“Gents, I"m Scott Winslow and this is my paralegal assistant, Donna.” Scott is forty-four years old, six feet two inches tall and flashes deep blue eyes filled with determination. Donna is thirty-seven years old, five foot five, and has short blonde hair and a likable smile. Her large brown eyes exude warmth and sincerity, and clients typically like her from the first moment. Scott and Donna operate with the proficiency of a team that has worked together for a dozen years and know each other well.
They shook hands. “Marty, I think you spoke to Donna when you called in to make this appointment.”
“Yes, that"s right,” Marty replied.
“I like Donna to sit in so that she has an awareness of the facts from the beginning. If this becomes a case, you will be regularly working with both of us.” He sat back in his seat and said, “The first thing I want you to know is that whatever you tell me is protected by the attorney-client privilege and it will be kept strictly confidential whether the matter goes any further or not.”
That announcement made Art relax. “That"s good to hear because we all feel like we have our necks overly-extended.”
Scott smiled and said, “I understand. Tell me about your respective roles at Aligor.”
“I am the National Product Manager,” Art replied. “Everything to do with each of the products Aligor markets is in my wheelhouse, from development to distribution. Marty is the Manager of Product Testing and Marketing. Anytime we conduct tests or trials, Marty"s people conduct it, make sure it"s done right, and assess the resulting data. Justin is the National Sales Manager. Once a product is released, he over sees the entire sales force in its sale and distribution.”
“Who do you report to?” Scott asked Art.
“I report directly to the CEO, Roland Cook. These guys report to me.”
“Got it,” Scott replied with a nod. “From the expressions around the table, I think something distressing has happened. Can you us off by providing an overview of what"s happening?”
Art looked at Marty and nodded. Marty looked at Scott and said, “We have been testing a new cancer d**g. The initial trial results were extremely good. Sixty-five percent of people were getting good results. But most recently we have done a larger round of trials, our phase three trials involving fifteen thousand participants, and the results aren"t the same.”
“What do the latest results show?” Scott asked.
“Instead of sixty-five percent of participants coming out better, that number is only twelve percent and we don"t know why. There are also a couple of side effects that could be significant that we didn"t see before. We are concerned that this information is not being divulged.” He drew a breath and added, “The CEO says he still believes this product will revolutionize cancer treatment. Our concern is that none of the expanded test findings are being shared by the Company. They still use the results generated by the phase one and phase two studies and those numbers are now misleading.”
“You approached the CEO about the need to change what is out in the public realm because of your findings?”
Justin nodded. “He reinforced his belief in the product and dismissed the latest data as an aberration.”
Art offered, “The three of us met with him twice. The second visit was just like the first. We just weren"t getting through to him, so we assembled the data in great detail and tried to set up another meeting. He refused to meet with all three of us but met with me alone. In that meeting I told him that we had been over all of the data again and what we were stating was accurate. His response was that we needed to give it time and let the positive effects of the d**g be discovered by the public. When we ended the meeting, he characterized the need to let the product be released so that it can help cancer victims as a test of my loyalty.”
Scott reflected a moment and asked, “So, he never acknowledged that these numbers reflect any problem with the product, is that right?”
“That"s right,” Marty replied. “Which is frustrating to those of us who can see these latest results are material and reflect on the performance of the product.”
“I assume that if this d**g could revolutionize cancer treatment, it is expected to generate big bucks?”
“Expected to and already has,” Art replied. “The stock price is way up and inflow of investor capital is astounding.”
“So, denying any problem is what you want to do if your primary objective is to keep the money flowing, right?” Scott concluded.
There were nods around the table. “Yes, that"s true,” Marty replied.
“But there"s more to it than the money,” Art added thoughtfully. “Cook thinks that he has found a d**g that will change cancer treatment and the impact of cancer forever. He sees himself ushering in a new era where people recover from late stage cancer. He really wants that to be his legacy.”
Scott nodded. “Even when he"s shown that it"s not working.”
“Right,” Justin acknowledged, entering the conversation. “We have taken him through the data. It"s nowhere close to what it should be, but he doesn"t want to acknowledge it. He understands the data, he simply rejects it because it doesn"t match the image in his head.”
“What do we do?” Marty asked. “I mean, we are now officially between a rock and a hard place. We are disloyal to Cook and the company or we make the adverse data known.”
“I take it that the FDA does not have the data that Cook doesn"t want to hear?”
“Seems right,” Justin replied, “because he won"t even acknowledge the data that undermines the d**g exists. The watch dog agency that analyzes the information for the FDA is the Center for d**g Evaluation and Research. The new data should have been conveyed to them for review, but that is not happening.”
Scott reflected a moment and then said, “I suggest that you prepare a memo to Cook pointing out that, as disclosed to him in prior meetings, the data shows positive results for only twelve percent of the participants and new side effects have been discovered. Ask him to confirm that he will promptly take action to address the problem, including conveying the information to the Center for d**g Evaluation and Research. Tell him that unless such essential corrective action is taken, you feel you will have no choice but to advise the Center because public safety issues are involved.”
“He will likely fire us before we go to the Center,” Marty added.
“He may, but then your path is clear. And going to the Center isn"t just sour grapes by a fired employee because you told him you planned to do so before you were fired. If he takes no action, then you write a communication to the Center for d**g Evaluation and Research and the FDA providing the new data. Because the failure to disclose adverse testing data presents serious public safety issues, if you are the subject of retaliation for coming forward with the warnings, you will have a whistleblower claim and termination in violation of public policy claim.”
Nervous faces considered this information for a time and then Marty asked, “And if we do this, will you represent us in this whistleblower claim?”
Scott considered a moment and then asked, “The company will likely take the position that you were fired for another reason, such as performance issues. Is there anything out there that would substantiate that position?”
All three men shook their heads. “Nothing I"m aware of,” Art replied.
“Do you have documentation of your achievements? Things like commendations, compliments, raise and bonuses? Things that we can rely on to establish positive performance?”
“Yeah,” Justin said. “Lots of it.” The others nodded agreement.
“Our Firm will take the case for you whether you are fired because of your complaints before or after going the Center and the FDA.” Scott regarded the attentive faces around the table and added, “The reason for preparing the communication to Cook is that there is no record that you went to him with your findings. This creates a piece of physical evidence establishing what you complained about. It helps us prove an essential element of the claim and minimizes his ability to mischaracterize the content of your communications.”
“If we do this and wind up fired and in a whistleblower action, how long would a lawsuit like this take to get to conclusion?” Justin asked.
“From filing the lawsuit to trial, about a year and a half. During that time, we take depositions and obtain critical documents. We gather all of the evidence we can in preparation for trial.” Scott added, “If you elect to move forward with this case, we will work on a contingency fee basis, so your only out of pocket expenses would be costs in connection with the litigation.” There was quiet around the table as the three considered this painful decision. “You should take your time and consider all of this before you make a final decision,” Scott offered. “If you have any additional questions, call and Donna and I will be available to provide answers.”
There were nods around the room. “Thank you, Scott,” Marty said. “The information that you have given us is helpful.”
They all shook hands and then the three left the conference room wondering if they could do what was suggested and fearing what might come next. As they walked to the car, Marty said, “What do you think?”
Justin replied, “I like Scott. He"s a smart guy, but this is going to cost us big time. I just don"t know. We survive for a year and a half during the litigation. We also have to worry about how a feud with Aligor affects our ability to get work somewhere else.”
Art shook his head. “I just can"t do this,” he said. “I"m almost sixty-years-old and just five years from when I plan to retire. I"m sorry, but I can"t go tell Cook that I am about to go to a public agency to blow the whistle, and I can"t think about having to look for a new job at age sixty.”
“I understand,” Marty said. “I"m going to talk to my wife, but I think I want to make this stand. How about you Justin?”
Justin nodded. “I"m in. I"m single, I have money put away, and I can"t let Cook mislead people who are looking at this product like it"s going to be their salvation in just the next few months.”
Marty nodded. “I feel the same, but I have to make sure Abby is up for what all of this will mean to us personally.”