Levaquin Lawsuits Address Tendon Rupture

Plaintiffs Arthur and Patricia Ilardi are the most recent victims to take Ortho-McNeil-Janssen and Johnson & Johnson to trial. Ortho-McNeil is a subsidiary of Johnson & Johnson, the manufacturer of Levaquin. Levaquin, an antibiotic prescribed to treat life-threatening and drug-resistant bacterial infections, has been linked to tendon rupture since 1997.

In July 2008, Mr. Ilardi took Levaquin over the course of several weeks. Ilardi's treatment coincided with an order from the Food and Drug Administration (FDA) to add a black-box (elevated) warning to Levaquin stating the product's risk of tendon rupture. Unfortunately for Ilardi, the warning had not yet been implemented. As a result of taking Levaquin, Ilardi claims he was rendered "sick, sore, lame and disabled" by "serious injuries," including Levaquin tendon rupture.

Levaquin Tendon Rupture Leads to More Lawsuits

A Levaquin tendon rupture lawsuit has been filed by Diane K. Eccles of Oregon, claiming that she suffered from Levaquin tendon ruptures in her shoulder, following using the medication for six months. Although there has been information about the potential risk of tendon damage on the drug’s label since it was first approved by the FDA in 1996, plaintiffs alleged that those warnings were insufficient and that the drug maker actively attempted to downplay the risk for years. Levaquin is the best-selling antibiotic in the U.S., pulling in about $1.5 billion last year. It is now also available as a generic from other drug makers. The most common Levaquin Lawsuit involves ruptures in the achilles tendon, though a growing number of cases are involving tears in the shoulder.

The FDA, in 2008, required an upgraded warning on tendon damage posed by Levaquin and similar drugs. In 2006, Public Citizen filed a petition with the FDA, requesting that stronger warnings be issued regarding Levaquin tendon rupture side effects. In January 2008, Public Citizen filed a lawsuit against the FDA in an attempt to compel the agency to order Levaquin’s maker to include a warning on the Levaquin label regarding the risk of tendon ruptures and other tendon injuries. Finally, in July 2008, the FDA issued a health alert notifying the manufacturers of certain antibiotics, including Levaquin’s maker, of the need to add a boxed warning to the prescribing information about the increased risk of developing tendonitis and tendon rupture in patients taking fluoroquinolones.

The tendon most frequently associated to the Levaquin induced ruptures is the Achilles tendon, however Levaquin has also been linked to tendon ruptures in the rotator cuff (shoulder), the biceps, the hand, and the thumb. So far, two Levaquin lawsuits of a reported 2,500 pending claims have made their way to court. One was found in favor of the plaintiff while the other was found in favor of Johnson & Johnson. The first lawsuit resulted in a jury awarded $1.8 million to a man who alleged he ruptured both Achilles tendons. In June 2011, however, a jury found in favor of Johnson & Johnson in a Levaquin lawsuit, after determining that the company properly warned about the risks associated with the antibiotic.

Drug Company Lawyer’s Request to Vacate Denied in Levaquin Lawsuit

The first Levaquin bellwether trial, which involved a lawsuit brought by John Schedin, resulted in a finding that the drug makers were liable for recklessly failing to warn consumers and doctors earlier about the risk of Levaquin tendon ruptures. The jury awarded $700,000 in compensatory damages and another $1.1 million in punitive damages as a penalty against pharmaceutical company. In December, a federal jury ordered Johnson & Johnson’s Ortho-McNeil-Jansen Pharmaceuticals to pay Schedin $700,000 in actual damages and $1.1 million in punitive damages. Actual damages will be reduced by $70,000 under the jury’s finding of 75 percent liability for the company. Ortho-McNeil’s lawyer argued that some of the closing statements made by Schedin’s lawyer were incendiary in persuading the Jury’s passions to award a large settlement. Judge Tunheim sided against this deeming all the statements “suitable for consideration.”

Levaquin Lawsuit Settlements Award Damages

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 vs. Levaquin

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.