Authors: Larry D. Thompson
Midafternoon brought another expert. Ramon Salazar, the chairman of the advisory committee that had approved Exxacia, was a distinguished professor in the department of infectious diseases at the University of Texas Health Science Center in San Antonio.
“Your Honor, for your planning and so the jury will know, Dr. Salazar will be Ceventa’s last witness. We expect to rest our case after he testifies.”
“Very well, Ms. Metcalf,” Judge Nimitz replied. “I’m sure the jury is delighted to hear that. Please proceed.”
Audrey Metcalf walked Dr. Salazar through his credentials and then asked, “Doctor, why do you take the time out of a busy schedule to advise the FDA?”
“Well, they pay me a small fee,” Dr. Salazar said with a smile, “but that hardly covers the time it takes me to read about new drugs and attend several meetings a year. Some of us doctors believe we owe such service to our profession and to the public. I’m happy to do it.”
Metcalf liked having a local touch to her experts, particularly a Latino physician who would appeal to the Latinos on the jury. “Doctor, were you on the advisory committee that approved Exxacia?”
“I was. We had meetings over about two years before we were satisfied that the drug was safe and effective.”
“Doctor Salazar, based on all you read and particularly based on the extensive clinical trial done by Ceventa and supervised by the folks at CDER, did your committee vote to approve the drug?”
“We did. The jury should know that our committee first rejected Exxacia. We wanted more data. Ceventa launched the largest clinical trial I believe I’ve ever seen. Based on the results of that clinical trial, we certainly had no reason not to approve the drug for bronchitis, sinusitis, and pneumonia.”
Satisfied that she still had the upper hand, Metcalf passed the witness.
Luke smiled to himself as she concluded.
We finally got a break.
In the heat of battle, she didn’t realize that she had just opened that door that the judge had locked. She actually asked Dr. Salazar about the entire clinical trial. Now he was going to ask a few preliminary questions and charge through it.
He rose and stood at his table, a quizzical look on his face. He took another shot in the dark and prayed he would hit the target. “Doctor, since you’re an infectious disease doc and since you headed the committee to approve Exxacia, I presume you regularly prescribe it to your patients.”
Dr. Salazar shook his head. “Matter of fact, right now I’m not using Exxacia with my patients. I rarely use any new drug for two or three years after it’s approved. I like to see how a new drug is received in the medical community and watch for postmarket reports of problems.”
Bull’s-eye! Audrey Metcalf was stunned. She hadn’t anticipated this line of questions. Still, she couldn’t think of an objection.
“However, Mr. Vaughan, it may be that I’ll start using Exxacia in another year or so. I need to evaluate the postmarket data.”
“Well, Doctor, since you raised postmarket data, actually Ceventa’s scientists submitted some European postmarket data to your committee, didn’t they?”
Dr. Salazar searched his memory for a few moments and replied, “I believe you’re correct, Mr. Vaughan. It must have been satisfactory. Otherwise, we wouldn’t have approved the drug.”
Luke rummaged through papers on his table until he found an article. “Doctor, first, you would agree that postmarket data may or may not be reliable, right? I mean, doctors or patients would have to report complications, and they may or may not do so. Then the drug companies have to report the complications to the FDA or similar agencies in other countries. Wouldn’t you agree that postmarket data may underestimate complications by as much as ninety percent?”
The doctor rubbed his temples as he thought. “I agree in part. I’m not sure about your ninety percent, but there’s no doubt that such data underestimates complications. Still, even with problems inherent with postmarket data, it can be useful.”
Luke turned on the overhead projector. “Doctor, have you seen this European study, published in
Lancet,
about Exxacia?”
The witness looked at the overhead. “I don’t recall it. May I see the entire article?”
“Certainly, sir,” Luke replied as he took a copy to the witness. “I’m not surprised you haven’t seen it, since it was published just two months ago.”
Dr. Salazar skimmed through the article, pausing to carefully read the conclusion, and then looked up at Luke, waiting for the next question.
“Doctor, that article is reporting an extraordinarily high incidence of liver failure and deaths with Exxacia in Europe, isn’t it?”
Dr. Salazar nodded. “Certainly higher than I have seen before. It may be that we will need several other studies before we can be more certain if Exxacia is causing liver failure or something else induced the reported liver toxicity. Just like one swallow does not a summer make, neither can one study confirm or reject the use of any drug.”
Luke smiled. “Doctor, we’ve just heard Dr. Thornberry discuss an article where he was one of the authors. As you just stated, you wouldn’t rely on any one article for decisions regarding your patients, would you?”
“Mr. Vaughan, I know Dr. Thornberry and know he is highly respected, but you’re correct.”
Luke put away the article and looked back at the witness, knowing his next question was going to cause an eruption of volcanic proportions from the other table. “Dr. Salazar, since you and Ms. Metcalf have been talking about the Exxacia clinical trial, let’s turn our attention to it and some of its problems.”
Audrey Metcalf leaped to her feet. “Objection, Your Honor. He’s intentionally violating your pretrial ruling.”
“Not so, Judge,” Luke replied calmly. “She opened the door.”
Judge Nimitz looked at the clock on the wall. “Ladies and gentlemen, I sense this may take a while. I’m going to release you for the day. See you back here promptly at nine unless the bailiff notifies you otherwise. Doctor, you’re also excused until nine tomorrow. Have a good day.”
Once the courtroom was cleared, the judge asked Audrey Metcalf, “Why have you now opened the door to the entire clinical trial? You intentionally asked questions that incorporated the whole damn thing and established that Dr. Salazar and his committee relied on all of the data.”
Metcalf was clearly thrown off guard. Had she created a mess that she couldn’t get out of? The last thing she wanted was to have the clinical trial and all of its problems be presented to the jury. She looked at Charlotte Bronson and turned to the judge. “Your Honor, obviously this is an important matter. Might I suggest that we postpone this discussion until in the morning? I’d like to have time to brief the subject and give you some case law to support our position.”
Judge Nimitz looked at Luke. Luke was thinking that he had information coming from Rockville that could change the course of the case. He also needed to get to the bottom of the Tylenol question. A few more hours could work to his benefit. “I have no objection to what Ms. Metcalf requests. Just for good measure, I propose that we take this up at nine tomorrow and have the jury return at one.” Luke didn’t say it, but he knew that by then Whiz would have the computer discs in his hands and would have had time to give them a quick once-over.
“Agreed, Judge,” Metcalf said.
“Well, I hate to delay the trial like this. A lot of these jurors need to be getting back to work. However, if the two of you are in agreement, that’s what we’ll do. See you tomorrow at nine.”
Luke stuffed the materials from his table in a large briefcase. Then he was out the door and down the steps. Reporters hollered questions, and all he said was that the case was going well.
When he got home, he found Whizmo and Brad, along with Samantha, in the conference room. “Hi, Dad, I just got up from my usual three-hour, midday nap,” Samantha said. “Where’s Sue Ellen?”
Luke paused to think about how to answer the question. “Sue Ellen’s not feeling well.”
“She’s worried about Josh, isn’t she, Dad?”
“Yeah, she is, sweetie. We’re going to have to do without her for a while.”
“Boy, I really feel sorry for her. Why can’t anyone find Josh?”
“They’re doing all they can, Sam. We have to let the law enforcement guys handle that. We’ve got a lawsuit to deal with.”
Brad handed Luke two journal articles, almost hot off the presses. One was American and had been published only the week before. The other came from a French journal but had been translated and published simultaneously in an American journal on infectious diseases. Luke flipped to the conclusions on both and smiled.
“Good work, Brad,” Luke said. “Right now I’m really more concerned about Tylenol and its effect on the liver.”
Brad shook his head. “Not good, Luke. Dr. Thornberry was right. All you have to do is Google ‘acetaminophen’ and ‘liver toxicity’ and you’ll get dozens of hits. It can definitely cause liver problems. Usually, they go away when the patient stops taking the pills, but there are a few reported cases of severe liver failure and even death. For some strange reason, a few people have taken the drug for years and all of a sudden they have liver problems. Bottom line is it’s a plausible theory. Because that drug has been around for so long, for every study we can find on Exxacia, they can find a dozen on acetaminophen.”
“Dammit to hell!” Luke exploded. “Sorry, everyone. Brad, print off those acetaminophen articles. I’ll stay up tonight reading them. Maybe I can find something to use with Salazar to neutralize the issue.”
“Luke, I’m not a lawyer,” Whizmo said, “and I’m only partway through that thumb drive, but I’ve got some really good stuff. It could turn the whole case. What’s the big deal about acetaminophen?”
“Whiz,” Luke replied, “that’s all well and good, but right now the judge’s ruling is still that the clinical trial doesn’t come into evidence. Metcalf may have screwed up and opened the door this afternoon. We now have a good shot that Nimitz will change his ruling. We’re arguing that at nine tomorrow. Still, if the judge continues to rule against us, Tylenol becomes a huge issue. Bottom line, our best shot is to make sure we get the real clinical trial, along with the forgeries and that other stuff, into evidence.”
Whizmo rubbed his hands together. “Then call the FedEx office and authorize me to pick up the package. I’ll be there when they open at eight. That’ll get us two more hours. As to the thumb drive, you’ll have what you need from it in a few hours.”
Luke went around the conference table to the wheelchair where Samantha sat beside Brad. He tried to hide his concern for how thin she was and how much more yellow her skin had turned. He gave her a big hug and said, “Hang in there, Sam. Tomorrow could be our day.”
“Is there going to be a bright glow in the eastern sky?” she asked.
“Prettiest sunrise you ever saw, and that’s a promise,” Luke replied. “Now let’s all say a prayer for Sue Ellen and Josh. Pray that Josh will be with us tomorrow.”
“Amen,” Samantha said.
Luke looked at the old grandfather clock in his office, one he’d bought at a yard sale in Kerrville a couple of years ago. It was eleven o’clock. Anyone who thought the life of a trial lawyer was glamorous and exciting had never spent the night reading medical articles written in language usually understood only by doctors. He put down an article on liver toxicity and went to the back to pour his first and only Scotch of the evening. As he returned to his desk, he heard the back door open.
“That you, Whiz?”
“Damn sure better be. Who else you figure would be coming in your back door at this hour of the night?” Whiz replied as he came through the office door and plopped down in a chair. “Luke, we have a visitor.”
“Go on,” Luke said, a questioning look on his face.
“One of my students works as a night desk clerk over at the Holiday Inn. He’s been monitoring the comings and goings of the Ceventa team. Hasn’t run across anything interesting until now. He just called. A black limo pulled up about thirty minutes ago. The driver got out and hurried around to the passenger door. A tall man, probably six and a half feet tall, got out. Gray hair and beard. Dallas Cowboys cap pulled low over his eyes, Dallas Cowboys T-shirt, jeans. As he entered the hotel, the elevator door opened, and Audrey Metcalf met him.”
Luke flew to his feet. “Hell, it’s Kingsbury!”
“You got it, Sherlock Holmes.” Whiz grinned. “Now what are you going to do with him?”
“He can’t be here to testify. Metcalf damn sure isn’t going to call him as a witness, and she knows I’d subpoena his ass the minute he set foot in the courthouse. Whatever the reason he’s here, he’ll be gone in the morning. We need to get him served, but they won’t let us get close to that floor of the hotel they rented. I hear they even have armed guards.”
“I’ll take care of it, Luke. You get over to that computer, print a subpoena, and sign it. I’ll get him served.”
“Alfred, what the hell are you doing here?” Metcalf asked as she poured them each a cup of coffee and they settled into easy chairs in her suite.
“I thought you knew me well. This case is the most important event in my life right now. My career, among other things, is riding on it.”
A quizzical look crossed Metcalf’s face.
Why is this case so important?
she thought.
Kingsbury continued, “I learned long ago that e-mail reports and telephone calls weren’t good enough. They don’t always convey the whole message. We’re near the end of the trial, and I wanted to see you face-to-face to satisfy myself that this is going as expected.”
Metcalf put down her coffee and walked to the balcony. She slid back the door and stepped out. Once she had surveyed the parking lot and the street in front of the Holiday Inn, satisfying herself that no one was around to see Kingsbury’s arrival, she returned. “Look, I’ll stay up all night to bring you up to speed if necessary, but you’re taking a major chance. If Vaughan and his team knew you were in town, they’d get you served and you’d be on the witness stand.”
“Believe me, Audrey, I thought this through carefully. I’ve been a risk taker my whole life. That’s what got me where I am today. Once we’re through talking, I’ll be heading back to Austin. My jet will be refueled and I’ll be gone. No one’s going to know that I dropped by in the middle of the night.”
“Okay, I’ll try to make this as quick as I can, but it’ll probably take a couple of hours. By the way, did you have to choose a Lincoln limo for a forty-five-minute ride? Most folks who visit Holiday Inns don’t arrive in a long black car with a driver.”
This time it was Kingsbury who walked to the balcony and looked down on the limo, now parked in the lot. He shrugged. “Well, I figured at this hour of the night, the usual rental places would probably be closed.”