On April 22, 2003, the California Court of Appeals handed down a unanimous decision in favor of Frank King, a doctor of chiropractic and naturopathic physician, against the National Council Against Health Fraud (NCAHF). The court upheld a Superior Court ruling issued in December 2001, in which NCAHF failed to provide any supportive evidence that homeopathic remedies produced and marketed by Dr. King's company were ineffective. The ruling is a significant victory for alternative-health-care practitioners, and deals a major blow to the credibility of NCAHF and those who testified on its behalf, including its former chairman, self-proclaimed "quackbuster" Dr. Stephen Barrett.
Dr. King is the president of King Bio Pharmaceuticals, a registered homeopathic manufacturing company. He also is a member of the Homeopathic Pharmacopoeia Convention, a group of homeopathic practitioners. All of the homeopathic remedies marketed by King Bio are listed in the Homeopathic Pharmacopoeia, and comply with regulations imposed by the Food and Drug Administration (FDA).
On Feb. 16, 2001, NCAHF filed suit against King Bio in California Superior Court, claiming numerous violations of the state's Business and Professions Code. In its complaint, NCAHF alleged that the advertising claims for 50 King Bio homeopathic remedies were false and misleading, and that the products were not effective.
Instead of providing scientific evidence against the efficacy of the remedies, however, NCAHF tried to persuade the court that King Bio's remedies were "drugs," and that the burden of proof - that the homeopathic remedies work as advertised - should therefore be shifted to King Bio. The case proceeded to trial, with Barrett and fellow "quackbuster" Wallace Sampson, MD, offering "expert" testimony on behalf of NCAHF.
Once evidence from both sides was presented, King Bio filed a motion for judgment, on the grounds that NCAHF failed to provide enough evidence to substantiate its claims. After weighing the evidence submitted by NCAHF, Judge Haley J. Fromholz granted King Bio's motion and ruled against NCAHF - but not before issuing a stinging rebuke of the council and its "expert witnesses."
Court documents obtained by Dynamic Chiropractic reveal that NCAHF failed to provide ample evidence that the burden of proof should be shifted to King Bio. "There appears to be no case in California to support the shifting of the burden of proof to the defendant in a case of this type," the court stated. "The burden of establishing each element of its claims therefore lies with plaintiff NCAHF." The plaintiffs failed to establish these claims, however, because under cross-examination, it was revealed that NCAHF had never tested any of King Bio's remedies.
In terms of evidence, the court found that NCAHF "offered no documentary or other evidence to support its claims." In fact, the main piece of physical evidence offered by NCAHF consisted of a collection of Information downloads from its own Web site, and those documents only established what King Bio's claims were, not the alleged falsity of those claims.
Judge Fromholz was even more blunt in his admonishment of Barrett. After listening to his testimony, the judge observed: "As for his credential as an expert on FDA regulation of homeopathic drugs, the Court finds that Dr. Barrett lacks sufficient qualifications in this area," and added, "Dr. Barrett's purported legal and regulatory knowledge" [of homeopathic remedies] "is not apparent."
"For these reasons, there is no sound basis on which to consider Dr. Barrett qualified as an expert on the issues he was offered to address. Moreover, there was no real focus to his testimony with respect to any of the issues in this case associated with defendants' products," Judge Fromholz concluded.
Despite the overwhelming defeat in the trial court, NCAHF chose to challenge the judge's decision and filed an appeal. In their appeal, NCAHF again failed to provide any evidence that the homeopathic remedies manufactured and advertised by King Bio were ineffective. Instead, it argued that while the trial court correctly imposed the burden of proof under current California law, the law itself is incorrect and should be changed so that in false-advertising suits, the burden of proof rests with the defendant.
After hearing arguments from both sides, the Court of Appeals sided with King Bio. In a unanimous opinion, Justice Margaret Grignon spoke for the court: "We conclude there is no basis in California law to shift the burden of proof to a defendant in a representative false and unlawful competition action. We conclude further that the Legislature has indicated an intent to place the burden on the plaintiff in such cases. Finally, we conclude federal authority is not apposite."
With regard to NCAHF's allegations that King Bio's products were unsafe, the court ruled that King Bio had complied with the FDA's regulations, and that its products' safety and efficacy were well-established. "Prior to marketing of a product by King Bio, the general efficacy and safety of the remedy has been substantiated to the extent required by federal law. Public policy would not be furthered under these circumstances by requiring King Bio to substantiate its advertising claims as to general efficacy every time a private plaintiff brings a false advertising action. This federal regulation of homeopathic remedies also makes it less likely that there is a substantial probability of wrongdoing by King Bio."
Specifically, the Court of Appeals found that NCAHF "failed to prove a false or misleading statement" made by King Bio, and "presented no evidence that King Bio's products were not safe and effective, relying instead on a general attack on homeopathy, made by witnesses who had no knowledge of, or experience with, King Bio's products, and who were found to be biased and unworthy of credibility."
The court also ordered that NCAHF bear Dr. King's and King Bio's court costs.
References
National Council Against Health Fraud, Inc., v. King Bio Pharmaceuticals, Inc., Frank J. King, Jr., and Does 1-50. Case #BC 245271. Filed in Superior Court of California, county of Los Angeles, Feb. 16, 2001.
National Council Against Health Fraud, Inc., v. King Bio Pharmaceuticals, Inc., et al. Filed in the Court of Appeals of California, second appellate district, division five. Certified for partial publication, April 22, 2003.
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