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Jury Weighs Conflicting Opinions on Link of Zoloft Use to Violence
New York Law Journal
September 22, 2009
Jurors in the assault trial of a Long Island, N.Y., man will have to weigh the drastically different opinions of two Harvard-educated psychiatrists to determine whether the popular antidepressant Zoloft can trigger a violent episode.
Brandon Hampson, 39, is facing misdemeanor assault charges for allegedly beating his girlfriend and preventing her from leaving his home in August 2006 after she refused to have sex with him. Hampson claims that he was going through Zoloft withdrawal at the time and did not intend to assault the woman.
In a packed Hempstead, N.Y., courtroom on Friday, Dr. Douglas Jacobs, the prosecution's expert, repeated his opinion that no generally accepted scientific evidence supports the defendant's claim.
"I have not seen any statement indicating that Zoloft causes violence," Jacobs, an associate clinical professor at Harvard, told defense attorney Eric Bernstein, on cross-examination.
On Thursday, Jacobs testified that since Zoloft first entered the market in 1992, 9 million people have been prescribed the drug. He acknowledged on cross-examination that since then, "probably" 50,000 "adverse events" have been reported.
Adverse events like insomnia, nausea and irritability are "not necessarily" caused by any drug but are reported by patients during a drug's clinical trials and then funneled to the Food and Drug Administration, Jacobs told the jury.
The FDA then "takes into account other causes" of potential side effects before determining whether to approve the drug for market use, and what warnings to issue, Jacobs told the jury panel of two women and three men.
And, he testified, "if there was a signal about harm to others it would have occurred during clinical trials" of Zoloft, the drug made by Pfizer.
Individual case reports of adverse reactions are not sufficient to establish causation, Jacobs said, as the "gold standard" relied on by the scientific community is a controlled clinical trial where two groups of patients with similar features can be accurately evaluated and monitored for reactions to a drug.
"I did not find any study that indicated that Zoloft, or [any drug in its class], in a study, increased aggression," Jacobs said, adding that there was "no indication" that discontinuing antidepressants led to violence.
'PRECURSORS TO VIOLENCE'
The defense expert, Dr. Stefan Kruszewski, testified Wednesday that a "small minority of individuals who take Zoloft could experience certain side effects and that includes violent acting out."
Kruszewski, of Harrisburg, Pa., like Jacobs a Harvard Medical School graduate, told the jury that Zoloft could cause "the precursors to violence," including aggression and impulsivity.
But Kruszewski admitted on cross-examination that he had conducted no experimental research or scientific tests in reaching his opinion. Instead, he said he interviewed Hampson and reviewed medical literature, "re-read the Zoloft label" and had done "a lot of online study."
He admitted he was "aware" that studies exist which show that antidepressants, including Zoloft, tend to decrease aggression, but maintained that there was a connection between violence and the after-effects of the drug.
"We've got thousands of reports over many years now since the introduction of Zoloft to the marketplace, that there is a linkage between violence and agitation problems associated with discontinuation of the drug," said Kruszewski, who was paid $10,000 to testify.
On cross-examination Friday, Jacobs hedged when asked if Pfizer was paying his daily $7,500 fee. He said that the company had never paid him but then admitted that an unnamed law firm in Colorado with ties to the manufacturer had arranged for him to be paid for his appearance.
"I only know that the law firm is billing Pfizer," he said, estimating he had made $60,000 on the case so far.
The Nassau County district attorney's office has acknowledged that Pfizer is paying Jacobs.
An erratic pace has marked the weeklong trial. Both sides have requested frequent bench conferences, and district Judge Rhonda E. Fischer has had to reign in both counsel and witnesses.
A heated exchange Friday afternoon between Bernstein and Jacobs came after Jacobs said he had not reviewed adverse event reports pertaining to Zoloft in preparing his testimony.
"Don't you think it would be important?" Bernstein asked.
"Not in this case," the doctor replied. "You wanna know why?"
"We'll get to that," retorted Bernstein, adding, "Thanks for asking!" which immediately led to a bench conference.
Assistant District Attorney Christina Colon is prosecuting the case.
Cross-examination of Jacobs was to continue Monday.
