Webster v. Body Dynamics, Inc.

• Decision Date: 24 February 2010
• Docket Number: No. 1D08-5114.,1D08-5114.
• Parties: Wesley WEBSTER, Appellant/Cross-Appellee, v. BODY DYNAMICS, INC. d/b/a BDI Pharmaceuticals, The Pantry, Inc. f/k/a Lil' Champ Food Stores, Inc. and Nittany Pharmaceuticals, Inc., Appellees/Cross-Appellants.
• Court: Florida District Court of Appeals

27 So.3d 805

Wesley WEBSTER, Appellant/Cross-Appellee, v. BODY DYNAMICS, INC. d/b/a BDI Pharmaceuticals, The Pantry, Inc. f/k/a Lil' Champ Food Stores, Inc. and Nittany Pharmaceuticals, Inc., Appellees/Cross-Appellants.

No. 1D08-5114.

District Court of Appeal of Florida, First District.

February 24, 2010.

Tracy Raffles Gunn of Gunn Appellate Practice, P.A., Tampa, for Appellant/Cross-Appellee.

David B. Weinstein and Kimberly S. Mello, Greenberg Traurig, P.A., Tampa, for Appellee/Cross-Appellant Body Dynamics, Inc.; Robert E. Biasotti of Carlton Fields, P.A., St. Petersburg, for Appellee/Cross-Appellant The Pantry, Inc.; and

Elliot H. Scherker and Brigid F. Cech Samole, Greenberg Traurig, P.A., Miami, for Appellee/Cross-Appellant Nittany Pharmaceuticals, Inc.

BENTON, J.

Wesley Webster, the plaintiff below, appeals a judgment exonerating all defendants in this negligent-failure-to-warn and products liability case. He argues the trial court erred in denying a pretrial motion seeking to put before the jury a Food and Drug Administration (FDA) rule banning all "dietary supplements"¹ containing ephedrine alkaloids, adopted some six years after a stroke felled him. The trial court excluded the FDA rule, and perhaps other evidence of the ban on ephedrine in dietary supplements, on grounds that the ban had no bearing on Mr. Webster's claims for damages for antecedent injuries. Exclusion may have been error but we affirm because any such error was harmless. Our disposition moots the cross-appeal.

Mr. Webster sued the manufacturers and/or distributors as well as the retail seller² of Super Minis³/Mini Thin Naturals,⁴ a "dietary supplement" containing ephedrine,⁵ alleging that they were legally responsible for his stroke. Dr. Triggs, one of the physicians Mr. Webster—at the time of the stroke, a 26-year-old university student—called at trial as a witness testified that sometimes young people have strokes for unexplained reasons. Another of the plaintiff's medical experts, Dr. Nadeau, testified that forty percent of the time young people suffer strokes, the cause is never identified. The jury apparently concluded this was one such case.

The stroke took place on June 6, 1998, after, Mr. Webster testified, he had ingested two Super Mini/Mini Thin Natural pills, one between six o'clock and seven o'clock the evening before, and one a few hours after that. He testified that taking two pills at such intervals had been his custom approximately two days every week over the previous four months.⁶ But neither Mr. Webster's blood nor his urine yielded any evidence of ephedrine present in his system at any pertinent time. A drug profile performed on the blood sample taken when he was admitted to the hospital on June 6, 1998, and a more comprehensive toxicology profile conducted on June 10, 1998, revealed no sign of ephedrine.⁷ The jury returned a defense verdict finding that no defendant had placed any ephedrine-containing dietary supplement on the market "with a defect which was a legal cause of damage" to Mr. Webster.

Before trial, Mr. Webster's trial counsel had asked the court to take judicial notice of the FDA rule "adulterating"⁸ dietary supplements containing ephedrine alkaloids, issued by the FDA in 2004, six years after Mr. Webster's stroke. See Final Rule Declaring Dietary Supplements Containing Ephedrine Alkaloids Adulterated Because They Present an Unreasonable Risk, 69 Fed. Reg. 28,6788 (Feb. 11, 2004) (to be codified at 21 C.F.R. pt. 119). In the rule—135 pages in length—the FDA premises the adulteration on its "conclusion that the risks of these products outweigh their benefits," explaining:

We are using this rulemaking authority for dietary supplements containing ephedrine alkaloids because ... it is more efficient to declare these products adulterated as a category than to remove them from the market in individual enforcement actions in which we would have to establish, for each individual product, that they present a significant or unreasonable risk.

. . . .

The government's burden of proof for `unreasonable risk' can be met with any science-based evidence of risk and does not require a showing that the substance has actually caused harm in particular cases.

Id. at 28,6794, 28,6798. The trial judge declined to take judicial notice of the rule and reserved ruling on its admissibility "with the understanding" that under no circumstance would he allow the entire 135-page document into evidence. The trial judge reasoned that the FDA rule in its entirety was "way more than any jury in this particular case even needs to begin to understand...." At trial, plaintiff's counsel asked the judge to "reconsider one aspect" of his pretrial ruling, arguing the FDA ban was relevant to show that the dietary supplement Mr. Webster allegedly ingested was unsafe and ineffective. The trial judge did not, however, alter his ruling.

We assume for purposes of decision that counsel's request that the trial court "reconsider one aspect" of its ruling regarding the FDA ban on ephedrine in dietary supplements is properly viewed as a request for leave to question Dr. Parisian (an FDA employee in charge of verifying that clinical trials had demonstrated the safety and effectiveness of products before they were marketed) in order to establish the fact of the FDA ban (even though no proffer was made). On this assumption, the trial court arguably⁹ abused its discretion by denying the request to prove that all dietary supplements containing ephedrine were later taken off the market. As the dissent explains, evidence of a post-accident recall may be admissible in strict products liability cases to prove that the product was defective when it left the possession of the manufacturer.¹⁰

But Dr. Parisian testified at length about the FDA's investigation of dietary supplements containing ephedrine during the period before Mr. Webster's stroke. In 1993, the jury learned, the Commissioner of the FDA testified before Congress regarding serious adverse incidents associated with the use of ephedra, including stroke. In 1995, after receiving reports of injuries associated with dietary supplements containing ephedrine, the FDA conducted a public meeting to discuss the risks of ephedra. In 1996, the FDA issued a press release that listed the names of dietary supplements containing ephedra and warned of the risks associated with them. In 1997, in the wake of reports of young people suffering serious adverse events such as stroke and heart attack after consuming dietary supplements containing ephedra, the FDA proposed to adulterate dietary supplements containing more than eight milligrams of ephedrine alkaloids per pill.¹¹ Manufacturers failed to heed the FDA's warnings and continued marketing dietary supplements containing in excess of eight milligrams per pill. Dr. Parisian informed the jury of this history in some detail, and testified to her opinion that a dietary supplement with more than eight milligrams of ephedrine alkaloids was "unreasonably dangerous for a consumer."

On appeal, Mr. Webster asserts the judgment must nevertheless be reversed because the jury did not learn that the FDA subsequently banned all dietary supplements containing ephedrine alkaloids. But any error in this regard was harmless under the standard for harmless error applicable in civil cases. Reversal is unwarranted in a civil case unless the appellant demonstrates that "it is reasonably probable that a result more favorable to the appellant would have been reached if the error had not been committed." In re Commitment of DeBolt, 19 So.3d 335, 337 (Fla. 2d DCA 2009) (quoting Damico v. Lundberg, 379 So.2d 964, 965 (Fla. 2d DCA 1979)). Any error here in precluding Dr. Parisian's testifying to the fact the FDA banned dietary supplements containing ephedrine was harmless on at least two bases.¹²

The jury was asked to determine whether the defendants had marketed an ephedrine-laden dietary supplement "[1] with a defect [2] which was a legal cause of damage" to the plaintiff. If the jury answered in the negative because it found Super Minis/Mini Thin Naturals were not "a legal cause of damage" to Mr. Webster because he had ingested no detectable quantity of ephedrine in the pertinent time period, the trial court's failure to admit evidence of the FDA rule—which arguably tended to prove a defect, but not ingestion or other legal causation of the stroke Mr. Webster suffered—could not logically have affected the verdict. 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.

In any event, 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.¹³

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.

Affirmed.

KAHN, J., concurs; THOMAS, J., dissents with opinion.

1. Over-the-counter medicines for asthma and certain prescription medicines containing ephedrine are still on the market. The recommended maximum daily allowance for the asthma...