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Ex-FDA head's testimony looms over Risperdal lawsuits

Physician and former U.S. Food and Drug Administration Commissioner Dr. David Kessler reportedly might testify in Risperdal lawsuit trials that may be held at a Philadelphia trial court. Kessler had submitted documents to the court consistent with the testimony he would have given in 2012 on behalf of the plaintiffs. But a defendant, pharmaceutical corporation Johnson & Johnson, settled several Risperdal lawsuits before trial back then.

Johnson & Johnson owns Janssen, which is Risperdal's manufacturer. Risperdal (risperidone) is an antipsychotic which, according to the prescribing information that the U.S. Food and Drug Administration approved in April 2014, is prescribed for the following purposes:

  • Treatment of schizophrenia
  • As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with bipolar I disorder
  • Treatment of irritability associated with autistic disorder

Kessler's 2012 statement would be just as convincing today as it was in 2012. One of the more persuasive points that his report makes is that "while promoting Risperdal for non-approved uses in children, Johnson & Johnson denied physicians the opportunity to know that Risperdal was associated with endocrine abnormalities that were greater than disclosed in the label." One of the Risperdal side effects is gynecomastia, the abnormal development of breasts in males.

"From the time of Risperdal's approval on December 29, 1993, until October 2006," Kessler's report reads, "the label for Risperdal included a Precaution for hyperprolactinemia with a statement that 'although disturbances such as ... gynecomastia ... have been reported with prolactin-elevating compounds, the clinical significance of elevated serum prolactin levels is unknown for most patients. In the section titled Adverse Reactions under the subsection 'Other Events Observed During the Pre-Marketing Evaluation of Risperdal,' the label listed 'Endocrine Disorders: Rare: gynecomastia.' The label stated that Risperdal's 'safety and effectiveness in children have not been established. According to Janssen's Risperdal label 'rare events are those occurring in fewer than 1,000 patients.'"

All of this meant, as Kessler, who is also an attorney, wrote, "Thus, from the period December 29, 1993, to October 2006, Janssen stated that the risk of gynecomastia was less than 1 in a thousand (less than Janssen's study RIS-INT-41 had an interim analysis of 319 patients produced on November 2, 2000)."

The gynecomastia rate was substantially higher, according to Janssen's study. "Thus, Janssen knew, according to its own study reports, that gynecomastia did occur at 8.3 percent and 12.5 percent in two trials."

Kessler then rounds third base and heads for home in this empirical home run for the victims. "In my opinion, by November 2, 2000, when the interim analysis of study RIS-INT-41 was conducted, Janssen knew that the risk of gynecomastia was significantly higher than the rate it reported in Risperdal's label."

A point that should not be overlooked at this point is that Johnson & Johnson agreed in 2013 with the Office of the U.S. Attorney General to pay $2.2 billion in criminal and civil penalties for, among myriad acts, allegedly marketing Risperdal to children from 1999 through 2005, a period prior to the FDA's approval of Risperdal for use in adolescents. Gynecomastia shows up primarily in younger patients.

Surgery is required from time to time to correct breast growth in Risperdal victims. In any case, the experience is, to say the least, traumatic.

A male who used Risperdal and who since has been diagnosed with gynecomastia may be entitled to compensation for medical expenses and for other losses. The Risperdal attorneys at Reich & Binstock represent Risperdal gynecomastia victims. A victim should contact the law firm, which operates in all 50 states, for a free consultation.

Contact Reich & Binstock either by calling the toll-free number below or by submitting an electronic message through the form located on this web page.

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