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Harnessing Expert Peer Review to Win: Building Upon the Silicone Implant Litigations

Traditionally, expert testimony is given by party experts, who are hired to analyze certain aspects of a case. Sometimes, these experts are given great autonomy to develop their opinions; in other cases, attorneys prefer to maintain tight control over their experts. In either case, a party expert’s opinion will obviously concur with and provide support for the party’s position – otherwise the expert wouldn’t be called to testify in the first place. In an alternative approach, court-appointed experts are sometimes used to make sense of complicated situations where the judge feels the need to have independent eyes on the case. This situation is fraught with uncertainty for the parties and fits awkwardly in the adversarial system, but tends to give judges the “least biased” information in determining the admissibility of expert opinion.

What is needed (and what JuriLytics offers) is a third approach to expert testimony that combines the best aspects of party and court-appointed experts. The key to this better approach is subjecting party expert testimony to peer review. This peer review allows attorneys to submit highly credible, neutral and independent analyses of their position to judges (for admissibility determination) while maintaining control of unfavorable reviews under work-product doctrine. For judges, peer review sidesteps the potential adversarial awkwardness of using court-appointed experts while providing a neutral assessment of expert testimony at a low cost.

The Silicone Implant Litigations as a Case Study

Litigation surrounding silicone breast implants, which began in the 1980’s but exploded in the early-to-mid 1990’s, provides a useful backdrop to better illustrate the useful aspects of peer review. Two federal judges separately utilized court-appointed neutral panels of experts in silicone implant cases in which plaintiffs alleged that the implants were the cause of auto-immune disease in patients. A 2001 Federal Judicial Center (FJC) Report chronicles the use of the neutral panels by Judge Robert E. Jones in the District of Oregon (Hall v Baxter Healthcare Corp.) and Judge Sam C. Pointer in the Northern District of Alabama (In re Silicone Gel Breast Implants Products Liability Litigation, MDL-926). While the two panels ultimately ended up producing quality information, the implementations were fraught with issues that limited their usefulness in litigation.

Judge Jones and Hall v. Baxter Healthcare Corp.

In Hall v. Baxter Healthcare Corp., Judge Jones convened a panel of technical advisors (as allowed under Federal Evidence Rule 104(a)) to educate himself about the scientific issues involved. Indeed, the goal of the panel was to aid the court in resolving various Daubert motions by defendants to exclude plaintiffs’ expert evidence. The advisory panel was selected by Dr. Richard Jones, a professor emeritus at Oregon Health Sciences University. The panel included advisors specializing in immunology, epidemiology, rheumatology, and toxicology. As advisors, they were not subject to deposition and testifying at trial, but Judge Jones agreed to provide a written set of instructions to the advisors, to communicate to the advisors on the record, and to allow the parties a limited opportunity to question the advisors regarding the content of their reports. Judge Jones was apparently satisfied with the process. All told, the costs associated with the panel ended up totaling $76,000, or $19,000 per expertise, and were paid by the parties. These costs are in line with what would be required for expert peer review.

Dr. Jones apparently had some difficulty in finding the right candidates for the job and ensuring conflict-fee participation. Further, the panel members complained that they were overwhelmed by the amount of materials they were asked to review and that they did not have a good grasp of the specific issues that needed to be addressed in their report. Finally, some attorneys complained that proper notice and procedure was not provided to the parties and that they did not have a proper chance to cross-examine the advisors. Below, we will describe how a peer review process can address these issues.

Judge Pointer and In re Silicone Gel Breast Implants Product Liability Litigation

In the larger multi-district litigation, Judge Pointer decided to assemble what he called a “National Science Panel” under Federal Evidence Rule 706. This was done at the urging of the plaintiffs, who preferred a unified process to deal with expert testimony. Judge Pointer first appointed a selection committee, which then recommended candidates for inclusion on the panel. Like Judge Jones, Judge Pointer identified that immunology, epidemiology, rheumatology, and toxicology were the relevant fields necessary to evaluate the scientific issues in the cases. The panelists were instructed both in writing and orally, although it appears that instructions were unclear at times. Special counsel was utilized to insulate the panelists from the court and parties. The panelists developed a single report that reached consensus that the implants could not be linked to the diseases. The panelists were also deposed; during the course of litigation, a panelist’s conflict-of-interest was discovered and further deposition was taken on the issue. All told, the panel spent $1,000,000 over a three year period. A further $1,000,000 was paid by the parties for retaining special counsel to represent the panelists. The costs here were much higher than what would be needed for peer review.

The National Science Panel ultimately produced high-quality scientific information in the litigation. However, many problems arose that complicated its use. The process used by the selection committee required great care in vetting for expertise and conflicts-of-interest. This search for panelists was tedious and appeared to not be particularly systematic (personal recommendations, recommendations from the National Academy of Science, etc. were utilized). Conflicts-of-interest were difficult to vet and exhaustive online searching was done to review statements made by the individuals regarding the litigation subject matter. This process, while effective, was not optimized. There was also confusion concerning how the work would be divided, what the ultimate work product was, and how members were to behave with regard to conflicts-of-interest. Several panelists were surprised to hear they were going to be deposed. However, the deposition process was modified so that attorneys had to submit questions beforehand. The reviewers’ notes and materials were also requested by plaintiffs. The experts were generally puzzled and/or angry that they were deposed. It seems that they were not aware this was part of their responsibility.

Peer Review of Expert Reports

The neutral scientific panels used in the silicone implant litigations provided an essential service: neutral and mainstream perspectives on a contentious scientific issue. In avoiding adversarial bias, neutral experts had a large effect in resolving the litigations in a fair and scientifically rigorous manner. In many ways, however, the neutral panels re-invented a wheel that scientists discovered long ago – peer review. Peer review in a legal context can provide the mainstream analysis that courts crave, and attorneys should heed. Indeed, bringing peer review to expert testimony looks to be the best answer to effectively advocating a case or evaluating scientific principles when a judge might not understand the science involved.

Bringing peer review to a legal context, however, does require many considerations arising from the adversarial system. The FJC report provided many recommendations on their future use. Ultimately, the conclusion was that the cost (in the panel used by Judge Pointer), effort, and awkwardness of the process limits its utility to the exceptional circumstances. Thankfully, many of the issues raised by the FJC study are easily solved using a peer review model. Without these barriers to use, peer review is poised as a more commonplace tool for injecting mainstream science into the legal system.

Below, we discuss the main sticking points to neutral expert panels that the FJC study uncovered during its analysis of the silicone implant litigations. A peer review solution, we submit, solves these issues effectively.

FJC ConcernSolution using Peer Review
"Appointment of such a panel should be undertaken only in extraordinary cases. The cost, time, and difficulty of finding appropriate candidates who are willing to serve, and the problems of administering the work of the panel, limit the role of such panels to only those cases with an exceptional need."Peer review, in general, is designed to have a light footprint. The process of finding and vetting experts can be streamlined with proper tools and a set methodology. The cost of peer review, is, by nature, low given that the scope of the work is limited to reviewing the methodologies used in expert reports, not a full case analysis.
"The role of the expert panel should be specified in advance of the appointment. The conditions of the appointment should then be tailored to fulfill this role, with the experts informed of the nature of their obligations at the time they are invited to serve. More specifically, the experts should be informed of the extent of depositions and cross-examination if those things are to be part of the experts’ service."Peer review is guided with a structured template focused on Daubert inquiries. The scope of the review is also limited by the fact that only existing expert reports are reviewed. All reviewers are informed before retention that they may be deposed and/or cross-examined. JuriLytics will provide independent counsel in the event they are subpoenaed.
"Areas of expertise should be sought that will match the evidentiary issues. Specifying such areas may prove surprisingly difficult where expertise in a combination of subjects is required. Considerable effort may be required to find appropriate candidates who are willing to serve."Specialized algorithms and search techniques based solely on research publication metrics can be used to objectively find relevant experts to peer review any topic that is a part of academia.
"Conflicts of interest should be defined with specificity, since science and law appear to recognize different standards for identifying a conflict. A screening questionnaire that requires written certification of the absence of conflicts will help convey the standards appropriate to the case. A screening procedure for conflicts of interest should also be developed for colleagues who will provide direct assistance to the expert panel members. A procedure should be created for experts to report or obtain guidance about possible conflicts of interest that arise during their service."Conflicts-of-interest are routinely managed in academic peer review – in legal contexts, more rigorous conflict evaluation is necessary. However, such screenings are routinely done by JuriLytics.
"A procedure for organizing the work of the panel should be specified soon after the panel is appointed. This procedure should indicate how the panel members should communicate with one another, as well as the extent and circumstances under which they may seek assistance from colleagues outside the panel."Peer reviewers do not collaborate. Each reviewer will come to his/her own conclusion – the commonality of the reports will be ensured since the analysis is guided by a structured questionnaire.
"The duties and functions of the experts should be specified in a written order, which should include the issues to be considered, the form of the panel’s final report, and the procedures for providing information to the court. A mechanism for clarifying the instructions should be developed."The structured questionnaire contains all information to perform the review. The Expert Report along with all cited literature and documents are provided for completeness. Additional literature search is encouraged as a part of the peer review analysis.
"The court should establish a budget, with input from the experts and parties, once the duties of the experts have been determined."Budgets are routinely estimated for clients at JuriLytics.
"The court must maintain administrative oversight of the work of the panel to ensure it proceeds in a prompt and efficient manner."Updates and/or communication are regularly conveyed to the client and reviewer. Reviews of large reports can be completed in a matter of weeks under the right circumstances.
"The court should consider appointing special counsel to represent the interests of inexperienced witnesses who are going to be deposed or cross-examined. Care should be taken in defining special counsel’s role and compensation."In the event of deposition, JuriLytics will provide counsel for the peer reviewers.

Conclusions

In analyzing issues of scientific integrity in the courtroom, it is important to keep in mind that almost everyone, attorneys and judges alike, agree that adversarial bias in expert testimony is the largest problem facing the system. Cross-examination of experts traditionally has been the check on this bias. However, given its zero-sum nature (i.e. both sides use it), judges and juries alike often get more confused after the dust has settled. In using neutral experts, problems abound in determining how experts are selected, what their roles are, and how parties can be effectively protected from their undue influence. Interestingly, these same issues, more or less, manifest already in science itself – and yet almost every scientific community has turned to and tuned the peer review process to inject scientific validity into the system. Now, it is time to do the same in the legal system, where the problem is further magnified by the adversarial process.

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