When Paxil was first approved in the US, although Glaxo did not list the number of birth defect cases reported on the label, if a doctor contacted the firm wanting information, Glaxo sent out medical information letters with the number of birth defects reported.
Tracey entered three such letters into evidence. The first letter listed 36, the second 42, and the third 64. Then in the late 1990s, instead of including the number of birth defects reported, the letters started only listing the percentages, and after that they went to listing nothing, Tracey told the jury in closing arguments. "It goes from numbers to percentages to nothing."
During the trial, a Doctor Hobbiger testified that Glaxo enacted a policy not to give doctors the numbers because doctors were incapable of putting them into context. "The funny thing about that to me," Tracey told the jury, "is why were the doctors capable of putting the numbers in context when the numbers were low?"
"How did they magically become incapable of rational thought once the numbers became high?," he pointed out.
He noted that a big thing happened in1998. Glaxo analyzed all the data they had been receiving on Paxil, and the person writing the report made the following finding: "The number of reports we have of women with birth defects is an alarmingly high number. We should not see this number of birth defects. It's four to five times what we would expect to see."
"This is an internal document that nobody has ever seen before, not the FDA, not anyone," Tracey said.
Earlier in the trial, he had showed the jury a letter from 1984, in which the FDA specifically told Glaxo they needed to tell the FDA "whether or not you receive any alarming information either in animal studies or in the human population."
"And in1998 this is their language, not mine," Tracy told the jury. "The incidence rate of congenital abnormalities as observed in data reported in this document is 13.3 percent."
This is a problem, he said, because the background rate "is 2-1/2 to 4 percent, depending on who you believe."
Birth Defect Info Request Refused
During the trial, the jury learned that in 2001, Glaxo received two emails from a woman specifically asking for any information Glaxo might have on birth outcomes of babies born to mothers who took Paxil.
The woman reported that she had recently gotten married and immediately became pregnant because they wanted lots of children. But when she was six months along, the pregnancy had to be terminated after tests showed the baby had a rare heart defect and would likely not survive to term or survive the necessary open heart surgery to save his life if born alive.
"To say the least, I was absolutely distraught with this news," the woman said. "I thought this was something that I did ... because I stayed on the Paxil for selfish reasons."
"I wanted to know if you could direct me to any information you might have of any woman that has taken Paxil and still had healthy babies," the woman wrote in late May 2001.
"My husband and I are ready to try again to get pregnant in the next month or two," she said. "I am so nervous."
The woman had been on Paxil for over four years and loved how the drug worked for panic attacks. "I don't want to stop taking my miracle pill," she wrote. "But, then again, if there is a chance that this might hurt or affect the baby, I want to know upfront."
