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California Court Rules that Jury Can Consider Action or Inaction by the FDA to Show Whether a Product is Safe or Unsafe


In O’Neill v. Novartis Consumer Health, Inc., decided February 27, 2007, the Second District Court of Appeal in California affirmed a defense verdict on behalf of the manufacturer of a nasal decongestant containing the ingredient phenylpropanolamine, commonly known as “PPA.”

One issue on appeal had been a jury instruction that action or inaction by the U.S. Food and Drug Administration, though not dispositive, could be considered to show whether a product was safe or unsafe.  The appellate court found no instructional error, noting that the trial court did not suggest that FDA regulations set the standard for determining whether there was a design defect.

Appellants also unsuccessfully claimed that the trial court committed prejudicial error by permitting Novartis to challenge the validity of the Yale Study’s findings about PPA with evidence that some of the cases in that study were misclassified.  The appellate court found that California’s standards for admissibility of expert testimony based upon valid scientific methodology did not apply to the Novartis evidence and that there was no undue prejudice under California Evidence Code section 352 since Novartis timely disclosed its intent to rely on their experts to criticize the Yale Study.