Battle over Botox
Lawsuit alleges malpractice from Hollywood doctor
EXCERPTS:
But she also blames Dr. Klein for not telling her he was a paid
consultant to the company that makes Botox, which she maintains was a
conflict of interest.
But what they're trying to keep the public from knowing is that there
are a lot of people what are not going to be helped and are gonna be
hurt."
Some of the reported reactions have been mild, but some of them have
been serious and associated with hospitalization, disability, even
death.
For Mrs. Medavoy the low-point since filing her lawsuit, she says,
was finding out she was being followed by private investigators. She
filed a stalking report, and "Dateline" was with her when officers
stopped a private investigator, one of three we saw shadowing her.
That's just business as usual, according to the drug manufacturer's
general counsel,...
The FDA has cited the drug company in the past for promotional
literature that was "misleading" and "minimizing of side effects."
~~~~~~~~~~~~~
http://www.msnbc.com/news/927823.asp
NBC NEWS
June 17 It's the drug of choice for millions who want to keep
looking young and appealing. A Botox shot for wrinkles is the fastest
growing cosmetic procedure in the country, with women and men flocking
to doctors, to spas, even to so-called "Botox parties" for the
injections. Now there's a Botox lawsuit, a case involving a well-known
Hollywood doctor, that's making some of the rich and famous both
anxious and angry.
ENTER THE WORLD of 44-year-old Irena Medavoy and her Botox
horror story. She says the hottest drug on the cosmetic market nearly
ruined her life. According to her, the ordeal began when her
dermatologist injected her with Botox for migraine headaches. What
began as the medical story of one angry patient has now made salacious
headlines, sparked heated debate and even elicited charges of
stalking.
The whole episode has turned into a drama of division and
loyalty on a scale that surprises even Hollywood veterans.
Carrie Fisher: "There are people on this side, and there are
people on this side."
Hollywood's big guns are blazing, dishing about a lawsuit that
pits the beautiful wife of movie producer and former studio chief Mike
Medavoy, the man behind dozens of films from "Rocky" to the current
"Holes," against the billion-dollar company Allergan that manufactures
Botox and the man who administered it to her, one of Tinseltown's most
cherished citizens and revered doctors, Arnold Klein, known as the
dermatologist to the stars. And some very big ones are standing up for
him.
Elizabeth Taylor: "Down to the very finest detail, he is the
definitive description of perfectionist."
There is no doubt Dr. Klein has been a big booster of Botox, an
acknowledged early pioneer in its cosmetic and medical use, even
demonstrating how to use it on NBC News three years ago. And there is
also little doubt that Irena Medavoy was once one of the drug's
biggest fans, willing to brave a needle and pay up to $1,000 a
treatment to get her flawless look.
Medavoy: "I don't know anybody who wasn't using it... every
single friend. Absolutely. We all have the exact same forehead. We
used to walk around with the same kind of forehead. No expression kind
of thing."
No expression because Botox, the trade name for the neurotoxin
botulinum toxin Type A, is a potent drug produced by bacteria that can
kill you but properly administered temporarily paralyzes muscles,
reducing the appearance of wrinkles and frown lines.
Most people who've heard about Botox know of it as a medical
fountain of youth from advertisements on television and magazines. But
the drug is increasingly being used to treat a variety of medical
ailments, from crossed eyes to spastic muscles, sweaty palms, back
pain, even multiple sclerosis. The FDA has only approved Botox for
three medical conditions and, cosmetically, for the frown line between
the eyes. But it's routine to test new drugs for what are called off
label uses, that is, for treatments not yet approved by the FDA.
Several of those off label uses involving Botox seem to hold great
promise. Among them, the use of Botox for migraines.
It's estimated that nearly one in five women suffer from
migraines, Irina Medavoy among them. She says she discussed her
headaches with Dr. Klein while she was being treated with Botox
cosmetically.
Medavoy: "There was a discussion about headaches, migraines.
Oh, do you get headaches? Yes, I get migraines. Oh, well you know
what? We're using Botox for migraines. I said, really? wow, I don't,
you know, I don't know. Oh, no side effects. It's nothing. It'll
definitely help you, it's great."
Maria Shriver: "Now you had a neurologist on the side that you
were seeing, who was treating your migraines. Did you think to call
him up and say, you know what. my dermatologist tells me Botox for
migraines. What do you think?"
Medavoy: "Guess what? I didn't. I trusted Klein. I've known him
for 25 years."
In retrospect, Irena Medavoy blames herself for not asking more
questions. But she also blames Dr. Klein for not telling her he was a
paid consultant to the company that makes Botox, which she maintains
was a conflict of interest. She also claims he didn't tell her that
using Botox for migraines was off-label. She admits, however, to
previously signing a consent form when she first got Botox for
wrinkles, when that use was also off-label.
Medavoy: "Off-label? What is off-label?
Shriver: "You didn't know what off-label was?"
Medavoy: "No. And I signed this consent form, and you know what
else it says in there? Don't lay down for four hours. And you might
get an eyelid droop and a transient headache. That's what it said."
She says the side effects for her last migraine treatment were
much more severe, so severe they have changed her life.
Medavoy: "One of the reasons I'm suing is that I would never
have taken the treatment if I had known that I could have life
altering headaches which is by the way, what I have now, life
altering headaches."
She says she had no reaction to her first Botox treatments for
wrinkles and migraines, but says that changed with her fourth
treatment for the headaches. According to the medical file Irena
Medavoy provided NBC News, Dr. Klein injected her on that occasion for
the second time in the neck, at the base of the skull, but this time
with 86 units of Botox, the largest dose he'd ever given her.
According to several neurologists we spoke with, both the location of
the injection and the dosage are standard for treatment of migraines.
But Irena Medavoy says she knew right away that something was wrong.
Medavoy: "I remember when I got up, I said, it's too much,
Arnie. It's too much. because there were so many shots."
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She says she followed instructions given by Dr. Klein's
office: no exercise, no lying down for several hours. She says she
felt fine, well enough the following day to take her four-year-old son
and some of his friends to Disneyland. But within days she says, she
began to feel unwell.
Medavoy: "About like the third day, fourth day, still, but
thinking, you know what, I'm thinking I'm coming down with the flu.
Something's wrong. I'm getting a little bit of chills. Something's
wrong. Kind of feeling off. The sixth, the seventh day, I got a
headache that I thought I was having a stroke. I got a headache like
I've never had in my life."
She says the pain increased and wouldn't respond to her regular
migraine medication. She called Dr. Klein.
Medavoy: "I said, Arnie, something's wrong. I've got like this
headache. He says, "oh I gave you too much. I gave you cosmetic and
migraine at the same time. Next time, I won't give you that much.'"
Shriver: "He said that to you, "I gave you too much?'"
Medavoy: "I gave you too much.' And I said, Arnie, there's
never going to be a next time. What can I take. Help me. What do I
take?"
She says Dr. Klein told her that nothing could help the pain,
but that it would subside in a matter of days. It didn't. She called
UCLA to speak with her neurologist, Dr. Andrew Charles, whom she had
been seeing for the migraines that plagued her three times a month.
But this headache was different.
Dr. Charles: "This was a incapacitating, unremitting headache
that was centered more around her neck and shoulders, and something
that didn't respond to any of the medications we tried on her."
Medavoy: "I wound up in the emergency room on the Saturday. I
said, I can't breathe, my head, I can't breathe."
There was a second trip to the emergency room, followed by
endless visits to doctors. Her internist of over five years, Dr.
Robert Huizinga, says he was perplexed by how his patient had suddenly
become so ill.
Dr. Huizinga: "She was really bedridden for several months. And
we were confused initially. And obviously we wondered, gee, is it an
infection? Because she did have flu-like symptoms and a temperature up
to 102."
Irena Medavoy says she spent most of the next three months in
bed, rarely able to leave her room. She says she could barely swallow,
that she lost 18 pounds in four weeks, suffered from extreme fatigue,
fever and excruciating pain. Her baffled team of doctors tested for
everything, even doing a brain screen and other tests to rule out
auto-immune and psychiatric diseases.
Dr. Huizinga: "At the end of the day, we felt it was due to a
Botox reaction, both because temporarily it happened within several
days. And number two, because it seemed to fit the pattern described
in previous reports."
Irena Medavoy says she finally began to function after three
months in bed followed by another three months of being pretty much
housebound. Even a full year later, she still complains of fatigue and
pain.
Medavoy: "The big difference in my life is that I went from
never taking a daily medication, to taking five."
Convinced that these health problems are a direct result of
using Botox, she filed suit, not just against Dr. Klein for
malpractice and failing to disclose his business relationship to
Allergan, but also against Allergan for producing and marketing a drug
she calls "an inherently dangerous product" when injected for
off-label uses.
As word spread of the Medavoy lawsuit, the Hollywood gossip
machine went into overdrive, especially when it was learned that Irina
Medavoy's husband, Mike, added the legal claim that his wife's
Botox-induced illness had deprived him of "her companionship, intimacy
and services..."
Shriver: "Why did you have him go in on this lawsuit with you?
why not just say, this happened to me. This is my lawsuit and I'm
going it alone?"
Medavoy: "Mike sued to give me support and say, you know what,
they're gonna take hit. Let's take the hit together.'"
Mike Medavoy has since dropped out of the lawsuit, but stands
firmly behind his wife's claims that Botox harmed her. And Irena
Medavoy's attorney, Arthur Leeds, says his client's case against the
drug company is solid.
Leeds: "This is not a situation where everyone who takes Botox
is going to be injured. Maybe a lot of people are going to be helped.
But what they're trying to keep the public from knowing is that there
are a lot of people what are not going to be helped and are gonna be
hurt."
Leeds says Irena Medavoy's case is bolstered by the numerous
letters and calls he's received since the case went public from other
people who say they've also had adverse reactions to the off label use
of Botox and some of their stories sound eerily similar to Irena
Medavoy's."
Last year, a 38-year-old woman who doesn't want her name used,
went to the dermatologist, who told her Botox could erase laugh lines
around the eyes. Within seven to 10 days she says she started getting
headaches, intense fatigue and flu-like symptoms. She didn't call
Allergan, but did call her doctor, who diagnosed her with palsy. By
day 10, the left side of her face became paralyzed. Woman: "I'd look
in the mirror and I didn't even see myself. I mean, it's just been
like the last few months where you look in the mirror and you start
seeing the person that you saw all those years."
In another case, 40-year-old nurse Debbie Sulzle says she
spiked a fever, suffered intense headaches and had the lower part of
her face paralyzed after getting Botox for the lines between her nose
and mouth. Frightened, she reported her reaction to Allergan. The drug
company does not deny that Sulzle may have had a reaction, but says
not all of her symptoms can be attributed to Botox, particularly the
ones she claims she still suffers from three years after her
treatment.
Sulzle: "I still drool a little bit off and on if I'm real
tired or something. It's just very weak in that area still. The
muscles are just not strong like they used to be."
It's difficult to know how many people have had adverse
reactions to Botox, and whether they were caused by the drug or how it
was administered. The FDA says it's received more than a thousand
reports on Botox since the drug was approved in 1989, but says that
number is small given the estimated two and a half million people
who've used the drug. Some of the reported reactions have been mild,
but some of them have been serious and associated with
hospitalization, disability, even death.
Irena Medavoy says it is the stories of others who've had
similar problems with Botox that inspire her to continue with a
lawsuit she admits has tested her mettle. And she knows the big hurdle
ahead will be to prove that her medical problems have nothing to do
with her personality and life and everything to do with Botox.
Shriver: "So when people say, Irina Medavoy, crisis queen,
dramatic, she's got a lot of other stuff going on not Botox related,
she will, she's doing this for the money and the attention?'"
Medavoy: "It's about they harmed me with Botox. I was injured
by it. It's the only way is it to hit them in the pocketbook so they
understand that they have to disclose the full risk."
Shriver: "What do you think did happen to Mrs. Medavoy?"
Howard Weitzman (Klein attorney): "Could have been a nervous
breakdown, could have been chronic depression, could have been a
number of things.
According to Dr. Klein's attorney, there is another side to the
story Irena Medavoy is telling.
THE OTHER SIDE
Irena Medavoy may complain of intense fatigue and excruciating
headaches a year after getting her fateful Botox injection, but
according to the manufacturer of the drug and the lawyer working for
the doctor who administered it, she will have a difficult time
convincing a jury that Botox is at fault.
Weitzman: "I don't dispute for a moment she was ill at some
point, and maybe very ill. I just don't think the evidence will show
that Botox was the cause."
--------------------------------------------------------------------------------
Weitzman is an attorney accustomed to trying high profile cases
that play themselves out in the press, having represented both John
DeLorean and briefly, O.J. Simpson.
Weitzman: "Some jury will decide if Dr. Klein committed
malpractice. I don't think any evidence will surface that he did."
Dr. Klein declined to be interviewed by Dateline, but through
his lawyer, disputes Irena Medavoy's story. The first point he
contests is that she wasn't told that Botox for migraines was an
off-label use of the drug. Weitzman says Dr. Klein told her it was,
and that she understood what that meant.
Weitzman: "I think Mrs. Medavoy is a smart lady. I think she
understood what off-label is."
Weitzman also denies that Dr. Klein ever told Irena Medavoy
that he gave her too much Botox. And he dismisses her charge that
there was any ethical problem with Dr. Klein working as a paid
consultant for Allergan.
Shriver: "Is it the ethical thing to do for Dr. Klein to have
divulged his relationship with Allergan to Mrs. Medavoy before he
injected her with Botox?"
Weitzman: "I absolutely think it has nothing to do with that. I
think being a consultant to a pharmaceutical companies is done by
doctors all over the world. That's the way pharmaceutical companies
learn how their product reacts in clinical situations."
Weitzman does admit, however, that the case has taken on a life
of its own.
Weitzman: "I don't think it can get much uglier, honestly."
For Mrs. Medavoy the low-point since filing her lawsuit, she
says, was finding out she was being followed by private investigators.
She filed a stalking report, and "Dateline" was with her when officers
stopped a private investigator, one of three we saw shadowing her.
That's just business as usual, according to the drug manufacturer's
general counsel, Douglas Ingram.
Ingram: "We have absolutely observed Mrs. Medavoy in public
places, which is very common in cases like this."
Shriver: "So you hired private investigators to observe her, to
follow her?"
Ingram: "To simply observe her in public places. Remember Mrs.
Medavoy has asserted not only in the lawsuit but in the media the
claim that this chronic condition has impacted her social life. We
obviously have to go to trial at some point in this case."
Shriver: "Her claim is that this changed her life. She is an
altered person from her experience from Botox."
Ingram: "If Mrs. Medavoy is suffering from any of these
ailments, I certainly feel sorry for her and I hope that she gets
relief and she finds out the cause of them. But never, to my knowledge
in the history of Botox has a constellation of side effects occurred
as Mrs. Medavoy is contending and persisted for a year."
The intensity and duration of Irena Medavoy's reaction does
surprise many doctors we spoke with, including the Chief of Neurology
at Kaiser Permanente in San Diego, Dr. Andrew Blumenfeld, who runs the
headache clinic. He says he has used Botox for 14 years, treating
migraines with it for the past five. He frequently injects in the neck
area and often in doses much larger than what Dr. Klein gave Irena
Medavoy and, he says, with great success.
Dr. Blumenfeld: "I've used it in relatively large doses and I
have not run into any significant side effects. most of the side
effects that I've seen have been mild or transient."
Shriver: "Such as?"
Dr. Blumenfeld: "It depends on the site that I'm injecting."
Dr. Blumenfeld says stiff necks, an increase in headaches and
droopy eyelids are the consequences he most commonly sees. And those,
he adds, can be minimized with medical expertise.
Dr. Blumenfeld: "The sites that we inject are very specific and
the technique is very important."
But Dr. Blumenfeld admits that while he hasn't seen a condition
as severe as Irena Medavoy's, incorrectly used, Botox could cause
problems.
Dr. Blumenfeld: "It's true that if you inject in large doses
and possibly incorrectly, that you would produce muscle weakness. It's
not into the artery, it's deep into the muscle where you're going to
maybe give too much of the medication, and you could aggravate the
headaches when you do that."
Allergan's general counsel insists Botox is safe. He says it's
been administered over seven million times and points out that in the
development of all new drugs from aspirin to penicillin, some patients
have had bad reactions. He acknowledges that in rare instances, the
side effects of Botox, especially with it's medical use, can be
severe."
The FDA has cited the drug company in the past for promotional
literature that was "misleading" and "minimizing of side effects."
Allergan says its materials have been updated, including the product
inserts it is required to send to doctors.
Shriver: "It says there are reports of adverse reactions with
cosmetic use that include headaches, respiratory infection, flu
syndrome, nausea and with Botox general use, even rare spontaneous
reports of death sometimes associated with dysphasia, pneumonia and/or
other significant disability."
Ingram: "I don't dispute that's in the label. There were
reports of not common, but rare reports of the various side effects
you mentioned pain at the injection site, headache and the like. it
should also be noted, however, that every one of those particular side
effects, were also noted in the placebo group."
In other words, according to Ingram, patients not injected with
Botox exhibited the same symptoms as those who were. And as for whose
responsibility it is to inform patients about the side effects listed
on those labels, he says that's in the hands of doctors.
Ingram: "Its really the physician's professional judgment and
responsibility that guides the physician in determining what kind of
conversations ought to occur between a physician and his or her
patient."
It's a conversation attorney Weitzman says did take place,
despite Irena Medavoy's claim that it did not.
Weitzman: "I think he met the standard of care necessary and
required by the medical profession. I think that's what the evidence
will show.
Until this lawsuit received notoriety, the only attention Dr.
Klein was accustomed to getting was praise for his considerable
medical and philanthropic accomplishments. But his high profile
friends and patients like Carrie Fisher and Elizabeth Taylor recognize
that today he is caught in the middle of a lawsuit that threatens a
lot more than just his medical practice
Shriver: "What's this case done to him? What effect has it
had?"
Carrie Fisher: "Well, it challenges his integrity. I mean, he's
this beloved man, and it challenges his word and his integrity and
stuff like that."
Shriver: "You obviously feel that it's important to support
this man, not just because he's your friend."
Elizabeth Taylor: "No. It's because I believe in him with all
my heart. I believe in his integrity more than any other human being
alive. He cannot, and does not, do or make a wrong move."
Shriver: "Isn't it possible that he made a mistake?"
Taylor: "No."
Shriver: "No?"
Taylor: "Arnie does not make mistakes."
The stakes are high not just for Dr. Klein, but also for
Allergan. Publicity could hurt the image of a drug estimated to earn
the company $580 million this year alone.
Ingram: "Dr. Klein and Allergan are both defendants in this
lawsuit and we're going to work together to ensure that this frivolous
lawsuit is resolved... and our product and Dr. Klein are vindicated.
And as for Irena Medavoy, she says it has become her mission to
warn other people who are considering the use of Botox to research the
possible consequences first.
Shriver: "You're not saying, don't touch Botox."
Medavoy: "It's everyone's life. They have to choose for
themselves. Is it worth the rewards they're going to get? But just be
informed."
Both sides have a court appearance next week, though no trial
date has yet been set. The FDA review of Botox incidents should be
completed in the next few months.
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