Giatras

CHARLESTON -- Charleston lawyer Troy Giatras was part of a legal team that obtained $1.7 million in damages from pharmaceutical giant Johnson and Johnson for a Minnesota man in federal court in Minneapolis.

Giatras is head of The Giatras Law Firm PLLC and has practiced law in Charleston since 1990.

On Wednesday, the jury awarded $1.1 million in punitive damages and $630,000 in compensatory damages to 82-year-old John Schedin of Edin, Minn. Five years ago, he ruptured or partially ruptured both Achilles tendons after taking the antibiotic Levaquin.

The jury found that Johnson and Johnson failed to provide adequate warning to patients and physicians that Levaquin can cause tendon damage.

About the drug

Levaquin, an antibiotic, is similar to amoxicillin in that it helps treat certain bacterial infections, such as bronchitis, pneumonia, and infections of the ears, nose, throat and urinary tract.

The drug, which was approved by the U.S. Food and Drug Administration in 1996, is not manufactured by Johnson and Johnson, but is sold by the company in the United States.

In 2007 alone, Levaquin accounted for 6.5 percent of Johnson and Johnson's total revenue, generating $1.6 billion, an 8 percent increase over the previous year, according to the company. That same year, the drug ranked 37th among the top 200 prescribed drugs in the U.S. and ranked 19th in world sales. Its patent expires in June 2011.

Despite its worldwide success, Levaquin has been found to, when combined with corticosteroids, cause tendon ruptures.

Tendons, which are the fibrous tissues that attach muscle to bone in the human body, can in some rare instances snap or rupture. A rupture can be a serious problem and result in excruciating pain and permanent disability if untreated.

The case

Schedin, a former Marine, never had filed a lawsuit in his entire life, his lawyer said. An active 82-year-old, he likes to walk the mall with his wife, who is 12 years younger, and play golf.

But now, five years after he first took Levaquin, those things are considerably more difficult. Even walking up the steps in his home, where he's lived for the last 50-some years, is an arduous task.

"Because of the damage to his tendons, he now must crawl up stairs on his hands and knees just to go to bed," Giatras said of his client.

In 2005, Schedin was prescribed the drug for bronchitis. He also was given a steriod to help with inflammation. After being on the drugs for just a couple of days, he noticed he was having trouble walking.

Since he couldn't get a hold of his physician, he called a toll-free number and talked to a nurse, who immediately told him to stop taking the drug.

"When taking that combination of drugs, there is an increased risk of almost immediately tendons rupturing," Giatras explained.

A physician found both of Schedin's Achilles tendons to be fully or partially ruptured.

But the Minnesota man isn't the only one to have been affected by the prescription drug.

Patients who have suffered tendon injuries after taking Levaquin have filed more than 2,600 lawsuits in state and federal courts nationwide, Giatras said. Schedin's case is among hundreds consolidated in U.S. District Court in Minneapolis and is the first to go to trial.

The trial

Giatras and his legal team took the position that the warning labels Johnson and Johnson had in the package insert were inadequate.

"It made reference to an increased risk in tendon disorders," he said. "It should have been a black box warning -- literally a black line or box around the warning part that 'this drug may cause an increased risk in tendon ruptures.'"

There is a "big difference" between disorder and rupture, he noted.

Giatras and his team also argued that the warning should've been communicated better via sales representatives and physician lectures.

"There are no physicians being sued because they were just as much in the dark," he said.

Meanwhile, Johnson and Johnson's defense was that they warned patients and physicians of tendon disorders. The physicians, their lawyers argued, should have done some of their own homework on the drug before prescribing it to patients.

The company also did their own study of the drug, which showed there was not an increased risk of tendon ruptures.

The jury

Perhaps the most interesting aspect of the trial for Giatras was the jury.

First off, there were 12 jurors instead of six, to which he's more accustomed.

Then, the judge allowed the jury to take notes and ask questions. The court even supplied them with notebooks, Giatras said.

"They were very active in the case," he said.

There were some, at least a handful, that must've had at least 20 or 30 pages of notes, Giatras said.

One of the jurors was so diligent that she brought her own sticky notes and highlighters, he said.

"That really encouraged the others to take notes," he explained. "Particularly when it came to the witnesses."

And though the jurors weren't allowed to verbally ask questions, they could write them down and put them in a box. The judge would review them and ask both sets of lawyers if they were going to get to the questions while presenting. If not, Giatras explained, the judge would ask their questions for them.

"It was very sophisticated," he said of the setup.

The outcome

After nearly 66 hours of testimony and two days of deliberating, the jury returned its verdict.

Giatras said he and his team were not only happy with the $1.7 million in damages awarded, but the possibility for a resolution in the thousands of other lawsuits against the company over the drug.

"Schedin has said he is less interested in the monetary damages than in ensuring other people don't face the problems he has had," Giatras said.

Plus, it doesn't make sense to keep trying the same case and getting the same result, he said.

"But we needed to have this trial so both sides could air their differences," he said.

Giatras said another trial has yet to be set. The judge in the case, he explained, has asked for both legal teams to meet with him after Jan. 1.

The defendants will most likely get to choose the next case to go to trial, he said.

Of the trial itself, Giatras said it was one of the best he's been a part of.

"There was a lot of congeniality on both sides," he explained. "Everyone exchanged their materials. The trial went really smoothly. And on the plaintiff's side, I don't think there was one objection to the defendant's case."

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