Commonwealth Court finds plaintiffs experts' science in Zoloft case unreliable; Miami attorney backs decision

By Hoang Tran | Nov 10, 2015

PHILADELPHIA - In a recent Zoloft lawsuit in Pennsylvania, the testimonies of two expert witnesses were thrown out for not meeting any relevant admissibility standards by the Commonwealth Court.

The case, Porter v. SmithKline Beecham Corp., et al, involved an infant born with a serious birth defect in which the abdominal organs formed outside the body. This defect, known as omphalocele, is due to the abdominal wall not closing properly.

The cause of this, according to the plaintiffs, was the mother’s usage of Zoloft while she was pregnant with the child. They are suing the manufacturers of the medication.

Jeffery Michael Cohen, an attorney for Carlton Fields in Miami and an expert who wrote in length about the usage of expert testimonies, said the court was right to exclude the testimony of two plaintiffs witnesses.

“The article explains in reasonable detail what these experts were expected to testify about and it also sets forth why the court found that their testimony was not admissible,” he said. “Based upon what is in this article, yes I do [believe that the court was right in dismissing the experts].”

The challenge for the court was to determine if the experts’ testimonies were admissible and relevant to the case.

The first expert, a Ph.D. of unnamed specialty, was excluded from testifying because the expert cited a 29-year-old study on animals and could correlate those conclusions to apply to humans. The expert also could not establish support for a direct correlation between increased levels of serotonin and embryonic development.

The second expert, a “forensic epidemiologist” with an M.D. from Sweden and a Ph.D. in Public Health (and a former chiropractor), was precluded from testifying because he relied almost exclusively on one study, which had a small sample and combined three types of data: Zoloft and omphalocele, SSRIs generally and omphalocele, and SSRIs and gastrointestinal and abdominal malformations.

Another defendant in the case, Pfizer, was granted summary judgment on Oct. 8 by a Philadelphia judge. The company argued the plaintiffs hadn't offered relevant evidence to support their claims.

“Today’s summary judgment ruling, which follows two jury verdicts in recent months in favor of Pfizer in the Zoloft litigation, affirms that that there is no reliable scientific evidence demonstrating that Zoloft causes the injuries alleged by the plaintiffs," the company said in a statement.

The Commonwealth Court conducted its own analysis of the reliability of the experts’ methodologies but with a caveat of having the expert’s opinion be “generally accepted” by the expert community. These two criteria were akin to combination of the Daubert and Frye standards.

“The use of expert testimony is basically governed by two cases. And they are federal cases,” Cohen said.

“The earlier case was called Frye [which] came out in 1923. And essentially, Frye said when you proposed to offer an expert, you must show that where he is offering testimony that is essentially new or novel, he’s got to show it as being generally accepted in the scientific community.

"And this is actually a very liberal approach because it only talks about stuff that is new. Where as opposed stuff that has been around a while that may still be in dispute, it doesn’t really have any test at all. And that was sort of recognized by the federal court.

"In 1993, the Florida Supreme Court came down with the Daubert case. And the Daubert case really discussed testimony from scientific experts. It didn’t really address issues from experts [who] are not basing their opinion on scientific evidence but, rather, they are offering opinions that may not be the subject of such scrutiny. Daubert is really more liberal than Frye in some respects although it appears to be more stringent.”

According to Cohen, there are three criteria which determine where an expert is qualified in Daubert jurisdictions.

“Whether the expert’s testimony is based upon sufficient facts, whether the methodology is reliable and whether the methodology has been reliably applied to the facts, and whether it will help the trier of fact understand the evidence.”

Pennsylvania is one of the few minority states that have yet to adopt the Daubert standard, Cohen said. Regardless of this stance, Cohen believed that it is important for the court to sift through expert testimonies and act as gatekeepers to ensure a high standard.

“Cases these days are frequently tried using experts. That term is very loosely interpreted. So you get a lot of really crazy stuff being proffered in evidence by people who claim to be experts," he said.

"And the court, at least in Daubert jurisdictions, is supposed to act as the gatekeepers. That is the language of Daubert. It says the court is the gatekeeper and the court has to determine whether or not, before an expert comes on the stand and offers his opinion, the court has to determine whether that opinion is acceptable under the standard that is used under that court. And that is why the court is called a gatekeeper: for the purpose of keeping out expert testimony that is really just [expletive deleted].

"And that is what the judge has to do. Lawyers know that you can basically hire an expert to say almost anything. The court has to undertake [its duty] to determine whether or not that is admissible.”

Cohen used the plaintiff’s first expert testimony as an example of the court acting as a gatekeeper.

“In this case, for example, the first expert opines on birth defects by relating that to animal studies and the SSRI. So that’s not really an appropriate indication from which you can base a distinction on humans," Cohen said.

"Just looking at the article, the study was 29 years old and they were making generalizations from [that study] on animals and trying to apply that today to a human birth. And basically they said that by altering the serotonin amount... which is what Zoloft does, that creates a congenital malformation.

"But there was nothing to demonstrate that when you alter the baseline level of serotonin, you would get any kind of particular result. So the judge acting as the gatekeeper essentially said ‘this guy is not going testify.’ It’s just, and you hear this phrase a lot, 'junk science.'”

Finally, Cohen believed that it is not only the duty of the court to be judicious about experts but also the responsibility of the plaintiffs and efendants. He compares junk science experts as actors.

“It’s a general rule that when you have an expert in a case, you must share his opinion with your opponent and based upon his report and sometimes a deposition of the expert and if you are opposing the expert you file a motion to exclude the expert testimony," Cohen said.

"In federal that is actually called the Daubert motion. The opponent of the expert comes to court and says ‘Judge, they are going to call this expert who is going to offer an opinion that favors their side but this opinion is not worthy of any real acceptance and therefore you should keep it out.’

"Imagine going out and hiring an actor and writing a bunch of double talk that sounds very scientific and putting it on the stand. Obviously he is a trained performer and he’s going to make it sound spectacular but it’s just nothing.

"It’s all in the packaging.”

In Cohen's home state, the Florida Bar is deciding which standard it should adopt.

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