Tuesday, October 10, 2017

Uncontradicted testimony that defendant’s claim lacks scientific support requires judgment for plaintiffs

Rosendez v. Green Pharmaceuticals, No. D071073, 2017 WL 4400011 (Cal. Ct. App. Oct. 4, 2017) (unpublished)

Plaintiffs alleged that Green’s SnoreStop, a homeopathic remedy for snoring, was a sugar pill falsely advertised to stop snoring. Although the trial court found the testimony of Green’s homeopathy expert was not credible and gave it no weight, the court also concluded that plaintiffs failed to meet their burden of proof on their UCL, FAL, and CLRA claims, noting they “proceeded on the theory that there is no scientific basis for the advertised efficacy of SnoreStop” but “provided no evidence of tests to determine the efficacy of SnoreStop.” The court of appeals reversed, implicitly rebuking a number of recent cases that have (wrongly) interpreted California’s standard—which does not allow private plaintiffs to require substantiation from defendants—as precluding claims by private plaintiffs that rely on evidence that shows no scientific support for the defendant’s scientific claims.

Green claimed that a clinical study showed that 79.5 percent of SnoreStop users reported noticeable improvements within the first five nights, but the study, according to plaintiffs, didn’t support the findings attributed to it and “is instead characterized by severe methodological deficiencies.” SnoreStop allegedly “simply consists of a myriad of toxic substances that are provided in such extremely diluted form that they have no impact on the human body whatsoever.”  Homeopathy relies on dilution, and of SnoreStop’s seven “purportedly active ingredients,” five were diluted to one part per million, one of to one part per ten thousand and one part per million, and one to one part per trillion.

Plaintiffs’ expert was Dr. Lynn Willis, who has a Ph.D. in pharmacology.  Willis testified about the two fundamental principles of homeopathy—the law of similars (treat a disease with substances that cause symptoms mimicking the disease) and the principle of dilution (diluting drugs makes them more powerful).   Willis testified he was not aware of any valid scientific support for dilution, which is in direct opposition to dose response theory, the basic principle of pharmacology.  The theory of homeopathy is that tapping the diluted solution against a hard surface causes a release of healing energy, but this has never been detected.  Based on his education, training, research, and scientific review of homeopathic literature, Willis opined that the homeopathic law of similars is “not compatible with conventional theories of how drugs and other medications work,” and was contrary to proven scientific theory, as was dilution.  He also specifically addressed each of SnoreStop’s seven “active” ingredients (including belladona) and their dilution levels.  He testified that each ingredient would not, in isolation, relieve snoring, and that he was unaware of any credible scientific evidence to support the claim that the combination, at that dilution level, would be able to shrink swollen tissues that block air passages (as claimed by defendant).  He further testified that defendant’s clinical study was unreliable: among other things, it relied on snorers’ bedmates’ opinions, and it failed to include a power analysis to figure out how many subjects would be needed to detect a real difference.  The study also showed that 45% of the placebo group showed a reduction in snoring, meaning that the test group was also likely responding due to placebo response.  The net improvement that should have been attributed to the treatment group was thus 20.4%, and he concluded that the study should not be relied on to claim efficacy for SnoreStop.

Plaintiffs’ evidence also included the named plaintiff’s testimony about her own experience with SnoreStop and its inefficacy for her.

At the close of plaintiffs’ case, Green moved for judgment as a matter of law, which was denied.  Green called, as an expert on homeopathy, Gregory Dana Ullman, who testified that he practiced homeopathy and had written hundreds of articles on homeopathy. He testified that he believed all of the statements at issue on the SnoreStop package label were accurately stated and correct.  After closing arguments, the court concluded that plaintiffs failed to meet their burden of proof, because Dr. Willis couldn’t testify to the product as a whole, and thus there was insufficient evidence that the combined ingredients failed to work.  As to the study, the court found that Dr. Willis hadn’t conducted counter-testing of his own or proved that the study was flawed.  However, the court found Ullman’s testimony not credible and entitled to no weight, in part because of his support for the use of a radionics machine, whereby a physician puts a picture of his patient on one side, and a few medicines on the other side, and then sees which of the medicines the needle points toward.

When the trial court concludes that the party with the burden of proof failed to carry that burden, the question on appeal is whether the evidence compels a finding in favor of the appellant as a matter of law. This requires a finding that appellant’s evidence was (1) “uncontradicted and unimpeached” and (2) “of such a character and weight as to leave no room for a judicial determination that it was insufficient to support a finding.”  A trier of fact isn’t automatically required to give a verdict that conforms to expert opinion, even if unanimous; the value of the expert opinion depends on the quality of the evidence the expert provides.  The trier of fact can only be reversed unless it could not, in light of the record, reasonably reject the expert’s testimony, which was the case here.
“Willis’s expert testimony regarding the efficacy of SnoreStop was uncontradicted and unimpeached and constituted ample proof that SnoreStop is not an effective snoring remedy.” Willis had relevant training and expertise; he testified that there was no valid scientific support for the dilution theory, and that it contradicted dose response theory, “the basic principle of pharmacology. Willis also testified that he had never detected any evidence to support the homeopathic idea that striking a substance releases healing energy, noting that ‘science has no way to measure this energy.’” Thus, he opined that homeopathic theories were “contrary to proven scientific theory.”  This testimony was unimpeached and uncontradicted; the trial court gave Green’s witness testimony no weight. And uncontradicted and unimpeached testimony of an expert witness may not be “arbitrarily disregarded” by the trier of fact. 
“Willis’s testimony about the inefficacy and scientific implausibility of homeopathy in general alone was sufficient to satisfy plaintiffs’ burden of proving the inefficacy of SnoreStop as a snoring remedy.”

Moreover, his testimony wasn’t limited to homeopathy in general, because he also testified about the inefficacy of each of SnoreStop’s “active” ingredients and the inefficacy of those ingredients in combination. The trial court mischaracterized his testimony in stating that Willis “could not testify as to the product as a whole.” But he testified that each ingredient wouldn’t work, and that he wasn’t aware of  any credible scientific evidence that the combination would work and that he was of the opinion that they wouldn’t.  Also, though the court stated that plaintiffs didn’t prove that Green’s cited study was flawed, Willis testified about a number of flaws in the study.  Contrary to the trial court’s statement, plaintiffs provided scientific evidence to support their theory that there is no scientific basis for the advertised efficacy of SnoreStop.

The trial court based its holding largely on plaintiffs’ lack of tests on the actual SnoreStop tablets. But Willis “was entitled to accept the information on the label and could competently testify that given that information, there is no scientific basis to conclude that SnoreStop could have any effect on snoring beyond a placebo effect.” An expert’s opinion is not unreliable simply because the expert’s opinions are based on data collected by others. Because Willis’s reasoning, qualifications, or credibility were unchallenged, the rejection of his opinions was arbitrary.

“Given the uncontradicted and unimpeached evidence that the fundamental principles of homeopathy have no basis in science and that SnoreStop in particular is not an effective remedy for snoring, the court should have found for plaintiffs on both of their causes of action and awarded the appropriate relief requested in plaintiffs’ complaint.”  In a footnote, the court noted that one older California appellate case suggested that if a homeopathic product is listed in the Homeopathic Pharmacopoeia of the United States (HPUS), its efficacy is sufficiently established under the FDCA to avoid false advertising liability. However, unlike non-homeopathic OTC drugs, homeopathic OTC drugs are not evaluated by the FDA at all, and the FDA explicitly says that a homeopathic drug’s compliance with the requirements of the HPUS “does not establish that it has been shown by appropriate means to be safe, effective, and not misbranded for its intended use.” So inclusion in the HPUS or compliance with FDA guidelines regarding the HPUS “does not establish, much less guarantee, the product’s efficacy.”

Finally, the trial court’s apparent decertification of the class was in error; there was no indication that the requirements for certification were no longer satisfied at the time of trial. The trial court was directed to determine the damages, restitution, and other relief to which the plaintiff class members were entitled. 

No comments: