Former FDA head testifies against J&J in “off-label” marketing case.

(Bloomberg) — Johnson & Johnson, which paid more than $2 billion to resolve a criminal probe over its antipsychotic drug Risperdal, knew as early as 2001 that the medication caused boys to grow breasts, a former government regulator said in the first case over the treatment set to be decided by a jury.

Officials of J&J’s Janssen unit funded a 2001 study that showed 3.8 percent of boys given Risperdal during the clinical trial developed breasts that were either “probably or very likely” caused by the drug, David Kessler, the former head of the U.S. Food and Drug Administration, testified Wednesday in state court in Philadelphia.

The study “certainly was a red flag to me,” Kessler told jurors in the trial of a lawsuit brought by a 20-year-old Alabama man who blames the drug for his 100-pound weight gain and his development of female breasts. The man alleges Janssen executives hid the risk that Risperdal could create abnormal breast development in boys.

J&J, based in New Brunswick, New Jersey, faces more than 1,000 cases over the Risperdal side effect in state court in Philadelphia. In 2012, he company settled the first case to go to trial over claims the drug caused gynecomastia, or abnormal breast development, in boys.

Janssen officials said Wednesday the company properly warned patients and their doctors about Risperdal’s risks and didn’t mishandle marketing of the drug.

‘Improved Lives’

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,” Robyn Frenze, a Janssen spokeswoman, said in an e-mailed statement.

In 2013, J&J agreed to pay $2.2 billion to resolve criminal and civil probes into claims that it illegally marketed the drug to children and the elderly. The settlement, which also includes marketing claims about two other J&J drugs, was one of the largest U.S. health-fraud penalties in history.

The accord resolved probes by federal officials and attorneys general in 45 states into allegations the company marketed the drug for unapproved uses. While doctors may prescribe an approved drug for any reason, companies can market them only for purposes authorized by the FDA.

Risperdal also has been linked to excessive weight gain and diabetes. The drug, once J&J’s biggest seller, generated worldwide sales of $24.2 billion from 2003 to 2010, reaching $4.5 billion in 2007. After that, J&J lost patent protection and sales declined.

Safety Warning

Kessler, testifying as an expert for the man suing J&J over Risperdal, described for jurors his September 2012 review of the drugmaker’s handling of the medication. A pediatrician, Kessler served as head of the FDA for six years starting in 1991. He now works as a medical professor in California.

The former regulator concluded that while J&J knew as early as 2001 that the drug could cause breast development, it didn’t include a warning on the safety label until 2006, the year it received approval to sell the medication to children.

In the years leading to that approval, the company pushed doctors to prescribe the medication through “off-label” marketing, Kessler added.

To fuel such sales, J&J officials provided doctors with trinkets such as children’s Lego-like blocks in bright colors adorned with the Risperdal logo, Kessler said in his report.

Lawyers for the Alabama man who developed breasts after taking Risperdal for five years contend that J&J encouraged doctors to prescribe Risperdal off label for treating childhood disorders such as attention deficit and disruptive behavior, according to court filings.

The case is PP v. Ortho-McNeil Janssen Pharmaceuticals, 120401997, Court of Common Pleas Philadelphia County (Philadelphia)

To contact the reporters on this story: Jef Feeley in Wilmington, Delaware at [email protected]; Sophia Pearson in federal court in Philadelphia at

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To contact the editors responsible for this story: Michael Hytha at[email protected] Andrew Dunn

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