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Center City Periodontists, P.C v. Dentsply International, Inc.

United States District Court, E.D. Pennsylvania

July 24, 2017

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

          MEMORANDUM

          C. Darnell Jones, II J.

         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 to a breach of an express warranty of safety and suitability contained in the DFUs. Id. at ¶¶ 64-75.

         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 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 § 13:30-8.5(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 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 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, 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 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.

         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.

         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 (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 “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' un der 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. 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 ...


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