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In re Actos Pioglitazone Products Liability Litigation

United States District Court, W.D. Louisiana

July 17, 2017






         I. FACTUAL AND PROCEDURAL BACKGROUND........................................................5

A. Prior to Establishment of MDL 2299......................................................................5
B. Establishment of MDL 2299...................................................................................7
C. State Court Proceedings........................................................................................11
D. Procedural History Prior to Bellwether Trial........................................................13
E. Discovery, Preparation for the Bellwether Trial, Allen v. Takeda........................17
F. The Master Settlement Agreement.......................................................................30
G. Implementation of the Settlement.........................................................................39
H. The Initial Hold-Back on Settlement Payments....................................................43
I. Nationwide Settlements........................................................................................45
J. Additional Comments on Common Benefit Efforts.............................................45

         II. COMMON BENEFIT FEE AND EXPENSE REVIEW PROCESS.............................49


A. Distinction between Reasonable Hourly Rates in Multidistrict Litigations and Class Actions........................................................................................................56
B. Calculating the Aggregate Fee Award..................................................................65

         IV. REASONABLENESS ANALYSIS....................................................................................67

A. Valuation of the Benefit Obtained............................................................................67
B. Benchmark Percentage..............................................................................................68
C. Johnson Factors........................................................................................................71
1. Novelty and Difficulty of the Issues (Factor 2); The Skill Required to Perform the Legal Service Adequately (Factor 3); and The Experience, Reputation, and Ability of the Attorneys (Factor 9)....................................74
2. Time and Labor Required (Factor 1); Preclusion of Other Employment (Factor 4); Time Limitations Imposed by the Client or the Circumstances (Factor 7)......................................................................................................75
3. The Amount Involved and the Results Obtained (Factor 8)........................78
4. Nature and Length of the Professional Relationship with the Client (Factor .....................................79
5. The Customary Fee for Similar Work in the Community (Factor 5), Whether the Fee is Fixed or Contingent (Factor 6), Awards in Similar Cases (Factor 12)...............................................................................................................81
6. The Undesirability of the Case (Factor 10)..................................................82
7. Conclusion: Johnson Factors.......................................................................83

         V. ALLOCATION OF COMMON BENEFIT FEES AND EXPENSES...........................84

         VI. CONCLUSION.................................................................................................................116

         Early in this MDL, and with the input of the plaintiffs' counsel and the Special Masters, this Court established a system to maintain ongoing records of all common benefit time and expense - i.e., time and expense incurred for the benefit of all plaintiffs, rather than any individual plaintiff alone.[1] According to that protocol, only certain kinds of time and expense would be allowed to be incurred for the common benefit, and any attorney who wished to perform common benefit work was required to submit a request to do so to the Plaintiffs' Steering Committee, which, along with the Court, was vested with the authority to approve or deny such requests with the instruction of the Court that all otherwise qualified attorneys who desired to perform common benefit work be allowed to do so. Furthermore, any approved common benefit time or expense that was incurred, also, would be submitted to Deputy Special Master DeJean, who was tasked with reviewing all such submissions on an ongoing basis, and either approving them, rejecting them, or returning them to the submitter for clarification or to address any deficiencies in the submission. A Master Settlement Agreement ("MSA")[2] was executed on April 28, 2015, and provided, in part, that participating claimants and their counsel agreed to submit a portion of each of their recoveries to compensate the common benefit expense and fees incurred, respectively.[3] On September 1, 2015, the Court entered a preliminary order setting aside a percentage of all recovery in anticipation of a final order establishing a common benefit fund and distribution.[4]Thereafter, by Order dated August 7, 2015,[5] this Court instructed Deputy Special Master DeJean to gather information relevant to this Court's decision of how best to allocate the common benefit fees generated as a result of the MSA and the Assessment Order, among Participating Counsel and the PSC,[6] and to provide that information to the Court. Subsequently, on September 1, 2015, this Court issued a "Case Management Order: Holdback Order" [Rec. Doc. 5850], ordering that funds be withheld from settlement payments in order to compensate common benefit attorneys' fees and expenses and/or costs, should a common benefit fund prove necessary. For the reasons given below, this Court (1) finds that a common benefit fund is necessary, (2) finalizes the amounts provided in the Holdback Order and "Case Management Order: Assessment of Common Benefit Fees and Expenses and/or Costs" [Rec. Doc. 6238], and (3) determines the amounts that will be allocated among participating firms and attorneys. In order to comply with this Court's Order to provide it with the information necessary to make informed allocation decisions, Deputy Special Master DeJean has submitted a Report and Recommendation, which is attached to this Ruling (Attachment A). For the reasons that follow, this Court adopts and incorporates herein Deputy Special Master DeJean's Report and Recommendation, and issues the following ruling on common benefit fees, their necessity, and their allocation, as well as common benefit expenses.


         A. Prior to Establishment of MDL 2299

          This multidistrict litigation concerns Pioglitazone (marketed in several formulations and under several brand names, but known by the commercial name and referred to herein as Actos®), which was approved for sale in the United States in 1999.[7] Actos® was developed and produced by Takeda Pharmaceutical Company Ltd. (a Japanese company with several subsidiaries in the United States, which, here, will be referred to collectively as "Takeda") and was marketed in the United States for a portion of time by Eli Lilly and Company ("Eli Lilly"); Actos® was available in the United States as early as 1999.[8] The plaintiffs allege that in June, 2011, regulators in Europe, Canada, and the U.S. took action to warn the public that Actos® might increase the risk of bladder cancer in humans.[9] According to the first Motion to Transfer filed with the Judicial Panel on Multidistrict Litigation ("JPML"), as of August 31, 2011, there were at least eleven (11) actions pending in eight (8) district courts alleging injury from usage of Actos® and seeking recovery from Takeda and Eli Lilly.[10]

         Shortly after certain governmental warnings were issued, attorneys who would eventually become Lead Counsel, members of the Plaintiffs' Steering Committee ("PSC"), and other Participating Counsel[11] began to file actions and to coordinate with one another, not only for the protection of their own individual clients, but with an eye towards the advancement and protection of the common and collective interests of others who were likely to become litigants at some point in the future.

         Attorneys, many of whom ultimately became members of the PSC, performed extensive legal and factual research in an effort to evaluate potential MDL locations and to prepare to litigate these matters. Counsel, also, poured a great deal of effort, time, and expertise into the extensive and challenging organization required to mount a complex and large, collective of cases, including case and leadership strategy, identification of potential experts, researching case-related science, and documenting potential injuries allegedly associated with the use of Actos®. A group of litigation leaders ultimately stepped forward and made multiple presentations throughout the country to educate and inform other already involved attorneys about Actos® and their theory of causation. As the cases were filed and were being brought to the attention of the JPML, these case leaders engaged in extensive coordination and communication with involved attorneys throughout the country. Thus, the organization and administration skill of the leadership proved of exceptional value to the litigation.

         In the meantime, these attorneys, also, had begun the daunting task of learning the complex and extensive science underlying these claims and finding and hiring experts in the scientific, regulatory, and clinical arenas to educate, inform, and in some instances possibly testify on behalf of all plaintiffs. As described below, developing an understanding of the complex scientific aspect of the plaintiffs' theory of the cases required an intensive investment of time, expertise, and effort, on the part of counsel, especially given the very short time frame this MDL followed. Due to the heavy reliance on sophisticated scientific knowledge required to move this litigation forward, those attorneys and firms, who provided the requisite expertise in the sciences, came to provide exceptional value to the PSC.

         B. Establishment of MDL 2299

          Once lawsuits began being filed throughout the country, a number of plaintiffs, through their counsel, together with the defendants, through their counsel, moved to have the JPML consolidate the Actos®-related lawsuits into an MDL; the JPML consolidated the Actos® cases and selected the Western District of Louisiana, Lafayette Division, and Judge Rebecca F. Doherty, to handle all pre-trial matters. The order establishing MDL 2299 ("In Re: Actos® (Pioglitazone) Products Liability Litigation") was issued by the JPML on December 29, 2011.[12] Just over two years later - on January 27, 2014 -jury selection began in the first, and what ultimately would become the only, bellwether trial conducted in these proceedings. The intervening two years were an incredibly active time for involved counsel and the Court.

         On April 11, 2012, this Court appointed a Special Master and two Deputy Special Masters to assist in managing these proceedings, each with his or her specific responsibilities, all designed to avoid any unnecessary overlap of effort or duties. Special Master Gary Russo was appointed with overall responsibility over case management in the MDL; Deputy Special Master Kenneth DeJean was appointed to manage and oversee matters related to the PSC, especially to oversee the ongoing submissions for common benefit fees and expenses; Deputy Special Master Carmen Rodriguez was appointed with primary responsibility over matters related to the law and legal analysis, especially with regard to avoiding disputes over or the need for issuing of formal rulings or contested motions.[13] In addition, the parties made the crucial agreement that the Special Masters could communicate ex parte with any party or attorney so long as it did not involve substantive legal issues filed and pending before the Court.[14] In combination, these aspects of the team of Special Masters and the agreement of the parties, made it possible for counsel for the parties to work closely with the Special Masters and, ultimately, the Court, to either resolve or avoid many disputes that threatened, and historically within MDLs have acted, to slow or stop the progress of the MDL. For example, no substantive discovery or dispositive motions were formally filed until June of 2013, approximately eighteen (18) months after the MDL was created; rather, those disputes were resolved by way of the Court through the Special Masters and the parties' agreement by way of counsels' full involvement, requiring constant, ongoing, and extensive involvement by the PSC leadership and the Court.

         Shortly after receiving the MDL assignment, and after having done its due diligence, this Court appointed the PSC by order dated April 13, 2012.[15] The Court assigned the PSC tasks that were both detailed and wide-ranging.

The PSC shall take the lead in litigating these matters on behalf of all plaintiffs, meaning that they shall play the lead role in making strategic, practical, and procedural decisions on behalf of the plaintiffs' counsel and pro se plaintiffs.
[T]he PSC shall be responsible for coordinating the plaintiffs' responses to the orders of the Court, for coordinating the presentation of issues to the Court for its consideration, and for overseeing the progress of these proceedings toward final resolution.
The PSC shall have the responsibility for assigning litigation-related tasks to counsel who provide indication of their willingness to work for the common benefit of all plaintiffs in the case. The committee are encouraged to distribute assignments among counsel who wish to work for the common benefit, taking into consideration the particular strengths and weaknesses of counsel requesting such assignments.
The PSC shall act as the first resource for counsel or parties with questions, comments, concerns, recommendations, or requests, and for transmitting to plaintiffs' liaison counsel or co-lead counsel any such questions, comments, concerns, recommendations, or requests that should come to the attention of the Court.
The PSC shall have responsibility for recommending the approval or denial of any claim made by an attorney for common benefit credit. Specifically ... the PSC shall review such claims and shall provide guidance to Special Master DeJean with regard to the propriety, fairness and reasonableness of such claims.
In the event of a global settlement, the PSC shall have the primary responsibility, with guidance and oversight by the Court through the Special Masters for management and oversight of the process of distributing funds, reimbursing fees and expenses incurred for the common benefit, and for distributing the remaining fees to all plaintiffs' counsel.[16]

         In addition to establishing the PSC, the Court, also, formed an Executive Committee of the PSC and assigned additional duties to the Executive Committee members: co-lead counsel were appointed; liaison counsel was appointed; state court liaison counsel was appointed; and a science coordinator was appointed.[17] Certain additional attorneys were appointed to the PSC as the MDL progressed, or were appointed to the Executive Committee from within the PSC as it became clear that their contributions and/or expertise brought exceptional value to the PSC.[18] For instance, Mark Lanier was appointed to the Executive Committee from the PSC and selected as trial counsel later in the litigation; the value of his contribution to the collective trial effort is illustrated by the verdict ultimately received.

         Even prior to the formal appointment of the PSC, certain counsel - many of whom would ultimately, also, become PSC members - had collected contact information from numerous involved plaintiffs' attorneys, and had begun to develop e-mail group service lists, which were constantly being tracked, supplemented, and updated.[19] The involved firms established and organized file materials, and began the process of arranging for IT services and personnel, which and who would be necessary in such a far reaching and complex matter. Co-lead counsel and other members of the PSC worked with defense counsel and the Court to lay the foundations for what would become the essential administrative and procedural frameworks for the litigation - this Court having adopted a "bottom up" approach allowing, and at times, requiring, counsel's involvement in all aspects of the case. The accomplishments obtained and the innovations employed by counsel in this matter - some initiated by this Court and others initiated by the PSC or defense counsel, but all created with active attorney participation - include, but are by no means limited to:

• use of lead counsel for plaintiffs and strategic and managerial leadership, while allocating communication responsibility to liaison counsel; and thus, relieving the Clerk of Court and its servers of part of the burden of disseminating the overwhelming amount of information created;
• allowing all plaintiffs' counsel who requested to work as Participating Counsel and who were qualified to do the requested work, to work as Participating Counsel;
• establishment of the duties of the Plaintiffs' Executive Committee ("PEC");
• adoption of a direct filing order;
• adoption of bundled complaints;
• a workable remote participation system for status conferences via telephone allowing all counsel and all state court judges who wished to participate to do so;
• adoption and implementation of predictive coding;
• exploration of proposed summary jury trials;
• exploration of a proposed expert round table;
• use of live trial witnesses via satellite transmission;
• creation of a process for selection of and the selection of a bellwether trial that occurred less than 2 years after appointment of PSC;
• a protocol which allowed the Court to preside over perpetuation depositions in a manner that significantly reduced the time required for resolution;
• a remand plan designed to circumvent the common experience of the remand "black hole";
• a privilege log best practices protocol involving in camera review by the Special Master of challenged documents, thus avoiding tremendous time and dispute;
• appointment of a Pro se Liaison for unrepresented plaintiffs, including those who are or were incarcerated;
• involvement by plaintiff and defense counsel in the negotiation and drafting of multiple Case Management Orders;
• establishment of document repositories and other file sharing programs; and
• State-Federal liaison efforts that included providing this Court with an overview of trial settings, verdicts, and activity in Actos® cases going forward in state courts across the country, and keeping those state courts apprised of what was occurring in this MDL.

         C. State Court Proceedings

         In addition to the cases filed in federal courts that were consolidated in the MDL, approximately an equal number of cases were filed in state courts throughout the United States. Particularly large numbers of cases were filed in some states, especially those in Illinois and California, which raised the possibility of employing those state courts' special procedural devices to manage the caseloads.

         The Illinois Supreme Court, in response to a Motion to Transfer and Consolidate, determined the approximately 4,000 Actos® cases filed in Illinois state court would be complex and would share common issues, and recommended they be consolidated before one court for coordinated pretrial proceedings. The Coordinated Proceedings were given the title In Re Actos® Related Cases, No 2011 L 010011, and were consolidated in the Circuit Court of Cook County, Illinois, County Department, Law Division, before the Honorable Deborah Dooling as coordinating trial judge (hereinafter "the Illinois coordinated proceeding").

         The Los Angeles Superior Court, similarly, conducted a hearing on a Petition for Coordination of the Actos cases filed in California. As a result of that hearing, the Honorable Carl West deemed the Actos® cases to be complex and to share several common issues, and recommended the cases be consolidated before the Los Angeles Superior Court, Central Civil West, pursuant to California Code of Civil Procedure section 404.3 and Rule 3.540 of the California Rules of Court. The Actos® cases filed in California were consolidated under the title In Re Actos® Product Liability Cases Coordinated Proceedings, JCCP 4649, before the Honorable Kenneth Freeman (hereinafter "the California coordinated proceeding"). Later in the proceedings, The Honorable William MacLaughlin, also, was appointed to assist the coordinated proceeding with the management of certain specific issues.

         The remaining state court Actos® cases, being more widely dispersed among state courts across the country, were handled in their respective courts according to those states' normal procedures. Ultimately, each of the eligible claimants in state court Actos® cases was given the opportunity to voluntarily participate in the Settlement Program established by the MSA in this MDL, and more than 99% of the eligible claimants chose to do so.

         D. Procedural History Prior to Bellwether Trial

         As early as possible, this Court endeavored to work with counsel to ensure that the extraordinary documentation that was expected to be involved in this MDL would be handled in the most efficient and cost-effective manner possible. To that end, Magistrate Judge Hanna took a primary role working with the Clerk of Court, in coordinating with the PSC, defense counsel, and with Tony Moore, the Clerk of Court for the Western District of Louisiana, to establish special filing procedures to be employed in the Actos litigation. One such procedure, adopted with assurances acquired by agreements between and among the parties, was this Court's order that plaintiffs be allowed to file their Actos® claims in the Western District of Louisiana directly, whatever the district of origin, without requiring each case be transferred through the JPML, within certain stated limitations.[20] Additionally, attorneys with multiple Actos® claims were allowed to file "bundled" complaints, which allowed counsel to drastically reduce expenditures on filing fees.[21] These two protocols allowed for a much more streamlined and efficient filing process, allowing the matter to move forward more rapidly than might otherwise have been the case, and reflected the active negotiation and participation by the PSC and defense counsel.

         In order to ease the complexity of any possible, ultimate, remand of any individual case(s), Magistrate Judge Hanna and the Clerk of Court worked with this Court to implement a "spread-texting" protocol for the Western District of Louisiana's CM/ECF system, which required training and mastery by the PSC and all involved counsel. Under this protocol, the MDL was provided a single "umbrella" civil action number and docket sheet, in addition to each member suit in the MDL having its own separate civil action number and docket history. Any documents that applied only to a member case were filed only in that case's docket, and any that applied to all cases in the MDL were filed in the umbrella docket and "spread" to the dockets of all member cases. In this way, the filing attorneys and the Clerk of Court could ensure that the docket sheet for any member suit would include only the entries specific to that case, but also, the entries that apply to all cases in the MDL could be found in one central location and could be easily accessed by all counsel and a transferor judge, if remand were required. In this way, a transferor judge who might receive a remanded case could easily access only those docket entries that apply to the remanded case, and not be confronted with the entire MDL docket sheet (which, as of this writing, comprises more than 6,800 entries), but will, also, have ready access to the entire "umbrella" docket. The leadership for the plaintiffs voluntarily took on the task, along with this Court's Clerk of Court, to train filing attorneys on how to file within and how to navigate within this system.

          As the MDL progressed and grew to include more than 4,000 individual member cases, the number of individual counsel involved who might require notice, created extraordinary strain on the ability of this Court's CM/ECF system to send Notices of Electronic Filing ("NEFs"). To alleviate that strain, the plaintiffs' leadership agreed, and, thus, this Court ordered, NEFs would be sent only to the Special Masters, the PSC, Defense Lead Counsel, and the leadership, particularly liaison counsel. Liaison Counsel for both sides took on the responsibility to disseminate those entries to all involved attorneys, creating a much greater administrative demand on the PSC, and in particular liaison counsel, Patrick Morrow, as well as upon defense counsel. Liaison counsel for plaintiffs, and defendants, at no small expense, generously agreed to establish their own systems for forwarding each NEF to all counsel who required notice.[22] To ensure the integrity and transparency of this system, liaison counsel agreed to, and thus, were ordered to, file monthly notices setting out (1) which NEFs had been forwarded in the previous month, and (2) the list of attorneys and email addresses to which each NEF had been sent.[23] These notices have been filed monthly since November, 2013, and each notice is, and has been, made fully available on the MDL 2299 website.[24] Additionally, this Court reminded individual counsel during each monthly status conference - at which all individual counsel could participate, whether in person or by phone by way of the innovative system provided by plaintiffs' leadership - of their duty to maintain current contact information both with the Court and with liaison counsel to ensure the NEF system remained functional throughout the duration of the MDL.[25] The PSC, and in particular, Liaison Counsel, assured such compliance by following up with contemporaneous notice of all relevant activity and quick response to all inquiries. Each of these systems allowed all plaintiffs' counsel to more efficiently lodge their cases with this Court, and allowed the Court to receive filings and communicate with the parties much more efficiently than would otherwise have been possible, all acting to benefit the common good of all the plaintiffs, and all as a result of plaintiffs leadership, and in this instance, Liaison Counsel, Patrick Morrow.

         While discovery went forward in the MDL, and after consultation with the Special Masters and counsel for both parties, this Court, along with the PSC and defense counsel, created a Pilot Bellwether Program. The PSC and defense counsel worked to adopt an agreeable process and ultimately, the Court fashioned a process under which the parties were to choose at least two cases that would be tried before this Court as bellwether cases. On February 19,2013, this Court entered a Scheduling Order setting the first bellwether trial, Allen, et at v. Takeda Pharmaceuticals North America, Inc., et at, for trial on January 27, 2014.[26] The often exhausting and hard work of plaintiffs' and defense counsel, and the unique structure created and employed in this MDL, along with the involvement of the Special Masters, contributed to the extraordinary feat noted above, i.e., coming to a jury verdict within two (2) years of the appointment of the PSC, with few formal substantive discovery or dispositive motions having been filed until June, 2013, when those in preparation for the first bellwether trial were filed. During the roughly six months before the bellwether trial began, a plethora of formal dispositive and discovery motions were filed and resolved, including more than forty (40) motions in limine, at least nine (9) formal Daubert motions, and a plethora of objections to proposed depositions of experts based not only on Daubert but, also, on foundational weakness. Also, exhaustive interaction with the Court and exhaustive discussion and briefing on the application of New York law was had. For the plaintiffs' counsel, the entire human resources of the trial team were brought to bear to obtain this result, and to, at the same time, prepare for the actual trial. Intense judicial involvement and review was required, which, also, necessitated extensive counsel involvement.

         An MDL of this scope has many sub-issues that must be managed and resolved while the overall process is ongoing in order for the entire matter to move forward efficiently, and counsel were intimately involved with the Special Master and Deputy Special Masters and the Court in management and resolution of these sub issues. Merely one such exemplary sub-issue was how the claims of litigants appearing pro se, and particularly those who were incarcerated, were to be addressed and handled. The Court tasked the PSC, along with Magistrate Judge Patrick Hanna, with taking lead on this task, and a special Pro se Liaison was appointed. Thus, a selected member of the PSC was appointed to be the Pro se Liaison, and tasked to maintain contact with all of the plaintiffs in the MDL who were or became unrepresented. Pursuant to order of the Court, the Pro se Liaison was not to represent any unrepresented litigant, but was to make himself available to provide information, explanation, and any other appropriate assistance needed to pro se litigants; especially those who were incarcerated and might have limited access to the internet and, thus, might require additional information. This role, also, included providing information as to possible participation in the Settlement Agreement.[27] By all accounts, the Pro se Liaison, Willie Singleton, assisted by Magistrate Judge Hanna and this Court when necessary, has proven to be yet another important contribution of the PSC here, ensuring the informed participation of unrepresented claimants within these MDL proceedings.

         E. Discovery, Preparation for the Bellwether Trial, Allen v. Takeda

          Discovery in this MDL was dual-tracked and staggered, requiring contemporaneous dual tracking for counsel: one track and group was dedicated to the overall litigation strategy against the defendants, i. e., general causation; the second, and parallel, track and group, was staggered and dedicated to the case specific discovery for the bellwether cases, i.e., individual causation. From March 22, 2012 until the Master Settlement Agreement was executed in April, 2015, the PSC, Participating Counsel, and defense counsel operated on these dual tracks. In order to facilitate this complex tracking, this Court held monthly status and working conference(s) at which PSC members physically appeared and reported to the Court and to all individual plaintiffs' counsel as to the ongoing progress of the matter, and, also, participated in working group meetings with the Special Master(s) and defense counsel and/or the Court in order to keep the litigation moving forward efficiently. Which plaintiffs' counsel, beyond the leadership, participated in the various working group meetings varied according to the issues to be discussed at each meeting, however, trial counsel and lead counsel were required at each meeting in order to create an institutional memory. Other working group meetings were also scheduled and often weekly telephone conferences were conducted as needed, as well. This Court meet weekly with the Special Masters to address and discuss specific issues and for resolution of problems. At the first overall status conference for all, this Court informed all counsel they had four years to complete these MDL pretrial proceedings and, therefore, they should anticipate they should plan to either settle these cases, prepare for their remand, or resolve them by motion or trial, within that time. In an effort to facilitate this deadline, Special Master Russo and Deputy Special Master Rodriguez, also, presided over weekly telephone discovery conferences when needed, where Lead Counsel and other Participating Counsel worked collaboratively with defense counsel to resolve hundreds of scheduling, discovery, privilege, and other pretrial issues and disputes. Counsel wrote scores of letter briefs to Special Master Russo and/or Deputy Special Master Rodriguez and/or opposing counsel; communicated daily with each other and with the Special Masters via e-mail regarding production and other logistical issues; and otherwise worked to either resolve old issues or follow-up on new ones. And, as noted, the Special Masters met weekly or monthly, depending upon need, with the Court in order to obtain the Court's involvement and to keep the Court informed. Additional unscheduled conferences with the Special Masters and/or with the Court, and counsel were held as needed. Thereafter, at the monthly status conferences, involved counsel reported on their work to the Court, and all counsel received new input and guidance from the Court, were able to raise issues to the Court, and fully report to all plaintiffs' counsel.

         With an eye to the necessary resolution, whether by remand or other procedure, counsel, along with the Court considered all viable possibilities for resolution. After fully considering summary jury trials and other innovative approaches for handling these proceedings, the PSC and defense counsel ultimately settled on using bellwether trials as the preferred manner to move forward toward resolution, and began the arduous task of full trial preparation of the bellwether cases. After extensive attorney negotiation and recommendation, this Court ordered two bellwether trials would be held, with the first plaintiff to be chosen by the PSC and the second plaintiff to be chosen by the defendants, and, thereafter, the Court, with full input from counsel, established the process to be used for selection of those two cases.

         During the run up to the first bellwether trial, the parties produced and reviewed millions of pages of documents, which were necessary to perform depositions, prepare experts, and conduct the necessary scientific and regulatory research. As noted in Deputy Special Master DeJean's Report and Recommendation, throughout this MDL, with special emphasis on trial preparation, more than 32 million pages of documents have been produced, organized and reviewed; approximately one hundred and thirty depositions have been taken; plaintiffs leadership designated seventeen experts in their Rule 26 Disclosure, and presented seven at trial; the defendants designated thirteen experts in their Rule 26 Disclosure, and presented five at trial. As is the case in any litigation, each of the experts offered by the parties needed to be deposed, needed to submit reports, and had to be prepared for trial. Furthermore, as noted by Deputy Special Master DeJean, "the PSC and other Participating Counsel collected, indexed, and produced an incalculable number of articles, science materials, and regulatory documentation, as well as voluminous scientific and corporate documents, in association with the Phase One expert reports and discovery." All of this documentary material had to be located, reviewed, processed, organized and stored in a manner to allow ready access, and this daunting task was performed for the plaintiffs, by the PSC and Participating Counsel.

         Preparing for the first bellwether trial presented a myriad of complex legal, organizational, logistical, scientific, factual, and discovery-related issues, all of which needed to be addressed simultaneously due to the short trial deadlines this Court had established in its First Scheduling Order.[28] By way of single example, perhaps, the New Drug Application, which, itself, was hundreds of thousands of pages in length, ultimately became a subject of dispute. The original production was done informally, however, objections were made to the first manner of production and were such that in order for a realistic review, this Court ordered a second, formal, production; however, some dispute and further resolution continued among the parties, and, ultimately, some one year after the PSC had begun review of the earlier informal production, the formal production was completed. The unfortunate, "staggered" production created additional work and, to some degree, a more complicated and time consuming review of this one item. As discovery proceeded along the multiple paths noted, simultaneously requiring extensive PSC involvement and extensive man and woman power, counsel were also actively and continuously involved in the work of developing this MDL. The factual and regulatory issues were multitudinous, complicated, and complex, and included such matters as toxicology, pharmacovigilance, marketing, epidemiology, experimental research (pre-clinical trials, clinical trials, and epidemiological/observational studies), regulatory, labeling, general causation, and specific causation, all areas requiring unique expertise and encyclopedic knowledge that the PSC, and particularly all involved trial counsel, would have to master. The parallel track of cases presented as many differing legal issues as there were active cases - the MDL included(s) cases from almost every jurisdiction in the United States, each governed by that state's substantive law - and thus, required tremendous threshold legal research on a number of legal issues as wide-ranging as service of process, state product liability statutes, punitive damages, attorney-client privilege, causation standards, adequate warning standards, historical development of the defendants' various associated business entities, spoliation, the impact of Lexecon, Inc. v. Milberg, Weiss, Bershad, Hynes & Lerach[29]on this Court's jurisdiction, and the scope of authority of this Court for contempt of court, and preemption, among others. All, again, requiring extensive and exhaustive work by the PSC, and calling upon the unique expertise of the PSC and Participating Counsel.

         As foreshadowed, discovery in these proceedings was extremely intense and involved a plethora of legal and factual questions - both general and specific in nature. Also, the tremendous number of documents involved created the need for an in-depth scientific understanding, as well as an efficient factual focus and organization, requiring counsel to create a document repository, and to develop creative analytics and unique search algorithms, as well as other advanced technological mechanisms, to organize the plethora of information into a useable and meaningful repository. In part, in response to this daunting task, counsel set about to adopt and implement predictive coding for application and use in this MDL, which will be discussed in greater detail below.

         The PSC, also, worked tirelessly to control the scope and pace of discovery along with defense counsel and the Court - working toward a balance that allowed all to prepare for the first bellwether trial, while also, discovering the general corporate causation information, with an eye to the Allen trial, as well as later trials to come. Intense coordination and co-operative scheduling among all involved counsel was required to keep the general causation discovery ever moving forward, all the while proceeding toward the specific discovery required for the bellwether trials, all under a schedule designed to keep the matter moving ever forward. Plaintiffs' leadership took on the tasks for plaintiffs required to develop, not only, the law and evidence to prove general causation, but also, the law and facts inherent in proving specific causation within the first bellwether case, with an eye to the second bellwether case, as well as to develop defendants, Takeda's and Eli Lilly's knowledge concerning the alleged increased cancer risk associated with Actos® generally, and as to the specific individual claimants, all simultaneously - no small feat. The task undertaken was at times daunting and at all times challenging. The PSC's efforts, it should be noted, were at all times being opposed by an equally resolute and vigorous defense team, large in number and unflagging in determination, who provided an aggressive defense of their clients at every turn, led by Sara Gourley. The multiple tracks of discovery and the vigorous responses and defenses mounted by defense counsel, required not only the time, but also, the expertise of the PSC to effectively meet. Often multiple assignments within the PSC were required and often the process consumed all available man and woman power, and all of a firm's resources; the process becoming all consuming, thus, severely limiting or prohibiting the PSC firms from taking on other cases or certainly from taking on leadership roles in other large cases. As noted, once discovery was sufficiently completed in order to mount their case in the first bellwether trial, the PSC, also, began preparing for the specific tasks involved in mounting and trying the first bellwether trial, i.e., finalizing and preparing their experts for producing reports and testifying at trial, preparing to defend experts' depositions and trial testimony, and preparing to introduce their experts' opinions at trial, as well as preparation of and for factual and medical witnesses, all the while responding to this Court's orders as to substantive legal issues, and mounting a full attack on spoliation. Again, the tasks were demanding and, at times, all consuming.

         This Court notes there were several other tangential issues that could have caused significant delay and could have negatively impacted the expected timeframe for the MDL to be completed, which the PSC and defense counsel, along with the Special Masters and the Court, met head on and ultimately resolved efficiently. Principal among those was the historically daunting issue of privilege, which has proven to be an inescapable morass in past MDLs. As the immense amount of discovery became clear, the parties suggested there might, ultimately, be more than 100,000 privilege claims. Considering the extraordinarily large number of privileges that might be asserted - a number that admittedly seemed to grow and contract over time and with the telling - no matter the actual number, the privilege issue had the potential to derail or cause a significant delay in the bellwether trial and thus, the overall litigation. The Court, consequently, instructed the parties to confer with Special Master Russo to determine if a more reasonable manner to resolve the massive number of privilege claims could be devised. The PSC and defense counsel spent much time and energy on this issue along with Special Master Russo, and ultimately, guided by Special Master Russo, negotiated and agreed to a new and unique privilege review process that involved submission by the defendants of select, specific documents for in camera review by the Special Master, allowing for due process review and appeal to the Court, and integrating a random selection of the remaining privilege claims for in camera review by the Special Master, again, allowing for due process review and appeal to the Court. The process created by Special Master Russo and the parties' counsel provided a truncated but, also, meaningful process to address this possibly overwhelming issue, and the possible privilege issue was managed and addressed, causing no undue delay in the process.

         Specifically, the parties set up, with the Special Master, a process whereby the Special Master was provided two hundred (200) allegedly privileged documents at a time, with a spreadsheet designed specifically for this privilege resolution process. The Special Master issued preliminary rulings as to privilege assertions, and provided a period for the parties to respond with additional argument before making final rulings as to the assertions. The evolving predictive information created by this process allowed the Court and the parties to facilitate a negotiated resolution of the entire privilege process in a relatively short time. The PSC worked tirelessly along with discovery counsel to resolve this seemingly insurmountable privilege review on a very timely basis, ultimately resolving more than 22,000 assertions of privilege in a manner that allowed the litigation and the bellwether trial to move forward as scheduled.

         The PSC and defense counsel, also, devoted a significant amount of time, energy, and expertise to setting up the systems that were used for document production. This MDL was one of the first to allow the use of a "predictive coding"[30] system to aid the discovery process and the production of relevant documents.[31] The predictive coding process required a significant amount of attorney time at the outset to devise and implement, and required the creation of an agreed to strict set of procedural and process safeguards, due to its relative novelty. Despite the initial "front loaded" investment of time required, the predictive coding system provided a unique way to, in part, realistically manage the immense amount of information needed to be produced and reviewed in this MDL. The predictive coding system, although not perfect or fully realized, nonetheless, provided an innovative efficiency to the discovery process when compared to the existing, prevailing methods of review. Although a process not yet fully mature, the PSC and defense counsel expended tremendous time, and computer and legal expertise, to harness this technological possibility with quite positive, if not complete, result. As this area involved cutting edge technology, those counsel who could bring their unique expertise and skill to the task were exceptionally valuable to the PSC.

         While the journey through discovery and pre-trial preparation was smoother than expected (there were a few sets of significant and aggressively disputed discovery-related cross-motions prior to the bellwether process), the parties, nonetheless, in conjunction with the bellwether trial, filed a plethora of pre-trial motions addressing both specific and general causation, including motions in limine, Daubert motions, motions for summary judgment, and motions for editing of and challenges to experts' depositions, and arguments of spoliation, all of which inured to the benefit of all plaintiffs and required tremendous attorney time and resource on the part of the PSC.

         The PSC and defense counsel, also, met the strict standards established and expected by the Court as to trial preparation, including direct involvement with each other and the Court in producing proposed jury instructions as to applicable New York law - an area of law not fully resolved by the New York Courts. The parties - with the plaintiffs led by the PSC - poured considerable effort into producing, discussing with the Court, and exploring, along with defense counsel, proposed jury instructions that met this Court's high expectations. The selected bellwether case, as was ultimately determined, was to apply New York law to each of the substantive legal issues, spawning a variety of legal issues, which, as noted, many were not clear or fully resolved under New York law. All such questions had to be fully briefed to the Court before jury instructions could be determined by the Court. The legal research and briefing required from counsel were both extensive and complex.

         The PSC s efforts to vet and identify their first bellwether case - a process that had involved a great deal of discussion, evaluation, review of medical records, conferences with prescribing physicians, etc. - ultimately led to the trial of Allen, et al v. Takeda Pharmaceuticals North America Inc., et al., which began on January 27, 2014 and ended on April 7, 2014.[32] Preparation for this trial, as noted, was an exhaustive, and demanding process for all; trial of this matter was even more so given the vigorous and aggressive defense mounted by defense counsel. The PSC and the trial team utilized focus groups, mock trials, and planned a trial strategy which called upon almost the entirety of all of the PSC firms' human resources, as well as the full support capabilities of those firms. The PSC and defense counsel each set up a "war room" in the courthouse and manned their respective war rooms continuously, almost 24 hours a day, and 7 days a week, throughout the trial; a trial process which brought to bear the entire human resource and collective expertise of the PSC -their firms' support staff- and all counsel of the trial team and their firms' support staff.

         Additionally, and simultaneously, requiring yet another PSC task force, on the basis of information revealed during the discovery process, the PSC mounted a concerted effort to present and pursue a motion for sanctions against the defendants for alleged spoliation of evidence - an issue that, also, impacted the impending trial strategy. The PSC vigorously pursued and defendants vigorously defended, the spoliation issue, and ultimately, this Court determined spoliation had occurred, thus requiring a time consuming and expertise intensive shift in the final trial strategy;[33]again requiring all the trial team to re-evaluate and, perhaps, adjust their trial preparation.

         As noted above, the trial, itself, was an intense and exhaustive process for all involved. In order to facilitate the efficient trial of the matter, this Court established a contemporaneous process for the speedy resolution of any, heretofore, unexpected factual trial deposition objections, which could not have been resolved before trial - experts having for the most part already been preliminarily addressed by counsel and the Court - including those disputes over how depositions that had been videotaped ahead of time and now would have to be used at trial, should be edited for presentation at trial. Defense counsel and the PSC appointed Sherry Knutson for the defendants, and Neil Overholtz for the plaintiffs, to contemporaneously address the large number of deposition objections made and anticipated at or during trial, but not within the trial proceeding, and thus, to address the contested admissibility of certain deposition testimony contained within the depositions the parties now sought to admit at trial. Consequently, these objections could be determined in a manner so as not to delay the trial. The PSC and defense counsel, with the Special Master presiding and with ready access and contemporaneous input from the Court, worked through a multitude of objections to a multitude of depositions, again, with full and contemporaneous input from the Court, before, and in some instances when required by time and circumstances, during the trial. These disputes continued to arise and to be decided up to and actually through the first several weeks of the bellwether trial. The extensive time and energy committed by the PSC, the trial team, defense counsel, Special Masters, and the Court to the resolution of these disputes allowed the bellwether trial to proceed without delay. The same procedure utilizing PSC representatives, defense counsel, and the Special Master, with review to the Court, was utilized in resolving several late arising motions in limine. Also, the innovation of plaintiffs' counsel to employ a recently added rule to the Federal Rules of Civil Procedure allowing for live transmission of remote witnesses during the trial, under specific circumstances, similarly, illustrated the expertise of the PSC, and the trial team in particular, and allowed the case to move forward without undue delay. Again, all involved counsel had to work with the Court to ensure all safeguards were met, and the unique process required counsel's technological expertise to work with this Court's capable information technology staff to set up the necessary technological requirements for real time remote transmission of the live testimony.

         During thirty-seven days of actual trial, the PSC trial team presented eighteen witnesses, the defendants presented eleven witnesses, and more than four hundred exhibits were admitted. The jury's deliberations led to a verdict for Mr. and Mrs. Allen in the amount of $1.5 million in compensatory damages, and $9 billion in punitive damages.[34] Post-trial motions were filed by the defendants and responded to by the PSC; the Court denied in part, and the Court granted in part.[35]The defendants appealed the Allen judgment to the Fifth Circuit[36] requiring the PSC to prepare appellate briefing and cross appeals;[37] however, ultimately, the appeal(s) was/were withdrawn in conjunction with the global settlement reflected in the MSA process.

         Almost immediately after the Allen trial was completed, and contemporaneously with the appellate process in Allen, members of the PSC and other Participating Counsel shifted focus to begin preparing for the expected second bellwether trial - a process that included additional case specific discovery and new legal research as New York law no longer would be the applicable law - and addressing a number of issues that had become relevant during and after the Allen trial (e.g., new scientific developments, discovery as against Eli Lilly, in-depth legal research as to a different state's law, strategic discussions, restoration of backup tapes inherent in the spoliation issues, and potential trial strategy for a new litigation). After the Allen verdict was rendered, serious settlement negotiations began, in conjunction with and under the guidance of Special Master Russo, and upon request, the Court, at that point, suspended further bellwether trials and thus, suspended the case specific discovery in order to provide the opportunity for settlement success. Thus, the PSC and defense counsel, at that point, had to again shift their focus, now to the equally complex task of settlement negotiations and creation of the MSA document and Settlement Program - again, no small task.

         Thus, this Court notes that throughout this entire process, in addition to the rigorous in-court and out-of-court trial demands, the PSC teams and their staffs, also, provided logistical and administrative assistance for the collective plaintiff effort, for the Clerk of Court, and for the parties as a whole as discussed earlier. Also, in addition to fully staffing a trial "War Room" almost twenty-four hours a day, and almost seven days a week, for and during the entire Allen trial, the PSC tracked the admission status of all exhibits and demonstrative aids for future use, and coordinated with all counsel and the Court regarding all submissions. During the trial, the PSC trial team participated in nightly conferences to review admitted evidence needed for and to be produced each day, and took lead responsibility for conferences with the Court on unanticipated evidentiary disputes. As noted, the PSC created a multilayered, expertise diverse trial team to assist the two trial co-counsel and the team, along with co-trial counsel and their firms' staff, spent extensive time revising, updating, assimilating, and indexing the significant evidence to be used in the Allen trial, and for potential use as a "Trial Package" and resource, for test cases in the MDL or for any possible unresolved transferred or remanded cases. Thus, the expenditure in time, effort, and resources by the PSC, trial co-counsel, and the trial team and their firms was extensive and at times, all consuming.

         F. The Master Settlement Agreement

         After the defendants filed their appeal of the Allen judgment and various related orders of the Court, as noted, with the help of the Special Master and Magistrate Judge Hanna - this Court being of the opinion that to avoid any possible future conflict, it should not be intimately involved in the forging of a settlement the Court might be called upon to interpret or enforce - the parties entered into extremely complicated, multi-sided settlement negotiations. The MSA that was ultimately agreed to, drafted, and executed was negotiated by Doug Marvin, representing Takeda ("settlement counsel") and various plaintiffs' counsel that ultimately became the Plaintiffs' Settlement Review Committee ("PSRC").

         As noted, in order to avoid the possibility of future conflict were this Court to have to address interpretation of, or enforcement of the settlement itself, this Court distanced itself from settlement negotiations, and instructed Special Master Russo and Magistrate Judge Hanna to assist the parties in their efforts to obtain a global settlement agreement, if possible or if needed. Both Magistrate Judge Hanna and Special Master Russo have reported to this Court that the time, expertise, and commitment of the PSC leadership was exemplary, extensive, and, again, at times all consuming. It is of note that the initial status conference the Court conducted with counsel was on March 22, 2012; the Master Settlement Agreement ("MSA") that ultimately resulted in the global settlement of approximately 11,000 claims for $2.4 billion was signed and submitted to the Court by the parties on April 28, 2015; an, heretofore, unheard of accomplishment in an MDL of this size. This result is due in no small part to the commitment and work of all involved, and in particular the PSC and its leadership, and co-lead counsel, Richard Arsenault and Paul Pennock.

         The MSA, itself, was the product of extensive, complex, and intensive negotiations among counsel and was executed by representatives of the PSC and the defendants. Although the MSA, itself, did not settle any claims outright, it did create a complete Settlement Program whereby all aspects of all the individual claims and claimants, who could provide sufficient documentation of a history of Actos® usage and a proper diagnosis of bladder cancer, would be eligible to apply to receive compensation, and would agree to dismiss any pending Actor®-related suits they might have against the defendants if their claim was accepted.

         The Settlement Program was intended, and was designed to be, global in nature, or, at least, to be available to as many claimants in the United States as possible - state and federal. To that end, the Settlement Program was made open to enrollment to two broad groups of claimants or potential claimants nationwide: (1) claimants who had filed a case - whether in federal or state court - as of the date the MSA was executed, alleging (a) use of Actos® prior to December 1, 2011, and (b) a diagnosis of bladder cancer; and (2) claimants with no case pending as of the date the MSA was executed, but (a) a retainer agreement to receive representation in an Actos® suit signed on or before May 1, 2015, and (b) allegations of Actos® usage prior to December 1, 2011 and diagnosis of bladder cancer prior to the date the MSA was executed.[38] As a result, as of this writing, approximately 99.4% of the approximate 11,000 claimants known to have cases alleging bladder cancer across the United States due to Actos® usage - or who have representation to bring such a case - have voluntarily agreed to and are participating in the Global Settlement Program created by the MSA.[39]

         The global acceptance of the negotiated Settlement Program was vital to the success of the MSA; the MSA provided the defendants would have the right not to participate in the Settlement Program unless certain thresholds of participation were met. These thresholds included 95% of all "Eligible Enrollees" (i. e., claimants either with a suit alleging bladder cancer caused by Actos® pending as of April 28, 2015, or with a retainer agreement for such a suit signed as of May 1, 2015).[40] Furthermore, while the MSA called for aggregate settlement funds of $2.37 billion, the agreed to settlement, also, provided the defendants would increase the total to $2.4 billion should the participation threshold exceed 97% of all Eligible Enrollees.[41] Thus, the created MSA was intended to be global in scope, included both "a carrot and a stick," and was designed to encourage the maximum level of participation.

         The procedural aspects of the MSA settlement were and remain complex and involved. Thus, Claims Administrators were selected, have worked with all, and have reported to the Court and the parties, throughout the process as to the administration involved, and reported in April, 2016 that not only had the 95% participation threshold been met - guaranteeing that the Settlement Program would go into effect - but the 97% participation threshold had also been met and surpassed, ensuring the increased funding of the settlement fund. This remarkable rate of participation is a testament to the ability and hard work of all involved, especially the PSC and co-leadership and their firms' work explaining the benefits, transparency, and operation of the Settlement Program to all plaintiffs' counsel, so those counsel could fully inform their clients and meet their ethical responsibilities. Also of note is the expertise of the Program's Administrators to oversee a large and complex claims evaluation process efficiently and transparently, and the ongoing involvement of the Special Masters, Magistrate Judge Hanna and the PSC leadership, co-lead counsel, and defense counsel.

         As the PSC and defendants, with help from Special Master Russo and Magistrate Judge Hanna, had created an MSA that had created an opt-in Settlement Program, claimants were required, through their attorneys, to affirmatively choose to take part in the process by providing a Notice of Intent to Opt-in, a release of all related Actos® claims, and a signed Stipulation of Dismissal.[42] In this way, the MSA addressed the possibilities of spurious claims attempting to enroll and diminishing the results for the legitimate claimants, eliminating such claims. Also, once enrolled, claimants were required, again, through their attorneys, to submit Claim Packages containing the relevant medical records for review by the Claims Administrator. The parties selected the firm of BrownGreer PLC to be the Claims Administrator, and by all accounts BrownGreer has done excellent, and outstanding work in that role. Per the terms of the MSA, part of the duties of the Claims Administrator is to review all provided documentation, to determine whether that documentation is complete or deficient, and to provide an opportunity for claimants, through their attorneys, to correct any deficiencies found. The Claims Administrator, upon review, either rejected or accepted the claim as eligible and issued a Points Award for each claim. In the event a claim was determined to be ineligible by the Claims Administrator, the claimant had the right to appeal that decision to an Eligibility Committee ("EC") composed of members of the Plaintiffs' Settlement Review Committee ("PSRC") and counsel for Takeda. The regular meetings of the Eligibility Committee, and the assistance of the PSC leadership, were instrumental in resolving these eligibility appeals. At the direction of this Court, Special Master Russo attended these EC meetings in order to ensure the Settlement Program did not become unnecessarily slowed by this appeal process or reflect bias of any nature. This Court received regular updates from Special Master Russo, which made clear the PSRC and/or members of their firms regularly attended these EC meetings, and were thoroughly prepared in order to resolve all appeals of eligibility decisions in an efficient, unbiased and timely fashion.

         Once review and approval of a claim were completed, the Claims Administrator assigned each claimant a number of points, according to a matrix agreed to by the parties.[43] The Points Matrix allotted points according to the level of injury and age of the claimant, with adjustments according to cumulative dosage and a set of agreed risk factors.[44] The value of each point would ultimately depend on the total number of points, compared against the total amount of funding provided. The total dollar value of each point could not be determined until the enrollment and evaluation processes had been completed, however, because total settlement funding was dependent on reaching certain participation thresholds, as noted above, and the final valuation could not be ascertained until the total settlement funding was final.

         In addition to regularly attending and participating in meetings of the EC, members of the PSRC, also, participated in the process devised to address certain claimants seeking extraordinary injury fund ("EIF") payments, pursuant to Section 7.02 of the MSA. The EIF was established to enhance payments for claimants with minor children, substantial economic loss attributable to their injury, or medical complications from bladder cancer not otherwise covered by the Master Settlement Program. The same group of PSRC members who attended the EC meetings, also, attended these EIF meetings. At the request of this Court, Special Master Russo, also, attended these EIF meetings, and/or had Ms. Katie Darden attend on his behalf. Special Master Russo and Ms. Darden provided periodic reports to the Court on the progress of the EIF meetings, and again it was clear to this Court that PSRC members regularly attended the meetings, were prepared, and were instrumental in determining whether or not claimants were eligible for EIF payments in an unbiased fashion.

         Because the MSA created by the parties, by necessity, included full due process review and the time delay a due process review entails, the MSA created additional procedures to ensure claimants received proper, efficient, but also, timely compensation. The Settlement Program included a system of interim payments, which could be and were made prior to the final completion of the Program, based on estimated point valuations.[45] As noted above, the MSA, also, created an Extraordinary Injury Payments procedure, whereby certain qualifying claimants were found to be entitled to additional recovery based on the severity of their injury.[46] Additionally, a procedure designed to find, evaluate, and satisfy private and public liens was put into place, which will be discussed in greater detail below.[47] Thus, the input and value brought to the benefit of all by those involved PSC members, again, cannot be understated.

         The MSA, also, took special care to ensure claimants had recourse to challenge the decisions being made regarding their cases as the Settlement Program carried forward, in light of their agreement not to further pursue their cases in court. At every stage of the submission and evaluation process, each claimant had the right to request reconsideration by the Claims Administrator, ask that the Administrator's decision be reviewed by a body created by the parties' counsel comprised of counsel selected by and from both parties, as discussed above, and/or ask the Special Master of the MDL to review those decisions.[48] All challenged decisions by the Claims Administrator were appealable to Special Master Russo and/or Katie Darden, and have been reviewed and disposed of. These due process procedures were built into the process and guaranteed that claimants and their counsel had multiple opportunities to contest decisions they might think improper, and to have full, adequate, impartial, and almost contemporaneous review of all decisions.

         Pursuant to the operation of the MSA and this Court's orders, as of this date, approximately 90% of the money set aside to satisfy claims in the Settlement Program has been paid. Again, the breadth, completeness, and success of the MSA, also, reflect the superior expertise of those involved in its creation.

         Especially relevant to this ruling, the created and agreed to MSA, also, required all claimants - as to expenses - and their counsel - as to fees - to agree to relinquish a portion of their respective recoveries to compensate the expenses - as to claimants - and fees - as to attorneys - that were incurred in the MDL on behalf of all plaintiffs; counsel to relinquish common benefit fees from their fees; claimants to be responsible only for a percentage of the common benefit expenses. Section 10.04 of the MSA is entitled "Common Benefit Fees and Reimbursement of Litigation Costs," and reflects the following agreement:

10.04 To ensure that common benefit attorneys (hereinafter referred to as "Common Benefit Attorneys") are fairly compensated and that their fees are reasonable, an assessment of Common Benefit Attorneys' fees will be imposed on counsel for each Claimant in accordance with the amount set by Order of the Honorable Rebecca F. Doherty to be entered in the MDL ("Assessment"). By opting into the Program, Program Participants and their counsel agree to, and waive, the right to any appeal of any order entered by the MDL court associated with the settlement. Any sum paid as a common benefit fee shall be deducted from the total amount of counsel fees payable under individual plaintiffs' counsel's retainer agreement.
(A) In addition to those amounts provided above, Common Benefit Attorneys shall also be entitled to reimbursement of their reasonable common benefit expenses. Reimbursement of these expenses shall be deducted from the clients' net recovery. The amount of common benefit expenses shall be determined by Order and entered in the MDL, which sum will be deducted from the Settlement Funds deposited into the QSF.[49]

         Pursuant to this portion of the MSA, each claimant who agrees/agreed to participate in the Settlement Program agrees/agreed to submit a portion of his or her recovery under the program to compensate for only, expenses incurred on behalf of all claimants, and agrees/agreed not to appeal this Court's orders related to the settlement. Also, each claimant's counsel, furthermore, agrees/agreed to submit a portion of his or her fees to compensate for a percentage of the fees incurred on behalf of all claimants, and, also, agrees/agreed not to appeal this Court's orders related to the settlement. It should not be overlooked that any amount this Court might allocate as common benefit fees, does not come from any individual claimants' recovery, rather it comes from the amount the claimant had already agreed to Pay to his or her attorney when he or she agreed to representation. Thus, common benefit fees are taken from the original attorneys' compensation - not the claimants' MDL recovery. Expenses, however, are taken from the claimant's recovery - much as with any single claim which is not within an MDL.

         As is reflected in this Court's orders this Court has, from the outset of this MDL, expected to compensate common benefit work, and early on established procedures designed to keep ongoing records of approved common benefit work and common benefit expenses and for regular and ongoing review and evaluation of that work and those expenses within the MDL.[50] Therefore, claimants now choosing to participate in the Settlement Program, and their counsel, have had full knowledge and notice from the outset of what would be required from them should they wish to participate in a global settlement and equally so, any attorney who might have desired to perform or claim compensation for work performed was given full notice of the applicable requirements. By voluntarily participating in the MSA, all have voluntarily agreed to abide by the procedures established and decisions made by this Court governing the compensation for common benefit work, i.e., fees and expenses.

         As noted above, many of the participants in the global Settlement Program do not, and did not, have cases pending in the MDL, rather had cases pending in various state courts. However, by virtue of the choice to participate in the Settlement Program, each individual claimant and his or her respective counsel, agreed to abide by this Court's decisions as to the amounts that might be retained to compensate the work done for common benefit of all and the expenses incurred for the benefit of all, as well as to this Court's decisions determining allocation of any amount among counsel.

         G. Implementation of the Settlement

         As described above, the MSA included an enhanced recovery for all participants in the settlement if 95% or more of those eligible to participate agreed to do so. Once the MSA was agreed to, the PSC leadership spent significant time and resource traveling around the country to explain the terms of the MSA to all involved counsel, meeting with various individual plaintiffs' counsel in the MDL, as well as meeting with those plaintiffs' counsel who had cases filed in state courts across the United States. The Special Master attended at least one of those meetings, held in California, and reported to the Court. The Special Master, also, received reports on a regular basis concerning other meetings that were being conducted throughout the country and reported to this Court on those meetings as well. These educational meetings, although both time consuming and perhaps costly, provided the needed detailed information to individual claimants' counsel to allow for informed consent, fulfillment of their ethical responsibilities, and for the extraordinary success of the Settlement Program. The success of the settlement program and almost complete participation is due in large part to the work and expertise of the PSC leadership, Special Master Russo, and settlement counsel for the defendants. Additionally, and perhaps uniquely, the PSC leadership has continued to lend their time, expertise, and finances to preparing and presenting the program even after the MSA has been executed and it is in no small part due to their time and commitment to the MSA and settlement process that has made it an unqualified success.

         As a result, the Settlement Program has been extremely and uniquely successful. At this writing, approximately 99.4% of the eligible claimants, nationwide, have opted into the settlement.[51] The percentage is expected to increase once the settlement process is fully completed and approach the unheard of 100% of all eligible individual claimants nation-wide, once all ineligible claims are removed. This rather unprecedented settlement success on the part of plaintiff participation, in part, is, again, a direct result of the PSC leadership's continued vigilance in handling issues arising after creation of the MSA process, as they have arisen, whether of the MSA, or other residual matters, along with the Special Masters' continued facilitation. Here, the PSC leadership did not abandon the process once the MSA was signed, which can so often, and regrettably, be the case. Their continued commitment and work has acted to the tremendous benefit of all.

         The first interim payment made to any claimants elected by the Settlement Process through the Claims Administrator, was announced on June 30, 2016, and the payment process began with the first payment being made to a claimant on July 20, 2016. The settlement process, much like the litigation, has been efficiently handled by the PSC leadership, along with the administrators, the Special Masters and defense settlement counsel - again, not without great expenditure of time and resource. This Court has kept in close communication with the Special Master and continued to monitor, guide, and oversee the progress of this matter, and is convinced that due, in large part, to the continuing administration, oversight, and management by the Special Master, PSC leadership and defense settlement counsel, all working closely with Brown Greer, that the settlement process has been a model of efficiency. The Special Master has reported that calls have been conducted each week by all involved, i.e., select PSC members, Takeda, and the Settlement Program's Administrators to make sure any issues which arose were and are resolved promptly. This dedication of continuing time and resources by the PSC leadership and defense settlement counsel to the settlement process, even after the MSA was entered, has contributed in large part to the unprecedented success of the MSA.

         Also, as a part of the implementation of the MSA, it was necessary to work with and address parties who withheld or had legal claims to liens, i.e., primarily, both public and private medical providers. This Court requested Magistrate Judge Hanna take the lead to assist the parties and settlement administrators with addressing those liens as he has developed a special expertise in this area. Magistrate Judge Hanna met regularly with the PSC leadership and defense counsel and the Lien Resolution Administrator[52] to create a fair and effective lien resolution process, and to help resolve all issues that have arisen in moving the settlement forward on this front. As with the Claims Administration process, the Lien Resolution Administration process was negotiated, and agreed to by the parties, here with the help of Magistrate Judge Hanna and, again, is unique and has proven quite effective. The medical lien resolution in all personal injury cases has proven, historically, to be problematic. With Magistrate Judge Hanna's leadership, the expertise of the counsel involved, and the operation of the Lien Resolution Administrator, resolution of all liens has progressed at an extraordinary pace.[53] The created process has employed unique and creative solutions heretofore not employed in an MDL of this size and has been, and continues to be, effective, transparent, and fair. According to all sources, the Garretson Group ("Garretson"), which was selected by the PSC and defense counsel to be the Lien Resolution Administrator, also, has been integral to the success, not only of the lien resolution program, but, also, integral to the success of the Settlement Program as a whole, as the settlement could not go forward without resolution of all outstanding liens. Thus, again, the expertise of involved counsel has acted to the benefit of all.

         In connection with Magistrate Judge Hanna, counsel, and Garretson, a lien resolution protocol was created, which, again, the parties negotiated and agreed to, under which Garretson has reached out to all private and public medical providers that had asserted liens on payments to claimants in the Settlement Program. Garretson has successfully reached agreements with each of the identified lien holders for resolution of their liens. The Court understands Garretson did most, if not all, of the work of locating, auditing, and valuing the liens in conjunction with the PSC, defense counsel, and Magistrate Judge Hanna. This process, while exhaustive and quite involved, was necessary to make it possible for Garretson, BrownGreer, and counsel to estimate the amount that would be needed to be withheld from each claimant's recovery and to ultimately facilitate pay outs to the individual claimants. This, in turn, again, helped ensure individual plaintiffs' counsel could have the necessary information required to engage in a thorough and meaningful discussion of the costs and benefits of the Settlement Program with their clients, before each client made his or her choice to enter or reject the proposed settlement. Thus, the work of the PSC leadership, again, allowed all counsel to meet their ethical obligations to their clients and the Court. This process operated with full transparency which, also, has helped the parties reach the required participation thresholds to allow the Settlement Program to proceed. Finally, and in some instances related to the lien resolution process, special attention has been paid to create an additional process for addressing those claims which might be affected by ongoing bankruptcies, and the specialized interaction with bankruptcy trustees and courts. Those counsel who lent their expertise to this issue have, also, been of great value to the litigation.

         Altogether, the MSA created by counsel using their expertise, the tremendous effort and commitment of time and resource involved by counsel, BrownGreer, Garretson, the Special Master, and Magistrate Judge Hanna, and the oversight of the Court has created a model of efficiency in the advancement of the Settlement Program, and have kept this matter moving ever forward to final completion at an unprecedented pace. According to estimates now available, at the current rate of progress, final payments could be completed as early as the end of 2017, which would represent approximately six years from inception of this MDL to resolution of the Settlement Program, resolving more than 99% of all cases in the MDL, and, also, resolving almost 11,000 eligible claims nationwide, which, in and of itself, is an extraordinary feat within the world of MDLs. This success is in large part attributable to the involvement of the Special Masters, the PSC leadership and defense settlement counsel involved, and to the PSC's able leadership, exceptional expertise, and the tireless work done on behalf of all plaintiffs.

         H. The Initial Hold-Back on Settlement Payments

          From the inception of these proceedings, based on historical precedent, this Court had anticipated that, in the event of a global settlement, those attorneys who had worked for the common benefit of all plaintiffs would need to be compensated for their work.[54] As noted above, the parties' counsel - out of whose recovery the fees will come - themselves, anticipated this Court would award common benefit fees and expenses and agreed to that award.[55] After the MSA was executed, this Court was repeatedly urged to give the participants in the Settlement Program a preliminary indication of the amount that might be used to compensate the PSC and Participating Counsel, so that individual counsel could effectively communicate with and inform their clients, as part of their ethical responsibilities; for that reason, this Court entered the preliminary Holdback Order on September 1, 2015, instructing the Settlement Program Administrators to, at that time, withhold 8.6% of any payments made pursuant to the terms of the MSA in order to have a preliminary amount available to compensate for common benefit fees, and to withhold $25 million to address common benefit expenses.[56] By Order dated February 16, 2016, the Court notified counsel and all parties to this proceeding that it would issue a final assessment order for common benefit fees and expenses in the amounts described in its Holdback Order, and provided full opportunity for all to object to any such assessment.[57] No objection(s) were lodged.[58] Thereafter, the Court entered its Case Management Order: Common Benefit Fees and Costs, assessing the amounts described in the Holdback Order.[59] The hold-back amount remains available for release, and this Court now enters its final Common Benefit Ruling allocating those amounts.

         I. Nationwide Settlements

         There were approximately 4,500 Actos®-related lawsuits filed in (or removed to) federal district courts throughout the nation, that were transferred into (or filed in) these proceedings. Another approximately, 6,500 were filed in (and remained pending in) state court systems throughout the country. As noted above, the MSA specifically permitted plaintiffs whose claims were in state court to participate in the MDL Settlement Program, should they so desire, and they have done so in almost all cases. This exemplary result is in no small part the result of the expertise, work, and time expended by the PSC leadership and defense settlement counsel; thus, the PSC has performed the extraordinary service of, also, providing settlement opportunities to more than twice as many state court claimants, a group above and beyond whose interests they were explicitly and formally obligated to protect, thus, providing exemplary benefit to all claimants and to the public.

         J. Additional Comments on Common Benefit Efforts

         The descriptions provided above address many, but certainly not all, of the common benefit services provided by the PSC and Participating Counsel; this Court should, also, note, it does not, however, address several discrete aspects of these proceedings that might help to further illuminate the full scope of the common benefit delivered to all of the claimants participating in the Settlement Program.

         First, the very large number of cases in this MDL, together with the large number of cases filed in state court, required an extraordinary level of organization, coordination, and cooperation among the PSC and all plaintiffs' counsel, i.e., among MDL plaintiffs' attorneys as well as between MDL plaintiffs' attorneys and plaintiffs' attorneys in the thousands of state court matters, and that cooperation, coordination, and expertise was supplied by the leadership of the PSC and the plaintiffs' state court liaison, Dawn Barrios, and defense team state court liaison, Sherry Knutson. The fact that the MDL cases did not overtake, step on, or otherwise interfere with the state court cases (including the Illinois and California coordinated proceedings), and that defendants were not overwhelmed by the sheer number of cases that might have remained in state courts throughout the country, is due in large part to the tremendous effort of the PSC and defense counsel - for the plaintiffs, by co-lead counsel, Richard Arsenault and Paul Pennock, by the state court liaison, Dawn Barrios, and their coordination with the Special Master and the Court. The ability to keep all sets of cases proceeding in parallel, without each tripping over the other, contributed immensely to the common benefit of all MDL plaintiffs and the public at large, and this Court wishes to acknowledge that fact. Co-lead counsel, Richard Arsenault and Paul Pennock, displayed an extraordinary talent and ability for organizational and administrative skill underlying true leadership ability. State court liaison for the PSC, Dawn Barrios, along with the state court liaison for defendants, Sherry Knutson, kept not only this Court, but all state courts, updated and informed as to the plethora of issues and matters involved as this MDL and those in the state courts as those cases moved forward, with full respect shown and given to all courts involved. Such coordination and communication were often nuanced, complex, and time intensive and were integral to the overall success achieved, as illustrated by the level of participation reached among claimants with cases in state courts.

         Second, a very important aspect of this litigation that might not be obvious to the casual observer is this: the PSC and Participating Counsel were working within cutting edge science, requiring rigorous research and investigative science; counsel education and mastery, and specialized expertise and training were required at every step along the way to resolution; thus, requiring highly capable counsel with unique and specialized talents working in tandem with highly capable staff and with identified outside medical and regulatory experts. The breadth of the necessary scientific knowledge required to identify the biological mechanisms that might contribute to the argued elevated carcinogenic risk alleged, required mastery of and development of multiple scientific theories across many scientific disciplines and within multiple regulatory environments. The grasp of the discrete subject matter required not only review of hundreds of thousands of scientific articles and treaties and documents, but, also, in numerous tutorials in order to understand, yield, and present in a manner lay jurors could grasp, what the PSC and their experts believed to be the three plausible biological mechanisms for Actos®-induced cancer ultimately presented at trial, within the complex and idiosyncratic regulatory context of those theories. Additionally, one must always be aware the PSC, at every step, had to meet an equally vigorous, and scientifically prepared, defense mounted by an equally prepared and aggressive defense team. Thus, in an area of cutting edge science and great regulation, extensive and specialized expertise, education, and research were required and presented a particular challenge for counsel; one, the trial result and settlement amount would argue, the PSC met. These efforts - developing de novo theories of general causation and applying those general causation theories to specific cases, and exploring and understanding the complex regulatory apparatus involved over some twenty plus years, made possible the result(s) obtained and came at a documented and expensive cost in time, resource, and expertise.

         Furthermore, those counsel who had the needed organizational, administrative and leadership skills, as well as those who had the needed specialized scientific expertise, along with those with the needed ...

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