Case 2:12-cv-02678-KOB Document Filed FILED - AboutLawsuits

Document 1Case 2:12-cv-02678-KOBFiled 08/10/12made clear in the internal November 4, 2011 Fresenius30.DespiteFDA violations andthethesepatient safetypenalties,FreseniusGranuflo formulationssodium diacetate.areother FreseniusuniqueThrough this formulation,to folinulations made with acetic acid.8mEq/L.Thisthat fordialysateshigher than the bicarbonate levelin theFresenius tofor pricing discounts.treatment world in thatdialysisInstead of adding 4made frommEq/Ltheyusedialysateof acetate, it addsGranuflo, the total buffer level is 8 mEq/Ldelivered from the bicarbonate concentrate.This increased buffer level with Granuflo32.productsaggressively marketGranuflo doubles the amount of acetate incomparedmeansFederal Trade Commission andpossiblesales divisions continued toproduct8 of 22memo.issues andproduct and routinely bundled Granuflo with31.Pagetreating clinicians, physicians,or nursesproductswas neverand could lead tobicarbonate levels and the associated risks of heart attack, y arrest,and/orsudden cardiac death.33.oneof theDaVitalargest providers34.andownsDaVitaand operatesof in-centeremploys, trains,over1, 600 dialysis clinics in the United States and isdialysis treatment in the world.and/or contracts with the individual clinicians, nurses,physicians who work in each of its individual35.in-centerdialysis facilities.DaVita entered into contracts with Fresenius toGranuflo andNaturaLyte productsfacilities. Thisincluded, but wasLemmondtreated in 2010.was36.monitoring,DaVita isandfornottreatmentslimited to, the DaVitaresponsiblehiring principles)hemodialysisforthat itspurchase,prepare, andin each of itsoverSylacauga facilityusethe1, 600 in-clinicwhereDizzy Deanensuring (through adequate training, instruction,clinicians,8nurses, andphysiciansknow how to

Document 1Case 2:12-cv-02678-KOBallproperly use37.hemodialysis products in a manner thatlabeling, ed 08/10/12wellaslack of effectiveapatientstreatments to9 of 22is safe and effective for theand instruction from Fresenius, resulted inproviding ng clinicians, physicians,a mannerthatwasneither safenoreffective.38.Through infoiniationGranuflo andNaturaLyte three times39.Da VitaandOnSylacauga.40.aweekAugust 11, 2010, DizzyHewasprovided withDecedent, DizzyDean41.safe and effective forDean Lemmond receivedGranuflousesosofarasfarthatwas42.Deanupon thethat theashemodialysistreatment atmisrepresentationshemodialysis productsheand actionswasbeingin his treatments.that theupon themisrepresentationsclinicians, physicians, and/ortrained, instructed, credentialed, and prepared formannerprescribedduring this treatment.Decedent, Dizzy Dean Lemmond, reliedof Defendant DaVita inwasbeginning in June 2010.Lemmond, reliedof Defendants Fresenius and DaVita inprovided werebelief, Decedent, Dizzy Dean Lemmond,properuseof allnurses wereand actionsadequatelyhemodialysis productsinasafe and effective.Afterusing theFresenius GranufloLemmond, suffered fromaproductat DaVitasudden heart attack and diedonSylacauga, Decedent, DizzyAugust 11,2010.COUNT ISTRICT LIABILITY (AEMLD)43.Plaintiff adopts and44.At all times materialbusinessofNaturaLyteincorporates by referenceall the aboveallegations.hereto, the Defendants Fresenius and DaVita engaged in theselling, distributing, manufacturing, marketing, labeling,andGranuFlo, whichareunreasonably dangerous,9and/orpromotingand therefore defective.These

Document 1Case 2:12-cv-02678-KOBproductsdefective becauseweretheywereFiled 08/10/12moredangerousPage10 of 22than would bereasonablycontemplated by the ordinary user.45.At all times materialLemmond without substantialDefendants and46.wereused inNaturaLytechangemannerwhich had beenwerewerepossession of theunreasonably dangerouswhentheyby Dizzy Dean Lemmond because:and GranuFlo contained manufacturing defects in that theycan cause heart attack, cardiac arrest, sudden cardiac death, and otheradverse medical conditions.NaturaLyte and GranuFlo were not safe as designed, taking into accountthat the foreseeable risks involved in their use outweighed their utility andtherapeutic benefits.b.NaturaLyte and GranuFlo were marketed and promoted for use inhemodialysis treatment, when they carried an unreasonable andunnecessary risk of serious injury. The risk of hann far outweighed thec.d.benefit of use.NaturaLyte and GranuFlo were insufficiently and inadequately tested, yetDefendants promoted them as being tested and safe for use.e.NaturaLyteand GranuFlo were not safe due to inadequate and defectiveinstructions and warnings at the time it left the possession of theDefendants. The warnings were inadequate to fully apprise the user andhealth care providers of the full nature and extent of the risks anddangerous side effects associated with the use;NaturaLyte and GranuFlo were marketed and promoted for use as safef.treatmentAsforth above,acharacteristic ofdirect andDizzyenumerated below.hemodialysis treatment, when they were not.proximateresult of the actions and inactions of the DefendantsDean Lemmond has sustainedDizzydialysisinDean Lemmond'streatment that cannotproducts used being dangerously defective as48.left thecontemplated.defective andreceivedtheyNaturaLytea.setin the condition in whichand GranuFloentered the stream of commerce and47.hereto, NaturaLyte and GranuFlo reached Dizzy Deaninjuriesdamageswereand is entitled tonotcausedbe eliminated, but d above.Defendants' actions and inactions10assetforth abovewereintentional and

Case 2:12-cv-02678-KOBDocument 1Filed 08/10/1211 of 22Pagedeliberate, and resulted in the death of Dizzy Dean Lemmond.WHEREFORE, THE ABOVE PREMISES CONSIDERED, Plaintiff demands judgmentof the Defendants, Fresenius and DaVita, forsuch other and further relief as allowed indamagesinamountandeterminedby the juryandequity or law.COI TNT TTFAILURE TO WARN49.Plaintiff adopts and50.NaturaLyteincorporates by reference all theand GranuFlocanbeaboveunreasonably dangerous,allegations.evenwhen used for itsintended purpose.Defendants51.concentrateFresenius,of the world'soneis held to the level ofproducts,Defendants Fresenius hadknowledgeGranuFlo of which it failed towarnknowledgelargestofmanufacturers ofdialysisexpert in the field, and further,anof thedangerousDizzyDeanof thelargest dialysis providersrisks and side effects of NaturaLyte andLemmond, and/or protect him by informingDefendant DaVita.52.DefendantDaVita,onelevel of knowledge of an expert in thedangerous53.warnDizzyDeanDizzy Deanorsimilardialysis concentrates,ofLemmond and/or protect him.Dean Lemmond did not have theadequate warning was54.field, and further, Defendant DaVita had knowledge of therisks and side effects of NaturaLyte and GranuFlo,which it failed toin the world, is held to thesameknowledgeasDefendant andnocommunicated to Plaintiff.Defendants Fresenius hadacontinuing dutyto warn consumers,including DizzyLemmond, and providers, including Defendant DaVita, of its products, and the risks anddangersassociated with them, andnegligently and/or wantonly breached11itsduty asfollows:

Case 2:12-cv-02678-KOBb.Defendant DaVita hadLemmond, of the dialysisassociated with them, andb.c.d.set forthAs12 of 22acontinuing dutyconcentratetowarnconsumers,products being used,including Dizzyand the risks anddangersnegligently and/or wantonly breached its duty as follows:Failed to include adequate warnings with the hemodialysis products thatwould alert consumers to the dangerous risks and serious side effects ofNaturaLyte and GranuFlo.Failed to provide adequate post-marketing warnings and instructions afterthe Defendant knew or should have known of the significant risks of heartattack, cardiac arrest, sudden cardiac death, and other adverse medicalconditions from the use of NaturaLyte and GranuFlo.Failed to inform Plaintiff that NaturaLyte and GranuFlo had not beenadequately and thoroughly tested for safety as a hemodialysis treatment.Failed to inform Plaintiff that the DaVita clinicians, nurses, and/orphysicians were not adequately trained, instructed, credentialed, andprepared for proper use of all hemodialysis products in a manner that wassafe and effective.a.56.Pageheart attack, cardiac arrest, sudden cardiac death, and other adversemedical conditions from the use of NaturaLyte and GranuFlo.Failed to inform Plaintiff that NaturaLyte and GranuFlo had not beenadequately and thoroughly tested for safety as a hemodialysis treatment.c.DeanFiled 08/10/12Failed to include adequate warnings with the hemodialysis products thatwould alert consumers to the dangerous risks and serious side effects ofNaturaLyte and GranuFlo.Failed to provide adequate post-marketing warnings and instructions afterthe Defendants knew or should have known of the significant risks ofa.55.Document 1adirect andproximate resultof the actions and inactions of the Defendantsasabove, Dizzy Dean Lemmond sustained injuries and died.WHEREFORE, THE ABOVE PREMISES CONSIDERED, Plaintiff demands judgmentof the Defendants, Fresenius and DaVita, forsuch other and further relief as allowed indamagesinanamountdeterminedbythe jury andequity or law.C'ClITNT IIIBREACH OF WARRANY OF MERCHANTABILITY57.Plaintiff adopts andincorporates by reference all the12aboveallegations.

Document 1Case 2:12-cv-02678-KOBWhen Defendants Fresenius58.commerce,Dizzytheyknew that theDean LemmondNaturaLytewas aLemmond, itjustPlaintiff thatasDizzyofuseand GranuFlo into the stream ofconcentrates would be used forsafe andacceptable meansWhen Defendant DaVita mixed theDeantreatmentsplaced NaturaLytedialysis treatments justknew that theDean Lemmonddialysisreceived,and GranuFloNaturaLyteof receivingNaturaLytethatuseasofdialysis treatment.andimpliedlyacceptableit toprovidedwould be used forexpresslysafe andwas ato Plaintiffand GranuFlo andconcentratesand13 of 22Pagereceived, and expressly and impliedly warrantedand GranuFlo59.DizzydialysisFiled 08/10/12dialysiswarranted toofmeansreceivingdialysis treatment.60.knowledgeGranuFloorwasinjuriesof merchantableInpurposes for whichandqualityand fit forfact, NaturaLyte and GranuFlofit for their intendedordinaryrelied upon thereasonablyof the Defendants and upon the express and/or61.safeDean LemmondDizzybecauseusetheyweredamages. NaturaLyteunduly dangerousinexpectedusetheyuseandimplied warranty that NaturaLyteandto treat bone loss.not of merchantablewerewereexpertise, skill, judgmentqualityunreasonably dangerousandwerenotand unfit for theused, in that NaturaLyte and GranuFlo caused seriousand GranuFlo breached the warranties becauseand didcauseundueinjuriesand the death oftheywereDizzyDeanLemmond.62.Asadirect andDizzy Dean LemmondWHEREFORE,proximatesustainedresult of the breach of warrantiestheDefendant,injuries and died.THE ABOVE PREMISESof the Defendants, Fresenius andbyCONSIDERED, Plaintiff demands judgmentDaVita, for damagessuch other and further relief as allowed inequity or law.13inanamount determinedby the juryand

Document 1Case 2:12-cv-02678-KOBFiled 08/10/12Page14 of 22COUNT IVNEGLIGENCE AS TO DEFENDANTS FRESENIUS63.Plaintiff adopts and64.Defendants Freseniusincorporates by referenceall theallegations above.negligently manufactured, designed, tested,developed, labeled, packaged, distributed, promoted, marketed, advertised,researched andand soldNaturaLyteand GranuFlo in the state of Alabama.65.reasonableAt all times materialcarein thehereto, Defendants Fresenius haddesign, manufacture,research anddutyato exercisedevelopment, testing, processing,advertising, marketing, labeling, packaging, distribution, promotionand sale of NaturaLyte andGranuFlo.66.Defendants Fresenius breached theirmisrepresentations,a.and omissions towardFailingDizzy Deanto test anddutyc.werenegligentLemmond in theinspect NaturaLytein their actions,following ways:and GranuFlo in a reasonablenot it was safe and proper for thein order to ascertain whether orpurpose for which it was designed, manufactured, and sold;Failing to utilize and implement a reasonably safe design in themanufacture of NaturaLyte and and GranuFlo inareasonablysafecondition;d.e.f.67.hadto warn the Plaintiff of the danger of heart attack, cardiac arrest,sudden cardiac death, and other adverse medical conditions from the useof NaturaLyte and GranuFlo;Failing to label NaturaLyte and GranuFlo reasonably so as to warn thePlaintiff of the danger of heart attack, cardiac arrest, sudden cardiac death,and other adverse medical conditions from the use of NaturaLyte andGranuFlo; andManufacturing NaturaLyte and GranuFlo, which are unreasonablydangerous and defective hemodialysis products.FailingDefendants Fresenius knewunreasonably dangerousorshould have known thatNaturaLyte and GranuFlorisks and caused serious side effects of which Plaintiff would not be14

Document 1Case 2:12-cv-02678-KOBFiled 08/10/1215 of 22PageDefendants Fresenius nevertheless advertised, marketed, sold and distributedaware.and GranuFloknowing that there weresafer methods andFurthermore, Defendants Fresenius68.violated the Federal Food,DrugFood, Drug and Cosmetic Law,areproductsguiltyofand Cosmetic Act, 21 U.S.C.aswellNovartis' acts and omissions constituteasanotherfordialysis sand the Shermanet seq.,applicable laws, statutes,adulteration and/orNaturaLyteandasregulations.definedbytheFood, Drug and Cosmetic Act, 21 U.S.C. §331. This is negligence per se.FederalDefendant Fresenius failed to meet the standard of care set forth69.statutes andspecificregulations. Legislatorsenacted these statutes andclass of citizens. The Plaintiff is part of this class.negligent per sein theregulationsby the followingfor the benefit ofTherefore, Defendants Freseniusaarefollowing respects:Thelabeling lacked adequate information on the use of NaturaLyte andGranuFlo (21 C.F.R. Section 201.56[a] and [d]);The labeling failed to provide adequate warnings of severe and disablingmedical conditions including, without limitations, heart attack, cardiaca.b.arrest, sudden cardiac death, and other adverse medical conditions as soonthere was reasonable evidence of their association with NaturaLyte andGranuFlo (21 C.F.R. 201.57[e]);There was inadequate information for patients for the safe and effectiveuse of NaturaLyte and GranuFlo (21 C.F.R. 201.57[f][2]);There was inadequate information regarding special care to be exercisedby the doctor or clinician for safe and effective use of NaturaLyte andGranuFlo (21 C.F.R.201.57[f][2]); andThe labeling was misleading and promotional (21 C.F.R. 201.56[b]).asc.d.e.70.DefendantsAsassetadirect andforth above,WHEREFORE,proximateresult of theDizzy Dean LemmondTHE ABOVE PREMISESof the Defendants Fresenius forfurther relief as allowed indamagesinansustained15actions and inactions of theinjuriesand died.CONSIDERED, Plaintiff demands judgmentamountequity or law.negligentdeterminedby the juryand such other and

Case 2:12-cv-02678-KOBDocument 1Filed 08/10/12Page16 of 22COUNT VNEGLIGENCE AS TO DEFENDANT DAVITA71.Plaintiff adopts and72.Defendant DaVitaand soldNaturaLytein theall theallegations above.negligently mixed, distributed, promoted, marketed, advertised,and GranuFlo in the state of Alabama.At all times material73.careincorporates by referencehereto, Defendant DaVita hadamixing, distribution, promotion, marketing, advertising,dutyto exercise reasonableand sale of andNaturaLyteand GranuFlo.74.providers,inDefendant DaVitaand/or cliniciansdialysis treatments75.carein theproperonthe properproceduresand instruction of itsand omissions towarda.Failingb.Failingc.to test andadutydialysis employees, providersand GranuFlo inDefendant DaVita breached theirmisrepresentations,implementing NaturaLyte andhereto, Defendant DaVita hadprocedures for implementing NaturaLyte76.fordialysis employees,GranuFloin the state of Alabama.At all times materialtrainingtrained and instructed itsnegligentlydutyandexercise reasonableand/or cliniciansnegligentin thein theirtheactions,following ways:and GranuFlo in a reasonablemanner in order to ascertain whether or not it was safe and proper for thepurpose for which it was designed, manufactured, and sold;inspect NaturaLyteto warn the Plaintiff of the danger of heart attack, cardiac arrest,sudden cardiac death, and other adverse medical conditions from the useof NaturaLyte and GranuFlo; andFailing to insure DaVita clinicians, nurses, and/or physicians wereadequately trained, instructed, credentialed, and prepared for properall hemodialysis products in a manner that was safe and effective.77.ondialysis treatmentswereDizzy Dean LemmondtoDefendant DaVita knewunreasonably dangerousorshould have known thatNaturaLyteuseofand GranuFlo hadrisks and caused serious side effects of which Plaintiff would not be16

Case 2:12-cv-02678-KOBaware.Document 1Filed 08/10/12Defendant DaVita nevertheless sold and distributedthat theresafer methods andwereclinicians, physicians, and/orpreparedtoshould have known that itsornurses werenotand distributedNaturaLyteclinicians, physicians, and/orandGranuFloaware.employees, contractors,ornurses were notAsadirect andset forthproximateDefendant DaVita nevertheless soldthat DaVitaknowingemployees, contractors,adequately trained, instructed, credentialed,prepared to safely and effectively use NaturaLyte andasknowingadequately trained, instructed, credentialed,serious side effects of which Plaintiff would not beDefendantand GranuFloNaturaLyte and GranuFlo in hemodialysis treatment without dangerous risks anduse79.NaturaLyte17 of 22products for dialysis treatment.Defendant DaVita knew78.PageorGranuFlo.result of thenegligentactions and inactions of theabove, Dizzy Dean Lemm.ond sustained injuries and died.WHEREFORE, THE ABOVE PREMISES CONSIDERED, Plaintiff demands judgmentof the Defendants DaVita forfurther relief as allowed indamagesinanamountdeterminedbythejuryand such other andequity or law.Cm TNT VIWANTONNESS80.Plaintiff adopts and81.Defendants Freseniusresearched andsoldNaturaLyte82.reasonableincorporates by reference all the allegations above.andrecklessly manufactured, designed, tested,developed, labeled, packaged, distribu

Case 2:12-cv-02678-KOB Document 1 Filed 08/10/12 Page 6 of 22 20. Ultimately, after the correlation between Granuflo use, alkalosis, and cardiopulmonary arrest was made by Fresenius, the company .