Last Week Tonight with John Oliver (2014–…): Season 6, Episode 13 - Medical Devices - full transcript

Today John Oliver talks about the multi billion medical device industry, which lacks proper monitoring and necessary regulations. He explains the huge difference between the terms FDA ...

Are you wondering how healthy the food you are eating is? Check it -
John: Welcome,

welcome, welcome to
"last week tonight!"

I'm John Oliver.

Thank you so much
for joining us.

Just time for a quick recap
of the week in which a lot

happened, from narendra modi
beginning his second term as

India's prime ministero the
national spelling bee ending in

an 8-way tie -- which is equally
important -- to Robert Mueller

holding a press conference to
scream the word "impeachment"

with his eyes.

And en -and then there
was Jared kushner,

a man who constantly looks like
he was just reset to factory


Jared has been hard at work
on his middle east peace plan,

an undertaking that requires
precision diplomacy and not

doing anything
needlessly inflammatory,

a skill very much not on display
this week when he visited Israel

and met prime minister
Benjamin netanyahu.

Kushner psented the prime
minister with a gift,

a gift signed by
President Trump.

It was a map of Israel that
includes the Israeli-occupied

golan heights.

John: Wow.

All else aside, a
map is a shitty gift,

and getting it from Jared
kushner is the shittiest way to

receive it.

It'd be like if you got a
bouquet of dead fish for your

birthday delivered
by Matt lauer.

No, and also, no.

Both no.

But much more importantly, that
map is a huge symbolic gesture.

The golan heights is an area
that virtually the entire

international community
considers occupied Syrian rrity,

so it's a willfully provocative
move with a finishing touch that

is pure Trump.

The word there, top
right, just circled there,

"nice." John: Holy shit.

I guess the only really
surprising thing there is that

Trump clearly spelled "noice"
wrong, because it's n-o-i-c-e.

Any of this year's eight
spelling bee co-champions could

ha tolyou that.

Well, three of them
could -- you know,

the three who actually
deserved to win.

They know who they are.

But for now, let's
move on to Tennessee,

rated one of the 49 best states
in the country by "obvious

references to Florida" magazine.

Tennessee's state legislature
has been embroiled in a major

scandal for the past month, and
while it may not be the most

important thing in the world,
every details spectacular.

It involves republican speaker
of the house Glen casada,

a family values conservative,
and his chief of staff,

Cade cothren, who, it's emerged,
has a history of sending some

pretty racist text messages.

In an exchange with casada,
cothren appears to refer to a

west Tennessee district
with this black people meme.

In a text with other
friends, cothren says,

"black people are idiots,"
and insists that tampa bay

quarterback jameis Winston be
called a "thug n-word." You

referred to jameis
Winston as a thug [bleep].

How can you justify that?

John: Okay, so it's not super
surprising that a Tennessee

republican and his top aide
are being flagrantly racist,

especially when one of them
is called Cade -- y'know,

the name you get when the
name "cha fucks a gatorade.

But also, for the record, that
reporter doesn't get to say the

n-word either.

Inact, there's only one old
white man who is allowed to say

the n-word, and it's this guy.

His name is Cole Swanson.

He lives in a sleepy
little Maine town.

He's a former Navy man and a
retired schoolteacher who never

remarried after his
beloved wife, Celia,

passed away after 55
blissful years of marriage.

These days, around evening time,
you can find Cole down by the


He likes watching the fishing
boats come in at sunset,

says there's a quiet
and noble poetry to it.

Anyway, in 2007, it was
unanimously decided that Cole is

the only ite y who's allowed
to say the full n-word.

But, friends, he never does.

And that's why he was chosen.

Anyway -- anyway, speaker of the
house casada initially defended

his chief of staff, suggesting
he'd been framed by liberals.

And yet, if you can believe
it, which you definitely can,

that defense quickly fell apart.

The text messages also included
this selfie that cothren had

taken at 2:15 A.M.

During a trip to Colorado.

He texted "tripping balls
out of my mind" at 2:15.

"Craziest experience
of my entire life.

Acid, cocaine, weed." After
a 2015 trip to the Dominican

Republic, cothren also texted,
"just did a gram of cocaine in

my office." It was
sent at 10:38 A.M.

on a workday.

John: Okay, okay, okay.

The emphasis on what time of day
these events occurred is a bit

weird there in that it seems to
suggest the main issue here was


Would noon have been a more
appropriate time to blow a g of

yayo off taxpayer-funded
office furniture?

If chrenad waited until
the dead of night,

snuck back into his
empty office building,

and then took a ski trip
to mount booger sugar,

that would have been
better, would it?

I don't think so.

But cothren's behavior clearly
reflects badly on his boss, who,

incidentally, lobbied to have
welfare benefits stried fm

people who test
positive for drugs.

As for cothren himself, he has
since issued what amounts to an

excuse-planation for those
text messages, saying,

"while I'm not proud of
who I was in the past,

I am proud that I've been able
to achieve so much in the years

since." And that may seem
implausible to you -- these

texts were sent just three
years ago -- but in fairness,

you n gea lot of personal growth
done when you're taking cocaine

at 10:30 in the morning.

And while cothren
wound up resigning,

it was clear that speaker casada
was absolutely culpable here

too, because they seemed on
the same page to a legitimately

disturbing extent.

The latest revelation comes amid
the ongoing text message scandal

involving casada and cothren,
part of which involved an August

2016 incident here
at party fowl,

a restaurant and bar right
on the edge of downtown.

In one exchange, cothren texted
casada boasting about having sex

with a woman in the
bathroom at party fowl.

"I knew it!"

Casada responded, asking,
"r u a minute man?"

"Like father, like
son," said the aide.

The response, "if I'm
happy, then all is good!"

Four days later, cas-pac
reported campaign funds paid out

to party fowl for $180.59.

John: Oh, my god!

I mean, setting aside the
questionable use of campaign

funds, there is no way that
cothran had sex in that


But if anything, that
actually makes it worse,

because the only thing on earth
more shatteringly distasteful

than attempting to impress a
state rep by bragging about

being a sexl disappointment
in the bathroom at a Tennessee

chicken restaurant that serves a
55-ounce bloody Mary topped with

two whole fried cornish
game eight fried okra,

and a whole avocado is
attempting to impress a state

rep by lying in a toilet text
about all the lightning-fast

orgasming you're doin in the
bathroom at said Tennessee

chicken restaurant.

Unfortunately, there's no way
to know what Cade cothren was

really doing in the
bathroom at party fowl.

The only thing we know
for absolute sure is,

whatever he was doing, he didn't
wash his hands after doing it,

because according
to one yelp review,

"the bhroolacked toilet paper
and soap." And look, look, look,

that review was from 2015.

But if you are tempted to give
them the benefit of the doubt --

tempted to say, "maybe party
fowl isn't proud of who it was

in the past.

Maybe it's been able to achieve
so much in the years since,

" don't be.

Because three years later,
"there was no soap and no toilet

paper in the restrooms." Also,
it seems crucial that you know

the floor of that restroom was
"so slippery it was like walking

on ice." Which does make sense.

That floor is probably
filthy with chicken grease,

Cade cothren's rapidly
expelled ejaculate,

and/or the flop sweat he
developed from trying to seem

like Mr. Cool x inront of
Tennessee state rep Glen casada.

Now, clearly, this
story is incredible,

but you should know casada's
announced that he'll meet with

republican leadership tomorrow
to determine a date on which

he'll resign.

Not that he has ch cice there,
having been abandoned by his

party, which overwhelmingly
passed a no-confidence vote in


And while that should
not be surprising,

it's worth noting just how
unusual that now actually is.

In fact, given the heinous
conduct that the republican

party has now
completely normalized,

the sight of them actually
holding one of their own to

account is -- to rrow misused
phrase -- "nice." And now this.

Announcer: And now,
animal planet's "Dr.

Dee: Alaska vet"
is on a mission.

I don't want to be pushy.

It's my first time in town, and
I don't want them to tnk that's

all I'm here for is to
castrate everything in sight.

Are you my first patient?

Can you sit?

Do you want to have
your balls cut off?

We don't want to hurt him.

We just want to castrate him.



Tiffany, we are going to
go cut some nuts off today.

Is that okay?

The's a lot of dogs and
testicles in this village.

Typical blonde Belgian.

I'm a typical blonde
veterinarian who cuts blonde

Belgian balls off.

Tip the little calf over.

Find the testicles,
take them off,

and you go home and
you have dinner.

He can be as testy as he
wants, because pretty soon,

I'm because pretty soon, I'm
going to have his testes in my


It seems like every
time I go to Tony's,

something loses its testicles.

I don't know what to say
except she enjoys her work.

John: Moving on.

For oumain story tonight, we're
going to talk about medicine,

the thing that doogie howser
pretended to be able to

practice, leading to 92
deaths and life in prison.

Yeah, that's how the show ended.

You didn't watch long enough.

Specifically, we're going to
talk about medical devices,

the modern-day miracles that
range from contact lenses to

pacemakers that keep hearts
beating to hip replacements that

can transform lives, as this
woman will tell you in a solemn


I wasery frhtened to
do a hip replacement.

I really didn't want to
do a hip replacement.

And she got the hip replacement,
and she's better than new.

It's just fascinating
to see her.

She's dancing as if she never
got a hip replacement, you know?

John: Admit it, you didn't
see that story ending with a

breakdancing group of
50-year-olds called -- and this

is true -- "momz in da hood."
And you're going to be even more

surprised when I tell you
they're actually here tonight.

♪ ♪ Please welcome
momz in da hood!

♪ ♪ They're not here.

They're not here.

They're not here.

Of course they're not here!

You think they're coming to a
post- "game of thrones" hbo?

They're momz in da hood!

They have better places to be!

It would be a waste of
their valuable time.

The medical device
industry is huge.

They constitute a $156-billion
market in the U.S., and more

people have one
than you'd think.

About 32 million Americans --
that's 1 in 10-have at least one

medical device implanted
in their bodies.

That's right, all these years
we've been waiting anxiously for

the robot apocalypse, and it
turns out the robot apocalypse

was insi us the whole time.

And while medical devices can
undeniably do tremendous good

and save lives, they can
also cause real problems.

And you're probably
aware of some of them,

thanks to personal injury
lawyer ads like these.

Have you or loved one had
complications after a knee

replacement or revision surgery?

Have you or a loved one
had hernia mesh implanted

specifically for hernia repair?

Have you or a loved one had an
ivc filter implanted to prevent

blood clots from
reaching the lungs?

Have you or a loved one
developed a drug-resistant

bacterial infection or a
superbug after undergoing an

ercp procedure using
a duodenoscope?

John: Yes, actually, yes, I do
have a loved one who's developed

a drug-resistant bacterial
infection or superbug after

undergoing an ercp procedure
using a duodenoscope.

And may I say, I thank god the
card categories at hallmark have

gotten so specific.

I had options on that one.

Now, while it's easy to roll
your eyes at ads like those,

the problems that they
are citing are very real.

Medical devices can malfunction,
sometimes in horrifying fashion.

Just imagine a defective
defibrillator painfully shocking

you multiple times or a
malfunctioning Insulin pump

giving you the wrong dose.

Well, both of those
things have happened.

In fact, a massive recent
investigation found more than

80,000 deaths and 1.7 million
injuries possibly linked to

medical devices were reported
to e fdin the past decade.

And while you'd naturally
assume that medical devices are

extensively tested before
they're put on the market,

that is not
necessarily the case.

Even devices that go inside you
may never have been subjected to

a clinical trial.

And don't feel bad if you're
suddenly surprised by that.

One researcher found many
doctors aren't aware of this


We were surprised to see how
little surgeons knew in our

study about the approval
process for devices,

that some of the surgeons
seemed to think that, well,

the fda had taken care of this.

That of course these devices
had been tested in humans.

John: That's terrifying that
even your doctor may not know

that you're essentially being
treated like a Guinea pig.

And nobody wants to be treated
like a Guinea pig unless it

means you get your o hanng water
bottle that you can suck on from

your bed, which actually sounds
completely delightful to me.

So tonight, let's talk about how
medical devices get approved.

And before we start, the nature
of this story means there are

two clips you'll see
that are a little gross.

So before each one, I'm going
to say a safe word, "opossum,

" and flash it on screen with a
sound effect like this: [Siren

wails] Basically, when you
see that, if you're squeamish,

you'll know to look away.

And now that you have been
fairly warned, let's begin.

For many years, medical devices
were hardly regulated at all.

Instead, the fda produced
sternly worded public

information messages like
this: Today's doctors, drugs,

and medical devices truly work
medical miracles for young and

old alike, but there are
some as phony as a $3 bill.

Like this zeta
applicator, for example,

which has claimed to cure
arthritis with "z-rays." There

are no z-rays.

John: He was right, of course.

Z-rays wouldn't be
discovered until 2011,

when they were identified as
the powerful sexual radiation

emanating from zayn Malik.

Feel the zs.

Feel the zs right now
burrow into your soul.

But in the 1970s, congress
passed a law giving the fda the

authority to approve
medical devices,

and you might assume that,
on the basis of that,

every single device
is fda approved.

But in fact, far more of them
are instead something called

"fda cleared," and that is
a distinction with a big

difference, because fda cleared
is a much lor bar to clear.

You've probably seen the phrase
"fda cleared" on products like

this anti-aging laser treatment,
but it can mean very little.

Even the sharks on
"shark tank" know this.

Watch their response when
someone pitched them an

acupressure band and tried to
pull the whole fda-cleared card.

Hey, romy, is there any proof
that this actually works?

It's an fda-cleared
medic device.

That's not an answer
to the question.

No, that's not what I'm asking.

John: Yeah, cubes is right.

When is he not?

My man cubes nailed it there.

Because saying something's fda
clead is in no way proof that a

device actually works.

It's a phrase that can promise
way more than it delivers.

Like when a cereal describes
itself as "part of a complete

breakfast." That doesn't
really mean anything.

Anything can technically be
part of a complete breakfast.

If you ingest it alongside
oatmeal, yogurt, granola,

fruit salad, and a
glass of orange juice,

eakfast.s part of a complete
and the way most products get

cleared is through a loophole
in the system called the 510(K)


It wasn't actually a bad idea
when they initially came up with


Basically, the fda wouldn't make
companies go through a strenuous

testing process if their device
was substantially similar to one

that hadome fore.

That way, they wouldn't
stifle innovation.

But it was only supposed
to apply narrowly.

The problem is, nowadays more
than 80% of medical devices are

clearethroh the 510(K) Loophole,
including around 400 implanted

medical devices every year
-- those are the ones that go

inside your body.

And that whole idea of being
"substantially equivalent" to

devices that came before has
some real problems with it

because it can essentially
become a high-stakes game of

"telephone." Let me
show you: In 2008,

a company called depuy received
fda clearance for a hip

replacement based on its
substantial equivalence to six

previous devices, all of which
were cleared because of their

similarity to devices before
that and devices before that and

before that, all the way back to
hips that were on the market in


Now, incredibly, some of those
devices had since been taken off

the market by their
manufacturers because of their

high failure rates.

But under fda rules, depuy could
still use them as a basis for

getting their hips cleared.

And the thing is, depuy's hip
really would have benefited from

clinical testing
in human beings,

because therwas big problem.

While it may've looked
similar to its predecessors,

it was crucially different in
that both its ball and socket

were made out of metal, and it
turns out that when metal rubs

against metal, bad
things can happen,

which sounds like the tagline
for a movie about a masturbating


You'll -- you'll notice that we
didn't actually come up with a

funny fake name for that movie
because the perfect name for a

movie about a masturbating
robot already exists,

and it's "chappie." But those
metal-on-metal hips began to

degrade with wear-and-tear,
and the consequences wergrim

orthopedic surgeon Dr. Herbert
huddleston of tarzana testified

at trial he's taken out dozens
of metal-on-metal hips th fled.

In the worst cases...

The bone and the soft tissues
around the hip started to look

like pieces of cheese, except
pitch-black pieces of cheese.

Sometimes we get in there and it
looks like it's filled with old

oil that you've
drained from your car.

John: Opossum!


[Siren wails] Shit!


I meant to say it
before the clip.

Soy, tt was an opossum.

That was one of them.

I won't miss the next one.

That's on me.

Anyway, depuy's parent company
has since spent more than $3

billion to settle thousands of
lawsuits over their metal hip


And you feel that this could've
been avoided if an outside agcy

had just had a closer eye
on what depuy was doing,

because the company
-- being, you know,

a company -- was excitedly
trying to put as many of its

hips in people as possible.

Just watch depuy's sales force
celebrate the early success of

its metal hips.

"Taking shares of business"
was the theme of a depuy sales

conference in 2008.

This video, shown to the jury,
stars depuy's then-top marketing

guru alongside
costumed alligators,

a bloody man with a hatchet,
and a giant metal hip implant.

John: Now, you probably have
a lot of questions there,

and if you're like
me, the first one is,

"why include an axe murderer
in your parade about medical


I can only assume it's a rdi
as-themed reference to the

axeman of New Orleans, a mostly
forgotten serial killer who

stalked the streets of
the big easy in 1918,

apparently threatening anyone --
and this is true -- who wasn't

joyi jazz enough.

And that is an admirably deep
cut, although if I'm honest,

I would have preferred them
to have put at least as much

research into metal poisoning as
they did into early 20th century

jazz-loving serial killers.

And 's n just the sales force
who were amped about the success

of depuy's hips.

One of the people
who helped design it,

Dr. Thomas schmalzried, was
excited too -- although not

entirely for the reasons you'd
hope a doctor would be excited

about a new medical device,
because he even made an

appearance to pump up depuy's
sales force at that meeting with

his special schmalzreid charm.

Did you know that the first
billion is the hardest?

Billion here, billion there,
pretty soon it adds up to some

real money.

Anyone here wanna go for two?

[Audience cheers] I'm
gonna say that again.

Does anyone here
wanna go for two?

[Audience cheers] John:
Now, I know that sounds bad,

but I'm sure if some of the
patients who had used his

product were there, they too
would have stood and cheered.

And then, you know, collapsed
in a heap because their hips are

now pitch-black cheese.

And if you're wondering why
a doctor should be so excited

about sales, depuy paid him $20
million in royalties for his

role in helping to
design their sale.

Including a cut of every and if
I may paraphrase a deeply smarmy

man, 20 billion here, 20 billion
ther pretty soon it adds up to

some real money.


But I'll say this for
metal-on-metal hips,

at least they can be removed.

It's not easy, and it's
sometimes dangerous,

but it can be done.

It's much harder to do that with
certain types of surgical mesh,

another fda-cleared device.

Very basically, mesh is
implanted in the tissue,

which then heals around
it, sealing it in,

which can make it risky to take
out without damaging surrounding

tissue and organs.

Meshes were initially cleared
by the fda for hernias,

but a few years backthey were
also cleared for use on vaginal

tissue, in many cases without
having had to undergo any

clinical trials.

And things did not go well.

And ahead of the next clip,
I am going to say opossum.

[Sir wails] Not because you're
about to see anything gross,

but because of what
you're about to hear.

It felt like a cheese
grater inside of me.

It felt like the material
was pulling on the muscles,

and I'd get shooting pains.

You almost felt like there was
something inside of you that was

like sandpaper, back and
forth, every time you'd walk.

John: That is viouy horrifying.

There is absolutely no
circumstance in which you should

feel like there is sandpaper in
your groin, apart, of course,

from when a cat is
going down on you.

That's the only time.

That's the only time.

And even then, even then there
are real problems involved.

Even then.

Take it down.

Take it down.

The good news -- the good news
is that the fda recently ordered

vaginal mesh manufacturers to
stop selling their product.

And as for metal-on-metal
hips, going forward,

they won't be fda cleared.

Instead, they'll have to go
through the much more rigorous

process that gets
you fda approved.

It requires that a high-risk
device be tested on humans,

which is great, but even
the approval system has its


For one thing, the fda relies
on manufacturers to do their own

clinical testing, and those
tests can be very limited.

And for just one example of the
approval system's shortcomings,

look at essure, metal coils that
were marketed as permanently

implanted birth control
devices for women.

Essure's manufacturer, in its
application for fda approval,

claimed that "99% of women
clical studies rated their

comfort with the device
as 'good to excellent,

'" and the fda approved it.

And yet, 15 years later, the
fda had received over 32,

000 reports of problems
with essure, including pain,

dislocation of the device,
genital hemorrhage,

and perforated organs, none of
which really sound particularly

"good" or "excellent" to me.

And if you're having trouble
squaring that with the sky-high

satisfaction rate in
essure's clinical studies,

some of the participants in it
say there may be a reason for


The first time I saw the
question "rate your comfort of

wearing the device," I
said, "what does this mean?"

I'm not wearing anything.

This is something that's
implanted inside of my body.

The nurse said,
"can you feel it?"

And I said, "I can feel
pain in my abdomen.

Where that pain is coming from,
I don't know." And she said,

"then you need to rate it as
excellent." They would say,

"are you happy
with the product?"

I would say, "no."
And they would say,

"but you're not pregnant?"

I would say, "correct." "Well,
then it's doing its job.

So you have to be happy
with that." John: Okay,

but just because something is
technically fulfilling its job

does not mean you have
to be happy with it.

Pennywise technically fulfills
all the requirements of a

birthday clown, but when you
book him for your kid's fifth

birthday party a
it esn't go well,

you should not be obliged
to rate him as excellent.

So I guess the big
question here is,

how can you know if a device
is potentially harmful?

And unfortunately, good
information is actually very

difficult to find.

For a start, one estimate
suggested less than half of 1%

of medical device failures are
even reported to the fda, which,

when you think about it,
is genuinely remarkable.

100% of rude waiters
are reported to yelp,

and those aren't
killing anybody.

In fact, public reporting of
issues with devices is so bad,

many patients have been forced
to learn about problems in

less-than-ideal ways, like from
that alarmingly alert woman in a

law firm commercial or
often even Facebook.

A couple of months ago, the fda
heldearings to alert women to

potential issues
with breast implants.

But for years and years
and year before that,

women were finding out simply
by warningne another online.

The private group is called
"breast implant illness and

healing by Nicole," and today
it has more than 79,000 members.

I was like, "this is
unbelievable that this can

happen to so many people." Page
after page, that's my story,

that's my story.

Everyone has the same symptoms.

John: Yeah, they found out
through Facebook groups,

traditionally the least
reliable source of information,

right below
horoscopes, "infowars,

" and a mole person screaming
in the subway tunnels.

Look, this system
clearly needs reform.

And don't just
take that from me.

Eight years ago, t instute of
medicine actually called for an

end to the 510(K)
Loophole -- you know,

the one that hips and mesh went
through -- saying it should be

replaced by a regulatory
framework based on sound


And that framework does not need
to be so strict that innovation

is stifled, just not so lax
that people are getng needlessly


At the very least, you would
hope that implanted devices

would undergo clinical testing
before being put inside you.

But any time that meaningful
reforms have been suggested,

device manufacturers have
lobbied hard and helped defeat


Because of course they have.

Any changes would mean
they'd have to work hard,

and nobody wants to work harder.

You think we like doing these
heavily researched stories?

You think this was fun for us?

Hbo makes us do this!

If it was up to us, we'd work
one day a week and every segment

would be two minutes long and
have a title like "pillows and

how they are soft, bye-bye."
But, look -- that would be fun.

But until our current system
is improved, unfortunately,

patients have to be
their own advocates,

and experts advise researching
any implanted device and asking

questions like, "is
there an alternative?"

"Can the device be removed
if something goes wro?"

And "how long has the
device been on the market?"

Because just because something
is new doesn't necessarily mean

it's better or even
that it's been tested.

The point here is, our medical
device system needs serious


And until it is fixed, it would
be nice if people were alerted

to the flaws with our process
with the same urgency with which

they're alerted to the
flaws with our devices.


If you or a loved one are
thinking about getting an

implanted medical device, you
may want to listen the fuck up,

because it turns out the fda
is so far up medical device

manufacturers' asses you can
only locate them with this


And thanks to that,
manufacturers are getting rich,

doctors are getting rich, and
patients are getting their

insides turned into
oil and cheese.



[S wails] You and your loved
ones need to know it can take

years before the public finds
out about problems with a new

device, and in the meantime,
your best source of information

may be fucking Facebook, and the
only thing you should ever learn

from Facebook is which of your
friends has the ugliest baby.

It's Greg's.

So act now to protect
yourself fore it's too late.

Basically treat medical devices
like guys who have played


Some are great, but new ones
aren't necessarily better,

and there are a few you
definitely don't want to let

inside your body.

And if hearing about
duodenoscopes and sandpaper

vaginas have made
you uncomfortable,

as long as it hasn't
made you pregnant,

I'm afraid you have to rate
your experience as excellent.

[Bell dings] John:
That's our show.

Thanks so much for watching.

See you next week.

Good night!

[Cheers and applause]