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MINNEAPOLIS - (Mealey's) The third Levaquin multidistrict litigation tendon rupture trial ended Jan. 26 with a defense verdict, defendant Johnson & Johnson's third compared to one plaintiff victory (Clifford Straka v. Johnson & Johnson, et al., No. 08-5742, D. Minn.).
The jury in the U.S. District Court for the District of Minnesota had been asked if Johnson & Johnson and subsidiary Janssen Pharmaceuticals Inc. failed to provide reasonably adequate warnings of the risks associated with Levaquin to the doctor for plaintiff Clifford Straka, if the failure to warn was a direct cause of Straka's ruptured Achilles tendons, whether there were violations of the Minnesota Consumer Fraud Act and Minnesota Senior Citizen and Disabled Person's Consumer Fraud and Deceptive Trade Practices Act.
The trial began Jan. 3, and the jury began deliberating Jan. 24. On the second day of deliberations, the jury asked Judge John R. Tunheim to define "reasonably adequate."
Early on Jan. 26, the judge asked the judge how long it should continue to deliberate if it could not reach a unanimous decision. The jury came back at 12:55 p.m. that day with a defense verdict.
In 2006, Straka, then 72, was prescribed a four-day course of prednisone corticosteroid to treat what he called a flare-up of his adult-onset asthma but what the defendants called pneumonia. When his symptoms did not improve, he was prescribed 500 milligrams a day of Levaquin-brand fluoroquinolone antibiotic for 10 days.
Eleven days after starting Levaquin, Straka developed acute pain in both Achilles tendons. He was diagnosed with Achilles tendonitis, and the doctor discontinued Levaquin because he thought that it was the cause of Straka's problem.
Straka underwent drug and physical therapy but did not improve. He was eventually diagnosed with ruptures of both Achilles tendons.
Straka claimed that his injuries seriously restricted his activities and that he continues to have pain and discomfort and walks with a limp.
In 2008, Straka sued Johnson & Johnson and Janssen Pharmaceuticals Inc., alleging that Levaquin caused his tendon ruptures. The Levaquin multidistrict litigation is located in the district, and the court chose Straka's case as the third bellwether trial.
Straka's causes of action at trial were that the defendants inadequately warned about the tendon rupture risk of Levaquin, making it defective and unreasonably dangerous; were negligent in marketing Levaquin by failing to bring adequate warnings to the attention of doctors; negligently concealed the extent of the risk; negligently described the safety profile of Levaquin; violated Minnesota's Consumer Fraud law; and acted with deliberate disregard for the rights and safety of others and with deliberate indifference to the high probability of injury to others.
The plaintiff argued that the defendants undertook a study conducted by Ingenix to counter other epidemiological studies that found a significantly heightened risk of tendinopathy and tendon rupture with Levaquin compared to other fluoroquinolone and nonfluoroquinolone antibiotics, particularly in the elderly and patients who used corticosteroids.
Although the Food and Drug Administration subsequently required Levaquin to carry a black box warning about tendinopathy and tendon rupture, Straka said the defendants still do not adequately warned doctors about the risk and continue to promote the drug as safe.
The defendants argued in court filings that Levaquin's label has warned about the risk of Achilles tendon ruptures since 1997 and that Straka's prescribing physician, Dr. Katayoun Baniriah, testified that she never read those warnings. They say they reasonably addressed the tendon rupture risk by ordering the so-called Ingenix study.
The Ingenix study, the defendants say, found no increased risk of tendon rupture from Levaquin compared to other fluoroquinolones, the class of antibiotics to which Levaquin belongs.
In addition, the defendants argued that Straka had other significant risk factors for Achilles tendon rupture and that Levaquin was not a substantial contributing factor to the plaintiff's injuries.
The defendants also argued that Straka cannot bring a Minnesota Consumer Fraud Statute claim because the law is limited to cases that will benefit the public. They said there is no valid scientific evidence that Levaquin has an increased association with tendon disorders compared to other fluoroquinolones.
Experts listed to testify for Straka were Greg Bisson, an epidemiologist; Cheryl Blume, a FDA regulatory issues and warnings expert; Martyn Smith, a toxicologist; Martin Wells, a biostatistician; and Tom Zizic, a rheumatologist.
Defense experts listed to be called were Jack Bert, M.D., an orthopedist; David Feigal, M.D.; and Peter Layde, M.D.
The first MDL trial ended with a $1.8 million verdict, and the second ended in a defense verdict. The first state court trial ended in October with a defense verdict in the Atlantic County, N.J., Superior Court.
Straka is represented by J. Gordon Rudd Jr., Ronald S. Goldser and David M. Cialkowski of Zimmerman Reed in Minneapolis; James A. Morris Jr. and Kacie Starr of the Morris Law Firm in Austin, Texas; Kevin M. Fitzgerald and Lewis J. Saul of Lewis Saul & Associates in Portland, Maine; and Stacy K. Hauer of Johnson Becker in Minneapolis.
The defendants are represented by James B. Irwin V of Irwin, Fritchie, Urquhart & Moore in New Orleans, Jane R. McLean Bernier, Dana M. Lenahan and Tracy J. Van Steenburgh of Nilan Johnson Lewis in Minneapolis and John Dames and William V. Essig of Drinker, Biddle & Reath in Chicago.
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