Patricia Murray Dental et al. v Dentsply International, DCA1/4, 1/10/18
This is an ill-conceived UCL class action brought by dentists against the maker of a dental device called Cavitron, an ultrasonic scaler. The dentists said that the scaler’s water-line would build up biofilm (a film covering microbes of bacteria), and couldn’t deliver sterile water into a patient’s mouth during surgical procedures. The dentists alleged that the risk of biofilm build-up wasn’t disclosed by the manufacturer. After a month long bench trial, the trial court found for Dentsply: As licensed dentists, plaintiffs knew the very facts that they claimed weren’t disclosed by Dentsply. They therefore failed to meet their burden of proof that the class was “likely” to be misled, the key element of UCL’s fraudulent business practices prong. Dentists appealed. Held: Affirmed.
The actual holding isn’t surprising becauseto the trial court’s ruling makes sense—dentists know about the potential for biofilm build-up in the water lines associated with their dental equipment, and have for a very long time—and challenging whether there was substantial evidence in support of the finding that dentists knew that biofilm would build up, is a long shot. Moreover, as the court noted, the plaintiffs’ task on appeal is almost impossible when the trial court finds that plaintiffs failed to meet their own burden of proof—The appellate court won’t reweigh the evidence or make judge witness credibility.
The court includes a brief discussion of the Federal Food, Drug and Cosmetic Act. The Cavitron is a regulated surgical device, and can only be sold to licensed dentists. Such a device is “misbranded” unless its label bears “adequate directions for use.” Adequate directions for use means directions under which the layman can use a device safely and for the purposes for which it is intended.’ (21 C.F.R. § 801.5 (2009).) By definition, ‘adequate directions for use’ cannot be prepared for prescription devices such as the Cavitron, because these devices must be used under the supervision of a licensed practitioner. However, such devices will escape the deemed designation of being ‘misbranded’ where, among other conditions, ‘[l]abeling on or within the package from which the device is to be dispensed bears information for use, including indications, effects, routes, methods, and frequency and duration of administration, and any relevant hazards, contraindications, side effects, and precautions under which practitioners licensed by law to administer the device can use the device safely and for the purpose for which it is
intended, including all purposes for which it is advertised or represented . . . .’
(Id., § 801.109(c) (2009).) The court said Dentsply accomplishes this directive by providing ‘Directions []’, . . . which it expects the dentist to read and follow in using the Cavitron.”
Dentsply’s old directions did not include contraindications—it has since changed that. However, at trial its expert testified that:
“it was not necessary for the Cavitron to include a biofilm warning because any dental healthcare professional, whether a periodontist, general dentist, or hygienist has a fundamental understanding of what biofilms are, both the biofilm on the tooth surface and the biofilm that accumulates in the waterline or could potentially accumulate in a waterline.”
The court gave a brief history of the biofilm issue in dentistry: It was first documented in the 1960s, and became a major issue in the 1990s, because of the prevalence of biofilms, the threat they pose to health, and the fact they and are difficult and/or expensive to clean and control. Even Plainitff’s expert testified that they were a “hot-topic.”
The lead plaintiffs were well aware of the biofilm issue, the each took steps to control it in his/her office; one even has a doctorate in microbiology and taught infection control! In addition, that same named plaintiff was familiar with the study co-written by one of her colleagues that included this finding concerning biofilms: “The same problems occurring in fixed dental units occur in portable accessory equipment such as ultrasonic scalers . . . . Typical ultrasonic scaling units might have over 16 feet of fine tubing, from the water connection to the end of the handpiece, in which to form biofilm.”
Therefore, the testimony by that lead plaintiff that she had no understanding that biofilm would form within the Cavitrons is, well, laughable.
The trial court held that the plaintiff’s failure to meet their burden of proof had a significant impact on the standard of review on appeal. Under the “substantial evidence” review the court looks only to the evidence in support of the judgment to see if it is sufficient. When the trial court finds that plaintiff failed to meet its burden of proof, there generally is a presumption that the trial court found that plaintiff’s evidence lacked sufficient weight and credibility to carry the burden of proof. In other words, the appellate court has no power on appeal to judge credibility or rewrite evidence.
With those words, you can almost hear the last nail being driven in the coffin.
A final comment on how to evaluate whether an ad or statement is “likely” to deceive under the UCL. The court confirmed that a court can look at the group of consumers targeted by the ad when evaluating whether the statement is likely to mislead the “reasonable” consumer. In other words, the trier of fact could look at whether a licensed dentist purchasing a Cavitron would be deceived by the failure to disclose the danger of biofilm build-up, and ignore the general consuming public—including people like me, who had never heard of biofilm until a couple of hours ago—because they weren’t the targeted consumer base.