CENTER CITY PERIODONTISTS, P.C. et al v. DENTSPLY INTERNATIONAL, INC.

Filing 139

MEMORANDUM AND/OR OPINION SIGNED BY HONORABLE C. DARNELL JONES, II ON 7/24/17. 7/25/17 ENTERED AND COPIES E-MAILED.(ti, )

IN THE UNITED STATES DISTRICT COURT
FOR THE EASTERN DISTRICT OF PENNSYLVANIA

CENTER CITY
PERIODONTISTS, P.C., et al.,
Plaintiffs,
v.
DENTSPLY
INTERNATIONAL, INC.,
Defendant.

Jones, II

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CIVIL ACTION
NO. 10-774

J.

July 24, 2017
MEMORANDUM

Plaintiffs bring this action, on behalf of a putative class of dentists and periodontists
residing in Pennsylvania and New Jersey, for breach of express warranty claims arising from
alleged deficiencies in the design and labeling of various models of the Cavitron ultrasonic
scaler, a dental device used for a variety of procedures above and below the gum line. Amend.
Compl. ¶¶ 9-10, ECF No. 36. Defendant Dentsply International, Inc., a Delaware corporation,
manufactures and markets the Cavitron and sells the device through authorized distributors
across the United States including Pennsylvania and New Jersey. Id. at ¶¶ 5-7.
The gravamen of Plaintiffs’ claims is that the Cavitron is not, and never was, safe or
suitable for its indicated uses because the internal walls of the device’s waterlines naturally
accumulate biofilm, exposing patients and dental staff to potentially hazardous bacteria levels in
excess of safe water standards, even when operated and maintained in a manner consistent with
the Directions for Use and related materials (“DFUs”). Id. at ¶¶ 28-35. According to Plaintiffs,
that “inherent defect” constituted a breach of the Cavitron’s express warranty against “defects in
materials or workmanship” and, together with Dentsply’s failure to disclose the defect, amounted
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to a breach of an express warranty of safety and suitability contained in the DFUs. Id at ¶¶ 6475.
Presently before this Court is Plaintiffs’ motion for class certification and appointment of
class counsel pursuant to Rule 23 of the Federal Rules of Civil Procedure (the “Class Motion”).
ECF No. 54. Also pending before this Court are three motions to preclude expert testimony,
filed in connection with the Class Motion, under Daubert v. Merrell Dow Pharm., Inc., 509 U.S.
579 (1993) (the “Daubert Motions”). ECF Nos. 104, 124, and 125. After careful consideration
of the voluminous record and the parties’ submissions, this Court decides the motions in
Defendant’s favor. Class certification is therefore denied.
THE CLASS CERTIFICATION RECORD
Center City Periodontists, P.C., and Affiliated Periodontists of North Jersey, P.A.,
brought this action in February 2010, after their original action, commenced in December 2006,
was dismissed for lack of subject matter jurisdiction. Mitchel Goldman, D.D.S., a Pennsylvania
dentist, joined the instant suit as party plaintiff in August 2012.
Center City was established under the laws of Pennsylvania and is owned by the estate of
the deceased Carole N. Hildebrand, D.D.S., a periodontist in Philadelphia County. Amend.
Compl. ¶ 1. Affiliated Periodontists was established under the laws of New Jersey and is owned
by Robert A. Jaffin, D.M.D., and Ashkay Kumar, D.M.D., periodontists in Bergen County, New
Jersey. Id. at ¶ 2. Plaintiffs purchased Cavitrons for use in various non-surgical procedures,
such as teeth cleaning and root debridement. Id. at ¶¶ 1-3.
One of the Cavitron’s features is to deliver a high-pressure, pulsating water stream into a
patient’s mouth through a hand piece at the end of a flexible tube that is connected to the
device’s main body. Id. at ¶ 21. The water stream helps to keep the working area cool and free

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of debris during procedures. Rowland Aff. ¶ 15, Pls.’ Class Br., Ex. 1. Because water can be a
vehicle for pathogenic microorganisms, various regulatory and professional guidelines instruct
dental health care professionals (“DHCPs”) to use water of a certain quality for non-surgical
procedures like the ones performed with the Cavitron. See id. at ¶¶ 8-11.
In particular, the U.S. Centers for Disease Control and Prevention (CDC) publishes
infection control guidelines and recommendations that DHCPs must follow to be licensed in
Pennsylvania or New Jersey. See 49 Pa. Code § 33.211(a)(7); N.J. Admin. Code § 13:308.5(a)(2). In 1993, the CDC issued guidelines recommending that waterlines should be flushed
with water at the beginning of each clinic day and after treating each patient. CDC,
Recommended Infection-Control Practices for Dentistry, 42(RR-8) RECOMMS. & REP. 1, 7-8
(May 28, 1993), Class Opp’n Br., Ex. 18, ECF No. 60-8. It is undisputed that Dentsply
incorporated these guidelines into “all of the Cavitron Directions for Use distributed throughout
the relevant period.” Class Opp’n Br. 15 n.19, ECF No. 61. By 2003, the CDC was advising
DHCPs that the number of bacteria in water used for non-surgical dental procedures should be
no greater than 500 colony forming units per milliliter (cfu/ml), the regulatory standard for
potable water established by the U.S. Environmental Protection Agency. CDC, Guidelines for
Infection Control in Dental Health-Care Settings, 52(RR-17) RECOMMS. & REP. 1, 29 (Dec. 19,
2003), Class Opp’n Br., Ex. 21, ECF No. 60-12. The CDC explained that water flushing was not
enough to achieve this goal and recommended additional practices such as using adaptive
devices or closed water systems combined with chemical flushing and other measures in
consultation with manufacturers. Id.
Likewise, as early as 1996, the American Dental Association (ADA) started to advise
members, including Plaintiffs, that biofilm formation in waterlines should be managed using a

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combination of strategies such as chemical treatment and independent water reservoirs. ADA
Statement on Dental Unit Waterlines, 127 J. AM. DENT. ASS’N __, 186 (Feb. 1996) (“ADA
Statement”), Class Opp’n Br., Ex. 19-B, ECF No. 60-10. It noted, “Dental unit water systems
currently designed for general dental practice are incapable of delivering water of an optimal
microbiological quality.” Id. at 185, Ex. 19-A, ECF No. 60-9. Like the CDC, the ADA advised
dentists to monitor water quality in dental units and adhere strictly to maintenance protocols in
consultation with manufacturers to reach water quality standards. Id. at 186, ECF No. 60-10.
The ADA also encouraged manufacturers “to develop accessory components that can be
retrofitted to dental units currently in use, whatever sources (public or independent), to aid in
achieving this goal.” Id. at 185, ECF No. 60-9. Two years later, Dentsply introduced the Dual
Select, an accessory that can be used to retrofit Cavitrons to deliver water from a closed water
system. It also allows for chemical flushing of the device’s waterlines. As of 1997, the
Cavitron’s DFUs identified the Dual Select as an available accessory. Ingram Decl. ¶¶ 27-28,
Class Opp’n Br., Ex. 7, ECF No. 60-3. The ADA continued to update these recommendations
about every three years and, by 2004, its advice had largely converged with the CDC’s
guidelines. Class Opp’n Br. 17-20; see also Ingram Decl. ¶ 29. According to Plaintiffs’
infection control expert, it is reasonable to expect DHCPs to be familiar with the ADA’s
recommendations and, in the exercise of reasonable care, to incorporate them into their practices.
Rowland 11/6/07 Dep. 237-242, Class Opp’n Br., Ex. 11, ECF No. 60-3.
In addition to these recommendations and guidelines, the Cavitron’s DFUs provide
installation, operation and maintenance instructions. The DFUs are a product of the regulatory
regime that applies to Cavitrons under the Medical Device Amendments (MDA) to the Food,
Drug and Cosmetic Act, 21 U.S.C. §§ 360, et seq. Id. at 11-12. Under applicable regulations,

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DFUs must include a description of the device’s “indicated” uses, “contra-indications,”
“warnings” of any hazards or risks, and “precautions” as to any potential risks to the patient’s
health from receiving treatment with the device. See 21 C.F.R. § 801.109. The DFUs vary from
model to model but, after 1997, the “indicated uses” for all Cavitrons included “[p]eriodontal
debridement for all types of periodontal diseases” and “[e]ndodontic procedures.” Pls.’ Class Br.
14-15; see, e.g., Directions for Use § 1, Pls.’ Class Br., Ex. 18. And at least one version of the
DFUs indicated that the device was an “open water system.” See, e.g., Directions for Use § 5.2,
Pls.’ Class Br., Ex. 21. The DFUs also directed users to flush the waterlines on a regular basis.
Id. at § 9.1. It is undisputed that the DFUs lack any reference to biofilm or its pathogenic risks.
Since 1990, however, Cavitrons have also included an Infection Control Information
card, which states:
The objective of this information is to supplement published
general guidelines for reducing cross contamination of infectious
diseases when using a Dentsply® Cavitron® ultrasonic scaler during
routine dental care. In the event any regulatory agency disagrees
with this information, the agency requirements take precedence.
Class Opp’n Br. 26-27; see also id., Infection Control Information, Ex. 30, ECF No. 60-28
(emphasis added). The DFUs explicitly refer purchasers to this card, as well as applicable state
laws and the CDC’s and ADA’s recommendations, for “maximal operator and patient safety.”
See, e.g., Directions for Use § 4, Pls.’ Class Br., Ex. 18. In 2001, Dentsply issued a Service
Bulletin informing purchasers of the biofilm problem that can arise when failing to comply with
the CDC’s guidelines, and recommending the complete removal and replacement of biofilmclogged waterlines. Pls.’ Class Br. 23 n.26; see also id., Ex. 24. And, as of 2006, new DFUs
started to advise purchasers against using the Cavitron in any procedure that required asepsis,
i.e., the absence of pathogenic micro-organisms such as those found in biofilm. Pls.’ Class Br.

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15-16. The new DFUs also strongly recommended, but did not require, chemical flushing on a
weekly basis. Id. at 16; See Directions for Use § 9.2, Pls.’ Class Br., Ex. 21.
Because the DFUs did not require installation on a closed water system or chemical
flushing, nor warned buyers of the biofilm problem, Plaintiffs purportedly believed that the
Cavitron would always deliver potable water—consistent with safe water standards for its
indicated uses—when installed on an open water source and flushed only with water in
accordance with the DFUs. See Amend. Compl. ¶¶ 49, 55, 61; see also Pls.’ Class Br. 14-17,
ECF No. 54-1. Plaintiffs concede the Cavitron met those expectations at first. See Amend.
Compl. ¶ 71. They also implicitly admit that the Cavitron can be used safely and effectively
with “the purchase of expensive additional or substitute equipment or systems.” Id. at ¶ 69. In
fact, Plaintiffs used Cavitrons to treat patients without incident for years, even though they did
not always connect them to a closed water system, attach a Dual Select or equivalent device, or
flush the waterlines with a biocide on a regular basis. See Class Opp’n Br. 12-14. Over time,
however, Plaintiffs discovered that, when left untreated, the Cavitron’s waterlines naturally
accumulated potentially hazardous levels of biofilm. See Amend. Comp. ¶¶ 49-50, 55-56, 61-62.
They claim this “inherent defect” renders the Cavitron unsafe and unsuitable for its indicated
uses; a material fact Dentsply supposedly omitted from the DFUs on purpose. See id. at ¶¶ 33,
41, 71-73, 89.
Plaintiffs initially raised three counts, or theories of liability, for Dentsply’s allegedly
wrongful conduct: (1) breach of express warranty, (2) negligent design, and (3) a violation of
New Jersey’s Consumer Fraud Act (NJCFA) specifically on behalf of class members residing in
New Jersey. Id. at ¶¶ 64-91. This Court dismissed the NJCFA and negligent design claims, but
denied summary judgment on breach of warranty; thus only the express warranty claims remain.

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Plaintiffs now seek certification of the following class:
All dentists, periodontists, dental and periodontal practices, and
dental and periodontal schools and institutions (a) who are citizens
of the State of New Jersey or the Commonwealth of Pennsylvania,
respectively, (b) who purchased Cavitron ultrasonic scalers during
the time period January 1, 1997 to the date of trial, and (c) who
were using a public water source for their Cavitrons at the time of
installation (the “Class”).
Class Mot., ECF No. 54. Plaintiffs also request certification of two Subclasses: “Subclass 1: All
members of the Class who are citizens of the State of New Jersey,” and “Subclass 2: All
members of the Class who are citizens of the Commonwealth of Pennsylvania.” Id.
Plaintiffs submitted various expert reports and affidavits in support of the Class Motion,
including the report of Timothy Ulatowski, a former administrator for the U.S. Food and Drug
Administration (FDA) who opined on the regulatory regime applicable to the Cavitron, and the
report of Steven Hazel, a public accountant who offered methods for calculating damages based
on three distinct remedies. Dentsply submitted its own experts in opposition to certification,
including Eric Gaier, Ph.D., an economist offered to rebut Hazel’s opinions.
The Class Motion was fully briefed on December 6, 2013, and after a series of
continuances requested by the parties, the certification hearings began on January 13, 2016. This
Court adjourned the proceedings into the summer to allow counsel the opportunity to examine
experts. In the interim, Dentsply moved to preclude Ulatowski’s and Hazel’s testimonies, and
Plaintiffs moved to preclude Dr. Gaier’s. The hearings concluded on August 9, 2016. This
Court is now prepared to rule on the Class Motion and related Daubert Motions.
DISCUSION
“To obtain class certification, plaintiffs must establish all four elements of Rule 23(a)
along with one provision of Rule 23(b).” Johnston v. HBO Film Mgmt. Inc., 265 F.3d 178, 183

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(3d Cir. 2001). Rule 23(a) requires a numerous class, common questions, typical claims, and
adequate representation. Id. Because Plaintiffs seek to proceed under Rule 23(b)(3), they must
also show that common issues predominate over individual ones and that a class action is the
superior vehicle for adjudicating the dispute. Id. at 184. The other “essential pre-requisite”
under Rule 23(b)(3) is “ascertainability.” Byrd v. Aaron’s Inc., 784 F.3d 154, 162 n.5 (3d Cir.
2015) (quoting Marcus v. BMW of N. Am., LLC, 687 F.3d 583, 592-93 (3d Cir. 2012)).
The Third Circuit requires rigorous analysis and consideration of “all relevant evidence
and arguments presented by the parties” to assure the requirements of Rule 23 are met. In re
Hydrogen Peroxide Antitrust Litig., 552 F.3d 305, 320 (3d Cir. 2008), as amended (Jan. 16,
2009). Rigorous analysis will frequently “entail some overlap with the merits of the plaintiff’s
underlying claim. That cannot be helped. ‘[T]he class determination generally involves
considerations that are enmeshed in the factual and legal issues comprising the plaintiff’s cause
of action.’” Wal-mart Stores, Inc. v. Dukes, 564 U.S. 338, 351 (2011) (quoting General Tel. Co.
of SW v. Falcon, 457 U.S. 147, 160 (1982)) (alteration supplied).
With this in mind, this Court first resolves the Daubert Motions before proceeding to the
Class Motion. See In re Blood Reagents Antitrust Litig., 783 F.3d 183, 187 (3d Cir. 2015) (“a
district court must make a conclusive ruling on any challenge to [an] expert’s qualifications or
submissions before it may rule on a motion for class certification.”) (citing Messner v.
Northshore Univ. HealthSystem, 669 F.3d 802, 812 (7th Cir. 2012)).
I.

Defendant Prevails on the Daubert Motions
The Daubert analysis governing the admissibility of expert testimony emerges from

Federal Rule of Evidence 702, which sets out three requirements commonly known as

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“qualification, reliability and fit.” Calhoun v. Yamaha Motor Corp., U.S.A., 350 F.3d 316, 321
(3d Cir. 2003) (quoting Schneider v. Fried, 320 F.3d 396, 405 (3d Cir. 2003)).
Qualification demands that “the witness possess specialized expertise.” Id. (quoting
Schneider, 320 F.3d at 405). The Third Circuit has “interpreted this requirement liberally,
holding that a broad range of knowledge, skills, and training qualify an expert as such.” Id.
(internal quotation marks omitted).
For reliability, “the expert’s opinion must be based on the methods and procedures of
science rather than on subjective belief or unsupported speculation; the expert must have good
grounds for his or her belief.” Id. (internal quotation marks omitted). “[T]he trial judge must
determine whether the testimony has ‘a reliable basis in the knowledge and experience of the
relevant discipline.’” ZF Meritor, LLC v. Eaton Corp., 696 F.3d 254, 294 (3d Cir. 2012)
(quoting Kumho Tire Co. v. Carmichael, 526 U.S. 137, 149 (1999)). The reliability prong
“applies to all aspects of an expert’s testimony: the methodology, the facts underlying the
expert’s opinion, [and] the link between the facts and the conclusion.” Id. at 291 (quoting Heller
v. Shaw Indus., Inc., 167 F.3d 146, 155 (3d Cir.1999)) (alteration supplied).
Fit means that “the expert’s testimony must be relevant for the purposes of the case and
must assist the trier of fact.” Calhoun, 350 F.3d at 321 (quoting Schneider, 320 F.3d at 405); see
also Meadows v. Anchor Longwall & Rebuild, Inc., 306 F. App’x 781, 790 (3d Cir. 2009) (“The
expert’s testimony must ‘fit’ under the facts of the case so that it will aid the [fact finder] in
resolving a factual dispute.”) (internal quotation marks omitted).
The proponent of the expert testimony has the burden of establishing its admissibility by
a preponderance of the evidence. Padillas v. Stork-Gamco, Inc., 186 F.3d 412, 418 (3d Cir.

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1999) (citing Daubert, 509 U.S. at 592 n.10); see also Mahmood v. Narciso, 549 F. App’x 99,
102 (3d Cir. 2013).
A. Ulatowski’s Expert Opinion Is Inadmissible
Plaintiffs have not demonstrated the admissibility of Ulatowski’s expert testimony.
Ulatowski is an “expert consultant on matters concerning medical device regulations, policies
and procedures administered by the [FDA].” Ulatowski Report 4, Pls.’ Class Br., Ex. 16. He
also has experience in the field of infection control for medical devices, germicides, sterilizers
and disinfectants. Pls.’ Ulatowski Br. 6, ECF No. 111. His opinions focus almost exclusively on
Dentsply’s compliance (or non-compliance) with the FDA’s labeling requirements and other
regulations. See Ulatowski Report 37-52.
Ulatowski’s qualifications and the reliability of his testimony are not in doubt. He holds
a bachelor’s degree in microbiology and a master’s degree in physiology with an emphasis on
biomedical engineering. Id. at 4. To support his expert opinions, he draws upon “36 plus years
of training, knowledge and utilization of the FDA medical device regulations, policies, review
procedures and practices.” Id. at 9. The totality of his “knowledge and experience” provides “a
reliable basis,” ZF Meritor, 696 F.3d at 294, for opining on the FDA’s regulatory and
administrative requirements involving medical devices and infection control practices.
The admissibility of Ulatowski’s testimony hinges on whether his opinions “fit under the
facts of this case.” Calhoun, 350 F.3d at 321. For purposes of answering this question, the
parties agree that the relevant factual inquiries are: (1) whether the Cavitron’s DFUs contain an
express warranty of safety and suitability, and (2) whether Dentsply breached that warranty.
Compare Pls.’ Ulatowski Br. 7 with Def.’s Ulatowski Br. 1, ECF No. 104-1.

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Accepting these limitations, Ulatowski’s testimony does not reach the relevant factual
issues, nor can his expertise assist the trier of fact in any other way. After all, finding that the
Cavitron includes a warranty of safety and suitability will depend on the language in the DFUs,
not the text of the FDA’s regulations. And establishing Dentsply’s breach will depend on
whether the Cavitron conformed to Dentsply’s representations, not the FDA’s regulatory
requirements. 1 During the hearings, Ulatowski all but admitted his testimony was irrelevant to
class certification or the merits of this case. He was unfamiliar with Rule 23’s requirements.
Class Cert. Hr’g Tr. 1/15/16 at 115:5-13. He agreed that the FDA does not deal with contractual
or warranty issues for medical devices. Id. at 91:17-93:1-5. And he admitted he cannot opine on
whether the DFUs create a warranty or whether prospective class members understood them as
such. Id. 93:18-95:13. In a separate, but related case, he also conceded that he cannot opine as
to whether or not dentists, “as a group,” looked at the DFUs. Pls.’ Ulatowski Br. at 8 n.8.
Plaintiffs’ arguments to the contrary are not persuasive. To start, Plaintiffs do not cite
any case in which a court admitted a regulatory expert’s testimony in support of a breach of
warranty or breach of contract claim, or any class certification case for that matter. Still,
Plaintiffs argue that Ulatowski’s testimony helps to show they can satisfy the commonality,
typicality and predominance requirements under Rule 23, because those factors focus on
“defendant’s conduct, and Mr. Ulatowski’s testimony will establish that Dentsply’s
representations . . . were both uniform throughout the class period and incorrect.” Pls.’
Ulatowski Br. 8 (emphasis in original).
But Ulatowski’s expertise is not necessary for determining the DFUs’ uniformity. The
DFUs speak for themselves, and a layperson is able to evaluate their uniformity without expert

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Plaintiffs acknowledge as much when they assure this Court that that their breach of express warranty claim is not
based on any purported violations of the FDA’s regulations. Pls.’ Ulatowski Br. 7.

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assistance. Nor is Ulatowski able to opine on the correctness of the DFUs. Indeed, he does not
know how Cavitron users interpreted the DFUs. Class Cert. Hr’g Tr. 1/15/16 at 95:7-23. He
cannot comment on how the DFUs interact with infection control guidelines; he did not even
know that DHCPs are required by law to comply with the CDC’s recommendations. Id. at
126:15-25. And he is not qualified to offer clinical opinions as to the Cavitron’s suitability for
its intended uses when connected to an open water source. Id. at 101:3-10; see also Pls.’
Ulatowski Br. 6-7. Ulatowski’s testimony does not fit this breach of warranty case and is
therefore inadmissible.
B. Hazel’s Expert Report Is Precluded
Hazel’s expert report is also precluded. Hazel is a certified public accountant and
possesses other certifications and accreditations in fields such as financial forensics and business
valuation. Hazel Report App. B, Pls.’ Class Br., Ex. 40. He proposes procedures for calculating
potential damages based on three remedies: reimbursement, retrofit, and replacement. 2 Id. at 3.
He opines that each of these costs could be proven through a combination of invoices and selfreported eligibility “verification” forms. Id. at 3-6.
Dentsply does not attack Hazel’s qualifications. Rather, it contends Hazel’s opinions are
unreliable and his “analysis does not fit this case.” Def.’s Hazel Br. 1, 4-6, ECF No. 124-1.
According to Defendant, Hazel incorrectly presumes that the Cavitron is “worthless” and
therefore fails to consider, and could not account for, the device’s value when used on an open
system. Id. at 4-6. Also, “Hazel’s class-wide damages do not fit Plaintiffs’ theory of liability

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Hazel anticipates that some class members will be entitled to full reimbursement of the Cavitron’s purchase price.
Hazel Report 3. Other class members may be entitled to restitution for costs incurred from retrofitting eligible
Cavitrons from an open onto a closed water source, including necessary auxiliary devices and chemical
disinfectants. Id. 4-5. Lastly, Hazel identifies alternative scalers that “could” deliver potable water without biofilm
formation, and posits that some class members would be entitled to recover the costs of replacing their Cavitrons for
one of these other scalers. Id. at 5-6.

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because they are not traceable to the alleged breach of express warranty,” as required under
Comcast Corp. v. Behrend, 133 S. Ct. 1426 (2013). Id. at 4, 6-7. Furthermore, Hazel’s
“opinions could not possibly prove damages here on a class-wide basis,” because individualized
trials would be required to determine class eligibility and “warranty damages.” Id. at 1.
Dentsply’s arguments are on point. When calculating damages for breach of warranty,
both New Jersey and Pennsylvania credit “the value of the goods accepted,” 13 Pa. Cons. Stat.
§ 2714 and N.J. Stats. Ann. § 12A:2-714, which includes any value obtained even with the
alleged defect. See, e.g., Bouie v. Chrysler Corp., No. 95-cv-4146, 1996 WL 460768, at *2
(E.D. Pa. Aug. 14, 1996) (“the standard measure of damages is the difference between the good
as warranted and the good in its defective condition,” citing 13 Pa. Cons. Stat. § 2714(b)); cf.
Samuel-Bassett v. KIA Motors Am., Inc., 357 F.3d 392, 402 (3d Cir. 2004) (finding that the
jurisdictional amount in a breach of warranty case could not be established solely from evidence
of the purchase price because the record did not include any data to ascertain “the value of the
automobile with and without the brake defect.”).
Hazel’s methodology fails to account for any revenue generated by class members from
successfully using their allegedly non-conforming Cavitrons—value Hazel conceded should be
discounted from any damages award. Hazel Hr’g Tr. 2/26/16 at 26:14-21. Hazel also indicated
that he would have modified his methodology to account for any value gained had he known that
Plaintiffs were using the device for its intended uses without incident. Hazel Hr’g Tr. 2/26/16 at
27:6-28:15. Failure to do so rendered his model unreliable and ill-fitting under the facts of this
case. Because individualized inquiries will be necessary to identify any value obtained by each
class member from using the Cavitron as accepted, Hazel’s approach is also unhelpful for
computing damages on a class-wide basis.

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Another impediment to admitting Hazel’s testimony is Comcast, which held that “a
model purporting to serve as evidence of damages in this class action must measure only those
damages attributable to that theory.” Neale v. Volvo Cars of N. Am., LLC, 794 F.3d 353, 374 (3d
Cir. 2015) (quoting Comcast, 133 S.Ct. at1433). As in Comcast, Plaintiffs originally brought
this case under multiple theories of liability, including violations of New Jersey’s consumer
fraud laws in addition to breach of express warranties. Hence, Hazel submitted an “expert
opinion on the range of damages that were sustained by Plaintiffs and the Class as a result of the
breach of express warranties by Dentsply and the conduct alleged under the New Jersey
consumer fraud law.” Hazel Report 3 (emphasis added). Because this Court dismissed the
consumer fraud claims, Hazel’s undifferentiated methodology is now irrelevant for purposes of
determining damages that are solely “the result of the wrong.” Comcast, 133 S. Ct. at 1434. 3 As
Hazel conceded, his model does not distinguish between damages attributable to the specific
breach alleged in this case or “something else.” Hazel Hr’g Tr. 2/26/16 at 58:14-59:4. Hazel’s
testimony is therefore precluded.
C. Dr. Gaier’s Expert Testimony Is Admissible
By contrast, Dr. Gaier’s testimony satisfies the requirements under Daubert. Dentsply
retained Dr. Gaier “to evaluate: (1) the ascertainability of the putative class, (2) the feasibility of
a common class-wide damages methodology, and (3) the report and expert opinions of plaintiffs’
damages expert Steven J. Hazel.” Gaier Decl. ¶ 5, Class Opp’n Br., Ex. 55, ECF No. 60-31.
Dr. Gaier’s qualifications and experience are more than sufficient to opine on methods
for computing economic damages in a breach of warranty case involving medical devices. He
holds a Ph.D. in economics from Duke University, and he “specialize[s] in performing economic
3
Although Comcast turned on “the straightforward application of class-certification principles” under Rule 23, 133
S. Ct. at1433, the parties implicitly agree it applies under Daubert. Regardless, Hazel’s methodology is unreliable
and unhelpful under either a Daubert or Rule 23 analysis.

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and statistical analyses of competition and pricing” for litigation and regulatory matters
involving “health insurance, pharmaceutical pricing and reimbursement, medical devices, [and]
surgical supplies.” Id. at ¶ 4.
Dr. Gaier’s opinions are reliable because they are supported by facts and do not venture
into the realm of “subjective belief or unsupported speculation.” Calhoun, 350 F.3d at 321.
Specifically, his conclusions that an individualized inquiry is necessary to ascertain class
membership and determine damages are based on his data analysis expertise, as well as his
review of Plaintiffs’ own experiences. Gaier Decl. ¶¶ 10-28. And his testimony fits this case
precisely because it sheds light on the difficulties of ascertaining class membership in an
objective manner and calculating damages on a class-wide basis pursuant to Rule 23(b)(3).
Plaintiffs do not offer any legitimate grounds for precluding Dr. Gaier’s expert opinions.
They do not challenge his qualifications other than to attack his supposed lack of “forensic
expertise,” Pls.’ Gaier Br. 4, ECF No 125-1, which has no obvious bearing on his ability to opine
on the feasibility of ascertaining class membership or class-wide damages. Plaintiffs’ attempts to
undermine his credibility and reliability fall short. Dr. Gaier’s purported failure to review “the
entire record” appears to be inconsequential; Plaintiffs did not identify a single document that
would have led Dr. Gaier to a different conclusion had he reviewed it. See id. at 4-5.
Plaintiffs are also mistaken when stating that Dr. Gaier’s “testimony does not fit any
theory of liability under Pennsylvania or New Jersey law, or the facts of this case.” See id. at 1.
Even though Dr. Gaier did not cite the most relevant legal authorities, he based his damages
formula on the applicable provisions of the Uniform Commercial Code (UCC), see Gaier Decl. ¶
28, which New Jersey and Pennsylvania have adopted, see 13 Pa. Cons. Stat. § 2714 and N.J.
Stats. Ann. § 12A:2-714. He also provides a fact-based explanation for why computing damages

15

in this case necessarily involves individualized inquiries based on Plaintiffs’ own experiences
and “each potential class member’s particular configurations.” See Gaier Decl. ¶¶ 23, 27. Dr.
Gaier’s testimony is admissible.
Having ruled on the Daubert Motions, this Court now addresses the Class Motion.
II.

Plaintiffs Have Not Met Their Burden for Class Certification
Class certification is not appropriate on the present record. Plaintiffs have not met their

burden of proving, by a preponderance of the evidence, that each of the prerequisites under Rule
23(a) is satisfied or that the class fits within the desired categories of class actions set forth in
Rule 23(b). See In re Hydrogen Peroxide, 552 F.3d at 320, n.14. “Failure to meet any of Rule
23(a) or 23(b)’s requirements precludes certification.” Danvers Motor Co., Inc. v. Ford Motor
Co., 543 F.3d 141, 147 (3d Cir. 2008).
A. Plaintiffs Do Not Meet All Four Requirements of Rule 23(a)
The analysis begins with the four requirements of Rule 23(a):
(1) the class is so numerous that joinder of all members is
impracticable; (2) there are questions of law or fact common to the
class; (3) the claims or defenses of the representative parties are
typical of the claims or defenses of the class; and (4) the
representative parties will fairly and adequately protect the
interests of the class.
Fed. R. Civ. P. 23(a) (emphasis added). Plaintiffs have demonstrated commonality, but failed to
prove typicality, adequacy or numerosity.
1. Plaintiffs’ claims satisfy commonality.
Commonality is met so long as “the named plaintiffs share at least one question of fact or
law with the grievances of the prospective class.” Reyes v. Netdeposit, LLC, 802 F.3d 469, 486
(3d Cir. 2015) (quoting Rodriguez v. Nat’l City Bank, 726 F.3d 372, 382 (3d Cir. 2013)). “A
court’s focus must be ‘on whether the defendant’s conduct [is] common as to all of the class
16

members[.]’” Id. (quoting Sullivan v. DB Invs., Inc., 667 F.3d 273, 298 (3d Cir.2011) (en banc))
(alterations supplied). The inquiry turns on “the capacity of a classwide proceeding to generate
common answers apt to drive the resolution of the litigation.” Wal-Mart, 564 U.S. at 350
(quoting Richard A. Nagareda, Class Certification in the Age of Aggregate Proof, 84 N.Y.U. L.
REV. 97, 132 (2009)) (emphasis supplied). The bar for establishing commonality is “not high”
and may be overcome even “when class members did not have identical claims[.]” In re Cmty.
Bank of N. Virginia Mortg. Lending Practices Litig., 795 F.3d 380, 397 (3d Cir. 2015).
According to Plaintiffs, commonality is met “because the breach of warranty claims all
share as the common issue that Dentsply represented in the [DFUs] that the Cavitron was
suitable for its indicated dental uses if purchasers followed Dentsply’s installation and
maintenance instructions.” Pls.’ Class Br. 38. Resolving this allegation, Plaintiffs argue, “will
resolve an issue that is central to the validity of each one of the claims in one stroke.” Id.
(quoting Wal-Mart, 564 U.S. at 350). Besides needing to prove the uniformity of Dentsply’s
representations, Plaintiffs must also prove that Dentsply breached that warranty by designing a
defective device and/or concealing the defect. Pl.’s Class Br. 39. This Court agrees that these
questions “will result in common answers that apply across the board to all members of the
Class.” Id. That is enough for commonality.
2. Plaintiffs do not satisfy typicality.
Even when common issues exist, however, typicality is designed to “screen out class
actions in which the legal or factual position of the representatives is markedly different from
that of other members of the class[.]” Marcus, 687 F.3d at 598 (quoting 7A Charles Alan
Wright, et al., Federal Practice and Procedure § 1764 (3d ed. 2005)). To determine whether a
plaintiff’s position is “markedly different,” courts address “three distinct, though related,

17

concerns: (1) the claims of the class representative must be generally the same as those of the
class in terms of both (a) the legal theory advanced and (b) the factual circumstances underlying
that theory; (2) the class representative must not be subject to a defense that is both inapplicable
to many members of the class and likely to become a major focus of the litigation; and (3) the
interests and incentives of the representative must be sufficiently aligned with those of the class.”
Id. (quoting In re Schering Plough Corp. ERISA Litig., 589 F.3d 585, 599 (3d Cir. 2009)).
Although the legal theory and factual basis for Plaintiffs’ claims are the same for all class
members (i.e., breach of express warranty based on Defendant’s alleged representations and
failure to deliver a conforming product), Dentsply raises several plaintiff-specific defenses that
undermine typicality. For instance, Dr. Hildebrand (Center City’s late owner) testified that she
purchased her Cavitron at a steep discount from an unauthorized Cavitron dealer. Class Opp’n
Br. 83. That fact alone could defeat her claim since Dentsply will argue that any existing
warranty covers only “products purchased from an authorized Dentsply Dealer.” Id. Dr.
Hildebrand also testified that she was aware of the biofilm problem, and even tried to close her
open systems after reading the 2003 CDC guidelines, Hildebrand 9/17/07 Dep. at 65:9-69:10,
Class Opp’n Br., Ex. 15, ECF No. 60-6, an admission that suggests she did not believe that
following Dentsply’s DFUs would be enough to comply with safe water standards. Likewise,
Dr. Jaffin (Affiliated Periodontists’ owner) and Dr. Goldman may have relied on their
professional knowledge or business judgment, not Dentsply’s DFUs, in deciding how to install
and maintain their Cavitrons. See Jaffin Dep. 9/26/07 at 122:16-123:14, Class Opp’n Br., Ex. 13,
ECF No. 60-4 (stating that cost and time may have factored into his decision to maintain his
Cavitrons on an open water source); Goldman Dep. 9/19/07 at 163:1-164:3, Class Opp’n, Ex. 16,

18

ECF No. 60-7 (stating that he believed an open water system complied with safe water standards
even after reading the 2003 CDC guidelines).
Indeed, none of the Plaintiffs read, or recall reading, all the relevant provisions of their
Cavitrons’ DFUs, yet they were all at least generally aware of the biofilm problem and the
various strategies for dealing with it based on their review of industry guidelines. See Class
Opp’n Br. 43-38, 44-46, 49-50 (citing each plaintiff’s deposition testimony). Because awareness
of a seller’s affirmations is a basic element of a breach of warranty claim in New Jersey and
Pennsylvania, Plaintiffs who were not aware of the DFUs’ relevant content cannot be typical
representatives of a class that was allegedly misled and damaged by Defendant’s representations
in those same DFUs. See Liberty Lincoln-Mercury, Inc. v. Ford Motor Co., 171 F.3d 818, 825
(3d Cir. 1999) (“a promise is presumed to be a ‘part of the basis of the bargain’ under New
Jersey law ‘once the buyer has become aware of the affirmation of fact or promise’”) (quoting
Cipollone v. Liggett Grp., Inc., 893 F.2d 541, 568 (3rd Cir.1990), overruled on other grounds,
505 U.S. 504 (1992)); Green v. Saturn Corp., No. 685, 2001 WL 1807390, at *6 (Pa. Com. Pl.
Oct. 24, 2001) (“the disparate and distinct ways and times that the Class members became aware
of the [alleged] representation, if they did at all, complicates the Court’s ability to determine
whether this representation became” a class-wide warranty).
Even assuming Plaintiffs lacked any knowledge about biofilm and relied solely on
Dentsply’s DFUs (a factual finding that would be at odds with their legal obligation to comply
with the CDC’s recommendations), Plaintiffs’ claims would still be markedly different from
those of class members like “schools and institutions” who were certainly familiar with the
biofilm problem and selected their equipment and infection control practices accordingly. See
Class Opp’n Br 24-25 (listing academic articles, starting in 1994, on biofilm in dental units).

19

These plaintiff-specific defenses, among other factors discussed below, make Plaintiffs’
positions different enough from those of the broader class so as to make it more likely that they
will “devote time and effort to the defenses at the expense of issues that are common and
controlling for the class.” Beck v. Maximus, Inc., 457 F.3d 291, 297 (3d Cir. 2006).
Plaintiffs’ claims are thus not sufficiently typical.
3. Plaintiffs do not satisfy adequacy.
In addition to defeating typicality, those same defenses weigh against Plaintiffs’ ability to
be adequate class representatives because plaintiff-specific defenses produce diverging “interests
and incentives” between Plaintiffs and the Class. See In re Cmty. Bank of N. Virginia, 795 F.3d
at 393 (“the linchpin of the adequacy requirement is the alignment of interests and incentives
between the representative plaintiffs and the rest of the class”) (quoting Dewey v. Volkswagen
Aktiengesellschaft, 681 F.3d 170, 183 (3d Cir. 2012)); see also Beck, 457 F.3d at 301 (“A
proposed class representative is neither typical nor adequate if the representative is subject to a
unique defense that is likely to become a major focus of the litigation.”) (emphasis added)); J.H.
Cohn & Co. v. Am. Appraisal Assocs., 628 F.2d 994, 999 (7th Cir. 1980) (“the presence of even
an arguable defense peculiar to the named plaintiff or a small subset of the plaintiff class may
destroy the required typicality of the class as well as bring into question the adequacy of the
named plaintiff’s representation.”) (emphasis added).
Another plaintiff-specific defense implicates the applicable statutes of limitations, an
issue that plagues two of the named Plaintiffs and militates against both typicality and adequacy.
In re Cmty. Bank of N. Virginia, 622 F.3d 275, 294 (3d Cir. 2010) (noting that timeliness of
claims touch on typicality and adequacy, but analyzing the issue under adequacy). Since breach
of warranty claims must be brought within four years of purchase, 13 Pa. Cons. Stat. § 2725(a),

20

(b) and N.J. Stats. Ann. § 12A:2-725(1), (2), any claims based on purchases pre-dating
December 2006 (the date the original action was commenced) would be time-barred. See Floyd
v. Brown & Williamson Tobacco Corp., 159 F. Supp. 2d 823, 831 (E.D. Pa. 2001) (the statute of
limitations starts “to run on the date of sale of the product.”). Center City acquired two
Cavitrons in February 2002 and Affiliated Periodontists purchased two in December 2001. Any
claims based on those purchases would therefore be untimely.
Plaintiffs argue that their untimely claims are saved by equitable tolling provisions
“allowing plaintiffs to bring claims for products purchased more than four years before, where
the defect was fraudulently concealed by the manufacturer and/or not discovered by the
purchaser until a later time or the warranty is unconscionable.” Pls.’ Supp. Br. 1, ECF No. 102.
This argument only highlights the complications that ensue from having plaintiffs with untimely
claims representing a class with timely claims. See In re Cmty. Bank of N. Virginia, 622 F.3d at
303 (noting that plaintiffs’ reliance on equitable tolling to save their claims was a “substantial
hurdle” that class members with timely claims did not need to overcome). Timely claims are
more valuable than untimely claims, because they require less effort to prosecute. Id. at 304
(citing Ortiz v. Fibreboard Corp., 527 U.S. 815, 857 (1999)). Having class representatives with
untimely claims creates an “intra-class conflict” because plaintiffs may be incentivized to spend
resources to save their less valuable claims without any obvious benefit to class members with
more valuable, timely claims. Id. at 303 (citing McAnaney v. Astoria Fin. Corp., No. 04-cv1101, 2007 WL 2702348, at *12 (E.D.N.Y. Sept. 12, 2007), on reconsideration in part, No. 04cv-1101, 2008 WL 222524 (E.D.N.Y. Jan. 25, 2008) (finding that named plaintiffs with untimely
claims did not “possess the same interest” as class members with timely claims and were

21

therefore “inadequate representatives of the instant class”)). Thus, Center City’s and Affiliated
Periodontists’ potentially untimely claims further separate their interests from those of the Class.
In addition to aligning “interests and incentives,” adequacy also concerns “the experience
and performance of class counsel.” Dewey, 681 F.3d at 181 (citing In re Cmty. Bank of N.
Virginia, 418 F.3d 277, 303 (3d Cir. 2005)). “When a close personal relationship exists between
the named representative and class counsel, ‘courts fear the danger of champerty,’” especially in
cases like this one where “attorneys’ fees will greatly exceed the class representative’s
recovery.” Martz v. PNC Bank, N.A., 2007 WL 2343800, at *5 (W.D. Pa. Aug. 15, 2007)
(denying class certification) (quoting London v. Wal-Mart Stores, Inc., 340 F.3d 1246, 1254
(11th Cir.2003)); see also Mowry v. JP Morgan Chase Bank, N.A., 2007 WL 1772142, at *4
(N.D. Ill. June 19, 2007) (“[g]iven that the potential recovery for Plaintiffs is minimal compared
to the potentially high amount of attorneys’ fees . . . [Plaintiffs] may be more concerned with
helping to maximize the monetary return of his friend, [class counsel], than to zealously advocate
on behalf of the class’ interests.”).
Mowry is particularly instructive. There, the plaintiff had been a personal friend of class
counsel for six years, and testified, “I’m here to help [the firm].” 2007 WL 1772142, at *4
(alteration supplied). Even though the friendship between the plaintiff and class counsel did not
rise to the level of a “familial relationship,” the court found them to be sufficiently close to raise
“serious concerns as to [the plaintiff’s] adequacy to represent the instant class.” Id.
These alarms sound even louder in the present case where Dr. Jaffin and one of plaintiffs’
counsels of record, Dr. Edwin Zinman, have been friends for twenty-five years—far longer than
the six years in Mowry—and “they still regularly keep in touch despite living on opposite
coasts.” Class Opp’n Br. 86 (citing Jaffin Dep. 9/26/07 at 30, Corrected Ex. 13, ECF No. 61-1).

22

Dr. Jaffin has even “treated members of Dr. Zinman’s family.” Id. As in Mowry, Dr. Jaffin also
testified that, when Dr. Zinman approached him about this lawsuit, Dr. Jaffin assured him, “If
there’s anything I can do to help you . . . let me know.” Jaffin Dep. 9/26/07 at 31:12-15.
Plaintiffs ignore these concerns.
For all these reasons, Plaintiffs are not adequate class representatives.
4. Plaintiffs have not proven numerosity.
The final requirement under Rule 23(a) is numerosity. Plaintiffs estimate that there are
more than 1,000 putative class members in each state based on “common sense assumptions.”
Pl.’s Class Br. at 36-37 (quoting Alberton v. Commonwealth Land Title Ins. Co., 247 F.R.D. 469,
476 (E.D. Pa. 2008)). Dentsply does not contest Plaintiffs’ numbers, but the court must make a
factual finding nonetheless. See Marcus, 687 F.3d at 596.
In Marcus, the Third Circuit found the district court had abused its discretion when it
“assumed,” “speculated,” or deferred to “common sense” with respect to how many class
members existed. Id. at 595-97. A plaintiff must produce evidence, direct or circumstantial,
“specific to the products, problems, parties, and geographic areas actually covered by the
proposed class definitions to allow a court to make a factual finding.” Id. at 596.
Although the Class may seem numerous at first glance, the record does not support it. As
in Marcus, Plaintiffs have not supplied sufficient evidence here to allow this Court to find that
the Class and Subclasses satisfy numerosity. Plaintiffs have adequate estimates for the number
of dentists practicing in New Jersey and Pennsylvania, but merely speculate as to how many of
them actually purchased Cavitrons during the class period based on Dentsply’s “company-wide”
rather than “state-specific” market share. See id. (holding that “nationwide” evidence “is not
necessarily sufficient to establish numerosity” for state-specific classes).

23

The estimated class size becomes even more speculative when trying to deduce how
many of the dentists who purchased Cavitrons in each state also connected their devices to an
open water source. For that calculation, Plaintiffs rely on a 2008 survey estimating that
approximately thirty-eight percent of dentists nationwide used public water in their practices
without even acknowledging that this study looked only at surgical rather than non-surgical
procedures, as would be relevant in this case. See Pls.’ Class Br. 37 (citing Jennifer Cleveland,
et al., Advanced Infection Control in Dental Care Settings, 143(10) J. American Dental Ass’n
1127 (October 2012)). None of the evidence supplied by Plaintiffs suffices to ascertain, or even
infer, the number of dentists who unwittingly used Cavitrons with public water for non-surgical
procedures in Pennsylvania or New Jersey. Plaintiffs have not met their burden on numerosity.
In sum, Plaintiffs failed to meet three of four requirements under Rule 23(a).
B. The Class Does Not Fit within the Contours of Rule 23(b)(3)
Even though failure to satisfy all of Rule 23(a)’s criteria precludes class certification, the
court must nonetheless address the conditions of Rule 23(b)(3), which requires a finding that
“questions of law or fact common to class members predominate over any questions affecting
only individual members, and that a class action is superior to other available methods for fairly
and efficiently adjudicating the controversy.” Fed. R. Civ. P. 23(b)(3) (emphasis added). To be
certifiable under Rule 23(b)(3), the proposed class must also be objectively and easily
“ascertainable.” Hayes v. Wal-Mart Stores, Inc., 725 F.3d 349, 354 (3d Cir. 2013) (citing
Marcus, 687 F.3d at 592-93). The court “must examine each element of a legal claim ‘through
the prism’ of Rule 23(b)(3).” Marcus, 687 F.3d at 600 (quoting In re DVI, Inc. Sec. Litig., 639
F.3d 623, 630 (3d Cir. 2011)).
1. Common questions do not predominate over individual ones.

24

The predominance analysis “begins, of course, with the elements of the underlying cause
of action.” Neale, 794 F.3d at 370 (quoting Erica P. John Fund, Inc. v. Halliburton Co., 563
U.S. 804, 809 (2011)); see also In re Modafinil Antitrust Litig., 837 F.3d 238, 260 (3d Cir. 2016)
(stating that predominance “is especially dependent upon the merits of a plaintiff’s claim”)
(internal quotation marks omitted).
Plaintiffs must “demonstrate that the element of the [legal claim] is capable of proof at
trial through evidence that is common to the class rather than individual to its members.”
Marcus, 687 F.3d at 600 (quoting Hydrogen Peroxide, 552 F.3d at 311) (alteration supplied); see
also In re Modafinil, 837 F.3d at 260 (“the nature of the evidence that will suffice to resolve a
question determines whether the question is common or individual”) (internal quotation marks
omitted). Thus, an “individual question is one where ‘members of a proposed class will need to
present evidence that varies from member to member,’ while a common question is one where
‘the same evidence will suffice for each member to make a prima facie showing [or] the issue is
susceptible to generalized, class-wide proof.’” In re Class 8 Transmission Indirect Purchaser
Antitrust Litig., No. 15-3791, 2017 WL 532296, at *2 (3d Cir. Feb. 9, 2017) (citing Tyson Foods,
Inc. v. Bouaphakeo, 136 S. Ct. 1036, 1045 (2016) (quoting 2 W. Rubenstein, Newberg on Class
Actions § 4:50, pp. 169-197 (5th ed. 2012)) (alteration supplied). If more elements, or the more
important elements, require individual rather than common proof, then class certification is
unsuitable. Tyson, 136 S. Ct. at 1045.
To prevail on their legal claims, Plaintiffs must first prove the existence of an express
warranty in Pennsylvania and New Jersey, both of which have adopted the UCC. See 13 Pa.
Cons. Stat. § 2313; N.J. Stats. Ann. § 12A:2-313. The focus of this inquiry usually turns on
whether the relevant affirmations or descriptions became “part of the basis of the bargain.” See

25

Liberty, 171 F.3d at 825 (quoting UCC § 2-313(1)(a)). “[T]he focus is not on any particular
language at a particular point in time but whether the seller’s actions or language when viewed in
light of his relationship with the buyer were fairly regarded as part of the contract to purchase the
good.” Id.; see also UCC § 2-313, cmt. 7.
Although New Jersey and Pennsylvania differ slightly on how express warranties arise,
both states require awareness of extrinsic representations to activate the presumption that they
became a part of the sales contract. See Liberty, 171 F.3d at 825 (noting that “a promise is
presumed to be a ‘part of the basis of the bargain’ under New Jersey law once the buyer has
become aware of the affirmation of fact or promise,” and remanding for trial as to the existence
of an express warranty in post-sale, extended service plans) (internal quotation marks omitted);
Green, 2001 WL 1807390, at *6 (denying class certification for express warranty breach
involving pre and post-sales representations in a product’s handbook, and stating that
Pennsylvania requires that “the buyer at least be aware of the seller’s representation prior to the
transaction’s consummation”).
Both states also require reliance on the affirmations to perfect an express warranty, even
though New Jersey only requires proof of reliance upon a showing by the defendant that the
plaintiff did not believe the representations were true. See Liberty, 171 F.3d at 825 n.7 (“If the
defendant has proven non-belief, the plaintiff may still recover economic damages if he can
prove reliance despite non-belief” under New Jersey law) (citing Cipollone, 893 F.2d at 568
n.31); Mazur v. Milo’s Kitchen, LLC, No. 12-cv-1011, 2013 U.S. Dist. LEXIS 89126, at *14
(W.D. Pa. May 24, 2013) (“in order to succeed [in a class action for breach of express warranty
based on representations on the product’s packaging and website], the plaintiff must allege the
statements made by the seller” and “reliance on those statements by the plaintiff”).

26

The parties agree that the Cavitron includes an express warranty against “defects arising
from faulty materials or workmanship” (although they disagree on the applicability and breach of
that warranty). The most vigorous disagreement persists, however, on the existence of an
express warranty of safety and suitability. Plaintiffs have not offered any suggestions for how
individual awareness of those representations, as well as a shared understanding of their
meaning, can be established using common evidence—a critical flaw that undercuts class
certification. See Green, 2001 WL 1807390, at *6 (“the disparate and distinct ways and times
that the Class members became aware of the [alleged] representation, if they did at all,
complicates the Court’s ability to determine whether this representation became a ‘basis of the
bargain’ for the Class as a whole.”). And, because information about biofilm was circulating
widely, and DHCPs have an independent obligation to comply with infection control guidelines,
individual inquiries will be necessary to determine whether each class member relied solely on
the DFUs, or something else, when deciding how to install and operate their Cavitrons in
compliance with safe water standards.
Instead of offering class-wide proof of awareness or reliance, Plaintiffs argue incorrectly
that neither of these elements is necessary. The most specious case, under Pennsylvania law, that
Plaintiffs cite in support of that proposition is Samuel-Bassett v. Kia Motors America, Inc., 34
A.3d 1 (Pa. 2011). Unlike the instant case, Samuel-Bassett involved warranties that were based
on “terms in each class member’s sales contract,” not extrinsic pre or post-sale affirmations. Id.
at 24-25. That holding is consistent with basic contract law; parties are bound to the written
terms of their agreement “without regard to whether the terms thereof were read and fully
understood.” Simeone v. Simeone, 581 A.2d 162, 165 (1990). Plaintiffs also misread the
Honorable William F. Smith’s majority opinion in Pritchard v. Liggett & Myers Tobacco Co.,

27

350 F.2d 479 (3d Cir. 1965) (applying Pennsylvania law). The “majority view on the question of
reliance is discussed in the opinion of [the Honorable Abraham L.] Freedman,” joined as to that
part by the Honorable James C. Ganey. Id. at 487. Contrary to Judge Smith’s minority view,
which would eliminate reliance altogether, Judge Freedman’s concurrence states: “the element of
reliance on the part of the buyer will be absorbed in the determination of the basis of the bargain,
but it will remain a question of fact to be determined by the jury where the seller seeks to show
that his affirmation was not a part of the basis of the bargain.” Id. at 492 (footnote omitted).
Similarly, in Gladden v. Cadillac Motor Car Div., the case Plaintiffs consider to be
“controlling” under New Jersey law, the state’s highest court noted that reliance “need not be
shown” for express warranties based on “dickered” aspects of the individual bargain. 416 A.2d
394, 402 (N.J. 1980). Even though that case involved representations in a handbook, the
defendant did not raise non-belief and thus the court presumed reliance consistent with New
Jersey law. See id. at 402. Lastly, the related case Weinstat v. Dentsply Int’l, Inc., 103 Cal. Rptr.
3d 614 (Cal. Ct. App. 2010), is unpersuasive. There, a California court of appeals found that the
Cavitron’s DFUs became part of the basis of the bargain without reliance, even though the DFUs
were not part of the “dickered” terms. Wienstat, at 627-33. But that case was decided under
California law, not Pennsylvania or New Jersey law; both of which require awareness and
reliance to perfect an express warranty rooted in representations made outside the four corners of
the sales contract. In effect, the alleged warranty of safety and suitability cannot be proven using
common evidence. 4
4

Besides being improvable with common evidence, the alleged warranty of safety and suitability may also be
legally untenable. In the course of this litigation, the Third Circuit ruled that general statements about a medical
product being “‘safe and effective’ for its intended use—contained on a label disclosing contraindications, risk
factors, and potential side effects” pursuant to FDA regulations—are insufficient to create an express warranty in
New Jersey as a matter of law. In re Avandia Mktg. Sales Practices & Products Liab. Litig., 588 F. App’x 171, 176
(3d Cir. 2014) (dismissing class action for failure to state a claim). Other federal courts have similarly construed
their respective states’ laws. See, e.g., House v. Bristol-Myers Squibb Co., No. 15-cv-00894, 2017 WL 55876, at *6

28

Even if the warranty could be proven in one swift swoop, Plaintiffs would still need to
show that Dentsply breached any of the applicable warranties. See In re Avandia Mktg. Sales
Practices & Products Liab. Litig., 588 F. App’x 171, 175 (3d Cir. 2014) (applying New Jersey
law); Samuel-Bassett, 34 A.3d at 35 (applying Pennsylvania law). They would also need to
prove that they suffered damages and that the breach was the proximate cause of those damages.
Marcus, 687 F.3d at 600 n.8 (citing Collins v. Uniroyal, Inc., 315 A.2d 16, 20 n.4 (N.J. 1974));
Samuel-Bassett, 34 A.3d at 35.
Proving causation, like reliance, is not possible on a class-wide basis. Individualized
inquiries will be necessary to determine what each class member knew about biofilm, when they
knew it, where they found the information, and on what basis they decided to operate their
Cavitrons on an open water source without respect for the CDC’s recommendations. See
Demmick v. Cellco P’ship, No. 06-cv-2163, 2010 WL 3636216, at *17 (D.N.J. Sept. 8, 2010)
(concluding that common issues did not predominate, even though the wireless service plans
“were sufficiently uniform,” because not all plaintiffs “were faced with the same information
when making their decisions” and thus it was “hard to imagine that any causal connection for
this claim could be established absent resort to individualized evidence”).
Nor are damages provable with common evidence. As explained earlier, when
calculating damages for breach of warranty, both New Jersey and Pennsylvania credit “the value
of the goods accepted,” 13 Pa. Cons. Stat. § 2714 and N.J. Stats. Ann. § 12A:2-714, which
includes any value derived from their use. Contrary to Plaintiffs’ assertion, it is not true that
Cavitrons had “zero value” at the time of sale. See Pls.’ Br. 9, ECF No. 127-1. An informed and
(W.D. Ky. Jan. 4, 2017) (“a determination that a drug is safe and effective—a determination which is made by the
FDA as part of its new drug approval process—is not, on its own, sufficient to create an express warranty.”); In re
Meridia Prods. Liab. Litig., 328 F. Supp. 2d 791, 818 (N.D. Ohio 2004) (finding that assurances that a prescription
drug was “safe and effective” were not sufficiently clear to create an express warranty), aff’d sub nom. Meridia
Prods. Liab. Litig. v. Abbott Labs., 447 F.3d 861 (6th Cir. 2006).

29

diligent class member could have known, and perhaps should have known, that the device could
be used safely in accordance with the CDC’s guidelines. Many class members may have
actually used it that way, just as Dr. Hildebrand believed she did. As Dr. Gaier explained, any
damages award that does not account for revenue gained from successfully using the Cavitron as
accepted would amount to a “windfall.” See Gaier Hr’g Tr. 2/26/16 at 163:25-166:11, Def.’s
Hazel Br., Ex. 2, ECF No. 124-3. Determining damages will therefore require individualized
inquiries based on “each potential class member’s particular configurations.” See Gaier Decl. ¶¶
23, 27. All these individual issues—awareness, reliance, causation, and damages—predominate
over the only element that could be proven with common evidence: the alleged breach.
Plaintiffs are correct that Defendant’s conduct is the focus of the breach. In New Jersey,
like in Pennsylvania, a breach occurs where “the product ultimately did not conform to the
affirmation of fact, promise, or description.” In re Avandia, 588 F. App’x at 175. In essence,
Plaintiffs aver that Dentsply delivered a non-conforming product because the Cavitron’s
waterlines naturally accumulate biofilm when operated and maintained on an open water source
in accordance with their understanding of the DFUs. Since biofilm theoretically increases the
odds of infection during non-surgical procedures, and Dentsply allegedly knew of this risk and
intentionally concealed the problem, Plaintiffs assert Dentsply breached both an express
warranty of safety and suitability and the express warranty against defects. See Amend. Compl.
¶¶ 64-70.
Notwithstanding Plaintiff’s allegations, common evidence does not support a finding that
a breach actually occurred. The Cavitron is capable of delivering potable water on its own when
connected to an open or closed water source so long as DHCPs follow the CDC’s
recommendations as directed by the Cavitron’s Infection Control Information card. In fact,

30

Plaintiffs testified that they used their Cavitrons without incident since the date of purchase,
employing a variety of configurations. See Class Opp’n Br. 12-14. Under the warranties as
alleged, Dentsply apparently delivered a conforming device. According to Plaintiffs, however, it
does not matter whether class members could, or in fact did, use the Cavitron safely. See, e.g.,
Pls.’ Hazel Br. 2. They claim Dentsply nevertheless acted wrongfully by failing to warn
purchasers of the biofilm problem. See, e.g., Pls.’ Clas Br. 5, 12, 16, 21, 22 nn.22, 24; Class
Reply 37, 42. In other words, Plaintiffs argue that class members would not, or perhaps should
not, have used Cavitrons at all had Dentsply disclosed the biofilm problem in the DFUs.
There is a fundamental disconnect between this failure to warn theory and Plaintiff’s
express warranty claim. Under this theory, the focal question becomes: did the DFUs contain
“accurate and adequate instructions”? See Class Reply Br. 39, ECF No. 67. But that inquiry is a
red herring unless Dentsply expressly warranted that the DFUs alone contain all the necessary
instructions to prevent biofilm; an allegation that is absent from Plaintiffs’ pleadings perhaps
because they also assert that the duty to ensure appropriate labeling and maintenance instructions
arises under the FDA’s regulations, not the DFUs. See Pls. Br. 11-14, 18-25. To be sure, this is
why Plaintiffs sought to introduce the opinions of an FDA expert, Ulatowski, to show that
Dentsply had a legal obligation to deliver complete and accurate DFUs, but failed to do so, under
the applicable regulations. Here is where the incongruity crystallizes: If Dentsply’s obligation to
warn or adequately label arises from the applicable regulations, then Dentsply’s alleged
omissions establish a regulatory violation or, at best, a common law tort, but not a breach of an
express warranty. 5

5

Without any express representations concerning biofilm in the DFUs, Plaintiffs are left to argue that Dentsply’s
“silence” gives rise to the express warranty. See, e.g., Pls.’ Class Br. 12 (averring that the DFUs “are the primary
vehicle for both omissions from and representations Dentsply made to the Plaintiffs and class members about the
installation, use and maintenance of the Cavitron.”) (emphasis added). But an express warranty cannot arise from

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Consider instead the inverse question: should DHCPs be expected to supplement the
DFUs with their professional judgment and their legal duty to comply with the CDC’s
recommendations? In this Courts’ opinion, the better answer is yes. The DFUs must operate in
tandem with each class member’s professional and legal obligations, especially since the
Infection Control Information card states that published guidelines and “agency requirements
take precedence.” ECF No. 60-28. From that perspective, the DFUs were more than adequate;
they were explicitly clear. More importantly, even if a breach did occur, that question does not
predominate over individual issues such as awareness, reliance, causation, and damages.
Therefore, Plaintiffs do not meet the predominance requirement.

something that is left unsaid; that is the textbook definition of an implied warranty. See Warranty, Black’s Law
Dictionary (10th ed. 2014) (defining an “implied warranty” as an “obligation imposed by the law when there has
been no representation or promise”). Plaintiffs recognize as much when they argue that a “necessary implication” of
the DFUs’ absolute silence “on the likelihood of the Cavitrons developing biofilm in their internal water lines” is
“that the Cavitrons remain safe and suitable for all ‘Indicated Uses’ if connected to a potable public water source
and flushed periodically with tap water.” Pls.’ Class Br. 16 (emphasis added). If that’s the case, then Plaintiffs’
claims, premised on an express warranty of safety and suitability, would dissipate.

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2. A class action is not a superior vehicle for Plaintiffs’ claims.
Turning to the superiority requirement, the court must “balance, in terms of fairness and
efficiency, the merits of a class action against those of alternative available methods of
adjudication.” In re Processed Egg Prods. Antitrust Litig., 284 F.R.D. 278, 293-94 (E.D. Pa.
2012) (quoting In re Prudential Ins. Co. Am. Sales Practice Litig. Agent Actions, 148 F.3d 283,
316 (3d Cir. 1998)). For this analysis, courts use the factors listed in Rule 23(b)(3): “(A) the
class members’ interests in individually controlling the prosecution or defense of separate
actions; (B) the extent and nature of any litigation concerning the controversy already begun by
or against class members; (C) the desirability or undesirability of concentrating the litigation of
the claims in the particular forum; and (D) the likely difficulties in managing a class action.” In
re Processed Egg Prod., 284 F.R.D. at 293 (quoting Fed. R. Civ. P. 23(b)(3)).
Defendant focuses on the unmanageability of the proposed class action. Because of the
various individualized issues—awareness, reliance, causation, and timeliness, among others—
Dentsply correctly points out that a “flurry” of mini-trials would be needed to fairly adjudicate
each class member’s claim, vitiating any potential efficiencies from using the class action
mechanism. See Class Opp’n Br. 89-90. Plaintiffs’ own Trial Plan acknowledges Dentsply’s
right to challenge the merits of each class member’s claim and the computation of their
individual damages. See Revised Trial Plan § IV(C)(1), Pls.’ Class Br., Ex. 57. Their avowal
that “the Class and Subclasses present no management difficulties” is surely an understatement.
See Pls.’ Class Br. 58.
The individual issues also raise the prospect that class members might wish to exercise
more control over the prosecution of their own claims. As noted, class members with timely
claims, for example, have nothing to gain from investing resources to prove equitable tolling.

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And, although class members have not brought any other cases that could interfere with this one,
Plaintiffs have not identified any reasons for concentrating these state claims in federal court.
Plaintiffs’ main argument focuses on the prohibitive costs of pursuing these claims on an
individual basis. According to Plaintiffs, Cavitrons are worth somewhere between $1,500 and
$3,500 each, plus installation and maintenance costs. Id. Plaintiffs maintain that the costs of
bringing individual actions would exceed the potential recovery, but offer no calculations or data
to substantiate that assertion. Litigation is expensive, but without even a semblance of a costbenefit analysis, this Court will not presume that litigating a class action will be more efficient
than pursuing individual claims in state court. Plus, fairness to defendants, not just plaintiffs, is
“an explicit criterion for a superiority determination.” Katz v. Carte Blanche Corp., 496 F.2d
747, 761-762 (3d Cir. 1974). Because the merits of Plaintiffs’ claims are in serious doubt, it
would be unfair to put Defendant in a position to settle a non-meritorious action for fear of
reputational harm. Id. (certification creates “additional settlement leverage which results from
the disruption or injury which may occur to a defendant’s business relationships regardless of the
merits of the claim by the mere sending of the [class certification] notice.”).
Plaintiffs failed to prove superiority.
3. The proposed Class and Subclasses are not objectively ascertainable.
Lastly, to be certifiable under Rule 23, a class must be “currently and readily
ascertainable based on objective criteria,” not “by potential class members’ say so.” Marcus,
687 F.3d at 593, 594. “Ascertainability provides due process by requiring that a defendant be
able to test the reliability of the evidence submitted to prove class membership.” Carrera v.
Bayer Corp., 727 F.3d 300, 307 (3d Cir. 2013). When nothing in company databases shows
whether individuals should be included in the class, the court must consider “whether there is a

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reliable, administratively feasible alternative.” Marcus, 687 F.3d at 594. “Accordingly, a trial
court should ensure that class members can be identified without extensive and individualized
fact-finding or mini-trials.” Carrera, 727 F.3d at 307 (internal quotation marks and citations
omitted). The Third Circuit has also emphasized that a party cannot “merely propose a method
of ascertaining a class without any evidentiary support that the method will be successful.”
Byrd, 784 F.3d at 164 (quoting Carrera 727 F.3d at 306, 307, 311).
The critical characteristic of the Class and Subclasses is water source, yet Plaintiffs have
provided no objective, class-wide method for ensuring that only dentists who unwittingly
connected their Cavitron to an open water source can recover on any potential judgment. Dr.
Gaier’s expert opinion on this point is helpful. He explains that, even if Plaintiffs could produce
a reliable list of purchasers in New Jersey and Pennsylvania for the class period, there is no
objective method to ascertain which purchasers operated their Cavitrons on an open water source
“given the variety of configurations in which a Cavitron device can be installed,” as exemplified
by Plaintiffs’ own experiences. Gaier Decl. ¶¶ 22-24. Neither Dentsply’s records nor any other
business records will show water source on a class-wide basis. Plaintiffs suggest asking each
class member to submit affidavits “attesting that his, her or its Cavitron(s) was (were) connected
to a public water supply.” Class Reply Br. 23. But that would be the same as accepting the class
members’ “say so,” which is not enough. Marcus, 687 F.3d at 594.
Furthermore, even if class members could provide invoices showing that they installed
their Cavitrons on an open water source or retrofitted them to a closed water source, due process
concerns arise because the Class definition is over-inclusive. As Plaintiffs have pointed out,
many DHCPs use public water to supply their dental equipment including their Cavitrons.
Because many of those same DHCPs may also use biocides and adaptive devices, consistent with

35

their professional training and industry guidelines, they would have no basis to complain about
the Cavitron’s water quality or bring a claim under Plaintiffs’ express warranty theory. Yet, if
Plaintiffs were to prevail, those same DHCPs will be able to file claims merely because they
were “using a public water source” for their Cavitrons, despite having no basis for seeking
recovery. 6 See Class Opp’n Br. 58.
The composition of the Class is not objectively or reliably ascertainable.
CONCLUSION
Plaintiffs have not persuaded this Court as to the Daubert Motions. Nor have they
satisfied the requirements of Rules 23(a) and 23(b)(3). Class certification is therefore denied.

BY THE COURT:

/s/ C. Darnell Jones, II
C. Darnell Jones, II J.

6

Plaintiffs argue that an “overly-broad” class is not a bar to certification, citing In re Whirlpool Corp. FrontLoading Washer Prods. Liab. Litig., 722 F.3d 838 (6th Cir. 2013). That case is distinguishable on its facts. Unlike
Cavitrons, whose waterlines can be treated by DHCPs to prevent biofilm formation, the washers in Whirlpool
developed biofilm “in places inside the machines that consumers cannot clean themselves.” 722 F.3d at 846.
Because the machine’s defect was inherent to the design, and unrelated to each purchaser’s maintenance practices, it
makes sense that the class definition would encompass purchasers who were satisfied with their washers or whose
washers had not yet accumulated biofilm.

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