The Trial (15 page)

49

Samantha and Cocoa appeared in Luke’s door. “Dad, Cocoa and I want to go for a ride in the Camaro with the T-tops off. I want to feel the sun and the wind in my face.”

Luke looked up from his computer, pleased that Samantha was up to an outing. “Your wish is my command. Let me shut down this computer and get the keys.”

When they got to the car, he went to the driver’s side.

“No, Dad. I want to drive. It’s my car.”

“Sam, are you sure you’re up to this?”

“Come on, Dad. I’ll take it slow, and you’ll be riding shotgun.”

Luke reluctantly agreed and went to the passenger side. Cocoa took her place in the backseat, close to the window so she could stick her head out.

Samantha backed slowly down the driveway and stopped at the corner. “Let’s head into the hills, okay?”

“You’re the driver. Your call. I’m just the copilot,” Luke answered.

It was a beautiful day full of sunshine, with temperatures in the midseventies. It had rained enough the night before that when they got to the first low water crossing, they met six inches of water.

“Take it slow, Sam, but don’t stop.”

“Don’t worry, Dad,” Samantha assured him. “I’ve done this before.”

Samantha got to the middle of the creek and then gunned the engine. As the car splashed to the other side, Cocoa barked when her snout was inundated with water.

After they climbed the hill on the other side, Luke glanced at his daughter. Her face was full of delight and excitement.
Thank God,
he thought,
we can still put a little happiness in her life.
Then he looked up into the azure sky.
Okay, God, I’m going to need a lot of help here. Please don’t let us down.
For some unexplained reason, a sense of peace came over him.

After thirty minutes, Samantha pulled into a roadside park beside a quiet bend in the river. Cocoa bounded from the car, dove into the river, and swam across. When she got to the other side, Luke whistled, and she happily swam back. Luke and Samantha sat on the grass under the shade of a live oak and watched the river. He idly started picking up acorns and tossing them into the water.

“Dad, am I going to be all right?”

Luke had known this question was going to come, and he had been dreading it. “I hope so, Sam, but I can’t promise. I can tell you that if there’s any way on God’s green earth to make you well, I’ll find it. That’s all I can do.”

Samantha reached over to hug her dad, and when they pulled apart, both had tears in their eyes.

50

As soon as Tom Lorance filed an answer for Dr. Challa, Luke fired back a request for production. He asked for all of Dr. Challa’s files on the clinical trial in which Samantha had been a patient. He didn’t know the name of the trial, the drug, or the pharmaceutical company, so he simply referred to it as “the Clinical Trial.” He didn’t want only Samantha’s chart but the charts on every one of Dr. Challa’s patients in the Clinical Trial, as well as any instructions from the as yet unidentified drug company and communications to and from that company, whether by letter, e-mail, or fax. For good measure, he asked for records of any phone conversations in which the Clinical Trial was discussed. Luke knew that he couldn’t possibly get everything he requested, but he could ask for all this information and take what the judge gave him.

Tom Lorance got the request and figured it was time to meet with his client. The next day he took the short drive to San Marcos. As he parked in the strip center lot, he tried to remember if he’d ever represented a client with such a run-down office. Before he entered, he stepped back to the street and used his cell phone to take several photos of the office and the center. He wanted to be able to show the insurance company what they were dealing with.

Lorance entered the office and waited. It wasn’t long before a small, dark-skinned physician in a white coat came from the back and introduced himself as Dr. Challa. Lorance explained what to expect as the lawsuit progressed and then asked to see all of the files from the clinical trial.

“But, Mr. Lorance, aren’t we violating federal privacy laws if I let you see any patient files other than those of Samantha Vaughan?” Dr. Challa cautioned.

Lorance pondered the question and then nodded his head in agreement. “I suppose you’re right, Doctor. We’d probably better wait to see what Judge Nimitz does on the production request before I review the others. Just let me have a look at Samantha’s and the communications between you and the drug company.”

Dr. Challa did as requested and sat quietly at his desk while the attorney studied Samantha’s patient chart. Lorance had been analyzing such charts as long as he had been practicing law. He looked through the vital signs on each visit and the lab results. “Dr. Challa, why is it that out of six visits, the lab results on three are identical?”

“That just happens sometimes, Mr. Lorance.” Dr. Challa shrugged.

“No, it doesn’t! Let’s get one thing very straight. I’m your lawyer. I expect the truth from you. If there’s a problem, I can figure out a way to deal with it. We have an attorney-client privilege, so let’s try this again. Why are the lab results on three visits identical?”

This time the reply was different. “She didn’t show up for those visits. The drug company insisted on lab work once a week. What could I do? I copied prior lab work and submitted the results.”

“Well, for one thing, you could have just kicked her out of the trial,” Lorance said with muted anger in his voice.

“But, Mr. Lorance, I’d already taken their money and already paid Ms. Vaughan.”

“Okay. Sorry I raised my voice. You’ve told me the truth. I’ll deal with it. Now, I see the drug is called Exxacia, manufactured by Ceventa. Haven’t there been a bunch of ads running on television about this drug lately?”

Dr. Challa nodded. “You’re correct, Mr. Lorance. It’s been approved by the FDA, and doctors all over the country are prescribing it. I’m even recommending it myself.”

Lorance continued to peruse Samantha’s chart until he got to the back. “Dr. Challa, she had to sign a consent form to be a subject of a clinical trial. You still haven’t found it?”

Dr. Challa grimaced. “First, I know that she signed one. All of the subjects signed one. I’ve searched all over this office. I’ve even looked in the charts of all of the other patients involved in the trial, thinking I must have misfiled it. It’s gone, at least for now.”

51

“Court, come to order. All rise!” the bailiff announced as the judge stepped through the door from his chambers.

“Good morning, ladies and gentlemen. This is our civil motion docket, and it looks like we have a big one. Who promises me that they can be through in less than five minutes?” A number of lawyers raised their hands and announced their cases. “All right, you’ll be first. Fair warning, though, I’ll cut you off at seven minutes and you go to the back of the line.”

Knowing that they were going to take twenty or thirty minutes, Luke and Tom Lorance settled down to wait.
All part of being a trial lawyer,
Luke thought.
Hurry up to get here on time and then cool your heels.
Fortunately, he had some editing he needed to do on a real estate deal. He reached into his old briefcase and fetched a fat file and began to mark up various paragraphs with a red pen. After an hour and a half it was their turn.

“
Samantha Vaughan v. Vijay Challa, M.D
. Mr. Vaughan and Mr. Lorance.”

“Morning, Judge,” Luke said as he walked to the bench. “This is Tom Lorance from Austin. He says he’s been in your court a time or two.”

“Indeed he has.” Judge Nimitz smiled. “Welcome back, Mr. Lorance. I see we’ve got a request for production. Mr. Lorance, it appears that you don’t want to give Mr. Vaughan anything, not even his client’s own chart.”

“If I may explain, Judge?” Lorance asked. “To start with Samantha’s chart, it would normally be discoverable. However, it’s part of a clinical trial.”

“I see that Mr. Vaughan has dubbed it the Clinical Trial.”

“Yes, sir. The questionnaires, design of the trial, even the consent forms are proprietary, developed by Ceventa.”

“Just a minute, Mr. Lorance,” the judge interrupted. “Is there anyone in this courtroom representing Ceventa?”

Silence.

“Sorry, Mr. Lorance, but you don’t have standing to make that argument. You will produce Samantha’s chart, and I presume you would make the same argument about the communications between Dr. Challa and Ceventa. Am I correct?”

Tom Lorance saw he was fighting a losing battle. He had asked Ceventa to have a lawyer intervene, but he couldn’t get their in-house lawyers to pay any attention to what they called a little pissant case in a small town in Texas.
Well,
he thought,
they made their bed.

“Then, Mr. Lorance, I believe you know my ruling on those documents. That brings us to the other patient charts.”

“Judge, I think I need to step in here,” Luke said.

“Be my guest, Mr. Vaughan.”

“No doubt those other patient charts have some information that would ordinarily be privileged. However, my client … my daughter … was part of a larger trial. These other patient charts may lead to relevant evidence and they may not. The only way to know is to see them.”

“Seems reasonable to me. What say you, Mr. Lorance?”

“Judge, I haven’t won a round in this fight yet. I honestly don’t know what is in those charts. Personally, I was so concerned about privacy issues that I decided not to even look at them myself.”

“Understood, Mr. Lorance. I think you probably made the right call at the time. Now I’m ordering you to turn over those charts along with the other documents to Mr. Vaughan. I’m sure Mr. Vaughan will sign a confidentiality agreement if you think it’s necessary. Anything else, gentlemen?”

Both lawyers shook their heads and asked to be excused. When they got out into the hallway, Tom pulled Luke to the side. “Just so you’ll know, I tried to get Ceventa to send a lawyer down here. They said they just didn’t believe they needed any advice from me. Their mistake. We’ll just see how it plays out.”

Luke nodded but said nothing.

“One more thing, Luke. When you get Samantha’s chart, you’ll find that the consent form is missing. I’m just giving you a heads-up. We’re not trying to hide anything. It’s just that my client can’t find it. If it turns up, we’ll supplement.”

Luke’s eyes got wide at Lorance’s confession. “Tom, if you don’t find it, you need to be offering your policy limits. I’m not sure if I can even take your policy, but your client’s got his ass in a crack.”

52

Luke got the bad news on a Friday. On Monday he and Samantha drove to San Antonio to see Dr. Shepherd Stevens, the hepatologist who had been assisting Clyde Hartman in Samantha’s care. They worked their way through the maze of buildings at the UT Health Science Center to the hepatology department and signed in. When they were escorted to the treatment area, they were met by a distinguished looking physician with a calm, gentle demeanor. He invited them to take a seat.

“Samantha and Luke, I’m pleased that you could come on such short notice. Samantha, after looking at your last blood work, I thought it was time for a full work-up.”

“I don’t understand, sir,” Samantha replied, her voice cracking with alarm.

“Samantha, your liver is still failing, even with the interferon. It’s time to do more testing.”

“Doctor, I’m only nineteen. Am I going to die before I’m twenty?” Samantha asked.

“Samantha, I have no intention of letting you die, okay?” Dr. Stevens replied as he handed her a Kleenex. “We may have to get you a new liver sometime soon. If we do, you’ll live a pretty normal life. There are thousands of people in the country who have had liver transplants. The even better news is that with your youth and good health, your chances of a normal life are really quite good.”

Samantha continued to sniffle. Luke had been quiet up to this time. “What’s on tap today, Dr. Stevens?” he asked now.

“We’re going to do a bunch of scans and imaging. CT, MRI, HIDA scan, ultrasound. They’re all designed to focus specifically on the liver. Samantha, the only one that will hurt a bit is a liver biopsy. We’re going to have to stick a needle in your abdomen and draw out a little piece of your liver. It’ll be done under local anesthesia and will take about twenty minutes.”

Samantha got through the day and was exhausted at the end of it. Dr. Stevens told Luke that he would call in no more than two days with the results. He lowered his eyes and refused to make eye contact with Luke as he spoke. Luke left, thinking he knew what the answer would be.

53

At ten the next morning there was a knock on the door. Luke opened it to find a FedEx delivery driver with a large box from Dr. Challa’s office. Luke knew it contained Dr. Challa’s charts. By midafternoon Luke, Whizmo, Sue Ellen, Brad, and Samantha were gathered around Luke’s conference table. Luke had tried to talk Samantha into staying in bed since the day before had been traumatic. She refused, insisting it was her lawsuit and she would help. Sue Ellen had taken the afternoon off from prosecuting criminals. Whizmo had planned to do research for a paper he was writing on the effects of the Vietnam War on modern America. That could wait.

“Thanks for coming, everybody. Sam, if you start feeling bad, you need to go back to bed.”

Samantha nodded her understanding, knowing she would stay until the last document was studied.

“I’ve already glanced through these. Ceventa is the manufacturer of the drug, named Exxacia.”

“Hell, Luke,” Whizmo interrupted. “I just saw some actor on television a couple of nights ago, telling people to ask their doctors about Exxacia. When it comes to drugs and advertising, we got one screwed-up system.”

“I couldn’t agree more, Whiz, only that system is for discussion on another day,” Luke replied. “They’ve got a very detailed protocol, at least on paper, that outlines what Dr. Challa was to do. The subjects have to be between eighteen and sixty-five. They don’t qualify if they don’t have pneumonia, bronchitis, sinusitis, or tonsillitis. They’ve got to sign a detailed consent form and initial six other pages. The dates have to match. When they get the pills, they don’t know whether they’re getting the drug or the benchmark antibiotic. However, there’s a numbering system so that, if Dr. Challa followed it, Ceventa knows which patients got the drug. We all know that Sam must have. Then the patients have to come back once a week for six weeks for a short physical—vital signs and more blood work—followed by a last visit at ten weeks. We need to check all of that on every one of these one hundred and five charts. Any questions?”

“Just one,” Whizmo said. “At the end of the day, what are we going to do with our findings?”

“Let me save my answer until the day’s over, Whiz, okay?”

Whizmo nodded, and they began to pore over the charts.

“By the way,” Luke added. “If you run across Sam’s chart, holler. Lorance has already told me the consent form is missing.”

“But Dad, I didn’t read anything. He just handed me a form and told me to sign the back page. Now I see that these forms had places to initial on each page. I don’t remember doing that,” Samantha protested. “I didn’t have any sinus problem, either, not even a sniffle when I went into that office.”

Luke walked around the conference table and patted his daughter on the back. “I understand, Sam. Believe me, I understand. One step at a time, though, okay?”

“Hey,” Sue Ellen said to no one in particular as she thumbed through a chart. “Let me fire up my computer.” Sue Ellen turned on her Dell, clicked through to the county clerk’s Web site, and went to a section listing deaths in the county by year. “Aha! Just as I suspected. Here’s a form completed by a dead guy, Francisco Saldana. I remember that name because I sent him to prison for cocaine possession a few years ago. I saw in the paper he died a while back. Must have been some powerful drugs he was doing. He came back from the dead, signed these forms, and even had a pulse and blood pressure.”

“I’ll be damned,” Luke said. “Challa was reading the obituaries.”

“I can get him for fraud, Luke,” Sue Ellen replied.

“Not just yet. Let’s see where this goes.”

They spent the rest of the afternoon carefully analyzing the charts. When they finished, they’d found a handful that appeared to be valid in every respect. The rest had problems, including twelve charts completed by people who had died long before they supposedly volunteered for the trial.