The Last Trial Page 32

  “This life I have lived has taught me immense respect for juries. Kiril Pafko has won the Nobel Prize in Medicine—The. Nobel. Prize. He is a genius, frankly. But he knows, I know, that the twelve of you who will deliberate, you together are even smarter than he is. Yes, there are remarkably complex government regulations at the heart of this case, mysteries of science like what causes and cures cancer, and of course complicated issues of law. But you together will figure out whatever can be known and said about this matter.

  “Yet you must approach that task with a willingness to speak what I, as an old man, can tell you are the hardest words in life to utter: ‘I do not know.’” He touches Pinky’s shoulder as he passes her. “When we say that—‘I do not know’—we are apt to feel like it means we are unintelligent. Or uneducated. Those words—‘I do not know’—might even mean that we are confessing for a moment that life does not make sense. But you must go into that jury room gripped with the courage to speak those words if you determine they are appropriate.

  “For that is what a not guilty verdict means. It means, in plain terms, We do not know, not for sure. ‘Not guilty’ does not mean innocent, not necessarily. It means something a bit different. If you say ‘not guilty,’ you are saying, as a group, We have thought hard about these charges and this evidence, and we do not know for sure. That is the wrong answer if you were back in school taking an exam. But not in the jury room. Do not feel you have failed because you come to that conclusion. In fact, it is your solemn obligation to say those words if they are true. You must convict only if you are convinced beyond a reasonable doubt. But if doubt remains—and frankly it must in this case—if you find reason to doubt, then it is your duty to come back here, stand before us all, and say, in substance, We do not know for sure. You have together sworn an oath to God or to whatever else you hold sacred to render a true verdict, and if, in the end, that is your conclusion—We do not know for sure—then the oath you have taken means you must say the words ‘Not guilty.’

  “Now in this case, there are some certainties. Data was altered. That has been proven. Stocks were sold. Proven. But we do not know for sure how those events occurred.” He stops for a second to brace himself on the defense table. With all the adrenaline, it feels like there is a hamster on a wheel inside his chest. He can see the look of concern on Marta’s face, and after a second, he winks at her. He will make it.

  “In the summation he gave before I started speaking, young Mr. Feld went through the elements of each crime the government has charged, the particular facts that the prosecutors must prove beyond a reasonable doubt, and how, in his view, the evidence fits the law. I am sure that over the course of this trial, you have been impressed by his intelligence, but as you would expect by now, he has not emphasized the points that are more troublesome for the prosecution. And that is fine, because that is my job, not his.

  “I will start with the obvious. The government in several counts alleges that Kiril Pafko committed fraud. The different counts name different victims—the Food and Drug Administration, the Medicare system, the patients treated with g-Livia who, supposedly, received a mislabeled medication—but it is the same fundamental charge: fraud—and I will address it as such, as one crime that the government has given several different names. And I tell you to start that the evidence has not shown that the FDA or anyone else was fooled or tricked at all.

  “The officials from the FDA who testified before you—they are not bad people. They are good people who are trying to protect us all. Kiril and I know that. But they are bureaucrats. They make rules. And like a parent or a prosecutor, a bureaucrat wants the rules to be obeyed. They are angry when the rules aren’t followed. And they act in anger.

  “g-Livia is a remarkable medication. From witness after witness you heard the evidence about the lives g-Livia saves.” He dares, very subtly, to touch his chest. “At times, I have wondered if the only great wrong proven in this case is that the FDA’s actions have driven g-Livia from the marketplace, with thousands of lives shortened as a result.”

  For the first time, Feld objects. “Your Honor, there is no evidence of that.”

  Sonny looks at Feld, longer than Stern might expect.

  “Well,” she says, “I’ll sustain the objection, but only on grounds of relevance. The FDA and its decisions are not on trial here, whatever the evidence might be.”

  Her phrasing is clearly a subtle nod to the defense. Stern continues.

  “Now, you will forgive me for being frank, but Mr. Feld glossed over a very very important point. He said—” Stern moves slowly back to the defense table for his yellow pad and turns a page. “Mr. Feld said, ‘Of course, if the FDA had seen the true data from this clinical trial, approval of g-Livia would never have gone forward as it did.’ To which I answer, Really?

  “‘Of course’ is not evidence. Mr. Feld’s view of what government officials could or would or should have done—that is not evidence. Evidence is only what has been presented to you in this courtroom. And what evidence did you hear? Think, please, about Marta’s very skillful cross-examination of Dr. Robb. Forgive, if you will, a father’s pride, but remember what Dr. Robb admitted to Marta: Given everything we know today, she, Dr. Robb, would hesitate to express her original opinion that g-Livia has not been shown to be safe—”

  “Objection,” says Feld. “That is not what Dr. Robb said at all.”

  “Overrruled,” says Sonny. “The jury heard the testimony and can recall it for themselves. Mr. Stern is entitled to argue what he regards as the reasonable inferences and Mr. Appleton will get an opportunity to respond, and it will be up to the jury to sort things out. Proceed, Mr. Stern.”

  “Thank you, Judge Klonsky,” says Stern, and then lifts a finger straight before himself, as if to set the record straight. “I repeat: What Dr. Robb said indicates that knowing what we know today, even including the allergic deaths—even knowing that, given the longer survival of g-Livia patients, the medication would have been approved for the marketplace. Certainly, the government has not proven the reverse beyond a reasonable doubt, as they must.

  “Now, as Judge Klonsky has just mentioned again, while the defense speaks only once at the end of the case, the prosecution speaks twice. Mr. Feld delivered his summation, now I am responding with the closing argument for the defense, and when I finish, Mr. Appleton will be allowed to answer by delivering a so-called rebuttal to my points. I understand that that may not seem fair to you—that the government gets two chances to address you, while we get only one. To be honest, it has never seemed fair to me either.” He smiles at himself, knowing he has been a bit of a wise guy, and a number of the jurors join him. If nothing else, they have come to appreciate his sense of humor. “But the law at least has a reason. The government in a criminal trial carries that heavy burden of proving a defendant guilty beyond a reasonable doubt. The defense by contrast must prove nothing. So the law says, in light of the great burden the government must meet, we will let them have the last word.

  “I suspect it has been clear to you that Moses and I have been in these positions before, prosecutor and defense lawyer, and thus I am able to predict a bit of what Mr. Appleton will say. As I speak to you now, I will do my very best to answer. But of course, the US Attorney has not given me any previews. So if it happens that he says something you think I did not address, please, when you get back to the jury room, ask yourself, What would Sandy say to that? As I have told you, I have faith in your intelligence. It is greater than mine, and together you will think of the right response.

  “To be guilty of the various frauds charged—mail fraud and wire fraud, lying to the FDA or the Medicare system or mislabeling—in all cases the supposed misrepresentations made must be ‘material.’ Judge Klonsky will tell you that. Now that is a strange word, ‘material.’ It is not the kind of word normal people use every day, unless they are talking about making new drapes.”

  There is a ripple of laughter in the courtroom, coming also from thr
ee of the women in the jury box, including, to Stern’s surprise, the female CPA.

  “But that word has a specific meaning in the law, and that, as Judge Klonsky will tell you, is that the alleged lie had a natural tendency or a capacity to influence the FDA. And the decision as to whether an alleged statement is a material lie—that is your decision, not the government’s, and it is a decision you must make beyond a reasonable doubt. So you will be faced with this question: Is it really material beyond a reasonable doubt, does it truly matter that some data was scrambled, when the FDA’s official in charge says, Well, looking at it today, knowing everything, assuming normal precautions are taken, I would hesitate to say g-Livia cannot be on the market. Is it a crime beyond a reasonable doubt to make a statement that the test of time shows doesn’t matter anyway? That is your decision, of course. But this is the first point when I say to you, Are you really sure? Are you really sure that is a crime?”

  He delivers a long, somber look. They hear him, they are listening, thinking. These are the Sterns’ ‘I don’t have a dog’ arguments: Kiril tried to fool the FDA, but it didn’t matter in the long run. Kiril didn’t report the deaths, but the regs requiring those reports are ultimately beside the point, as Robb acknowledged. The fourteen people in the box appear to be giving serious reflection to these questions.

  “Now, of course, the government’s main evidence on these counts about the altered dataset, about Kiril’s supposed false statements, that comes from Dr. Wendy Hoh. Dr. Hoh says she spoke to someone on the phone who said he was ‘Kiril Pafko.’ She never wrote the name down, but that is what she says now.

  “So, for a second, let us assume it actually was Kiril. I am sure after all the difficulty that this changed dataset has made for Kiril Pafko, you might anticipate an attack on Dr. Hoh. You might expect me to emphasize that Dr. Hoh admitted that she lied about what happened in that phone call. She lied when she was first questioned by her employers after the news stories about g-Livia, including questions about the clinical trial, began appearing in the fall of 2018. She told her bosses at Global that she had no idea how the dataset was changed. She lied. She lied, and now she comes here under oath, asking you to believe her. There is an old saying in the law: False in one thing, false in all. With liars, you just do not know what to believe. Dr. Hoh’s lies, the lies she admits, mean you have every right to disregard everything that Dr. Hoh said.

  “But let’s assume you look past that point, that you say, as a group, We saw Wendy Hoh, we understand that she told a lie to save her job, but we won’t reject all of her testimony for that reason.

  “So allow me to tell you what may have actually happened.”

  Stern has always taken some pride in the inventions he can perform on the admitted evidence, constructing, as the law calls them, ‘hypotheses of innocence.’ It can become a beguiling fantasyland of what-ifs. The problem for the defense lawyer, especially when the defendant has not testified, is that the jurors may not tolerate an endless parade of ‘it might have beens.’ Sooner or later they start thinking, ‘Very amusing. Very imaginative. But your client knows what actually happened. And so do you. So stop telling us bedtime stories.’ Stern will be telling them a number and will be watching for the moment when their body language tells him they’ve heard enough.

  “You saw who Wendy Hoh was when she testified before you: Eager to please. So excited to be speaking to this Nobel Prize winner—no matter who was actually on the phone. Thrilled to be involved with this remarkably important, lifesaving medication. And delighted also, no doubt, to be involved in a matter likely to make her company millions of dollars in revenue, if further testing went on. So we know that for many reasons Wendy Hoh wanted Kiril Pafko to be happy. And despite her lies to her employer, perhaps her story to you is true, that is, in her eagerness to please this person calling himself Kiril Pafko, she did what she thought he asked.

  “But what actually was said? Remember how this whole clinical testing procedure works, how long and involved it is, and how prone to error the normal rigmarole makes it.” He lifts a hand to Pinky, who illuminates Stern’s next slide. “The clinical trial subject, the patient, talks to their doctor and nurses about how they are doing, and the site staff performs tests—blood work, scans. The doctor, the nurses, the staff relay this information to someone else they work with, who keys that information into the database maintained by the CRO. If there is a problem, someone at the CRO, like Wendy Hoh, informs the research supervisors at PT. The research supervisors report to Dr. Lep. And Lep then speaks to his father about whether to inform the outside safety monitors.”

  With each line of this summary, another line slowly appears on the ‘Clinical Trial’ chart with an arrow beside it.

  → Patient

  → Doctor/Nurse/Staff

  → Keypunch operator

  → CRO

  → Testing supervisor

  → PT Research Supervisor

  → PT Medical Director

  → PT CEO

  → Monitors???

  “It is like the children’s game of Telephone, in which a message is passed along a line of boys and girls. Each child repeats to the little boy or girl on the left what she or he has heard from the person on the right.” Stern acts this out, turning first one direction with his hand to his ear, then revolving the other way and pretending to speak. “What started as ‘The sky is blue’ comes out at the other end sounding a little like the government’s case: ‘I don’t know why or who.’”

  The quip gets quite a laugh from the jury. Even Sonny, who has always had a wicked sense of humor, fails to stifle an audible chuckle. Moses, God bless him, is shaking his head but laughing, too.

  “My point is that the people in this system have good reason to doubt whether what has been reported is what actually occurred. That is why the data that has been recorded must be scrubbed and analyzed before it can be presented to the FDA, because there may be things on paper that are simply strange statistical oddities.

  “Judge Klonsky will tell you that good faith is an absolute defense to a charge of fraud, that someone acting sincerely, without an intent to deceive, is not guilty, even if they were stupid or stupidly hopeful. Now remember, please, what many witnesses said: Allergic reactions appearing only in the second year of use of a drug or biologic are virtually unprecedented. It does not happen. Remember what Dr. Kapech said, what Dr. Hoh said, what Dr. Robb said. This kind of sudden problem with a medication that has performed so well for a year is utterly baffling. It does not make any sense. And so any experienced researcher, certainly someone like Kiril—or Lep—their first impression would be that what was recorded by Global was not right. What is that term they like to use? ‘Noise in the data.’ It was noise, numbers that appear as supposed results but which have no real statistical significance.

  “So could someone like Kiril Pafko have thought, looking at the unblinded database, ‘This is nonsense, this is noise.’ That would be a logical, reasonable, good-faith thought to have as he got on the phone with Wendy Hoh.

  “So you have Kiril on one end—perhaps Kiril, but let us assume as much right now—Kiril, with well-founded skepticism about these reports of sudden deaths, and on the other end, Wendy Hoh, so, so eager to please this Nobel Prize winner.

  “Now, you heard Dr. Hoh speak English. You have heard me speak English, for that matter. You know, from listening to me, that I was not born here. Now and then, I am sure, the way I pronounce words has left you baffled for a second. I do my best.

  “Imagine, please, what happens when two persons who were not born speaking English are conversing. You know that Kiril Pafko passed his youth in Argentina. You know from listening to her that Dr. Hoh has difficulty with spoken English. Dr. Hoh, of course, speaks English far, far better than I could speak any dialect of Chinese, of which I do not know a word. But she told you that her difficulties with spoken English are one reason she prefers e-mail.

  “With respect, could what happened on the phone
have been a miscommunication? Could the person on one end, with natural doubts about what gets repeated down the line, unwilling to believe that a biologic would produce sudden deaths only in the second year of treatment, could that person have said something like, ‘Are you sure about this data, have you checked with the investigators, could this be a programming error, any chance that patients who withdrew were reported as fatalities?’ And could Wendy Hoh have thought her caller was saying that was what happened? A scratchy international connection. Two people conversing in a language neither of them was born speaking, and in which one of them struggles to this day. They are not face-to-face. They get none of the clues we see from one another’s expressions.

  “Can you say for sure that is not what happened? Was that why Wendy Hoh lied at first to her employers? Because she suddenly realized she had corrected something she had not even been asked to correct? Did she tell you what she wants to believe now, with her job at stake? People do that, remember what they wish happened rather than what occurred. But can you be certain that she did not simply misunderstand what Kiril was saying, the questions he was asking? We do not know. We do not know for sure.

  “One thing that is beyond doubt, however, is that the way the government viewed all this, what they told you to start—that is not true. Something was very wrong with the way the government conceived of the evidence at the beginning of this case. You know they did not prove what they told you they were going to prove. You know now that their opening statement was dramatically incorrect.”

  “Objection.” It is Moses this time who stands. “Your Honor has asked the lawyers to make no reference to the dismissed evidence.”