The Last Trial Page 19

  And so, with precision, Lep relates the tale he has promised the prosecutors he would tell. He elaborates his impressive education, two postgraduate fellowships, various awards, and then his appointment in both the medical college and the Computer Science Department at Easton, leading to his work in his father’s lab and at PT. He then gets to the meat of the matter, describing his duties as director of medical research at Pafko Therapeutics and his role in the development of g-Livia.

  On September 15, 2016, a little more than two weeks before the clinical trial was to conclude, Dr. Tanakawa told Lep about a concerned call he had received from Dr. Wendy Hoh the prior day, suggesting that in recent months there had been a surge of sudden fatalities in the study.

  “And what did you do after speaking to Dr. Tanakawa?”

  “I went immediately into my father’s office, which is next door to mine.”

  “Did you have a conversation?”

  “Yes, of course.”

  “What was said by each of you?”

  “I can’t tell you exact words. But we were both somewhat concerned. Every indication we had was that g-Livia was performing remarkably. My dad said to me, ‘Well, let’s take a look.’”

  “What did you understand that to mean?”

  “That we should unblind the database ourselves to see if the patients who were dying suddenly were on g-Livia.”

  “And what did you do in response to your father’s remark?”

  “I went to my office for the unblinding codes we’d gotten from Global at the start of the trial. Under the protocol, they were to be utilized in the event of an emergency situation regarding patient safety. I brought them back with me, but by then I had second thoughts. Overall, I felt the unblinding should be done by the outside safety monitors, perhaps in conversation with the agency.”

  “What ‘agency’?”

  “The FDA.”

  “What did your father say?”

  “He didn’t agree at first. We were both upset at the prospect of a problem for the medication, so close to the end of the trial. But I was tight for time. I had a late plane to Seattle, where I gave a presentation at a conference the following morning. Greta, my wife”—he stops for a somewhat obligatory smile as he nods in her direction—“was flying out the next day, and we were going to hike for two days on the Olympic Peninsula. I still had work to do on my slides for the speech, and I also needed to pack, and so I told my dad, Kiril, we should put a pin in this until Monday. I told him we’d be better off with time to think.”

  “What did he say?”

  “He was unhappy but agreed to wait.”

  “And where did you leave the unblinding codes?”

  “I am not positive, but I think I left them there in his office.” ‘I am not positive’ is a new addition. Stern’s heart perks up at the prospect that notwithstanding the bitterness Lep displayed in the men’s room, he is going to do his best to take it easy on his father. Moses pauses, breaking his set meter, apparently fearing the same thing.

  “Now, you say you and your father were upset. Was there any conversation between the two of you about his concerns?”

  “He didn’t need to explain. He’d said often enough that he felt we were under time pressure with g-Livia.”

  “Foundation,” says Marta, meaning she wants to know exactly where and when that comment was made and Kiril’s exact words.

  “We had the same conversation countless times. His office, my office. At least once a month, he’d say something on the subject.”

  “And what was that?” asks Moses.

  Marta objects to Lep summarizing a number of conversations and Sonny waves her off.

  “Subject to further objection,” says Sonny to Lep, “you may continue.” Usually, during the testimony, Sonny takes notes on a legal pad and, when things are predictable, looks over other papers—motions, rulings. But she has turned about completely to face Lep and is sitting back in her tall leather chair to assess him. Like everyone else here, she is captivated by the family drama, as old as Oedipus holding a sword over his father’s head.

  “Please tell us what Kiril said to you about time pressure,” says Moses.

  “He was concerned that if the approval process dragged on the way these things often do, he wouldn’t live to see the end of it. I’d try to reassure him that he was in great shape and would outlast even the FDA.” Having heard from the FDA officials about the complicated rigmarole of pharmaceutical testing, several of the jurors and reporters laugh spontaneously.

  “And did you do as your father and you had agreed and see him first thing Monday morning?”

  “I saw him, but actually he came into my office as soon as I got there.”

  “Did you have a conversation?”

  “We did.”

  “What was said?”

  “Well, this I remember word for word. He said, ‘I have great news.’”

  “And did you ask what the great news was?”

  “Yes, naturally. He told me that after I left the prior Thursday, September 15, he had been too upset to wait. He had called Wendy Hoh at Global. He had a lot of questions, he said, trying to be sure what we’d heard about were genuine results, and by the end of the day Friday, Dr. Hoh had called back.”

  “Did your father tell you what he claimed Dr. Hoh said?”

  “Objection to ‘claimed,’” says Marta.

  “Sustained.” Looking down at Lep, Sonny says, “Just tell us, Dr. Pafko, what the elder Dr. Pafko said.”

  Nodding as he absorbs the judge’s instruction, Lep takes a second to adjust himself on the stand.

  “He said that she, Wendy, had told him that she’d spoken to many of the investigators who’d reported these deaths and realized they had been recorded in error. It was a computer programming problem. The dozen patients had all withdrawn from the trial earlier, but had been listed as non-cancer-related fatalities in the prior two quarters.”

  “Was that the end of the conversation?”

  “No. He told me that Wendy, Dr. Hoh, had corrected the dataset, and that there was really nothing further to worry about.”

  “Did you agree?”

  “I went and talked it over with Tanakawa. We were both a little uneasy—”

  “Object to ‘we.’”

  “Just speak for yourself, Dr. Pafko,” Sonny tells him.

  “Right,” says Lep. “I was uneasy. But frankly, I didn’t want to get into any unblinding, or more conversations with the investigators, since even the little that Wendy had done, according to my father, put the integrity of the trial at risk, if we needed to continue it.”

  “So you took no other steps?”

  “No, Tanakawa and I went online, entered the database, and did a run for serious adverse events for the prior 180 days. There were many, but no sudden deaths. So it was clear that what my dad said was true and that Wendy had investigated and corrected the database. We were both satisfied.”

  “Now, did your father tell you at any point that he had unblinded the dataset that Thursday night?”

  “No, he’s never said that to me.”

  “And did you know at that time that these supposed computer errors had occurred only in the g-Livia arm of the study?”

  “No. I thought it was a generalized problem.”

  “Now let me show you a document in evidence as Pafko Computer-A.” The screenshot from Kiril’s office computer. “Have you ever seen that dataset before?”

  “In your office.”

  “Never before we showed it to you?”

  “No.”

  “And did Dr. Kiril Pafko ever relate any of the data contained there, showing twelve sudden deaths among g-Livia patients?”

  “Never.”

  “And as an expert medical researcher, if you had seen that dataset, what would you have done?”

  “There was no choice. I would have immediately informed the safety monitors and the FDA.”

  “But given what your father had told you, did y
ou believe you needed to report suspected serious adverse events under the FDA regulations?”

  “No. Accepting what my father told me, as confirmed by the Global database, there had been no measurable increase in serious adverse events.”

  Not incidentally, Lep’s supposed gullibility is greatly to his advantage in the civil suits, since it reduces his personal liability.

  Moses goes through the FDA meetings that Kiril attended between 2014 and 2016 and later, but there’s little new information there. Lep’s testimony ends with him saying that before he signed the marketing application, Government Exhibit-1, which verifies the truth of everything contained in the hundreds of pages attached, he had informed Kiril and asked him if it was okay to proceed. Kiril said yes.

  Appleton turns to Marta and says, “Your witness.”

  She is up quickly and tells Lep to hold on to the first few pages of Government Exhibit-1, which Moses was asking Lep about at the end of his direct. She has Lep again identify his signature.

  “The application, Government Exhibit-1—as Mr. Appleton just pointed out to you—it contains a representation that all FDA regulations have been complied with, does it not?”

  “Yes.”

  “At the time the document was prepared and signed, did you believe that to be true?”

  Marta is standing, but she has not departed from the defense table, so that she is beside Kiril, ensuring that Lep has no choice about looking at his father, which he did not do once while Moses was questioning him. Even so, Lep appears to be trying hard to hold Marta’s eye.

  “I did.”

  “And based on your own knowledge, what you’ve observed personally, and leaving aside gossip or anything you’ve seen or read, is that still the case?”

  It is a dangerous question, but Marta has vetted it with Lep’s lawyers. Despite that, after what Stern saw in the men’s room, he would have skipped the inquiry, but Lep answers, “Based on what I know personally, it is still the case.”

  Lep has just taken most of the sting out of his direct. As far as the son is concerned, nobody has shown him that his father deliberately lied about anything. That might be blind loyalty or like believing in unicorns, but notwithstanding the great anger he feels with his father, Lep will do whatever he can to help Kiril, as long as he doesn’t violate his deal with the government. With thoughts of Peter still not far away, Stern feels like standing up and cheering for Lep.

  Marta goes to the witness stand, takes the signature page of the application from him, then crosses the courtroom and drops the document on the prosecutors’ table from waist height, as if now it’s nothing but rubbish. Stern meant what he told Marta last week—she is leaving the profession on a high note. She has always been effective in court, but not with the same freewheeling confidence she’s exhibited the last several days. A bit awkward-looking, always socially ill at ease, Marta, like her father, found a second self in the courtroom, becoming the person she needed to be for the sake of her client—adept, appealing, and smart, not as a show-off but rather someone who is there to explain on behalf of a person who deserves to be understood. For Marta, like Stern, it has been the same fundamental experience, born into this lumpy body and discovering a forum where you sometimes had the grace of a dancer. For Peter, working with his father would have been like the torture of Prometheus, who according to Greek myths was chained to a post while his guts were eaten each morning by a vulture. But for Marta, it has been liberating. Stern gives himself no credit. It was her decision alone. But beginning with US v. Cavarelli, her first criminal trial, which they won against Moses decades ago, her unhappy youth ended. She soon married Solomon, then was a mother managing a high-powered career, a person with an impossibly full life who still bounded out of bed every morning to face a wide realm of responsibilities, all of which, on balance, she loved. Stern understands that by now she’s had enough—a widespread reaction of lawyers in their late fifties. But he is proud of how well this life has suited her, how good she looks in her closing moments in their shared calling.

  “Now, you said when you departed from PT on September 15, 2016, to go home to pack, you may have left the unblinding codes with your father.”

  “I may have,” says Lep. “I may not have.”

  “And you worked side by side with your father for close to twenty years?”

  “Yes.”

  “You yourself have a doctorate in computer science?”

  “Yes.”

  “In your opinion, how would you characterize your father’s computer skills?”

  Moses objects that this is not proper opinion testimony, but Sonny overrules him.

  “I would describe his skills as pretty basic. If he needed something with a computer, generally he asked me or somebody else.”

  “And in your opinion, given his computer skills, could Kiril Pafko have unblinded the dataset?”

  Moses objects again, and Marta and he move to the sidebar. While they are gone, Stern feels the weight of someone’s eyes and glances back to find Donatella’s thick dark brows pinched in a reproachful look. It requires a second for Stern to understand that it is Marta’s question that has upset her. If Kiril didn’t do the unblinding, then, as Donatella sees it, it might have been Lep. But Marta implied no such thing. She is merely questioning the government’s entire reconstruction of events. In response, Stern scowls back at Donatella. She would throw Kiril off the cliff rather than see her son within a mile of the edge.

  When Marta returns from the sidebar, the judge sustains Moses’s objection, but she allows the next question, which is whether applying the unblinding codes requires more than what Lep would classify as basic computer skills.

  “I would say so,” Lep answers.

  She then asks a question contained in a note Stern handed her, a thought he had while she was conferring with Moses and the judge, an idea for his closing.

  “And by the way, given your father’s basic computer skills, did you happen to learn his computer password?”

  Lep smiles for the first time. “He drove the IT people crazy, because he insisted on something he wouldn’t forget. It was eight ‘1’s. Because of all the arguments with IT, everyone in the C-suite knew it.”

  Given the constraints Kiril and Donatella have imposed, Marta has little more ground to cover.

  “Now, you have worked beside your father since you finished your fellowship after your PhD, correct?”

  “Yes.”

  “And by the way, I don’t think we’ve gone through the formality of having you identify for the record the person you have been referring to as your father. That would be the gentleman beside me, the defendant in this case, Dr. Kiril Pafko?” With that, Marta, using a gesture like a conductor at the end of a symphony, beckons Kiril to rise, so that he is staring straight at his son. Lep takes some time before answering yes, and Marta holds Kiril’s elbow so he does not sit again, but continues to face Lep.

  “And as a distinguished scientist yourself, do you have an opinion about your father’s honesty and integrity as a scientist?” The question is carefully framed. Marta didn’t ask ‘as a husband’ or ‘as a person.’ And Lep’s lawyers have promised he will deliver. Nonetheless, it is a high-wire moment for the defense, even assuming Lep remains friendly, because the question could open the door for the prosecutors to call witnesses like Kateb. On balance, Stern and Marta have agreed that Sonny will take this as proper cross-examination, designed to limit the effect of the testimony the prosecutors elicited, rather than establishing a separate beachhead in the defense to which the government would be entitled to respond.

  “Yes,” says Lep.

  “What is that opinion?”

  “The highest.”

  “Even today?”

  “Even today.”

  “Nothing further.”

  “Brava,” Stern whispers when Marta sits down.

  The redirect of Lep is brief. Moses is clearly stung by Lep’s testimony that even today he would sign the marketing
application. The US Attorney asks a few questions aimed at getting Lep to agree that if the uncorrected dataset, Pafko Computer-A, were accurate then the regs required reporting those deaths. That, in turn, would make the application false. But Lep says—correctly—that regulations about reporting serious adverse events are complex and leave a great deal to the judgment of the trial sponsor. Moses absorbs the answer, glowering briefly at Lep. Yet Moses’s wisdom in the courtroom is hard won. He could quarrel more with Lep in front of the jury, even attack him, but that would only deepen the impression that the government has been damaged. Besides, Moses knows he can blunt Lep’s cross in argument: ‘Of course, a son wants to believe his father isn’t a liar, but how does that stand up to the facts?’

  Accordingly, after a few more questions, Moses stops. Marta declines to recross and Sonny tells Lep he may step down and declares a recess for lunch.

  While the jury is still on its way out, Lep comes straight from the witness stand to his father, who stands to receive his son in his arms. Lep gives one anguished outcry and shakes with sobs.

  Several of the jurors have stopped to watch. Stern feels some instinct to intervene, fearing that this display on balance is not helpful to Kiril. But if nothing else, the sight of the two men locked in each other’s arms demonstrates how torturous the entire circumstance has been to both of them. When Lep has recovered, with a wad of Kleenex pressed to the middle of his face, he finds his wife and starts out of the courtroom with her, arm in arm. Donatella is a step behind.

  21. Innis Returns

  Over the weekend, the prosecutors made another change to their witness list, deciding to call an FDA lawyer to testify about the many regulations underpinning some of the fraud counts. She comes to the stand Monday afternoon, following the morning session with Lep. Her testimony is clearly a response to Dr. Robb’s cross and Robb’s concession that current information seems to show that g-Livia is ‘safe’ for the market.