Over the last few months, we have been sharing a new blog series around ESI Protocols. In Episode 17 of ACEDS‘ #CaseoftheWeek, host Kelly Twigger continues focusing on ESI Protocols with a case that highlights the importance of knowing your data before negotiating your ESI Protocol. The case is In re Valsartan, Losartan, and Irbesartan Prod. Liab. Litig. 2020 WL 7054284 (D.N.J. 2020) December 2, 2020, presided over by United States Magistrate Judge Joel Schneider.
Good morning and welcome to our #CaseoftheWeek for March 16th, 2021, I am Kelly Twigger, the CEO of eDiscovery Assistant and principal at ESI Attorneys. Through our partnership with ACEDS at eDiscovery Assistant, each week I select and talk about a different case in eDiscovery and the practical implications for what that case means for you, your practice, as well as your clients.
Before we get started, there are a few links to look at, depending on what platform you’re and you’ll be able to view all of those links. The first is the public link to eDiscovery Assistant for the case we’re going to be discussing today. You’ll also see a link there for the 2020 Annual eDiscovery Case Law Year in Review report that we put together with Doug Austin at eDiscovery Today. There’s also a link to an article that Doug Austin wrote on eDiscovery Today about the same case we’re going to be discussing today 𝐈𝐧 𝐫𝐞 𝐕𝐚𝐥𝐬𝐚𝐫𝐭𝐚𝐧. The last link you’ll see is for the University of Florida eDiscovery Conference, which is coming up this Thursday.
We are really excited about the conference. So far we have more than 2,700 people registered, so please join us. We’ll be starting off the conference with a judicial panel. We’ll have a case law session that I’ll be joining. We’ll be talking about search, proportionality, a number of fantastic topics. We’ve got a great lineup of speakers, so check out that link and get registered. If you register, you’ll be able to view it for six months after the event. So if you can’t stay for the whole day, the event will be recorded. We’re offering 9.5 CLE credit hours under Florida. Generally speaking, those hours can be applied in other jurisdictions. You can apply for credit based on Florida’s accreditation. That’s been largely successful for most of our attendees over the years.
Let’s get into our case for this week. If you follow our blog at eDiscovery Assistant, you’ll notice that we’ve been doing for the last couple of months a multipart series on ESI protocols. This last week, we wrote a piece on ten situations that you can avoid with a ESI good protocol. While it wasn’t included in our list, this is a great case to illustrate a situation that you can avoid. This decision from In re Valsartan is from December of 2020. It’s actually a year old, but it’s really important in highlighting how crucial the negotiation of how you’ll treat data is in your ESI protocol at the outset. Essentially, the dispute in this case, which is a decision from December 2, 2020 from Judge Joel Schneider, who’s the United States magistrate judge in the District of New Jersey, essentially looks at whether or not the parties were acting in compliance with their ESI protocol based on the language they chose and the actions that followed.
Let’s dive in.
In re Valsartan is a multi-district litigation about a prescription drug, Valsartan, which is a blood pressure medication made, sold and dispensed by multiple manufacturers, including Teva Pharmaceuticals. The plaintiffs allege that the blood pressure medication they ingested was contaminated with cancer causing chemicals. There are more than 650 cases filed throughout the country. Potentially we’re looking at a very high seven figure — eight figure case here in terms of value.
These decisions were consolidated or these cases have been consolidated into multi-district litigation in front of Judge Schneider in the District of New Jersey. As is consistent with MDLs, the judge rule on discovery disputes in the case prior to trial.
One of the important things right away we want to take from this case is we’re looking at discovery for across many, many, many lawsuits. Also you’re looking at the value of these lawsuits. These are cancer causing chemicals. So we’ve got high value lawsuits to the plaintiffs and high dollar considerations. The cost of discovery is going to be very high.
Currently, the motion that’s in front of the judge on this particular decision is a request for an order from Teva Pharmaceuticals foreclosing additional review of documents, based on a TAR protocol that Teva developed, that are predicted to be non-responsive.
Teva wants to essentially say we don’t have to review documents that are determined to be non-responsive according to the TAR protocol that we developed. If the plaintiffs argue that manual review should be done of those non-responsive documents, then Teva wants cost-shifting to require the plaintiffs to pay for that review. That’s really where we are. The court essentially has to decide whether the terms of the ESI protocol takes precedence over the unilateral TAR protocol that Teva adopted. Let’s dive into where the court gets into that analysis.
The protocol that the parties entered into, the ESI protocol, was signed by the court in June of 2019. That’s really important from a timing perspective. We always talk about these cases in terms of the timeline and here it’s no different. As you’ll pick up on, I’m always talking about early planning, early looking at your data. While, as always, it’s difficult to know what the parties were doing when, it does appear here that the parties entered into an ESI protocol without knowing exactly what their plan was going to be for data.
The ESI protocol entered into said that the parties agreed that they would cooperate in good faith regarding the disclosure and formulation of appropriate search methodology, search terms and protocols, and any TAR or predictive coding prior to using any such technology to narrow the pool of collected documents to a set to undergo review for possible production.
The parties also agreed to meet and confer as early as possible to discuss search methodologies to be utilized, including, but not limited to boolean searches and technology assisted review or predictive coding. That’s what the protocol agrees to. It also says that the parties will meet and confer regarding any dispute as to whether or not they should produce documents in conformity with the protocol, and if the parties cannot reach agreement, then they’ll bring the issue to the court’s attention for resolution.
Really important right away out of the ESI protocol you’ve got that the parties say they’ll agree about any process to use TAR or predictive coding, and that they’ll meet and confer about any disputes. So what happens? Teva is part of a manufacturer group of defendants, so there’s three different groups of defendants in the case, one of which is the manufacturers. There are also distributors and retailers. Teva was part of the manufacturers group, and those defendants all negotiated search terms for months with the plaintiffs as well as custodians that would be required. Each manufacturer had its own custodians and then search terms to be applied to those custodians.
All of that negotiation took place over months of time, and most of that happened prior to December of 2019. The protocol was entered into in June of 2019. By December of 2019, Teva was aware of the core group of custodians that were going to be used in connection with its document search.
Now, Teva along with the other manufacturers, refused a request from the plaintiff to conduct sample runs of hit reports to determine whether or not the search terms that had been proposed and agreed upon were overbroad.
In hindsight, that would have been a great tool to use to avoid this entire controversy, but I’ve seen that a lot when we work on both sides of the v, that there’s a real reticence for defendants to run search term reports early. Frankly, it’s a great tool, it’s one that should be utilized and we’ll talk about it a little bit more in the takeaways.
When the manufacturers finally ran those reports after the entry of a court ordered decision on the search terms, which is part of this judge’s decision on December 23rd of 2019, the defendants then complained that the search terms they agreed to were overly broad and unduly burdensome. At that point, of course, because the plaintiffs had already engaged upon months of negotiating search terms, they objected that the defendants were now trying to move the goal posts.
Eventually, the plaintiffs relented and accommodated Teva and the other manufacturers by narrowing the search terms, and then that amended search term list was entered on June 24th of 2020. That’s really where the problem starts.
So, you’ve got your protocol that says the parties are going to agree to any use of TAR. You’ve got the plaintiffs agreeing to search terms and saying these are the search terms we want, please run sample reports. Defendants refused to run the sample reports. Court has to order the defendants to run the sample reports. Defendants run the sample reports and then object that the volume of hits are overly burdensome. So the plaintiffs say, wait a minute, they said you could run sample reports earlier and you didn’t do it and now you’re objecting to it. Then the plaintiffs agree, to move the case forward, to narrow the search terms, and those are entered in June of 2020.
Now, as of the December 2019 order, Teva was to complete its production by the end of May 2020. You can tell already that we didn’t even amend the search terms until a month after Teva was supposed to finalize its production. As it turns out, prior to the June amendment of search terms, Teva and probably other manufacturers and the plaintiffs agreed to a further out schedule to produce documents where Teva would be producing documents periodically on rolling productions over the summer, all the way into the fall, all the way into November of 2020.
For the first time on July 1st, 2020, after all of these things have already happened, a year after the protocol was entered, more or less a year after the party started negotiating search terms, seven months after the entry of the first order setting search terms, and a week after the order narrowing the search term list, Teva told the plaintiffs for the first time that they would be utilizing a TAR based platform to assist them with review and production of ESI. In the actual decision, they refer to it as a continuous modal learning platform, but essentially for our purposes, we’re talking about TAR.
The problem here is that Teva stated that once the system identified documents that were non-responsive, it would identify those to the plaintiffs and it would no longer review those documents. Plaintiff’s position was that, wait a minute, we never would have agreed to narrow the search terms if you’d told us that you were going to use TAR to narrow responsive documents after the fact, we would have preferred to have the broader search terms and then agreed to a protocol where you could use TAR to review those documents. That’s what the ESI protocol called for, is for us to meet and confer and agree on a process here.
Now, there’s a lot of information in this decision, so I’m boiling it down to the nuts and bolts for you. That essentially we have a protocol where the parties said they would agree, the parties went through a whole process, the plaintiffs agreed to narrow things based on that process, and then, a year later the defendants decided, wait, we’re going to use TAR. Not only are we going to use TAR, but we’ve decided on our own protocol. We don’t have to discuss it with you. This is what we’re going to do and court we’d like you to order that to be so.
The Court then said, wait a minute, we need to look at what the ESI protocol says here. Now, there is some noise in this decision, and I call it “noise” because I think it kind of detracts from the actual point, where the plaintiffs want to discuss that it’s not appropriate to layer the use of search terms to identify a large set of data and then to apply TAR after it.
The Court does address that briefly, but I think it’s important to note that that is exactly what most really great practitioners do, is you find not just search terms, but parameters of data to be able to bring in a larger collection set and then to use a technology such as TAR to be able to narrow that set by pulling the responsive information to the top and allowing you to produce that responsive information more expeditiously. Try not to get lost in that noise of that discussion, but the court does clear it up that there’s a good line of cases that say that layering search terms and TAR is an acceptable method. But it is important that if you agree in your ESI protocol and then you have the Court sign off on it that you’re going to agree with the other side how you’re conducting things, you then have to agree with the other side.
The court then said, OK, let’s get into this. Let’s determine whether or not the ESI protocol here allows Teva to set up their own TAR process to be able to review information that’s been identified as a result of the search terms and not review information that is determined to be non-responsive according to the TAR protocol.
Essentially after this came to the court, the parties all sat down and they came to an agreement on a process except for two things. Teva said we don’t want to put the process on the record. We don’t want it to be public information, what the process is that we agreed to. They also refused to permit the plaintiffs to review 5,000 supposed non-responsive documents that would allow them to evaluate whether, in fact, the TAR process that Teva was following was sufficient. They wanted to basically sample those 5,000 documents and say, hey, we found some stuff that’s responsive, so we think that you need to change your TAR process up. Teva said no.
Essentially, Teva is saying exactly the opposite of what they agreed to in the ESI protocol, which is that the parties would collaborate on coming up with a process. Once Teva refused to put the process on the record and refused to allow the plaintiffs to review those documents, they withdrew the dispute from the courts and essentially brought to the court a separate motion, which is the one before us that says: Judge, we just want you to validate the process that we’ve used. Teva writes that “the fundamental disagreement is that the defendants cannot agree to a non-confidential validation protocol which permits plaintiffs to review non-response of documents.”
What happened then is Teva turned around after saying we’re not going to agree to this process, came up with their own process and used TAR to validate that many of the high level custodian documents were non-responsive and asked them to validate that process.
What did the court do? We talked about this a little bit already. The court looked strictly at the language of the Court ordered ESI protocol that I’ve talked to you about a couple of times. They said specifically that we’re only looking at the language of the protocol. We’re not ruling on whether or not the TAR expert or the process that’s been laid out by Teva are valid, or whether they’re credible. We’re not looking at any of that. Those are not the issues here. The issue is whether or not Teva has violated the ESI protocol that the parties put in place.
Then in doing that, the Court agreed with the plaintiffs that Teva’s intention to use the TAR should have been disclosed at the earliest possible time, whether it was before the protocol was entered or shortly thereafter. What we find out in the opinion is that the protocol was entered in July. By November, Teva was already talking with a TAR consultant about a process to be used, and yet that process was not disclosed to the plaintiffs until the following July. So we’re looking at seven, eight months before the process was even disclosed. At that time, Teva had already undertaken much of the process.
The court looked at a long line of cases that held that TAR requires an unprecedented degree of transparency and cooperation among counsel in the review and production of ESI responsive to discovery requests.
Now, I have some issues about this line of cases, as you compare them to the Livingston vs. City of Chicago case, which we’ve talked about previously on the #CaseoftheWeek, in which the court stated that Rule 34 does not require that the parties discuss or agree on how they will produce responsive information. The difference here between Livingston and this case is that the ESI protocol in this case said the parties would agree to meet and confer and provide transparency on TAR related issues.
If you don’t want to provide that information, don’t put it in your protocol. That’s the big issue here. That’s the big difference. I think there’s still some discrepancy in the case law and it’ll be interesting for us to discuss this with the judges during our case law panel during the UF Conference, if you can join us please do, as to what the parties real obligations are to disclose the TAR process.
In terms of the ruling here, the Court denied Teva’s request to impose the unilaterally adopted TAR protocol because it violated the protocol that the parties agreed on. It denied Teva’s request for cost shifting. It denied the plaintiff’s request to have Teva manually review the non-responsive documents because that didn’t make any sense and would cost millions of dollars. It also denied plaintiff’s request that it review non-responsive documents with a privilege filter. So, instead of all of those things that the parties proposed, the Court looked at what really makes sense and it ordered Teva to review the non-responsive documents using the TAR protocol the parties negotiated but failed to consummate in August of 2020.
One of the things I forgot to mention is that Teva said in July, we’re going to use TAR, the plaintiff said, wait a minute, you told us you weren’t going to do that. The parties then agreed to a process. Teva said no because of the two conditions that we did talk about and then that came back. The Court said you agreed to this process, this is what the protocol said, you’re going to follow the process that the parties agreed on in August 2020.
What are our takeaways?
Plan, plan, plan, plan, plan.
Now, this is a huge case, exponentially very large in terms of discovery, and it means that there were a lot of custodians and a lot of documents. I mean, we’re talking about the development of a drug and having been involved in cases of that magnitude, the scope can be very large. What really needed to happen here, and I’m sure that pieces of this did happen and like always, we only know what’s included in the decisions that we read, we’re not privy to every single thing that happened in the case, is that this needed to be done in an incremental fashion. Perhaps the ESI protocol going into place should have been delayed until the parties had gone down some of this road. Until they had agreed on custodians, until they had looked at search terms, until they had run sample reports, until they had truly understood the scope of the data and the process that would be employed, that having an ESI protocol in place that locks you into an existing process or requires agreement for a process is too early.
Get in there and know your data early. It doesn’t matter whether it’s a small case or a gigantic case like this MDL case. You’ve got to know that data early.
Be transparent about what you learn when you need a different approach than what was agreed to. So second takeaway, if you agree to something, as happened here, and you decide that you may have to take a different approach, you’ve got to be transparent about it early. Now, as someone who’s in data all the time, I know that seven months can go by in the flash of a pan without you knowing or having a full understanding of what you would disclose to the other side. That is in practice a reality. It happens so quickly. You’re so mired down in so many different things that are happening. Everybody has more than one case they’re working on. There’s so many things that happen, but when it comes to a Court and the Court looks at a seven month time frame, from the time that you started talking to a custodian, to the time that you finally disclosed and here it would have actually been closer to 10 months, then that’s going to be a problem for the Court. You have to understand those visuals.
When you first start recognizing that you’re going to need to use a TAR process that has to be agreed on by the parties, then you’ve got to start having those conversations with the plaintiffs. What that’s going to require, though, is it going to require a better cooperation and a better dialog between counsel. I can foresee that here, if in November Teva had said we’re going to try to employ a TAR process as one manufacturer in a huge group of manufacturers in a multi-district litigation, that the dialog between Teva and the plaintiffs would be difficult. There are an awful lot of things at play here that it’s difficult for the Court to really take into account in ruling on these kinds of issues.
The point is, you’ve got to plan early on. You’ve got to have somebody who is thinking about how is this going to look, what does the protocol say, and what are our obligations to disclose here and coordinate with the other side. And I think that’s where things kind of broke down here. Clearly, the lawyers involved will know exactly what happened, but it’s very easy to see how this transpired and how when you suddenly get into the data and suddenly realize the scope of what you have, why there are new issues.
Now, it’s also easy to see from a defense perspective why, when you’ve got 5,000 non-responsive documents, you wouldn’t want to review those documents. There’s no specifics in the decision about the level of response that those documents got in terms of a rating on the TAR protocol, we generally go from one hundred percent responsiveness down to zero. There’s no discussion as to what percentage responsiveness we were talking about or any kind of validation statistics, so we’re not able to evaluate any of those. What’s really important is that you’re making good, important economic decisions here. It’s very difficult for plaintiffs in large class actions like this to be able to take face value of what defendants say, particularly when the defendants wouldn’t run those early reports or be forthcoming. You can see why there’s a lot of adversarial action that’s happening here.
Finally, when you’re drafting your protocol language, however you draft it, if you do it early on and agree to agree later the way that these parties did, you also need to say that the parties can amend or agree to a revised protocol and you need to go back to the court and ask the court to amend or revise the order. There’s no harm in doing that. There’s no harm in entering a revised protocol. When you need to do that, sit down and agree with the other side about how things are going to work, put in a revised protocol, because essentially what happened here is that Teva was in violation of a court order. That doesn’t look good from a court perspective and that was the sole focus of what the Court looked at here, not whether or not to have a TAR process unilaterally was a good process, which it very likely could have been. But because the parties had agreed that they would agree on what a process look like, that’s what the court ordered.
That’s our #CaseoftheWeek for this week. Thanks for joining me. I’ll be back next week with another edition of The #CaseoftheWeek. If you’re an ACEDS member interested in using eDiscovery Assistant, there is a discount available to current ACEDS members and a trial for folks that are taking the ACEDS exam. If you’re interested in either one of those, just drop us a line at ACEDS@eDIscoveryAssistant.com and one of our team will be in touch.
Please remember to register for the UF conference coming up this Thursday, March 18th, and share that information with your networks. We all need some great high quality free CLE right now, and this is a great opportunity to hear from judges and top practitioners in the field. As I mentioned, we’ve already got more than 2,700 registrations.
Have a great week. Stay safe and healthy and we’ll look forward to seeing you next week. Thanks for joining me.
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