The legal record of Botox remains unblemished. In its first brush with the law, Allergan, Inc., the drug's manufacturer, was cleared of responsibility for Irena Medavoy's many ailments after a 2002 injection. Medavoy, a former model and actress, received a dose of Botox from Dr. Arnold Klein, dermatologist to the stars. She claims to have sought the injection to help ease her migraines—an off-label use of the purported anti-wrinkle drug. For the next four months, Medavoy claimed to suffer from an unbearable migraine, fatigue, neck weakness, and difficulties breathing and swallowing.
Medavoy sued both Allergan and Klein, who happens to be a $100,000 a year consultant for Allergan. The focus of her case? Failing to warn her about the potentially serious side effects and intentionally misleading her about the safety of Botox. She sought reimbursement for both her medical bills and her lost wages from a proposed talk show. Appropriate compensation for pain and suffering was left to the jury. But the jury eventually sided with Allergan, 9-3.
The five-week trial was heavy with medical testimony. About 20 doctors speculated on off-label uses of Botox and the cause of Medavoy's illnesses. Klein, who keeps Elizabeth Taylor youthful, testified that Botox has been safely administered in much higher doses than what Medavoy received. The doctor denied that he exceeded a safe dosage. He also noted that in his personal history of administering over 15,000 Botox injections, only Medavoy had ever experienced a severe headache after the session.
Despite much positive testimony, the trial wasn't without wrinkles for Botox. Mitchell Brin, a senior vice president at Allergan, admitted the product insert states that Botox has unknown risks as an anti-wrinkle treatment in doses higher than 20 units. He also acknowledged that the drug can spread to other areas of the body. Moreover, Allergan's own clinical studies of Botox found a potential link to headaches, pain, flu-like symptoms, and respiratory problems.
The high-profile trial was closely watched for more than legal and medical interest. Medavoy is the wife of producer Mike Medavoy, chairman of Phoenix Pictures. The trial took a Hollywood turn as attorneys showed Medavoy attending galas despite claims she was bedridden. Medavoy's last twenty-five years of emotional and physical health became fair game as attorneys discussed her divorces, career troubles, depression, and chronic fatigue syndrome.
Botox, an injectable form of botulinum toxin, has been around for nearly two decades. It's also the leading cosmetic procedure in the U.S. When injected, the drug paralyzes or weakens the muscle, preventing it from creating unwanted creases. Treatment is recommended every three to four months. The usual side effects include bruising, temporary headaches, nausea and flu-like symptoms.
In 2003, Botox brought in about $564 million for Allergan. Sales went up 17% in 2004. A big lift for Botox came in 2002, when it was approved to treat "glabellar lines," the vertical wrinkles between the eyebrows. Additionally, Botox is currently in the second of three stages of FDA testing in its quest to be named as a migraine treatment.
The Medavoys insist that despite the jury's verdict, they have won their personal battle. They've increased public awareness regarding the financial relationships between doctors and drugs as well as educated the public about the dangers of off-label drug use. Indeed, in the wake of the Botox trial, Irena Medavoy is a new kind of celebrity. She is the spokeswoman for a band of disgruntled Botox patients who blame the drug for pain and paralysis. Botox-bashers would like Medavoy to write a "how to cope" book based on her experiences.
Medavoy herself has proclaimed she is no longer concerned with her appearance. She has apparently decided to grow old gracefully. Whether Medavoy's experience will influence others is questionable. After all, Dr. Ava Shamban, a cosmetic dermatologist in southern California said, "If Botox were lethal, half of Beverly Hills would be dead and the other half would be suicidal."
So, the march against time continues. Somewhere Ponce de Leon is smiling next to his Fountain of Youth because, Botoxless, he can.