J&J lawyers aim to discredit ex-FDA chief in Risperdal breast-development case

Former FDA commissioner David Kessler

Johnson & Johnson ($JNJ) has fired back against former FDA chief David Kessler, who testified against the company last week in a Risperdal liability case. Kessler can't be trusted on drug safety, J&J's lawyers said, because he's a "hired gun" known for attacking drugmakers in court.

Kessler is an expert witness for the parents of a young man who developed breasts while using J&J's antipsychotic drug. The plaintiff says J&J didn't adequately warn doctors and patients about that risk. After reviewing documents related to the issue, Kessler last week suggested that J&J must have known about the potential side effect years before adding information about it to Risperdal's official label.

J&J lawyer Diane Sullivan painted Kessler as a biased witness bent on discrediting drugmakers, Bloomberg reports. The former FDA chief commonly testifies in drug-safety trials, and commonly finds that companies haven't properly warned about a product's risks, Sullivan said. For instance, Sullivan said, Kessler testified for plaintiffs in lawsuits over Merck & Co.'s ($MRK) now withdrawn painkiller Vioxx, and more recently, for a plaintiff suing Takeda and Eli Lilly ($LLY) over the diabetes drug Actos.

Kessler disputed Sullivan's charges. "Each case is complex and there is an enormous amount of details associated with them," Kessler said in court (as quoted by Bloomberg). "To say I've testified each and every time the same way would be incorrect."

During cross-examination in the latest case, Sullivan accused Kessler of cherry-picking documents to support his conclusion that J&J executives knew Risperdal had caused boys to develop breasts, but did nothing about it for years.

Sullivan said that J&J's Janssen unit asked to add information about safe dosing in children to Risperdal's labeling before the breast-development warning went on in 2006. But the drug wasn't approved for children until then, Kessler pointed out, and the agency didn't want the official label to spur off-label use.

Janssen maintains that the company's warnings were complete and proper, and that it did not mismarket the drug. In a statement provided to the news service, a Janssen spokeswoman said Risperdal "has improved the lives of countless children and adults throughout the world who suffer from debilitating mental illnesses, and it continues to improve patients' quality of life today."

- read the Bloomberg story

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