20/20 Transcripts
=============================================
==
ABC NEWS 20/20 Transcript #1353
December 17, 1993
HUGH DOWNS, ABC News: Good evening. I'm Hugh
Downs. BARBARA
WALTERS, ABC News: And I'm Barbara Walters
and this is
20/20 ANNOUNCER: From ABC News, around the
world and into
you home, the stories that touch your lives,
with Hugh
Downs and Barbara Walters -- this is 20/20.
Tonight, the
medical device they say ruined their lives--
JOE
WILLIAMSON: Steffe Back Screw Victim: I put
my wife and
child through hell every day, every day,
because of this.
ANNOUNCER: --back screws inserted in their
spines. The FDA
insists they were experimental, but these
patients never
knew it. CARROLL CARDER: Steffe Back Screw
Victim: He said
"These things are a sure shot. Without it you
don't have a
chance." ANNOUNCER: Now they live with
terrible pain that
may never go away, How can this happen with
the top
doctors, the best hospital: and the
government watching?.
Dr. DAVID KESSLER, FDA Commissioner: There is
a full scale
investigation underway.
ANNOUNCER: Dr. Timothy JOHNSON with a
shocking exposé and a
warning that
could save you from 'The Secret of the Back
Screws."
[Commercial break]
HUGH DOWNS: It's a fact that 80 percent of us
will have
hack pain sometime during our lives. Now, for
some of those
with serious pain, there is a surgical
treatment using back
screws and every year tens of thousands of
people have
these screws surgically implanted into their
spines. But a
20/20 investigation has uncovered some
shocking facts about
this technique that have never been reported
before.
BARBARA WALTERS: Well, first, the FDA says
that these back
screws are experimental. Patients don't know
that and the
results can be disastrous. And how can this
happen when
they are being used by doctors in hospitals
across the
country? And isn't the govern-government
supposed to
protect us from this kind of risk?
[voice-over] Tonight Dr.
Timothy JOHNSON investigates these important-
questions.
Dr. TIMOTHY JOHNSON, ABC News Medical Editor:
[voice-over]
Lake Charles is a town of 76,000 people in
southwest
Louisiana. The area is rich in oil end is
just upriver from
the Gulf of Mexico, which makes it ideal for
oil refineries
and chemical plants. But Lake Charles is also
the scene of
a burning controversy about a medical device
for back
surgery, a controversy that raises ques-tions
about how
thousands of patients across the country
became virtual
guinea pigs.
At the heart of this potential scandal are a
group of
patients in Lake Charles who were told they
needed special
back surgery, and then ended up with canes
and braces and
ruined lives after screws and plates were
implanted in
their backs. Some had previous back surgery
that had
failed. Others had simple ruptured disks.
Un-fortunately,
the screws that were supposed to help them
broke.
CARROLL CARDFER, Steffe Back Screw Victim: It
got to where
when the plates was in here, it felt like
somebody had a
knife in my back. MARIE RAYBURN, Steffe Back
Screw Victim:
My back felt like it was being pulled apart,
like something
was behind me and something was in front of
me, just
pulling.
JOE WILLIAMSON, Steffe Back Screw Victim: I
put my wife and
child through hell every day, every day,
because of this.
JOHNSON: [voice-over] Screws and plates are
used in back
surgery when there
is a concern about the stability of the spine
after
surgery. In a typical operation, bone from
the vertebra is
removed. Then, to stabilize the spine, screws
are inserted
through plates into the part of the vertebra
called the
pedicle. The risks of the operation are
frightening. The
pedicle is right next to the spinal column
and emerging
spinal nerves. If the screws break or are
inserted
incorrectly, the results can be catastrophic,
including
permanent nerve damage. And the screws, as
first developed
in the early '80s, did often break, nearly
one in three,
according to one early study. They broke so
often they had
to be repeatedly redesigned. The screws in
Willie Gilbert
tore his vertebra, causing loss of feeling in
his legs and
bladder problems. Joe Williamson suffered
damage to the
nerves leading to his bladder when four
screws broke.
Carroll Carter had two broken screws that had
to be
removed. MR. CARDER: And ever since then I've
had pain in
both of my legs. I can hardly walk. Sometimes
a Leg will go
out end I fall and it just-- it's ridiculous.
JOHNSON: [voice-over] We asked the Lake
Charles patients
how many have
suffered nerve damage hike loss of bladder
control or
weakness in a leg since the surgery. We then
asked the
patients how many have been unable to work
since the
devices were im-planted.
Dr. ARTHUR STEFFE, Former Chairman, AcroMed
Corp.: We can
put those in and they are stronger than a
brace.
JOHNSON: [voice-over] The men many of these
patients blame
is Dr. Arthur
Steffe, the Cleveland back surgeon who
developed and sold
the so-called "Steffe screws end plates" to
many surgeons.
The Lake Charles patients say their surgeons
then sold them
on the devices. MR. CARDER: And he said, "The
only way that
it's going to work," he said, if I use these
Steffe
plates." He said, "These things are a sure
shot. Without it
you don t have a chance."
Mr. WlLLIAMSON: State of art -- this was his
presentation
to me of my
introduction to Steffes.
JOHNSON: [voice-over] But after the surgery,
the Lake
Charles patients
discovered to their horror that they were
much worse. Their
lives had changed dramatically.
CAROLYN DOUCETTE, Steffe Back Screw Victim:
Well, I was a
road runner before the surgery. I was on the
go all the
time. But since the surgery, I can't. I can't
do any of my
housework.
WILLIE GILBERT, 8teffe Back Screw Victim: I
can't tie my
shoes. It took me six months to learn how to
go to the
bathroom, just to learn how because I
couldn't wipe myself.
MR WILLIAMSON: I've lost my activities with
my wife. I have
not slept in the same bed with my wife since
my surgery of
1986. JOHNSON: [voice-over] For some, the
anger has turned
to tears. CORNELIUS BULLER: Steffe Back Screw
Victim: I'm
just--l'm a nothing now. I can't do anything.
I can't
travel. I can't stand to go across town too
much. It's
just-- l hurt too much.
KENNETH WADE, Staffs Back Screw Victim: They
don't know how
it feels when your six-year-old son has to
come up and ask
you, "Daddy, is your Legs hurting?.' And !
tell him, "Yes.
Why?" "Cause I wanted to sit on your lap."
And you can't
let him sit on your lap because your Legs are
hurting too
bad. JOHNSON: [voice-over] But were the
problems with the
Steffe devices limited to Lake Charles? Dr.
Steffe was
asked about the ex-tent of the breakage
problem during a
malpractice deposition.
DR. STEFFE: --The breakage because it's not
been a problem.
It's only been a problem in your cases.
JOHNSON: [voice-over] Not so, according to
our
investigation. For example,
in Philadelphia, we found many patients like
this who
suffered complications when screws broke
following surgery.
In fact, when WPVI-TV, who had been working
with 20/20 on
this story, aired their report last month,
the station was
flooded with nearly 200 calls, most of them
from
Philadelphia patients complaining of painful
complications.
Typical of these Philadelphia patients is RON
ROSCI, a
truck drive, who has been in almost constant
pain since the
Steffe screws in this back broke in
1986. He hurts when he walks. He hurts when
he's sitting
down. He even hurts when he's in the
whirlpool for therapy.
Ron's pain was very visible during our
interview with him
and his wife, Kim.
RON ROSCI, Steffe Back Screw Victim: When I
lay down, my
spine lays down. I actually feel it drop. If
I was to get
in bed and lay down and roll over on my back,
I could
feel-- I could actually feel my spine move.
JOHNSON:
[voice-over] Back in 1987, Ron actually tried
to kill
himself by swallowing a half-bottle of
Valium.
Mr. ROSCI: I felt like I was useless,
worthless and didn't
have no life and why should I be here if I'm
going to be
like that? JOHNSON: Were you surprised by
this or shocked
by this? KIM ROSCI, Wife: I don't know what
he's going to
do to himself, so I just-- I just watch him.
JOHNSON: [voice-over] But who was responsible
for
protecting patients like
Ron Rosci and those in Louisiana? There is a
lot of
finger-pointing. Mr. WILLIAMSON: They should
stop these
quack doctors from doing what they're doing
to people. I
think it's out of control. They do what they
want to. MARIE
RAYBURN: How about, the hospitals too? Aren't
the hospitals
supposed to get an approval on things before
they're used
in their facilities? Mr. GILBERT: Who is the
FDA? Nobody
knows nothing. Where were they at when all
this was going
on? This has been going on for years. Where
are they at?
JOHNSON: So how did spine plates and screws
get unleashed
on the public? Before a new device or an old
device being
proposed for a new use can be marketed, it
must be approved
by the Food and Drug Administration. Now,
plates and screws
like this have been approved for a long time
for use in
long bones -- arms and legs --but back in the
mid-1980's,
Dr. Steffe and his new company, called
AcroMed, went to the
FDA and asked for the device to be approved
for a new use,
in the spine. Twice, they said no. They said,
'"That's a
new, potentially dangerous use. It must be
studied first
for safety and effectiveness." However, just
a few months
later, the FDA did approve the device after
AcroMed simply
changed the name from "spine plates and
screws" to "bone
plates and screws," and Dr. Steffe now claims
that meant he
could use it in any bone, including the
spine. [voice-over]
But did the FDA ever give such approval? We
showed current
FDA commissioner, Dr. David Kessler, Dr.
Steffe's video
testimony when he was asked if the FDA said
he could market
his device for use in the spine. DR. STEFFE:
There was no –
ATTORNEY: Did they say that, sir?
DR. STEFFE: Yes, they did.
Dr. DAVID KESSLER, FDA Commissioner: That is
an— JOHNSON:
Okay, stop the-- Dr. KESSLER: That is an
incorrect
statement. JOHNSON: He said, "Yes, they did."
They never
said that? Dr. KESSLER: FDA never said that.
In fact, we
repeatedly said they could not market the
device for use in
the spine. We had al-ready told them twice.
JOHNSON: And
they weren't changing their tune at this
meeting. Dr.
KESSLER: Absolutely not.
JOHNSON: [voice-over/But for years. Dr.
Steffe bas stuck by
his claim that
the FDA did give him approval after he simply
changed the
name to bone screw,
DR. STEFFE: But they said I could use it and
could teach it
and we could sell it as a bone plate and bone
screw and it
could be used by the physician at his
discretion.
JOHNSON: [voice-over] But now, for the first
time, Dr.
Kessler not only
disputes Dr. Steffe's claim that he could use
the device in
the back, but Dr. Kessler makes a serious
charge about what
AcroMed did. Dr. KESSLER: It's fair to say
that they
circumvented the law. JOHNSON: You're being
kindly and
lawyerly and I know you're also a lawyer, but
I mean they
just literally—
DR. KESSLER: Tim--
JOHNSON: It sounds to me like they lied, fiat
and simple.
They said they
were going to use it in long bones for
fractures. They
didn't do it. Instead, they turn around and
use it in the
spine. Dr. KESSLER: Tim, it's an enormous
concern to me
what hap-pened back in 1985, 1986. There is e
fun-scale
investigation un-derway. JOHNSON: 20/20 has
learned that
AcroMed is in fact the subject of a grand
jury
investigation for possible criminal
violations, but the
serious questions about AcroMed have remained
a virtual
secret until now, a secret that has allowed
widespread
abuse and the treatment of patients with an
experimental
device without their knowledge. [voice-over]
At St.
Vincent's Hospital in Cleveland, Dr. Steffe
taught the
procedure to hundreds of surgeons. He not
only trained the
doctors in Lake Charles and Philadelphia, but
they have
testified Dr. Steffe told them the device was
approved for
use in the spine. After he trained in
Cleveland, Lake
Charles orthopedic surgeon Dr. William Akens
testified that
he performed about a hundred procedures in
the next year.
Dr. Clark Gunderson, who still practices in
this building
in Lake Charles, testified he did over 50 in
the next year.
In contrast, many experts we talked to do
less than 10
screw-and-plate operations a year. Darryl
Tschrin, attorney
for the Lake Charles patients, said he could
not believe
how often the surgeons were implanting the
devices. DARRYL
TSCHIRN, Victims' Attorney: I asked the
doctor, I said,
"Well, do you mean that every Monday,
Wednesday and Fri-day
you all were implanting one of these--- doing
one of these
pro-cedures?" And, "Well, he said, I guess
that's about
right."
JOHNSON: [voice-over] While none of the
device
manufacturers limited their
sales to doctors who were doing approved
research studies,
other companies sold to anyone who would buy.
One for-mer
salesperson not with AcroMed told 20/20 his
company
encouraged him to sell unapproved devices.
FORMER MEDICAL
SALESMAN: I was also told, "Don't worry about
it. Go ahead
and sell it.'
JOHNSON: [voice-over] This kind of aggressive
marketing
helped to spread the
operation. Today an estimated 50,000 to
70,000 of these
procedures are done every year. The FDA
estimates up to
300,000 patients have these devices in their
backs.
Dr. KESSLER: Here's a device that's being
used that was
never approved by the agency, and the best I
can discern,
the patients didn't know that. JOHNSON:
[voice-over]
Patients also didn't know that name doc-tors
had financial
ties to AcroMed. Ron Rosci's attorney says
that Ron's
orthopedic surgeon, Dr. Sanford Davne, who
testified he
per-formed over 700 procedures, had potential
conflicts of
interest.
JOSEPH MESSA, Jr., Attorney for Ran Rosci:
Dr. Davne
himself was a member of AcroMed's medical
advisory board.
He held stock options in AcroMed Corporation
and he himself
had a finan-cial interest in implanting and
selling these
screws end plates.
JOHNSON: Once the operation had spread, the
FDA conducted a
largely
ineffective campaign to stop unapproved use.
Critics say
the FDA often sent confusing or mixed
signals, on the one
hand sending stern warning letters to AcroMed
while at the
same time tolerating repeated and obviously
illegal
marketing efforts. It wasn't until 1990, when
Dr. Kessler
took command, that the FDA got tougher, but
as he himself
says. by that time the genie was out of the
bottle.
[voice-over] Meet Dr. Arthur White, one of
the leading
spine surgeons in the country. Dr. White
actually did one
of the early studies of pedicle screws, using
AcroMed's
devices. We showed him excerpts from Dr.
Kessler's
interview, in which Dr. Kessler sug-gests
AcroMed
circumvented the law by getting approval for
a bone screw
which they then used in the spine. Dr. ARTHUR
WHITE, Spine
Surgeon: I guarantee you 90 per-cent of the
people using
pedicle screws did not know what the status
was and that
there was all of this problem going on,
includ-ing myself.
JOHNSON: So the company was lying to you
guys, too, in
essence.
DR. WHITE: I think that's true, but we were
thanking them
for doing so because they were making these
things
available to us to use on our patients.
JOHNSON: [voice-over] Even Dr. White admits
these devices
are being abused
and should be limited to skilled spine
surgeons. But even
if a surgeon is skilled, shouldn't a patient
be told that
the device is not approved for use in the
spine? Neither
Lake Charles Memorial Hospital in Louisiana
nor Thomas
Jefferson University Medical Center, where
Ron had his
surgery, realized that the devices had never
been approved
for use in the spine. In fact, 20/20 surveyed
18 of the
most prestigious medical centers in, the
United States who
appeared on an AcroMed customer list.
Thirteen of them
either didn't know or refused to tell us
whether they
thought the devices were experimental. While
the hospitals
were under no legal obligation to know that,
attorney
Tschrin thinks they had a moral obligation.
Mr. TSCHIRN:
Oh, no question about it. The hospitals, I
think, have a
responsibility to ascertain that before a
product comes
into their hospital that it's been properly
approved by the
FDA for the intended usage for which that
hospital is
getting the product.
JOHNSON: [voice-over] And so hospitals and
doctors are
still put-ting these
devices in backs, often without telling their
patients that
they are experimental, Companies openly
promote and sell
these devices. An industry seemingly built
around lies
continues to flourish to the tune of ever
$150 million a
year. And patients who were injured grow more
and more
angry over what they feel is at the heart of
what went
wrong. CAROLYN DOUCETTE: It all boils down to
one thing --
greed. money. They saw easy money and they
took it.
WALTERS: Well, Tim, then should these screws
and plates
never be used?
JOHNSON: No. In the right hands, the hands of
a skilled
surgeon who has
experience in this kind of surgery, for the
right reasons,
such as certain surgery for tumors of the
back of for
certain kinds of frac-tures, those plates and
screws can be
very helpful.
The problem is that when we're doing 50,000
to 70,000 s
year, it's far too many. We talked to many
experts off the
record about how many should be done a year.
And nobody can
say for sure, obviously. but one person said
only 10
percent of tho~9 being done today are tru-ly
necessary. The
highest estimate we could get was 50 percent,
which would
mean, in the best case, even 50 percent are
unnecessary. So
obviously too many are being done. WALTERS:
But if you
can't believe in the hospital that you're
going to, then
how do you know whether it should be used for
you? JOHNSON:
Well, if there was ever a mandatory case for
a second
opinion, this is it. If a doctor says. "You
need these
plates and screws," you must seek another
opinion and not
from the doctor's partner or the same
hospital, from a
disinterested party because this is a case
where it's a
huge decision, as we've obviously
illustrated. You've got
to get a second opinion. WALTERS: Thank you,
T 
