United States District Court, E.D. Pennsylvania
Darnell Jones, II J.
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.
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 to a breach of an express
warranty of safety and suitability contained in the DFUs.
Id. at ¶¶ 64-75.
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
Class Certification Record
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.
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
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 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.
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 § 13:30-8.5(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
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 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.
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.
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, 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
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
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 biofilm-clogged 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. 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.
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.
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.
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.”
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.
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
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 (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)).
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
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)).
Defendant Prevails on the Daubert Motions
Daubert analysis governing the admissibility of
expert testimony emerges from Federal Rule of Evidence 702,
which sets out three requirements commonly known as
“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)).
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).
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).
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' un der the facts of the case so that it
will aid the [fact finder] in resolving a factual
dispute.”) (internal quotation marks omitted).
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. 1999) (citing Daubert, 509 U.S. at
592 n.10); see also Mahmood v. Narciso, 549 F.
App'x 99, 102 (3d Cir. 2013).
Ulatowski's Expert Opinion Is Inadmissible
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.
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
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