The Trial (25 page)

88

Ryan Sinclair walked to the end of his parents’ driveway and picked up copies of the
Washington Post
and the
Montgomery County Sentinel.
He waved at a neighbor who was already heading into Washington to work and walked back into the house, where everyone else still slept.

Ryan poured a mug of coffee and buttered two English muffins when they popped out of the toaster. Then he sat at the kitchen table to catch up on the overnight news. As was his habit, he picked up the
Post
first. A two-inch filler caught his eye on the back of the national section. It was about the case involving Samantha Vaughan and Ceventa. All it said was that a young woman was dying and had sued Ceventa, alleging the company caused her condition.

He put his coffee down and picked up the
Sentinel,
which he knew had a beat writer who covered the pharmaceutical industry that was such a large part of the local economy. He flipped through the pages until he found a full story about Samantha Vaughan’s case against Ceventa. Two doctors, one a liver specialist, had testified the day before that Samantha was dying and Exxacia was the cause. Alfred Kingsbury was quoted as saying that he felt sorry for the young lady, but he was certain the court and jury would find that her liver failure was not caused by Exxacia. In fact, he said, they had extremely strong scientific evidence to show no possible connection between her liver failure and Exxacia.

“Horseshit!” Ryan yelled out loud and then hoped that he had not awakened Sara and his parents. He picked up his coffee and walked out to the backyard, where he paced the deck and thought about what to do. He knew that Exxacia must have caused the girl’s liver failure. He’d had the data to prove it until his house was fire bombed. After his Corvette was destroyed and then his house, he had promised Sara that he would not get involved. That was until he read what Kingsbury had to say. Maybe it was the last straw. Maybe it was the straw that broke the camel’s back. Whatever it was, he realized he could not sit idly by on the sidelines while Kingsbury defended Exxacia. If Kingsbury won this case, doctors all over the country would continue to prescribe Exxacia. The result would be patients experiencing more liver problems and death, all because of a drug no better than ampicillin. It had suddenly hit him that he couldn’t go through the rest of his life watching the adverse event reports appear on the FDA’s Web site and counting the deaths he could have prevented. Twice he’d had the chance to stand up and state his opinions about this drug, and twice he had bowed to pressure from Boatwright. If he’d done his job, Exxacia would never have seen the light of day. Maybe he couldn’t save Samantha’s life, but he had one more chance to voice his opinions, this time in a public forum, and he was going to do it. If he was going to be convincing, he needed something to corroborate what he would say, only his evidence was gone. Then it hit him. Within twenty minutes he had showered and kissed Sara good-bye and was on the freeway to the office.

The guard on the first floor tried to talk sports. Ryan told him it would have to wait until later as he punched the elevator button, then punched it a second time when one didn’t appear immediately. Finally the door opened. A few seconds later he was exiting on the fourth floor. He rushed by Lucille’s desk. She looked up and tried to stop him.

“Dr. Sinclair. You’re not on Dr. Boatwright’s appointment calendar this morning, and he’s on a very important phone call.”

“He’s about to get off that call, Lucille,” Ryan said as he burst through Boatwright’s door and locked it behind him.

Boatwright was indeed on the phone and stared at Ryan with incredulity that Sinclair would dare enter his office unannounced. Ryan walked to his desk, reached over, and pushed the disconnect button on the phone.

“Dr. Sinclair, have you gone mad? This will certainly go in your personnel file. Now, turn around and march back where you came. I don’t have time to talk to you.”

“The hell you don’t. I’ll stay here until I get what I want. Give me the complete version of the Exxacia clinical trial, including all of my recommendations from beginning to end.”

Boatwright nervously adjusted his tie and then stood to confront Sinclair. “Well, Dr. Sinclair, you really are mad. That version and your recommendations no longer exist. My policy is to destroy everything done on a preliminary basis once the study is submitted to the advisory committee.”

Ryan moved deliberately around the desk and seized Boatwright’s tie, shoving him against the wall. “You’re lying, Boatwright! I know you always keep a personal copy of the complete clinical trial data on every drug that goes through this department. You either give it to me right now or I’m going straight to Capitol Hill to the Senate oversight committee. You and Kingsbury can explain to the committee about the clinical trial and how you destroyed the backup data.”

Boatwright’s voice trembled as he said, “All right. Let me go. I’ll give it to you on one condition.”

“And that is?” Ryan asked as he released his hold.

“You won’t give it to Congress or to the media.”

“Deal. Turn it over.”

Boatwright walked to a locked file cabinet and punched in the combination to one of the drawers. When it opened, he handed Ryan a box of computer discs. Ryan seized them from Boatwright and turned to leave.

“Hey, why do you want it?” Boatwright asked.

“None of your damn business,” Ryan replied as he slammed the door behind him.

When he got to his office, he did a quick search of each disc to confirm that the clinical trial data appeared complete. Next he confirmed that all of his recommendations were still there. Last, he typed in “Samantha Vaughan,” and her file appeared on the screen. He recognized Dr. Challa’s name as one of the clinical investigators who had multiple problems and had been part of an ongoing investigation. He was about to leave the site when he noticed the date that Samantha Vaughan became a subject. “Double horseshit!” he said. “She was one of the last few subjects. Why didn’t Boatwright and Kingsbury listen to me?”

Ryan knew that Lucas Vaughan would be in court and he couldn’t track him down until that evening. He counted the hours until he could place a call.

89

As soon as Boatwright could compose himself, he shut the door to his office and called Kingsbury’s cell. It rang four times, and Boatwright assumed he would have to leave a message, but then he heard, “Kingsbury here.”

“Alfred, it’s Roger Boatwright.”

“Roger,” Kingsbury boomed, “how are you? How’s Joanne? Sorry if I sound out of breath. I’m on the golf course and was leaving the fourteenth tee when I heard the phone ring. What can I do for you?”

“Alfred, Ryan Sinclair stormed into my office just now and demanded the complete version of the Exxacia clinical trial, the one I had locked up.”

Kingsbury walked away from the golf carts as the other members of the foursome were returning. He lowered his voice. “You didn’t give it to Sinclair, did you?”

“I didn’t have any choice. He threatened to go to Congress if I didn’t. I did get him to agree that he wouldn’t turn it over to Congress or the media. That’s the best deal I could make.”

“Dammit, Boatwright, I told you to destroy that data.”

“Alfred, what kind of a fool do you take me for? Those discs were my insurance policy to make sure you kept your part of our bargain.” Boatwright hesitated. “And I’m losing patience pretty damn quick. I need the rest of that five million in my account.”

“All right, Boatwright, simmer down. I’m working on it. If Sinclair does what I think, this whole thing could unravel. I can’t let that happen. Give me a week and I’ll make it right with you.”

Kingsbury clicked off his phone and told the other three golfers that he had a business emergency. His cart mate volunteered to drive him back to the clubhouse; on the way he commiserated with Kingsbury for having to leave such a fine round before the end.

Kingsbury stepped from the elevator at the penthouse and told his assistant that he was not to be disturbed. He locked the door behind him and went to a secure phone. His two primary bodyguards were in Texas, but he had backups who were capable of doing the job. He placed a call, advised the recipient of his mission, and negotiated the financial arrangements. When he hung up the phone, he thought about all he had done to ensure the success of Exxacia. All of the problems seem to have stemmed from that damned case in Texas. Clearly it was time for him to do a firsthand assessment.

90

There was another delivery to Sue Ellen overnight. This time it was one of Josh’s Nike running shoes. Sue Ellen called Luke at six in the morning.

“Luke, one of Josh’s shoes was on my front porch,” Sue Ellen cried into the phone. “I don’t think I can go on.”

Luke hesitated, unsure what to say or do. “Sue Ellen, stick it out one more day. The combined task force is now over a hundred officers. They’re bound to find Josh soon.” Luke paused and continued. “I need your help. So does Sam.”

Luke heard a quiet click on the line, and Sue Ellen was gone. When he got to the courthouse, though, he found her sitting at their counsel table, head down and hands folded in front of her. He touched her shoulder and said, “Thanks.”

At the end of the previous day, Luke had evaluated their case after the testimony of Dr. Stevens. The ruling that kept out the clinical trial data left them with their epidemiologist, several of Samantha’s friends to testify about her life before and after developing hepatitis, and Samantha herself. Over Metcalf’s strenuous objection, Nimitz had granted Luke’s request that Samantha testify by video feed from home.

Ruth Ann Crawford, MD, PhD, the epidemiologist, was short and a little stocky, with her gray hair in a bun. Her expertise was statistics, particularly in the field of medical trials and drug efficacy. She had been prepared to launch a scientific attack on the entire Exxacia trial, but the judge’s ruling cut her testimony by eighty percent. Still, Luke thought he could get some value from her.

“Dr. Crawford, tell the jury a little about your background and education,” Luke said after she had been sworn in and given her name for the record.

An experienced witness, she turned to the jury and tried to look each one of them in the eye as she spoke. “I have a medical degree from Baylor College of Medicine in Houston, and my PhD is from the University of Texas. I’m what’s called an epidemiologist. That’s a medical numbers person. We usually study diseases and their prevalence in certain populations. We also get involved in clinical trials to evaluate the risks of new drugs that are being studied.”

Luke watched the jury and saw that they were quite interested in what was ordinarily a very dry subject.
Too bad,
he thought,
we couldn’t lay out all the problems with the complete clinical trial.
“Dr. Crawford, I want you to focus only on the Exxacia clinical trial data that was prepared by Dr. Challa. Is that clear?”

Judge Nimitz nodded toward Luke, pleased that he was not going to intentionally violate his rulings.

“I understand, Mr. Vaughan. I know that Judge Nimitz has ruled that the rest of the data won’t come into evidence.”

Oops,
Luke thought as he looked at Judge Nimitz to see if he was going to get a reprimand because his witness injected the judge’s ruling into the case. Judge Nimitz maintained a poker face. Audrey Metcalf started to object, thought better of it, and returned to her seat.

Luke handed Dr. Challa’s patient charts to the witness. “Doctor, based on your experience and training, how do you evaluate this portion of the clinical trial?”

Again Dr. Crawford turned to the jury. “Frankly, this is about as sloppy a piece of work as I’ve ever seen. Not only should it not be relied on by anybody evaluating Exxacia, but further, the incidence of liver problems is higher than with any antibiotic I’ve ever seen.”

Luke looked at Sue Ellen, who nodded. “Thank you, Dr. Crawford. That’s all I have.”

Audrey Metcalf tapped her pen on her table long enough that she was about to be chastised by Judge Nimitz when she finally spoke. “Of course, Dr. Crawford, you would agree that no one should rely on so little evidence to determine the efficacy and safety of any drug.”

“I agree, Ms. Metcalf,” Dr. Crawford said, nodding. “If you like, I’ll be happy to discuss the remainder of the clinical trial.”

Luke jumped to his feet. “Your Honor, we certainly have no objection if Ms. Metcalf wants to get into it.”

Metcalf figured she’d better give up on Dr. Crawford. Questioning some witnesses was like Br’er Rabbit and the tar baby. Obviously, Dr. Crawford was one of those witnesses.

Metcalf rose. “Your Honor, I appreciate Mr. Vaughan’s offer, but I decline. No more questions.”

Two jurors on the back row looked at one another. One whispered that he didn’t understand why they couldn’t learn more about the drug.

Samantha’s friends took up the next several hours. Luke timed it so that the last hour would be for Samantha. Each of them described her as the all-American girl who was capable of doing anything in life she chose, that is, of course, until she got sick. Brad was the last friend to testify. He tried to be strong and stoic but finally broke down and testified between loud sobs. Two women on the front row grabbed for Kleenex.

It was four o’clock, and Luke announced, “Judge, we are calling my daughter, Samantha Vaughan.”

The jurors looked toward the door, expecting to see Samantha wheeled in, until the judge said, “Ladies and gentlemen, we’re doing something a little different here. I’ve ruled that Samantha can testify by video from her home. Bailiff, would you roll the television to the usual place where all the jurors can see it.”

As he did so, a technician paid by Luke clicked it on and called his counterpart at the Vaughan house. Momentarily, Samantha appeared on the screen, seated in her wheelchair beside her bed. Sue Ellen had left the courtroom and was standing behind her. Judge Nimitz administered the oath.

“Sam, can you hear me?” Luke asked.

“Fine, Dad.”

“Sam, you can’t see us, but thirteen jurors and the judge are watching you, also Audrey Metcalf and her team for Ceventa. How are you feeling today, Sam?”

Sam smiled at the camera and replied, “About the same as most days.”

“Most days you’re sleeping twelve to fourteen hours at night and then take a long afternoon nap?”

“Yes, sir. Mary just got me up thirty minutes ago and helped me put on a little makeup. I’m sorry, ladies and gentlemen, for how I look.”

All of the women on the jury smiled in understanding.

“When did this start, Sam?”

“Dad, you know that you and Brad are the ones that first noticed it. I thought that I was just studying too hard and staying up too late. It was a few months after I quit seeing Dr. Challa, I think.”

“Sam, I don’t want you to get too tired. So that’s all I’m going to ask. I’ll see you when I get home.”

Judge Nimitz had walked over to stand by the jury to watch Samantha. From there he asked, “Ms. Metcalf, do you have any questions?”

“Just one, Judge. Ms. Vaughan, even before you took Exxacia, you took Tylenol regularly, didn’t you?”

Samantha frowned as she thought. “Well, ma’am, when I would get a headache I would take a few Tylenol until it went away, just like anyone else would.”

“That’s all, Your Honor.”

“Sam, we’re going to turn off the television now,” Luke said.

Luke checked his notes and then spoke to the judge. “Your Honor, plaintiff rests.”

The judge turned to face the jury. “Ladies and gentlemen, here’s the good news. You’re getting out early today. The better news is that tomorrow is Friday and we won’t have court. Now, don’t you go telling your neighbors that Judge Nimitz takes Fridays off and goes fishing. I’ve got a full docket of motions in the morning, and in the afternoon I’ve got to hear criminal pleas. I’ll see you Monday morning at nine o’clock.”