"And I will somehow stop taking it for the time being," she added. "Please contact me as soon as possible. Please don't forget about me."
The woman sent a second email on June 1, 2001, and stated: "This response is in regards to an e-mail that I had sent you previously."
"I was asking to see if you have any or are in the process of any clinical trials for women who are currently on Paxil and pregnant," she said. "I wanted to find out information to see how many women were on Paxil during pregnancy and if they were able to successfully have healthy babies."
"I love the product, and I don't think I could have gotten through my panic attacks without the wonderful help of this miracle drug," she told Glaxo.
"I just want to start to try and get pregnant again soon," she wrote. "I do not want to put my unborn child through anything that would hurt him/her."
"Please, if you do not have this information, where is this information held?" she wrote. "Does anyone do studies like this? Please, any information you may give me would be great."
Glaxo wrote back on June 6, 2001. "We are attaching a copy of our current product information for Paxil. Please review the section on use during pregnancy," the letter read.
"Further questions about your treatment should be directed to the physician, pharmacist or healthcare provider who has the most complete information about your medical condition," they said. "Because patient care is individualised, we encourage patients to direct questions about their medical condition and treatment to their physician."
"We believe that because your physician knows your medical history, he or she is best suited to answer your questions," Glaxo wrote. "Our drug information department is available to answer any questions your physician or pharmacist may have about our products."
Glaxo sent the woman basically a form letter on June 13, 2001, asking for a signature on an authorization to get her medical records, but provided no answers to the woman's questions.
On a Glaxo internal document with the same date, the box "almost certain" was checked for "Relatedness assessment to medication." There is no higher category of certainty that Paxil caused the birth defect than the box checked.
Jane Nieman, a Glaxo employee at the time, was listed as the contact person on a report sent to the FDA. Before trial, Tracey took Neiman's deposition and questioned her about Glaxo's policy for reviewing adverse event reports prior to showing her the documents about the mother who aborted her baby that said it was "almost certain" that Paxil caused the defect.
Portions of the deposition were played for the jury. Before Nieman knew about the "almost certain" document, she testified that when a causality assessment was made a physician was involved and it was a team effort. "I think it is very much a team," she said. "I think that's really how they worked."
"They would look at the case and they would form a medical opinion as to whether there was a possible, probable or no causality," she stated.
Tracey told the jury that Nieman was "stunned" when she saw the document with "almost certain," checked so he asked her whether she was uncomfortable with the fact that the assessment was made. "It was made. It's a fact," she said in the deposition. "I don't feel uncomfortable with it."
Later in the deposition, Nieman claimed she did not know who checked that box. "Somebody from GSK filled that in," she said. "There's a possibility someone made a mistake and checked the box wrong."
