I. EVIDENCE
A. The Cavitron
The Cavitron ultrasonic scaler is a prescription dental device that enables mechanized debridement of calculus from tooth root surfaces. It serves the same function as a dentist's hand scaler, but its tip vibrates at high frequency (25,000 or 30,000 hz) to assist in removing calculus deposits. Because the vibration generates heat, it sprays water from its vibrating tip to act as a coolant and to provide lavage (flushing) at the treatment site. All Cavitrons, except the "Select" model, are designed to be plumbed to an external water source. ( Weinstat , supra ,
The Cavitron has been widely used for over 40 years in a range of surgical and nonsurgical dental procedures. Class representative Dr. Patrick Keeley first learned about using Cavitrons during surgical procedures while he was in dental school in the 1970's. Dr. Keeley regarded the Cavitron as the "premier [ ]" scaler. And when the time came to get an ultrasonic scaler for his practice, he purchased a Cavitron because he "wanted the best" scaler. Dr. Keeley was quite familiar with using Cavitrons, as he had used them throughout his "entire career." Like Dr. Keeley, class representative Dr. Patricia Murray's exposure to Cavitrons spanned many years, beginning in dental school, where its instructional uses included periodontal surgery. Dr. Murray estimated that, between 2001 and 2006, she performed approximately 3,000 surgical procedures using a Cavitron.
B. The Cavitron is a Regulated Medical Device
The Cavitron is a "Class II" medical device regulated by the Food and Drug Administration (FDA), and is classified as a "surgical device."
C. Cavitron Directions
In 1993, the Directions indicated the Cavitron's use for "root planing during surgery." Dentsply also began marketing DiamondCoat handpiece scaling tips for use in surgical debridement. In 1997, new Cavitron models were introduced in which the indications were stated in broader language to encompass " '[a]ll general supra and subgingival scaling applications' and '[p]eriodontal debridement for all types of periodontal diseases.' " (1997 Directions). ( Weinstat , supra ,
Dr. Keeley testified that he never heard any contraindications about the Cavitron and assumed it could be used in surgery. Dr. Keeley admitted that he never read any Cavitron product literature before purchasing the device. He also admitted that he did not read the Directions. It was only after speaking with counsel, did Dr. Keeley ask his officer manager to get a copy of the Directions. Dr. Keeley first read the Directions while preparing for his deposition.
Dr. Murray also did not read the Directions prior to her 2002 purchase. She testified that she would not have purchased a $3,000 device if she knew it could not be used in surgery, because she already had $300 units that could have been used for nonsurgical purposes.
D. Periodontal Disease and Treatment
Periodontitis is a bacterial infection within a " 'periodontal pocket ' " that forms between the gum and adjacent tooth root surface and jaw bone. If untreated, it can lead to loss of the tooth or adjacent teeth. Periodontitis is treated by debriding (scraping, scaling, or planing) the bacteria-laden calculus (tartar) to remove it from the root and bone surfaces.
In more serious cases, periodontal debridement requires the opening of a gum with a scalpel to expose the infected root and bone surface beneath the gum. While the periodontal pocket itself is infected, cutting the gum exposes normally sterile internal (subcutaneous) tissues and blood vessels to infection from outside agents. On some occasions, this procedure entails cutting (recontouring) the adjacent bone. Periodontal debridement may be performed during various procedures, such as tooth extractions, gingivectomies, and dental implants. Basic periodontal debridement may be performed by periodontists, general dentists, and dental hygienists. However, periodontal debridement with surgical aspects may only be performed by general dentists and periodontists.
A "dental unit" is comprised of the dentist chair, with its directed light, instrument tray, rinsing cup, and automated instruments, including the high-speed hand drill, with lines for electrical power, rinse water, air, and evacuation from the mouth. The most common dental unit is the "A-Dec." Dental unit waterlines represent "the tubes that connect the highspeed handpiece, air/water syringe and ultrasonic scaler to the water supply." (American Dental Association (ADA), ADA Statement on Dental Unit Waterlines, 127 J. of Am. Dental Assn. (JADA) (Feb. 1996) p. 185.)
Biofilms represent "microbial communities that adhere to solid surfaces in the presence of moisture, and are found virtually everywhere in nature. Protected by a thin slime layer ... these microorganisms, which can include a wide variety of bacteria ... colonize and replicate in water sources forming a biofilm .... Since they are everywhere, biofilms are found in virtually all municipal water lines, including drinking fountains, faucets, showerheads, and dental unit waterlines." (OSHA Review, Regulatory Compliance and Employee
Biofilm contamination of dental unit waterlines was first documented in the 1960's, but it was not until the 1990's that it garnered substantial interest in the dental industry. (OSHA Review at p. 1.) The ADA, as early as 1978, suggested flushing dental unit waterlines with germicides as a means of controlling biofilm formation. (Shearer, Biofilm and the Dental Office, 127 JADA (Feb. 1996) pp. 181, 187.) Since that time, the ADA has sought to develop a consensus solution for improving the quality of dental unit water. (Ibid. ) In 1995, the ADA issued its "Statement on Dental Unit Waterlines" (1995 ADA Statement), advising that various microorganisms in dental unit waterlines "inevitably" form biofilm on the interior surfaces of waterline tubing. (Id. at pp. 185, 187.) The 1995 ADA Statement acknowledged that then-existing commercially available options for improving water quality were limited and involved some additional expense. (Id. at pp. 185-186.) The included use of 1) independent water reservoirs; 2) chemical treatment regimens; 3) daily draining and air purging regimens; and 4) point-of-use filters. (Id. at p. 186.) The ADA urged manufacturers of dental equipment to "develop accessory components that can be retrofitted to dental units," to allow water to be supplied by an independent water reservoir and chemically treated to control biofilm. (Id. at p. 185.) The 1995 ADA Statement was included in the February 1996 JADA cover story, "Biofilm in the Dental Office." (Id. at pp. 181-188.) The cover story noted the absence of any scientific documentation establishing that biofilm in dental unit waterlines represents a definable public health risk. (Id. at p. 184.)
Dr. Rowland explained that by the 1990's, it had become common practice for California dentists to "close" their dental waterline systems to ensure an end-to-end treatment of the water. Systems can be closed in a variety of ways, including the use of bleach or other chemical to reduce the bacteria count. Dr. Keeley closed his system in the 1990's, and his officer manager, Patricia Mitchell, taught continuing dental education classes at his office on ways to control biofilm through waterline maintenance. Based upon coursework that she completed in 1990's and literature that she reviewed, as part of state mandatory continuing dental education on infection control, Mitchell understood that biofilm contamination in dental waterlines occurs when biofilm forms on the wall of small bore plastic tubing that delivers water to dental handpieces, ultrasonic scalers, and air water syringes. Mitchell implemented water treatment protocols for Dr. Keeley's office that included ultrasonic scalers connected to dental units.
Dr. Murray has a doctorate in microbiology and has taught dentistry, using Cavitrons. Dr. Murray also taught oral microbiology and infection control at the university level for 10 years. Since the mid-1990's, Dr. Murray weekly ran a 10 percent bleach solution through her Cavitrons. She was familiar with the Occupational Safety and Health Administration (OSHA) guidelines, California Dental Regulations and CDC guidelines.
Dr. Murray was also familiar with a 2001 article published in the Journal of Periodontology entitled "Evaluation of Ultrasonic Scaling Unit Waterline Contamination After Use of Chlorine Dioxide Mouth Rinse Lavage." The article was cowritten by one of Dr. Murray's colleagues, Dr. Robert Wirthlin.
Dr. Murray maintained, however, that she had no understanding that biofilm would form within Cavitrons. Dr. Murray did not have any information that was not privileged-i.e., independent from the information provided by class counsel that the Cavitron had a level of biofilm not present in her dental units.
F. Surgical Standards and Water Quality Guidelines
In 1993, the CDC released its "Recommended Infection-Control Practices for Dentistry, 1993." (CDC, Morbidity and Mortality Weekly Report, Recommendations and Reports, Vol. 42, No. RR-8 (May 1993) (1993 CDC Recommendations).) The recommendations included a section on dental unit water quality, advising: 1) sterile water for surgical procedures that involved the cutting of bone; and 2) thorough flushing of all waterlines between each patient and at the beginning of each day. (1993 CDC Recommendations at pp. 7-8.)
Then, in 1994, the Dental Board of California (DBC) adopted the 1993 CDC Recommendations as legal mandates, requiring minimum water quality standards in
The 2003 CDC Guidelines cautioned that "[c]onventional dental units cannot reliably deliver sterile water even when equipped with independent water reservoirs because the water-bearing pathway cannot be reliably sterilized." (2003 CDC Guidelines, at p. 29.) Instead, "[d]elivery devices (e.g., bulb syringe or sterile, single-use disposable products) should be used to deliver sterile water ...." (Ibid. ) The 2003 CDC Guidelines further noted that oral surgery and implant handpieces, including ultrasonic scalers were commercially available that bypass the dental unit to deliver sterile water or other solutions by using single-use disposable or tubing capable of being sterilized. (Ibid. )
Dr. Keeley agreed that most procedures, whether surgical or nonsurgical, produce blood. He also agreed with the OSHA Review that it is difficult to define "surgery" for purposes of sterile water delivery. Dr. Keeley explained that in any given procedure a dentist may switch between treated drinking water and sterile water. He gave the example of doing three quadrants of scaling and surgery on two teeth. In that situation, he said a dentist might scale with the treated water and then switch to sterile water when in the surgical area. Based on his professional judgment and training, Dr. Keeley selected the type of water depending on the nature of the procedure and the needs of the patient.
Dr. Murray, like Dr. Keeley, used her professional judgment when deciding whether to use water from her A-Dec unit or sterile water from a bulb syringe. Although Dr. Murray knew that once sterile water was input in an A-Dec unit, it came out unsterile, she still expected the Cavitron hooked up to her A-Dec unit to output sterile water. Upon further cross-examination, she admitted that even if sterile water was input into a Cavitron, the output into a patient's mouth would not be sterile. Between 2001 and 2006, Dr. Murray had performed approximately 3,000 surgeries using a Cavitron. And, each time she performed one of those procedures, she was aware that the Cavitron did not provide sterile water. Based on her professional judgment as a trained periodontist and microbiologist, she deemed the Cavitron was safe for those procedures.
II. DISCUSSION
A. Standard of Review
We generally apply the familiar substantial evidence test when the sufficiency of the evidence is at issue on appeal. Under this test, " '[W]e are bound by the established rules of appellate review that all factual matters will be viewed most favorably to the prevailing party [citations] and in support of the judgment .... "In brief, the appellate court ordinarily looks only at the evidence supporting the successful party, and disregards the contrary showing ." [Citation.] All conflicts, therefore, must be resolved in favor of the
However, when the trier of fact has expressly or implicitly concluded the party with the burden of proof did not carry the burden and that party appeals, " 'it is misleading to characterize the failure-of-proof issue as whether substantial evidence supports the judgment .... [¶] Thus, where the issue on appeal turns on a failure of proof at trial, the question for a reviewing court becomes whether the evidence compels a finding in favor of the appellant as a matter of law. [Citations.] Specifically, the question becomes whether the 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." ' " ( Dreyer's Grand Ice Cream, Inc. v. County of Kern (2013)
"Where, as here, the judgment is against the party who has the burden of proof, it is almost impossible for him to prevail on appeal by arguing the evidence compels a judgment in his favor. That is because unless the trial court makes specific findings of fact in favor of the losing plaintiff, we presume the trial court found the plaintiff's evidence lacks sufficient weight and credibility to carry the burden of proof. [Citations.] We have no power on appeal to judge the credibility of witnesses or to reweigh the evidence." ( Bookout v. State of California ex rel. Department of Transportation (2010)
B. Fraudulent Practices Under the UCL
1. Applicable Law
The UCL prohibits as unfair competition "any unlawful, unfair or fraudulent business act or practice. ..." ( Bus. & Prof. Code, § 17200.) Written in the disjunctive, this language "establishes three varieties of unfair
Under the "fraudulent" prong, a business practice violates the UCL if it is "likely to deceive the public. [Citations.] It may be based on representations to the public which are untrue, and ' "also those which may be accurate on some level, but will nonetheless tend to mislead or deceive .... A perfectly true statement couched in such a manner that it is likely to mislead or deceive the consumer, such as by failure to disclose other relevant information, is actionable under" ' the UCL. [Citations.] The determination as to whether a business practice is deceptive is based on the likely effect such practice would have on a reasonable consumer." ( McKell v. Washington Mutual, Inc. (2006)
In cases involving advertising or statements that are not literally false,
"The fraudulent business practice prong of the UCL has been understood to be distinct from common law fraud. 'A [common law] fraudulent deception must be actually false, known to be false by the perpetrator and reasonably relied upon by a victim who incurs damages. None of these elements are required to state a claim for injunctive relief' under the UCL. ( Day v. AT & T Corp. (1998)
2. Plaintiffs Failed to Prove the Directions Were Likely to Mislead a Significant Portion of the Targeted Consumers Acting Reasonably
The Directions provided that the Cavitron could be used in " '[p]eriodontal debridement for all types of periodontal diseases.' " To be sure this wording is not a model of clarity, periodontal debridement can be just a deep cleaning or it could involve surgical aspects, such as cutting open a gum. Add to that the ambiguous reference to "all types of periodontal diseases," which arguably could include diseases requiring surgery, the Directions, to the general public, could be viewed as representing that the Cavitron is suitable for surgical use. However, the fatal flaw in this reasoning is that the targeted consumers of this product are licensed dental professionals.
Whether a statement or advertisement is likely to mislead is generally a question of fact. (See Linear Technology Corporation v. Applied Materials, Inc. (2007)
Several cases examine the knowledge base of the targeted consumer in
In Lavie , supra ,
Both Chern and South Bay challenged the identical banking practice of lending money at a " 'per annum' " interest rate that was based on a 360-day year, rather than a full year, thus favoring lenders. Chern held that, "[i]n the absence of any evidence" that the general public understood the "365/360" lending practice, the practice was misleading, i.e., likely to mislead future bank customers from the general public, under the UCL as a matter of law, despite the class representative's discovery of the loan terms shortly before signing the agreement. ( Chern , supra , 15 Cal.3d at pp. 873, 876,
The South Bay plaintiffs challenged the same practice on behalf of car dealerships who received General Motors financing (GMAC) and cited Chern . ( South Bay , supra ,
As noted in Lavie, " South Bay was a case involving loans made to 'a financially sophisticated automotive dealership with knowledge of the lender's use of the 365/360 method in the parties' ongoing relationship.' ( [ South Bay , supra ,]
As a question of fact, it was squarely within the province of the trial court to evaluate whether the Directions were likely to deceive a significant portion of licensed dentists acting reasonably by examining the language in the
Dr. Murray testified that she used the Cavitron in thousands of surgeries based on her belief that the treated, potable water coming out of her dental unit was sufficiently safe. Dr. Murray conceded that she knew if she put sterile water into a Cavitron, the output would not be sterile. The trial court found Dr. Murray's testimony that she expected that the Cavitron would put out sterile water was not credible, in light of the fact that she has a doctorate in microbiology, directly assisted in experiments with waterline biofilm, and has known about the standards on sterile water in surgery since the mid-1990's.
Like Dr. Murray's credibility,
B. Breach of Warranty
As we explained in Weinstat , " Section 2313, subdivision (1)(a) and (b) of the California Uniform Commercial Code governs this cause, providing that express warranties are created as follows: '(a) Any affirmation of fact or promise made by the seller to the buyer which relates to the goods and becomes part of the basis of the bargain creates an express warranty that the goods shall conform to the affirmation or promise. [¶] (b) Any description of the goods which is made part of the basis of the bargain creates an express warranty that the goods shall conform to the description.' Hence, to prevail on a breach of express warranty claim, the plaintiff must prove (1) the seller's statements constitute an ' "affirmation of fact or promise" ' or a ' "description of the goods" '; (2) the statement was ' "part of the basis of the bargain" '; and (3) the warranty was breached." ( Weinstat , supra ,
In Weinstat , supra , we concluded that the Directions had formed an express warranty. (
Plaintiffs once again have failed to carry their burden of proof. The Cavitron is available only as a subset of the public and a sophisticated one at that-licensed dentists.
Their evidence was not uncontroverted or unimpeached and of such character and weight to leave no room for judicial determination that it was insufficient to support the trial court's conclusion that Dentsply promised or
III. DISPOSITION
The judgment is affirmed. Dentsply is entitled to costs on appeal. ( Cal. Rules of Court, rule 8.278(a)(1).)
We concur:
RUVOLO, P.J.
RIVERA, J.
Notes
As will be described in further detail, biofilm is a naturally occurring bacteria that adheres to solid surfaces in virtually all aquatic environments.
The FDA classifies numerous devices as "surgical devices," including hand instruments (
"Asepsis is the 'condition of being asceptic [sic ],' i.e., free 'from pathogenic microorganisms.' (Merriam-Webster's Collegiate Dict. (10th ed. 2001) p. 67 [definitions for 'aseptic' and 'asepsis '].)" (Weinstat , supra ,
Co-Counsel Edwin Zinman is a licensed attorney and licensed dentist. Drs. Zinman and Murray had known each other since 1985; Dr. Murray has acted as a paid expert in Dr. Zinman's dental malpractice claims. Dr. Zinman has also referred plaintiff patients to Dr. Murray for treatment as part of the damages requested in such dental malpractice claims.
The Environmental Protection Agency standard for safe drinking water is water having fewer than 500 "colony forming units" per milliliter of water (cfu/ml). (2003 CDC Guidelines, at p. 29.)
Dr. Keeley had known Dr. Zinman for approximately 30 years. Dr. Zinman called Dr. Keeley two weeks after he had purchased his Cavitron. During that conversation, Dr. Keeley agreed to be a class representative.
In the trial court, plaintiffs also claimed that Dentsply violated the unlawful prong by reason of its failure to comply with the MDA. Plaintiffs have not raised this issue on appeal.
Plaintiffs argue that the trial court improperly incorporated a reliance element into its fraud analysis under the UCL. The trial court, however, addressed reliance in terms of whether plaintiffs had established standing. We express no opinion on the standing analysis, as we have directly proceeded to merits.
The trial court also found plaintiffs' regulatory expert, Timothy Ulatowski, to be lacking in credibility because he did not know what was commonly known to dental practitioners. As such, he had no basis for opining what information should have been included in the Directions. Similarly, the trial court was not persuaded by the opinion of plaintiffs' human factors expert, Alison Vrendenburgh. The trial court determined Vrendenburgh was similarly not in a position to render an opinion about the type of warnings that were advisable. We will not second-guess these determinations. (See In re Maya L. (2014)