"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.
The purpose of this letter and the enclosed preliminary results is to alert you to my findings, as I believe it will have important implications for our current phase II and III studies in human beings. I will forward a detailed anatomical and biochemical analysis when my study is completed.
Daniel was stunned. Kaidanov's letter was the smoking gun that could destroy Geller Pharmaceuticals' case, and Aaron Flynn had just told Arthur Briggs that Daniel had placed the lethal weapon in his hands.
Chapter Six.
While Daniel read the letter in shocked silence, Susan Webster's fingers flew across the keys of her laptop.
"I have a few questions about this document, Dr. Schroeder," Aaron Flynn said in a cordial tone.
Susan slipped beside Arthur Briggs and gestured at a case she had called up on her computer. She whispered hurriedly in his ear and Briggs shouted, "Objection! This is a confidential communication between Dr. Kaidanov and his attorney that has been inadvertently turned over to you. You had an ethical obligation to refrain from reading the letter once you saw that it was an attorney/client communication."
Flynn chuckled. "Arthur, this is a report of the results of a preclincal test on rhesus monkeys. Your client, probably at your suggestion, has been instructing its scientists to send all their test results to in-house counsel, so you can raise this silly objection to our discovery requests, but it's too transparent to take seriously."
"You'll take this damn seriously when I report you to the bar disciplinary committee."
Flynn smiled. "Take any steps you think you must, Arthur."
Flynn nodded and one of his associates sped several copies of a legal document across the polished wood table.
"I want the record to reflect that I have just served Dr. Schroeder and his counsel a request for production of Dr. Kaidanov's study and all supporting documentation, as well as a notice of deposition for Dr. Kaidanov and Mr. Fournet."
Flynn turned back to the witness. "Now, Dr. Schroeder, I'd like to ask you a few questions about the Kaidanov study."
"Don't you say a thing," Briggs shouted at the witness.
"Arthur, Dr. Schroeder is under oath and we're in the middle of his deposition."
Flynn's tone was calm and condescending, and it raised Briggs's blood pressure another notch.
"I want Judge Norris on the phone." A blood vessel in Briggs's temple looked like it was about to burst. "I want a ruling on this before I'll let Dr. Schroeder give you the time of day."
Flynn shrugged. "Call the judge."
Daniel barely heard what Briggs and Flynn said. All he could think about was the steps he'd taken when he reviewed the discovery. How could he have missed Kaidanov's letter? He had skim-read many of the documents, but he was specifically looking for privileged information. A letter to an attorney would have raised a red flag. It didn't seem possible that it could slip by, but it had. Daniel was devastated. No one was perfect, but to be responsible for an error of these proportions . . .
As soon as Judge Norris was connected to the conference room, Flynn and Briggs took turns explaining the legal arguments supporting their position in the Kaidanov matter. The judge was too busy to deal with a matter of this complexity over the phone. He told the attorneys to stop questioning Schroeder until he ruled and he ordered Briggs and Flynn to submit briefs on their positions by the end of the week.
As soon as Flynn and his minions cleared the conference room, Briggs waved Kaidanov's letter in Schroeder's face.
"What is this, Kurt?"
"I've got no idea, Arthur." The Geller executive looked as upset as his attorney. "I've never seen the damn thing in my life."