Do no Harm a Dateline Special

00:28:59
https://www.youtube.com/watch?v=o3jYYFINJnc

Sintesi

TLDRO vídeo apresenta uma investigação sobre uma catástrofe médica envolvendo a Solzer Orthopedics, onde implantes de quadril defeituosos levaram milhares de pacientes a cirurgias repetidas e dolorosas. A empresa, ao tentar economizar custos, alterou o processo de fabricação de seus implantes, removendo uma etapa crucial de limpeza, o que resultou em contaminação por óleo. Pacientes vivenciaram dor insuportável e precisaram de revisões cirúrgicas. A Solzer foi acusada de saber dos problemas meses antes do recall e de recolocar implantes defeituosos no mercado após uma limpeza inadequada. Alguns pacientes morreram devido às complicações dos procedimentos repetidos. Eventualmente, a empresa enfrentou ações judiciais, resultando em um acordo financeiro substancial com as vítimas. Solzer desde então mudou seu nome para Center Pulse e alega ter corrigido os problemas encontrados.

Punti di forza

  • ⚠️ Os implantes de quadril da Solzer eram defeituosos, causando dor e repetidas cirurgias.
  • 🔍 A Solzer teria escondido informações dos médicos, pacientes e do FDA.
  • 💰 A empresa enfrentou processos legais e pagou indenizações significativas às vítimas.
  • 📉 Tentativas de cortar custos levaram à remoção de etapas vitais no processo de fabricação.
  • 🔄 A Solzer reprocessou implantes defeituosos e os recolocou no mercado.
  • 😷 Alguns pacientes morreram devido às complicações dos implantes.
  • 📜 Documentos internos mostraram que a empresa sabia dos problemas meses antes do recall público.
  • 🔨 Um ex-empregado relatou manipulações nos registros dos processos de limpeza dos implantes.
  • 🤝 A Solzer alcançou um acordo financeiro com milhares de pacientes afetados.
  • 💼 A empresa mudou de nome para Center Pulse após o desastre.

Linea temporale

  • 00:00:00 - 00:05:00

    Susie, uma paciente, foi submetida a uma cirurgia de substituição de quadril três vezes devido a um implante defeituoso. A Dateline investiga um desastre médico onde uma empresa ocultou informações cruciais, impactando milhares de pessoas.

  • 00:05:00 - 00:10:00

    Os pacientes com implantes de quadril defeituosos sofreram dores intensas e, em alguns casos, perderam a vontade de viver. Apesar de várias queixas, a empresa demorou a agir, enquanto os implantes defeituosos continuavam a ser usados.

  • 00:10:00 - 00:15:00

    Antes do recall, a empresa sabia de várias falhas e se preocupava mais com as vendas do que com os pacientes. O óleo nos implantes, resultado de cortes na limpeza para economizar custos, impedia a fixação óssea.

  • 00:15:00 - 00:20:00

    Mesmo após o recall, as falhas continuaram. A empresa reprocessou e reinseriu implantes que ainda eram problemáticos. Documentos internos e testemunhas sugerem práticas enganosas, inclusive falsificação de registros.

  • 00:20:00 - 00:28:59

    Apesar dos recalls de quadris, a empresa não fez o mesmo com os joelhos contaminados. A falta de comunicação e respostas inadequadas da empresa e da FDA deixaram muitos pacientes sofrendo por anos.

Mostra di più

Mappa mentale

Video Domande e Risposte

  • Quantos implantes defeituosos foram retirados de pacientes?

    Quase 4.000 implantes defeituosos foram removidos de pacientes.

  • Por que os implantes não funcionaram?

    Os implantes continham resíduos de óleo deixados pela falta de um processo de limpeza adequado, impedindo que o osso se fixasse corretamente no implante.

  • Qual foi a resposta legal das pacientes afetadas?

    Três mulheres ganharam um processo com uma indenização de 15 milhões de dólares contra Solzer por fabricar um produto defeituoso.

  • O que a Solzer fez com os implantes não implantados durante o recall?

    Solzer recuperou, limpou novamente e revendeu os implantes não implantados, alegando que estavam limpos e seguros.

  • Qual foi a reação da empresa perante o FDA?

    Solzer não forneceu informações completas e precisas ao FDA sobre quando recebeu as primeiras queixas sobre falhas nos implantes.

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Scorrimento automatico:
  • 00:00:00
    [Music]
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    do no harm it's the first rule of
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    medicine
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    did they break it
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    she needed major surgery but never
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    imagined she'd have to go through the
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    same operation three times oh well i was
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    in pain oh my gosh
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    behind the nightmare crucial information
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    that a trusted corporation kept from
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    doctors and patients for months you
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    believe there was a cover-up here
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    now dateline reveals what triggered a
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    medical catastrophe affecting thousands
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    they let me tell you lee thompson with a
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    dateline investigation
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    [Music]
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    and now
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    do no harm
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    here is stone phillips
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    good evening it's major surgery that
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    many consider a minor miracle allowing
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    thousands to walk again but what if you
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    had to go through the operation not once
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    not twice but three times
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    it's what happened to patients you're
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    about to meet and dateline has learned
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    that it may not have had to happen at
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    all
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    after months of pouring over documents
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    we've uncovered a story of corporate
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    secrets a company's evasions
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    and the devastating impact it has had on
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    thousands of lives
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    here's chief consumer correspondent lee
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    thompson with a dateline investigation
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    okay ready grab it right there for me
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    come up here a little bit
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    give me some scissors
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    you're inside the operating room where a
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    surgeon is implanting an artificial hip
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    in one of his patients
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    it's long invasive traumatic surgery
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    you have to learn how to walk all over
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    again but it works hip replacement is
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    one of the most successful surgical
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    advances in the last 50 years
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    once patients recover they usually have
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    a new lease on life i've had young
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    patients and i've had old patients both
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    but imagine finding out the artificial
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    hip already implanted in your body was
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    defective it didn't work
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    imagine
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    finding out you had to go through the
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    operation all over again it was horrible
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    i couldn't imagine anybody having a
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    surgery like that
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    but it gets worse
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    imagine finding out the company that
  • 00:02:18
    made that hip implant knew it was
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    defective before you ever went to the
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    hospital
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    i don't think companies out there should
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    do what they did they shouldn't get away
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    with it it happened to this woman
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    and thousands more here in the u.s and
  • 00:02:32
    around the world
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    tonight the results of a six-month
  • 00:02:36
    investigation into a medical catastrophe
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    dateline reviewed hundreds of documents
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    documents that show one of the largest
  • 00:02:44
    manufacturers of medical devices was
  • 00:02:46
    keeping information from the government
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    from doctors
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    and from patients
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    are you going to help mama get up yeah
  • 00:02:55
    patients like susie [ __ ] a 37 year old
  • 00:02:58
    mother of two small children for her it
  • 00:03:01
    all started with a bad fall i slept
  • 00:03:05
    and that's when
  • 00:03:07
    i felt pain just go up my leg
  • 00:03:10
    surgery was supposed to restore susie's
  • 00:03:13
    active lifestyle
  • 00:03:15
    i used to play tennis my husband would
  • 00:03:18
    take me fishing
  • 00:03:20
    we would go hunting susie's doctor chose
  • 00:03:22
    an innovative top of the line implant
  • 00:03:25
    called the interop hip made by salzer
  • 00:03:27
    orthopedics of austin texas
  • 00:03:30
    you went into surgery
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    worried apprehensive i was really
  • 00:03:34
    excited because
  • 00:03:36
    i was in so much pain
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    what we see is a stem her surgeon
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    michael britt had used the soldier
  • 00:03:44
    implant successfully dozens of times i
  • 00:03:47
    felt it was very trustworthy product
  • 00:03:49
    here's how the hip works a metal rod
  • 00:03:52
    called a stem is inserted into the thigh
  • 00:03:55
    bone then a metal ball which replaces
  • 00:03:57
    the old joint goes onto the stem and a
  • 00:04:00
    titanium shell with a porous coating
  • 00:04:03
    replaces the old hip socket the bone is
  • 00:04:06
    supposed to literally
  • 00:04:08
    grow into this rough surface i can
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    probably grow onto it as a more accurate
  • 00:04:12
    description dr britt told susie her new
  • 00:04:15
    hip was expected to last up to 30 years
  • 00:04:18
    but it only took a few weeks to figure
  • 00:04:20
    out something wasn't right susie wasn't
  • 00:04:22
    getting any better oh i was in pain
  • 00:04:26
    oh my gosh i had a burning pain in my
  • 00:04:30
    hip
  • 00:04:31
    that you could not imagine
  • 00:04:36
    and
  • 00:04:37
    i was just taking pills after pills
  • 00:04:39
    realizing she was getting hooked on pain
  • 00:04:41
    pills and thinking maybe she wasn't
  • 00:04:43
    working hard enough at her rehab
  • 00:04:46
    susie a former athlete really kicked in
  • 00:04:48
    on her physical therapy but the pain
  • 00:04:51
    only got worse
  • 00:04:53
    that's the type of pain they could make
  • 00:04:55
    i guess you could say somebody go crazy
  • 00:04:57
    did you feel at times you were going
  • 00:04:59
    crazy
  • 00:05:00
    yes
  • 00:05:02
    susie wasn't alone it turns out
  • 00:05:05
    thousands of patients all over the
  • 00:05:06
    country were going through the same
  • 00:05:09
    torment it's like someone stabbing you
  • 00:05:11
    in the leg arthritis patients like naomi
  • 00:05:16
    lillian helen and joel were all
  • 00:05:18
    wondering why am i having all this pain
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    why why can't i function you knew pretty
  • 00:05:23
    quickly i mean this hip wasn't working
  • 00:05:26
    yes i did i couldn't walk without pain
  • 00:05:29
    after months of torturous therapy naomi
  • 00:05:33
    like the others just couldn't take it
  • 00:05:35
    anymore i became so despondent
  • 00:05:38
    i told my daughter i don't care whether
  • 00:05:40
    i live or not if i have to go through
  • 00:05:42
    this
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    joel once an agile rancher thought a new
  • 00:05:46
    hip would put him back in the saddle
  • 00:05:48
    again but after surgery he felt it was
  • 00:05:51
    hopeless
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    if they have to take my leg off
  • 00:05:55
    you know then let's take it off let's
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    get it done and get it over with i want
  • 00:06:00
    out of this pain his doctor told him
  • 00:06:02
    while it almost never happened his body
  • 00:06:04
    must have rejected the implant he'd have
  • 00:06:07
    to go through the same surgery all over
  • 00:06:10
    again he took an x-ray and said joel
  • 00:06:13
    it's loose
  • 00:06:16
    i said loose
  • 00:06:17
    and he said yes he said we're going to
  • 00:06:19
    have to do a revision so joel went in
  • 00:06:22
    for a second surgery and i'm saying you
  • 00:06:25
    know was there an error in surgery did
  • 00:06:27
    the doctor make a mistake
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    living on pain pills resigned to a life
  • 00:06:31
    of misery joel and the others were soon
  • 00:06:34
    stunned by a startling announcement i'm
  • 00:06:37
    gary sabins president of souls
  • 00:06:39
    orthopedics seemingly out of the blue
  • 00:06:42
    solzer the maker of all those hip
  • 00:06:44
    implants said it was not the doctor's or
  • 00:06:46
    patient's fault the implants were
  • 00:06:49
    defective on december 5th 2000
  • 00:06:52
    our company began a voluntary recall of
  • 00:06:55
    specific lots of our interop acetabular
  • 00:06:57
    shells
  • 00:06:58
    used in hip implants
  • 00:07:00
    40 000 artificial hips were recalled the
  • 00:07:04
    problem was 17
  • 00:07:07
    500 of them were already inside patients
  • 00:07:11
    when she got the news from her doctor
  • 00:07:13
    susie was horrified and then i panicked
  • 00:07:17
    on the phone and he said no no no wait a
  • 00:07:19
    minute
  • 00:07:20
    don't worry susie
  • 00:07:22
    some patients were simply in denial i
  • 00:07:24
    said no way jose i don't have one i'm
  • 00:07:27
    just not going to have it don't let me
  • 00:07:29
    think that you're going to tell me this
  • 00:07:31
    it has to be done again he said yes it
  • 00:07:33
    does
  • 00:07:34
    lillian was still in the hospital
  • 00:07:35
    recovering from her first hip surgery
  • 00:07:38
    when the doctor gave her the bad news
  • 00:07:40
    dr britt had tears in his eyes
  • 00:07:43
    and i felt so bad for him
  • 00:07:46
    that i couldn't think about myself
  • 00:07:49
    that's because dr britt was shocked to
  • 00:07:52
    find out why the soldier hip wasn't
  • 00:07:54
    working and many of his 64 patients who
  • 00:07:57
    received them the interface between
  • 00:08:00
    the bone and the prosthesis
  • 00:08:03
    never matured and the bone never grew
  • 00:08:06
    into the prosthesis so this surface
  • 00:08:09
    was rubbing on somebody's raw bone yes
  • 00:08:13
    but the patient's tears would soon turn
  • 00:08:15
    to anger as some of them began to hear
  • 00:08:17
    whispers that soldier had known about
  • 00:08:19
    problems with its hip implants
  • 00:08:22
    long before it told anybody what they
  • 00:08:25
    heard was right
  • 00:08:26
    while soldier was telling patients in
  • 00:08:28
    this video release it took action as
  • 00:08:31
    soon as it saw a problem we began to act
  • 00:08:33
    immediately as soon as we received the
  • 00:08:35
    first complaint dateline has put
  • 00:08:37
    together a timeline that shows the
  • 00:08:40
    company knew far more than it led on
  • 00:08:42
    publicly months before it announced the
  • 00:08:45
    recall
  • 00:08:46
    in the summer of 2000 at least seven
  • 00:08:49
    months before the recall solzer started
  • 00:08:51
    getting reports from doctors that its
  • 00:08:53
    interop hips were failing
  • 00:08:56
    one doctor an actual designer of the hip
  • 00:08:58
    saying something strange was going on
  • 00:09:01
    by late september seven doctors were
  • 00:09:04
    reporting 21 failed implants but the
  • 00:09:07
    company didn't say anything
  • 00:09:09
    so surgeons were replacing defective
  • 00:09:12
    soldier implants in people like joel
  • 00:09:14
    with incredibly enough another saucer
  • 00:09:17
    hip made in exactly the same way how do
  • 00:09:20
    you explain that how can you justify
  • 00:09:23
    that more than a month and a half before
  • 00:09:25
    the recall that same designer was
  • 00:09:28
    telling the company
  • 00:09:29
    i have a bit of an epidemic here
  • 00:09:32
    a month before the recall 14 doctors
  • 00:09:36
    were reporting hip failures but still no
  • 00:09:39
    warning bulletins to doctors instead the
  • 00:09:41
    company was writing memos to sales
  • 00:09:43
    agents giving them kudos on hitting an
  • 00:09:46
    all-time sales record
  • 00:09:48
    1500 implants sold in the past month
  • 00:09:52
    two weeks before the recall
  • 00:09:54
    29 doctors were reporting problems and
  • 00:09:56
    internal documents revealed the company
  • 00:09:58
    suspected a cleaning problem with the
  • 00:10:01
    implants
  • 00:10:02
    but doctors were still putting them
  • 00:10:04
    inside people's bodies
  • 00:10:06
    they knew what was wrong inside they
  • 00:10:09
    just didn't reveal it in fact just days
  • 00:10:11
    before the recall dateline has
  • 00:10:14
    discovered a soldier supervisor was
  • 00:10:16
    still contending i don't feel that the
  • 00:10:18
    hip investigation needs to be discussed
  • 00:10:20
    with the fda the food and drug
  • 00:10:23
    administration the agency responsible
  • 00:10:25
    for regulating medical devices by the
  • 00:10:28
    time of the december recall seven months
  • 00:10:30
    after the first complaint soldier knew
  • 00:10:33
    of 110 hip failures including 61 cases
  • 00:10:36
    where the implant had to be removed this
  • 00:10:39
    woman is outraged by that they were
  • 00:10:42
    concerned about the competition about
  • 00:10:44
    their impression with the physicians but
  • 00:10:46
    not about the patients
  • 00:10:48
    dr suzanne parisian is the former chief
  • 00:10:50
    medical officer for the fda's medical
  • 00:10:52
    device section who now does consulting
  • 00:10:55
    work for medical device manufacturing
  • 00:10:57
    companies but sometimes testifies
  • 00:10:59
    against them in court if you're not
  • 00:11:01
    selling a safe and effective product
  • 00:11:02
    then you're not in compliance with the
  • 00:11:04
    law and what is the law
  • 00:11:07
    the law says if a company gets a serious
  • 00:11:10
    complaint about a medical device it must
  • 00:11:12
    investigate and report the problem to
  • 00:11:15
    the fda
  • 00:11:16
    if a company knows a product puts
  • 00:11:18
    patients at risk the law says it must
  • 00:11:21
    stop selling the device
  • 00:11:23
    even if it doesn't know why it's failing
  • 00:11:26
    but former fda medical officer parisian
  • 00:11:29
    says based on her reading of the
  • 00:11:31
    documents in this case that is not what
  • 00:11:34
    solzer did they were doing everything
  • 00:11:36
    they could to try to
  • 00:11:38
    hide that there was an issue going on
  • 00:11:40
    with their device they were trying to
  • 00:11:41
    sell more hips irresponsible i believe
  • 00:11:44
    it was she's angry but not as angry as
  • 00:11:47
    the patients if this would have been
  • 00:11:49
    corrected my life would be a whole
  • 00:11:51
    different story today and if they were
  • 00:11:54
    aware that there may be a problem with
  • 00:11:56
    this
  • 00:11:58
    then for goodness sakes let's don't put
  • 00:12:00
    it into somebody's body so how could a
  • 00:12:03
    company allow this to happen what went
  • 00:12:05
    wrong
  • 00:12:07
    for years soldier hips were made by a
  • 00:12:09
    subcontractor who had a good track
  • 00:12:11
    record that may explain why so many
  • 00:12:13
    doctors were later caught off guard
  • 00:12:16
    after all why would a part that for
  • 00:12:18
    years was reliable suddenly become
  • 00:12:21
    defective but what the doctors didn't
  • 00:12:24
    know was that in order to cut costs
  • 00:12:26
    solzer decided to change the
  • 00:12:28
    manufacturing process
  • 00:12:30
    first it decided to make all the hips
  • 00:12:32
    in-house no more subcontractor
  • 00:12:35
    then to save money solzer cut out a key
  • 00:12:38
    step on the assembly line a key step in
  • 00:12:41
    the cleaning process that would have
  • 00:12:43
    removed lubricating oil used in the
  • 00:12:45
    machining of parts from the surface of
  • 00:12:48
    the implants
  • 00:12:49
    and how much did that save the company
  • 00:12:52
    ironically dropping that procedure only
  • 00:12:54
    saved one dollar fifteen cents per
  • 00:12:57
    implant on a device for which patients
  • 00:13:00
    are billed more than nine thousand
  • 00:13:02
    dollars they were never satisfied with
  • 00:13:04
    what their profits were michael frolick
  • 00:13:07
    worked as an inspector for salzer at the
  • 00:13:09
    time it was an ineffective process they
  • 00:13:12
    used the wrong cleaning process from the
  • 00:13:14
    beginning dateline has discovered salzer
  • 00:13:17
    never did any testing for oil
  • 00:13:19
    contamination after it dropped the
  • 00:13:21
    cleaning step a clear violation of fda
  • 00:13:24
    rules and frolic says a company engineer
  • 00:13:27
    told him oil contamination on the
  • 00:13:30
    implants might have also come from
  • 00:13:32
    another source they were handled
  • 00:13:34
    improperly
  • 00:13:36
    by machinists who were handling these
  • 00:13:38
    parts with contaminated
  • 00:13:41
    dirty oily gloves this internal salzer
  • 00:13:45
    report confirms workers dropped implants
  • 00:13:48
    on the floor got oil on their hands and
  • 00:13:51
    did not use gloves while handling parts
  • 00:13:54
    in the manufacturing process it's left
  • 00:13:56
    on the back side of this cup wherever it
  • 00:13:59
    came from once inside the patients that
  • 00:14:02
    oil residue kept the pelvic bone from
  • 00:14:05
    properly bonding to the hip implant
  • 00:14:07
    leaving thousands of people limping and
  • 00:14:10
    in excruciating pain it was like a
  • 00:14:12
    nightmare
  • 00:14:13
    as a result of this medical disaster
  • 00:14:16
    people like susie kuhn would have to
  • 00:14:18
    have their failed hip implants removed
  • 00:14:21
    and go through more nightmarish surgery
  • 00:14:24
    and what brand of new hip was likely to
  • 00:14:27
    be implanted believe it or not
  • 00:14:29
    another soldier
  • 00:14:31
    that's because soldier brought back all
  • 00:14:33
    those contaminated hips not yet
  • 00:14:36
    implanted in patients re-cleaned them
  • 00:14:38
    and promised doctors a safe product
  • 00:14:41
    no more oil
  • 00:14:43
    no more problems
  • 00:14:45
    guess again what did you eventually find
  • 00:14:48
    out about that second hip implant
  • 00:14:52
    i could no longer walk
  • 00:14:56
    the agony increases along with the
  • 00:14:59
    problems he says i got to take those
  • 00:15:01
    knees out and put new ones in more
  • 00:15:03
    implants are failing while the company
  • 00:15:05
    maintains its silence when do no harm
  • 00:15:08
    continues
  • 00:15:12
    we now continue with do no harm
  • 00:15:18
    returning to our story a company has
  • 00:15:20
    recalled the hip implants that have left
  • 00:15:22
    thousands of people in pain and promised
  • 00:15:24
    to fix the problems
  • 00:15:26
    but what the company did next would
  • 00:15:28
    prolong the medical nightmare for many
  • 00:15:30
    here again
  • 00:15:32
    lee thompson
  • 00:15:34
    it was a medical disaster of enormous
  • 00:15:37
    proportion who would ever think that a
  • 00:15:40
    medical device implanted in thousands of
  • 00:15:42
    people would be contaminated and have to
  • 00:15:45
    come out
  • 00:15:46
    for anguished patients like susie kuhn
  • 00:15:49
    it meant more
  • 00:15:50
    surgery more unbearable pain and another
  • 00:15:53
    heart-wrenching talk with her doctor i
  • 00:15:56
    told him i i just couldn't
  • 00:15:58
    i'd i'd rather be dead and bury than
  • 00:16:01
    have to go through a surgery like the
  • 00:16:03
    first surgery you know
  • 00:16:08
    and then he said
  • 00:16:10
    he got real upset
  • 00:16:13
    and i asked him if i was gonna die
  • 00:16:16
    i was i'm scared
  • 00:16:19
    did you really think you would die
  • 00:16:22
    i
  • 00:16:24
    i think these days you just never know
  • 00:16:28
    when
  • 00:16:33
    a complication or something can happen
  • 00:16:37
    susie's fears were not unfounded
  • 00:16:39
    dateline has uncovered several cases
  • 00:16:41
    where patients did die of complications
  • 00:16:44
    as a result of having defective soldier
  • 00:16:46
    implants removed
  • 00:16:48
    the company meanwhile was trying to cut
  • 00:16:50
    its losses rather than destroying the
  • 00:16:52
    recalled hips solzer had those not yet
  • 00:16:55
    implanted in patients returned to the
  • 00:16:57
    plant
  • 00:16:58
    it announced it could re-clean them with
  • 00:17:01
    a new improved process that would get
  • 00:17:04
    rid of the oil
  • 00:17:05
    michael frohlich worked as a parts
  • 00:17:07
    inspector at the solser plant if we
  • 00:17:09
    could just get the all of the parts from
  • 00:17:12
    the field that may have been
  • 00:17:14
    contaminated back into the plant and
  • 00:17:16
    enough volunteers to come in during
  • 00:17:18
    their christmas vacation to re-clean the
  • 00:17:20
    parts and repackage them we would get
  • 00:17:22
    them all out and no one would know the
  • 00:17:24
    difference and that's exactly what souls
  • 00:17:26
    are dead assuring doctors the recalled
  • 00:17:29
    hips were now clean and safe
  • 00:17:32
    dr michael britt susie coon's doctor
  • 00:17:34
    believed if the hip was now clean it was
  • 00:17:37
    still the best choice for his patient
  • 00:17:39
    doctor why would you put in a hip
  • 00:17:42
    that had been recalled and reprocessed
  • 00:17:45
    at that time you'd have faith in what
  • 00:17:47
    you were being told i just looked at him
  • 00:17:49
    and i said i i trust you and and you're
  • 00:17:52
    my doctor so do what you think we need
  • 00:17:54
    to do
  • 00:17:55
    so dr britt and surgeons all around the
  • 00:17:58
    world went back to the operating room
  • 00:18:01
    but soon after her second soldier
  • 00:18:03
    implant susie knew something was wrong
  • 00:18:07
    her hip began to fail just as the first
  • 00:18:10
    one had and i couldn't sleep at night
  • 00:18:13
    it just seemed like i was just miserable
  • 00:18:15
    all day and all night unbelievable as it
  • 00:18:18
    may sound susie's supposedly oil-free
  • 00:18:21
    hip implant failed in exactly the same
  • 00:18:24
    way as the first hip
  • 00:18:26
    michael frolick isn't surprised he says
  • 00:18:29
    the company at least initially never
  • 00:18:31
    changed the cleaning process on the
  • 00:18:33
    recalled hips a process it knew by then
  • 00:18:37
    was faulty
  • 00:18:38
    when they did bring in all the parts and
  • 00:18:40
    tried to reclaim them they immediately
  • 00:18:42
    encountered problems the plan that they
  • 00:18:44
    set out to reclaim the parts failed in
  • 00:18:47
    fact there have been at least 138 cases
  • 00:18:51
    in which the supposedly fixed hips had
  • 00:18:53
    to be removed from patients when i found
  • 00:18:56
    out this part was bad
  • 00:18:58
    i just
  • 00:18:59
    couldn't understand how
  • 00:19:02
    you know
  • 00:19:02
    they promised my doctor a good part
  • 00:19:06
    and they let him down and they let me
  • 00:19:08
    down
  • 00:19:09
    solzer says it never skipped any of the
  • 00:19:11
    cleaning steps on the reprocessed hips
  • 00:19:14
    and disputes there ever was any problem
  • 00:19:16
    with them the company says the initial
  • 00:19:19
    results of a study it sponsored show the
  • 00:19:21
    failure rate with those reprocessed hips
  • 00:19:24
    was no greater than would be expected
  • 00:19:26
    with any hip implant
  • 00:19:28
    these people hadn't learned any lessons
  • 00:19:31
    but former salzer employee michael
  • 00:19:33
    frolick differs with salzer's account he
  • 00:19:36
    says for instance he was told by a
  • 00:19:38
    supervisor to lie on company records we
  • 00:19:41
    falsified records we falsified test
  • 00:19:45
    results falsifying records is illegal it
  • 00:19:48
    probably is at the time i wasn't
  • 00:19:49
    informed of that i understand it is now
  • 00:19:52
    why did you do it
  • 00:19:53
    i did it because the environment there
  • 00:19:55
    in the plant
  • 00:19:57
    was so pervasive
  • 00:20:00
    with this kind of behavior
  • 00:20:03
    that
  • 00:20:04
    there just wasn't any dissent
  • 00:20:07
    frolick says he finally went over the
  • 00:20:09
    heads of his supervisors to top company
  • 00:20:11
    management and told them what was going
  • 00:20:14
    on and he was fired
  • 00:20:16
    salzer says its investigation found
  • 00:20:18
    frolic violated company procedures and
  • 00:20:20
    falsified records on his own not at the
  • 00:20:23
    direction of supervisors
  • 00:20:26
    but who falsified what doesn't much
  • 00:20:28
    matter to susie kuhn as unimaginable as
  • 00:20:31
    it seems she had to go in for a third
  • 00:20:34
    surgery to remove that second bad hip
  • 00:20:37
    implant
  • 00:20:38
    all in less than a year
  • 00:20:40
    as they wheeled you in
  • 00:20:42
    a third time
  • 00:20:45
    what was going through your mind
  • 00:20:47
    i was real scared
  • 00:20:49
    and i need to make it through this
  • 00:20:52
    today just looking through a mountain of
  • 00:20:54
    medical records and bills is enough to
  • 00:20:56
    relive the agony all over again
  • 00:21:01
    but wait there's even more
  • 00:21:03
    solzer also made artificial knees at
  • 00:21:06
    that austin plant but at the time of the
  • 00:21:09
    hip recall the company said the oil
  • 00:21:12
    problem did not extend to any of its
  • 00:21:14
    other products and told the government
  • 00:21:16
    it was confident in the safety of its
  • 00:21:19
    knees right here on its website it said
  • 00:21:22
    no other soldier orthopedics products
  • 00:21:24
    are suspect
  • 00:21:26
    our other products do not go through the
  • 00:21:28
    same manufacturing process
  • 00:21:31
    but as dateline has discovered the
  • 00:21:33
    company knew that wasn't true when i
  • 00:21:36
    came out of the navy
  • 00:21:38
    i went to work on the river roger porter
  • 00:21:40
    was a commercial fisherman for 50 years
  • 00:21:43
    it took a physical toll on his body just
  • 00:21:46
    two months after salzer recalled its
  • 00:21:48
    hips roger entered the hospital for a
  • 00:21:51
    double knee implant he remembers talking
  • 00:21:54
    to his doctor i go oh you're scared i
  • 00:21:57
    said yeah yeah i'm scared
  • 00:21:59
    it was a gruesome ordeal they cut it
  • 00:22:02
    open
  • 00:22:03
    and then they cut off this kneecap
  • 00:22:06
    and lay it down
  • 00:22:08
    then they have a machine that fits onto
  • 00:22:10
    the lower part and then they trim the
  • 00:22:12
    bone off square what roger didn't know
  • 00:22:15
    was that months before his implant a
  • 00:22:18
    soldier vice president was telling his
  • 00:22:20
    staff that word is beginning to spread
  • 00:22:23
    of loose knee implants
  • 00:22:25
    and emails from doctors were alerting
  • 00:22:27
    soldier that failed knee implants
  • 00:22:30
    appeared to have the same symptoms as
  • 00:22:32
    the recalled hips
  • 00:22:34
    when soldier recognized that it had a
  • 00:22:36
    problem with hip implants
  • 00:22:38
    did it also by definition have a problem
  • 00:22:40
    with knee implants the knee implants
  • 00:22:42
    which were
  • 00:22:44
    produced in the same way as the hip
  • 00:22:46
    implants they should have definitely
  • 00:22:49
    known that there would be a
  • 00:22:50
    contamination risk with those lots of
  • 00:22:53
    knees
  • 00:22:54
    roger's knees weren't healing and then
  • 00:22:57
    came the call from his doctor he says
  • 00:22:59
    you've got oil in him you got to come
  • 00:23:01
    right back he says i got to take those
  • 00:23:02
    knees out and put new ones in
  • 00:23:05
    period roger's verdict that's really
  • 00:23:08
    criminal what really makes him furious
  • 00:23:10
    is just a month after his first surgery
  • 00:23:13
    the company abruptly stopped selling
  • 00:23:15
    that knee implant yet never called his
  • 00:23:18
    doctor
  • 00:23:19
    the big word is
  • 00:23:20
    why why would you do something like this
  • 00:23:25
    you know
  • 00:23:26
    because this is affecting people all
  • 00:23:27
    over the country
  • 00:23:29
    according to court records of the over
  • 00:23:31
    1300 souls or knees implanted after it
  • 00:23:34
    changed its cleaning process at least
  • 00:23:37
    600 had to be removed
  • 00:23:40
    still there has never been any recall
  • 00:23:43
    the company says for business reasons
  • 00:23:46
    not safety it pulled them off the market
  • 00:23:48
    so there were no knees left to recall
  • 00:23:51
    and that is what salzer also told the
  • 00:23:53
    fda
  • 00:23:55
    but internal documents obtained by
  • 00:23:57
    dateline show at about the time salzer
  • 00:23:59
    stopped selling knees it knew of at
  • 00:24:01
    least 20 failed knee implants already
  • 00:24:04
    removed from patients and knew of more
  • 00:24:06
    than 35 other suspect cases
  • 00:24:10
    dr suzanne parisian used to be chief
  • 00:24:12
    medical officer for the medical devices
  • 00:24:14
    section at the fda
  • 00:24:17
    surely nobody in this company
  • 00:24:19
    wanted to hurt anybody
  • 00:24:22
    that's not what this is about i don't
  • 00:24:24
    think you would take anyone from salzer
  • 00:24:26
    and and they would want to go out and
  • 00:24:28
    hurt people like this but it's so easy
  • 00:24:30
    when you make a product to forget that
  • 00:24:32
    there's a human being involved and you
  • 00:24:35
    have to wonder where was the food and
  • 00:24:37
    drug administration during all of this
  • 00:24:39
    it is supposed to regulate medical
  • 00:24:41
    devices
  • 00:24:43
    we asked the head of the fda's medical
  • 00:24:45
    device section for an on-camera
  • 00:24:47
    interview he declined
  • 00:24:49
    but he told us he felt sulzer acted in a
  • 00:24:52
    responsible and timely manner in
  • 00:24:54
    recalling its hips
  • 00:24:56
    based on the stories you've just heard
  • 00:24:59
    how could he say that
  • 00:25:01
    well it appears the fda's file in this
  • 00:25:04
    case obtained by dateline simply doesn't
  • 00:25:07
    contain much of the information in our
  • 00:25:10
    report
  • 00:25:11
    typical of cases involving a voluntary
  • 00:25:13
    recall the government relied heavily on
  • 00:25:16
    information supplied by the company
  • 00:25:19
    was soldier honest with the fda
  • 00:25:22
    not from the documentation i've seen
  • 00:25:24
    they were not you believe there was a
  • 00:25:26
    cover-up here yes there was a cover-up
  • 00:25:29
    by salzer to keep the information from
  • 00:25:32
    the physician and the public and the fda
  • 00:25:35
    one reason dr parisian believes there
  • 00:25:37
    was a cover-up was because the company
  • 00:25:39
    told the fda it only heard about hip
  • 00:25:42
    failures two and a half months before
  • 00:25:44
    the recall not seven months as dateline
  • 00:25:47
    has found
  • 00:25:49
    and why didn't solzer notify doctors and
  • 00:25:51
    the fda sooner solzer contends it needed
  • 00:25:54
    time to figure out the problem and until
  • 00:25:57
    it knew the cause alerting the public
  • 00:25:59
    and the medical community would have
  • 00:26:01
    been irresponsible and caused widespread
  • 00:26:04
    panic
  • 00:26:04
    dr parisian says that's no excuse and
  • 00:26:08
    the minute they knew that this product
  • 00:26:10
    was not performing the way it was
  • 00:26:11
    supposed to that's when they should have
  • 00:26:13
    said stop using this product we're doing
  • 00:26:15
    a recall the law doesn't say you have to
  • 00:26:17
    have the fix
  • 00:26:19
    it was a hideous two years
  • 00:26:21
    it hurt physically
  • 00:26:23
    it hurt emotionally it makes you sick
  • 00:26:26
    just sick to think that you've gone
  • 00:26:28
    through all this
  • 00:26:29
    at least some people agreed in august
  • 00:26:31
    2001 in corpus christi texas a jury
  • 00:26:34
    awarded these three women lillian naomi
  • 00:26:37
    and helen damages of 15 million dollars
  • 00:26:41
    asserting soldier was guilty of
  • 00:26:43
    manufacturing a defective product guilty
  • 00:26:46
    of malice and that it knowingly caused
  • 00:26:48
    injury to elderly patients they later
  • 00:26:51
    settled
  • 00:26:52
    it's hard to imagine but between them
  • 00:26:55
    this small group of patients has
  • 00:26:57
    undergone more than a dozen hip
  • 00:26:59
    surgeries in just two years susie and
  • 00:27:02
    joel endured three surgeries each
  • 00:27:05
    have any of you
  • 00:27:07
    ever gotten a letter of apology from
  • 00:27:09
    salsa no
  • 00:27:10
    have you ever gotten a phone call no
  • 00:27:13
    the company says in letters to dateline
  • 00:27:16
    it deeply regrets the pain and
  • 00:27:18
    discomfort our implants caused some of
  • 00:27:20
    our patients that the well-being of
  • 00:27:22
    patients who receive our products is of
  • 00:27:25
    the highest priority to us and we have
  • 00:27:27
    done our best to be proactive in
  • 00:27:29
    supporting everyone affected by the
  • 00:27:31
    recall
  • 00:27:33
    as for those manufacturing changes which
  • 00:27:36
    led to the defective hips the company
  • 00:27:38
    says in addition to being a
  • 00:27:40
    cross-cutting move it removed steps from
  • 00:27:42
    the cleaning process because at the time
  • 00:27:44
    it didn't think they were necessary
  • 00:27:47
    also says it was trying to cut down on
  • 00:27:49
    the use of hazardous chemicals in the
  • 00:27:51
    plant
  • 00:27:53
    so far almost 4 000 defective implants
  • 00:27:57
    have been removed from patients
  • 00:27:59
    salzer which has since changed its name
  • 00:28:01
    to center pulse tells dateline in the
  • 00:28:04
    two years since the problems occurred a
  • 00:28:06
    new management team has taken aggressive
  • 00:28:08
    action to make sure nothing like this
  • 00:28:10
    happens again the company says its
  • 00:28:13
    products are now clean and safe are you
  • 00:28:16
    in pain i still have pain
  • 00:28:19
    and as i look back at all the time i
  • 00:28:21
    missed out with my kids
  • 00:28:26
    and my family
  • 00:28:28
    you can't bring it back to me
  • 00:28:30
    susie is one of 4 000 patients who
  • 00:28:33
    recently reached a financial settlement
  • 00:28:35
    with the company
  • 00:28:36
    because of the repeated surgeries
  • 00:28:39
    susie's tennis days are over and sadly
  • 00:28:42
    her recovery may be a lifelong struggle
  • 00:28:46
    i only hope
  • 00:28:47
    that
  • 00:28:48
    this doesn't happen to anybody else in
  • 00:28:50
    the future
  • 00:28:59
    you
Tag
  • implantes de quadril
  • desastre médico
  • Solzer Orthopedics
  • recall
  • cirurgias repetidas
  • complicações
  • contaminação por óleo
  • mudança de processo
  • registro médico
  • indemnização