THE BLOG
09/14/2010 01:54 pm ET Updated May 25, 2011

Botox Bullet

Five years after the end of my lawsuit against Allergan -- which I believe was the first lawsuit of its kind seeking damages for off-label use and misbranding of Botox -- it is interesting to see that company finally agree to pay the federal government hundreds of millions of dollars to settle criminal accusations.

Like many plaintiffs who have attempted to obtain justice in the courts against pharmaceutical companies, I did not succeed at trial -- including in my claims that close financial and professional ties between my doctor and Allergan should have been disclosed to me. I famously (or perhaps infamously) lost at trial when a divided jury ruled against me on my claims regarding the physical harms I alleged and the trial court judge refused to hear my claims regarding alleged illegal marketing of Botox.

But I now take comfort in the hope that my lawsuit may have played a role in raising public awareness about, and ultimately federal government attention to, Allergan's practices in marketing Botox. According to the Department of Justice's full press release about the settlement, if the settlement is approved, then Allergan must post on its website information about payments to doctors, such as honoraria, travel or lodging, in order to increase the transparency of Allergan's interactions with physicians. This basic issue of disclosure is a matter of great importance to me, and should be for all members of the public.

The federal government's settlement with Allergan is an important step in the right direction, but it is not a complete solution. Wholly apart from whether Allergan in particular must now disclose such information about the doctors that it compensates is the far greater issue of why all doctors and pharmaceutical companies do not disclose such information regarding any drug or treatment being prescribed. In my opinion, it is important for patients to know such information, and there should be a legal right for patients to know such information, if such a right does not already exist under laws governing fair business practices.

When I brought my lawsuit against Allergan alleging that I had been seriously and life-alteringly harmed by the spread of Botox throughout my body, my claims were met in some circles with disbelief and ridicule -- and in other circles with full belief in their validity. Just a few years later, on July 31, 2009, according to information still available on the website of the Federal Drug Administration, the FDA "approved the following revisions to the prescribing information of Botox/Botox Cosmetic . . .: A Boxed Warning highlighting the possibility of experiencing potentially life-threatening distant spread of toxin effect from the injection site after local injection."

In my lawsuit, I also argued that Allergan's promotion of off-label uses of Botox was against the law. Now, according to the Department of Justice press release, Allergan has been the subject of a criminal FBI investigation for its marketing practices. That investigation surely was an ugly experience for Allergan that must have caused its executives to experience headaches that could not be cured by Botox.

Even though Allergan has had some success in beating back litigation by private plaintiffs like myself, finally, in the face of criminal charges by the federal government, Allergan has agreed to pay hundreds of millions of dollars based on charges similar to those that I alleged and that others like me alleged. Other plaintiffs now have their own lawsuits pending against Allergan regarding Botox. My hope is that those other plaintiffs, with the recent history of federal regulatory action against Allergan, will find success in the courts and that in the future potential patients will be adequately informed and protected from harm.