Blockbuster Drug Kicks Up A Legal Storm

Blockbuster Drug Kicks Up A Legal Storm [Star Tribune, Minneapolis]


From Star Tribune (Minneapolis, MN) (December 7, 2010)


Dec. 07--When 76-year-old John Schedin was diagnosed with bronchitis five years ago, his doctor prescribed a popular antibiotic called Levaquin, plus a steroid, to lick the lingering chest infection once and for all.

But after taking the drugs for three days, Schedin ruptured both of his Achilles tendons, a bizarre injury he attributes to Levaquin. In 2008, the Edina resident sued the unit of pharmaceutical giant Johnson & Johnson that markets the drug, Ortho-McNeil-Janssen Pharmaceuticals.

Schedin’s case is one of hundreds that have been consolidated in U.S. District Court in Minneapolis before Judge John Tunheim -- and is the first to go to trial. A jury of eight men and four women heard closing arguments Monday morning and began deliberating.

All told, more than 2,600 lawsuits have been filed by Levaquin patients with tendon injuries in state and federal courts nationwide. Schedin, a retired salesman, is seeking an unspecified amount in punitive and compensatory damages.

At issue is whether J&J adequately warned doctors and patients about the potential for Levaquin to cause tendon damage throughout the body.

"Levaquin (pronounced LEEV-ah-qwinn) is a good drug that saves lives," J&J attorney John Dames said Monday, noting that the product’s labelling had long contained a warning about tendon-related issues. "No information was withheld or concealed."

But Mikal Watts, the lead attorney for Schedin’s team, said J&J "obfuscated and manipulated the truth for profit." Since its U.S. launch in 1997, the blockbuster drug has consistently reaped upwards of $1 billion in annual sales for the company and by 2006, it was the most-prescribed antibiotic in the world, according to court documents.

After several European regulatory authorities issued warning letters in 2002 to doctors about the drug’s tendon-related side effects, J&J paid for a epidemiological study using U.S. data from Minnetonka-based health insurer United Health Group’s Ingenix unit. The study "found no increased risk" of tendon injuries in patients who had taken fluoroquinolones, the class of antibiotic drugs that includes Levaquin, Dames said.

But Watts characterized the Ingenix study as an "overwhelming pile of nonsense" involving "academic fraud and a manipulation of science."

Missed warning

Schedin, of course, was unaware of any of these machinations when he visited Dr. John Beecher in 2005 while suffering from a bad chest cold. Beecher, of Edina Family Physicians, testified that he knew fluoroquinolone antibiotics could cause tendon damage. But he said he had no idea that Levaquin mixed with a steroid could be prove more toxic in the elderly, a warning that had been added to the drug’s label in 2002.

"I feel so badly that this happened to him," he testified. "I feel very frustrated with myself. I didn’t become a physician so that people could have bad outcomes."

Beecher said the Ortho-McNeil sales rep, Monica Sadar, called on his office frequently, but didn’t mention any tendon-related issues regarding Levaquin.

Sadar, who has called on the busy practice monthly for the past 30 years, testified that she tucked the packaging insert highlighting side effects in a bin holding drug samples at the clinic.

She couldn’t recall on the witness stand if she ever warned Beecher about Levaquin, but described sales calls as brisk, almost cursory, interactions. "If I saw [doctors] for 10 to 15 seconds at a time, I’d consider myself lucky," she said.

By 2008, the Food and Drug Administration required J&J and other manufacturers making sister drugs to place a serious "black box" warning on packaging describing the risk of tendon injuries, including those over 60 also taking steroids.

Yet Schedin’s lawyers claim the label is inadequate and "buried" in a 14-page package insert.

Around that time, Schedin’s wife, Vicki, saw an ad on television from a law firm looking for clients to join a Levaquin lawsuit against J&J’s Ortho-McNeil unit. Because of his age, Schedin didn’t get surgery to repair his tendons, and the healing process has proven difficult for the once-enthusiastic mall-walker and golfer.

Schedin, now 82, testified his quality of life has declined since his injury -- he can’t vacation with his family and when he goes to bed, he said he has to "crawl" up the stairs on his hands and knees.

So he called the toll-free number. "Maybe it could help others," he said he remembers thinking.

A defense witness, noted orthopedic surgeon Dr. George Holmes, testified that Schedin’s injury may have been caused by his high blood pressure, marginally high cholesterol, and the steroid he was prescribed-- and not by Levaquin. Company’s attorney Dames also said that Dr. Beecher, who treated Schedin, "has the responsibility to know the pitfalls of the drugs he prescribes."

The jury will resume deliberations Tuesday morning.

Janet Moore --612-673-7752

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Posted: December 2010


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