From 2008-2010, there was a rash of headlines around pharmaceutical manufacturers manipulating study data and publication of study data. The issue came to light through the work of several expert witnesses. What you may not have realized is that those claims were proven with largely public data.
Litigation attorneys so often focus upon the discovery demands and responses that we can forget the obvious: what’s available through public information?
In these cases, pharmaceutical expert witness reviewed the content of published studies and marketing materials and questioned the line between science and marketing. The analysis revealed patterns in the data presentations, including pharmaceutical manufacturers spinning negative findings into a more positive framework, bundling negative and positive studies to dilute adverse copy, and publishing full studies on positive studies while publishing abbreviated studies on negative ones.
These pharmaceutical expert witnesses were then able to combine public information with discovery responses and create a compelling story. The lawyers, for example, uncovered e-mails through the discovery process that bolstered the pharmaceutical expert witness findings. The specific, lawyer-secured materials added that edge of intrigue and bad corporate governance to a methodology of findings captured in the plain of the public realm.
Other, similar examples of pharmaceutical expert witnesses include their analysis of reviews and commentaries from paid ghostwriters to tout the benefits of a drug.
As with any pharmaceutical case, it is for the lawyer to develop fluency in the uniform requirements for medical journals, according to the International Committee of Medical Journal Editors, and to know on and off label uses for pharmaceuticals under the False Claims Act. Even so, the pharmaceutical expert can help us bridge the legal framework put over the medical field, by getting us inside a medical brain to arrive at a better understanding of not only industry practices, but, also, how to use industry publications to help us prove our case and help our clients recover.
Ultimately, we capture our juries and judges when we present a technical case in a manner that can be understood and remembered. The pharmaceutical expert witness can talk through a technique for collection, review, and analysis of materials published by the defendants to the public making specific claims in a manner that equates “unethical” with “unlawful.” It’s just one creative and effective application of the pharmaceutical expert witness who helps us bring the jury bring back in favor of our clients.
By: Paloma A. Capanna, Attorney at Law