Guest Column: ‘B’ for Botox and B movies, V for verdict

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The case against Dr. Arnold Klein, dermatologist to Hollywood luminaries, and Allergan, the creators of Botox, ended with the jury voting 9-3 in favor of the defense. The jurors found that plaintiff Irena Medavoy’s claims of having suffered severe headaches, said to be life altering, and fibromyalgia, extreme exhaustion, difficulty breathing and swallowing, among other complaints, were not caused by Klein’s “off-label” use of Botox to treat Medavoy’s migraine headaches as well as her wrinkles.

Before the case even went to the jury, Judge Victor Chavez had dismissed claims of fraud, intentional misconduct and improper promotion of nonapproved uses of Botox. Following the verdict, Chavez dismissed the remaining claims (withheld from the jury) against Klein and Allergan of improper business and profession code violations arising out of unfair, false and misleading advertising regarding the “safe” usages of Botox.

The trial, at times, seemed to mimic the current presidential electioneering, if not its messianic mien—the spinmeisters, experts and celebrities all weighing in on the credibility of Medavoy’s claims and the value and safety of Botox.

Men and women all over the world have received the benefits of a wrinkle-free existence from the use of Botox, a drug distilled from a derivative of a toxin that causes botulism. Botox temporarily paralyzes the muscles in the forehead, e.g., causing the deep frown and sun-etched lines to disappear. However, it requires regular maintenance, which is what Medavoy had been receiving. Like Medavoy, many celebrities and the power-elite have availed themselves of this anti-wrinkle drug, some even going so far as to give “Botox parties” where friends join together in receiving injections, not unlike the sophisticated cocktail parties of old featuring the likes of Bobby Short.

But there was far more at issue than the use of Botox for cosmetic purposes, namely the off-label use of Botox to combat migraine headaches, among other things. Indeed, Botox has been used to combat muscle spasms, muscle stiffness in stroke victims and for treatment of crossed eyes, among other uses. While the FDA has yet to approve Botox for migraines, it is not illegal or considered unethical to use it (off-label) where there is authoritative evidence that it can “safely” alleviate migraines or other medical conditions.

The verdict reflects that 9 of the 12 jurors believed the defense experts’ opinion that there was no causal relationship between the injections and Medavoy’s claimed conditions. But three jurors apparently did. Allergan was quoted as stating, “The verdict is not merely a vindication of Allergan and Botox, it is a victory for good science and medicine … that has brought relief and better quality of life to millions of people suffering from debilitating conditions.”

Medavoy, after the verdict, said she will “…continue her fight to show Allergan misled the public about Botox’s safety.” She also said people should know of the risks of the off-label use of prescription drugs. However, she acknowledged what may be implicit in a trial about a “trophy wife” of a powerful movie mogul suing a world famous celebrity doctor. “Maybe a non-Hollywood person suing a non-Hollywood doctor won’t get this kind of dirt thrown at them.”

Like a B movie there was a digression during the trial into Medavoy’s two TV projects entitled “Behind the Gates” and “Trophy Wives.” The latter is said to have alluded to one plot line involving a woman, who, needing attention, falsely claims to be ill. Medavoy claimed it was gratuitous while the defense said it was fair game because Medavoy was claiming loss of wages due to her claimed inability to complete these projects.

The trial could have become a salacious circus had not Medavoy’s husband, Mike Medavoy, had the good sense to withdraw his claim that his wife’s condition had resulted in a loss of consortium. One can only imagine the cross examination regarding such intimate matters in this glass-house town we live in.

What is unstated is that it is always difficult to know how a lay jury will relate to the “rich and famous.” It is obvious that the defense was very successful in portraying Irena Medavoy in an unflattering light. It did not help her cause to appear at trial as a relative “plain Jane” only to have the defense then allude to her jet-set existence allegedly wearing gowns that cost a year’s wages, traveling to far-away exotic places, attending and giving parties to which only A-list invitees are welcome.