Patricia A. Murray Dental Corp. v. Dentsply Int'l, Inc.

227 Cal. Rptr. 3d 862, 19 Cal. App. 5th 258
CourtCalifornia Court of Appeal, 5th District
DecidedJanuary 10, 2018
DocketA141377
StatusPublished
Cited by34 cases

This text of 227 Cal. Rptr. 3d 862 (Patricia A. Murray Dental Corp. v. Dentsply Int'l, Inc.) is published on Counsel Stack Legal Research, covering California Court of Appeal, 5th District primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Patricia A. Murray Dental Corp. v. Dentsply Int'l, Inc., 227 Cal. Rptr. 3d 862, 19 Cal. App. 5th 258 (Cal. Ct. App. 2018).

Opinion

REARDON, J.

*261Plaintiffs brought this action on behalf of California dentists who purchased the Cavitron ultrasonic scaler (Cavitron) for use during oral surgical procedures. Plaintiffs sued defendant Dentsply International, Inc. (Dentsply)-the manufacturer and marketer of the Cavitron-asserting causes of action under the Unfair Competition Law (UCL) ( Bus. & Prof. Code, §§ 17200 et seq. ) and for breach of express warranty. The gist of plaintiffs' claims is that the Directions for Use (Directions) indicate Cavitrons can be used in " '[p]eriodontal debridement for all types of periodontal diseases,' " which by implication includes oral surgery, but in fact they cannot because the device accumulates biofilm1 in its waterlines and is incapable of delivering sterile water during surgical procedures. This is the second appeal in this case. In the first appeal, we reversed the trial court's denial of class certification and remanded for the limited purpose of deciding whether the named representatives could meet the UCL standing requirements specified in In re Tobacco II Cases (2009) 46 Cal.4th 298, 93 Cal.Rptr.3d 559, 207 P.3d 20 ( Tobacco II ), and if not, whether amendment should be permitted. ( *866Weinstat v. Dentsply International, Inc. (2010) 180 Cal.App.4th 1213, 1236, 103 Cal.Rptr.3d 614 ( Weinstat ).) After certifying the class and conducting a nearly month-long bench trial, the trial court found in favor of Dentsply on all claims. The trial court found that plaintiffs, as licensed California dentists, were well aware that biofilm forms in all dental waterlines and that Cavitrons do not produce sterile water. Accordingly, the trial court determined that the dental professionals already knew the facts which they claim ought to have been disclosed. As such, the evidence failed to establish that the class was likely to be misled. Similarly, the trial court concluded that the weight of the evidence established that dental professionals did not understand the warranty that the Cavitron was suitable for use in " '[p]eriodontal debridement for all types of periodontal diseases,' " as a statement that the Cavitron delivered sterile *262water, or water without biofilm. Finding substantial evidence supports the trial court's rulings, we affirm the judgment.

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 , 180 Cal.App.4th at p. 1220, 103 Cal.Rptr.3d 614.)

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."2 ( 21 C.F.R. § 872.4850 (2014).) It is only sold to licensed dentists. As noted in Weinstat , "the Cavitron comes under the purview of the FDA, with its sale restricted to dental professionals. The original iterations of the Cavitron predate the Medical Device Amendments of 1976 (MDA) to the Federal Food, Drug and Cosmetic Act. Because the subsequent, *867post-MDA versions are substantially equivalent to the preexisting technology, the newer versions have been cleared for marketing by the Food *263and Drug Administration through a premarket notification process rather than the full premarket approval process. (See 21 U.S.C. § 360(k) ; 21 C.F.R. § 807.92(a)(3) (2009).)... [¶] Under the Federal Food, Drug and Cosmetic Act, a medical device is deemed misbranded unless its labeling bears 'adequate directions for use.' ( 21 U.S.C. § 352(f)(1).) '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.

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Cite This Page — Counsel Stack

Bluebook (online)
227 Cal. Rptr. 3d 862, 19 Cal. App. 5th 258, Counsel Stack Legal Research, https://law.counselstack.com/opinion/patricia-a-murray-dental-corp-v-dentsply-intl-inc-calctapp5d-2018.