Case 3:21-cv-03917-TAD-KDM Document 1 Filed 11/09/21 Page 1 of 28 PageID #: 1
`
`IN THE UNITED STATES DISTRICT COURT FOR THE
`WESTERN DISTRICT OF LOUISIANA
`MONROE DIVISION
`_________________________________
`
`RONALD NAPPIER
`
`
`Plaintiff,
`
`
`v.
`
`KONINKLIJKE PHILIPS N.V.; PHILIPS
`NORTH AMERICA LLC; and PHILIPS RS
`NORTH AMERICA LLC,
`
`
`
`Case No.
`COMPLAINT
`DEMAND FOR JURY TRIAL
`
`
`
`Defendants,
`
`
`Plaintiff Ronald Nappier (“Plaintiff”), for his complaint against Defendants Koninklijke
`
`Philips N.V. (“Royal Philips”), Philips North America LL (“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, as follows:
`
`INTRODUCTION
`
`1.
`
`Plaintiff brings this action for injuries caused as a user 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.
`
`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
`1
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`

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`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 of PE-PUR Foam in these
`
`devices include headache/dizziness, irritation (eyes, nose, respiratory tract, skin), hypersensitivity,
`
`nausea/vomiting, toxic and carcinogenic effects.
`
`
`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/cdam/b2bhc/master/landing-pages/src/update/documents/philips-recall-clinical-
`information-for-physiciansand-providers.pdf (accessed September 20, 2021).
`
`
`
`2
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`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
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`for life-sustaining therapy consult with their physicians regarding alternative ventilator options.
`
`8.
`
`In or about 2020, Plaintiff purchased a Philips DreamStation ASV CPAP device,
`
`which he used nightly from the date of purchase until he learned of the recall.
`
`9.
`
`Prior to the purchase and use of the Philips DreamStation ASV CPAP device
`
`Plaintiff did not have any serious respiratory or pulmonary problems.
`
`10.
`
`11.
`
`Subsequently, this Plaintiff developed respiratory problems.
`
`
`
`Plaintiff has experienced chest tightness and respiratory irritants during his use of
`
`the Philips’ CPAP machines. Since being notified of the recall, Plaintiff has experienced anxiety
`
`concerning the serious health risks he is facing from possible exposure to off-gassed or degraded
`
`PE-PUR Foam in the Recalled machines, including the DreamStation ASV CPAP used by
`
`Plaintiff.
`
`12
`
`.Plaintiff 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.
`
`PARTIES
`
`13.
`
`14.
`
`Plaintiff Ronald Nappier is a citizen of Monroe, Ouachita Parish, Louisiana.
`
`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
`
`
`
`3
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`

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`Philips NA and Philips RS.4 Upon information and belief, Royal Philips controls Philips NA and
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`Philips RS in the manufacturing, selling, distributing, and supplying of the recalled CPAP, Bi-
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`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
`
`JURISDICTION AND VENUE
`
`17.
`
`Jurisdiction of this Court is based on Diversity of Citizenship and the amount in
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`controversy exceeds the jurisdictional limit of $75,000.00. 28 U.S.C. Section 1332(a)(1).
`
`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
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`the events or omissions giving rise to Plaintiff’s claims occurred in this District; and because the
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`Plaintiff resides in this 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
`
`
`4 Philips 2020 annual filing with the SEC, fn. 8,
`https://www.sec.gov/Archives/edgar/data/313216/000031321621000008/phg-exhibit8.htm (accessed
`September 20, 2021).
`5 Philips 2020 annual filing with the SEC,
`https://www.sec.gov/ix?doc=/Archives/edgar/data/0000313216/000031321621000008/phg-20201231.htm
`(accessed September 20, 2021).
`6 Philips announces completion of tender offer to acquire Respironics, WEB WIRE,
`https://www.webwire.com/ViewPressRel.asp?aId=61199 (accessed September 20, 2021).
`
`
`
`4
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`

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`out of and relate to Defendants’ contacts with this District. Defendants Philips RS and Philips NA
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`are controlled by their parent Royal Philips. Defendants’ affiliations with this District are so
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`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
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`furtherance of the unlawful acts alleged in this Complaint in this District, as well as throughout
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`the United States. The unlawful acts of Defendants have been directed at, targeted, and have had
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`the effect of causing injury to persons residing in, located in, or doing business in this District, as
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`well as throughout the United States.
`
`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
`
`
`
`5
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`performance, and long-term health. CPAP therapy helps treat sleep apnea by preventing the
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`person’s airway from collapsing while breathing during sleep cycles, which can help prevent
`
`interruptions in breathing.
`
`II.
`
`22.
`
`Bi-Level Positive Airway Pressure Therapy
`
`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
`
`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.
`
`BiLevel 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.
`
`
`
`
`
`
`
`6
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`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.
`
`IV.
`
`25.
`
`Philips Sleep & Respiratory Care Devices Endangered Users
`
`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
`
`BiLevel 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)
`
`
`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).
`
`
`
`7
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`

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`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
`
`27.
`
`The list of the devices recalled by Philips (the “Recalled Devices” or “Recalled
`
`Machines”) include:
`
`Philips CPAP and Bi-Level PAP Devices Manufactured Before
`April 26, 2021 Subject to Recall
`Device Name/ Model Type
`E30 (Emergency Use Authorization)
`
`Type
`Continuous Ventilator, Minimum
`Ventilatory Support, Facility Use
`Continuous Ventilator, Non-life
`Supporting
`
`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
`
`
`
`
`
`
`
`
`
`Non-continuous Ventilator
`
`
`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-
`certainsleep-and-respiratory-care-devices.html (accessed September 20, 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-
`healthrisks-n1270725 (accessed September 20, 2021)
`
`
`
`8
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`
`
`
`
`Philips Mechanical Respirator Devices Manufactured Before
`April 26, 2021 Subject to Recall
`Device Name/ Model Type
`Trilogy 100 Ventilator
`Trilogy 200 Ventilator
`Garbin Plus, Aeris, LifeVentVentilator
`A-Series BiPAP Hybrid A30
`A-Series BiPAP Hybrid A30
`Philips A-Series BiPAP A40
`Philips A-Series BiPAP A30
`
`Continuous Ventilator, Minimum
`Ventilatory Support, Facility Use
`Continuous Ventilator, Non-life
`Supporting
`
`Type
`Continuous Ventilator
`
`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.”
`
`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.”11
`
`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.”12
`
`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.”13
`
`
`11 Philips Sleep and Respiratory Care Update – Clinical information for physicians, June 14, 2021,
`philips-recall-clinical-information-for-physicians-and-providers.pdf (accessed September 20, 2021).
`12 Id.
`13 Recall Notice (Exhibit A hereto).
`
`
`
`9
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`
`
`V.
`
`
`32
`
`The Health Risks Associated with Use of the Recalled Devices Renders Them
`Worthless to Patients
`
` 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
`
`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 Device.
`
`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.”14
`
`• “For patients using life-sustaining mechanical ventilator devices: DO NOT
`discontinue or alter prescribed therapy, without consulting physicians to determine
`appropriate next steps.”15
`
`
`
`
`
`
`
`
`14 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/srcupdate#section_2 (accessed
`June 27, 2021) (Questions and answers) (emphasis in original)
`15 Id.
`
`
`
`10
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`35.
`
`As a result of the above, Plaintiff will have to undertake considerable expense
`
`replacing the Recalled Device.
`
`VI.
`
`36.
`
`Philips Unreasonably Delayed its Recall
`
`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).”16
`
`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.
`
`VII. Plaintiff Ronald Nappier
`
`39.
`
`Plaintiff Ronald Nappier is a resident and citizen of Monroe, Ouachita Parish,
`
`Louisiana.
`
`40.
`
`Plaintiff purchased a Recalled Device, a DreamStation ASV CPAP device, prior to
`
`June 14, 2021.
`
`
`16 Recall Notice (Exhibit “A” hereto).
`
`
`
`11
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`41.
`
`The manuals accompanying Plaintiff's DreamStation ASV 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 Defendants
`
`informed Plaintiff of these risks, he would not have purchased or used the Recalled Device.
`
`42. Without knowing of the health risks associated with use of the Recalled Device,
`
`Plaintiff used his Recalled Device regularly to treat sleep apnea until learning on or about June 26,
`
`2021, that the devices were recalled.
`
`43.
`
`As a result of the health risks associated with continued use of the DreamStation
`
`ASV CPAP device, Plaintiff suffers injury not limited to respiratory illness, sinus infections,
`
`headaches, skin and eye irritation, and economic damage.
`
`TOLLING AND ESTOPPEL
`
`I.
`
`DISCOVERY RULE TOLLING
`
`44.
`
`Plaintiff had no way of knowing about Philips’ conduct with respect to the health
`
`risks associated with the use of the Recalled Device.
`
`45.
`
`Plaintiff, through the exercise of reasonable care, could not have discovered the
`
`conduct by Philips alleged herein. Further, Plaintiff 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.
`
`
`
`
`
`
`
`12
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`II.
`
`47.
`
`FRAUDULENT CONCEALMENT - TOLLING
`
`By failing to provide immediate notice of the adverse health effects associated with
`
`continued use of the Recalled Device, Philips concealed its conduct and the existence of the claims
`
`asserted herein from Plaintiff.
`
`48.
`
`Upon information and belief, Philips intended its acts to conceal the facts and
`
`claims from Plaintiff. Plaintiff was unaware of the facts alleged herein without any fault or lack of
`
`diligence on his part and could not have reasonably discovered Defendants’ conduct. For this
`
`reason, any statute of limitations that otherwise may apply to the claims of Plaintiff should be
`
`tolled.
`
`CLAIMS FOR RELIEF
`
`COUNT I
`NEGLIGENCE
`
`Defendants had a duty to individuals, including the Plaintiff, to use reasonable care
`
`49.
`
`in designing, manufacturing, marketing, labeling, packaging and selling the recalled machines,
`
`including the DreamStation ASV CPAP machine. Should non-Louisiana law control this case,
`
`common law negligence and strict liability theories apply.
`
`50.
`
`Negligently marketing, advertising, and recommending the use of Paraquat without
`
`sufficient knowledge as to its dangerous propensities
`
`51.
`
`Defendants were negligent in failing to use reasonable care as described herein in
`
`designing and manufacturing, the recalled machines, as well as the DreamStation ASV CPAP
`
`machine that Plaintiff purchased and used. Defendants breached their aforementioned duty by:
`
`a.
`
`
`
`
`
`Failing to design the recalled machines, as well as the DreamStation ASV CPAP
`machine so as to avoid an unreasonable and increased risk of harm of cancer and
`other injuries in users;
`
`13
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`Case 3:21-cv-03917-TAD-KDM Document 1 Filed 11/09/21 Page 14 of 28 PageID #: 14
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`Including in the design of the recalled machines, as well as the DreamStation ASV
`CPAP machine, flawed polyurethane PE-PUR sound abatement foam that could
`break down, flake off and/or chemicalize and infiltrate the device’s air pathway
`while the user is sleeping, exposing them to increased and unnecessary risk of
`cancer, including lung cancer, as well as other injuries;
`
`Manufacturing certain Philips machines, including the recalled machines and the
`DreamStation ASV CPAP machine with a specific lot and/or lots of flawed
`polyurethane PE-PUR sound abatement foam that could break down, flake off
`and/or chemicalize and infiltrate the device’s air pathway while the user is sleeping,
`exposing them to increased and unnecessary risk of cancer, including lung cancer,
`as well as other injuries;
`
`
`Otherwise negligently or carelessly designing, manufacturing, marketing, labeling,
`packaging and/or selling the DreamStation ASV CPAP machine.
`
`b.
`
`
`c.
`
`
`d.
`
`
`
`52.
`
`Defendant also negligently failed to warn or instruct the Plaintiff in the following
`
`manners:
`
`a.
`
`
`b.
`
`
`c.
`
`
`d.
`
`
`e.
`
`
`f.
`
`g.
`
`the recalled machines, including the DreamStation ASV CPAP machine’s flawed
`polyurethane PE-PUR sound abatement foam propensities to break down, flake off
`and/or chemicalize and infiltrate the device’s air pathway while the user is sleeping,
`exposing them to increased and unnecessary risk of cancer, including lung cancer,
`as well as other injuries;
`
`the recalled machines, including the DreamStation ASV CPAP machine’s
`polyurethane PE-PUR sound abatement foam propensities to degradation,
`fragmentation and/or chemicalization;
`
`the rate and manner in which the polyurethane PE-PUR sound abatement foam
`would break down, flake off and/or chemicalize and infiltrate the device’s air
`pathway while the user is sleeping;
`
`The risk of chronic inflammation resulting from use of the recalled machines,
`including the DreamStation ASV CPAP machine;
`
`the risk of chronic infections resulting from the recalled machines, including the
`DreamStation ASV CPAP machine;
`
`the risk of lung, kidney, and/or rectal cancers from exposure to the foam;
`
`the need for corrective or revision surgery to adjust or remove cancerous tumors
`and/or nodules as a result of usage of the recalled machines, including the
`DreamStation ASV CPAP machine;
`
`
`
`14
`
`

`

`Case 3:21-cv-03917-TAD-KDM Document 1 Filed 11/09/21 Page 15 of 28 PageID #: 15
`
`
`h.
`
`
`53.
`
`the severity of complications that could arise as a result of implantation of the
`recalled machines, including the DreamStation ASV CPAP machine;
`
`As a direct and proximate result of Defendants’ negligence, the Plaintiff has
`
`experienced significant mental and physical pain and suffering, has sustained permanent injury,
`
`has undergone medical treatment and will likely undergo further medical treatment and
`
`procedures, has suffered financial or economic loss, including, but not limited to, obligations for
`
`medical services and expenses, lost income, and other damages.
`
`WHEREFORE, Plaintiff demands judgment against Defendants, and each of them,
`
`individually, jointly, severally and in the alternative, and requests compensatory damages, punitive
`
`damages, together with interest, costs of suit, attorneys’ fees, and such further relief as the Court
`
`deems equitable and just.
`
`COUNT II
`DESIGN DEFECT UNDER R.S. 9:2800.55 OF THE
`LOUISIANA PRODUCTS LIABLITY ACT (LPLA)
`
`The recalled machines, including the DreamStation ASV CPAP machine used by
`
`54.
`
`Plaintiff was not reasonably safe for its intended uses and was defective as described herein with
`
`respect to its design. As previously stated, the DreamStation ASV CPAP machine’s design defects
`
`include, but are not limited to:
`
`a.
`
`
`b.
`
`
`c.
`
`the use of polyurethane PE-PUR sound abatement foam in the recalled machines,
`including the DreamStation ASV CPAP machine and the immune reaction that
`results from such material, causing adverse reactions and injuries;
`
`Failing to design the recalled machines, as well as the DreamStation ASV CPAP
`machine so as to avoid an unreasonable and increased risk of harm of cancer and
`other injuries in users;
`
`Including in the design of the recalled machines, as well as the DreamStation ASV
`CPAP machine, flawed polyurethane PE-PUR sound abatement foam that could
`break down, flake off and/or chemicalize and infiltrate the device’s air pathway
`
`
`
`15
`
`

`

`Case 3:21-cv-03917-TAD-KDM Document 1 Filed 11/09/21 Page 16 of 28 PageID #: 16
`
`while the user is sleeping, exposing them to increased and unnecessary risk of
`cancer, including lung cancer, as well as other injuries;
`
` Failing to use alternatively available sound abatement materials and/or foams in
`the recalled machines, as well as the DreamStation ASV CPAP machine, such as
`plastic, silicone, or rubber, which would not break down, flake off and/or
`chemicalize and infiltrate the device’s air pathway while the user is sleeping;
`
`Otherwise negligently or carelessly designing, manufacturing, marketing, labeling,
`packaging and/or selling the recalled machines, including the DreamStation ASV
`CPAP machine.
`
`At all times, the use of the recalled machines, as well as Plaintiff’s use of the
`
`
`d.
`
`
`e.
`
`
`55.
`
`DreamStation ASV CPAP machine (and its components, such as the facemask) was at all times
`
`foreseeable and foreseen by Defendants as it was used by Plaintiff in the manner intended by
`
`Defendants.
`
`56.
`
`The recalled machines, including the DreamStation ASV CPAP machine used by
`
`Plaintiff, was defective in their design in that they failed to perform as safely as a reasonable
`
`consumer would expect when used in an intended or reasonably foreseeable manner.
`
`57.
`
`The recalled machines, including the DreamStation ASV CPAP machine used by
`
`Plaintiff are further defective in that the risks of danger inherent in its design outweigh the
`
`benefits, in that the gravity of danger posed by the design was great, the likelihood that such
`
`danger would cause injury was substantial, there were feasible, safer alternative designs known
`
`to Defendants at the time of manufacture, the financial costs of an improved design was minor
`
`and there were likely no adverse consequences to the product, or to the user, that would result
`
`from an alternative design.
`
`58.
`
`Defendants, and each of them, knew that the recalled machines, including the
`
`Plaintiff’s Dreamstation machine, and the component parts of these CPAP machines would be
`
`
`
`16
`
`

`

`Case 3:21-cv-03917-TAD-KDM Document 1 Filed 11/09/21 Page 17 of 28 PageID #: 17
`
`purchased and used without inspection for defects in the design of the machine or its
`
`masks/attachments.
`
`59.
`
`The recalled machines, including the Plaintiff’s Dreamstation machine, and the
`
`component parts of these CPAP machines were defective when they left the control of each of
`
`these Defendants.
`
`60.
`
`As a direct and proximate result of the recalled machines, including Plaintiff’s
`
`defective DreamStation ASV CPAP machine(s) aforementioned defects as described herein, the
`
`Plaintiff has experienced significant mental and physical pain and suffering, has sustained
`
`permanent injury, has undergone medical treatment and will likely undergo future medical
`
`treatment and procedures, has suffered financial or economic loss, including, but not limited to,
`
`obligations for medical services and expenses, lost income, and other damages.
`
`61.
`
`Defendants are strictly liable to the Plain