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Former FDA Chief Testifies Against Johnson & Johnson in Male Breast Growth Case

Jury Could Be First to Decide Whether J&J is Liable For How it Marketed Risperdal
Risperdal Wikipedia

PHILADELPHIA, PA–The antipsychotic drug Risperdal, once Johnson & Johnson’s biggest seller, has been linked to abnormal breast development or “gynecomastia” in men, caused by an imbalance of the hormones estrogen and testosterone. 

Originating in Philadelphia Common Pleas Court, a 2012 case over claims the drug caused gynecomastia was the first to go to trial. However, before David Kessler, the former head of the U.S. Food and Drug Administration took the stand, J&J settled.

In reportedly one of the largest U.S. health-fraud penalties in history, J&J agreed to pay $2.2 billion in 2013 to resolve criminal and civil probes associated with illegally marketing the drug.

On Friday, January 30, another key Risperdal trial moved forward. Kessler testified against J&J for the third time in the case, which is being heard in Philadelphia Court of Common Pleas, a Pennsylvania state court. 

The so called “bellweather”case is expected to go on for several weeks, and its verdict could have a ripple effect on other claims against the company.

J&J lawyers attacked Kessler, who testified for a 20-year-old with severe autism, calling him “a biased witness with a penchant for finding that drugmakers hide their medicines’ risks,” according to a report from Bloomberg.

Diane Sullivan, one of the J&J lawyers, told the court that Kessler has become a “hired gun” for consumers suing drugmakers since he left the federal government in 1997, according to the report. She said Kessler now routinely finds companies fail to adequately warn the public about their products’ risks.

“Sullivan accused Kessler of ‘cutting and pasting’ findings from other cases into his conclusion that officials of J&J’s Janssen unit knew Risperdal caused some boys to develop female breasts and failed to alert patients, doctors and regulators about it,” Jef Feeley writes in the report.

“Each case is complex and there is an enormous amount of details associated with them,” Kessler countered, according to the report.

“To say I’ve testified each and every time the same way would be incorrect.”

Kessler said executives at J&J "knew by 2001 that Risperdal could cause abnormal breast development in boys."

But it didn’t include that information in any safety label until 2006, when the drug was approved for use in children, writes Feeley.

“In the years leading up to that approval, however, the company pushed doctors to prescribe the medication through ‘off-label’ marketing, Kessler added,” according to the report.

In one rebuttal involving safety warnings, Kessler said “that he’d also testified on behalf of pharmaceutical makers in some cases and found they’d ‘improved their safety warnings.’ ”

Exchanges between the defense lawyer and Kessler over the FDA’s denial of Janssen’s request to include "safe child dosing information" on the safety labels prior to 2006, before the medication was approved for autism, ended with Kessler saying the FDA was correct, as it would have been a "backdoor approval" without the required studies.

“There is nothing preventing true warning information from being included in a label. Janssen’s offer to include dosing material could be construed, however, as an effort to pump up off-label sales of the drugs to children,” said Kessler, according to the report.

"Janssen appropriately analyzed and reported data from clinical trials," spokeswoman Robyn Reed Frenze said in a statement following the January 29 court proceedings.

Risperdal generated worldwide sales of $24.2 billion from 2003 to 2010 for J&J.

But after sales peaked at $4.5 billion in 2007, the company lost patent protection and saw a decrease in sales.