Former FDA head has become “hired gun” for plaintiffs in lawsuits, drug company alleges

BMJ 2015; 350 doi: (Published 05 February 2015) Cite this as: BMJ 2015;350:h697
  1. Owen Dyer
  1. 1Montreal

Lawyers for the drug company Johnson & Johnson questioned the credibility of the former chief of the US Food and Drug Administration David Kessler in a Philadelphia court this week, after he took the stand as an expert witness in a mass tort suit against the drug maker and its subsidiary Janssen Pharmaceuticals over the antipsychotic drug risperidone (marketed as Risperdal).

The consolidated case in Pennsylvania groups together over 1200 plaintiffs from all over the United States who allege that they experienced side effects that the manufacturer knew about but sought to hide from regulators. The most common side effect was gynecomastia, mostly in teenage boys.

Johnson & Johnson faced several individual lawsuits on these grounds last year, and Kessler was scheduled to testify, but the company settled them all swiftly before they could go to court. The current case, that of a severely autistic young man from Alabama who developed large breasts as a teenager after taking risperidone from the age of 8 years to the age of 12, has been selected from the consolidated list of plaintiffs as a bellwether case. Its result will be used as a guide to predicting the outcome of the other cases, facilitating agreement on settlements. It is the first time that the issue has gone before a jury.

Johnson & Johnson’s attorney Diane Sullivan claimed that since then Kessler, who led the FDA from 1990 to 1997, has become a “hired gun” known for attacking drug makers in court. She said that he also testified for plaintiffs in litigation over the antidiabetes drug pioglitazone (Actos) and the non-steroidal anti-inflammatory drug rofecoxib (Vioxx) and had a history of testifying that companies failed to warn of products’ risks.

Kessler replied, “To say I’ve testified each and every time the same way would be incorrect.” In some cases, he said, he had praised drug makers in court for improving their warning labels.

Sullivan said that Kessler had “cherrypicked” documents to support his contention that the company knew about the risk of gynecomastia in boys. She added that Johnson & Johnson had asked the FDA to allow it to print dosing information for children before 2006 but had been refused. Kessler replied that the drug had not been approved for children before then and that Janssen’s offer to include pediatric dosing information could be construed as an effort to spur off-label sales to children.

In November 2013 Johnson & Johnson and Janssen paid $2.2bn (£1.4bn; $1.9bn) to resolve civil and criminal charges alleging the off-label marketing of three drugs, including risperidone, for unapproved pediatric indications. The drug provided its makers with more than $24bn in revenue from 2003 to 2010.

The risk of gynecomastia became public knowledge in 2006, with the publication of a study in the Journal of Clinical Psychopharmacology.1 Before then risperidone carried a warning of a possible association with elevated levels of prolactin but no mention of gynecomastia. Plaintiffs in the current case allege that the manufacturer represented the risk of breast enlargement to the FDA as less than one case in 1000 boys taking the drug, when in fact it was more than one in 100. Many of the plaintiffs in the Philadelphia case have undergone liposuction and even mastectomy.


Cite this as: BMJ 2015;350:h697


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