scanned · county (minnesota) district court, filed august 30,2010, courl file no. 69du-cv-10-2167....

Alice Pierceo trustse for the next of kin otCarol Givens. decedent"

Plainrifl

v.

Medtronic, Inc. ; Msdtronic Diabetes;Medtronic lVliniMed" Inc.; McdtranicPuerto Rico Operations Company;ConvaTecn Inc.; Unomedical' Inc. {aDivision of ConvaTec, Inc.); UnomedicalA/S (a Division of ConvaTec, lnc.):Unomedical llevices S.A. de C.V'; and

Unomedical Infusion Devices (a division ofConvaTec" Inc.)"

UNITtrD STATES DISTRICT COURTDISTRICT OF MINNESOTA

COURT FTLE NO.:

JURY TRIAL DEMANDED

Defendants.

COMPLAINT

COMES NOW. Flaintift- Alice Pierce, trustee far the next of kin of Carol Givens,

decedent, for her Complaint against Defendants: Ivfedronic. Inc.; Medtronic Diabetes; Medtronie

MiniMed, Inc.; Medtranic Puerto Rico Operations Cornpany; ConvaTec. Inc.; Unomedical, lnc.

(a Division of ConvaTec, Inc.): Unomedical A/S (a Division of ConvaTec, Inc.)l Unomedical

Devices S.A. de C"V.; and Unomedical Infision Devices (a division of ClonvaTsc, Inc.), states

and alleges and as tbllows:

TUE P*nrtns

1. Plaintiff Alice Pierce is a resident of the State of Wisconsin and has been duly

appoinred trustee for the next of ki:r of her daughter, Carol Givens. by Order of the St. Lr:uis

County (Minnesota) District Court, filed August 30,2010, courl file no. 69DU-CV-10-2167.

SCANNED N

rulCI sz,ln 6U.S, DISTRICI COURT DULUTH

CASE 0:12-cv-01601-PJS-LIB Document 1 Filed 07/03/12 of 25

?.

aJ.

+.

Carol Givens was a resident of Wisconsin.

Carol Givens died at St. Mary"s Hospital in Dululh, Minnesota on July 9. 2009"

Alice Pierce brings this actian on behalf of the next *f kin of Carol (iivens.

pursuant to Minn.Stat. s\ 573.02.

5. Defbndant Medtronieo Inc. is a corporation organized under the laws of

Minnesata.

6. Medtronic, Inc."s principal place of business is in Minneapolis, Minnesota.

7. Defendant Medtronic Diabetes is a division of Medtranic, Inc. with its principal

place of business is in Northridge, Califbrnia.

8. Defendant Medtronic MiniMed, Inc. ("Medtronic MiniMed") is a cotporatinn

organized under the laws of Delaware.

9. Medtronic MiniMed, Inc.'s principal place of business is in Northridge,

Calif'ornia.

10. Defendant Medtronic Puerto Rico Operations Company ("Medtronic Fuerto

Rico") is division of Medtronic, Inc" with its principal place of business in Puerlo Rica.

1 1. Ail entities identified in paragraphs 5 through I 1, above. are collectively referred

to as the "Medtronic Defendants."

12" Defendant ConvaTec, Inc. ("'Conval'ec") is a corporation organlzed under the

laws of Delaware' with its principal place of business in Skillmano New Jersey.

13. Defendant Unomedieal, In*. is foreign corporation with irs principal place of

business in Mcallen. Texas.

14. Unamedical, Inc. is, and has been at all times relevant, a subsidiary of

Unomedical A/S and ConvaTec. lnc.


15. Deibridant Unomedirsl AIS is loreign business entity and a resident of the

Kingdom of Denmark.

16. Ur:omedical A/S is, and has been at all times relevant, a division of ConvaTec.

Inc.

17. Unornedical, Inc. and Unomedical AIS are so closely related that Unomedicai.

Inc. is Unsmedical A/S's agent for service of process as a malter of larv. pursuant to

Yolksv'agenaryrk Aktiengesellsch.afi v. Schlunk,486 tJ.S. 694, 108 S.Ct. ?104 {1q88).

18. Defendant Unometlical Infusion Devices is a division of ConvaTec. Inc. with its

principal place of business in Osted, Denmark.

19. Defendant Unomedical Devices S.A. de C.V.. alkla Unomedical Devices S.A.

C.V., a4i/a lJnomedical Devices S.A. de C.V" on Beha. is a division of ConvaTec. lnc. with

principal place of business in Mexico.

20. Unomedical Devices S.A. de C.V. is. and has been at all tirnes relevant" a

subsidiary of Unomedical.Inc., Unomedical S/A, and ConvaTec, Inc.

21. AII entities identified in paragraphs l? through 20. above. are collectively retbrred

to as the "Unomedical Deferdants."

27. Delbndants include any and all parents, subsidiarjes, afliliates, divisions,

franchises, partners. jcint venturers, and organizational urits of any kind, their predecessors,

successilrs: and assigns, and their present officers. directors, employees. agents. representatives.

and other persons acting on their behalf.

Junrsolctroru lnu YnNup

23. Plaintiff repeats and re-alleges paragraphs I through 22 as if fully set out herein.

de

its


24. Given the amount in controversy and the nature of claims plead herein, and given

the diversity of citizenship between the parlies, this Caurt has subject matter jurisdiction over

this matter pursuant to 28 U.S.C. $ 1332(aXl).

25. This Court has personal jurisdiction over Defendants.

Medtronic.Inc.

26. I4edtronic, Inc,, as a Minnesota corporation with its principal place of business in

Minnesota, is subject to the jurisdiction and venue in this Court.

Nledtronic Di*betes

27. Medhonic" lnc. has wholly owned and controlled its division known as

"Medtronic Diabetes" at all times relevant to this action.

28. I'o the extent that Medtronic Diabetes is an independent business entity.

Medtronic Diabetes is suhject to the Court's iurisdiction because Medtronic Diabetes designed.

manufactured, assembled, marketed, and/or distributed the rnedical product giving rise to

Plaintiff s claims in Minnesota.

?9. To the extenl that Medtronic Diabetes is an independent business entity,

Medtreinic Diabetes is subject to the Corut's jurisdiciion because Medtronic Diabetes has

sufficient minimum contacts with Minnesota, including its ioint enterprise activities and/or

partnership activities with Medtronic, lnc., such that the exercise of jurisdiction over Medtronic

Diabetes would not offend traditional notions of fair play and substantial justiee.

Medfronie MiniMed

30. Medtronic. Inc. has wholly owned and controlled Medtronic MiniMed fi all times

relevant.


31. Medtronic MiniMed is subject to the Coufi's jurisdiction because Medtronic

MiniMed designed, raanufactured, assembled" marketed, andlor distribuled the medical

equipment giving rise to Plaintiff s claims in Minnesota.

32. Medtronic MiniMed is subject to the Court's jurisdiction because Medtronic

MiniMed has sufficient minin'ium contacts with Minnesota. including its joint enGrprise

activities and/or parlnership activities with Medtronico Inc., such that the exer*ise ofjurisdiction

over Medtronic MiniMed would not ofl-end traditional notions of iair play and substantialjustice.

Medtronic Puerta Ricc

33. Medtronic, Inc. has wholly owned and ccntrolled its division knawn as

"Medtronic Puerto Rico Operations Company'u at all times relevant"

34. Medtronic, Inc. publicizes the Puerto Rico cities of Villabla, Humacao. and

Juncos as locations for its manufacturinc facilities and distribution cenlers.

35. Medtronic Pue*o Rico manutactures products for live of Medtronic, Inc.'s

business units, including the diabetes unit.

36, Medtronic Puerto Rico manufactures various madels of insulin pumps, including

the medical praduct giving rise to Plaintiff s claims in Minnesota"

37. To the extent that Medlronic Puerto Rico is an independe*t business entity,

Medtronic Puerto Rico is subject to the Court's jurisdiction because Medtronie Puerlo Rico

designed, manufactured, assemlrled, marketed. and/or distributed the medical product giving rise

to Plaintiff's claims in Minnesota.

38. To the extent that Medtn:nic Puerto Rico is an independent business entity.

Medtronic Puerto fuco is sutrject to the Court's iurisdiction bccause Medtronic Puerto Rico has

sufficient minimum contacts with Minnesota. including its joint enterprise activities andlor


partnership activities with Medtronic, Inc., such that the exercise of .iurisdiction over Medtronic

Puerto Rico would not otTend traditional notions of fair play and substantial justice.

Conva,Tec" lnc.

39. Conva'fec, Inc. acquired Unomedical AIS on or about Septen'rber 3. 2008.

4A. Con,i'aTec. Inc. is the successor-in-interest of Unomedical A/S such that

ConvaTec. Inc. is e:rtitled to all of Unon:edical A/S's rights and subject to all its abligations and

liabilities involved in this action.

41. ConvaTec, Inc. acquired lJnomedical, Inc. on or about September 3. 2008.

42. ConvaTec, Inc. is the successor-in-interest of Unomedical, Inc. such that

ConvaTec, Inc. is entitled to all of Uno:nedical, Inc.'s rights and subject to all its obligations and

liatrilities involved in this action.

43. ConvaTec, lnc. acquired Unomedical Devices S.A. de C.V. on or about

September 3. 2008.

44. ConvaTec. Inc. is the successor-in-interest of Unomedical Devices S.A. de C.V.

such that ConvaTec, Inc. is entitled to all of Unomeclical Devices S.A. de C.V.'s rights and

subject to all its obligations and liabilities involved in this action.

45. ConvaTec, Inc. is, and has been at all times relevanto registered with the

Minnesota Secretary of State as a fureign corporation and may be served by serving its registered

agent for service of process. CT Corporation, ai 100 S 5th Street #1075. Minneapolis, Minnesota

55442.

46. ConvaTec, Inc" has procured a ceftificate of authority to transact business in

Minnesota, as required by Minn. Stat. $ 303.03.


47. As a fcrreign corporation operating

State of Miruresota" ConvaTec. Inc. in'evocably

pursuant to Minn. Stat. $$ 303.06 and 303.13.

under a certificate ol'authority issued by the

consented to the servise of process upon it,

48. ConvaTec, Inc. is subject ta the Coufi's jurisdiction because CanvaTec" lnc.

sufficient minimum contacts with Minnesota" such that the exercise of jurisdiction would

offend traditional notions of fb.ir play and substanrial justiee.

49. ConvaTec. Inc. is subject to the Court's jurisdiction because ConvaTec, Inc.

designed, manufuctured, assembled, marketed, and/ar distritruted the rnedical equipment giving

rise to Flaintiff s claims in Miruresota.

Unomedical A/S" Unoms:dical" Inc." UnomedicRl Devices S.A. de C.Y,,nnd Up-qugdical Infusion Devices

50. Unornedical. Inc.. Unomedical A/S" and Unomeclical Devices S.A. de C.V. are so

closely related lhat Unomedical. [nc. is Unornedical A/S's and L]nomedical Devices S.A. de

C.V.'s agent for service of process as a mafter of law. pursuant to Voll*v'ugenwerk

Aktiengesellschaft v. Schlunlr,486 U.S. 694. 108 S.Ct. 2104 (i988).

51. Unomedieal, lnc.. Unomedical A/S, and Unomedical Devices S.A. de C.V. are so

closely related that Unomedical, Inc. holds an insurance policy covering the liabilities of all three

entities.

52. The Paradigm Quick-Set Infusion Sets sold and delivered to Carol Given were

assembled in Mexico for UnomedicalA/S.

53. The Paradigm Quick-Set In&rsion Sets sotd and delivered tei Carol Givens were

assembled in Mexico bv Unomedical Devices S.A. de C.V.

54. Unomedical A/S. Unomedical. lnc." and Unomedical Devices S.A. de C.V. are

subject to the Court's jurisdiction because Unomedical A/S. Unomedical- Inc., and Unomedical

has

not


Devices S.A. de C.V. designed, manufactured. assemtrled, marketed, and/or distributed the

n:edical product giving rise to Plainti{f s claims in Minnesota.

55. Unomedical A"/S. Unomedical. Inc.. anel Unomedical Devices S.A. de C.V. are

subject to rhe Court's jurisdiction because Unomedical A/S, Unomedical. Inc.. and Unomedical

Devices S.A. de C.V. have had sufficient minimum sontacts with Minnesota. such that the

exercise ofjurisdiction wculd not olftnd traditional notions of lbir play and substantial justice.

Unom edical Infusion Devip"p,p

56. ConvaTec, lnc. has wholly owrted and cantrolled its division known as

"Unomedical Infusian Devices" at all tin"res relevant to this action.

57. To the extent that Unomedical Infusion Devices is an independent business entity.

ConvaTec. is subiect to the Court's jurisdiction because Unomedical ln sion Devices designed,

manufactured, assembled, marketed, and/or dish:ibuted the medical product giving rise to

Plaintiffs claims in Minnesota.

58. To the extent that Unomedical Infusion levices is an independent business entity,

it is subject to the Court's iurisdiction because Unomedical Infusion Devices has sufficient

minimum contacls with Minnesota, including its joint enterprise activities and|/or partnership

activities wift ConvaTec. Inc., such that the exercise of jurisdiction aver Unomedical Infusion

Devices would not of nd traditional notions of fair play and substantial justice.

59. Venue is appropriate in this Court because all Defendants are subject to

iurisdiction in this district at the firre of the commencement of this action.


Statement of.faets Annlicabl$ to All Counts

60. Medtr*nic, Inc. designed. manufactured. assembled. marketed. and distributed the

MiniMed Paradigm insulin pump, which was advertised to provide for the regular intrclduction of

a msasured amount of insulin into a diabetic user's system.

61. Insulin pump therapy allows patients to wear a pump that delivers insuiin though

a tube inserted iffo the pafient's subcutaneous tissue eliminating the need for daily injections.

62. Medtronic, Inc. designed, manufactured, assembled. marketed, and distributed the

Paradigm Quick-Set Infusion Set"

63. l['he Paradigni Quick-Set Infusion Set consists cf disposable plastic tubes and

other parts intended to transport insulin from the MiniMed insulin pump lo the patient's body.

64. All Paradigrn Quick-Set Infusion Sets have vents incorporated into the tubing

c0nnector.

65. The vents of the Paradigm Quick-Set Infusion Sets are intended to allo*' air to

pass in and aut of the pump's reseryoir compartment.

66" The vents of the Paradigm Quick-Set Iniusion Sets are necessary ta equalize

pressure in the reservoir compartment of the insulin punp with the surrounding atmosphere to

ensure insulin is properly delivered to the patient.

67. At all times relevant to this action. Carol Givens owned and used a Medtronic

MiniMed Paradigm Insulin Purnp and the Paradigm Quick-Set lniusion Sets-

68" Carol Givens did not know, and would not know through any reasonable means.

that the Paradigm Quick*Set Infusion Sets matketed and sold to her by Deftndants were

defective in design, manufacture. and marketing. and that, even when used in contbrmancc with


Defendants' instructions, the sets were prone to deliver incoruest and life-threatening doses of

insulin.

69. Medtronic. Inc. represents that "No other company has 25 years of continuous

leadership in cliabetes device solutions that improve patientsn lives. At Medtronic l)iabetes. we

are passionate about diabetes c*re. have a highly tmsted brand and proven track record fcr

advancing solutions."

70. Medtronic, lnc. represents that it "strive[s.l without reserve for the greatest

possible reliability and quality in our [Medtronic's] products; to be the unsurpassed standard of

comparison and to be recognized as a company of dedication, honesty,. integrity, and selice""

7 |. Pricr to ?009, Medtronic, Inc. had seven main "business units" which developed

and manufaclured devices and therapies: Cardiac Rythmic Disease Management (CRDM).

Cardiovascular, Plrysio-Control, Spinal and Bialogics, Neuromodulation, Diabetes, and Surgical

Technology.

72. In 2009, Medtronic. Itc. combined the seven units into two units: the Cardiac and

Vascular Group ar:d the Restorative Group. The Restorative Croup includes Diabetes.

73. The diabetes unit accounted for $1.2 billion, or 8Yo, of Medtronic. Inc.'s $15.8

billion in revenue in fiscal vear 2010.

74. The United States Food and

Medtronic's processes at its Medtronic Puerto

December 15. ?008.

Drug Administratian {"FDA") investigated

Rico operations flom November 12, 2008 to

75. By letter to Medtronic's president and chief executivc officer, William Hawkins.

dated June 1. ?009, the FDA criticized Medtronic's manufacturing and reporting processes

LA


relative to Medtronic's infusion sets. including the Paradigrn Quick-Se1 inllsion Sets. The FDA

cited Medtrcnic for:

Failure to repofi to FDA no later than 30 days afler the day that you receive

or otherwise become aware of information. froni any source. that reasonatrly

suggests that a device you market: (l) may have caused or contributed to a

death or serious injury; or (?) has rnalfuirctioned and this device or a similar

device that you market would be likely to cause or contribute to a death or

serious injury, if the malfunction were to occur, '.

76. Medtronic ha<t failed to report arr inciclent involving a MiniMed insulin pump in

rvhich "devioe failwe or malfunction may have eontributed or caused the user's hospitalizatian

and the device's malfunction would be likely to cause or contribute to a death or serious injury, if

the malfunction were to reeur."

77. The FDA alsc found fault with the personnel that Medtronic entrusted at its

*ranufacturing operations in Puerto Rico for determining whether a Medtronic device rn'as

dangerous. Specifically, the FDA cited Meeltronic for:

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 c&use or

contribute to death or serious injury if it were to recur, as required by [UnitedStates Federal Law]. Persons qualified to make a medical judgment include

physicians, nurses, risk managers. and biomedical engineors. under ltlnitedState Federal Lawl.

78. As the FDA's investigation revealed^ Medronic's employee entrusted w-ith

making this rnedical judgment "only had a high school diploma witlr some additional in-hr:use

tralnlng.

79. In listins these and other vioiations" the FDA concluded that the problems may be

"synrptomatic of serious problems in" Medtronic's manufacturing procedures and its quality

controls.

t1


80. An accurate copy of the FDA's June 1.2009 letterto lv{edtronic's president and

chief executive officer. William Hawkins, is attached hereto as Exhibit I arid incorporated

herein.

81. On June 29. 2009. the FDA issued a Class I recall for cenain Paradigm Quick-Set

Infusion Sets.

8?. The alTected infusion sets had reference numbers MMT-396, l\'lMT-397, MMT-

398. MMT-399 and lot numbers stafting with the number 8 ("Lot 8").

83. A Class I recall is the most serious type of recall in which there is a reasonable

probability that use of the product w'ill cause serious injury or death.

84. An accurate copy of the Jrme 29, ?009 FDA Class 1 recall lbr ce*ain 9aradigm

Quick-Set Inftlsion Sets is attached hereto as Exhibit 2 and irrcorporated herein.

85. Medtronic sent an "tJrgent Medical Device Recall'" letter in July 2009 to users ofl

the infision sets, issuing a recall for approximately 3 rnillion Paradigm Quick-Set Infusion Sets.

86. An accurate copy of Medtronic. Inc.'s "Urgent Medical Deviee Recall" letter is

attached hereto as Exhibit 3 and inctirporated herein.

87. The affected Paradigm Quick-Set intirsion Sets were manutbctured and

distributed from December 1. 2007 throuch June 18. 2009"

88. A lubricant applied during the manufacturing process caused clogging in the vents

of the affected Paradigm Quick-Set Infusion Sets.

89. When the vents clogged, the affected Paradigm Quick-Set lnfusion Sets did not

allow the insulin puntp to vent air pressure properly causing the devicr: to delivcr too much cr

too little insulin into the patient's body. causing seriors injury or death.

L2


90. Insulin is a hormone that is required to sustain lifu. Insulin is needed to convefi

sugar, stalches and other lbod into energy. ln most peaple, insulin is naturally produced in the

pancreas. A person with Type I diabetes, howevet, does not produce insulin.

91. Carol Civens had Type 1 diabetes and was required to infuse insulin into her hod-v

to control her blood suqar.

92. In Fetrruary 2008, Carol Oivens began using the Medtrr:rnic MiniMed insulin

pump with the Medtronic Paradigm Quick-Set lnfusion Set.

93. Carol Givens received a shipment of Medtronic Paradigm Quick-Set Inflision

Sets, MMT-398,6mrn 43"" Lot 8200921.

94. The Paradigm Quick-Set Inf'usion Sets received by Carol Givens have Medtronic,

Inc.'s logo and "Medtronic MiniMed" displayed on the packaging.

95. The Paradigm Qnick-Set Infusion Sets received by Carnl Givens represent that

the products were distributed by Medtronic MiniMed, Northridge, CA 91325, USA.

96. The Paradigm Quick-Set Infusion Sets received by Carol Civens represent that

the prnd*cts were assembled in Mexico tor Unomedical AlS. DK4000 l,loskilde" Denmark.

97. An accurate copy of the package lahel of one these Paradigm Quick-Set Infusion

Sets received by Carol Givens is attached lierelo as Exhibit 4 and incorporated herein.

98. Carol Givens correctly used the Lot 8 Paradigrn Quick-Set Infusion Set with the

MiniMed insulin pump, but tire pnrduct failed to deliver tlre correct dose of insulin to manage her

diabetic condition"

99. As a result of the Lot 8 product'

Carol Oivens experienced cornplications in

hospitalization for diabetic ketoacidosis.

s failure to deliver the correct dose of insulin.

stabilizing her glucose levels. resulting in

:3


100. On May 22. ?009" Carol Givens w'as admiued to St. Mary's Emergency Room in

Duluth, Minnesr:ta, complaining of general weakness, falls i.vith loss r:f consciousness and

fatigue. During the hospitalization. her blood sugar was 400 and 580 befbre it was stahrilized.

101. On May 24, 2009, Carol Civens returned home and cr:ntinued to use the Paradigm

Quick-Set infusion sets from "Lot 8" with the Medtronic insulin purnp-

102. On May 29, ?009. Carol Givens \i/as transported by amhulance to St. Mary's

Medical Center. where she was fuund to be having a hypoglycemic event in which her blood

glucose level of 25. Her insdinpump was removed by hospital personnel and her sugar levels

were monitored"

103. On J*ne 2, ?009, while at a canliology clinic, Carol Givens appeared somnolent

a:rd her blood sugar was found to be 19. She was sent to St. Mary's mergency Room. While

hospitalized, her insulin pump was rernoved by hospital persomel and she was once again

stabiiized. Upon returning home, Carol Givens started using her Medtronic insulin pump again.

104. On June 19, 2009, Carol Givens' insulin plurlp was disconnected by St. Mary's

hospital personnel and insulin was admirristered from a:r insulin drip.

105. On June 20, ?009, Carol Givens was transfemed ont of the ICU at St. Mary's. Her

insulin pump was re-connected by hospital personnel in preparation for discharge.

106. On June 21,2009, Carol Givens was fuund uruesponsive with a bk:od sugar of g.

She was tansferred back to the ICU at St. Mary's where her blood glucose rose to the 800's.

She was diagnosed with diabetic ketoacidosis and ftil into a conra.

107. Carol Civens never regained any appreeiable consciousness. l{er physicians

deemed her prognosis poor and she was transferred to the hospice unit.

1A


108. Carol Givens disd on July 9,2009. The cause of death rvas cerebral anoxia with

diabetic hypoglycerriic conta.

TH s Mn nlnoN r r: l) nrsr{ nA,Nrql" Jornr Ex'ra Frnl ss(Medtronie, Inc.. Medtronic Diatretes. Medtronic MiniMed, lnc.. zurd

Medtronic Puefio Rico Operations Company)

109, The Medtronic Delbndants have established a joint enterprise in that:

a. The Medtronic Delendants had a mutual understanding for the common

purpose af designing, manufrcturing, assembling, marketing, and distributing the Paradigm

Quick-Set Int'usion Set praduct;

b. The Medtronic Def'endants each had a right to a voice in the direction and

control of means used to catry out their comriron purpose; aud

c. Each Delbndant in this joint enterprise acted as an agent of the other for

the purpose of designing. manufacturing, assembling. rnarketing, and distributing the Paradigrn

Quick-Set lnfusion Set product.

110. As a consequence of the joint enterprise. the Medtronic Defendants owed a joint

duty to design, mzurufacture. assemble, malket-. and distribute the MiniMed Paraelism insulin

pump and the Paradigm Quick-Set Infusion Set products in a safe and reasonable manner.

I I I. As a consequence of the joint enterprise. each of the Medtronic Defendants'

wrongful acts and omissions constitute the acts and omissions of the otlier Medtronic Defenclants

and the fault of the Medtronic Defbndants shall be aggregated.

T gn Nl uorRox rc Dnrall oarurs' pnr{cr pat -4.c Frr R[l-lrrorus g rp(Medtronic, Inc.. Medtronic Diabetes* Medtronic MiniMed, Inc.. and

Medtronic Puerto Rico Operations Company)

112. Medtronic. Inc. established a Principal-Agent relationship with Medtranic

Diabetes. Medtronic MiniMed, Inc,, and Medtronic Puerto Rico Operations Compan,rr" in that:

15


a. Msdronic..

MiniMed. Inc.. and

Inc.'s agents;

Inc. {as the principal) manihsted that Medtronic Diabetes

Medtronic Puerto Ricr: Operalions Company would act asMedtronic

Medtronic"

b. Medtronic Diabetes, Medtronic MiniMed, Inc.. and Medtronic Puerlo Rico

Operatians Company accepted this undertaking; and

c. There was an understanding by the parties that Medtronic, Inc. was to be

in control of the undertaking.

I 13. As a consequence of the principal-agent re lationship between Medtronic, Inc. and

the other Medtronic llefbndants, Medtronic. [nc. is liab]e for wrongful acts of its agents,

Medtronic Diabetes, Medtranic MiniMed, Inc., and Medtronic Puerlo Rico Operations

Clompany, resulting in the death of Carol Givens and the harm to her next of kin.

Darnun4]xts' Dn Flcfo Pl4TJrsnsHr p

{Medtronic, Inc." Medtronic Diabetes. Medtronic MiniMed. Inc.. andMedtronic Puerto Rico Operations Company)

1L4. At all times relevant, the Medtrorric Defbndants associated to design"

manul'bcture, assemble, market. and distribute the Paradigm Quick-Set Infusion Set product as a

business for profit and thereby formed a pafinership pursuant to Minnesota larv, including but

not limited to Minn. Stat. $ 323A.02A?.

115. At all times relevant to this action, the Medtronic Defendants each receiveci a

share of the profits of the Paradigm Quick-set Infusion set product.

116. ln the partnership, the Medtronic Defendants each served as an agenl of the other

in the design, manufacture, assembly" n:arketing, and distributiori of the Paraeligm epick-Set

infusion Set product.

1€,


117. The acts and omissions of each of the Medtronic Del-endants carried on in the

ordinary course in the design, manufucture. assembly. marketing, and distribution of the

Paradigm Quick-Set Infusion Set products bind the partnership, pursuent to Minnesota law,

including but not limited to Minn.Slat. $$ 3234.0301(1) and 3234.0305.

ll8. In the par:tnership" the Medtronic Defendants are liable j<lintly and severally for

all obligations of the partnership pursuant to Minnesota law. including but not limited to

Minn.Stat. $ 323A.0306.

Conponarn,4rrur fco(Medtronic, Inc,, Medtronic Diahetes, Medtronic Minilvled. Inc., and

Medtronic Puerto Rico Operations Company)

119. The Medtronic Diabetes. Medtronic MiniMed, Inc., and Medtronic Puerto Rico

Operations Cornpany each acted as the alter ego of Medtronic, Inc, at all times relevant.

l?0. Medtronic, Inc. set the oper:ational and strategic course ibr Medtronic Diabetes"

IVfedtronic MiniMed. Inc." and Medtronic Puerta Rico Operations Company at all times relevant.

1?1. I\4edtronic, lnc. provided oversight and confiTl for the design, manufuc,ture,

assembly, marketing, and distribution of the MiniMed Paradigm insulin pump and the Paradigrn

Quick-Set Infusion Se! products, including the day-ta-day operation of Medtronic Diabetes.

Msdtroiic MiniMed,Inc., and Medtronic Puefic Rico Operations Company.

122. Medtronic, lnc. cornpletely dorninated and co:rtrolled the activities and finances

of Medtronic Diabetes, Medtronic MiniMed, Inc., and Medtrcnic Puerto Rico Operations

Company at all times relevant.

1?3. Medtronic.lnc. decided the scope and range of functions aird activities perfcrnned

by Medtronic Diabetes, Medtronic MiniMed. Inc., zurd Medtronic Puerto Ricr: Operations

Company at all times rslevant.

1l


l?4. Because Medtronic Diabetes, Medtranic MiniMed. Inc., and Medtreinic Puertit

Rico Operations Campany each acted as the a/tsr ego of Medtronic, lnc., Medtronic. Inc. must

be held liable for the rnrongful or:rissions and acts conducted by Medtronic Diabetes, Medtronic

MiniMed, Inc". and Medtronic Puerto Rieo Operations Company as the ulter ego of Medtronic,

lnc.

125. Piercing the corpolate veil r:f Medtronic, Inc. and the other Medtronic Defendants

is necessary tql avoid an injustice ar,d f'undamental unfaimess.

Dl nrcr Conponnrn LU.nl lrry{Medtrorric, Inc.}

126. Medtrr:nic" Inc. controlled. had the right til contol, directed and/or authorized the

day{o-day operations of Medtronic Diabetes, Medtonic MiniMed" Inc., and Medtronic Puerto

Rico Operations Company. including the involvement ol'each in the design, manufacture,

assembly, marketing, and distribution o1'the Paradigm Quick-Set Infusion Set product.

127. Medtronic, Inc. mandated an overall business and budgetary strategy lbr

Medtronic Diabetes, Medtronic MiniMed. Inc.o and Medtronic Puerto Rico Operations

Company, including the invalvement of each in the design. manufacture, assenrbly, marketing,

and distritrution of the Paradigm Quick-Set Infusion Set product. Medtronic, Inc. caried out that

strategy by its own specific direction and authorization. ln doing so, Medtronic, Inc. surpassed

the conlrol exercised as a nortral iricident of ownership in disregard lbr the interests of its

subsidiaries.

128. Medtronic. Inc. owed a duty to operate Medtronic Diabetes, Medtronic MiniMed.

Inc., and Medtronic Puerto fuco Operations Compaay in compliance witli all applicable federal,

state. and local laws. regulations, and codes, and with accepted professional standards and

iB


principles that apply to the desigr, manufacture, assembly, marketing, and distribution of'

medical device products.

1,29. Medtronic, Ine. negligently controiled and parlicipated in the day-to-day

administrative and standard making functions, operations. plarning. management, and quality

control of Medtronic Diabetes, Medtronic MiniMecl, Inc.. and Medtronic Puerto Rieo Operations

Company in the design, manufacturc, assembly, marketir:g, and distribution of the Paradigm

Quick-Set Infusion Set product.

130" As a parenl company interfering directly in tire manner in which its subsidiaries

undertook the activity of designing" manufacturing, assembling, rnarketing, and distributing the

Paradign Quick-Set Int'usion Set product, Medtronie, Inc. expcsed Carol Givens and other

diabetic patients to a substantial risk of harm from a defbetive product.

131. The direct and independent negligence of Medtronic. Inc. resulted in the

placement of the defective product into the stream of con"rmerce u'here it nas expected to be used

by diabetic patients like Carol Givens"

FsptiRllLnw-Dou Nor PRcEnrt Plarxrtnr's Tonr Curms

132. Plaintiffs tort claims against Deferidants are not preempted by the Medical

Device Amendments ("MDA"). ?1 U.S.C. $ 360c" et seq", because the Paradigm Quick-Set

lnfusion Set product is a Class 11 device.

133. The MDA only preempts claims made as to Class II devices (which are not

subject to the same level of regulation as Class Ill devices) vvhen specific regulations have been

promulgated about the device at issue and. even then" claims are only preernpted to the extent the

regulations address the aspect ofthe device at issue.

19


134. The FDA has not estalrlished specific ftderal regulations applicable to this

particular Class II device.

COUNT IStricf Lipbilitv

135. All other paragraphs of this Cornplaint are incorporated as if fully set forth herein.

136. The Deferidants, and each of them. are medical device companies engaged in the

design and/or research and/or manulhcture and/or producdon and/or testing and/or assembling

and/or labeling an#or packaging an#or distribution and/or sale and/or otherwise involved in

placing into the stream of commerce various medical devices, as hereinbefore set furth. intended

for huntan use including facilitating the infusion and/or consumption and ingestion of drug

products such as insulin {br the control of diabetes.

I37. At the times and places aforesaid and at all times material hereto, Defendants, and

each of them, held themselves ollt as knor.r.ledgeable and possessing the requisite skill peculiar tr:

the research and/or manufucture and/or production anrJlor testing and/or assembling an#or

labeling a"nd/or packaging and/or distribution and/or sale of such producrs.

138. At tlre times and places afbresaid" and at all times material hereto. Defendar:ts.

and each of them, placed into the stream of commerce medical devices which failed to function

as intended andlor malfirnctianed and were therefore untit for their intended and foreseeable uses

and were in a defective and dangerous condition.

139. Defbndants, and each of them, caused or otherwise allowed, enabled or facilitated

the placement of clangercus praducts in a defective condition into the strearx of conrmerce and

are strictly liable in tofi pursuant to Minnesota lan.


140. Carol Givens did not anticipate, and could not have anticipated, the detective and

dangerous condition of the Paladigm Quick-Set Infusion Set product sold ta her for her use as a

diabetic patient.

141. The unreasonably defective and darigert"rus condition of the Paradigrn Quick-Set

Infusion Set product rvas dangerous to an extent beyond that which would tre contemplated by

the ordinary user, including Carol Givens, who purchased and used the prclduct.

14?. As a foreseeable, direct. and prcxirrate resuit of the placement into the stream of

corrrmerce by Defendants" and each of them. of a dangerous product in a defective condition,

Carol Givens died prematurely and her next-of-kin have incurred expenses fbr tlie last illness and

fimeral expenses of Carol Givens, they have sustained pecuniary and non-pecuniary losses

within the rneaning of Minn. Stat. $ 573.02. and were otherwise danraged, all to their damage in

a sum exeeeding sevenly-five thousand dallars ($75.000).

COUNT IINegligence

l4l. All cther paragraphs of this Complaint are incorporated as if fully set frrrth herein.

144. At all times relevant. Defendants had a duty to assure that the produc* that rhey

placed or caused to be placed into the stream of comn:ercs were free of de{bcts and reasonablv

fit and suitable for their inrended or foreseeable uses.

145. At all times relevantn Defendants and each of them, placed. or caused to be placed

into the stream of commerce, a product or products rvhich malfunctioned an#or failed to operate

as intended or expected and w'hich n'ere therefore defeclive and/or not reasonably fit or suitable

for their intended or fbreseeable uses.

?l


146. As a foreseeable, direct zurd proximate result of l)elbndants' negligence as

hereinbefbre set forth. Carol Givens was exposed to a substantial risk of harm fiom a defective

product in a dangernus condition.

147. As a foreseeable, direct and proxirnate result of the negligence of Defendants, and

each of them, Carol Givens died prematurely and her next-of-kin have incumed expenses for the

last illness and funeral expenses of Carol Givens, they have sustained pecuniar:y and non-

pecuniary losses within the meaning of Minn. Stat. $ 573.02, and were otheil&'ise damaged. all to

their damage in a sum exceeding seventy-five thnusand dollars {$75.000).

COUNT IIIDu-tv ta Provitle Reasorable Warnins

148. All other paragraphs of this Complaint are incorporated as if fully set forth herein"

149. Defendants kne\4', or should have known in the exercise of reasonable care, that

their product or products could malfunction and cause iqiury but negligently placed these

products into the stream of commerce where they wo*ld be expected to be used by diabetics like

Carol Givens.

150. After placing the dangerous and defective prodr"rct into the stream of commerce.

Defendants knew or irad a reason to know that tire product was. or was likely to be, dangerous

u'hen used by persons to whom the product had been delivered, like Carol Giroens.

151 . At all times relevant. Defendants had a duty lo exercise reasonable care to inform

persons to whom the product had been delivered. like Carol Givens, of the danger or otherwise

protect them against it.

152. Defbndants failed to exercise reasonable care to infernn Car*l Givens of the

danger or otherwise protect her againsi the danger.

2?_


153. Defbndants were negligent in their managemsnt or concealment of information

regarding the dangerous and defective condition associated w'ith the Quick-Set ln sir:n Set

prcduct, resulting in an unreasonable delay in the disclosure of the dangerous and defective

conelition to persons to whom the product had been delivered,like Carol Givens.

154. As a foreseeable, direct and proximate result of Defendants' negligence as

hereinbe{bre set forth, Ca:'ol Given$ was expclsed to a substantial risk of hann f}onr a def'ective

product in a d*ngerous conditi<ln.

155. As a foreseeable, clirect and proximate result o1'the negligence of Defendants. and

each of them, Carol Givens died prematurely and her next-of-ki* have incurred expenses fur the

last illness and fuueral expenses of Carol Givens, they have sustained pecuniary and non-

pecuniary losses within the rneaning of Minn. Stat. $ 573.02. and were otherwise damaged, all to

thelr damage in a sum exceeding seventy-five thousand dollars ($75,000).

CQUNT IVBreach of Express Warranfi'

156. All other paragraphs of this Complaint are incorporated as if fully set fonh herein.

157. At all times relevant hereto, Delbndants expressly wamanted by rvay of r,'oryitten

and electronic communications. including, but not limited to product labeling. patient package

inseds, web sites, video presentations, advertising or other documents and/or promotional

materials directed to Carol Givens's physicians. to other healthcare providers, and to Carol

Givens. by and through statements and representations made by Deftndants. and each of them,

or their authorized agents or sales representatives, that their product was safe, effective, fit and

proper for its intended use or fbreseeable uses.

158. Carol Civers was prescribed" purchased, and used Delbndants' producl for the

pulpose af controlling her blood glucose levels by way of an insulin pump with its associated

23


equipment and devices" including Defendants' infusion sets. In so doing, Carol Givens relied

upon the skill. judgment. representation and the foregoing express written warranties of the

Defendants. Said warranties and representations were false, misleading, and inaccurate in that

t}e aforementioned product malli.urctianed during use and was not thsrefore safe and was unfit

lor the uses lbr which it was intended with the knowledge and/or encouragement andlor approval

of Defendants.

159. As a foreseeable. direct anci proximale result olthe breach of express warranties

by the Defendants, and each of them, Carol Givens died prematurely and her next-of:kin have

incurred expenses fcr the last illness and funeral expenses of Carol Civens, they have snstained

pecuniary and non-pecuniary losses within the meaning af Minn. Stat. $ 573.0?. and were

otherwise damaged, all to their damage in a sum exseeding seventy-fir'e thousand dollars

($75.ooo).

couNT IyBrench of lmpliecl Warranfy

160. All other paragraphs of this Complaint are incorporated as if fully set larth herein.

161. Prior to the time that the aforementioned product was used by Carol Glvens.

Defendants irnpliedly u'arranted to Carcl Givens, her physicians and other healthcare praviders

that the product was of merchantable quality and safe and fil for the use fur which it vsas

intended or for other kncwn or fbreseeable uses.

162. Carol Givens was and is unskiiled in the research. design, and manufacture of the

aforementioned products and reasonably relied entirely or the skill, iudgment and implied

warranties of the Defendants in being prescribed, purchasing. consuming and otherwise urilizing

the aforementioned product.


163. The afirrenrentioned produc.t was neither salt f'crr its intended, known or

fureseeable uses, nor of merchantahle quality: as warranted by Defendants in that it had the

potential to cause serious and pennanerit injuries, including death, when put 1o its intended.

hrown or foreseeable uses.

164. As a result of the aforementioned breach of their implied wamanties by the

Defendants. and each of them, Carol Civens died prematurely and her next-of-kin have incurred

expenses for the last illness and funeral expenses of Carol Givens, they have sustained pecuniary

and non-pecuniary losses within the meaning of Minn. Stat" $ 573.02, and were otherwise

damaged, all to their damage in a sum exceeding seventy*five thousand dollars ($75,000).

PRAYER FOB RNLItrT

WHEREF'ORE. Plaintiff demands judgment against Defbndants, individuaily,

vicariously. jointiy and severally" for a reasonabls sum in excess of seventy-five thousand dollars

($75"000), together with interest. costs and disbursements herein, as well as such other legal ar

equitable relief, including attorneys' fees, and such otlrer legal or equitable relied as the Court

deems just an<l equitable.

PLATNTIFF DAMANDS A JURY TRIALFOR ALL CAUSES AND CLAIMS HEREIN

Dated: Julv 3. ?012

KOSISRADZK]I SMITH LAW FIRM, LLC

s/ Joel E. Smith

Mark R. Kosieradzkt {ID #57745}Joel H. Smith (lD #2131 84)Kara Rahimi (iD #0389480)3675 Plymouth Boulevard, Suite 105

Pl1'rrloutn. MN 55446Phor:re: (763) 746-7800Atlorneys for Plaintiff

?\


Medfronic Puerto Rico Operations Company

,""'" 2t\ {(-\\"&

Department of Health and Hunran Serl'ices

Public Health SewiceFood and Drug AdministrationSan Juan DistrictCompliance Branch466 Fernandez Juncos AvenueSan Juan Puerto Rico 00901-3223Telephone: 7 87 -47 4-9 500FAX: ?87-729-6658

June l, ?009

WAITNING LETTERsJN-2009-08

Certified MailReturn lleceipt Requestctl

Mr. William A. HawkinsCEO and PresidentMedtranic Inc.710 Medtronic ParkwayMinneapolis, MN 55432-5604

Dear Mr. Hawkins:

Food and Drug Administration

Dlrilg an inspecticn of'your firm located af Road 31 Km 24 Ceiba Norte Inclustrial Park Juncos, Puerto

Rico, on NovEmber 12, ?008, tluough December 15, 2008, investigators from the United States Food and

Drug Administration (FDA) detenninedthat your iitm manutlctures Syncllromed@ II Fumps and

MiniMed Paradigrn{& Insulin Pumps. Under sectinn 201(h) of tire Federal Food, Drug and Cosmetic Act(the Act), 2l U.S.C. $ 321{h), these products are devices because they are intended for use in the

diaglosis of disease or other conditions or in the cure, nitigation, treatment, or prcvention of'disease' or

are intended 1o affect the structure or function clf the body'

Exhibit I

$CANNEDJUL 0 3 e0tz

U S. DISTRICT COUNT DULUTFI

CASE 0:12-cv-01601-PJS-LIB Document 1-1 Filed 07/03/12 Page 1 of 18

This inspection revealed tlmt the Synchrcmed& II Pumps ars adultemted within the meaning of section501 (h) of the Act (21 U.S.C. $351 (h)), in that the methods used in, or the iacilities or sontrols used fbr,their manufacture, packing, storage. or installation are not in conf'ormity with the Current GoodManufbcturing Practice (CGMP) requirenrents of the Quality System (QS) regulation found at Title 21,Code of Federal Regulations (C.F.R.), Part 820. We received written responses from Mr. ManuelSantiago, Vice President of Medtrronic Pueflo Rico Operations Cornpany (MPROC), dated January 20,2009, and March 31,2009, corrcerning our investigators' observations noted on the fomr FDA 483, List ofInspectional Observations that was issued to your firm. We address these responses belo'*v, in relation toeach of the noted violations. Thess violations include, but are ncrt limited to, ths following:

1) Faiiure to establish and maintain process control procedures that describe any process controlsnecessary to ensure conformance to specificalions, which shall include monitoring and control of processparameters and component and device characteristics during production, as required by 2l CFR8?0.70(a).

For example:

a) Multiple Synchromed@ ll Purnps were releasecl for distribution and ir:rplanted in patients eve:r lhoughthey were not filled r.vith propellant as required by your Process Operation Description (pOD) (b) (4)Your firm's iuvestigation, Nonconformance Report (NCR) (lr) (4) which started in (b) (a) fbund thatseveral implantable punlps, including scrial numbers NGV300069H, NGV301 I33l{, NGP302B23H,NGV300225H, NGV401554I'I, NGV4022253H, NGP30709lH, NGP301055H, and NCP30485lH, werereleased to the market without being filled with propellant and this was not discovered in the propellantweight check durilg manufacturing. Your firm's manufacturjng step requires a (b) (a) after the propellantis added to the pump. The 100% mass check was ineffective to identify that devices lacked the propellant.You becarne aware of this situation after confirming two complaints receive on (b) (4) (Product CommentReport (IJCR) (b) (4) ar:d (b) (4) (PCR (b) (4) PCR (bi fi) states that the product had to be explantedbecause of issues related to the lack of propellant. PCR (b) (4) created in (b) fi) also documented thal trvopumps had to be explanted on (b) (4) ar"rd (b) (4) due to lack of propellant.

b) On June 23, 2008. at the (b) (4) one Syncluomedr$ II Pump was found thal did not show er.idence of a

perforated septum. The (b) (4) is perfonned at this station. The (b) (4) is perfomed to detect obstmctionin the (b) (4) early in the nianufacturing process. (b) (alAs part of your finn's assessment(Nonconformance Evaluation Request (NCER) (b) (4) that were al tlr"is manufacturing stage were visuallyinspected. This inspection revealed that (b) (4) of the (t)) (4) Synchromed@ Il Pumps did not contain the(b) (4) indicaiing that tlie (b) (4) was not conducted on these (b) t4) Synciuomed@ II Purmps.

c) On June 25, 2008, at the (b) (4) one Synchromed@ II Pump was found without a (b) {a) at the (b) (4)The {b} (4) needs to be perfora€ed to test the (b) (4) T|e (h) (4) is a safety mechanism that seres toassure that the purnp is never overfilled. As part of your finn's assessment {NCER (tt) (4) ,theSyichromecl@ ll Pumps in the firnr's existing inventory at MPROC were visually inspected. (b) (4) werefound without the {b} {4i l{owerar, the electronic device history record for these devices showed entriesindicatin,s that the (b) (4) was conducled. Your finrr expanded the scope of the investigation (NCR (b) (4)and found (b) (4) additional Synchromed& II Pumps'*'here the (b) (4) pressure rvas not conducted and


(lr) (4) {evices with testing ciiscrepnncies. Ycur finn's investigation further cletendncd that a total of (b)

(4) Syncluarned@ II Pumps had records that indicated that the (b) (4) was perfnmred. r,vhen the test was

lot actually cglducted. Of these afTected devices, (b) (4) pumps rvere distributed to customers.

We have reviewecl your responses dated January 20, 2009, and Marcll J1, 2009' and our colrclusions

foliow:

a) Regarding the corrective actions that your firm has taken to address the Synchromed@ II Purnps rvith

tire missing propellarrt, you initially identified this problem in May 2006. You initiated a corrective and

preventive action (CAPA) investigation in January 2007, determined the root cause to be related to the (b)

i+1 f"iti,,g to properly fill pr"opellant into the Sl,nchromed@ II Pump reseloit, *nd failure of (b) (4) to

verify the fill weight of devices aller being processed through the filling equipment. Your finn conducted

a Health Hazard Assessment irr March ?008. In May 2008, your firm conducted a voluntaty recall of the

Synclrromed@ iI pumps that did not contain any propellant, and notified the FDA, Your finn's response

indicates that MPROC has confinned that the corrective actions regarding the Synchromed@ iI Punrps

with the lrissing propellant were completed and efTective. FDA is concemed with your failure to initiate a

recall for devices affected by the propellant probleni in a tirnely marurcr. Based on the chreinology

identified in your l€sponse, it took almost 2 years from when the missing propellant was initiallyidentified to conduct a recall. Tlre adequacy of your response carulot be detennined at this time. FDA willassess the effecliveness of your finn's recall procedures and CAPA's during the next inspection,

b) Regarding the actions tirat your firm has taken to prevent recuffeoce of Syncluon:ed& II Pun'rps liombeipg distr-ibuted without propellant, you conducted process validation for the manufacturing process

chalges between April and ti,lay 2007. Subsequently, you updated your procedures and re-trained your

personlel on these pmcedures. Tire adequacy of your response cannot be detennined at tlds time. FDAwill assess the el'ftctivencss 0f your CAPA's during the next inspection.

c) Regarcling the failure to concluct the and the (b) (4) and {b) (4} the adequacy of the response cannot be

detenlined at this time. Based on your rssponse, the root cause was determined to be relalEcl to {b) ( )manufacturing insiructions for the Synclrorned@ lI Punrps. MPROC has perfbrmed detailed Health

Hazard A:ralyses ftrr lhese two problems. Your lirm has established additional checkpoints in the

nianufacrwing process to verif,i the (b) (4) and (t)) t4) are being completed; reviewed the manufacturing

process to e11sure that the steps were correci and specific; retrained empltlyees in perfonning the

manufacturilg steps; ar:d establisl-red adriitional oversight by increasing the irrtemal process audits of tlie

Synchromecls Il Pump manufacturing operation. Your fint iderrtified other improvement actiotts that

will be implemented r.vithin the next year, as identified by the timetable in your responses. The adequacy

61'your comeclive anil preventive actions will be detenni:red during the next inspection.

2) Failure to establisir and maintain procedures for implernenting corrective and preventive aclion that

include identifying the action(s) needed to coffect and pruvent recurrence ofnonconfonning product and

other quality problems, as required by 21 CFR 820' 100(a).

For exatlple:


On October 5, 2008, your tinn perfcnned a (b) (a) of data from the (b) (4) records (which stores theresults of in-process testing) and the {t}} (4} manufacturing records (which controls the manufucturingprocess for the Synclromsd@ II Pump). The intent of the (b) fl) was to pror,icie another level r:rf oversiglrtto ensure that in-process tests were actually being perf<rrmecl on devices, as they progressed throughmanufhcturing. This report, however, revealed that another step, (b) (a) fcr each Synckomed@ II Pump,was not per{bnned during manufacturing. (b} (4) are unique ts each device and have values thal varyfrom (b) (4) This ccnstanl is used by the device in critical internal functions such as calculating drugreseryoir levels and drug dispensing rates. Our investigators found over (b) (4) complaints in your finn'scomplaint handling system related tcl accuracy rates. The (b) (4), reporl did not reference any NCR orother type of investigation into this problem.

We have reviewed your respoflses dated January ?0, 2009, and March 31, 2009, and our conclusiorrsfollow:

Your responses state that a comprehensive rerniew of the CAPA procedures at M?ROC wili be conductedby July 31 , 2009. The adequacy of your response carurot be determined at this tinre. The adequacy of yourfirm's corrective actions will be determined during the next inspection.

3) Failure to establish and maintain procedures to ensure that Device History Records (DHR's) for eachbatch, lot, or unit are mainfained to demonstrate that the device is manufactur"ed in accordanee with theDevice Master Reccrd (DMR), as required by 2l CFR 820.184.

Specifically, a revierv of thirleen (13) DIIR's for the Syncluomed@ II Pumps revealed that your finn'sprocedure entitled (b) (4) {Procedure POD (b) (4} Revision (b} (4) is nr:t always followecl. For example:

a) A cornparison between DHR's fcr the Syncluomed@ II Purnp serial nun:bers NGP319205H andNCV416698H, ancl the respectivE (b) (a) revealed that these tr,vc devices were dispatched into thestedlizer after the (b) (4) Your procedures require that the devices be placed into the (b) (4)

b) DHR's for Synclrorned@ 1I Pump serial r:umbers NGV416743H, NGV404480I-1, NGV417063H,NCP306I74H, NGV4164511{, NGV4I657BH, NGV418q43H, and NCP305847FI show that theverification ofthc (b) (4) and (b) (4) and (b) {4} were recorded after the slearn sterilization cycle hadcompleted, and not prior to initiating the cyele, as required by Prccedue POD (b) (4)

We have reviewed your resporlses dated January ?0,2009, and March 31, ?009, and our conclusionsfbllow:

Your responses staies that the devices described above went through l1re complete sterilization pfoccss,and were determined to be sterile at the conclusion of the cycle. I-Iorvever, your firm acknowledges thatthe sterilization process rvas not perfomred in the order spccified by your procedures. Thc aderluacy of


your response cannot be detenlined at this tir:re. Tlie adequacy of your firm's corrective and preventive

actions 'll,ill be determined iluring the next inspectittn.

4) Failure to reviel, evaluale, and investigate complaints involving the possible failure of a device,

iabeling, or packaging to meet any of its specifications, as required by 31 CFR 820.19B{c).

For example:

(b) (4) received on (b) (4) and (h) (4) received on (b) {4) both describe events where patients who wereimplanted with ihe Synchromed@ II Pump developed infections. A review of the DHRs for the devices

identified in the PCR's Synchromed@ II Pump serial nunrbers NGP319205H and NGV4I6698H,respectively) show that the devices were dispatched into the sterilizer after the (b) (4) had ah'eady stafied.

The complaint records stated that an investigation had been opened to assess these complaints. However,

a copy of this investigation was Rot included as part of the complaint record, lhere was nc reference to aspeci{ic investigation repofi number, and {rere was no documentation wliether the irrvestigaticn was

successfully closed. Also, there was no record in the complair:l hle tliat Medical Device Reports werefiled by your firm rvith FDA ior tliis complaint,

Your responses dnted Jauuary 2A.2009 and March 31, ?009, did not address this chalge lrecause it was

not included in the FDA 483 issued to you on Decenber 15. 2008. The adequacy of your corective and

preventive actions will be determined during lhe next inspection.

Our inspection also revealed thal your MiniMed Paradigm@ Insulin Punrps are misbranded uncler section

502(tX2) of the Act [21 U.S.C. 352(tX2)], in that your finn failed or refusecl to fuinish rraterial orinfonnation respecting the device thal is required by cr under section 519 of the Act, 21 U.S.C. 360i, and

21 C.F.R. Parl 803 - Medical Device Reporling (MDR) regulation. Significant deviations include, but are

not lirnited to, the following:

5) Failure to repofi to FDA no later than 30 calendar days after the day that you receive or otherwisebecome aware of information, from any source, that reasonably suggesis that a device that you marliet: (1)

may have caused or contributed to a death or serious injury; or (2) has malfrrnctioned and this device or asimilar device that yor-r market would be likely to cause or contribute to a death or serious iqiury, if the

malfunction were to recur', as required by 2i CFR 803.50(a),

For example:

a) Complaint No^ (b) (4) states that tire rcported complaint lvas not reportable as an MDR to the FDAbased on testing of the retumed MiniMed Paradigrr:@ Insulin Pump" Information in the complaintindicated that the patient was hospitalized for diabetic ketoacidosis allegedly follorving battery probleilswith the plu:1p" flre corlplaint file states that analysis erf the pump did not find a baitery problem. Your


finn conclucled that although "infonlialion does suggest that a device malfunction ocoured," the

malfunction rvas unlikely to resuh in death or injury if it were to recur.

However, a review of the MDRs submitted lry your firm to the FDA througir MedWatch shows that your

firm has sg6mirted serious injnry MDRs with a diagnosis of diabetic ketoacidosis resulting from the use

of the MiniMed Para<ligm$ Insulin Pump. Since your {irm has previously repcned these MDRs where a

patient had been hospitalized for diabetic ketoacidosis from the use of the MiniMed Paradigm$ Insulin

itunrp and your fimr received a complaint of a similar nature, this device malfunction, if it were to recur'

*ould be likely to cause or contribute to the same serious injury. Fu$hermore, under 21 CFR 803.3,,,Cttrrsetl or cgntriht$crl means that a death or serious iqjury was or may have been attrjbuted to a medical

device, or tfat a medical dsvice was or nray have been a factor in a death or serious ir{ury..'."

Basecl on the inlbrnation in the cornplaint lile, device failure or tnal{itnction may have contributed to or

causecl the useCs hospitalization and the device's malfunction would be likely to cause or contribute to a

death or serious injury, if the malfunction were to rscur. As a result, this serious injury is a reportable

MDR evenl under 2l CFR 803.50(a). Yorrr fimr did submit MDR (b) (4) for this complaint. The "Date ofEvent" and the "Date of Repofi" are listed as May 30, 200?. Your firm reported this as a serious injury on

tlie Mandatory Reporting Form, FDA-3500A, on November 14, 2008. which is i8 months after the day

that your fitm received infonnation of an MDR reportable event'

b) Complaint (b) {4) states that the reported complaint was noi repoflatrle as an MDR to t}re FDA based

on rssting of the retumed MiniMed Paradigm@ Insulin Pump. The infonnation in the conplaint indicated

that the user- contactecl your finn because the user had a blood glucose level of 456, and that the user's

MiniMeci Paraclignr@ lnsulin Pump had failed to alann when it stopped delivering insulin. The user was

subsequently hospitalized ar:rd diagnosed with diabetic ketoacidosis. Follow-up revealed that the user had

troubli keeping the user's blood glucose level down, and when the uscr replaced infusinn sets, the

camulas were benl. Tlie complaint record states that, (bi (4) Under ?1

CFR 803.3. ,'Caused or contributed means that a death or serir:us iujury was or may have been altributed

to a meclical der.ice, or that a n:edical device was or may have been a fector in a death ol scrious

ir{ury..-." ln t}is instance, the patient had complained of a potential device fhilule, and the patient was

subsequently hospitalized tbr diabetjc ketoacidosis. Based on the infcrrmalion in the cornplaint file,

because your tinn was aware of information that reasonably suggested that the user's MiniMedParadigm& ft:sulin Pump may have caused or contritruted to a serinus injury, you were required to repoft

this event to FDA as an MDR within 30 calendar days of receiving or otherwise

becoming aware of this infunr:ationu under ?1 CFR 803-50(a).

We harre revieived your responses dated January 20,1669. ar;d March 3l, 2009, ancl our concllrsions

fbllow:

Your responses state tlrat I\,IDR repofis were submitted for the cornplaints identilied above" Your firm has

also updated your procedure

(b) {4) A4etlical Devica Repart (Effecti.r'e Dale: Deceruher 17, 2008}, to rel'lect new criteria for MDRrepo$i1g, and re-trained ynur employees on the new procedure on December 16, 2008. The adequacy ofyour corrective and preventive actions will be determjned during the next inspection.


6) Failure to have a person who is qualified to nrake a medical judgnent reasonably coliclude that a

device dicl not cause or contri$ute to a death or serious irtjury, or that a malfunction would no1be likely tocause or contribute to a death or serious irtury if it wt:re to recur, as required by 2l CFR 803.20(c)(2).

Persons qualihe{ to make a medical judgnrent include physicians, nurse$, risk mana*qers. and biomedical

engineers, under 2l CFR 803.20(cX2).

For example:

Our investigators cletennineil that a product reporting specialist was making decisions about MDRreporlability fbr the MiniMecl Paradigrn@ Insulin Punrps. The training record for this particular enrployee

sltowed thal this person only had a high school diploma with sorne additional in-house training.

Your responses dated .Ianuary 20,2009 and March 3l, 2009, did not address this charge because it was not

included in the FDA 483 issued to you on December 15, 2008. The aclequacy of your corrective and

preventive actions will be detennined during the next inspection.

You sliould take prompt action to correct the violations addressed in this letter. Failure to promptly

correct these violations may result in regulatory action being initiated by the Food and Drug

Administration without fuither notice. 'l'hese actians include, but are not limited to, seizure, injunction,

and/or civil rnoney penalties. Also, federal agencies are advised of tlre issuance of all Waming Letters

about devices so that they may take this inRlrmation into accounl when considering the award ofcontracts. Additionally, pren'iarket approval applications for Class III devices to which the Quality System

regulation deviations are reasonably related will not be approved until the violations have been corected.

Requests for Certificates to Foreign Govenxrents will not be granted until the violaiions related to the

subject devices have been corrected.

Please notity this office in writing within fifteen (t 5) working days fro:n the date you receive this letter ofthe specific steps you have takcn to correct the noted violations, including an explanation of how you plan

to prevent tlrese violations, or similar violations, from occurring again. include documenfatiou of the

corrective action you have taken. If your planned correctiolts will occur over titne, please include a

timetable for inrplernentation of those coruections. If corrective action cannot be completed r.vithin 15

working days, slate the reason lor the delay and the tirne within N,hich the corrections will be completed.

Your response should be sent to:

U.S. Food and Drug Admir-ristrationAttn: Mrs. Maridalia TorresDistrict Director466 Femandez Jurrcos AvenueSan Juan, PR 00901 -3223


If you have any questiorrs about the content of this letter please contact Ms. Margarita Santiago,

Compliarice Officer, at (787) 4744789.

Finally, you should know that this letter is not intended to be an all-inclusive list of the violatieins at your

faciliry. it iu your responsibility to ensure compliance with applicable laws and regulations administered

Uy fOA. The specific violations noted in this letter and in the lnspectional Observations, Fotm FDA 483

fna +A:;, issued at the closeout of the inspection may be symptomatic of serious problems itr your

finn,s manufacturing and quality assurance systems. You should investigate and determine the causes oftlLe viqlations, anct take prompt actions to correct the violatir.rns ancl to bring your products into

compliance.

Regarding your firm's CAPA's for t]:e Syncluomed& II Pumps that did not have tlie (b) (4) test perfomed

urrih"rr-,, your tirm has not indieated how it will address product that is currently distributed to cusiomers.

FDA's t"ui"* of your firm's investigation report(NCR (b) (4) did not reveal any evidence to demonstrate

that (b) (4) was tested in subsequent manufacturing steps to verify that the safety mechanism perfomed

as inrended. As srated in tlie charges above, (b) (4) Synchromed@ II Pumps on which the (b) (4) was not

perfomred were distributed to customers. Shnuld your firm rmdertake a volunlary correction clr rernoval

ior the Synchromed$ II Pumps where (b) (4) the was not per'fumed, it must subnrit a written repod to

FIIA r,r'ithin 10 working daysof initiating such an action, as specified by 2l CFR 806.10{a) & (b)' See 2l

CFR parl 806 fcrr additional iilformation about conectives and removals.

In adclitiol to the a6ove char.ges, our inspection revealed that your fitr]l uses one manufbcturing ptocess

systenr tbr both the Sy11cluomed@ ll Pumps and the MiniMed Paradigrn@ Insulin Pumps. To the extent

that any of t[e above CGMP violations for the Syrchromed$ II Pumps also irnplicate the h4iniMedparad.igm@ lnsulin Pumps, your correclive actions should address and extend to the manufhcturing

procedures of the MiniMed Paradigm$ lnsulin Pumps.

Sincereiy,tsl

Maridalia Torres lrizanyDistrict l)irectorSan Juan District

Ensiasure: Form FDA 483

cc: Mr. Manuel SantiagoVice PresidentMedtronic Puerto Rico Opaations Company

CallBox 4070Juncos, PR 00777


cs: HFC-210 (electronic via CMS)l-lFZ-333 Nikhil Thakur. CDRHHFI-35 (redacted via CMS)HFR-SE1DD {MTI)DrB (VM)CSO (Marilyn Santiago)EF (30043693 r8)CBRFCB WL File

MS/rneb: 06-01-2009

H:\Cornpliance Branch\Compliance Officers\Santiago\nredtronic\X4edtronic2009.doc

WL 2009-08 dated 06-01-


U$e:QecallingFirm;

lffi [J.s. Food and srug Administretion

llerrlq ! L{sdisal Dcvisel ' Mcdi-cal-0.edcs-lalely " Sedical0-cvlce Re"catlr

Medical Devices

Medtronic MiniMed Paradism Quick-Set lnfusion SetsRecall Class: Class IOate Recall June 29, 2009lnitiated:Prosl$ct: Paradigrn Quick-Set lnfusion Sels, Moclels li,ltu'lT-396, MNT-397, MMT-398, and MMT'399 {trith lor numbers

beginning ivith "B," for example EXXXXXX)

The lot number is clearly marked pn both ttre prsduct lei:el, and utt each individual infusion set package.

Only "Lot 8" Paradigm Quick-set infusion s€ts are affected by this recall.

Th€$r devices were manufactured and distributed from December l, 2007 through June 18, 2009.

An infusion set is a thin plastic tr"rbe used to deliver insulin from an insulin lump tcr a diahetes paiient.

f"ledtronic Miniltled18000 Dev$nshire StreetNortlrriclge, California 91 3?5

Reason for Thcse infusion sets may not nllow the insulin purnp to vent air pressltre properly. This coulC potentiallyRecall: result in the device delivering too much or too litlle insulin and may cause serioL,s injlry or deeth"Public The corpany rnay be contacted anylime, ?4 hours a day, seven days a rveek.Contact: l,nysrclans:

* rnay coiltact a lvledtrclnic Oiabetes medicel officer a[ 1-S18-576-42f 1

r report nrorjuct problenrs at 1.-800-345-8139

Patients/CustsmerslE may contact thc company at 1-800-345-8139

See additional inforrnation under UEeful Links below.

FDA District; Los AngelesFDA patients shoultl stop using "Lot 8" Quitk-set infusion sets.Cornmanis:' From July 6-9, 2009, the {ompany sent letters to healthcare professionals, distributors, active custonrers

and patients (sets pr-rrchased after lanuary 1, ?009) and inactive customeis {sots purchased baforeJanuary 1, ?009). Acti\re palients and customers received one box of replacement sets with their letters.

Letters to pa[ients and custon']ers inctuded instructions to:

G st$p [sing the recalled infirsion sets.r notify the company by any of the folloling methods:

$ complete and mail the enclosed reply cardss visit tlreir websitefi fall tne company

* conirrm receipt of the recall notice.* iclentify any unused sets to return.o order replacemenl sets.

Letters to digtributors whc purchased the affectecJ ctevices includeC directions to:

:to1: distributing the affectecl product.

rrotify ell pitients they lrave providecl infusian sels ior ur provide pratient nanle$ and addfesses tothe Firnr $o that Medtronic Minil"led can inform the patients.

Ciass I recalls are the mogt serious tvpe of recall and lnvolve situation$ in rvhich there is a reasonoble

I

Exhibit 2


probability that use of these products wtll c*use sericue injury or deatn,

Health care prc.rfessianals and consumers may report edverse reactiotts or quality problems experrenccd

with the use of lhese prodLlcts to the FDA'S Medlvatch Adverse Event P.eporting progranr either online, by

regr*lar rnail or bY FAX.

Useful Link$:

o Recall -- l-trrr Press Releasc L

o t"le<ltrsnic Diabetes trVebsite2

" MedWatch: The FDA Safety Information and Adverse Event fteporling Program'

Llnks on this page:

L. http;//rvww.fda,gov,/gafety/RecalltlArchiveltecalls/2009lucm17l588.htm

2. htttr :/1rvw'ry. m ccl troni cdia betcs'com/lotS

3. http : llrvww.fda, qovlSafety/MeclWatcfr/default'htm


ffi*SiR$"q:*:i:i*

JrrlYr T,2"699

i"l ;{ i; il ri "f" j,* * } | il J:, 1". i} i: V ; i- * fi I t i *- i.

NTCALL OT QU!C!{-5ET'1' ! NFUSIQru 5TT5

Mnd*ls MMT-3S6, MMT-39/, MIVIT-:98 and MMT-399 (L*ts StartinE with 8)

Dear Quick-set€ Infusion Set LJser:

Medtronic's diabetts business unil is voluntarily recalling Qr:ick-set infusion sets that have lot nurnbersstarting wirh tlre number"B" {"Lot 8" QLrick-set infusiori sets). These infirsion sets are used with MiniMedPararligm" insrrlin pumps. We are takirrg this action because we identified a snrall psr{ent af infusion sets

thai rnay not vrork propcrly.

Tlre situation is le lated to the tubirrg ccnneclor. Apprr:xinately 2V,: nf the affcctcd infr-rsion sets (wlrichfeprcscrtts approxinrately 60,000 infr-rsiorr sets orlt r:f an estinrated 3 nrilliori infrision sets with cuslomers)rilay nat allcln; the insulin plllp t(: venl prr;perf y. Venting is n*ee s:ary tr equaliz* tlre pressut'e in thereservoir comp;lrtment lvith tlre sullolltcling atnrosplrere. lf tl.re verrl clor*s nr:t urork pro;:erly, tlris e*q.nld

p*tentia$By s"osili€ $m t*m ntuch ofl too l$tt!* insu$ie-r h*img c**{iv*a'ed anc$ may fe*efi to sarlelqrs ia'rjuny or.

eiemth.

The ventitrg issuc lras been ccrrected arrclv/e are provic{ing replacement bc}xe5 tn people who neecl them.Or:r records indicate that yr:Lr liave not orde recl any Quicl<-set infr"rsion sels fronr l\4cdffonic witlrin tlre last six

nreintlrs. J"liere{*r'e, lve clo nr:I linou', il'you ar* :till r-rsir"rg thir praclucL or ily*u ltirve atty unuse'd haxe s tlratnt*ecl to be returnecj. Orir {irst priority is ro provicle you replace nrent irrfusisn sets if yau ne*d tlre m. li'yar-r

have switched tr:;tnotlr€r type r:f infitsion set, please bc. at:ur*d rro otlrer Medtrurric inf*sion sets are

affected by this recall.

Actiorrs to Tnke

Step 1.

Step 2.

Siep 3.

(.inrr I

$t*p *sImg "l-ot E" Qu*c$r-sst [mfcisi$!t $r*ts r;$ht fiweySwitclr to an unaffectecl infr-rsiein srt c,f inrplerl*nt tlre lxrcle'r.:p injeciiorr planestal:iished with your cloctarContact us i:sing olre nf tlrese nrethnds:

" Fill ar,rt the encloscd rcply card anrJ clrop ir in llre n:ail

" Visit our we bsitr: ar :ygutme_Cji{an1tflig"l:*t{tc.-cnrrllc,!$. Call olrr autsnrated system at 800.345.U139

f:ie lr:rn any unusecl "Lot B" Qr.riclq-set infusion sets Lr5irlg tl:e e nck:s*d pre*paidrelurn label. Simply clrop ynur pacl<ngr off ftt any UPS locatic'rn or call Up5 atS00.7d?.5877 tn schedr"rle a picl< rrp.

khibit 3

iril:iii'.rr-iiriil..:filrlr,'r.:11.,.::,)i:r'tllili:.1:;.rll;,!r:.rt.r',1i,t].,,::-i,nirilt'ir,.1' ". r,a!rr!,ri1, i,i,,r,,;r, i.,,,; ttt j|, E t; \\it\iiit;,t 1r':.Jt..j::ri..t:;,!lt,t.trtt:i.i-1r.a,r'-ii,.,11,:ritil,:fi::.1,i,.1,r.. :.j,1'.4i:triitl\2.t,.:.rt|.


Tli* rrolificatiorr ircti*nl in St*p i irhnvc i,r,illallerw us lc l<nor,nr if you n*ecl to he s*rlt rc1:lacettrctrt infLl:i*t:

se t:. ll yor,t c;o, vri: will llrip y1p11' repl*cr.'rllttr infr-tgiotl 5ri! vi;l LlPS olrtl rniltlrl ilrliv*ty wilf rin 48-Hattrs of

rcce iviriq yrui.poti{icatiarr. fvur if yor-r elo not nencl re placeinerrt sets, please fr:llnw tlte rrr:tiircatisn plo{e5s

as regulitl,'y gniclelirrn: r*rlrire us to collect tlris irTfornlfitistr. 5n thnt we catl setve all orrl cLlstonl€15, we

will 6e le nclipg replae*rn*nts .-rrrd ne,,v orclers *f Qtricl<-set infLtsion 5€t$ at thr rilte nf cne box every thlee

wee ks until r.r,* ;ire aL:le tn :lrip trnre.

!f yau clo nr:{ h*ve an acloclr:ate supply of infusion seis, g:f ease see the attaclred docitment'

yoLt niay have cfrestirlnr nr concef ns thfit are nor I'ully acldressecl in this letter. I'eit this reason, we have set

up a websire ilt !.T*xJ1*,;bq::l{**}elg}-{si!ti_?_Lg witlr arrswers to fieqr-rcntly askecl qlr*stiolls. "Ilxj'ye&5llc,

lgatso rhe ri"Ur{ecflj,Jjdltt_ss{-cffele{Lf-WsyJqc&clr gy.lge "Lot 8" Qu-lrk-Sel-&f"a5jfl}Jgff-ffldlgJ:pJqge-fieyf-

$r*dg-4.{df-{5,

ln the evFnt ynil cannot aecers tlre altr-)ve website, or lrave;rrklitiottalqueslions, yctlt lnay also call

8CI0.345.Si 39 at Me clrrsrric Oiabet*s ?4-haurs a clay. Doctors wlra rvor:ld like to speak with a Mecltrcrric

Diaberes rnrclic.rl of1irer nl;ry contact Medrranic Diabetes by calling 818.576,421 '1.

As is alw;:ry,s tlre ci:tc, yar-r slroulcl rr: p$rt ;r 6rrorluct problenr by calling S00.345.8139 at any tilne' Aelverse

reactiuns or qr,r;ility 1:iuhl*nrs nray also br reportecl to the FDA's MedWatch Aclverse [vent 11*porting 1:t-o-

gr,rr1 *ither onlin*, by t*clLrlar ntall ar by f;rx.

" Onlirrs:

" Regular M;il

" Flx:

l'/vi-i#,f {k}*g-Mfi -rsdlYjjith&e!*il..h"i m"

llse tlre postage-paid FDA fornr 3500 avai[.rble at:

uv/r;yjqi.*t ryrlilr'l eq!1lllgj:{*r-tjgryPs,ixir, .

h4ail to MEdWatch, 5500 Fislrers Lfine, ftr:ckville, MD 2085:-97S7

1.800.Fn4.01 7S

We cleel:ly ;rp*lngi:e for thr: inc*nveni*rrce of tlrir process. We are t;rkirrg l lris ac{ir;tt to orlsLlre yor"tr lafcty

anclwe arr cloinq alltlrnt vt/f dlrll to Inaltf tlris el elsy a! possible fr:r yoit.

At youi setvi{e,

Mr:citr*nic Dial:etes


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b:ihy i; i\,i,rritr**le r**;liling "{**i $" Qtiltk-s*t' ii:fu;i** se irl

Wc r*c*rrtly icl*rrtifitl th,:t apprcxirnrlcly 2% of "Lc;t S"Quiclt-set irrfimiun s*ls rnecJ witlr Miiriivl*ri Par,r';ligrn"it"rsulin purrlls may not v;ork prnp*rly sr:nre of thesr. infu:ion sets do not ;illeiw tlre irrsulin lllt'r1llto yent. Thir c;rir pot*niially caustr lon rnuch or too littlc ir"tsr;lin to he drliv*recl,

Ar* th* v*nis *x*el in **ick-sat in{is:l*n scl;? 9"1*s l,{**tranic st*g:p*x* :hippia"r$ "t*t S" Q*iek-setinfus!*n s*ts?

fSP{nF$_{LUri$Xl#iS}

l'ri*l* cl* i reiilrrr :"iry ii,l$::{J "L*t $"Quiclq"set ilrfla.;;i; n s*?s?

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*r*** i i*tr:in *-:y r-lr"u,:rerl "L{tl*" QLri*k's*t i*ir.rsisi': s*t5 1* v*r;, fi*u',yiil I k**rv if lvi**]*r'*;"lir" r*;*irr*t-ither*?

rrf vi;Lrr rl'li1rn":rrrt vi,r l"lP5.

raJ**-ti'irt l'v* r'ir;iifi*i ful*di:'*nic 1i:;:l! r:il.:;l r'*p{r;*r:ia*{ii:fssg,,- .-,;, i:.ir. r..iill il '.,.1:3yr:irl* lr,,;llji'*{*i'r* iiirelii

['lca s*ri.:1rht enrrrrt l"iox

A. Yec. The vrntinq ilsr"r* h;s been {ix*d alrd we;rre no lorrEtr shipping "Lot S"Quick-lsi irrfurirrn rct:.

Q3. Ar* r*p{*c*m*nt Uili{l{-$et l*filsi*n s*ts caf* ir. *se?

A. Ye:! Witli the ventirrg issue lixecl, so yoLr c;irr feel perfectly rnrnforurl:le usil'tg yoilr te1:lacernerrt irrfusion s*is

Q4. tltfhat s*ixti*r'r ig lt'1*r:l?r*nir }:r*vidlnE t* !ts c**tor:l*ts?

A. Mecltronic is exclrtrnqinr; a ny unu:ed "Lq:t 8" Qrricli-se I infu:iorr ssts fr-:r custome ri lvhtt h;irr* rrlceive,e I "l nt 8"QLrirk-set infrr:ian :tl ls at no aclrliti*nel clrarqe.

***; t3"ris r*e *ll xffe et aii Quie k-s*i i*f*si** setsi

I'ln. titrrl;rP;rrdic;nrQr,rick-re{ir:fu:i*nlctstlraihavelotrrurrrberrs5tarlifgrvithtlrerrunrb*r'"{l"vyitlttlrr,--foll*wing refere rrce nrrril.:ers a,'e *f{ected hy this rr:rall: MMT-3t}6, Mlvll--.?q7, t\4M1--198 arril fi4Ml"-3*9. lk:t;rssurrcl,;rll lil,:dtrnrric infusi*rt s*is *t'lrertluin "l-ot 8"P;rracligrn Quiek set infr-r:ion sets are flri* [l Lr:r.:.

M*ylr*ait*ialvr!ap;t*clrnng*r'*yi;tfursinns*t! iji:sts?nrieci u:ing*"i*l*"*t,:l*k-s*iinfu:i*:r;et*n*l-1avs**lrltr ing*llrrr;lrerv,*"lir. !r,r.r&$ldpr*$ert*urrri"lf i:r;,ullns*!***;':'trv*st*it,

f'| E

l\'-t'{tllee*"ntr;il€*dr-{.|i!ll_l''.]'/]{Jij{iilj{(j|i|:1l]t{l-Qi:r-c,l:j*.1fsrrtiteinlu|jrr.|le;itlinrrwl|t.rt|!'ef|ft.r:;,;|<it.tg|ltisrr'cnrrrrngncn1iollr,,rill br :*n;r irr:Lrlin lyrjttr ifi{l d**piy ;iplrliigi:* fr:lr lhi; 5i1u,:tio'r.

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A'I}|el:rli*lli:anroitientton*tifyt'l:fVtjl..|i!"yr:uc|r:ri.t|rvllllly.'L,c.ti; rorifirnr tli;t yoLr've re(:.'iv{:;l tl"ris natificatir:ti bcr;ul* yltrr ra{i:ty ir {lttr to1: llfinrily'

e12. {har.;ln:ullipl*b*x*s*f rrrfvsi**$*tstcrstxrn. XlJ,ili ir*:*iven:;rr*pl*r*r**ntiarfrici{ln-E*tEa}} nt***s?

A, W*'r* sorry. In orcle r tn s(:rvs ali ouI cLr"$f{il-ners cluring tlris r*:;ll, v'le ilfc slrippirrg; repl;cen:tril i:ritt:i*rr lclrijt a raf * oi c,ne bo: e very llrrer: vt*elis. \l/e d**1:ly apclcrr;i:* fnr tlte int*nvcni'ln{n * oLlr fir:f lirint'ity is iotruke 5ttrr {v{:ryoll{* has tlte ittf r-lsir:tt :t'ts ihty rrtccl.

& rys?gis N&e-*iJ, g sxas$

Q13, 1{lhy d* Par**ligrn **ie k'r*t infus!an set; hav* venig?

$.,A||Parac|ir;ntirr|usicln:ctrli;tv*vcn|:itrt'ttt1'tr:ratcdin.t0th*tubirtc1C0rlnfCts|.T'|ri:r.etltsllLricl,tap;rssirt;rnrjor"rlr-rItlti:r'ssrjl'voit'{filrp."rrtrurnt. Vetrtine;istrtc*s:*ryt**c1r-raliri:ili*prrrstrle irr

tlre rcseivoir ($tul-rilf tfttrlf clf tlre insulin pur*gr with tl:n ltrrroultciinq nlrrtusl:ltcre.

el4, !{l}r.:t is el*gging tire v*nts in appr*Nimately 3s,'L *f o'Lst &" Quiek-sct ifl{ilricn sets?

A.Aittl:licatttc|crt111tr|||:rvr:r'iircrt;ippr;xintliely2tl.*o|...Lots,,Qrril:i<-r*tiiifr.rlir:nsttl,Tilt|t.lbiic;lr1e lir.rrinat*cl fr,r,ii-ihr: nrlrilrf;rctlrring prr,{*ri, ro ynls cin Irsl i'::rtlr*ci tltil ir no lorrgi:t: prr:L:iltlt" All

M*lltronic irrfusir-rn s*t:; olhoi tlulr "l-r;t 3'' Quick.l*l inltrri*rt t€:ts iirf iirr* 10 t-tse .

e1S. ln l.;hat {ir{$i.fi$tance c*xld tc* nrueh in:ulin be r*ailvtrpei xsi*g * "Lot E" &r,e!e l'."set inf*sian sli?

,\. Wlr*rt;rrtd*liv*r'erI.lix;tlttprie,;o|tliisiril-lrlt|t.,..,lrrn.ill;.ril1:l,rlt*i:l;l,'ittgtl|tv.ttiotr,lrrr|tjrrr,.rlrrr,clti'littcJt|p;.iI,t.10|||)i'.1itt.Asrcri|ici'|1lfV||.1*|iy;:rI*|iitrttlinllli|yii)|until ;lftr,'r il lrl", ncrltt'rr:ti. Tlti;;lrci tre,ltrnent. D0 il$t Fly in a;r airpl;iit(' ,)r urr!J.r!J,,ir, .j!r\' ,rrlivilV tit.it il':vul'ru: * rilttil'ii:;:nl inct.e;l:l*

in altiiucle if tt:inq "t,at it"{)uielq-5e1- ittf it:,ir-rtt sqt:'

ei6. iil lvirat circumlt*:rc*s v;*sicrl qrr* liitl; in:u1i* he ej*iiv*r*d usi*E * "Lcit *"*uicll-:*t !lrf*si*;r s*t?

A.Wltr:nanirr|'Lt:;ir:n5{-:tt|$f1|l()lvi]rilpreipr:-|y,fV{iiiitEt.t|rle;rltitt;rlreirttetr.r't;ttt|'"l|ririlapptt.l:hrlc;til5s]titt1rrintir-rgpI*.t-i1i1lJy|JUiirjt,l1":;:ir1rtr:sl(0|]1'}irtller:t"T1iein:Lllin1rilnr1:cr:r'l1cl|it|l*:insr.rlirrbcirr.|tell|ivcrsrcl,i./llic}icr:i.ticlc,tu:,*}rir;lrh!*rrclElr-lr,r:sr:l'}L.i:.l.|i.A:;iw;ly:;ih*rl1.r5',

*i Z. W1ieir fr4**ii-*nir irifr::i*;r l*ts e *lr } use,.,;ltfr my ii''linit{*rl Pal'er!igru'i' }*lu1i;'r pur"l1p?

A.irr|y,,Li:t|],,para{"1i!Jfi0uirl...-sets,'tr;y lr* use4 lri nr;r,ag*5rrl-:;r:|.infr-rsi,*rlsnt:,Sr:i*-.l...irrfttlinnlrtl;nrlPal1lf1.

in;u'1n'l0.]|lit../1y1rtcr{ittflt:i*rr:,i:t:,lr*Lllt]i:rtdirn;.:inr-,);tlil|iati

l"lr;tttli y*r:1t:t te;reiinrl ll':i:, rJr"irA Arkliiit"'tuil CliiA j:' rlrrrtil"ri'rl* oll (')!:r wi:l'::;iiit r.li )1't"7"'11

,-. I .;r: i..r',,i1,..| !. : -ia,.ii:i:.'r,,.,,:i1,1:: .',.i,rr ri,. f,


'':: r:.,,11":, - '::. - l' ,'

" i,* 1 i;" il ii l{li-: ['t'' I N'i f *5]r: ]J $f T n ;:{A t-L

I itl I ii li TA |i'i i" !" i 1. ;iA r i' { il}; I I } f {l irTi i-: i'; I

Ple ase revie w this infornration reqardinit tl'lsrapy eonsicletatilns dssuciatecl witlr []tr'"Lpl B" Ouick-le tinlusian set recall:

"Lot B"Qniclt-set'" inl'usicrr se is are the crrly infusion sets affected by rl'ris recall. lf yorr clo not have leplace-ment Quick-set infusion sots, yoLr aan uss a$ly sther frSeeltrootie inf$sio$l sets yon trrave heelx tnaimed onane{ have avaif*h!e, Tlre se inclueje Quick-sets other than "Lct 8," 5ilhouette" infusion sets, Sof-set Qn* ISof-set Ultirri;rte QR. infusion :ets, Sure-l"n' infusinn rets and Polylin" infirsion sets for Ltse with fuliniMed Par.l-

cligm* insulin pumps, Any therapy adjustnrents, irrcluding lhc use of a different infusion set, slrould be nradeirr consultation witlr yourr h*altlrcare prcvicle r.

{f elg'cc*$r}st&i"}e es ${ca,rr w}tes.e ycar do,$ot h*v* am nlternative !mfusior} set avsi3able, ome *ption !s toreve rt to t$'lc becla-eag: imjectiom Bian *sta$r!&s[ted wlth youn dcetor. FBeasa be avrara *f tl"le fo{lowimgris&{s ass*ciatec* witlt eos]tisrued use of "Levt S"Q$8ek-set is']fusl&n sets:

?ero fVir"rch Insulin Can be Delivered

Chariges in air pressure could cause too nruch insr-rlin to he cleliverad wlran r:sing art infusionsei lhat does not venl properly.A rapicl clrange in air pressure may cause a signifir.arri over cleliv*r1r of insulirr that nray not becletected until after il lras occurred.Examples wlrere an increase in altitude can clrange air pressure ilrclude vulren arr airl:lane is

taking off, and wlren tr*veling fron"r sea level lo a higher elevalicr,, st-lclr as drivirrq r"rp

l nrountain.

Atty sigtr frr syn",ptotn of ttypaglyce:wi* rw1uires immediate rtffrnfi*n and freatment.

?bo Little lns*lin C*n b* *elivsr*cl

[velr at stablc aiti[ueJe cr slal:le air pressure, insulin clelivery can be iriterrupteci r,vlren usirrg

arr inftrsiorr sCIt thfii cleies not v*nt properly.Thc prirling process build; up air pressure in ilte reservoir conrpattrrtent atrci makes tlrcinsr,rlirr puffp ;rpirs;r to be r,vorkirrg prol:e rly v.,rlr*n it is not.As erlways with insulin pllltp tlrerapy, nny interrilpti(rn irr insLrlin rlelivery wnulC hCI detecteelth l* r"rph freq uent hloorl gh:cose nra rritot'i n g"

When ttlaod glurase does r,*t {i:spt}t',rl f d} {? rolr(}{fi*tt dcsc, t{ou t1}Ltst *lw*ys $trspe tf thrst tft*infirsjsfl se fi it p-ptworking Stroperly. There{r:re, b* pr*Ss*r** t* giv* *n injwti*ti c:l*dcfrcng* your inft,rsi*n s*t.I


i: r-i; i i::1,r, i i' il;i"*i{ir; ;il1-

$-i*\ryT* L*cA?{:ThJr L*T N{"}MmAR 0N Y0{JR lN$:l.isNsi{ 5[ I pA{KAG$NC

Thr: lot nlinrl:er.il clclrly rrrarkrcl on b,:ih tlrc box l"rbel nnd crr eaclr intlividrral int'l"rsion 5€t paclinte.-fhe ;:ictrrre s be-

l,lw willhelp you iln;riify vorSere tei firrd thc lnt nuntber. Please n*te, tltat llris produet recallaffects only"Lot S"Quick'

stlt infusinn :cts v*ith the {olltr;*inrl refere trce nulttbers: MMT-196, fu1tvlT-397. MA4T-39S and MMT 399'

8ox Label

{ ;"''*l t i..r,Sr'+*gffir4: re$Ii't..

,,.*il)i''J*;.*\i--*"'I

I e 0:53;3-001 05?t]0i)

f ne{ivic{*al Package l-a}r*l

{--| "*lt &K*d*rr*;:lrxs

I Quie lq- Sct "" il*rixfl

It[i: t/Nl1-396

LOT rt' Sxxxxxx '/

{:a:*

5,{1i1-.::ii t.|.;.' 't:'" ''''-"1.r-ix'kj--t'

*::,1..

L)uii:lt- 5oi " fraraeJigrrl"

Rnr- l\4MT-3S6

jr*fi ffi::

W

L


$WMq&*resa$*M rr.tt M En

x,i1!:a;r got. B?jlttc dc Infuslor,' d'$posil;ld1 Fer{usilnrni,,rioi'ior' sai der rniusionc' rnlduslc'i' ;stusiGnss&t

infuu$iosait ' infusions$elt ' ifilusions$at

zesia'* iniurylny'c;rr iYxir:nq ' ini0zlli {icrlpiaYa

#B{m,f,k @

L.i-p. iqnt l lc : ,?1;,C'! l; ir'3sii 0t I

PARADiGtu4 QUICK-SDistlbutsd bY;l!,tedt.ef ie l,1l nllrl"{l.l${hr;dgs. CA !t3l*U$,180n-i;i{..:d3:i iei*"ld!..iJcdl6rr'570-1;i5E,U, lleprssFfitoltvsl-.5siJ:ifnic A.V.[rd Aekiicfis:iel 1*442: PJ t'irillsnttB l.:ethgtt*dsi311 45 56fi eq01lYarrillinmed c{6

Asrembled in Me{i{i* ?$q:

t.Jn0nediieit &lSUi{-ls0t RcEklic;fi€nnaik

Brhibit 4


IS 44 (Iter.09ll l] CryIL COVER SHBET

provided bv local nrlcs ()f court. l'his fbrm,puryrosetrfiniriaringthecivil docketshcot. (sftri/tJsfitiicno$s(]$,r!il.!?'IvctltoltTl.lNI,{}ltV.)

L (a) PLAINTIFFSAlice Pierce, trustee for the next of kin of Carol Givens,decedent

(b) Cnunty r:f Resitlence nf First l.isted Plaintiff Dg1glas C_gul$yu--lq -

/n"\T.'tJ,f IN {l,t n..4tNt]t4; {^s{;s)

DEFXNDANTSMedtronic, Inc., et al

County ofResidcnce ofFirst Listed Def€ndant

Nt]T[;

Altorne)'s (lf Known)

{IN tl.s. PI-AIMII,,F(:d\-ii.f {] .ty,i

IN LAND CONNIMNATION CASES, USE TIIE LOCATION OFT}IE TRACTOF LAND INVOLVED.

ard Orc llox lw DefendantjPTF DEF

IncorpomtednrPrincipalPhc* F 4 tr4ofBusiness In This Stale

lncorporaled rzd Priucipal Place n 5 fil 5

ofBtrsiness Io Anolher Stnte

ForeignNntion n 6 tr6

(c) Attonrel's {l:i ru liam t, 4t*!rcss, antl'l'elephone Nun be r)

Joel Srnith, Kosieradzki Smith Law Firrn, 3675 Plymoutlr Blvd.,Ste. 105, Plyrnouth, MN 55446

ll. BASIS OF JURISDICTION ('!ace un "x" in ot* Boxonty) III. CITIZENSHII' OF PRINCTPAL PARTIES ptace m "x" in one Box.fir Pt*h,tti)

n I U.S.Coven:nrenl

Plaintilf[3 Federal Qucstion

(1.5" llowrnment Not a I'uttS,)

ll;ar Diversty (.\srs (hiyJT'TF

CirizenoffhisStnte I I

Citizen ofAtrother Slate El :

Citrzenor.Srrbjn't ol a tr3 n I

Df,F

nln1n: U.S, Covernmert $ 4 Diversity

Defbtrdimt (lntlicilte (ili:enship d'Partiet tu lteil lll)

IV. NATURE OF SUIT (FId.'c on "x" in Qnc llox onlt)

PEITSONAL IN.N,IRY-il0 Airplane315 Aiqrlane Product

Liabilily330 Assrult, Libel &

Slander330 Fedenl Employers'

Liahilill'340 Mar,reid5 Marine Product

Liabilityi50 Motor Vehiqle355 Motor Vehicle

Product l"iatrilily160 Other Persoml

lnjury362 Personal lrriury -

Med. Mahrmctice

PERSONAL INJURT[t 365 Personal Injury -

Froducl Liatrilityfl 367 l{ealth Care/

PhmaeeuticalPersonal lnjuryProduct Liability

[ 3(r8 Asbesros Pcrsonallnjury ProdrclLiabilily

PEITSONAL PROI'ERTYn t?o orherFr$ril[ 371 Trath in Lrnding[ 380 OtherFersonal

Pr0pert] DanageE 385 Property Danrage

Itroduct Liability

6:5 Drug Rclated Seizue0fl''operry ?l USC 881

6q0 01ler

El 42? Appeal 28 USC 158

n41] wirlldrawal?8 USC 15?

Aot?20 l-abor;Mgr(. Relalions740 Raihvay Labor Act?51 Family and Medical

Lceve Act790 Olher Lahor Litigatian?91 [rnpl. Rei- lnc.

Seeurity Ast

[ 863 Black Lung (923)[f 863 DtwciDlww (405(s))n 864 sstD Tirte XVtm s65 RSr (4oj(s)i

F R | $t)^r" E R P[ Tl Tlt]\ S

.t'l! Olhcr Crvri Rtghlsd4l Vothrg4{? Employnen443 llousing/

Accoonnodalions

445 Amer. wiDisabilities -

Enrployn:ent;ld6 Arner. u'rDis*bilities.

Oth€ril48 Educatton

Silntencelt$bers Coq)ns:

n 530 C€neral

fl 535 Death Penalry

E 540 Mmdamui & Othor[ 550 Civil Rigfitsn 555 Prisan Cotrdilion[ 560 Cieil Detainec -

Conditions ofConfinenenl

or Dcfendant)8? I lRs-l'hird l,aily

26 USC ?609

I I l0 lmuanceE tlo Marinen 130 Millcr ActE 140 Negothble lnstrument

fl 150 Recorery of0verpaynrent& 0nforcemeut of Judgment

n l5l Medictre Aca

il lJ2 Rccorcry, ofDcfaultedStlde*t Laons

(Excl. Vstemos)

fl | J3 Recnvery ol'Overpayrneniof Veten*'s Be*:fits

n 160 Stoekhold€rs' Sililsn 190 Ofher C0nractE 195 Contract Producr Liabilityfl 196 Fnnchise

llU LandCl)sderrnsilon220 Foreclosure

n 130 Rert L€:lse & Ejectmenr

fl240 Torrs lo Lend

E:.15 Ton Product Liability

D !90 All Uther Real Property

n 3?5 I'alse Clainrs Acln 400 S$teReapponionm€iltE 4l0A:tirnrstE 410 Banks and Bankirg

fl 450 Cornmerce

[ 460DeporrarionD ,t?0 Raeketcer lnfluenced snd

Comrpt OrganizadonsE 480 Con$urnerCredii

E 490Cable/SatTV

lf 850 S{csrities/ComnrodirieslErchange

ff 890 Other Sraturory .Acilons

fl 891 A,gri€ultual Acrs[ 893 Envirolnrental N{atters

E 895 Freedom ofllfomrationAct

I 396Arbitration

E 899 Admirristrarive Procedure

Act/R€des or App€al 0fAgency Dceision

n 950 Conslitutignality ofStale Statutes

nV. ORIGINtr I Original

l,roceedrng

lllacc an "-Y" in One Box Onlv)

[ 2 Removed lrom tr 3Statc C0url

ns{Do aot clteJufistlidional stalutes untess diversibl:

n 6 MultidistrictLitignti0n

CIIECK YES only if demande.d in complainl:

JIIRY DDMAND: I Yes flNcr

the2S U.S,C. l3i2(aXl )

causeProduct Liabilit

f] CHECK IF THIS 'S

A CLASS ACTIONUNDER F-R.C.P.23

Remandcd iionrAppellate Courl

Reillslatsd orReopened

Transfered fromanother district

VI. CAUSE OF ACTION

VII. REQUESTED INCOMPLAINT;

DEMAtrior r,:ffi;'vIIr. RELATED CAS[(S) (steinsrrilttitlntt:

IF ANY JUDCE DOCKETNUMFER

7- A .-e.o/4,r.'oR ofFlcn usE oNLl'

RICIIPTf AI\,IOUNT

URE OF ATTORNTY OF RTCORD

SCANNEDJtl[ SJ,zotzAPPLYING II1P

tI.S, DISTRICT COURT DULUTH


scanned · county (minnesota) district court, filed august 30,2010, courl file no. 69du-cv-10-2167....

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