by Rene Fomby
Kelley crawled into bed without disturbing her. He set his phone to buzz and placed it on the nightstand beside him. Just in case there was some breakthrough in the middle of the night.
He thought sleep would come pretty easy, after a long hard day checking and rechecking the test results from the lab, but for some reason he just couldn’t shake the nagging feeling that the key to whatever had happened with Allurea was buried somewhere in the clinical trials. Especially the Phase IIIs. He hadn’t been on board at Labarum back then—the head of research had quit suddenly and basically disappeared, just as the submission to FDA was being finalized, and his own job at another biotech down the street was at a dead end when his company’s HIV drug failed its Phase IIs, so the job had just kind of fallen into his lap. But it wouldn’t be too hard to piece together what had happened from all the data. Maybe a day’s worth of work, two at the tops. Plus it sure beat looking over everyone’s shoulders in the lab, being more of a nuisance than a help. And, after all, to hell with Boucher—what Boucher didn’t know wouldn’t hurt him, and if he could find the answer in the data …
7
La Jolla
Kissing his wife softly on the forehead as she slept, Kelley eased out of the bedroom without waking her and headed off to work early. He’d slept fitfully all night, not able to shake thinking about what the Phase III data might hold.
When he got to his office, the night shift was still hard at work in the lab, trying desperately to ferret out some inkling of what had gone wrong with the drug. He logged on to his computer and checked his email, and was happy to discover that someone in IT had found the raw data at some point during the night and sent him a link to the files on the secure server. Clicking on the link, he sipped at the cup of coffee he had collected from down the hall and got to work.
Most of the data was pretty routine, and a quick search for arrhythmia in the files turned up nothing. Not surprising, as that would have definitely raised some red flags at FDA during the approval process. He then waded through the entire submission file-by-file, checking and double checking all of the case reports for side effects, but, just as he might have expected, Allurea looked to be one of the safest drugs ever submitted for approval.
By the time he finally glanced up from sorting carefully through the data, it was almost lunchtime, and his growling stomach reminded him that he had missed breakfast. Along with dinner the night before. And he still didn’t have the slightest clue what had happened. Or even what to look for. He jotted down a few notes to remind himself where he had left off with the search, then grabbed his jacket off the back of his chair and headed down the hall toward the company cafeteria, hoping that a hot meal and a short break might be just the right prescription to clear his mind and let him see what just had to be hiding somewhere in all that data. Probably in plain sight.
8
Houston
Larry Bowser was already waiting in his office when Alden Lantanna swept in, a breakfast taco clutched in his left hand and a large mug of steaming coffee in his right. “Morning, boss. I see you’re well provisioned to start the morning.”
“Yeah, just some jet fuel to get the morning started. I take it from your text message that the report on Peter Boucher is back. All right, big guy, what have we got?”
“Actually, surprisingly little, Alden. It seems that pretty much all throughout his career, Boucher has been a bit of a shadowy character, throwing off more rumors than facts.”
“Okay, then, let’s start with the facts.”
“Right. Well, he was born in Marseille, France, the son of a moderately wealthy owner of a fleet of fishing boats. His birth name was Pierre, but by the time high school rolled around, he was sent to attend a boarding school in England, followed by Oxford. That’s when he adopted the English version of his name, Peter.”
“In other words, we’re going up against a pretty smart and successful dude, seeing as how a fisherman’s son made it into Oxford.”
“Very smart, and surprisingly successful, in fact,” Bowser agreed. “After Oxford, he bounced around a number of medically-oriented companies, mostly near Paris. He didn’t really have a background of any sort in the biological sciences, but he did seem to have a special knack for business. Maybe picking some of that up from his old man. I can’t imagine the fishing industry would be an easy world to survive in, much less thrive. Anyway, he wound up working at the French branch of an American pharma company that’s since disappeared, blended into one of the other giants. That’s when he got his big break. A drug manufacturing plant just outside of Paris blew up, leaving hundreds of casualties and just as many questions. Boucher’s boss was among the dead, so he stepped in and took over immediately. Managed to cover up the cause of the blast, and paid off all of the victims’ families before the lawyers could swoop in. I think his mantra at the time was that this was an ‘opportunity,’ not a tragedy. Needless to say, his handling of the situation made him a big hero with the folks back in America, and so began a long series of promotions that ended up with him being hand-picked to head up Labarum when the company was first established out in La Jolla. In short, he has a reputation as a fixer, a guy who makes problems disappear. And clearly that’s what he’s trying to do right here.”
“So he’s a guy who seems to have a knack for getting things done.”
“Right. But he also has a reputation for being rather absolute in his management style.”
“How so?” Lantanna asked.
“He doesn’t tolerate mistakes very well, and he seems to have zero tolerance for anyone who doesn’t follow his orders to the letter. As a result, the company has had a remarkable amount of turnover at the highest levels, particularly considering how successful they’ve been.”
“And what about the personal side?” Lantanna asked. “Any family? Wife? Kids?”
“No, he appears to be a lone wolf. Focused on nothing other than his company. Although—”
“Yeah? What is it?”
“There are some persistent rumors of his being a big womanizer. A number of women have left the company rather abruptly for no apparent reason, and not a single one of them later turned around and sued the company.”
“So obviously they were being paid to keep their mouths shut.”
“That’s what it looks like to me. And it wouldn’t be the first time something like that has happened. I mean, being a family man usually seems to settle those kinds of guys down. Or at least makes them behave more discreetly. But guys like Boucher—well, once a fox gets a look at the inside of the chicken coop, it’s incredibly hard keeping them locked out. Of course, at the end of the day, I don’t see how that helps us. Sure, maybe it could come up in a trial, work to turn the jury against him, but even if we could get one of the women to talk, I don’t see how we could sneak it past the rules of evidence.”
Lantanna looked thoughtfully at his untouched taco, tucking that last bit of knowledge away to chew on again later. “Anything else?”
“Not really. His finances appear to be in order, at least as far as we could figure out. No other scandals. Just a singularly focused man with a side issue keeping his pants zipped up tight.”
“Gotcha. Okay, let’s move on to the trial planning. It’s still not too early to put together a framework on how we’re going to approach this. I’m thinking our first three targets for test trials will be California, New York, then Texas. Three of the largest states, making up a significant percentage of our clients in this case. What are your thoughts on how many plaintiffs we should line up for each trial?”
Bowser drummed his fingers on his lips for a moment. “Well, the last time we tried one of these cases, the surgical mesh case, we went with solo plaintiffs on the first two trials and got our asses handed to us in a sling. I think when the jury sees just one person who was injured, they say to themselves, hey, everybody makes one mistake in their lives, every dog gets one free bite. Let’s cut the doctor a break. But when we pa
rade a series of patients in front of them, all suffering from the same act of medical malpractice, they can’t help but see the pattern.”
Lantanna nodded curtly. “I couldn’t agree with you more. And those last two cases had a major impact on our final payout.”
“They certainly didn’t help, that’s for sure. Clearly then, one or two victims is too small a number. And from our recent experience, anything north of six just becomes a sideshow. The jury’s anger gets worn down by the repetition.”
“So let’s aim for a number between four and six. With as many plaintiffs as we’ve got lined up in those three states, we shouldn’t have any problem finding four to six people whose stories are so compelling, so tragic, even the defendant would want to vote guilty. So that leaves our final question of the day. State court or federal?”
Bowser walked up to the whiteboard and wrote the names of the three states in large block letters near the top. “We know that they can easily move any trial out of state court and into federal if they choose to do so. When we did the breast implant case, the other side opted to keep the cases in state court, and that wound up biting them firmly in the butt. I think we can count on Labarum picking up on all that and doing everything they can to remove them if we file in the state courts.”
“And that would introduce more delays to the trial process, while we want to slug them between the eyes as quickly as possible,” Lantanna suggested. “While the dying and suffering is still very fresh in the public’s mind.”
“I’m with you on that. Looking at it from the political angle, with the geographical spread of plaintiffs we have, we can still pretty much cherry pick our judges, regardless of which way we go. At any rate, the federal benches in California and New York are no more conservative as a whole than the state judges. And in Texas, outside of the major cities, we’d be far better off sticking with federal judges.”
“Agreed.” Lantanna picked up Bowser’s marker and, walking back over to the whiteboard, underlined Texas. “So let’s set our first trial here, in federal court. See if you can line up the right number of plaintiffs somewhere around the Austin metro area, or at worst, Houston. With our choice of plaintiffs, they won’t have a ghost of a chance moving it to the Northern District, or anywhere else in Texas that might lean favorably in their direction.”
“Will do, boss. And, if you’re headed over to refill that coffee, I’ll walk with you. It looks like I’ll be needing a little extra energy this morning, too. This case is rapidly heating up to be a real barnburner. I’m just glad it’s not us on the other side. Looks like a can’t win situation from their point of view. Boucher may have finally met his match.”
9
La Jolla
It should have been obvious all along, and Kelly could have kicked himself for missing it. The answer clearly didn’t lie in the data that was submitted to FDA. It was in the data that wasn’t submitted.
The Phase III clinical trials were each assigned a codename, making it easier to log data into the database and letting the researchers perform various complex mathematical transformations on the raw data. But these codes were not just randomly generated or assigned—they were broken down into sub-elements that defined the general location of the trial, its start date, its cohort size, and numerous other pertinent parameters. And one significant part of that code was a simple sequential number, starting with a ‘1’ for the first trial, ‘2’ for the second, and so on. Buried among all of the other sub-elements of the code, it wasn’t immediately apparent that some rather large and unexplained gaps had appeared in the sequence. Meaning there were some large and unexplained gaps in the data, as well. Kelley saved his work, printed off a copy of the spreadsheet he had put together to highlight the missing data, and rushed down the hall toward Boucher’s office.
Peter Boucher was seated at his desk, pouring over some papers spread out in a neat row in front of him. He smiled as he looked up. “Why, Robert, great timing. I was just about to give you a call to see if we’ve made any progress with the assays on Allurea.”
“I found something, boss!” Kelley shouted, so excited that he might finally be on to something that could explain the arrhythmias. “I was checking out the Phase III data, and—”
“You what?” Boucher jumped out of his seat, livid. “I thought I made it abundantly clear that you were to stay away from that data!”
“Yeah, well, I couldn’t get to sleep last night, and I got to thinking—”
“I don’t pay you to think, Kelley! I pay you to follow orders! And I ordered you to drop it!”
“But I think I found something. Something in the data. A bunch of it is missing!”
Kelley saw a look of alarm cross Boucher’s face for a brief instant, followed immediately by the clench of his jaw and an icy glare in his eyes that suddenly had Kelley in fear of his job. If not his very life.
“Listen to me very carefully, Kelley,” Boucher told him in a dangerous undertone that Kelley had never heard before. A tone that immediately made him want to be somewhere very far away from this office. “There is no missing data. I managed that submission myself, so I would know. But I am ordering you right now to drop what you’re doing, to delete whatever data you’ve been looking at and never go near any of that again. Do we understand each other? Never.”
“But—but boss, what if someone lost the data, or worse, deleted it, and the answer to the arrhythmias is—”
Boucher had both hands pressed flat to his desk and was looking straight down, his head swaying slightly back and forth like a vulture’s. “This isn’t a discussion we’re ever going to have again, Kelley,” he hissed, barely audible. “This isn’t some kind of negotiation. It’s an order. I am ordering you to drop it. And delete the data files. All of them. Do you understand me?”
Kelley swallowed hard. Deleting the clinical trial data—that just wasn’t done. No one ever deleted data. He wasn’t even sure if that was legal. But, even on a good day, Boucher wasn’t a man you wanted to tangle with, not someone you ever wanted to cross. So there was only one right answer to that question. And he could always make a spare copy of the data before deleting the copy on the server. Just in case. “Yes, sir,” he said, already checking behind him for a quick escape. “I’ll get it done.”
“You do that,” Boucher growled. “And, while you’re at it, don’t even think about making a copy of that data first. I’ll be watching. And—Kelley—you don’t want to disappoint me ever again. You understand?”
“I—I do, sir,” Kelley stammered, turning as quickly as he could and darting for the safety of the outer office. He glanced back for just the briefest moment as he shut the door behind him, and the look he saw on Boucher’s face rattled him to the core.
10
Houston
“How are our caseloads holding up?” Lantanna asked, standing in front of the plate glass window in his office and looking out across the top of the city. He could easily make out Minute Maid Stadium across the way, even in the early evening gloom. “Are we still getting more cases pouring in from the feeders?”
“Still trickling in,” Bowser answered, double checking his tablet to get a more up-to-date figure. “Well over two thousand now, mostly from the usual fifty or so feeder attorneys who’ve been busy with all the TV ads and such. Unlike most of our prior cases, these are pouring in pretty quickly. Which is what you’d expect, given the acute nature of the poisoning.”
They’d taken to using the word “poisoning” to describe what had happened, usually in conjunction with the modifier “deadly.” It had scored much better with focus groups than any of the other ideas they had come up with, and had already been picked up by the media. Clearly, the actual problem at the heart of the case was some kind of manufacturing error, but the idea that Labarum had slipped its victims a deadly poison carried a far more powerful emotional appeal. And emotions added up to billions of dollars at the end of the day.
Lantanna turned, leanin
g back against the window, thinking. “With two thousand, I’m thinking we could average at least two to three million bucks a head. So a minimum four to six billion. That sound about right to you?”
Bowser scratched his chin for a second. “I’d have to run the numbers on deaths versus short term hospitalization first, and of course the demographics. Luckily, most of the Alleurea users were fairly young, and since it was a prescription drug, almost all of them had health insurance. Which means good paying jobs. So I’m thinking the mix for economic damages might be even higher than we’ve seen in our prior cases.”
“So … even more, maybe?” Lantanna asked. “Ten billion?”
“Well, there is the issue of how much blood we’ve got left in the turnip,” Bowser suggested. “Labarum is a newish company, and Allurea hasn’t been out long enough to build up a large war chest yet. But, on the other hand, if it bounces back pretty quickly, there’s always the downstream cash to think about.”
“Okay, what I hear you saying is, their best option is to work out a quick deal with us and get all of this well behind them. Assuming they ever figure out what happened in the first place, and can put a lid on it.”
“Hmph,” Bowser snorted. “I don’t know about you, but no matter how good that drug is, I’d have to think twice, and then twice again, before I ever popped another one of those pills in my mouth. Claritin is good enough to get the job done, let me tell you.”