`
`UNITED STATES DISTRICT COURT
`FOR THE EASTERN DISTRICT OF VIRGINIA
`NORFOLK VICINAGE
`
`
`
`
`
`DARROLL SAVAGE, on behalf of himself
`and all others similarly situated,
`
`
`
`
`
`
`
`
`Plaintiff,
`
`v.
`
`
`KONINKLIJKE PHILIPS N.V.; PHILIPS
`NORTH AMERICA LLC; and PHILIPS RS
`NORTH AMERICA LLC,
`
`
`
`
`
`
`
`Defendants.
`
`
`
`
`Case No. __________
`
`CLASS ACTION COMPLAINT
`
`DEMAND FOR JURY TRIAL
`
`
`Plaintiff Darroll Savage (“Plaintiff” or “Plaintiff Savage”), on behalf of himself, the class
`
`and subclass of all others similarly situated as defined below, for his complaint against
`
`Defendants Koninklijke Philips N.V. (“Royal Philips”), Philips North America LLC (“Philips
`
`NA”), and Philips RS North America LLC (“Philips RS”) (collectively, Royal Philips, Philips
`
`NA, and Philips RS are “Philips” or the “Defendants”), alleges the following based on (a)
`
`personal knowledge, (b) the investigation of counsel, and (c) information and belief.
`
`INTRODUCTION
`
`1.
`
`Plaintiff brings this action on behalf of himself and a proposed class of purchasers
`
`and users of Continuous Positive Airway Pressure (CPAP) and Bi-Level Positive Airway
`
`Pressure (Bi-Level PAP) devices and mechanical ventilators manufactured by Philips, which
`
`contain polyester-based polyurethane sound abatement foam (“PE-PUR Foam”).
`
`2.
`
`On April 26, 2021, Philips made a public announcement disclosing it had
`
`determined there were risks that the PE-PUR Foam used in certain CPAP, Bi-Level PAP, and
`
`mechanical ventilator devices it manufactured may degrade or off-gas under certain
`
`circumstances.
`
`
`
`Case 2:21-cv-00519-RCY-LRL Document 1 Filed 09/17/21 Page 2 of 33 PageID# 2
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`3.
`
`On June 14, 2021, Royal Philips issued a recall in the United States of its CPAP,
`
`Bi-Level PAP, and mechanical ventilator devices containing PE-PUR Foam, because Philips had
`
`determined that (a) the PE-PUR Foam was at risk for degradation into particles that may enter
`
`the devices’ pathway and be ingested or inhaled by users, and (b) the PE-PUR Foam may off-gas
`
`certain chemicals during operation.1 Philips further disclosed in its Recall Notice that “these
`
`issues can result in serious injury which can be life-threatening, cause permanent impairment,
`
`and/or require medical intervention to preclude permanent impairment.”2
`
`4.
`
`Philips has disclosed that the absence of visible particles in the devices does not
`
`mean that PE-PUR Foam breakdown has not already begun. Philips reported that lab analysis of
`
`the degraded foam reveals the presence of harmful chemicals, including: Toluene Diamine
`
`(“TDA”), Toluene Diisocyanate (“TDI”), and Diethylene Glycol (“DEG”).3
`
`5.
`
`Prior to issuing the Recall Notice, Philips received complaints regarding the
`
`presence of black debris/particles within the airpath circuit of its devices (extending from the
`
`device outlet, humidifier, tubing, and mask). Philips also received reports of headaches, upper
`
`airway irritation, cough, chest pressure and sinus infection from users of these devices.
`
`6.
`
`In its Recall Notice, Philips disclosed that the potential risks of particulate
`
`exposure to users of these devices include: irritation (skin, eye, and respiratory tract),
`
`inflammatory response, headache, asthma, adverse effects to other organs (e.g., kidneys and
`
`liver) and toxic carcinogenic affects. The potential risks of chemical exposure due to off-gassing
`
`
`1 See Philips Recall Notice attached hereto as Exhibit “A.”
`
`2 Id.
`
`3 Philips Sleep and Respiratory Care Update; Clinical information for physicians,
`https://www.philips.com/c-dam/b2bhc/master/landing-pages/src/update/documents/philips-recall-clinical-
`information-for-physicians-and-providers.pdf (accessed June 27, 2021).
`
`
`
`2
`
`
`
`Case 2:21-cv-00519-RCY-LRL Document 1 Filed 09/17/21 Page 3 of 33 PageID# 3
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`of PE-PUR Foam in these devices include: headache/dizziness, irritation (eyes, nose, respiratory
`
`tract, skin), hypersensitivity, nausea/vomiting, toxic and carcinogenic effects.
`
`7.
`
`Philips recommended that patients using the recalled CPAP and Bi-Level PAP
`
`devices immediately discontinue using their devices and that patients using the recalled
`
`ventilators for life-sustaining therapy consult with their physicians regarding alternative
`
`ventilator options.
`
`8.
`
`In approximately June 2016, Plaintiff Savage purchased a Philips DreamStation
`
`CPAP device, which he used nightly from the date of receipt until August 2018.
`
`9.
`
`In August 2021, Plaintiff Savage learned, via news media, that his Philips
`
`DreamStation CPAP device was subject to a recall due to the presence of a dangerous PE-PUR
`
`Foam that could cause him to suffer from adverse health effects, including, inter alia, cancer and
`
`organ failure.
`
`10.
`
`He learned that it was recommended that users of recalled devices, like himself,
`
`discontinue use of the devices.
`
`11.
`
`12.
`
`Plaintiff Savage has and will suffer economic loss to replace the devices.
`
`Plaintiff Savage seeks to recover damages based on, inter alia, Philips’ breach of
`
`express warranty, breach of implied warranties, misrepresentations, omissions, and breaches of
`
`state consumer protection laws in connection with its manufacture, marketing and sales of
`
`devices containing PE-PUR Foam on behalf of himself and the proposed Class and Subclass. In
`
`addition, Plaintiff Savage seeks medical monitoring damages for users of Philips’ devices
`
`identified in the Recall Notice, who are at risk of suffering from serious injury, including
`
`irritation (skin, eye, and respiratory tract), inflammatory response, headache, asthma, adverse
`
`effects to other organs (e.g., kidneys and liver) and toxic carcinogenic affects.
`
`
`
`3
`
`
`
`Case 2:21-cv-00519-RCY-LRL Document 1 Filed 09/17/21 Page 4 of 33 PageID# 4
`
`PARTIES
`
`13.
`
`14.
`
`Plaintiff Darroll Savage is a citizen of the Commonwealth of Virginia.
`
`Defendant Royal Philips is a Dutch multinational corporation with its principal
`
`place of business located in Amsterdam, Netherlands. Royal Philips is the parent company of the
`
`Philips Group of healthcare technology businesses, including Connected Care businesses
`
`focusing on Sleep & Respiratory Care. Royal Philips holds directly or indirectly 100% of its
`
`subsidiaries Philips NA and Philips RS.4 Upon information and belief, Royal Philips controls
`
`Philips NA and Philips RS in the manufacturing, selling, distributing, and supplying of the
`
`recalled CPAP, Bi-Level PAP, and mechanical ventilator devices.5
`
`15.
`
`Defendant Philips NA is a Delaware corporation with its principal place of
`
`business located at 222 Jacobs Street, Floor 3, Cambridge, Massachusetts 02141. Philips NA is a
`
`wholly-owned subsidiary of Royal Philips.
`
`16.
`
`Defendant Philips RS is a Delaware corporation with its principal place of
`
`business located at 6501 Living Place, Pittsburgh, Pennsylvania 15206. Philips RS is a wholly-
`
`owned subsidiary of Royal Philips. Philips RS was formerly operated under the business name
`
`Respironics, Inc. (“Respironics”). Royal Philips acquired Respironics in 2008.6
`
`
`
`
`
`
`4 Philips 2020 annual filing with the SEC, fn. 8,
`https://www.sec.gov/Archives/edgar/data/313216/000031321621000008/phg-exhibit8.htm (accessed June
`30, 2021).
`
`5 Philips 2020 annual filing with the SEC,
`https://www.sec.gov/ix?doc=/Archives/edgar/data/0000313216/000031321621000008/phg-20201231.htm
`(accessed June 30, 2021).
`
`6 Philips announces completion of tender offer to acquire Respironics, WEB WIRE,
`https://www.webwire.com/ViewPressRel.asp?aId=61199 (accessed June 27, 2021).
`
`
`
`4
`
`
`
`Case 2:21-cv-00519-RCY-LRL Document 1 Filed 09/17/21 Page 5 of 33 PageID# 5
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`JURISDICTION AND VENUE
`
`17.
`
`This Court has subject-matter jurisdiction pursuant to the Class Action Fairness
`
`Act, 28 U.S.C. § 1332(d), because (1) the matter in controversy exceeds the sum or value of
`
`$5,000,000, exclusive of interest and costs, (2) the action is a class action, (3) there are members
`
`of the Class and Subclass who are diverse from Defendants, and (4) there are more than 100
`
`class members. This Court has supplemental jurisdiction over state law claims pursuant to 28
`
`U.S.C. § 1367, because they form part of the same case or controversy as the claims within the
`
`Court’s original jurisdiction.
`
`18.
`
`Venue is proper in this judicial District pursuant to 28 U.S.C. § 1391(b) and (c)
`
`and 18 U.S.C. § 1965, because Defendants transact business in this District, a substantial part of
`
`the events or omissions giving rise to Plaintiff’s claims occurred in this District; because the
`
`Plaintiff resides in this District; and because the Defendants caused harm to class members
`
`residing in the District.
`
`19.
`
`The Court has personal jurisdiction over the Defendants because Defendants
`
`conduct substantial business in this District, and the events giving rise to Plaintiff’s claims arise
`
`out of and relate to Defendants’ contacts with this District. Moreover, Defendants’ affiliations
`
`with this District are so continuous and systematic as to render them essentially at home in the
`
`forum State. Further, Defendants have transacted business, maintained substantial contacts,
`
`purposefully targeted consumers and medical professionals for sales of its devices and/or
`
`committed overt acts in furtherance of the unlawful acts alleged in this Complaint in this District,
`
`as well as throughout the United States. The unlawful acts of Defendants have been directed at,
`
`targeted, and have had the effect of causing injury to persons residing in, located in, or doing
`
`business in this District, as well as throughout the United States.
`
`
`
`5
`
`
`
`Case 2:21-cv-00519-RCY-LRL Document 1 Filed 09/17/21 Page 6 of 33 PageID# 6
`
`FACTUAL BACKGROUND
`
`I.
`
`Continuous Positive Airway Pressure Therapy
`
`20.
`
`Continuous Positive Airway Pressure (“CPAP”) therapy is a common nonsurgical
`
`treatment primarily used to treat sleep apnea. CPAP therapy typically involves the use of a hose
`
`and a nasal or facemask device that delivers constant and steady air pressure to an individual’s
`
`throat to help individuals breathe.
`
`21.
`
`Sleep apnea is a common sleep disorder characterized by repeated interruptions in
`
`breathing throughout an individual’s sleep cycle. These interruptions, called “apneas,” are caused
`
`when the soft tissue in an individual’s airway collapses. The airway collapse prevents oxygen
`
`from reaching the individual’s lungs which can cause a buildup of carbon dioxide. If the
`
`individual’s brain senses the buildup of carbon dioxide, it will briefly rouse the individual from
`
`sleep so that the individual’s airway can reopen. Often these interruptions are so brief that the
`
`individual will not remember. Despite the brevity of the interruptions, the sleep cycle disruption
`
`caused by sleep apnea can dramatically impact a person’s lifestyle, including negatively
`
`impacting energy, mental performance, and long-term health. CPAP therapy helps treat sleep
`
`apnea by preventing the person’s airway from collapsing while breathing during sleep cycles,
`
`which can help prevent interruptions in breathing.
`
`II.
`
`Bi-Level Positive Airway Pressure Therapy
`
`22.
`
`Bi-Level Positive Airway Pressure (“BiPAP”) therapy is a common alternative to
`
`CPAP therapy for treating sleep apnea. Similar to CPAP therapy, BiPAP therapy is nonsurgical
`
`and involves the use of a nasal or facemask device to maintain air pressure in an individual’s
`
`airway. BiPAP therapy is distinguishable from CPAP therapy, however, because Bi-Level PAP
`
`devices deliver two alternating levels—inspiratory and expiratory—of pressurized air into a
`
`
`
`6
`
`
`
`Case 2:21-cv-00519-RCY-LRL Document 1 Filed 09/17/21 Page 7 of 33 PageID# 7
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`person’s airway, rather than the single continuous level of pressurized air delivered by a CPAP
`
`device. The inspiratory positive airway pressure assists a person as a breath is taken in.
`
`Conversely, the expiratory positive airway pressure is applied to allow a person to comfortably
`
`breathe out. Bi-Level PAP devices deliver one level of pressurize air (the inspiratory positive
`
`level) to assist as a person inhales, and another level (the expiratory level) as a person exhales.
`
`III. Mechanical Ventilation
`
`23. Mechanical ventilation is a treatment to help a person breathe when they find it
`
`difficult or are unable to breathe on their own. A mechanical ventilator pushes airflow into the
`
`patient’s lungs to help them breathe. Mechanical ventilation may be invasive ventilation with a
`
`tube inserted into the patient’s airway, performed in the intensive care unit in the hospital or a
`
`long-term institutional setting. Non-invasive ventilation can be used at home by people with
`
`respiratory difficulties.
`
`SUBSTANTIVE ALLEGATIONS
`
`24.
`
`Philips developed, marketed, and sold a variety of CPAP and Bi-Level PAP
`
`respirator devices and mechanical ventilators under its “Sleep & Respiratory Care” segment of
`
`its business designed to assist individuals with a number of sleep, breathing, and respiratory
`
`conditions, including obstructive sleep apnea, central sleep apnea, complex sleep apnea
`
`syndrome, and Chronic Obstructive Pulmonary Disease (COPD), as well as to assist those
`
`individuals requiring invasive and non-invasive ventilators for acute and sub-acute hospital
`
`environments. Philips’ CPAP and Bi-Level PAP respirator devices and its mechanical ventilators
`
`typically cost several hundred, if not thousands of dollars. Philips has sold millions of these
`
`devices in the United States.
`
`
`
`
`
`7
`
`
`
`Case 2:21-cv-00519-RCY-LRL Document 1 Filed 09/17/21 Page 8 of 33 PageID# 8
`
`III. Philips Sleep & Respiratory Care Devices Endangered Users
`
`25.
`
`On April 26, 2021, in its Quarterly Report for Q1 2021, Philips disclosed for the
`
`first time, under a section entitled “Regulatory Update,” that device user reports had led to a
`
`discovery that the type of PE-PUR Foam Philips used to minimize noise in several CPAP and Bi-
`
`Level PAP respirators and mechanical ventilators posed health risks to its users. Specifically,
`
`Philips disclosed that “the [PE-PUR] foam may degrade under certain circumstances, influenced
`
`by factors including use of unapproved cleaning methods, such as ozone[], and certain
`
`environmental conditions involving high humidity and temperature.”7
`
`26.
`
`Seven weeks later, on June 14, 2021, Philips announced a recall of numerous
`
`models of CPAP and Bi-Level PAP devices, as well as a variety of its mechanical ventilators “to
`
`address identified potential health risks related to the polyester-based polyurethane (PE-PUR)
`
`sound abatement foam component in these devices.”8 Specifically, Philip announced that it had
`
`determined that the “PE-PUR foam may degrade into particles which may enter the device’s air
`
`pathway and be ingested or inhaled by the user, and the foam may off-gas certain chemicals.”9 In
`
`total, Philips announced that “[b]etween 3 million and 4 million” devices are targeted in the
`
`recall.10
`
`
`7 First Quarter Results, PHILIPS (Apr. 26, 2021),
`https://www.results.philips.com/publications/q121/downloads/pdf/en/philips-first-quarter-results-2021-
`report.pdf (accessed June 27, 2021).
`
`8 Philips issues recall notification* to mitigate potential health risks related to the sound abatement foam
`component in certain sleep and respiratory care devices, PHILIPS (June 14, 2021),
`https://www.philips.com/a-w/about/news/archive/standard/news/press/2021/20210614-philips-issues-
`recall-notification-to-mitigate-potential-health-risks-related-to-the-sound-abatement-foam-component-in-
`certain-sleep-and-respiratory-care-devices.html (accessed June 27, 2021).
`
`9 Id.
`
`10 Associated Press, Philips recalls ventilators, sleep apnea machines due to health risks, NBC NEWS,
`https://www.nbcnews.com/business/consumer/philips-recalls-ventilators-sleep-apnea-machines-due-
`health-risks-n1270725 (accessed June 27, 2021).
`
`
`
`8
`
`
`
`Case 2:21-cv-00519-RCY-LRL Document 1 Filed 09/17/21 Page 9 of 33 PageID# 9
`
`27.
`
`The list of the devices recalled by Philips (the “Recalled Devices”) include:
`
`Philips CPAP and Bi-Level PAP Devices
`Manufactured Before April 26, 2021 Subject to Recall11
`Device Name/Model Type
`Type
`
`E30 (Emergency Use Authorization)
`
`DreamStation ASV
`DreamStation ST, AVAPS
`SystemOne ASV4
`C Series ASV
`C Series S/T and AVAPS
`OmniLab Advanced Plus
`SystemOne (Q Series)
`DreamStation
`DreamStation GO
`Dorma 400
`Dorma 500
`REMStar SE Auto
`
`Continuous Ventilator, Minimum Ventilatory
`Support, Facility Use
`
`
`Continuous Ventilator, Non-life Supporting
`
`
`
`Non-continuous Ventilator
`
`Philips Mechanical Respirator Devices
`Manufactured Before April 26, 2021 Subject to Recall12
`Device Name/Model Type
`Type
`
`Trilogy 100 Ventilator
`Trilogy 200 Ventilator
`Garbin Plus, Aeris, LifeVentVentilator
`A-Series BiPAP Hybrid A30
`Philips A-Series BiPAP V30 Auto
`
`Philips A-Series BiPAP A40
`Philips A-Series BiPAP A30
`
`
`Continuous Ventilator
`
`Continuous Ventilator, Minimum Ventilatory
`Support, Facility Use
`
`Continuous Ventilator, Non-life Supporting
`
`
`
`
`
`
`
`11 Recall Notice (Exhibit “A” hereto); see also Medical Device recall notification (U.S. only) / field safety
`notice (International Markets), PHILIPS RESPIRONICS (June 14, 2021),
`https://www.usa.philips.com/healthcare/e/sleep/communications/src-update#section_2 (accessed June 27,
`2021); Royal Philips Update on the recall notification, https://www.philips.com/a-
`w/about/news/archive/standard/news/press/2021/20210614-philips-issues-recall-notification-to-mitigate-
`potential-health-risks-related-to-the-sound-abatement-foam-component-in-certain-sleep-and-respiratory-
`care-devices.html (accessed June 27, 2021).
`
`12 Id.
`
`
`
`9
`
`
`
`Case 2:21-cv-00519-RCY-LRL Document 1 Filed 09/17/21 Page 10 of 33 PageID# 10
`
`28.
`
`According to Philips, the PE-PUR Foam used in Recalled Devices puts users at
`
`risk of suffering from: “[i]rritation (skin, eye, and respiratory tract), inflammatory response,
`
`headache, asthma, adverse effects to other organs (e.g. kidneys and liver) and toxic carcinogenic
`
`affects.”13
`
`29.
`
`Philips reported to physicians that PE-PUR Foam particles “may cause irritation
`
`and airway inflammation, and this may be particularly important for patients with underlying
`
`lung diseases or reduced cardiopulmonary reserve.”14
`
`30.
`
`Further, Philips reported that “based on lab testing and evaluations, it may be
`
`possible that these potential health risks could result in a wide range of potential patient impact,
`
`from transient potential injuries, symptoms and complications, as well as possibly serious injury
`
`which can be life-threatening or cause permanent impairment, or require medical intervention to
`
`preclude permanent impairment.”15
`
`31.
`
`Philips announced that it has received reports of specific complaints from users of
`
`Recalled Devices who suffered from “headache[s], upper airway irritation, cough, chest pressure
`
`and sinus infection.”16
`
`IV.
`
`
`32.
`
`The Health Risks Associated with Use of the Recalled Devices Renders Them
`Worthless
`
`As a result of the health risks associated with the use of the Recalled Devices,
`
`together with Defendants’ concealment of these risks from the date they were first reported to
`
`13 Id.
`
`
`
`14 Philips Sleep and Respiratory Care Update – Clinical information for physicians, June 14, 2021,
`philips-recall-clinical-information-for-physicians-and-providers.pdf (accessed June 27, 2021).
`
`15 Id.
`
`16 Recall Notice (Exhibit A hereto).
`
`
`
`10
`
`
`
`Case 2:21-cv-00519-RCY-LRL Document 1 Filed 09/17/21 Page 11 of 33 PageID# 11
`
`Defendants or discovered by Defendants through April 26, 2021, the Recalled Devices have been
`
`rendered completely worthless or, at the very least, have been substantially diminished in value.
`
`33.
`
`The information described above, including the now-known health risks of Philips
`
`CPAP devices, Bi-Level PAP devices and mechanical ventilators, the recall, and the medical
`
`warnings and advice issued by Philips, have rendered the Recalled Devices worthless to patients
`
`with sleep apnea and respiratory conditions. Individuals not using life-supporting ventilators
`
`must immediately discontinue their user of the Recalled Devices or face serious health risks as
`
`grave as organ failure or cancer. If they choose to discontinue use of the Recalled Devices they
`
`must pay for another expensive device in order to receive effective treatment for their sleep
`
`apnea and/or respiratory conditions. Individuals using life-supporting ventilators must seek an
`
`alternative treatment before discontinuing use of the Recalled Devices.
`
`34.
`
`Recognizing this, Philips issued the following advice to patients using any of the
`
`Recalled Devices:
`
`• “For patients using BiLevel PAP and CPAP devices: Discontinue use of
`affected units and consult with physicians to determine the benefits of continuing
`therapy and potential risks.”17
`
`
`• “For patients using life-sustaining mechanical ventilator devices: DO NOT
`discontinue or alter prescribed therapy, without consulting physicians to
`determine appropriate next steps.”18
`
`
`35.
`
`As a result of the above, Plaintiff and the Class and Subclass will have to
`
`undertake considerable expense replacing the Recalled Devices.
`
`V.
`
`Philips Unreasonably Delayed its Recall
`
`
`17 Medical Device recall notification (U.S. only) / field safety notice (International Markets), PHILIPS
`RESPIRONICS (June 14, 2021), https://www.usa.philips.com/healthcare/e/sleep/communications/src-
`update#section_2 (accessed June 27, 2021) (Questions and answers) (emphasis in original).
`
`18 Id.
`
`
`
`11
`
`
`
`Case 2:21-cv-00519-RCY-LRL Document 1 Filed 09/17/21 Page 12 of 33 PageID# 12
`
`36.
`
`At no time prior to its Regulatory Update on April 26, 2021, did Philips disclose
`
`to purchasers or users of the Recalled Devices that the PE-PUR Foam contained therein may off-
`
`gas or degrade upon use. Similarly, prior to the Update, Philips did not disclose any health risks
`
`associated with use of the Recalled Devices.
`
`37.
`
`Defendants have not disclosed when they first discovered or received reports from
`
`users of their Sleep & Respiratory Care devices “regarding the presence of black debris/particles
`
`within the airpath circuit (extending from the device outlet, humidifier, tubing, and mask).”19
`
`38.
`
`At a minimum, as a result of user reports, Defendants were aware of the off-
`
`gassing and degradation of the PE-PUR Foam used in the Recalled Devices at some point prior
`
`to the recall, yet continued to manufacture and sell the Recalled Devices with such awareness.
`
`During this period, Defendants unreasonably and unjustly profited from the manufacture and sale
`
`of the Recalled Devices and unreasonably put users of the Recalled Devices at risk of
`
`development of serious adverse health effects, including organ failure and cancer.
`
`VI.
`
`Plaintiff Darroll Savage
`
`39.
`
`40.
`
`Plaintiff Darroll Savage is a resident and citizen of Horntown, Virginia.
`
`Plaintiff Savage purchased the Recalled Device, a Philips DreamStation CPAP
`
`device, prior to June 14, 2021.
`
`41.
`
`The manual accompanying Plaintiff Savage’s Respironics DreamStation CPAP
`
`device did not contain any language or warnings of health risks associated with use of the device,
`
`including irritation (skin, eye, and respiratory tract), inflammatory response, headache, asthma,
`
`adverse effects to other organs (e.g., kidneys and liver) and toxic carcinogenic effects. Had
`
`
`19 Recall Notice (Exhibit “A” hereto).
`
`
`
`12
`
`
`
`Case 2:21-cv-00519-RCY-LRL Document 1 Filed 09/17/21 Page 13 of 33 PageID# 13
`
`Defendants informed Plaintiff of these risks, he would not have purchased or used the Recalled
`
`Devices.
`
`42. Without knowing of the health risks associated with use of the Recalled Device,
`
`Plaintiff Savage used his Recalled Device regularly to treat sleep apnea until August 2018.
`
`43.
`
`As a result of the health risks associated with continued use of these devices and
`
`the recall, Plaintiff Savage’s DreamStation CPAP device is now worthless. Plaintiff Savage was
`
`forced to replace the device at considerable cost.
`
`TOLLING AND ESTOPPEL
`
`I.
`
`DISCOVERY RULE TOLLING
`
`44.
`
`Plaintiff and the Class and Subclass had no way of knowing about Philips’
`
`conduct with respect to the health risks associated with the use of the Recalled Devices.
`
`45.
`
`Neither Plaintiff nor any other members of the Class or Subclass, through the
`
`exercise of reasonable care, could have discovered the conduct by Philips alleged herein. Further,
`
`Plaintiff and members of the Class and Subclass did not discover and did not know of facts that
`
`would have caused a reasonable person to suspect that Philips was engaged in the conduct
`
`alleged herein.
`
`46.
`
`For these, reasons, all applicable statutes of limitation have been tolled by the
`
`discovery rule with respect to claims asserted by Plaintiff, the Class, and Subclass.
`
`II.
`
`47.
`
`FRAUDULENT CONCEALMENT TOLLING
`
`By failing to provide immediate notice of the adverse health effects associated
`
`with continued use of the Recalled Devices, Philips concealed its conduct and the existence of
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`the claims asserted herein from Plaintiff and the members of the Class and Subclass.
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`48.
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`Upon information and belief, Philips intended its acts to conceal the facts and
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`claims from Plaintiff and members of the Class and Subclass. Plaintiff and the members of the
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`Class and Subclass were unaware of the facts alleged herein without any fault or lack of
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`diligence on their part and could not have reasonably discovered Defendants’ conduct. For this
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`reason, any statute of limitations that otherwise may apply to the claims of Plaintiff or members
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`of the Class or Subclass should be tolled.
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`CLASS ACTION ALLEGATIONS
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`49.
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`Plaintiff brings this action as a class action pursuant to Federal Rules of Civil
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`Procedure 23(a) and 23(b)(3). Plaintiff seeks class certification on behalf of a class defined as
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`follows (the “Class”):
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`NATIONWIDE CLASS: All persons in the United States who purchased or used
`a CPAP, Bi-Level PAP, or Mechanical Ventilator device that was manufactured
`by Philips before April 26, 2021, and recalled by Philips on June 14, 2021.
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`50.
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`Plaintiff seeks certification on behalf of a subclass defined as follows (the
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`“Subclass”):
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`NEW JERSEY SUBCLASS: All persons who were or are citizens of the State of
`New Jersey who purchased or used a CPAP, Bi-Level PAP, or Mechanical
`Ventilator device that was manufactured by Philips before April 26, 2021, and
`recalled by Philips on June 14, 2021.
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`Plaintiff reserves the right to modify or refine the definitions of the Class or
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`51.
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`Subclass based upon discovery of new information and in order to accommodate any of the
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`Court’s manageability concerns.
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`52.
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`Excluded from the Class and Subclass are: (a) any Judge or Magistrate Judge
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`presiding over this action and members of their staff, as well as members of their families; (b)
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`Defendants’ and Defendants’ predecessors, parents, successors, heirs, assigns, subsidiaries, and
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`any entity in which any Defendants or their parents have a controlling interest, as well as
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`Case 2:21-cv-00519-RCY-LRL Document 1 Filed 09/17/21 Page 15 of 33 PageID# 15
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`Defendants’ current or former employees, agents, officers, and directors; (c) persons who
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`properly execute and file a timely request for exclusion from the Class or Subclass; (d) persons
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`whose claims in this matter have been finally adjudicated on the merits or otherwise released; (e)
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`counsel for Plaintiff and Defendants; and (f) the legal representatives, successors, and assigns of
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`any such excluded persons.
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`53.
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`Numerosity (Rule 23(a)(1)). The Class and Subclass are so numerous that
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`joinder of individual members herein is impracticable. The exact number of members of the
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`Class and Subclass, as herein identified and described, is not known, but sales figures and the
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`Recall Notice indicate that millions of individuals have purchased the Recalled Devices.
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`54.
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`Commonality (Rule 23(a)(2)). Common questions of fact and law exist for each
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`cause of action and predominate over questions affecting only individual Class and Subclass
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`members, including the following:
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`• whether Defendants owed a duty of care to Plaintiff and the Class and Subclass;
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`• whether Defendants knew or should have known that the PE-PUR Foam used for
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`sound abatement posed health risks;
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`• whether Defendants wrongfully represented that the PE-PUR Foam used for
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`sound abatement in the Recalled Devices was safe;
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`• whether the Recalled Devices retained any value post-recall;
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`• whether Defendants wrongfully represented that the Recalled Devices were safe
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`to use;
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`• whether Defendants wrongfully failed to disclose that the PE-PUR Foam used for
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`sound abatement in the Recalled Devices posed health risks to Recalled Device
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`users;
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`Case 2:21-cv-00519-RCY-LRL Document 1 Filed 09/17/21 Page 16 of 33 PageID# 16
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`• whether Defendants’ representations and omissions in advertising, warranties,
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`packaging, and/or labeling were false, deceptive, and/or misleading;
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`• whether those representations and omissions were likely to deceive a reasonable
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`consumer;
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`• whether a reasonable consumer would consider the presence, or risk of, health
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`risks as a material fact in purchasing one of the Recalled Devices;
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`• whether Defendants had knowledge that those representations and omissions were
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`false, deceptive, and misleading;
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`• whether Defendants breached their express warranties;
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`• whether Defendants breached their implied warranties;
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`• whether Defendants engaged in unfair trade practices;
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`• whether Defendants engaged in false advertising;
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`• whether Defendants’ conduct was negligent per se;
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`• whether Defendants made negligent and/or fraudulent misrepresentations and/or
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`omissions; and
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`• whether Plaintiff and the members of the Class and Subclass are entitled to actual,
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`statutory, and punitive damages.
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`55.
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`Typicality (Rule 23(a)(3)). Plaintiff’s claims are typical of the claims of the other
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`members of the proposed Class and Subclass. Plaintiff and members of the Class and Subclass
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`(as applicable) suffered injuries as a result of Defendants’ wrongful conduct that is uniform
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`across the Class and Subclass.
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`56.
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`Adequacy (Rule 23(a)(4)). Plaintiff’s interests are aligned with the Class and
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`Subclass he seeks to represent. Plaintiff has and will continue to fairly and adequately represent
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`16
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`Case 2:21-cv-00519-RCY-LRL Document 1 Filed 09/17/21 Page 17 of 33 PageID# 17
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`and protect the interests of the Class and Subclass. Plaintiff has retained competent counsel
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`highly experienced in complex litigation and class actions and the types of claims at issue in this
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`litigation, with the necessary resources committed to protecting the interests of the Class and
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`Subclass. Plaintiff has no interest that is antagonistic to those of the Class and Subclass, and
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`Defendants have no defenses unique to Plaintiff. Plaintiff and his counsel are committed to
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`vigorously prosecuting this action on behalf of the members of the Class and Subclass. Neither
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`Plaintiff nor Plaintiff’s counsel have any interest adverse to those of the other members of the
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`Class and Subclass.
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`57.
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`Superiority. This class action is appropriate for certification because class
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`proceedings are superior to other available methods for the fair and efficient adjudication of this
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`controversy, and joinder of all members of the Class and Subclass is impracticable. The
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`prosecution of separate actions by individual members of the Class and Subclass would impose
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`heavy burdens upon the Courts and Defendants, would create a risk of inconsistent or varying
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`adjudications of the questions of law and fact common to members of the Class and Subclass,
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`and would be dispositive of the interests of the other members not parties to the individual
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`adjudications or would substantially impair or impede their ability to protect their interests. Class
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`treatment will create economies of time, effort, and expense and promote uniform decision-
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`making.
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`58. Manageability. This proposed class action presents fewer management
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`difficulties than individual litigation, and provides