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`SHAUN K. MUAINA, ESQ.
`Nevada Bar No. 12829
`HENNESS & HAIGHT
`8972 Spanish Ridge Avenue
`Las Vegas, Nevada 89148
`Telephone: (702) 862-8200
`Facsimile: (702) 862-8204
`shaun@hennessandhaight.com
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`SHREEDHAR R. PATEL
`Texas Bar No. 24074864
`(Pro Hac Vice to be filed)
`SIMON GREENSTONE PANATIER
`1201 Elm Street, Suite 3400
`Dallas, TX 75270
`Telephone: 214-276-7680
`Facsimile: 214-276-7699
`spatel@sgptrial.com
`Attorneys for Plaintiff
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`IN THE UNITED STATES DISTRICT COURT
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`FOR THE DISTRICT OF NEVADA
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`Case No.:
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`Plaintiff,
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`GLORIA JEAN ROGET, Individually and
`As Special Administrator and Heir to the Estate
`of ANDRE CARL ROGET, Deceased,
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`vs.
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`MEDTRONIC, INC., a California
`Corporation, MEDTRONIC MINIMED,
`INC., a Minnesota Corporation, and DOES 1-
`20, ROE CORPORATIONS 1-20,
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` Defendants.
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`PLAINTIFF’S ORIGINAL COMPLAINT FOR WRONGFUL DEATH,
`SURVIVAL ACTIONS AND JURY DEMAND
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`COMES NOW Plaintiff, GLORIA JEAN ROGET, Individually (hereinafter “Plaintiff”)
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`and as Special Administrator and Heir to the Estate of ANDRE CARL ROGET, Deceased
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`Case 2:22-cv-00646 Document 1 Filed 04/19/22 Page 2 of 25
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`(hereinafter “Decedent”), by and through the undersigned counsel, who brings this action for
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`wrongful death pursuant to Section NRS 41.085 of the Nevada Rules of Civil Procedure, and
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`come now Plaintiff who brings this survival action pursuant to NRS 41.130 of the Nevada Rules
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`of Civil Procedure against Defendants, MEDTRONIC, INC., and MEDTRONIC MINIMED,
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`INC., DOES 1-20 and ROES 1-20 (collectively “Defendants”). As grounds thereof, Plaintiff
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`states the following:
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`INTRODUCTION
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`1.
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`This is a products liability action against Defendants for the failure of their
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`medical device, prescribed to Decedent. The device was used by Decedent, and because of
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`defects related to the device, Decedent suffered an insulin-induced coma that led to his eventual
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`death on May 14, 2020.
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`2.
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`This complaint alleges claims under parallel state law duties based on the
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`Defendants’ failure to conform with the FDA’s Pre-Market Approval (PMA) process for this
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`medical device and failure to conform and violations of FDA regulations.
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`3.
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`The Decedent was a Type II diabetic and was prescribed the Defendants’ insulin
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`infusion medical device – Medtronic’s MiniMed 630G insulin infusion pump - intended and
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`used for the treatment of Type II diabetes mellitus. The Decedent then used the device that
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`malfunctioned and put him in an insulin-induced coma causing his eventual death. Plaintiff and
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`Decedent were informed and believed and thereon allege that these devices, were researched,
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`designed, tested, manufactured, produced, processed, assembled, inspected, distributed,
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`marketed, labeled, promoted, packaged, advertised for sale, placed in the stream of commerce,
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`and sold or otherwise provided to Decedent by Defendants, MEDTRONIC MINIMED, INC.
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`and/or MEDTRONIC, INC. and/or DOES 1-20 and/or ROES 1-20.
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`Case 2:22-cv-00646 Document 1 Filed 04/19/22 Page 3 of 25
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`JURISDICTION AND VENUE
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`4.
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`This Court has jurisdiction over Defendants and this action pursuant to 28
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`U.S.C. § 1332, because there is complete diversity of citizenship between Plaintiff and
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`Defendants. Defendants are either incorporated and/or have their principal place of
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`businesses outside of the State of Nevada in which the Plaintiff resides.
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`5.
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`The amount in controversy between Plaintiff and Defendants exceeds
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`$75,000, exclusive of interest and cost.
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`6.
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`7.
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`The Court also has supplemental jurisdiction pursuant to 28 U.S.C. § 1367.
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`Venue is proper within this district pursuant to 28 U.S.C. § 1391 in that
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`Defendants conduct business here and is subject to personal jurisdiction in this district.
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`Furthermore, Defendants sell, market, and/or distribute insulin pumps within the District of
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`Nevada. Also, a substantial part of the acts and/or omissions giving rise to these
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`claims occurred within this district.
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`PARTIES
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`8.
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`9.
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`Plaintiff is an adult citizen and resident of Las Vegas, Clark County, Nevada.
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`Plaintiff is the surviving spouse and personal representative of Decedent’s estate.
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`10.
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`Plaintiff and Decedent were married on May 13, 1967, and remained married
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`until Decedent’s death.
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`11.
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`The Decedent died on May 14, 2020, in Las Vegas, Clark County, Nevada.
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`12. At all times material hereto, Defendant, MEDTRONIC, INC., was and is a
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`Foreign For-Profit Corporation (incorporated in Minnesota) which, at all times relevant to this
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`lawsuit, was authorized to do business in the State of Nevada, and which operated, conducted,
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`engaged in, and/or carried on a business or business venture throughout the State of Nevada for
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`Case 2:22-cv-00646 Document 1 Filed 04/19/22 Page 4 of 25
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`which it received substantial revenue. Its principal place of business is located at 710 Medtronic
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`Parkway, Minneapolis, Minnesota 55432. This defendant may be served via its Registered
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`Agent: Corporation Service Company, 112 North Curry Street, Carson City, Nevada
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`89703.
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`13. At all times material hereto, Defendant, MEDTRONIC MINIMED, INC., was
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`and is a Foreign For-Profit Corporation (incorporated in Delaware) which was doing business
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`throughout the State of Nevada for which it received substantial revenue. Its principal place of
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`business is located at 18000 Devonshire Street, Northridge, California 91325. This Defendant
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`may be served via its Registered Agent: Corporation Service Company, 251 Little Falls
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`Drive, Wilmington, DE 19808.
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`14.
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`Plaintiff does not know the true names and identities of those Defendants
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`designated as DOES I through 20, ROES I through 20 inclusive, but alleges that each of said
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`fictitiously named Defendants was negligently and unlawfully responsible for the events herein
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`described, and for the injuries and damages sustained by Plaintiff and Decedent. Plaintiff will
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`ask leave of court to amend this complaint when the identity of each such fictitiously named
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`Defendant has been ascertained.
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`15. Decedent’s injuries, including death, proximately resulted from the wrongful,
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`reckless, and negligent acts and omissions, and fraudulent misrepresentations of Defendants
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`and/or each of them, all of which occurred within the venue of this court.
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`16. At all times relevant to this action, the term "Defendants" includes all Defendants
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`unless otherwise noted, including but not limited to MEDTRONIC MINIMED, INC.,
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`MEDTRONIC, INC., DOES 1 through 20, and ROES 1 through 20, inclusive.
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`///
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`Case 2:22-cv-00646 Document 1 Filed 04/19/22 Page 5 of 25
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`17. At all times material hereto, Defendants were the manufacturer(s) and/or sellers
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`and/or distributors of the MiniMed Insulin Infusion Pumps, Model Nos. 630G and 670G are
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`described as an “artificial pancreas,” designed, manufactured, and intended to monitor a
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`patient’s blood glucose levels in real-time and deliver and/or suspend basal and bolus insulin
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`doses under pre-set but modifiable parameters.
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`THE COMPANIES
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`18. Medtronic is a global healthcare products company, with annual revenue in the
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`billions of dollars. Medtronic touts its leadership in the medical device industry, explicitly
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`representing that it has 25 years of continuous leadership in diabetes device solutions that
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`improve patients’ lives. Medtronic claims to be passionate about diabetes care, with a highly
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`trusted brand and a proven track record for advancing solutions. This claim is echoed in part of
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`Medtronic’s mission statement. Medtronic vows to “strive without reserve for the greatest
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`possible reliability and quality in our products; to be the unsurpassed standard of comparison
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`and to be recognized as a company of dedication, honesty, integrity and service.”
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`19. Despite Medtronic’s stated mission, infusion sets have been the subject of a
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`myriad of problems and defects over the years. For example, in sharp contrast to Medtronic’s
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`Website, are statements from a June 1, 2009, letter from the United States Food and Drug
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`Administration (“FDA”) to William A. Hawkins, Medtronic’s president and chief executive
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`officer, regarding Medtronic PR Operations Co. In criticizing Medtronic’s manufacturing and
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`report process, the FDA cited Medtronic for:
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`Failure to report to the FDA no later than 30 calendar days after
`the day
`that you receive or otherwise become aware of
`information, from any source, that reasonably suggests that a
`device you have on the market: (1) may have caused or contributed
`to a death or serious injury; or (2) has malfunctioned and this
`device or a similar device that you market would be likely to cause
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`Case 2:22-cv-00646 Document 1 Filed 04/19/22 Page 6 of 25
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`or contribute to the death or serious injury, if the malfunction were
`to recur...
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`In contravention of applicable federal regulations, Medtronic has failed to report
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`an incident involving a MiniMed insulin pump in which “device failure or malfunction may
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`have contributed to or caused the user’s hospitalization and the device’s malfunction would be
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`likely to cause or contribute to a death or serious injury, if the malfunction were to recur.”
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`The FDA also found fault with the personnel that Medtronic entrusted at its
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`manufacturing facility in Puerto Rico when determining whether a Medtronic device was
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`dangerous. Specifically, the FDA cited Medtronic for:
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`Failure to have a person who is qualified to make a medical
`judgment reasonably conclude that a device did not cause or
`contribute to a death or serious injury, or that a malfunction would
`not be likely to cause or contribute to a death or serious injury, if it
`were to recur, as required by [United States Federal Law.]
`Personnel qualified
`to make a medical
`judgment
`include
`physicians, nurses, risk managers and biomedical engineers under
`[United States Federal Law.]
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`22. According to FDA Investigators, this plant had a wide range of problems that
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`included lax testing of products for defects, improper record-keeping, and employing someone
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`with insufficient training as a medical expert to determine danger or defects. Said employee
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`only had a high school diploma with some additional in-house training. In listing these and
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`other violations, the FDA concluded that the problems may be symptomatic of serious problems
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`in Medtronic’s manufacturing process and its quality controls.
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`23. None of the cited violations reflect Medtronic’s promise to strive “without
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`reserve for the greatest possible reliability and quality in our products; to be the unsurpassed
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`standard of dedication, honesty, integrity, and service.”
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`Case 2:22-cv-00646 Document 1 Filed 04/19/22 Page 7 of 25
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`24. On or about June 29, 2009, these issues led to a Class 1 recall of many of the
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`Defendants’ insulin infusion sets labeled Paradigm Quick-Set Infusion Sets. Said recall included
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`lots manufactured between 2007 and 2009. Approximately three million disposable infusion
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`sets were recalled.
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`25. On or about June 7, 2013, Medtronic MiniMed Paradigm infusions sets were
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`recalled via a Class 1 recall. The recall was issued “because of a potential safety issue that can
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`occur if insulin or other fluids come in contact with the inside of the tubing connector. If this
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`occurs, it can temporarily block the vents that allow the pump to properly prime.”
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`The 2013 recall admitted that “[t]his can result in too much or too little being
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`delivered resulting in hypoglycemia or hyperglycemia which can be severe and lead to serious
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`illness.”
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`The 2013 recall was virtually identical to the 2017 recall with regard to the
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`infusion set at issue in this case. The same problems fluid causing a vent blockage resulting in
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`the same outcomes over-delivery of insulin are at issue in both recalls.
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` It is clear that Medtronic did not resolve the problem with their product which
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`resulted in the 2013 recall. Medtronic marketed the subject infusion sets without fixing the
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`problem, resulting in another recall for the same defect in 2017.
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`29. Unfortunately, non-conformance with FDA’s approval and regulations, including
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`past recalls and problems associated with Medtronic infusion sets did not result in Medtronic
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`putting safer products into the stream of commerce for use by Andre Carl Roget.
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`THE CURRENT RECALL
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`30. On September 7, 2017, Medtronic issued an “Urgent Medical Device Recall”
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`regarding Medtronic MiniMed Infusion Sets.
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`Case 2:22-cv-00646 Document 1 Filed 04/19/22 Page 8 of 25
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`The Recall Notice states that “Medtronic has become aware of recent report of
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`potential over-delivery of insulin shortly after an infusion set change.” Medtronic further notes
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`that it has received reports of hypoglycemia requiring medical attention related to this issue,
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`which Medtronic concedes can result in “hypoglycemia and in extreme cases, death.”
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`The Recall Notice states that this problem is caused by fluid blocking the
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`infusion set membrane during the priming/fill tubing process, which prevents the infusion set
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`from working properly. The result can be fast delivery of multiple days’ worth of insulin.
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`33.
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`The Recall Notice also announces that Medtronic has an alternate infusion set
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`design, which contains a “new and enhanced membrane material that significantly reduces the
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`risk.”
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`34. As a result of the defective MiniMed Infusion Sets, Decedent received a large
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`quantity of insulin, which resulted in severe hypoglycemia, diabetic coma, and his death on
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`May 14, 2020.
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`35. On November 21, 2019, Medtronic issued an “Urgent Field Safety Notification”
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`to patients warning them of the potential risk of hyperglycemia (high blood glucose) or
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`hypoglycemia (low blood glucose) associated with broken or missing pump retainer rings on the
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`630G and 670G model insulin infusion pumps. Exhibit 1. The retainer ring enables the insulin-
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`containing reservoir to be locked into place. Medtronic alerted patients to “reported incidents of
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`a loose reservoir that can no longer be locked into the pump . . . due to a broken or missing
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`retainer ring that prevents a proper lock.” Id. The Field Safety Notification continued:
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`If the reservoir is not properly locked into the pump, it could lead to over or under
`delivery which could then result in hypoglycemia or hyperglycemia.
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`•
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`For example, if the pump retainer ring is broken or
`becomes detached from the pump, and the user
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`infusion set is still connected to the body, it could
`result in a rapid infusion of insulin, which could
`cause hypoglycemia. The under delivery of insulin
`could occur if the reservoir is not properly locked
`into place by the retainer ring, creating a space
`between the pump and the reservoir, and preventing
`the pump from pushing the expected insulin into the
`body, which could cause hyperglycemia. Id.
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`Medtronic instructed patients to discontinue using the pump and consult with their
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`healthcare providers “if the reservoir does not lock into the pump or the retainer ring is loose,
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`damaged or missing.” If, however, the reservoir “properly locks in place by the reservoir ring"
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`patients were instructed to "continue to use your pump.”
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`36. Almost exactly 3 months later, on February 12, 2020, Medtronic issued a recall
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`of more than 300,000 of their 630G and 670G insulin pumps in the U.S. Upon information and
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`belief, this is the entire installed base of these models pumps in the U.S. It is also believed that
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`more than 100,000 additional units outside of the U.S. were subject to the recall. The FDA
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`Case 2:22-cv-00646 Document 1 Filed 04/19/22 Page 10 of 25
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`classified the recall as a Class I recall because it deemed the use of these devices under the
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`circumstances "may cause serious injuries or death." Exhibit 2. The affected lots are those
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`manufactured before October 2019 and distributed between September 2016 and October 2019
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`(630G model) or manufactured before August 2019 and distributed between June 2017 and
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`August 2019 (670G model). Id. The FDA reported that Medtronic had received a total of more
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`than 26,400 complaints of which 2,175 reported injuries with one (l) known death. Id. This
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`letter was sent on March 5, 2020. Exhibit 3.
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`37. Consistent with the Quality Systems Regulations, 21 C.F.R. § 820, which govern
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`the manufacture of Class III pre-market approval (“PMA”) medical devices, the November
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`2019 “Urgent Field Safety Notification” which preceded the February 2020 Class I recall would
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`have been the result of Medtronic initiating a “Corrective and Preventative Action” (“CAPA”)
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`process in response to complaints received from patients. That CAPA process would have been
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`triggered when Medtronic detected a “safety signal” through post-marketing complaints about
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`the device. As its name suggests, the purpose of the CAPA is to identify the cause of the
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`problem and develop “corrective” measures for the problem and take “preventative” actions to
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`make sure that non-conforming products do not make it to market. See 21 C.F.R. § 820.100. A
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`foundational aspect of a CAPA is a “root cause analysis” to determine, among other things, if
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`the problem is one of design, manufacturing, or potentially both.
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`THE PUMPS
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`A. Model 630G
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`The 630G is the successor to the 530G, Medtronic's first “artificial pancreas”
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`approved in 2013. The 530G differed from all of its predecessors in that the real-time sensor
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`values from the continuous glucose monitoring functions of the pump could directly interact
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`Case 2:22-cv-00646 Document 1 Filed 04/19/22 Page 11 of 25
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`with insulin delivery through the “threshold suspend feature” which could automatically
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`suspend insulin delivery for up to two hours if sensor glucose values fell below a threshold and
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`the patient failed to respond to alerts and alarms. Medtronic described the “major difference”
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`between the 530G and 630G, which was approved for marketing on August 10, 2016, as an
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`updated display screen that presented in color. The 630G used the same "threshold suspend"
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`algorithm as the 530G.
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`B. Model 670G
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`The 670G was approved for marketing six weeks after the 630G on September
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`28, 2016, as an “Automated Insulin Delivery System,” which included an “Auto Mode” feature
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`which could “automatically adjust basal insulin delivery using continuous glucose monitor data
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`[and] automatically increase or decrease the amount of insulin delivered based on sensor
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`values.” As described in the Summary of Safety and Efficacy Data (SSED), the 670G has an
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`“Auto Mode,” a “new tool” that
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`uses an algorithm to automatically adjust basal insulin delivery using continuous
`glucose monitor data. When in Auto Mode, the pump responds to fluctuations in
`interstitial fluid glucose levels measured by the continuous glucose monitor; the
`Auto Mode feature can automatically increase or decrease the amount of basal
`insulin delivered based on sensor glucose values.
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`The Auto Mode algorithm is designed to adjust the user's basal insulin rates to try
`to keep them at a target blood glucose level. The standard target glucose setting in
`Auto Mode is 120 mg/dL, and the target can also be set temporarily to 150 mg/dL
`for exercise and other events. In addition, blood glucose readings above 150
`mg/dL will prompt the Auto Mode feature to calculate if a correction bolus is
`needed; if needed, a correction bolus will be recommended to the users, who can
`choose whether they want to deliver that correction bolus. Users should check
`their blood glucose levels using a blood glucose meter before administering a
`correction bolus.
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`///
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`///
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`- 11 -
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`Case 2:22-cv-00646 Document 1 Filed 04/19/22 Page 12 of 25
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`STATEMENT OF DECEDENT’S FACTS
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`40. Decedent was diagnosed as Type II diabetic in 1999. As a result, he was
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`prescribed to use an insulin infusion pump which he used and would receive a new pump
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`approximately every five (5) years.
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`41.
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`In January 2019, Decedent received his new Medtronic MiniMed 630G insulin
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`pump from the Defendants. Since January 2019, Decedent used the Medtronic MiniMed 630G
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`Insulin Pump, serial number NG2135451H, until his hypoglycemic episode that resulted in
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`going into a diabetic coma for seven days and ultimately dying on May 14, 2020.
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`42. Because of his diabetic condition, Decedent managed his diabetes through the
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`use of insulin pump therapy, specifically; by using the Medtronic MiniMed 630G Insulin Pump
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`to deliver the necessary amount of insulin into his bloodstream to properly treat his diabetes.
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`When functioning correctly, these devices and their components mimic how a healthy pancreas
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`works by delivering continuous and controlled doses of rapid-acting insulin, 24 hours a day, to
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`match the user’s body’s needs.
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`43. On April 18, 2020, Decedent was at his home and went to bed early due to not
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`Decedent feeling well. The Medtronic MiniMed 630G MMT-1755K Insulin Pump at issue was
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`part of an FDA Class 1 Device Recall on November 21, 2019. Unfortunately, Plaintiff states
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`that she does not remember receiving any notification of the recall, nor does she remember her
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`husband receiving any notification of the recall. Thus, Decedent continued using his insulin
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`pump.
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`44. On the morning of April 19, 2020, Plaintiff found her husband, Decedent,
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`unconscious and unresponsive in their bedroom. Plaintiff called 9-1-1, and the paramedics
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`arrived to treat Decedent.
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`- 12 -
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`Case 2:22-cv-00646 Document 1 Filed 04/19/22 Page 13 of 25
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`45.
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`The Decedent was rushed by ambulance to SHM – Summerlin Hospital Medical
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`Center in Las Vegas, Nevada, where it was determined that he was suffering from profound
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`hypoglycemia due to his insulin pump.
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`46.
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`The collective Defendants, along with their agents and employees, negligently
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`caused the defective insulin pumps to be designed, manufactured, assembled, distributed, and
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`sold to members of the public, and they further negligently failed to remove the recalled
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`infusion sets from the marketplace and stream of commerce after they had knowledge of the
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`defects as well as the recall.
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`47.
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`The Defendants designed, manufactured, marketed, and distributed
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`the
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`Medtronic MiniMed 630G Insulin Pump and Pro Set Infusion Sets, which were marketed to
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`deliver insulin to a person with diabetes in measured amounts. The MiniMed pump was
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`manufactured with a retainer ring designed to lock the patient’s insulin cartridge into place in
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`the pump’s reservoir compartment. Pro Set Infusion Sets consist of a membrane and disposable
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`plastic tubes which transport insulin from the pump to the patient’s body. The Medtronic
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`MiniMed 630G Insulin Pump and Pro Set Infusion Sets are used in conjunction with one
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`another to help people with diabetes regulate their blood sugar by providing a constant source of
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`insulin. They provide an alternative to daily injections of insulin. The pump connects to flexible
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`plastic tubing that delivers insulin to the body. Users set the pump to deliver insulin throughout
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`the day. It can be programmed to release larger doses at meals or when blood sugar levels are
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`too high.
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`48.
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`Plaintiff, nor the Decedent, had any way of knowing that the Medtronic
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`MiniMed 630G Insulin Pump and Pro Set Infusion Sets that he used on the night of the incident
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`were defective in design, manufacture, and marketing, and that, even when used in conformance
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`- 13 -
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`Case 2:22-cv-00646 Document 1 Filed 04/19/22 Page 14 of 25
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`with Defendants’ instructions, were prone to deliver doses of insulin incorrectly and in life-
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`threatening doses.
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`CAUSES OF ACTION
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`FIRST CAUSE OF ACTION
`STRICT PRODUCT LIABILITY
`(Against all Defendants, Does 1-20 and Roes 1-20)
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`The Plaintiff and Decedent incorporate by reference and reallege each and every
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`49.
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`allegation in this Complaint the same as though specifically set forth herein.
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`50.
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`Plaintiff and Decedent hereby assert a strict liability claim for defective
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`manufacturing pursuant to applicable Nevada law.
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`51.
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`Each of the Defendants are medical device companies engaged in the design
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`and/or research and/or manufacture and/or production and/or testing and/or assembling and/or
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`labeling and/or packaging and/or distribution and/or sale and/or otherwise involved in placing
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`various medical devices into the stream of commerce, intended human use including facilitating
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`the infusion and/or ingestion of drug products such as insulin for diabetes control.
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`52. At the times and places mentioned above and at all times material thereto, each
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`of the Defendants, held themselves our as knowledgeable and possessing the requisite skill
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`particular to the research and/or manufacture and/or production and/or testing and/or
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`assembling and/or labeling and/or packaging and/or distribution and/or sale of such products.
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`53. At the times and places aforesaid, and at all times material hereto, Defendants,
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`and each of them, placed into the stream of commerce medical devices which were
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`unreasonably dangerous through defective manufacture and/or which failed to conform to the
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`specifications approved by the FDA and/or failed to function as intended and/or malfunctioned
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`and were therefore not safe and effective, and were unfit for their intended purpose and
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`- 14 -
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`Case 2:22-cv-00646 Document 1 Filed 04/19/22 Page 15 of 25
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`foreseeable uses and were in a defective and dangerous condition in violation of the approvals
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`received by the FDA, and the requirements thereunder.
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`54. Defendants, and each of them, caused or otherwise allowed, enabled or
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`facilitated the placement of unreasonably dangerous products in a defective condition, and in
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`violation of the FDA’s requirements, into the stream of commerce, and are strictly liable in tort.
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`55. As a foreseeable, direct, and proximate result of the direct and proximate cause
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`of the manufacturing defects and the Defendants’ conduct alleged herein, Decedent sustained
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`injuries and damages, including his death for which a cause of action is hereby stated.
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`SECOND CAUSE OF ACTION
`NEGLIGENCE
`(Against all Defendants, Does 1-20 and Roes 1-20)
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`The Plaintiff and Decedent incorporate, adopts by reference, and reallege each
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`56.
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`and every allegation of this Complaint the same as though specifically set out herein again.
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`57. At all times relevant to this Complaint, Defendants had a duty to assure that
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`those products that they placed into the stream of commerce were free of defects and reasonably
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`fit and suitable for their intended or foreseeable uses and conformed to the FDA-approved
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`specifications.
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`58. At all relevant times material hereto, Defendants, and each of them, placed or
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`caused to be placed into the stream of commerce, a product or products which were in a
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`defective and unreasonably dangerous condition, not in conformance with FDA-approved
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`specification and/or not reasonably fit or suitable for their intended or foreseeable uses or
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`otherwise not conforming with specifications.
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`59. Defendants and each of them knew or should have known in the exercise of
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`reasonable care that their MiniMed products were defective and in a dangerous condition and/or
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`- 15 -
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`Case 2:22-cv-00646 Document 1 Filed 04/19/22 Page 16 of 25
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`not reasonably fit or suitable for their intended or foreseeable purpose uses and negligently
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`placed these non-conforming and defective products into the stream of commerce where they
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`would be expected to be utilized by insulin-dependent diabetics like Decedent.
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`60.
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`Injuries and damages sustained by the Decedent, including his death, were both
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`proximately caused and a reasonably foreseeable result of Defendants’ products and conduct.
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`61. As a foreseeable, direct, and proximate result of Defendants’ negligence,
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`Decedent and Plaintiff and each of them was injured, with Decedent suffering bodily injury,
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`harm, and ultimately his death, and both Plaintiff and Decedent sustained damages compensable
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`under Nevada law.
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`THIRD CAUSE OF ACTION
`BREACH OF EXPRESS WARRANTY
`(Against all Defendants, Does 1-20 and Roes 1-20)
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`The Plaintiff and Decedent incorporate by reference and reallege each and every
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`62.
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`allegation in this Complaint the same as though specifically set forth herein.
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`63. At all relevant times, Defendants expressly represented and warranted through
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`written literature, including but not limited to product labeling, patient package inserts, articles
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`in medical journals, advertising, and other documentation and/or promotional materials directed
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`to Decedent’s physician, and/or the Decedent and Plaintiff, by and through Defendants’
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`authorized agents or sales representatives orally and in writing that the Medtronic MiniMed
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`Infusion Sets and MiniMed 630G Insulin Pump were safe and free from defects, effective, and
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`fit and proper for their intended use or foreseeable uses in accordance with and conformed to
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`FDA regulations and specifications. Said representations were in the form of marketing
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`materials, device information, and product materials provided to Andre Roget, Decedent.
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`Decedent justifiably relied on said representations and express warranties in electing to use said
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`- 16 -
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`Case 2:22-cv-00646 Document 1 Filed 04/19/22 Page 17 of 25
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`product.
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`64.
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`For example, on its webpage, Medtronic touts that it is “delivering on our
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`promises through medical innovation” and invited viewers to “discover our full breadth of
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`reliable, safe, high-quality devices.” Following the hyperlink “Browse Our Products” leads to a
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`page in which additional links for the 630G and 670G are available. Clicking on the 630G link
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`leads to a promotional brochure captioned “Better Control, Fewer Lows. Making it easier for
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`patients to manage their diabetes – so they can live exceptional lives.”
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`65. On Page 4 of the Medtronic bro