The Law Offices of Sean M. Cleary, P.A. presents the 8th issue of our legal newsletter. In this issue we discuss about Pharmaceutical Litigation, Defective Drugs and Medical Devices.

1. SeanM.Cleary
OVER
15YEARS
OFEXPERIENCE
ProductLiabilityor
MedicalMalpractice?
DEFECTIVE
MEDICALDEVICES
MOSTPUBLICIZED
PHARMACEUTICALLITIGATIONCASES
PharmaceuticalLitigation:
DefectiveDrugsand
MedicalDevices
Defectivedrugsand
associatedrisks
PersonalInjuryLegalNewsletter
Issue806.30.2013
PERSONALINJURYATTORNEY
WWW.CLEARYPA.COM

2. PharmaceuticalLitigation:DefectiveDrugsandMedicalDevices
harmaceuticallitigations,alsoknownastoxictortcases,arepersonalinjurylawsuitsfiledduetoinjuriessustainedasresultofexposureto
chemicals.Mostpharmaceuticallitigationsaremasstortcasesbecausedrugsarebeingconsumedbythousandsofpatients.Thesecasesarefiled
againstdrugormedicaldevicemanufacturesanddistributorsandtheyarebasicalyproductliabilitycases,differentfrommedicalmalpracticeclaimsP
Call:305.416.9805
Defectivedrugsand
associatedrisks
Defectivemedicaldevices
hemajorityofprescriptiondrugsavailableonthe
U.S.marketatthe momentinvolve the risksof
differentsideeffects.EverytimeanewdrugisbeingT
Drugandmedicaldevicemanufactureshavethelegalresponsibilitytoprovideitsconsumerswithsafeandeffectiveproducts.Unfortunatelydespitethe
factthatpriortotheirreleaseonthemarketallprescriptiondrugsneedtobetestedandapprovedbytheFDA,therearestillahighnumberofmedications
thatcauseseveresideeffects,oftenworsethantheoriginalconditionbeingtreated.Someofthemostseveresideeffectsthatmightdevelopfrom a
prescriptiondruginclude:Birthdefects:antidepressantstakenduringpregnancyhavetheabilitytodevelopcongenitalmalformationsinthefetus,Heart
atackatackorstroke,Congestiveheartfailure:certaindiabetesmedicationsarelikelytoworsenexistentheartconditionsandincreasetheriskofheartfailure,
Bloodclots:certainbirthcontrolpillshavebeenlinkedtoanincreasedriskofdevelopingbloodclotsthatcouldleadtoheartproblemsandstroke.
edicaldevices,justlike prescription drugs can
sometimescarryhighinjuryrisks,exposingpatients
toadditionalhealthproblemsandcomplications.MWhilethesedevicesaredesignedtopreventillnessand
improveoverallhealth,designormanufacturingissuescan
leadtooppositeresults.Whenmedicalequipments,prosthetic
devices,surgicalimplants,surgicalordiagnosticequipments,
hearing and visualaids are defective orunreasonably
dangerous,theyarelikelytocauseinjuriestopatients.Some
ofthemedicaldevicesrecentlylinkedtoincreasedriskof
injuryinclude:injuryinclude:
• Hipreplacements
• Kneeimplants
• Transvaginalmeshimplants
• Bladderslings
• Heartdevices
Hip replacementsare common proceduresperformed on
elderlypatients,whenthenaturaljointisdamagedenoughto
allow apinless movement.Although a relatively simple
procedure,itdoesrequirelongterm,painfulrecoveryranging
from6monthsuptooneyear.Incasethedevicefailstobond
withthenaturaljoint,orfailsprematurely,asecondrevision
surgerywillbeneeded,exposingpatientstoadditionalpain
andanevenlongerrecovery.Defctivekneeimplantscarry
similarrisks.
TTransvaginalmeshesjustlikebladderslingsaremedical
devicesdesignedtorelievethesymptomsofpelvicorgan
prolapse and urinaryincontinency.Unfortunatelyin many
casesmesheswerefoundtobedefective,exposingwomento
seriousinternalinjuriesand considerable pain.Defective
bladderslingscanjustaseasilyresultinserioussideeffects
rangingfrom infectiontoseverepain,vaginaltissueerosion,
bladderdamageandvaginalscaring.bladderdamageandvaginalscaring.
Heartdevicesaremedicalequipmentsdesignedtomaintaina
normal functioning of the heart. Stents, pacemakers,
defibrillatorsorartificialheartvalvesaredevicesthatcanbe
lifesaving:iftheyfunctionproperlywhenneeded.Ifhowever
these devicesare poorlydesigned,forexample when a
pacemakerfails to delivera shock to the heartwhen
necessary ortransmits electricalimpulses atthe wrong
moment,moment,theconsequencescanbefatal:thearterialwalls
mightbedamages,bloodclotscandevelopandhearthattack
mightoccur.
releasedonthemarket,theFDAisnotifiedaboutassociated
risks and considers them acceptable compared to the
conditionthemedicationisdesignedtocure.Howeverthese
sideeffectsshouldn’tcausepatientssevereorpermanent
injuriesanddisabilities,oratleastconsumersshouldbe
properlyinformedabouttheriskstheyareexposedto.Inthe
caseofthefollowingmedications,manufacturesfailedto
respectrespectFDA safety standards and exposed patients to
unreasonablyhighrisks:
-Actos:diabetesmedicationlinkedtothefollowingsevereside
effects:heartfailure,bladdercancerandliverfailure
-Fosamax:prescribedtopreventosteoporosisandtotreat
differentbonedisorders,itisknowntocauseabnormalbone
growth,resultinginosteonecrosisofthejawandfemurfacture
-Paxil: an antidepressant prescribed to treat anxiety,
depresionandpanicdisordersthathasbeenlinkedtoan
riskofsuicideandthedevelopmentofbirthdefectsiftaken
duringpregnancy
-Reglan:-Reglan:apopulardrugprescribedtotreatgastrointestinal
issuesthathasrecentlybeenlinkedtotardivedyskinesia,a
severe condition characterized by involuntary facial
movement
-Topamax:epilepsydrugthattakenduringearlypregnancy
increasestheriskofcongenitalmalformationespeciallythatof
cleftlipandpalate
--Yaz/Yasmin:popularbirthcontrolpilsrecentlyassociated
withhighriskofbloodclots,pulmonaryembolism,strokeand
heartattack
Zoloft: an antidepressant drug prescribed to treat
premenstrualdysphoricdisorderhasbeenlinkedtoseveral
birthdefectswhentakenduringpregnancy
THELAW OFFICESOF
SEANM.CLEARY
PERSONAL INJURY ATTORNEY
W W W.CLEARY.COM

3. Productliabilityor
medicalmalpractice?
Protectingtherightsofinjuredvictimsandtheirfamilies
fthemedicaldevicemanufacturingcompanyfulfilled
itsdutyandprovidedclearinstructionstophysicians
andnursesabouthowtheproductshouldbeusedas
wellasclearinformationaboutpotentialrisks,theyare
I
P
unlikelytobefoundliableforresultingdamages.Inthis
case,injuredvictimsshouldfileamedicalmalpracticeclaim
topreserverealisticchancesforcompensation.
Since between product liability and medical
malpracticethereisoftenathinline,thoroughinvestigation
isrequired to make sure allaspectsofthe case are
correctlyunderstoodandapropriateclaim isfiled.Injured
patientsshould also considerthatproductliabilityand
medicalmalpracticecasesmighthavedifferentstatuteof
limitationbutthediscoveryruleusuallyapplies,meaning
thethetimelimitstartsrunningwhenthepatientbecomes
awareoftheinjury.Eitherwaycontactinganexperienced
pharmaceuticallitigationattorneyisrecommended.
ofJohnson&Johnson,failedtorecallitsproductuntil2010,
exposingthousandsofpatientsworldwidetoawellknown
risk.Theirnegligenceresultedinmorethan11,000personal
injurylawsuits,fromwhichtwohavegonetotrialin2013.
JohnsonJohnson&Johnsonarefacingthousandsofotherpersonal
injurylawsuitsforanotherdefectivemedicaldeviceaswell.
Thetransvaginalmeshisanimplantdesignedtosupportthe
weakened tissues ofthe lower abdomen.After being
implantedtothousandsofwomen,sufferingfrompelvicorgan
prolapseorurinaryincontinencyasaresultofchildbirthor
menopause,menopause,in 2011 the FDA released a safetywarning
regarding the complications associated with the implant.
Womenareatriskofsuffering:
•vaginalwallerosion
•perforationofinternalorgans
•vaginalinflammationandscaring
•painandinfection
InIn February 2013 one ofthe lawsuits filed againstthe
negligentmanufacturerbyaninjuredpatientresultedin$11.1
millionverdictforcompensatoryandpunitivedamages.New
casesareexpectedtoreachtrialphasethisyear.
Third-generationThird-generation contraceptives such as Yaz/Yasmin,
NuvaRing or Mirena were also often subjects of
pharmaceuticallitigationsin2012.Thesehighlypopulardrugs
havebeenlinkedtothedevelopmentofbloodclotsthatcan
resultinpulmonaryembolism amongotherconditions.By
2013atleast23deathshavebeenlinkedtothebirthcontrol
pillYaz.Bayer,themanufacturerofthedrugalreadypaidmore
than$1billiontosettlethousandsoflawsuitsintheU.S.than$1billiontosettlethousandsoflawsuitsintheU.S.
IN ACCORDANCE WITH THE U.S.FEDERAL LAW,
PRESCRIPTION DRUG AND MEDICAL DEVICE
MANUFACTURERS HAVE THE RESPONSIBILITY TO
PROVIDE THEIR CUSTOMERS WITH SAFE AND
RELIABLEPRODUCTS.OTHERWISETHEYCANFACE
PRODUCT LIABILITY CLAIMS FOR DAMAGES
SUSTAINED BY THEIR CLIENTS. HOWEVER
DETERMININGDETERMINING LIABILITYINAMEDICALCASEISFAR
FROMBEINGSIMPLE.
THELAW OFFICESOF
SEANM.CLEARY
PERSONAL INJURY ATTORNEY
W W W.CLEARY.COM
Call:305.416.9805
Mostpublicizedpharmaceuticallitigationcases
classactionlawsuittomorrow.Consideringtheamountof
timeandmoneyinvestedinthedevelopmentofanewdrug
andthecompetitionbetweenlargedrugmanufactures,
thereisnosurprisethesecompaniestendtominimizethe
sideeffectsofanew product,onceitreachesthetrial
phase.Unfortunately these side effects willsurface
eventuallywhenthedrugisreleasedonthemarket.
Althoughthispracticeishighlyunethical,from an
economicpointofview,thecompany’sbenefitswillbe
considerablylargercompared to the amounttheywill
eventuallypayaspartofasettlementwithinjuredclients.
Someoftherecentlargepharmaceuticallitigationsare
proofofthispolicy.
Oneofthelargestmedicaldevicefailuresinhistoryis
thecaseoftheDePuyASRhipreplacementsystem.The
prostheticdevicewasfirstreleasedonthemarketin2003
andby2005thecompanystartedreceivingearlyfailure
reports. Patients were complaining about the
metal-on-metalstructureofthedevice,whichwasreleasing
metaldebrisintosurroundingsofttissues,resultingin:
•• pain
• inflammation
• bonedamage
• hipfracture
• implantfailure
DespitetheseproblemsDePuyOrthopaedics,asubsidiary
harmaceutical litigations are not uncommon
nowdaysandpatientsarebecomingmoreawarethat
today’swonderdrugmightturnintothesubjectofa

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19WestFlaglerStreet#618,Miami,FL33130
SeanM.Cleary
thetitleofJurisDoctor.Mr.ClearyobtainedhisFloridaBar
admission the same yearand started practicing ata
well-knownandrespectedlaw firm,Stroock& Stroock&
Lavan,handlingcomplexcommerciallitigationcases.In2005
afterleavingoneofFlorida’smostrecognizedtrialfirms,Mr.
ClearyfoundedhissolopracticeTheLawOfficesofSeanM.
Cleary,P.A.Throughouttheyearsheobtainedsubstantial
verdictsverdictsandsettlementsforhisclients.Mr.Clearyhasalso
received multiple awardsand nominationsacclaiming his
skillsasaMiamipersonalinjurylawyer.AttorneySeanM.
Clearycontinuestofightfiercelyforthevictimsofpersonal
injury,medicalmalpractice,auto accidentsand defective
productsinstateofFloridainorderforthemtoreceivethejust
compensationtheydeserve.
ttorneySeanM.Clearybeganhislegalcareerwhen
heenrolledtotheUniversityOfMiamiSchoolOfLaw,
whichhecompletedin1998withhonorsreceivingA
AboutSeanM.Cleary
Florida.ThesolepurposeoftheLaw OfficesofSeanM.
Cleary,P.A.is to offer an exceptionallegalaid and
representation for those who suffered physical or
psychologicalinjuriesduetocareless,recklessandnegligent
actionsofotherparties.Ourlawfirm specializesinpersonal
injury,medicalmalpractice,wrongfuldeathandcommercial
litigationclaimsandhasneverfailedtorepresentourclients
andandtoachievethedesiredresult.Withourvastexperience
andknowledge,wearededicatedtoprotectingtherightsand
interestsofthosewhohaveenduredpainandsuffering.Ifyou
oryourlovedones havebeenrecentlyinjuredandyou’re
lookingforanattorneytorepresentyouoryoujustseeklegal
advice,don’thesitatetocontactus.
oundedin2005byattorneySeanM.Clearywithan
alreadyprovenandestablishedreputationasahighly
skilledandexperiencelawyerintheCourtHousesofF
AboutOurLawFirm
seekinglegaladvicefromMr.Clearycandiscusseverymatter
regarding the often painfulpersonalinjuries they have
suffered.TheLawOfficesofSeanM.Cleary,P.Ahasalways
offeredafreeconsultationandalwayswill,Mr.Clearywill
personallyreview yourcaseandwillprovideyoulegaland
professionaladvice.
urlaw office islocated convenientlyin downtown
Miamiandwhilebeingasolopracticelaw firm,the
office provides a calm environmentwhere thoseO
LocatedinMiami,FL