Botox Lawsuit Is Raising Eyebrows

News   ·   October 3, 2004

By MIREYA NAVARRO
New York Times Staff Writer

Published: October 3, 2004

He is a Beverly Hills doctor known for pioneering work in cosmetic dermatology and for a star-studded patient list, where “Michael” is for Jackson and “Elizabeth” is for Taylor.

She is an A-list Hollywood wife, active in the right philanthropies and Democratic Party politics, and married to a famous movie producer.

But after a doctor-patient relationship of more than 20 years, Arnold W. Klein and Irena Medavoy are facing off in a medical malpractice trial in Los Angeles Superior Court that has tongues wagging as much about the players as about what they are fighting over: Botox.

The trial, now in its fifth week, is more than fodder for gossip. It is the first time Botox injections, the leading cosmetic procedure in the country, have come under attack before a jury, the drug’s manufacturer, Allergan Inc., said.

And in a city that puts Botox up there with makeup and facials for beauty maintenance, there is more than passing concern about the issues Mrs. Medavoy’s lawsuit has raised, including “off label” uses of approved drugs and the sometimes cozy relationship between doctors and drug makers.

“People need their Botox, and they come in regardless,” said Dr. Brent Moelleken, a plastic surgeon in Beverly Hills with his own celebrity practice.

He added: “Every other patient who comes in for Botox asks me about complications. The Medavoys are prominent people, and Arnie Klein is a prominent doctor, and people are all buzzing about this.”

Mrs. Medavoy, 45, wife of Mike Medavoy, the former head of Orion Pictures and TriStar Pictures and current chairman of Phoenix Pictures, is accusing Dr. Klein of treating her with Botox for migraine headaches without warning her of the risks or disclosing that he was a paid consultant for Allergan.

Botox is approved by the Food and Drug Administration for specific uses, including the treatment of certain frown lines, and the agency considers a drug “safe and effective” only for those applications, a spokeswoman said. But it is not uncommon or illegal for doctors to try out new uses. Such off-label uses, doctors note, often win federal approval, as Botox did in 2002 for “glabellar lines,” the vertical wrinkles between the eyebrows.

Plastic surgeons and dermatologists say Botox is popular for its versatility, particularly in the entertainment industry: it is a quick fix that can erase crow’s feet (unapproved) for a movie role or control sweaty underarms (approved) on the red carpet. Another off-label use of Botox is to dull migraine headaches, a feat doctors report the drug accomplishes in many patients.

During the trial Mrs. Medavoy said she had used Botox for wrinkles and headaches with no complications. But after one treatment in March 2002, she testified, she got a headache unlike any she had ever had, “like somebody put a three-sizes-too-small helmet on you.”

For about four months, she said, she could not go out, and could hardly eat and sleep. Cynthia Sikes Yorkin, an actress who is the wife of television producer Bud Yorkin, testified that Mrs. Medavoy called her at 3 a.m. one night in March 2002 “to say that she was just incapacitated.” The two had been due to work on a television project the next day.

Three months later, Ms. Sikes Yorkin testified, she found Mrs. Medavoy, who has a 6-year-old son, still in bed, tired and pale.

Mrs. Medavoy claimed that when she called Dr. Klein, he said, “I did too much,” her lawyer, Jeff Benice, said in an interview. “Our position is that she was overdosed.”

But Dr. Klein, 59, who lectures about Botox, denied on the stand that he went over a safe dosage. He said that after giving some 15,000 Botox injections since the mid-1990’s, only one patient, Mrs. Medavoy, has complained of a severe headache.

Lawyers for Dr. Klein and Allergan, which is also named as a defendant, have sought to portray Mrs. Medavoy as a hypochondriac who has long had severe headaches. Under questioning, she revealed her medical history over the last 20 years in embarrassing detail (her ailments include chronic fatigue syndrome, vertigo, spastic bowel and anorexia) and was forced to admit, “I go to doctors a lot.”

Dr. Klein had his own humbling moments on the stand. He admitted he had not changed his patient consent form to include new reports in the literature of “life-altering headaches” associated with Botox injections in cosmetic uses. And he confirmed what a gold mine Botox can be for some doctors. Up to a quarter of the $20,000 his practice generates a day comes from Botox treatments, he said, and Allergan paid him more than $100,000 a year.

Allergan is fighting Mrs. Medavoy’s allegations that the company failed to disclose all known adverse reactions and of misleading advertising. The F.D.A. has chastised the company for exaggerating Botox’s powers in ads and minimizing its risks, but a spokeswoman, Caroline Van Hove, said those issues have been resolved.

The case has drawn lines through Hollywood social circles. Dr. Klein is known for developing injection techniques in dermatology and for his involvement in causes like fighting breast cancer and AIDS. He is also known among tabloid readers for being the doctor who announced that Michael Jackson suffered from vitiligo, the skin discoloring disease.

His defenders include Elizabeth Taylor, who went on “Dateline” last year to say, “Arnie does not make mistakes.”

At the University of California, Los Angeles, where Dr. Klein is a professor, the division of dermatology at the David Geffen School of Medicine announced this summer that “friends and associates” had donated at least $1 million for an endowed dermatology chair in his name.

“This kind of thing can occur, ” Dr. Robert L. Modlin, chief of dermatology, said of the lawsuit. “Our respect for Arnie has not changed.”

But Mrs. Medavoy, a former actress and model who is active in fund-raising for charities, has her own supporters. Friends like Arianna Huffington call her “incredibly brave” for taking on a drug maker and her friends gave her a birthday lunch whose host was Cheryl Saban, the child advocate and wife of Haim Saban, the media magnate.

Mrs. Medavoy’s allegations have not been entirely dismissed by the Botox set, which is wrestling with doubts even while maintaining that rested look. Some dermatologists said their Botox business dropped right after news of the lawsuit broke.

Treatments of Botox, an injectable form of botulinum toxin that paralyzes or weakens the injected muscle, are recommended every three to four months. Doctors said the most common problems caused are bruising, temporary headaches, nausea and flulike symptoms.

But Dr. Simon Ourian, a cosmetic dermatologist in Beverly Hills, and other doctors said they had never heard of such severe complications as Mrs. Medavoy has alleged.

“My best answer is that I do it myself for my frown lines,” said Dr. Ourian, who is 36.

Like the effect of Botox, some doctors report, the jitters seem to have been temporary for many. They say their Botox business is booming.

“If Botox were lethal, half of Beverly Hills would be dead and the other half would be suicidal,” said Dr. Ava T. Shamban, a cosmetic dermatologist in Santa Monica.

If the trial is having limited impact on the drug’s appeal