“You’re Dr. Challa, aren’t you?”
He handed Dr. Challa an official-looking document and turned to leave the store.
“Wait, Deputy. Why are you giving me this? I haven’t done anything wrong.”
The deputy turned and looked over his shoulder. “Doctor, I just serve the papers. You can read on there what you have to do.”
Dr. Challa sat on the stool behind the counter and read the petition. The instructions from the summons attached to it said he had twenty days to file an answer. He knew that doctors got sued. He was told when he came to the United States that it was just a part of the practice of medicine. Still, it was his first time, and he was alarmed to see a claim of damages over a million dollars. He considered just packing his things and moving back to India. Instead, he locked the liquor store and went next door to his office, where he rummaged through cabinets until he found his file on Ceventa. When he got to an instruction sheet, he dialed the number of Rudy Kowalski.
“Mr. Kowalski, this is Dr. Challa. I’m calling from San Marcos, Texas. I was one of your clinical investigators in the Exxacia study.”
“What can I do for you, Doctor? Wait, first of all, let me tell you we appreciate your help. Thanks to good physicians like you, Exxacia is now on the market and saving lives.” He omitted that Ceventa was already making millions on sales of the antibiotic.
“Sir, it may be saving lives, but I’ve just been sued by one of my patients, a young woman named Samantha Vaughan who was in the study. She claims she’s got hepatitis from the drug. Your company needs to represent me. She’s claiming a million dollars in damages.”
“Dr. Challa, maybe you didn’t read the contract you signed. You agreed that Ceventa would have no liability to any of your patients. As a matter of fact, according to the contract, if we get sued, you can be asked to indemnify us.”
Dr. Challa rarely raised his voice. This was an exception. “How can that be?” he shouted. “It’s your drug! I just followed the instructions.”
“Sorry, Doc. Not a thing we can do. Maybe next time you better read the fine print.”
Rudy Kowalski knew what he was required to do. According to the FDA, any adverse event was to be reported to the agency, where such events and their frequency could be monitored. Dr. Kingsbury had countermanded that mandate, issuing an edict that nothing would be reported to the FDA on Exxacia until he decided it would. Instead, Rudy went to his computer and clicked to a screen titled “Exxacia adverse events.” He recorded the information reported by Dr. Challa. It was the forty-seventh report of a liver problem, and the drug had only been on the market a little over a month. If it was true that only about 10 percent of adverse events were ever reported to the drug company, they were about to have a gigantic problem on their hands. Kowalski knew that he could get in trouble if the FDA discovered he was holding back information, but he needed a job, and this happened to be the only one he had.
48
Dr. Challa slammed down the phone, cussing out Rudy Kowalski and Ceventa as he did. Next he chastised himself for deciding to make some easy money. Finally, he searched his desk until he found an insurance policy issued by Texas Preferred Doctors Insurance Company. He located the phone number to report a claim and did so. Next he faxed a copy of the petition to the claims person in Dallas, who called a lawyer in Austin that the company regularly used to represent its doctors.
Tom Lorance was a seasoned malpractice defense lawyer. He was short with a fringe of red hair and a matching complexion. His basic nature was to be polite to everyone, foe and friend alike. When the petition was faxed to him, he read through it and calendared the answer date. Then he went to the Texas Medical Board’s Web site and checked out his new client. From what he saw of Vijay Challa’s credentials, he was certainly not impressed. Last, he picked up the phone to call Dr. Challa.
“Dr. Challa, this is Tom Lorance. I’m an attorney in Austin. Preferred Doctors has asked that I represent you in this Vaughan case.”
“Yes, sir, Mr. Lorance. Thank you for calling so quickly. I’m very worried about this matter. I only have a fifty-thousand-dollar policy.”
“I’ve noted that, Doctor. You don’t need to worry. I’ll take care of you. Let me put out a couple of fires here, and I’ll drive to San Marcos to meet with you later in the week.”
“Yes, sir,” Dr. Challa agreed. “However, Mr. Lorance, you should know that there’s very little in the chart. I’ve got it here on the desk in front of me.” Dr. Challa hesitated. “Right now I can’t even find the consent form. I’m sure she signed it. It must be misfiled.”
“Hmmm, that could be a major issue, Doctor,” Lorance replied. “Please do your best to find it.”
Tom Lorance’s next call was to Luke Vaughan. “Luke, this is Tom Lorance from Austin. I’ll be defending Dr. Challa. First I want to say that I’m sorry about your daughter.”
Luke was a little surprised to get a call from a defense lawyer so soon, but also pleased. Considering Sam’s deteriorating condition, the sooner the better. “What can I do for you, Tom?”
“Mainly I’m just touching base. I’ll get an answer on file in a week or so. How’s Samantha doing?”
“Not very good.” Luke sighed. “We’ve got her on interferon, but I’m not seeing any improvement.”
“Boy, that’s too bad,” Tom said. “I’ve got a teenage daughter. Sure would hate to have her in that condition. Can I ask you a personal question, Luke, and maybe give some advice?”
“Have at it,” Luke said, somewhat puzzled at the offer.
“You sure you’re doing the right thing? I mean, we all know that it’s never a good idea to represent a family member. I could give you the names of a couple of good plaintiff lawyers who could handle Samantha’s case without letting personal involvement interfere with their decisions.”
Luke hesitated, thinking about it. “I appreciate your suggestion, Tom. I really do. I did some soul-searching about taking this on, but I think that it’s going to be pretty cut-and-dried. I’ll make the right calls. By the way, how much coverage does Dr. Challa have?”
“Not much. Fifty thousand. Well, I just wanted to call so we can get this one off on the right foot.”
“Appreciate it, Tom. By the way, I’m going to ask Judge Nimitz to put this on a fast track, and I’ll be sending out a request for production of all of the clinical trial files in Challa’s possession.”
“I don’t object to the fast track, Luke. If it were my daughter, I’d be doing the same. We may have a problem with the documents, though. I’ll look for your request as soon as I file an answer.”
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.”
The Trial Page 13
