Jury to Settle Adequacy of Drug Warning Label

MINNEAPOLIS (CN) - Johnson and Johnson and several other pharmaceutical companies cannot dismiss claims that a man ruptured his Achilles' tendons because of inadequate drug labels, a federal judge ruled.

A doctor prescribed the antibiotic Levaquin to Clifford Straka after he developed an upper respiratory infection in 2006. The drug's warning label included a section about possible tendon ruptures, but the Food and Drug Administration did not add a black-box warning to the drug, emphasizing the risks of tendon ruptures, until 2008.

Straka ruptured his Achilles' tendons just nine days after starting his prescription and filed suit, claiming the warning labels did not accurately portray the drug's risks.

When questioned about the prescription, Straka's doctor said she did "not remember if she had read the package insert for Levaquin," according to the court's summary. She also "testified that she was not aware of the risk of tendon injury associated with Levaquin ... at the time of the prescription - nor did she become aware of the risk or the warning on the label until a couple of years ago."

Johnson and Johnson, McNeil-Janssen Pharmaceuticals and Ortho-McNeill Pharmaceutical moved for summary judgment, arguing that "they had no duty to warn other than through the label and regardless of the adequacy of the label.

They also claimed that Straka cannot prove causation because Dr. Baniriah did not read the label before prescribing Levaquin to Straka," the court summarized.

U.S. District Judge John Tunheim disagreed, however.

"Although Dr. Baniriah admitted she did not remember reading the Levaquin package insert in 2006, she did not state that she had never read the Levaquin package insert prior to her prescribing decision," Tunheim wrote (emphasis in original). "Rather, she merely testified that she was not aware of the language regarding tendon disorders in the package insert."

Straka can also claim that the drugmakers violated Minnesota's Consumer Fraud Act since "the court finds that this lawsuit may indirectly cause defendants to redress a public safety hazard, a result that would benefit the public, as required by the Private Attorney General Act."

"The court also rejects defendants' argument that the Levaquin label now contains the strongest warning warranted; it is at least theoretically possible that comparative labeling or stronger wording could be added to the label, and additional enumeration of the drug's risks could potentially provide a public benefit," Tunheim wrote.

"Determining whether the defendants' warning was adequate - and what type of communication was required to make it adequate - is a question of fact for the jury," the 12-page decision concludes.

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