures. Schedin filed suit against Ortho-McNeil on the grounds of insufficient product warning regarding tendon rupture, especially the case of elderly patients.
Lawyers for Ortho-McNeil argued that the label for Levaquin had contained warnings regarding tendon rupture since 1997, and that the company had updated the label in 2001 to reflect an increased risk of tendon rupture in seniors. Schedin's lawyers countered that updated fine print did not constitute adequate warning. Schedin's doctor was unaware of the updated label, and would not have prescribed the medication had he been aware. Furthermore, Schedin's physician explained that he no longer prescribed Levaquin, unless a patient demanded the drug. The jury agreed with Schedin's case and awarded the plaintiff $700,000 in compensatory damages and $1,115,000 in punitive damages.
Ortho-McNeil fired back, moving for a retrial. The company's lawyers claimed that the Schedin verdict went "against the clear weight of the evidence." They also alleged that "erroneous evidentiary rulings" denied them a fair trial, and that Schedin's lawyer delivered improper closing arguments. U.S. District Judge John R. Tunheim did not agree, and said that the jury had sufficient evidence and reason to deliver their verdict. Judge Tunheim denied the request for retrial. The Schedin ruling stands.
Judge Tunheim's ruling bodes well for pending and future Levaquin lawsuits. The decision sets a strong precedent regarding Ortho-McNeil's responsibility in Levaquin tendon rupture, and establishes that manufacturer labels are not always sufficient warning. According to the Schedin jury, a "Dear Doctor" letter or stronger warning label was necessary.
As of October 2011, a New Jersey mass tort Levaquin lawsuit is underway, and a third bellwether trial in multidistrict litigation is scheduled for November 2011. Understandably, Ortho-McNeil lawyers are nervous, given the outcome of the Schedin case, but plaintiffs are buoyed by its result.
