PHILADELPHIA — As Risperdal trials press forward, things are looking good for the plaintiffs for a change, particularly in the Austin Pledger v. Janssen Pharmaceuticals and Johnson & Johnson case where a Pennsylvania judge has chastised the defendant’s counsel for attempting to use an employee as an expert witness and for reintroducing the same evidence multiple times.
During defense testimony, Johnson & Johnson’s counsel called a biochemist employed by Janssen Pharmaceuticals, the co-defendant, to testify. The judge concluded that, in the interest of a “fair trial,” the defendant’s employee could only testify as a fact witness about his knowledge of the approval process for Risperdal by the United States Food and Drug Administration (FDA) and not on pharmaceutical regulations, which would require an expert witness who had provided an expert report. The biochemist ended up testifying that the U.S. FDA did approve Risperdal’s use on seven occasions and expanded the use of it when it reviewed the drug. He also testified that the FDA’s approval did include use for children and that Risperdal was not linked to the alleged side effects which, among others, include gynecomastia, or male breast growth. The judge also admonished Johnson & Johnson’s counsel for trying to introduce evidence that had already been admitted and expressed concern about how many times the jury was going to have to see and hear the same evidence.
Even though it is public knowledge that the FDA approved Risperdal for certain uses, including use by some children, this testimony does not address one of the underlying claims in almost all of the Risperdal lawsuits – that Johnson & Johnson and Janssen Pharmaceuticals downplayed the risks of the drugs while promoting its prescription for off-label use. Janssen’s employee’s testimony that Risperdal does not cause side effects such as male breast growth or diabetes directly conflicts with testimony given by the former commissioner of the FDA, who recently testified in the case and cited a study from 2001 that showed that nearly 4% of boys who took Risperdal developed abnormal breast tissue development. The former commissioner also testified that both the FDA and the defendants were aware of the risks, and he went on to state that the defendants did promote the drug for off-label use.
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