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J&J Accused of Hiding the Tendon Risks of Levaquin

From Star Tribune (Minneapolis, MN) (June 2, 2011)

June 02--Lawyers squared off in federal court Wednesday in a jury trial that pits an elderly Worthington man against Johnson & Johnson over claims that the drug giant failed to warn patients about the risks associated with a popular antibiotic and possible tendon damage.

Opening arguments in U.S. District Court in Minneapolis before Judge John Tunheim were politely contentious before a jury of nine women and three men. The case, the second of close to 1,000 that have been consolidated in Minneapolis federal court, follows a jury verdict against New Jersey-based J&J in December that awarded an Edina man with a similar injury $1.7 million in damages.

The current case was filed by Calvin Christensen, an 84-year-old retired businessman who was hospitalized in May 2001 for pneumonia. His doctor prescribed Levaquin (pronounced LEEV-ah-qwinn), as well as a steroid, to combat the respiratory condition. Christensen subsequently ruptured his Achilles tendon, an injury that required surgery to repair.

Ronald Goldser, a Minneapolis attorney representing Christensen, said his client hasn't been the same since the Achilles injury, which has curtailed his beloved activities -- including shopping at Wal-Mart, fishing and golf. His lawsuit calls for an unspecified amount of damages.

Goldser argued that Johnson & Johnson failed to adequately warn doctors about the risk of tendon injury associated with Levaquin when used with some steriods, a drug cocktail commonly prescribed to treat respiratory infections.

But J&J's lawyers pointed out that ever since Levaquin was approved by the Food and Drug Administration (FDA) in 1996, its packaging has contained warnings about tendonitis and tendon ruptures. In 2008, the FDA required that J&J's Ortho-McNeil-Janssen Pharmaceuticals unit -- as well as competitors making similar drugs -- enclose a "black box" warning on the label that describes tendon-related risks.

In his opening statement, Lewis Saul, a New York attorney representing Christensen, carefully unfurled the 2-foot-long Levaquin label packed with small type and proclaimed it an inadequate warning for both doctors and patients.

J&J's lawyer James Irwin said "doctors know exactly where to look" on the label to detect any special warnings or instructions associated with the drug. Further, he noted, Christensen's doctor was well-aware of the risks associated with prescribing Levaquin with a steroid, but did so because the combination works in combating serious chest infections. "He chose this medication because it was more important to get this man home to his wife," he said.

Over the years, Levaquin has been a blockbuster drug for Johnson & Johnson -- in 2010, sales of the antibiotic were $1.4 billion, according to securities filings.

The trial is expected to last up to three weeks.

Janet Moore --612-673-7752


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Posted: June 2011