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In the first Paxil birth defect trial against GlaxoSmithKline, much of evidence focused on the doctors on Glaxo's payroll involved in the corruption of the medical literature and seminars given to promote the off label use of Paxil with pregnant and nursing mothers.
On October 13, 2009, the trial of Kilker v Glaxo ended with a Philadelphia jury awarding $2.5 million in compensatory damages to the family of Lyam Kilker, after finding that Glaxo "negligently failed to warn" the doctor treating Lyam's mother about the risks of Paxil and the drug was a "factual cause" of the child's heart defects.
Glaxo's lead attorney at trial was King & Spalding partner Chilton Varner, and the family's lead attorney was Sean Tracey from Houston.
During his opening statement on September 15, 2009, Tracey told the jury that Doctor David Healy is "one of the most, if not the (most) world-recognized expert on pharmaceutical industry influence and the medicine, he is up there in the top five."
Healy "is going to explain to you how GSK corrupted the medical literature," he said, "how they used their money and influence to have doctors that they paid put out literature into the world so doctors ... could read literature that looked like literature, looked like science, smelled like science, appeared to be science, from very important people, people that were on boards, people that were professors, people that published hundreds of articles."
Healy is going to explain to you that what they didn't tell people ... "is, we are paying these doctors to do all these things," Tracey told the jury.
"There is a book, it looks like a telephone book," he said, "of names of doctors, influential doctors, on their payroll, the names of these doctors you will see on this literature that looks and smells like science."
"And just coincidentally, this science that they are going to parade before you, all seemed to help them," he told the jury. "Some of this happened in the last couple weeks before this trial started."
Advisory Panels and KOLs
While testifying, Tracey had Healy explain the concept of key opinion leaders (KOLs) and drug company advisory boards.
"When a pharmaceutical company is bringing a drug to market," Healy said, "a few years before they bring the drug to the market they look at the academic physicians in the field and work out who will be the key people who will be the advocates for the drug."
"They recruit advisory panels for the drug, which will be senior figures within the field who they believe they will be able to depend on to persuade the rest of their colleagues to think seriously about using this drug," he noted.
In explaining a "national" advisory board, Healy said, when "a drug comes to market, they will have a range of senior people in the field, it could be 10 or 12 different people from different parts of the country whom they think are going to be the most influential in helping to get their drug moving within the market here in the U.S. or the U.K."
"Then there is a further group of people down below," Healy said, "who are called the key opinion leaders or KOL for short."
"These, again, are fairly senior doctors," he told the jury. "These are the people whom it is thought will go out and give lectures on the drug to the doctors who are actually doing most of the prescribing of the drug."
In the early 1990s, Healy was on a Paxil advisory board around the time the drug was launched in the UK. People who did not think Paxil was a great product would usually be dropped from the advisory panel, he told the jury.
