Case 6:21-cv-03447-MJJ-PJH Document 1 Filed 09/27/21 Page 1 of 44 PageID #: 1
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`UNITED STATES DISTRICT COURT
`WESTERN DISTRICT OF LOUISIANA
`LAFAYETTE DIVISION
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`JURY DEMAND
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`MARY ORTEGO,
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`PLAINTIFF,
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`V.
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`KONINKLIJKE PHILIPS N.V.;
`PHILIPS NORTH AMERICA LLC;
`PHILIPS HOLDING USA, INC.; and
`PHILIPS RS NORTH AMERICA LLC;
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`DEFENDANTS.
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` ) Civil Action No. 6:21-cv-3447
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`COMPLAINT
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`Plaintiff Mary Ortego, by and through her undersigned counsel, hereby submits the
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`following Complaint and Demand for Jury Trial against Defendants Koninklijke Philips N.V.
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`(“Royal Philips”), Philips North America LLC (“Philips NA”), Philips Holding USA, Inc.
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`(“PHUSA”), and Philips RS North America LLC (“Philips RS”) (collectively referred to as
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`“Philips” or the “Defendants”) and alleges the following upon personal knowledge and belief, and
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`investigation of counsel:
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`INTRODUCTION
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`1.
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`Philips manufactures, markets, sells, and distributes a variety of products for sleep
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`and home respiratory care.
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`2.
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`Philips manufactures, markets, imports, sells, and distributes a variety of
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`Continuous Positive Airway Pressure (CPAP) and BiLevel Positive Airway Pressure (BiLevel
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`PAP) devices for patients with obstructive sleep apnea (“OSA”).
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`3.
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`Philips also manufactures, markets, imports, sells, and distributes a variety of
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`ventilator devices for patients with respiratory conditions.
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`4.
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`On June 14, 2021, Philips issued a recall notification for many of its CPAP and
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`BiLevel PAP devices as well as a number of its ventilator devices.
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`5.
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`In its recall notification, Philips advised of potential health risks related to the sound
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`abatement foam used in the affected devices.
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`6.
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`Philips informed patients using these affected devices of potential risks from
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`exposure to degraded sound abatement foam particles and exposure to chemical emissions from
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`the sound abatement foam material.
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`7.
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`Specifically, Philips notified patients that the risks related to issues with the sound
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`abatement foam include headache, irritation, inflammation, respiratory issues, and possible toxic
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`and carcinogenic effects.
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`8.
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`Plaintiff Mary Ortego was prescribed to use and purchased the DreamStation CPAP
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`device, one of Philips’ recalled devices, a to treat her obstructive sleep apnea.
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`9.
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`Plaintiff used Philips’ DreamStation CPAP device (the “subject device”), one of
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`Philips’ recalled devices, on a daily basis for a number of years.
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`10.
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`11.
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`In or around September 28, 2020, Plaintiff was diagnosed with kidney disease.
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`As a direct and proximate result of Philips’ conduct, Plaintiff has suffered serious
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`and substantial life-altering injuries.
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`12.
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`As a direct and proximate result of the subject device, manufactured, marketed,
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`imported, sold, and distributed by Philips, Plaintiff has suffered physical, emotional, and financial
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`injuries, including kidney disease.
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`PLAINTIFF
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`13.
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`Plaintiff Mary Ortego is an adult resident and citizen of Opelousas, Louisiana.
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`Opelousas, Louisiana is located in St. Landry Parish.
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`14.
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`Plaintiff has been a resident and citizen of Opelousas, Louisiana since the time she
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`was prescribed her Philip’s DreamStation CPAP through the present, including the time she was
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`diagnosed with kidney disease.
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`DEFENDANTS
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`15.
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`Defendant Koninklijke Philips N.V. (“Royal Philips”) is a public limited liability
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`company established under the laws of The Netherlands, having its principal executive offices at
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`Philips Center, Amstelplein 2, 1096 BC Amsterdam, The Netherlands. Royal Philips is the parent
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`company of Philips NA and Philips RS. Royal Philips can be served with process via the
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`Convention on the Service Abroad of Judicial and Extrajudicial Documents in Civil or
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`Commercial Matters (“Hague Service Convention”).
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`16.
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`Defendant Philips North America LLC (“Philips NA”) is a Delaware corporation
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`with its principal place of business located at 222 Jacobs Street, Floor 3, Cambridge, Massachusetts
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`02141. Philips NA is a wholly-owned subsidiary of Royal Philips. Upon information and belief,
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`Philips NA manages the operation of Royal Philips’ various lines of business, including Philips
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`RS, in North America. The sole member of Philips NA is PHUSA, which is a Delaware
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`corporation with its principal place of business located at 222 Jacobs Street, Floor 3, Cambridge,
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`Massachusetts 02141. Philips NA may be served through its registered agent, Corporation Service
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`Company, at 501 Louisiana Avenue, Baton Rouge, Louisiana 70802.
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`17.
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`Defendant Philips Holding USA, Inc. (“PHUSA”) is a Delaware corporation with
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`its principal place of business located at 222 Jacobs Street, Floor 3, Cambridge, Massachusetts
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`02141. PHUSA is a holding company that is the sole member of Defendant Philips NA. PHUSA
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`may be served through its registered agent, Corporation Service Company, at 501 Louisiana
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`Avenue, Baton Rouge, Louisiana 70802.
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`18.
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`Defendant Philips RS North America LLC (“Philips RS”) is a Delaware corporation
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`with its principal place of business located at 6501 Living Place, Pittsburgh, Pennsylvania 15206.
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`Philips RS was formerly operated under the business name Respironics, Inc. (“Respironics”).
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`Royal Philips acquired Respironics in 2008.1 Philips RS may be served through its registered
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`agent, Corporation Service Company, at 501 Louisiana Avenue, Baton Rouge, Louisiana 70802.
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`19.
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`Royal Philips, Philips NA, PHUSA, and Philips RS are hereinafter collectively
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`referred to as “Philips” or the “Defendants.”
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`JURISDICTION AND VENUE
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`20.
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`At all times pertinent to this Complaint, Defendants were and are in the business of
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`designing, manufacturing, marketing, promoting, advertising, and selling devices for the treatment
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`of obstructive sleep apnea, including the DreamStation device prescribed for and purchased by
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`Plaintiff at issue in this lawsuit (the “subject device”).
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`21.
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`At all times pertinent to this Complaint, Defendants were the mere alter egos or
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`instrumentalities of each other. There is such a unity of interest and ownership between
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`Defendants that the separate personalities of their entities ceased to exist. Defendants operated as
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`a single enterprise, equally controlled each other’s business affairs, commingled their assets and
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`funds, disregarded corporate formalities, and used each other as a corporate shield to defeat justice,
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`perpetuate fraud and evade contractual and/or tort liability.
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`22.
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`At all times pertinent to this Complaint, Defendants acted in all respects as agents
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`or apparent agents of one another.
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`1 Philips announces completion of tender offer to acquire Respironics, WEB WIRE,
`https://www.webwire.com/ViewPressRel.asp?aId=61199 (accessed June 30, 2021).
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`23.
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`At all times pertinent to this Complaint, Defendants acted in concert in the
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`designing, manufacturing, marketing, promoting, advertising, and selling of devices for the
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`treatment of obstructive sleep apnea, including the subject device. Defendants combined their
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`property and labor in a joint undertaking for profit, with rights of mutual control over each other,
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`rendering them jointly liable to Plaintiff.
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`24.
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`Defendants regularly transact business in Louisiana that includes marketing and
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`selling devices for the treatment of obstructive sleep apnea, derive substantial revenue from their
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`business transactions in Louisiana, and have purposely availed themselves of the privilege of doing
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`business in Louisiana.
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`25.
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`Defendants shipped or participated in shipping the subject device and other devices
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`with the reasonable expectation that the devices could or would find their way to Louisiana through
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`the stream of commerce.
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`26.
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`Defendants’ actions in marketing and selling their devices in Louisiana should have
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`led them to reasonably anticipate being hauled into Court in Louisiana.
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`27.
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`Defendants have sufficient “minimum contacts” with Louisiana that subjecting
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`them to personal jurisdiction in Louisiana does not offend traditional notions of fair play and
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`substantial justice.
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`28.
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`As detailed below, Plaintiff suffered injuries in St. Landry Parish, Louisiana from
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`the subject device that Defendants negligently designed and/or manufactured either in Louisiana
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`or outside of Louisiana. Thus, Defendants committed a tort either in Louisiana or outside of
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`Louisiana that caused injuries in Louisiana, and the Court has personal jurisdiction over
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`Defendants under Louisiana’s Long Arm Statute, La. Rev. Stat. Ann § 13:3201.
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`29.
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`This Court has personal jurisdiction over Philips NA, PHUSA, and Philips RS
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`because of their systematic and continuous contacts with Louisiana as well as their maintenance
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`of a registered agent for service of process in Louisiana.
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`30.
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`This Court has personal jurisdiction over Royal Philips because of its systematic
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`and continuous contacts with Louisiana.
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`31.
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`This Court has original jurisdiction in this matter pursuant to 28 U.S.C. §1332(a)(1)
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`and §1332(a)(2), as there is complete diversity between Plaintiff and Defendants and the amount
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`in controversy exceeds $75,000.
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`32.
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`There is complete diversity between Plaintiff and all of the members comprising
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`Philips NA and Philips RS.
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`33.
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`This Court is a proper venue for this civil action pursuant to 28 U.S.C § 1391(b)(2)
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`as the event giving rise to the Plaintiff’s claims occurred in St. Landry Parish, Louisiana.
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`34.
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`This Court’s exercise of personal jurisdiction over Defendants comports with due
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`process.
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`BACKGROUND
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`35.
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`At all relevant times, Defendants manufactured, marketed, sold, and distributed a
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`lineup of CPAP and BiPAP devices as well as ventilator devices under its “Sleep & Respiratory
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`Care” portfolio. These devices are designed to assist individuals with a number of sleep, breathing,
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`and other respiratory conditions, including sleep apnea.
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`36.
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`Defendants sought and obtained Food and Drug Administration (“FDA”) approval
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`to market the Recalled Devices, including the subject device used by Plaintiff, under Section
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`510(k) of the Medical Device Amendment to the Food, Drug and Cosmetics Act. Section 510(k)
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`allows marketing of medical devices if the device is deemed substantially equivalent to other
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`legally marketed predicate devices marketed prior to May 28, 1976. No formal review for safety
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`or efficacy is required.
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`A.
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`Continuous Positive Airway Pressure Therapy
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`37.
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`Continuous Positive Airway Pressure (“CPAP”) therapy is a common nonsurgical
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`treatment primarily used to treat sleep apnea. CPAP therapy typically involves the use of a nasal
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`or facemask device and a CPAP device helps individuals breathe by increasing the air pressure in
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`an individual’s throat.
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`38.
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`Sleep Apnea is a common sleep disorder characterized by repeated interruptions in
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`breathing throughout an individual’s sleep cycle. These interruptions, called “apneas,” are caused
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`when the soft tissue in an individual’s airway collapses. The airway collapse prevents oxygen
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`from reaching the individual’s lungs which can cause a buildup of carbon dioxide. If the
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`individual’s brain senses the buildup of carbon dioxide, it will briefly rouse the individual from
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`sleep so that the individual’s airway can reopen. Often these interruptions are so brief that the
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`individual will not remember. Despite the brevity of the interruptions, the sleep cycle disruption
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`caused by sleep apnea can dramatically impact a person’s lifestyle, including negatively impacting
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`energy, mental performance, and long-term health. CPAP therapy helps treat sleep apnea by
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`preventing the person’s airway from collapsing while breathing during sleep cycles, which can
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`help prevent interruptions in breathing.
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`B.
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`Bi-Level Positive Airway Pressure Therapy
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`39.
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`Bi-Level Positive Airway Pressure (“BiPAP”) therapy is a common alternative to
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`CPAP therapy for treating sleep apnea. Similar to CPAP therapy, BiPAP therapy is nonsurgical
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`and involves the use of a nasal or facemask device to maintain air pressure in an individual’s
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`airway. BiPAP is distinguishable from CPAP therapy, however, because BiPAP devices deliver
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`two alternating levels—inspiratory and expiratory—of pressurized air into a person’s airway,
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`rather than the single continuous level of pressurized air delivered by a CPAP device. The
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`inspiratory positive airway pressure assists a person as a breath is taken in. Conversely, the
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`expiratory positive airway pressure is applied to allow a person to comfortably breathe out. BiPAP
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`devices deliver one level of pressurize air (the inspiratory positive level) to assist as a person
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`inhales, and another level (the expiratory level) as a person exhales.
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`C.
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`Philips’ Sleep & Respiratory Care Devices Were Endangering its Users
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`On April 26, 2021, as part of its Quarterly Report for Q1 2021, Philips disclosed
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`40.
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`for the first time, under a section entitled “Regulatory Update,” that device user reports had led to
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`a discovery that the type of PE-PUR “sound abatement” foam Philips used to minimize noise in
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`several CPAP and BiPAP respirators posed health risks to its users. Specifically, Philips disclosed
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`that “the [PE-PUR] foam may degrade under certain circumstances, influenced by factors
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`including use of unapproved cleaning methods, such as ozone[], and certain environmental
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`conditions involving high humidity and temperature.”2
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`41.
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`Philips has utilized polyester-based polyurethane (PE-PUR) sound abatement foam
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`to dampen device vibration and sound during routine operation.
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`42.
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`On June 14, 2021, as a result of extensive ongoing review following the
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`announcement on April 26, 2021, Philips issued a recall notification for specific affected devices.3
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`2 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 30, 2021).
`3 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 30, 2021).
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`43.
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`In its recall notification, Philips identified examples of potential risks which include
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`exposure to degraded sound abatement foam particles and exposure to chemical emissions from
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`the sound abatement foam material.4
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`44.
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`Philips reported that, based on lab testing and evaluations, it may be possible that
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`these potential health risks could result in a wide range of potential patient impact, from transient
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`potential injuries, symptoms and complications, as well as possibly serious injury which can be
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`life-threatening or cause permanent impairment, or require medical intervention to preclude
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`permanent impairment.5
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`45.
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`According to Philips’ recall notice, the PE-PUR Foam used in Recalled Devices
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`puts Recalled Device users at risk of suffering from the following health harms: “Particulate
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`exposure can cause headache, irritation [skin, eye, and respiratory tract], inflammation, respiratory
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`issues, and possible toxic and carcinogenic effects[;]” whereas the “potential risks of chemical
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`exposure due to off-gassing include headache, irritation, hypersensitivity, nausea/vomiting, and
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`possible toxic and carcinogenic effects.”6
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`46.
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`On June 14, 2021, Philips also issued a brief report titled “Clinical Information for
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`Physicians.” In this report, Philips disclosed that “[l]ab analysis of the degraded foam reveals the
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`4 Philips issues recall notification, PHILIPS RESPIRONICS (June 14, 2021), https://www.usa.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 30, 2021) (emphasis added).
`5 Id.
`6 Philips issues recall notification, PHILIPS RESPIRONICS (June 14, 2021), https://www.usa.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 30, 2021) (emphasis added).
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`presence of potentially harmful chemicals including Toluene Diamine, Toluene Diisocyanate, and
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`Diethylene glycol.”7
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`47.
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`In its report titled “Clinical Information for Physicians,” Philips also disclosed that
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`lab testing performed by and for Philips has also identified the presence of Volatile Organic
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`Compounds (VOCS) which may be emitted from the sound abatement foam component of the
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`affected devices. “VOCs are emitted as gases from the foam included in the [affected devices]
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`and may have short- and long-term adverse health effects. Standard testing identified two
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`compounds of concern may be emitted from the foam that are outside of safety thresholds. The
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`compounds identified are the following: Dimethyl Diazine and Phenol, 2,6-bis (1,1-
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`dimethylethyl)-4-(1-methylpropyl)-“8.
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`Philips’ Recalled Devices
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`D.
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`48.
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`In total, Philips announced that “[b]etween 3 million and 4 million” devices are
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`targeted in the recall.9
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`49.
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`The list of the devices recalled by Phillips (the “Recalled Devices”) include:
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`7 Sleep and Respiratory Care update, Clinical information for physicians, PHILIPS (June 14, 2021),
`https://www.philips.com/c-dam/b2bhc/master/landing-pages/src/update/documents/philips-recall-clinical-
`information-for-physicians-and-
`providers.pdf?_ga=2.43039205.1759564883.1625006706212130326.1624473291&_gl=1*2nhu1w*_ga*MjEyMTM
`wMzI2LjE2MjQ0NzMyOTE.*_ga_2NMXNNS6LE*MTYyNTE1MTQ3MC4xNi4xLjE2MjUxNTE1OTUuMTg.
`(accessed June 30, 2021).
`8 Id.
`9 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 29, 2021).
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`Philips CPAP and BiLevel PAP Devices Subject to Recall10
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`Device Name/Model
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`Philips E30 (Emergency Use Authorization)
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`Philips DreamStation ASV
`Philips DreamStation ST, AVAPS
`Philips SystemOne ASV4
`Philips C Series ASV, S/T, AVAPS
`Philips OmniLab Advanced Plus, In-Lab
`Titration Device
`Philips SystemOne (Q Series)
`Philips DreamStation, CPAP, Auto CPAP,
`BiPAP)
`Philips DreamStation GO, CPAP, APAP
`Philips Dorma 400, 500, CPAP
`Philips REMStar SE Auto, CPAP
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`Type
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`Continuous Ventilator, Minimum Ventilatory
`Support, Facility Use
`Continuous Ventilator, Non-life Supporting
`Continuous Ventilator, Non-life Supporting
`Continuous Ventilator, Non-life Supporting
`Continuous Ventilator, Non-life Supporting
`Continuous Ventilator, Non-life Supporting
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`Non-continuous Ventilator
`Non-continuous Ventilator
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`Non-continuous Ventilator
`Non-continuous Ventilator
`Non-continuous Ventilator
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`Philips Mechanical Respirator Devices Subject to Recall11
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`Philips Device Name/Model
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`Philips Trilogy 100 Ventilator
`Philips Trilogy 200 Ventilator
`Philips Garbin Plus, Aeris, LifeVent
`Ventilator
`Philips A-Series BiPAP Hybrid A30
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`Type
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`Continuous Ventilator
`Continuous Ventilator
`Continuous Ventilator
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`Continuous Ventilator, Minimum Ventilatory
`Support, Facility Use
`Philips A-Series BiPAP V30 Auto Ventilator Continuous Ventilator, Minimum Ventilatory
`Support, Facility Use
`Continuous Ventilator, Non-life Supporting
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`Philips A-Series BiPAP A40
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`Philips A-Series BiPAP A30
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`Continuous Ventilator, Non-life Supporting
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`10 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 30, 2021).
`11 Id.
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`11
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`50.
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`51.
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`Philips issued the following advice to patients using any of the Recalled Devices:
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` “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.”12
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` “For patients using life-sustaining mechanical ventilator devices: DO NOT
`discontinue or alter prescribed therapy, without consulting physicians to
`determine appropriate next steps.”13
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`Philips Unreasonably Delayed its Recall
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`Defendants have not disclosed when they first received reports from users of its
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`E.
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`Sleep & Respiratory Care devices “regarding the presence of black debris/particles within the
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`airpath circuit (extending from the device outlet, humidifier, tubing, and mask).”14 However,
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`given how long ago the first of the Recalled Devices came to market, it is unlikely that Defendants
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`only recently learned of these issues.
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`52.
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`Thus, as a result of user reports and other testing performed by and on behalf of
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`Defendants, Defendants were aware of the degradation of the PE-PUR sound abatement foam used
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`in the Recalled Devices, yet continued to manufacture, market, and sell the Recalled Devices with
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`such awareness for a significant period of time. During this period, Defendants unreasonably and
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`unjustly profited from the manufacture and sale of the Recalled Devices and unreasonably put
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`users of the Recalled Devices at risk of developing adverse health effects, including kidney disease.
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`12 Id. (emphasis in original).
`13 Id. (emphasis in original).
`14 Medical Device recall notification (U.S. only) / field safety notice (International Markets), PHILIPS
`RESPIRONICS https://www.usa.philips.com/healthcare/e/sleep/communications/src-update#section_2
`(accessed June 30, 2021).
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`Case 6:21-cv-03447-MJJ-PJH Document 1 Filed 09/27/21 Page 13 of 44 PageID #: 13
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`PLAINTIFF MARY ORTEGO
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`53.
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`Plaintiff Mary Ortego is an adult resident and citizen of Opelousas, Louisiana.
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`Plaintiff has been a resident a citizen of Opelousas, Louisiana at all relevant times to this action.
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`54.
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`On or around 2019, Plaintiff was prescribed the use of and purchased a
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`DreamStation device (the “subject device”). The subject device prescribed for and purchased by
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`Plaintiff was one of the Recalled Devices.
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`55.
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` At the time Plaintiff was prescribed the use of and purchased the subject device,
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`she was a resident and citizen of St. Landry Parish, Louisiana.
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`56.
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`57.
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`Since 2019, Plaintiff used the subject device daily to treat her sleep apnea.
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`At all times Plaintiff used the subject device, she used the subject device in
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`accordance with the guidelines, manual, and instructions for use set forth by Defendants.
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`58.
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`At all times Plaintiff used the subject device, she used the subject device for a
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`purpose for which the subject device was marketed, designed, and intended.
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`59.
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`At all times Plaintiff used the subject device, she used the subject device in
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`accordance with the directions and instructions issued by her physician who prescribed the use of
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`the subject device.
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`60.
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`After, and as a result of using the subject device, Plaintiff has suffered personal
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`injuries including harm to her kidney system, cellular damage, DNA damage, and lung kidney
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`disease, among others. These injuries would not have occurred but for the defective nature of the
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`subject device and/or Defendants’ wrongful conduct.
`
`61.
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`62.
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`Plaintiff was diagnosed with kidney disease on or around September 28, 2020.
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`Plaintiff’s use of the subject device caused or significantly contributed to her
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`development and progression of kidney disease, which has permanently changed her life.
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`63.
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`By reason of the foregoing, Plaintiff has had to undergo significant treatment, will
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`be required to undergo significant treatment in the future, and now requires constant and
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`continuous medical monitoring and treatment due to the defective nature of the subject device
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`and/or Defendants’ wrongful conduct.
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`64.
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`As a result of the aforesaid conduct and subject device manufactured, designed,
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`sold, distributed, advertised, and promoted by Defendants, Plaintiff was injured, resulting in severe
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`mental and physical pain and suffering. Such injuries will result in some permanent disability to
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`her person. As a result of such injuries, Plaintiff has suffered damages for which compensatory
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`damages should be awarded.
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`CAUSES OF ACTION
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`COUNT I
`STRICT PRODUCTS LIABILITY – DESIGN DEFECT
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`71.
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`Plaintiff adopts and incorporates by reference all of the foregoing language of this
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`
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`Complaint as if fully set forth herein and further states as follows.
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`72.
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`Plaintiff pleads this count under Georgia’s strict liability provision, OCGA § 51–
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`1–11.
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`73.
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`Defendants have a duty to provide adequate warnings and instructions for their
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`products including the Recalled Devices, including but not limited to the subject device, to use
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`reasonable care to design a product that is not unreasonably dangerous to users.
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`74.
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`At all times herein mentioned, Defendants were involved in researching, designing,
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`developing, manufacturing, testing, selling and/or distributing the Recalled Devices, including the
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`subject device, which are defective and unreasonably dangerous.
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`75.
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`The subject device is defective in its design or formulation in that it is not
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`reasonably fit, suitable or safe for its intended purpose and/or its foreseeable risks exceed the
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`benefits associated with its design. The subject device is defective in design because it causes
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`headaches, irritation of the skin, eye, and respiratory tract, inflammation respiratory issues, asthma,
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`adverse effect to organs (including the kidneys and liver), hypersensitivity, nausea, vomiting, and
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`toxic and carcinogenic effects. It is more dangerous than other available devices indicated for
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`similar conditions and uses, and the utility of the device does not outweigh its risks.
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`76.
`
`The defective condition of the subject device rendered it unreasonably dangerous
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`and/or not reasonably safe, and the device was in this defective condition at the time it left the
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`hands of Defendants. Subject device was expected to and did reach Plaintiff and her physician
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`without substantial change in the condition in which it was designed, manufactured, labeled, sold,
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`distributed, marketed, promoted, supplied, and otherwise released into the stream of commerce.
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`77.
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`The subject device was used for its intended purposes by Plaintiff and the subject
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`device was not materially altered or modified prior to its use.
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`77.
`
`The subject device is defective in design because the PE-PUR foam comprising
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`part of the device can degrade into particles that enter the device’s air pathway and can off-gas
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`certain chemicals. These characteristics cause, among other problems, kidney disease.
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`78.
`
`At or before the time the subject device was released on the market and/or sold to
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`Plaintiff, Defendants could have designed the product to make it less prone to causing the above
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`listed health harms, a technically feasible safer alternative design that would have prevented the
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`harm Plaintiff suffered without substantially impairing the function of the device.
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`79.
`
`Plaintiff was not able to discover, nor could she have discovered through the
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`exercise of reasonable diligence, the defective nature of the subject device. Further, in no way
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`could Plaintiff have known that Defendants had designed, developed, and manufactured the
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`subject device in a way as to make the risk of harm or injury outweigh any benefits.
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`80.
`
`The subject device is and was being used in a way which the Defendants intended
`
`at the time it was prescribed to Plaintiff.
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`81.
`
`Defendants had a duty to create a device that was not unreasonably dangerous for
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`its normal, intended use and breached this duty.
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`82.
`
`Defendants knew or should have known that the Recalled Devices, including the
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`subject device, would be prescribed to patients and that physicians and patients were relying on
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`them to furnish a suitable device. Further, Defendants knew or should have known that patients
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`for whom the Recalled Devices would be used, such as Plaintiff, could be and would be affected
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`by the defective design and composition of the devices.
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`83.
`
`Defendants researched, designed, manufactured, tested, advertised, promoted,
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`marketed, sold, and distributed a defective device which, when used in its intended or reasonably
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`foreseeable manner, created an unreasonable risk to the health of consumers, such as Plaintiff, and
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`Defendants are therefore strictly liable for the injuries sustained by Plaintiff.
`
`84.
`
`As a direct and proximate result of Defendants’ placement of the subject device
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`into the stream of commerce and Plaintiff’s use of the product as designed, manufactured, sold,
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`supplied, and introduced into the stream of commerce by Defendants, Plaintiff suffered serious
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`physical and mental injury, harm, damages and economic loss and will continue to suffer such
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`harm, damages and economic loss in the future.
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`
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`WHEREFORE, Plaintiff demands judgment against Defendants, and each of them,
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`individually, jointly, and severally, and requests compensatory and punitive damages, together
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`with costs and interest, and any further relief as the Court deems proper.
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`COUNT II
`STRICT PRODUCTS LIABILITY – FAILURE TO WARN
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`85.
`
`Plaintiff adopts and incorporates by reference all of the foregoing language of this
`
`
`
`Complaint as if fully set forth herein and further states as follows.
`
`86.
`
`87.
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`Plaintiff pleads this count under Louisiana’s strict liability provision, RS 9:2800.54.
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`At all times herein mentioned, Defendants designed, developed, researched, tested,
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`and knew or should have known about significant kidney disease risks with subject device.
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`88.
`
`At all times herein mentioned, Defendants advertised, promoted, marketed, sold,
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`and distributed the subject device that was used by the Plaintiff.
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`89.
`
`The subject device was expected to and did reach the usual consumers, handlers,
`
`and persons coming into contact with said device without substantial change in the condition in
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`which it was produced, manufactured, sold, distributed, and marketed by the Defendants.
`
`90.
`
`Defendants each had an independent duty and continuing duty to warn the medical
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`community and Plaintiff’s physicians about the significance of the risks of disease, cancer and
`
`other health harms with the subject device.
`
`91.
`
`Plaintiff used the subject device in a manner intended and foreseeable by
`
`Defendants.
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`92.
`
`The subject device was defective due to inadequate warnings because Defendants
`
`knew or should have known that the product created a significantly increased risk of disease,
`
`cancer, among other health impacts, and failed to warn the medical community and Pla