• 08
  • June
    2011

In our previous post, we noted that Johnson & Johnson and its Ortho-McNeil Pharmaceutical unit are current facing a large number of lawsuits by patients who had tendon damage after taking the Levaquin, a drug developed to treat life-threatening infections.

One of the suits now on trial, brought by an 84-year-old man who had taken the drug in 2006, claims he was left with "permanent instability and loss of balance," and that he is unlikely to fully recover from his injury. That case is combined with nearly 1,000 other claims in a federal court in Minneapolis, Minnesota. Sources said another 1,512 cases are pending in a New Jersey federal court, as well as others in other states.

A previous trial on the drug ended in a $700,000 award for actual damages and an additional $1.1 million in punitive damages. In that case, the plaintiff was found 10 percent liable for his injuries.

Although Levaquin has always come with label warnings concern potential tendon damage, the FDA required Johnson & Johnson, as well as manufacturers of other drugs in the same class, to provide enhanced warnings on the risk of tendon ruptures, particularly for patients over 60 years of age, those who take steroids, and those who have had kidney, heart, or lung transplants. But according to the claims now brought against Johnson & Johnson, the company was aware of the heightened risk, but failed to adequately warn doctors and patients.

Although regulators in France, Italy and Belgium sent letters warning doctors of the risk of tendon injury for elderly persons back in 2002, Ortho-McNeil heightened its label warning without sending letters of warning to doctors concerning the change, and later "muted" the warning.

The claim that the warning was "muted" refers to the fact that Johnson & Johnson's incomplete warning implied that elderly patients who weren't on steroids had no additional risk of tendon injury.

As these combined cases proceed, Johnson & Johnson may face additional liability on claims that its warnings concerning Levaquin were inadequate.

Source: Businessweek, "Johnson & Johnson Hid Antibiotic Levaquin Risk, Lawyer Says," Margaret Cronin Fisk and Beth Hawkins, 1 Jun 2011.