Phillip Margolin - The Associate

Kate answered defensively. “Believe what you want to believe, but I don’t lie,” Daniel said angrily as he turned on his heel and walked down the hall to his office.

Reed, Briggs used a large wood-paneled room on the twenty-ninth floor for important depositions. As Daniel hurried toward it he narrowly missed running into Renee Gilchrist. “ ’Morning, Renee,”

Daniel said as he stepped aside to let her pass. Renee took a few steps, then turned around. “Daniel.” “Yeah?” “Mr. Briggs thought you did a good job on the Fairweather memo.” “Oh? He didn’t say anything to me about it.” “He wouldn’t.” The partners never told Daniel what they thought about his work and the only way he could tell if they believed it was any good was by the volume of work they gave him. It dawned on Daniel that Briggs had been loading him up for the past month. “Thanks for telling me.” Renee smiled. “You’d better get in there. They’re about to start the deposition.” At one end of the conference room, a wide picture window offered a view of the Willamette River and, beyond it, Mount Hood and Mount St. Helens. On another wall, a large oil painting of the Columbia Gorge hung over an oak credenza. On the credenza, silver urns filled with coffee and hot water stood next to a matching platter loaded down with croissants and muffins and a bowl filled with fruit. Dr. Kurt Schroeder, a Geller Pharmaceuticals executive who was about to be deposed, sat at the end of a huge, cherrywood conference table, with his back to the window.

Schroeder’s thin lips were set in a rigid line and it was obvious that he did not enjoy his position on the hot seat. To Schroeder’s right sat Aaron Flynn and three associates. To Schroeder’s left sat Arthur Briggs, a reed-thin, chain-smoker who always seemed to be on edge.

Briggs’s jet-black hair was swept back revealing a sharp widow’s peak and his eyes were always moving as if he expected an attack from behind. In addition to being one of the most feared attorneys in Oregon, Briggs was a mover and shaker of the first magnitude with a heavy hand in politics, civic affairs, and almost every conservative cause of note. Daniel thought that Briggs was probably a sociopath who had channeled his energy into law instead of serial murder. To Briggs’s left was Brock Newbauer, a junior partner with a sunny smile and whitish-blond hair. Brock would never have made the cut at Reed, Briggs if his father’s construction company had not been one of the firm’s biggest clients. Daniel took the chair next to Susan Webster.

Arthur Briggs shot him an annoyed glance, but said nothing. Susan scribbled, You’re late, on her notepad and moved it slightly in Daniel’s direction. “Good morning, Dr. Schroeder,” Aaron Flynn said with a welcoming smile. Daniel placed a legal pad on the table and started taking notes. “Good morning,” Schroeder answered without returning the smile. “Why don’t we start by having you tell everyone your occupation.” Schroeder cleared his throat. “I’m a board-certified pediatrician by training and am currently a senior vice-president and chief medical adviser to Geller Pharmaceuticals.” “Could you tell us a little bit about your educational background?” “I graduated from Lehigh University with a chemistry major and biology minor. My medical degree is from Oregon Health Sciences University.” “What did you do after medical school?” “I had an internship in pediatrics at the State University of New York, Kings County Hospital Center, in Brooklyn.

Then I was assistant chief resident at the Children’s Hospital of Philadelphia as a pediatric resident.” “What did you do after your residency?” “I spent several years in private practice in Oregon before joining Geller Pharmaceuticals.” “When you joined Geller did it have any particular focus on pediatric drugs?” “Yes, it did.” “Could you describe for us your job history after joining Geller?” “I began in the clinical research and development division and rose through the ranks in various different positions of responsibility until I was appointed vice-president for medical affairs and later was promoted to senior vice-president. For the past eight years I’ve had responsibility for the development of, and gaining approval for, products we’ve discovered.” “And that would include Insufort?” “Yes.”

“Thank you. Now, Dr. Schroeder, I’d like to discuss with you the normal process for drug development and marketing and just sort of walk through the steps so that I’ll have an understanding of what’s involved in bringing a drug onto the market. And am I correct that the first step is identifying something that might have some pharmacological value?” “Yes.” “And then you conduct preclinical studies, studies that are not done with humans.” “Yes.” “And the preclinical studies involve animals.” “Not necessarily. Prior to animal studies, you might conduct studies in tissues or cells. Maybe you would do a computer simulation.” “Okay, but at some point you get to the stage where you do what are called preclinical studies to assess both safety and effectiveness?” “Yes.” “And when you do preclinical studies, the results of those studies are submitted to the Federal Drug Administration, or FDA, for review in what’s called an investigational new drug application or IND, is that correct?” “Yes.”

“What is an IND?” “It’s a request for an exemption from the regulations which preclude physicians or companies from giving a substance which has not been approved by the FDA to humans in a clinical situation. If the FDA approves the IND, you are permitted to conduct clinical studies of the drug with humans.” “Can I assume that you, as chief medical adviser to Geller Pharmaceuticals, were familiar with the results of the preclinical and clinical studies conducted to determine if Insufort was a safe and effective product?” “Well, I certainly reviewed the studies.” Flynn smiled at Schroeder. “Can I take it that is a yes?” “Objection,” Briggs said, asserting himself for the first time. “Dr. Schroeder did not say that he read each and every study and all of the documents involved.” “That’s true,”

Schroeder said. “Well, Geller Pharmaceuticals conducted extensive preclinical rodent studies, did it not?” “Yes.” “You were aware of the results?” “Yes.” “And there were studies of primates, pregnant monkeys?” “Yes.” “And you were aware of those results?” “Yes, I was.”

“And there were phase-one clinical studies of human beings?” “Yes.”

“And you know about those results?” “Yes.” “Tell me, Dr. Schroeder, did any of the clinical or preclinical studies show that Insufort can cause birth defects?” “No, sir. They did not.” Flynn looked surprised.

“None of them?” he asked. “None of them.” Flynn turned to the young woman on his right. She handed him a one-page document. He scanned it for a moment, then returned his attention to Dr. Schroeder. “What about the study conducted by Dr. Sergey Kaidanov?” Flynn asked.

Schroeder looked puzzled. “Do you have a scientist in your employ named Dr. Sergey Kaidanov?” “Dr. Kaidanov? Yes, he works for the company.” “In research and development?” “I believe so.” Flynn nodded and the associate to his right pushed copies of the document that Flynn was holding across the conference table as Flynn handed a copy to the witness. “I’d like this marked Plaintiff’s Exhibit 234. I’ve given copies to counsel and Dr. Schroeder.” “Where did you get this?”

Briggs demanded as soon as he’d skimmed the page. Flynn smiled and gestured toward Daniel. “I received it as part of the discovery that young man over there delivered to my office a few days ago.” Every eye in the room focused on Daniel, but he did not notice because he was reading Plaintiff’s Exhibit 234, which appeared to be a cover letter for a report that Dr. Sergey Kaidanov had sent to George Fournet, the in-house counsel for Geller Pharmaceuticals. Dear Mr. Fournet, I have great concerns about thalglitazone (trade name, Insufort) based on the results emerging from our congenital anomaly study in pregnant primates. We have to date studied the effects of an oral dose of one hundred micrograms per kilogram, given for ten days beginning on the thirtieth day of conception, on the fetus in forty pregnant rhesus monkeys. The early results are striking-eighteen of the forty neonate primates (45 percent) were born with maxillofacial abnormalities, in some cases severe, the most severe being complete cleft lip and palate. It is unclear to me how this could have been missed in the rodent studies, but as we all know this does happen from time to time.