Last week, a Florida appellate court affirmed a defense verdict in a products liability case despite finding that the trial court had erred by excluding evidence. The evidence that was excluded was that the U.S. Food and Drug Administration had later banned the substance at issue, ephedrine, some six years after the Plaintiff took it. In that case, Webster v. Body Dynamics, Inc., the appellate court found the exclusion constituted harmless error, in part because of the Plaintiff’s successful introduction of evidence indicating the risks of ephedrine through an FDA witness. See — So.3d —-, No. 1D08-5114, 2010 WL 624182 (Fla. Ct. App. Feb. 24, 2010) [PDF].
The Plaintiff, a twenty six year old university student at the time of the alleged injury, suffered a stroke in the summer of 1998. For four months prior to the stroke, he had been taking Super Mini/Mini Thin Natural pills, dietary supplements containing ephedrine alkaloids, which were later banned in 2004 by the FDA. The Plaintiff sued the manufacturer and the retail establishment at which he had purchased the pills. The defendants’ theory was, in part, that young men occasionally have strokes for unexplained reasons, and the appellate court noted that “[t]he jury apparently concluded this was one such case.” (Bolstering the defense theory was the fact that no ephedrine was found in the Plaintiff’s system at any time after the stroke.).
Both before and during trial, the judge refused to take judicial notice of the ban or otherwise permit evidence of it to be heard by the jury. The appellate court found that in excluding evidence of the ban the trial court “arguably” erred because such evidence can be introduced to establish that a later-recalled product was defective at the time of the litigated injury, even if that injury occurred before the recall. However, the court found that any error was harmless. In so doing, the court noted that the jury “may well have concluded that there was no convincing proof that ephedrine was in the plaintiff’s system when he suffered the stroke.” It also referenced the detailed testimony of Dr. Parisian, an FDA official who recounted the FDA’s pre-1998 public warnings on ephedrine and the substance’s risks, including the risk of adverse effects, such as strokes, in young people taking the substance. Dr. Parisian also testified that with each pill the Plaintiff had ingested more than three times the amount of ephedrine that she considered “unreasonably dangerous” in such supplements. Nevertheless, the appellate court rejected the the notion that Dr. Parisian should have been able to testify to the ban:
. . . Dr. Parisian’s testimony conveyed in great detail the health and safety concerns that underlay the FDA’s proposal to adulterate dietary supplements containing ephedrine alkaloids in excess of eight milligrams per pill, and ultimately led to the ban of dietary supplements (but not other over-the-counter medications) containing any ephedrine alkaloid at all. Dr. Parisian testified unequivocally that manufacturers continued to market dietary supplements containing ephedrine at levels not recognized as safe and effective by the FDA. She opined in no uncertain terms that the pills Mr. Webster allegedly consumed were “unreasonably dangerous.” The testimony that strokes had been associated with ephedrine use was uncontroverted.
Dr. Parisian’s testimony explained to the jury the reasoning behind the eventual ban of dietary supplements containing ephedrine, and the entire rationale eventually set forth in the text of the rule effecting the ban. The appellant has not demonstrated a reasonable probability that proof of the ban itself would have led to a different result.
See id. at *2 (Footnotes omitted).
The majority’s ruling drew a dissent from Justice Thomas, who argued that “[a] mandatory recall and ban is relevant evidence and demonstrates a product’s design defect, even where the recall and ban is issued after the date of the product’s manufacture.” Presumably, there’s still time for the Plaintiff to appeal this decision, so perhaps the Florida Supreme Court will address the issue.