A medical expert who has testified on behalf of Risperdal lawsuit plaintiffs claims that Janssen Pharmaceuticals “controlled and manipulated” a major study in order to downplay the drug’s association with the development of gynecomastia in boys. Dr. David Kessler, a pediatrician who once served as the head of the U.S. Food & Drug Administration (FDA), has also been a strong critic of the methods Janssen used to market the antipsychotic medication.
The article in question appeared in Clinical Psychiatry in 2003, and was co-authored by three pediatricians and three Janssen researchers. The paper concluded that long-term use of Risperdal was safe and not associated with excessive male breast growth in boys or any other specific side effects. However, a report recently posted at SAFARI.org noted that data which directly contradicted these findings were omitted from the final manuscript. In addition, the data was never submitted to the FDA, which would go on to approve the use of Risperdal in children in 2006.
The 2003 study was one of 44 that Johnson & Johnson and its Janssen subsidiary were ‘managing’ to promote sales of Risperdal. In an assessment prepared on behalf of 400 Risperdal gynecomastia plaintiffs, Dr. Kessler asserted that Janssen “controlled and influenced” all of those studies in a way that “misled physicians and the scientific community.” He also slammed the drug maker for allegedly promoting the off-label use of Risperdal in children.
Last month, The Toronto Star reported that an independent biostatistician had been tapped to conduct a reanalysis of the 2003 study in order to determine whether the original results need to be corrected.
Dr. Denis Daneman, a Canadian pediatrician and one of the three non-Janssen researchers listed as authors on the 2003 paper, told the Star that he will feel “used” if it is proven that the data was manipulated. Dr. Daneman added that he was not included in internal Janssen discussions about certain revisions to the article, and maintained that there was no intent on his part to exclude significant results.
Hundreds of Risperdal lawsuits have been filed in U.S. courts on behalf of individuals who allegedly developed gynecomastia due to its use. If you or a loved one were harmed by this medication, please call Bernstein Liebhard LLP today at (888) 996-0335 to arrange for a free case review.