On Wednesday, a Minneapolis jury ordered the Johnson & Johnson (JNJ) subsidiary Ortho-McNeil-Janssen Pharmaceuticals to pay 87-year-old John Schedin $1.7 million because its antibiotic Levaquin so damaged his Achilles tendons that he lost his ability to play golf and walk through malls. Company spokesman Michael Heinley told DailyFinance, "We're disappointed with the jury's decision and will vigorously defend against plaintiff's claims on appeal."

The verdict is the first from approximately 2,600 similar lawsuits that have been filed so far in state and federal courts nationwide. More than 430 million prescriptions have been written for Levaquin, so more suits could follow.

Given that nearly two-thirds of the jury's award to Scheidin -- $1.1 million -- was in punitive damages, the loss is a bad omen for Ortho. What remains to be seen is how bad.

First, the verdict or damages could change on appeal. "The verdict and the amount of punitive damages is at odds with the evidence presented at trial," Heinley contends. Second, these product liability suits are very fact-driven, and it's likely that some or even many of the other suits have less plaintiff-friendly facts than Schedin's.

An Ideal Plaintiff?

On the other hand, to win, Schedin had to prove Ortho failed to adequately warn of the risks of taking Levaquin. On that issue, it's significant that in 2008, the FDA required Ortho to upgrade the warning that had been on the Levaquin packaging for many years to the most serious type: a Black Box Warning. That's exactly what it sounds like: A warning message highlighted by being placed inside a black rectangle on the drug's label to help it catch the attention of doctors and patients. If the original warning was adequate, why the upgrade? On the other hand, people who experienced negative side effects after the Black Box warning was put in place will have a harder time arguing that Ortho failed to warn them.

Although Heinley says, "We believe that Ortho-McNeil-Janssen Pharmaceuticals properly informed the public of the benefits and risks associated with Levaquin and acted responsibly," the Schedin jury didn't agree. Since the facts about Ortho's warnings won't vary radically from case to case, that's a bad sign for Ortho, at least for pre-Black Box cases.

Proving that the warnings were inadequate isn't enough to win, however. Plaintiffs must also prove that the drug was what damaged their tendons, and not something else, like playing tennis. On the causation issue, Schedin seems to have had particularly favorable facts. The risk of tendon damage is higher for the elderly, and higher still for people taking the drug in combination with a steroid, as the Schedin was. Finally, Schedin's tendon problems developed within three days of his taking the drug, suggesting that it was a trigger. Unlike the failure to warn issue, causation facts will vary significantly.

As a result, more verdicts, based on other fact patterns, will have to come down before the scale of liability faced by Ortho can really be assessed. And those verdicts will eventually come, as the company is not disposed to settle at this point. Heinley said, "With regard to the ongoing cases, the company intends to defend them on an individual basis."


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