Advisory Commission on Childhood Vaccines Meeting

March 6-7, 2008

Meeting transcript for Chief Special Master Golkiewicz’s full presentation

Agenda Item: Omnibus Autism Proceedings Update and Implications of Causation Standard in the Program – Chief Special Master Gary Golkewicz

CHIEF SPECIAL MASTER GOLKEWICZ: Thank you very much. I was prepared almost to say I’ll junk this and answer your questions after listening to the news this morning. I almost fell off my treadmill listening to Sanja Gupta’s discussion of the autism case. And for the first time, I actually sent in a corrected email and got a call back from CNN. There’s been some references to a court decision and so forth. I couldn’t hear exactly what the question was. There has been no court decision in that case. So as long as everyone understands that. The press reports to the contrary are just incorrect.

I’m going to apologize upfront. I prepared this thing. I think it’s important, and I haven’t had much of an opportunity to continue to go over it. So I’m going to have to read most of it. So if I’m not making eye contact in traditional speech form, please bear with me.

First of all, I’d like to apologize to the three new Commission members. I missed the orientation, and I enjoy those orientations, the give and take. If at any point in time you want to reschedule or I’ll make myself available to sit down with you and answer any questions you might have about the court and so forth.

And second of all, I guess I agreed to this talk some time ago, and they asked for a title for the talk. And so I whipped something off the top of my head and without thinking about what I was actually going to say. And then when I went back to actually sit down and write it, I said holy cripe. So I’m kind of taking great liberty with the title and stretching it to fit the talk.

But I would read the word implication to refer to the impact on the processing of cases, and this whole talk that I’m going to give is geared towards the workload. And Mr. Matanoski referenced a little bit, and I’ll touch on it as well, the impact of the autism cases, and I’m not talking about the test cases which is an incredible effort, but the remaining 4800 cases on everybody is just for years to come is going to be an incredible strain on resources.

Before I begin, I’d like to give several points of understanding, however. One is that my job or the court’s job is to resolve cases. I take no position. In fact, it would be improper for me to do so on any of the policy matters that are being discussed at any point in time.

Second, I would say that some of what I’m going to talk about is very complex, and it has a multifaceted issue, especially as I talk about causation a little bit. And there’s a lot of room for reasonable people to disagree about the interpretation of the causation standard decisions out there and so forth. And certainly in one hour and for your sakes hopefully far less than one hour, I’ll be skimming the surface of that particular iteration.

Then thirdly, you need to understand the players, two players in this. One, myself with the very generous introduction. I’ll just simply is that I’ve been deciding cases in the Program since the very beginning. So I have going on 20 years of experience in reviewing these cases. I guess you can look at that two ways. One, I know what I’m talking about, or, two, is you need to get out of it.

And then most importantly, you need to understand the references to the Federal Circuit. I know there’s many non-lawyers in here. But it’s very important to understand that in practical terms they’re the final arbiters of these cases. Now in a technical sense, it’s the Supreme Court. Everyone knows, I think, from reading the papers how difficult it is to get a case to the Supreme Court.

There has been one vaccine case there. But in a practical sense, it’s the Federal Circuit sets the law that’s binding on the special masters and the parties. I guess to put it another way, as I was taught years ago, I’ve been in the court system for over 20 years, by a very sage judge that I had the pleasure of working with as we both went down a case I worked on with him and we went down in flames in one of the Federal Circuit and I was just distraught, and he took me aside. And he said, listen, he said, the Federal Circuit, they’re not last because they’re right. But they’re right because they’re last. And it’s very important to say for our purposes, they’re right.

Now with those points of understanding, let me begin. In the past, I’ve addressed the Commission on various causation issues and the impact on the litigating process. I’m not going to repeat those talks here. Now if anyone is sleeping well at night, I’ll be happy to send you hard copies of these talks if you want to learn a little bit more about it. But I certainly don’t want to go back over those grounds.

Now on two occasions in the past two years, I’ve addressed the Commission’s and I think it’s Workgroup on Process. I’m not real sure. The first talk concerned the need to be clear on one’s policy objective when discussing the appropriateness of a table injury or causation standard since, depending on your respective goal, the standard of causation could look very different.

I noted as Professor Gray, a law professor from Arizona State University observed at our judicial conference in November of ’06, I believe some Commission members were fortunate enough to attend that conference. We were fortunate to have them. It’s important to understand whether you’re promoting a policy based standard of causation or a traditional tort based standard.

I’ll note for the Commission members that a transcript of that conference and the last couple conferences is on our new and improved website which I heard Tawny Buck’s voice, we benefited from her insight in improving that website, and I think it’s communicated out there, but I won’t give you the website here. Forget it. But I’m sure Dr. Evans will provide it.

If you believe that the causation standards are correctly tort based, you may take issue with several of the recent Federal Circuit opinions discussing the appropriate causation standard to apply in vaccine cases. As Professor Gray stated at our conference, she took issue with those recent decisions. She characterized them at one point using the very precise legal phrase. I believe it’s Latin. Mumbo Jumbo. If you believe the causation standard should be policy based, you have to determine what your primary policy objective is.

We all know from the legislative history, Congressman Waxman, a primary architect of the program, stated at several Congressional hearings, the purpose of the Program is to promote receipt and production of vaccines by protecting manufacturers and administrators from liability, but also to compensate those who suffer a vaccine-related injury.

However, Congressman Waxman also articulated a competing policy concern. I call it protecting the vaccine’s integrity, and that is that vaccine does not cause every injury that follows immunization. There’s a tension between these two objectives, a tension that affects dramatically the litigation of the cases, the parties’ arguments and ultimately who wins.

I think it’s fair to say that the recent Fed Circuit opinions lean more heavily towards promoting of vaccine by setting a standard whereby more cases are compensated. Thus, the pool of potential cases for seeking redress against the manufacturer or administrator is reduced.

I also think it’s fair to say that advocates of policy protected vaccines believe that the Federal Circuit opinions are incorrect. Another way of looking at it is that the recent Federal Circuit opinions have moved away from applying tort principles in deciding causation under the Act. They have moved more towards a policy based standard. Again, as noted by Professor Gray, the Federal Circuit was moving towards a policy based decision without explicitly saying so.

This overall discussion at our conference prompted quite an exchange at the conference. Kevin Conway, a petitioner’s counsel throughout the vac’s existence, defended quite strongly the Circuit’s decisions. He viewed the Circuit’s decisions as policy based decisions. In reacting to injecting more policy into the Program through the Table, Dr. Evans, again I’m not taking issues or pointing fingers. I’m just trying to give you information, stated that adding a lot of different injuries to the table is going to have some public health consequences.

I interpreted that statement as protecting the vaccine. Understanding the different objectives is critically important to understanding the discussion of vaccine causation. I’m going to make the point one more time using different information.

You can see this dichotomy of objectives by comparing statements from HHS’ public notices during the ’95 table changes with the Federal Circuit’s decisions on the appropriate causation standards. In November of 1995, HHS wrote, “Making recommendations to change the table involves the difficult task of balancing scientific concerns and public policy concerns. The Department’s overall goal consistent with Congress’ intent in enacting the VICP is to provide just and fair compensation to those individuals who experience adverse events that are reasonably be determined to have been caused by covered vaccines. The Department views its role as requiring consideration of public policy concerns as well as the purely scientific data in translating these determinations into decisions to change the table.”

Thus, both science and public policy have a role in shaping the table changes. However, earlier in February 8th of the same year in response to a comment on the proposed changes increasing lawsuits against manufacturers and administrators, the Department responded, “In enacting the NVICP, Congress determined that one of the goals of the Act was to reduce the number of civil actions filed against vaccine administrators and manufacturers. The other major goal was to provide compensation to those individuals whose conditions were caused by vaccines.”

In balancing those two Congressional goals, the Department has determined that the benefits of fulfilling the later requirement compensating vaccine-caused conditions, outweigh the risk that an increased number of civil actions will be filed against vaccine administrators and manufacturers.

Finally, in February of 1997, the Department wrote regarding its rule amending the table that the Secretary’s charged with revising the table where such revisions are in keeping with scientific evidence. The goals to have the table and qualification and aids reflect current scientific knowledge on the relationship between certain adverse events in covered vaccines. Where that scientific research concerning the relationship between the disorder and a vaccine is incomplete or non-existent, the Secretary believes it would be inappropriate and inconsistent with her statutory responsibility to revise the table.

If you compare these three pronouncements, you will find the emphasis is on science with the Act’s policy taking a subsidiary role or, in the 1997 statement, no role. Now compare that to the Federal Circuit’s approach to causation.

The Federal Circuit has articulated a three-part test for establishing causation. The petitioner must prove a medical theory causally connecting the vaccine and injury, a logical sequence of cause and effect showing that the vaccine was the cause or reason for the injury, a showing of approximately temporal relationship between vaccination and injury.

In reaching this test, the Circuit relied heavily upon the intents and purposes of the Act. Thus, the policy by the Act. In doing so, they expressly rejected relying too heavily on science, but instead counseled that circumstantial evidence was envisioned by the prepondering standard in this system created by Congress.

Thus, the Circuit has stated that requiring medical literature to support a claim is legally impermissible. Requiring proof of the specific biological mechanism is inconsistent with the purpose of the program. Close calls regarding compensation are resolved in favor of the injury claimants.

One judge has even objected to the requirement of establishing medically appropriate temporal relationship, and the court is now split on whose burden it is to rule out other potential causes of the alleged injury, the requirement under traditional tort law that rests squarely with the plaintiff.

Now the question can be raised is there a difference between comparing these statements because HHS was commenting on table changes while the Circuit was commenting on causation of fact.

I think not because clearly causation of fact, what the Circuit was deciding, is a higher burden than the presumptive table. Yet the Circuit is articulating a standard that is non-scientific, the use of circumstantial evidence, while the Department is articulating a scientific standard.

Now why do I draw this to your attention? My purpose is to show you that there are different interpretations of the primary goals of the Act. The Department’s view that the vaccine’s causative role in providing compensation as supported by science is paramount, while the Circuit views the compensation of the injured to eliminate further lawsuits as the primary goal and thus the more lenient standard.

Accordingly, we now operate under a table that is very stringent and a causation and fact standard that is far more lenient. One might say that the original act with a very lenient table and a causation and fact standard that was interpreted is very difficult to meet has been flipped on its head from where we began in 1988.

Why is it important to understand these policy – which policy predominates? In essence, it defines how much evidence must be produced to establish your claim. Science may require epidemiological evidence, while the Federal Circuit requires only circumstantial evidence. This affects the workload as I discussed with the Commission’s Workgroup last year or two years ago.

Now last year I addressed – I believe it’s the same workgroup, and addressed the issue of delay in the processing of cases. I took issue with the premise of that discussion that there was delay. Given the legitimate interpretative questions of what is required to prove causation. I stated that the amount of time spent on the cases was reasonable and to be expected.

Well, everyone agrees that ideally you would like to see the cases resolved more quickly, until the parties view the cases through the same causation lens, sufficient process must be allowed to permit the parties to fully present the information that supports their position. And make no mistake about it, process takes time and it’s costly.

Process involves collecting medical records, accumulating factual information from witnesses, possibly seeking information from treating doctors, researching and submitting medical literature, locating and retaining appropriate medical experts, analyzing these reports, determining whether issues raised by the experts require obtaining additional relevant information, which information I just noted additional information includes now the use of subpoenas to an extent that we’ve never seen in the past, and that’s subpoenaing manufacturers’ data, genetic testing now, government data, the PSC data. We’ve even had motions now to exhume a body to subpoena information underlying an original study, the NCS study over in England. It has taken up a tremendous amount of time gathering this additional information, even dealing with the request.

The scheduling of the cases which require coordinating the schedules of lawyers, doctors and lay witness, conducting evidentiary hearings, submitting post-trial arguments, and the court writing an opinion, and this is just the issue of entitlement.

If entitlement’s found, damages must be calculated. This process involves its own collection of relevant information, the collating of that information to a life care plan, negotiations between the parties. In most cases, as Mr. Matanoski indicated, he’s absolutely right. Tremendous efforts on both sides. Most cases are settled at this stage. And if the negotiations fail, a trial and a decision.

Finally, the attorneys’ fees and costs must be resolved. The accumulation of this effort is what was questioned as delay. There’s no doubt that a week or month here and there can be squeezed out of each case. But the amount of process involved to resolve disputed cases of causation takes time, and it is very costly.

Now I want to note that the debate over causation has shifted tremendously over the last five years. Five years ago, and I pick five years. I’m thinking it was five years ago. As I get older, the years kind of – I didn’t check it, but I think it was five years ago, the discussion involved petitoners’ inability to prove a case.

The judging of the cases was finding routinely against the petitioners. The Academy of Pediatricians presented to the Commission an alternative to causation which might open the door to more compensation. My talks to the Commission and others decried the lack of clear standards for judging causation cases with resultant lack of consistency and certainty.

But one thing that was clear at that time, petitioners were losing the vast majority of cases. The times have changed dramatically in some respects but are the same in others. The Federal Circuit’s recent rulings in Althen/Capizzano have changed the legal landscape for petitioners. Indisputably, the application of the Circuit’s three-part test has resulted in far greater findings for petitioner.

In fact, I ran out of time. But I really wanted to take and just run one year, say 1999-2000, the judgments, come up with a percentage of how many received compensation and run it against the judgments from last year. I think it would be very telling as far as how dramatic that shift has been.

Unfortunately, what hasn’t changed is still a great deal of uncertainty of how much proof is necessary to establish causation. We know it’s less proof than was originally thought. But there’s clearly plenty of interpretative room left in the Federal Circuit’s opinions. And that means the parties looking at the same evidence are reaching different conclusions.

In fact, the arguments following Althen Capizzano are not that much different than they were prior to Althen Capizzano. The outcomes are different, but the arguments are pretty much the same. That means even post-Althen Capizzano, a great deal of process continues to be necessary to resolve disputes.

The bottom line, to fairly resolve issues takes process, the opportunity to present information and argument. Thus, the more issues and more complex the issues, the more process involved which takes even more time and is even more costly.

The answer is to eliminate the issues or reduce the degree of difficulty, and you reduce the time and cost. The Congressional Budget Office estimated prior to the start of this program that the cost of litigating a causation case would be about $50,000 in fees and costs. That’s 20 years ago when gas was a dollar. But we just paid out our first $400,000 attorney’s fees and costs in a particular case, and I don’t think that’s going to be abnormal for much longer.

What efforts can we make to reduce the process as much as feasible while not impinging on the party’s right to fairly and fully present their case. The biggest problem are the medical records. I read the minutes, I believe, from the last meeting, and I know Mark Rogers spoke on this particular issue. There’s many difficulties with providers giving the records up quickly, completely at a reasonable cost. Petitioners’ statements of frustration are rampid. The one dollar per page to copy, records are warehoused, employer record of immunizations are missing.

Just the other day, I had respondent’s counsel related to us that two requests from a genetic testing facility did not yield the result of the test. They went to the referring doctor and were given the test results. No one can explain why the subpoena to the genetic testing facility resulted all the paperwork except the result. But each of those subpoenas, requests is time.

We found on too many occasions that the process of getting medical records is incredibly frustrating, time consuming and costly. I believe I copied this right from Mr. Rogers’ notes that in talking about the delay in the process or where the time is being spent, and he said the petitioners accounted for over 80 percent of that time. And I would say that 75 percent of that time is obtaining medical records.

Another area that we can more fully utilize to move cases more quickly is the use of alternative disputes resolution. We do quite a bit of ADR, and we have what I think is a very successful program. But we could do more, and I have fully intended for several years to do more. I’ve reached out to the educational arm of the federal judiciary which is the Federal Judicial Center, and they’ve offered to help me in this regard.

But unfortunately, and as I get to the end of this, you’ll understand why, no one has the time to do it. I don’t have the time to devote to actually sitting down, pausing and actually think through this and set up a program, and I know my counterparts at Justice and the petitioners’ bar that I would call on to do the same, they don’t have the time right now to do it. So that initiative simply waits until we get a pause in the system and get a chance to just work on this a little bit, and that’s unfortunate.

Mr. Matanoski talked about damages, the 80-90 percent, I would say, are being settled. When you get to the damages phase, it’s probably one of the most successful efforts and changes in the program from the early days to now. It’s an incredibly successful effort on all sides. They still take too long. But the reality is that some of these young children in getting to providers and getting the appropriate amount of information and so forth and getting the correct life care plan and the correct needs assessment and, therefore the correct costs, no one is going to deny the petitioner the time to put together a correct analysis of this.

But clearly, in the area of putting damages together, at least 90 percent of the time is on the petitioner’s side of the equation, and they’re making good use of it. I don’t mean to indicate that that’s in any way any sort of delay.

The attorneys’ fee, most settle. But we now have, and Mr. Matanoski talked about it a little bit, several issues have come up that are certainly requiring some time, and there’s going to be some litigation in that area, including no only, as Mr. Matanoski talked about, the attorney’s hourly rates, but also the expert’s hourly rates are starting to become an issue.

Two areas, and they’re somewhat related, where we could really squeeze some more efficiency out is identifying similar cases that have either settled in the past or been found compensable by special masters and moved them to the damages phase without going through a lengthy process of experts and even hearings and getting another decision and so forth.

We’re simply not learning or benefiting from past settlements and decisions. We have too many cases spending literally years in the program only to be settled at the back end of the case. Sometimes you understand that because that’s the whole process of a case moving through the system is developing information, and everyone learns from that information. The government, when they first look at a case, has X amount of information. But the time it gets to the back end, they’ve got X, Y, Z, and frequently to their credit, will reevaluate, take a different position and it gets resolved.

The trick, if we can, is that when that happens with the same vaccine, same injury, I call it a clean case, there’s no factors unrelated, nothing to distinguish it, is to recognize and triage it right upfront and push it to the front of the line, get it to the damages where we’re so successful in doing the damages, free it up and get it out of there. It not only impacts that particular case but has a rippling effect through the whole system in that it frees up the attorneys on both sides, it frees up the court in processing that case through entitlement and so forth. That is an area where I think that we have a lot of room for improvement. And it’s probably an area much like the ADR that we simply don’t have the time to sit back and think through and put in a system to try to do that.

We try hard in our shop to compare notes. It’s a small office. There’s eight special masters and you send an email around, hey I got this vaccine, this injury, do you have anything, you know. But as special masters leave, new ones come on, that institutional knowledge goes and there’s only so much tracking that we have of these cases.

Now litigative risk is part of the settlement process, and that’s probably our biggest growth area at this point in time. It’s a double-edged sword. On the one hand, this is a very good thing in the sense that cases are moving, and they’re being compensated. On the other hand, there’s a slight element of concern here because cases in some instances are being paid out in full with no finding of the table injury and no finding of causation.

And so one might ask yourself, you know, on what basis is this being compensated. Now if similarly situated petitioners with the same vaccine, same injury were being treated the same in each case, you’d have less reason for concern. In fact, if you go back to my last paragraph where I talk about that, that could be a very good thing because you build up a knowledge base that, hey, we got this vaccine, this injury was compensated at three different times. The fourth time, we ought to do it again. Let’s get it out of here and move it.

And that’s what happens by word of mouth. However, in this litigative risk area times your success is a function of your attorney, your attorney’s knowledge and experience in a program. Not only the petitioner’s attorney but also the Department of Justice’s attorney. They get new people in. They don’t have the institutional knowledge. They get hit with this case, and then it becomes the special master involved.

Now does the special master remember a situation, hey, I had this case. Well, there’s only two of us now from the original group which is probably a good thing. We have new blood in there. But they’re sending out and, hey, I don’t have this experience base. And if someone else isn’t there to tell them we’ve compensated these before and so forth, there’s no one to say, you know, that one ought to be compensated as well.

And we went through a little of this in a successful way with the flu GBS cases. The respondent didn’t concede the cases, but they didn’t contest them. The special masters coordinated their efforts and found that the cases were being paid fully, and we found that some were being paid fully, some were being negotiated at a lesser level, and we took steps in-house to say, well, wait a second, you know, let’s track these and make sure the next government counsel that comes in here knows that you paid this in full.

Now to the government’s credit, they reacted in kind and now we’re paying those out in full. But what we have is I call it the under-the-table table. We have vaccines and injuries that there’s no finding on but are being compensated. And as they get compensated and as we communicate around our office, we know the next one we see, you know, that we’re going to bring it to the government’s attention, and we’re going to push to resolve that case and pay it off. And that’s probably the biggest growth area right now. Again, if you went back, and I don’t know if the judgments themselves would say this, you would almost have to audit the cases of the last two years. It would not surprise me to find that over half of the compensated cases are litigative risk cases.

A lot of these should be litigated – call it a gray area. There’s a lot of risk on both sides, and there’s good reason to settle a case. But there’s also a large group in there that are becoming cases that have been compensated before and, for whatever reason, the government doesn’t want to come out and say we concede it. That’s fine. That’s their policy, their business, not mine. But we have to catch it and bring it to their attention and make sure that that petitioner’s treated the same as the other. And that’s an area of concern, and we’re trying our best to track this and keep everyone equal. But it’s difficult.

Now while some may respond, you know, that’s litigation, I ask whether that was Congress’ intent for this program. In sum to this whole first part, the continued lack of precision in the causation standards allows for reasonable differing interpretation of those standards and, thus, what cases should be compensated. In turn, that requires the necessary process to resolve the cases. Process takes time and is expensive.

That’s the first part. I promise you I’ll get through the second part faster. The second part has to do with autism. Now I just will spend a couple minutes on this, and I’ll note upfront I read the minutes of the last meeting. Tom Powers, the petitioners’ counsel, did a very nice summary of the autism cases. Mr. Matanoski knows them far better than I do as well on the test cases.

I’m on the periphery. I’m not one of the three special masters working on the test cases, and I don’t have anything to add in particular to how the test cases are being handled except to say that it’s a pleasure to watch the quality of lawyers that are involved in this, not only from our office, from the Department of Justice and from the petitioners’ side. It is a monumental effort, and I said to you upfront I’ve been in the court since I kind of lost track, from 1984, and I was the Chief Judge’s Chief of Staff, and I’ve been involved in a lot of major litigation from the court’s standpoint of managing. This is equal to anything that we’ve seen over at the court that has evolved, and this is a massive effort, and it’s being very, very well handled, and it’s only being well handled because of the quality of the people and the cooperative efforts.

They’ve got a lot of issues to battle out, and that’s understandable. But when it comes time to get the process going, it’s an incredibly cooperative effort.

We initially held the petitioners off from filing medical records in the non-test cases. The court did. That was not totally agreed on by the parties by any means. This was done as a calculated measure to devote all resources to preparing the test cases for trial.

Now that the test cases are moving forward, we must prepare the non-test cases so that they will be in a position to receive the guidance that will ultimately come from the Federal Circuit. It will tell us what is right. Another factor, and Mr. Matanoski noted this, is the 36 month rule that you have to file your case under the Act within 36 months following the first symptom or manifestation of injury. And the Federal Circuit wrote a very nice opinion recently which set forth pretty clear guidance on that point. The case was Markovich.

This issue, however, can be very difficult when you’re talking about autism with its insidious onset. Knowing the incredible amount of work to try to get 4800 people to all of a sudden start dumping records into the court, just sending orders to petitoners’ counsel who are bogged down with it, the government responding and so forth. I asked for them, and this was one of these cooperative efforts. Mark Rogers from the government and Tom Powers and other petitioners’ counsel, we got together, and I asked them to help me craft an order, come up with a process that we can do this in an organized fashion so it doesn’t weight us all down.

The only thing I asked for was that (1) I wanted it done prior to the Federal Circuit ruling on the test cases. Now I’m guesstimating and I think it’s questionable. I’m hoping at least that it’s going to be three years before we get a Federal Circuit opinion. I may be whistling in the dark, I don’t know. But three years is what I’m aiming at. So I plan to have these 4800 cases ready in a three-year period.

So I said I wanted 200 cases a month that we’re going to deal with, and I want them to do two things. Initially, I want them to address the 36 month rule, the 36 month requirement. Second of all, if it meets the 36 month requirement, then we’re going to just get the medical records. Once we get the medical records, we’ll put it on the shelf and wait for the Federal Circuit to rule.

So they came up with language that would order the petitioners first to file the necessary records to deal with the 36 months, and then we’ll go through those and go on. Now we started that process beginning with a group of about 100 cases that I carry on my docket that were filed post the first autism test case trial, the Cedillo file which was in June of 2007. About 100 cases came in after that trial was filed.

We followed up with 200 orders went out in January, 200 more went out in February, and we’re going to keep going out with 200 more. We now have about 500 orders outstanding. Now it’s going to be an incredible process. I did something like this years ago with the old Priac cases. We had about 2300 of them, myself and my secretary. We did the same thing with orders, and it was an incredible effort.

Once we start getting a thousand of these orders out there and the responses coming in and so forth, this is going to really strain everybody. To give you some impact on – I can speak only of our office obviously, the special masters. You have eight special masters. You have eight law clerks. Each special master has a law clerk, and we have two staff attorneys.

We have three special masters and three law clerks and one staff attorney are doing nothing but work on the nine autism test cases. They’re completely out of the loop of all other cases at this point in time.

Working on the information gathering for the 4800 autism cases, we have myself. That’s in addition to my full docket and my administrative responsibilities and the office’s second staff attorney which, of course, pulls that person off of what that person was designed to do, and that was to help the special masters as a whole on whoever has a big case or whatever.

Now petitioners, in addition to their non-vaccine cases, now must begin filing the medical records and showing that the cases are timely. The Department of Justice must evaluate the filings to say that they were timely filed, or, if not, what records indicate that they weren’t timely filed.

We then go out with an order to the petitioner, and they must respond. If petitioner and respondent disagree over whether, based upon the records, there was a timely response, the case then goes to one of my colleagues, and it becomes another issue that has to be resolved.

Out of the first 100 orders, 12 presented a dispute as to the timeliness – a dispute between the parties as to the timeliness and will have to be resolved. This could require factual testimony, interpretation of medical records, testimony from treating doctors or even expert testimony.

Extrapolating from that experience from the first 100 orders, you’re talking about 500 additional cases out of the 4800 where additional process will be required to resolve the timeliness issue – not the entitlement issue, not the damages issue, but simply whether the case was timely filed.

The bad news from a workload standpoint is I believe that 12 percent rate from the first 100 cases is low, and that’s because these 100 cases were filed clearly based upon the publicity of the autism trial, and many of them were obviously late filed. And there’s also another 30 of those 100 haven’t even responded yet. So that the 12 percent actually is not accurate. It should be 12 divided by 70, whatever that is. So it’s a high rate.

I believe we’re going to see 20-25 percent rate that are going to require special master determination. Now if that’s true, we’re talking about over another 1,000 cases, effectively another 1,000 cases that will be in the system that the special masters are going to have to divide up. Given that my three colleagues are out of the loop, we’re talking about dividing those 1,000 cases between five which is 200 cases which.

Now to give you some perspective right now, I’ve always tried for years to keep my colleagues at a rather sane level number of cases, and I keep the insanity in my office. So I’ve always kept them at about 100 cases, and they all are now under 100 cases – my other four colleagues. And we’re talking about potentially adding another 200 cases to their docket.

So mercifully concluding, the next several years promise to be extremely challenging. The causation decisions from the Federal Circuit are couched in language that is subjected to different but reasonable interpretations. While the application of that language is clearly bent or leaning in the direction of compensation, until that language is further refined, cases will continue to be contested which requires process, and process takes time and is expensive.

At the same time, the autism trials and the preparation of the 4800 autism cases will tie up resources for several years. At this point, it’s anyone’s guess what will happen when the autism test cases reach the Federal Circuit. Their decision will dictate what kind and how much more process will be required to resolve the remaining 4800 cases. When no substantial process will be required, we just don’t know how substantial.

Now if you slept through the entire speech, listen to this last paragraph, please, and I forgive you anyway.

Please clear that the vaccine compensation program is running at 100 percent capacity. There’s no growth room without additional resources. We dodged a bullet with the minimal number of flu cases filed under the eight year look back period. We are one 200-block case filing away from break point.

The only saving grace at this point is the continued and incredible work efforts from petitioners’ and respondents’ counsel, their willingness and ability to work cooperatively with themselves and the court as they represent their clients’ interests, produce the creative solutions to overcome the lack of sufficient resources in handling the current workload.

However, dedication and hard work have their limits. I sincerely believe we’ve reached that limit. Thank you, and I’ll take any questions. Oh, I have one more announcement, one more. Never give a mike to a lawyer, right. November 19th of this year is the court’s next judicial conference. I think the last three, I’ve extended invitations to the Commission members, and I will certainly get another one. I just want to get the date out there now. If we do this one right, this will be our best. I think the people who have attended the past ones, it’s been very good. I think this one potentially can be even better. We’re going to zero in on this discussion of how you draw the line of compensation, how you draw that and determine that needle of compensation in such a program, discussing the various issues, the ramifications, the impact on scaring parents from vaccines, raising concerns, the litigation end to the manufacturers, administrators and so forth. We want all those issues out on the table and just discuss them. And I certainly will be – I see some people in the audience that haven’t received my phone call yet to participate, but they will. And I know I can’t get – I don’t think I can get a current Commission member, but I certainly am going to reach out and get a prior Commission member, and I have my former boss, the former Chief Judge of the Court has agreed to moderate.

Like I said, I think if we do it right, it should be a very substantive program. That’s my intent just to discuss these legitimate issues and get it out there. But November 19th, it will be in D.C. And I think that what we’re going to do because I think we will have enough interest in it is that we will have a telephone hook up like we did for the autism trial so that we’ll publicize that so anyone can call in and listen to the proceedings. And with that, I’ll hand over the mike.

MR. SCONYERS: Well, thank you very much, Chief Special Master. It’s really our privilege and pleasure to have you come and address us. And I am pretty sure that nobody caught any sleep during your remarks. Well, I saw you nodding off, but you pulled yourself up.

Before we go to questions, I’d just like to, if Jeff Evans would like to take a minute to say anything in response or anything by way of comment.

DR. EVANS: Could I take half the time of the Special Master took? No, I think that Gary’s first part of his talk was particularly striking to me because that – where you set the bar is so important. I mean, after all the program was created because of the inability to settle disputes over causation, DTP being the primary vaccine at that point. And there’s this meld of science, policy involved that continues throughout. Clearly, we see our mission on HHS as trying to preserve science which Chief Special Master referred to as tort – as the tort aspects of it versus the policy which some could view as results oriented meaning compensation.

And how you begin to figure out where that bar should be, how it should shift, and the quotes that you used during your discussion to begin with had to do with, for example, the 1995 quotes about policy. That was a table directed program. The first half of our history really was a situation in which most of the compensation was on the basis of the presumptions that were arrived at by finding a table condition, and that was a key part. And I think that we’ve heard over and over again, especially at the judicial conferences that that’s what Congress had in mind.

But we’ve entered another phase, another part of our program’s history in which we have to wrestle with causation. And how you do that is very difficult. Again, we have our mission, our approach. We try to make the most of science, determinations on science, keeping in mind that there can be exceptions.

Keeping also in mind that the exceptions that we make and the ultimate determinations that are made either whether we concede a case or whether the court in its own wisdom decides to compensate a case, and in this new category of activity where we are settling a great deal of cases, keep in mind that there is a perception of risk that flows from that. And one needs to look no further than what’s happening today in the mainstream press and the Internet in which the perceptions of risk that float around information, whether rightly or wrongly that’s being reported about a case that’s in our program. And I think it’s important that as we try to make this program function better and be able to compensate and live up to its policy goals that Congress intended, that we keep in mind that there is this other side to compensation that we have to worry about.

There was just a story in the New York Times this week about again more evidence of diminished immunization uptake, and it’s not going to be long before there’s going to be public health consequences of that that we’ve seen on these immunization surveys.

So the key issue, difficult issue, ethical issue, and I look forward to this being the topic that’s going to be coming up this fall for further discussion.

MR. SCONYERS: Be interested in questions or comments from anyone on the Commission? Tammy?

MS. TEMPFER: I have a question. Is there any possibility you’ll be able to increase your staff with the workload increasing so dramatically?

CHIEF SPECIAL MASTER GOLKEWICZ: The short answer is no for two reasons. One is the statute has the special masters capped at eight. It actually says eight special masters. The second part is the way that the judiciary were housed allocates resources. So it’s a real caste system. The Supreme Court gets X. The appellate courts gets X minus 1. The district courts get X minus 2. The magistrates used to be at the bottom until we came around. We are the bottom. So no, we are limited to one law clerk, and actually I had to fight – the magistrates do not get staff attorneys. I had to fight that out to get the two staff attorneys, and I’m told I will get no more.

So unless there is legislation that changes that, no, we’re at our max at this point.

MS. TEMPFER: I have another question. I’ll take all the questions. Can you comment on what caused the dramatic shift five years ago where you cited a turn around in how the cases were –

SPECIAL MASTER GOLKEWICZ: Oh, it was the Federal Circuit’s decisions. There was a period of time anyone that would, if you went back and compared the Federal Circuit’s – not only the Federal Circuit. I should say it’s also the Court of Federal Claims judges. It’s an odd system in the sense that because of its evolution that the first level of appeal from our decisions goes to the judges of the Court of Federal Claims which is the trial court. So they get the first whack at us, and then it goes up to the Federal Circuit.

If you went and reviewed the appeals in the ‘90s, even the late ‘90s of the special masters’ decisions and compared those to the decisions that are coming out now not only from the Federal Circuit, but I think even more so from the Court of Federal Claims, I mean it looks like two completely different programs going on. You would actually think that there had been a change in the law. It’s that dramatic.

Cases that were being denied in the ‘90s and affirmed as denials are being compensated now. There is a tremendous shift. And what’s interesting in this is that the Federal Circuit, not explicitly, but it basically said and it said at our conference that there has been no change. They said that the decisions they’re issuing now are what they said before.

Well, they’re saying it. But I’ll tell you our judges are not interpreting it that way. And I think anyone practicing can’t even believe that they would say such a thing. There’s been a tremendous, tremendous shift. And I really believe if you want see it and I would do it if you want me to have someone pull it is to take a year prior to the – take the year before Althen came out and the judgments of that year. It would be pretty rough, but take a year and compare it to like last year. I won’t venture a guess, but it will be dramatic. It will be dramatic.

I don’t know if anyone has or calculated a percentage compensation rate. People that actually received money. It’s got to be over 50 percent.

DR. EVANS: I was told by the head of our operations branch that we are now settling more than twice as many cases versus last year. Settlement rates has increased by more than two.

CHIEF SPECIAL MASTER GOLKELWICZ: And I would think that trend will continue unless there is a – I know Mr. Matanoski already talked about it. There’s a pretty big appeal up in the Federal Circuit now that the government took up De Bazen and there’s some issues presented in there. But you know, at this point in time you’ve had three or four panels that have looked at the issue, and one is tracked on to the other. With the number of judges that you start counting that Mr. Matanoski talked about en banc, that’s how you get the Federal Circuit to come out with one statement of law. But you start counting the number of judges that were on those three-judge panels, and it’s starting to look like a majority. So I think this is what the law’s going to be.

DR. EVANS: Just one more. At one point in the past, I tried to articulate the fact that one of these circuit decisions, I believe, involves a condition in multiple sclerosis after a Hepatitis B vaccine which is one of the few conditions among many that the Institute of Medicine had looked at and found that there’s proven evidence against a causal connection. Yet, that was the signature case that led to one of those key decisions that loosened up or appeared to relax the burden of proof for causation. So I found that rather ironic.

DR. SALMON: I have a couple of questions, and my training’s in science and not law. So I’ll try not to use too many legal terms. It may not sound what I mean. But if I heard and understood you correctly, for non-table claims, causation is determined from a theory of a biological mechanism and a temporal relationship. Is that correct?

CHIEF SPECIAL MASTER GOLKEWICZ: That’s correct.

DR. SALMON: And so I wonder when you talk about a theory of a biological mechanism, I mean when something bad happens, anybody can come up with a theory or an excuse. And the question is how good of a theory or how good of an excuse is it. I mean, I think almost of my children when anything bad happens, there’s always an excuse. The question is, is it a good excuse or is it not a good excuse. And likewise with theories, I don’t know how one necessarily rates how good of a theory it is. But it’s hard to imagine that somebody couldn’t come up with a theory for anything that happens in the world.

So I wonder if when you talk about a theory of biological mechanism if there isn’t some bar that’s associated with that. Is it just a theory that somebody has, or does it have to be a reasonable theory? Does it have to be a theory that is supported by some sort of observation? Does it have to be a theory that’s accepted by mainstream medical community? Is there any criteria that goes along with the idea of having a theory for biological mechanism?

CHIEF SPECIAL MASTER GOLKEWICZ: All of those. You see the adage of comparing making of sausage, legislative sausage. You wouldn’t want to see how a decision gets rendered sometimes.

That’s the area of dispute right now frankly. That’s one of the key areas of dispute that is outstanding in the sense that I will tell you upfront I am disappointed in what the Federal Circuit handed down to us. They had multiple opportunities to clarify and at least narrow and instruct the special masters as to what they should be looking for in establishing a case of causation.

What they came up with is what I read to you. And one of the key issues out there and one of the reasons we’re going to have a lot of process for some years to come and hopefully at some point the Circuit will nail down is how much proof is enough on each of those items. Now on the timing, obviously, that’s an easy one. But it’s not known at this point in time, and that’s one of the reasons you have a lot of these litigative risk settlements quite frankly is because the parties are uncertain and the special masters are uncertain.

Is it enough to have a doctor just simply come in and say here’s the theory, here’s what happened, this an appropriate time frame, that’s it. Now I will tell you some people think yes, that is enough. Others will say no, that’s not enough. It’s not enough just to have a doctor. You have to have a doctor with some objective information to support what that doctor is saying, you know, point to something and say here’s why I back it up.

This isn’t just theoretical. It isn’t something I just made up. It’s been studied, it’s been published or the medical community, the relevant medical community is in line with this. You know, that is a huge area. You know, it’s nice to have that three-part test. But when you start looking at it and trying to understand exactly what it means, there’s lots smarter people out there than me. But I’ll tell you there’s a lot of confused people right now in applying that, and that is one of the major reasons that we have this litigative risk. And people are looking at it, and they have a doctor. And you’re getting down to – and this goes back to Dr. Evans’ comments. I hope I didn’t – again, I start out. The point of my talk was not to say someone was right or wrong. It was simply to point out that I think there’s legitimate differences of opinion in approach to causation which is generating questions, which is generating issues, and they have to be resolved.

And the same with the Federal Circuit. Until we get to a point where we agree that, for example, with that plausibility of this happening, that it’s not enough to be theoretical, that you have to have some objective support for it. If we can agree on that, then you check that box. You have it or don’t you, you know. But we don’t know. We don’t know.

And it’s unfortunate. Sometimes cases come down to is what doctor is it. You know, what are the credentials of that doctor. And that’s where I have a problem from the standpoint not only in this talk but if you trace back to remarks that I’ve always made. All I’ve ever argued for or tried to present is that the court needs – we resolve cases, and we need some clarity as to what we’re judging against – standards. And if we can get some that’s a little more clear, we’ll move cases a lot faster. We’ll all benefit.

And at this point in time, it’s not clear, and there’s a disparity of when you have lack of clarity, what you have is that who’s winning, losing, getting litigative risk settlements is a function of what lawyer you have, how in tune is that lawyer to the Vaccine Program which a lot of them are not, what resources does that lawyer have or that petitioner have to get a doctor, what access does that particular petitioner have to a particular doctor. And you’ll see it all the time in cases, and there’s not much you can do about it.

The government, to their credit, in some instances have gone to them and said to a petitioner that’s unable to get a doctor, I look at it and I say, geez, it looks like there may be something there, and I’ve ordered the government at least to have a doctor take a look at it, even if it’s a doctor from HHS. At least someone will look at it and see if there’s a callable claim here.

And in some instances, we’ve agreed, gone out and got a doctor to take a look at it on behalf of – so at least someone takes a look at it. There’s a big difference if you can get a doctor from Hopkins to take a look at this thing. Or in some instances, one of the government’s experts was the treating doctor.

DR. SALMON: You mentioned a temporal relationship. It seems pretty straightforward, and I was going to pick on that one next. You know, you discussed how it’s very useful to have an institutional memory so that if the court has already ruled that vaccine X is compensatable for outcome Y and it’s been decided that way a few times, then the next time that it comes up that that decision is understood, and that’s it handled in an expedited way.

And certainly from a logistical standpoint, that’s very clear. I just wonder where the role of new science comes into that. So if you take, for example, the temporal relationship and it may be that a certain adverse health outcomes becomes apparent at say, age two, after a vaccine is given and then new science comes out and shows that in fact it may be asymptomatic for the first two years of life and that actually the injury occurs inutero. So new science might suggest that the temporal relationship isn’t what it seems to be.

So as you suggested, the benefits of having an institutional memory so that cases can be consistent. My question is where the role of new science comes into that, and is it maybe not an evolving issue which isn’t at least in some cases, and perhaps you can comment.

CHIEF SPECIAL MASTER GOLKEWICZ: It’s actually the role of counsel, and hopefully you haven’t been exposed to the court process, and I hope you never do. But you have advocates on both sides. And first of all, I should say that the special masters’ decisions are not binding on anyone. So only the Federal Circuit’s decisions that are binding.

So when I say that, you know, that you have a special master makes a finding, they’re not even binding on each other, you know. So it’s a matter of how persuasive an individual’s decision was on a particular case, and you may take issue with it. And we have disagreements in house as to those causation standards. So we’re not always in line on this.

But you have a couple special masters find that vaccine A causes this particular injury and so forth and whatever party decides, says okay, we’re throwing in the towel, we’re not going to litigate this again. We’ve lost it four times in a row and blah blah blah.

Now new science comes along. That party that was losing is certainly going to – you rely on them, they’re going to bring the information to you. Now we also, we read and are in tune to as much as we can be in tune to. But we rely on parties to bring the information to us, and that’s where it would come in. It would – if there’s a change in for or against, I’m sure there has been. Maybe Dr. Evans probably knows better than I do. But there’s during the course of handling cases, there would be a change. There’s actually a nice example. It was the Department reacting on the table changes to Special Master Hastings’ decision with the rubella arthritis cases, and the Department reacted to that and took parts of it and actually put it on the table. So that was a good example of a very good effort from all sides producing very good information. A decision came off from a special master, and the Department reacted to it and put parts of it on the table and the benefits of moving forward.

But I think on that one, even that one, there was then some subsequent information came out, and they had to have another hearing. Wasn’t there another study that came out on the rubella arthritis that required another hearing and adjustment to the –

DR. EVANS: There was a second. There was an omnibus hearing initially, and then there was a second hearing. And I don’t remember how later in the ‘90s or more recently, in fact 2002, that that took place, too. And I think there was another decision that was rendered in that case. But also Jeffrey just mentioned the most recent exception, the auto virus which again the government CDC sponsored studies, and that led to a table revision.

CHIEF SPECIAL MASTER GOLKEWICZ: But that’s an example of how as new information came out, the government asked for and that was after the initial hearing, decision, a number of cases settled pursuant to the first decision. Then there was another study came out, and the government came back and said, well, wait a second. Based on this new information, we want another hearing. And they had another hearing on the same matter. So you know, it’s always fluid.

MR. SCONYERS: We’re just about out of time. Meg, do you have a question?

DR. FISHER: I’m still having a little trouble with the three-part test. So what are the three parts?

CHIEF SPECIAL MASTER GOLKEWICZ: Oh, geez. The plausibility of the vaccine causing the injury.

DR. FISHER: Is that the same thing as the theory?

CHIEF SPECIAL MASTER GOLKEWICZ: Well, yes, I would say it’s the same as the theory.

DR. FISHER: Okay.

CHIEF SPECIAL MASTER GOLKEWICZ: And then number two is the logical sequence of cause and effect between the vaccine and the injury.

DR. FISHER: So that’s the temporal part?

CHIEF SPECIAL MASTER GOLKEWICZ: No, the temporal’s the third part, and you’re not alone in having problems with the three-part test.

MR. SCONYERS: Dr. Fisher is one of the ones who missed the briefing from Chief Special Master as she came on the Commission. So we’ll have to figure out a way to get you the benefit of all his insights.

Tawny, I just wanted to see if you have any questions?

MS. BUCK: Well, I always have a comment, and I want to thank Chief Special Master Golkewicz for his time. I always appreciate his insight into this process. I really do – I’m very interested in this idea of the under the table table, understanding that there’s some logic to looking at cases and payments and trying to find or identify what is sort of the same, what’s common, you know, and trying to make that system more efficient.

I mean, the table which we haven’t used in a long time is always going to have to be dynamic. I mean, it changes when science changes, and it should change when policy changes. And for me, I think this idea that you combine both science and policy to establish some guidelines for this program is something that should be looked at more.

So I really do appreciate the time spent to go over this topic with us again. I think it’s been very informative.

MR. SCONYERS: Tammy, do you have one final?

MS. TEMPFER: I just want to clarify. When you talk about close calls, does that really kind of go along with what Dan was saying about if you get conflicting reports from expert witnesses on the different sciences, that would kind of set you up for like a close call kind of decision?

CHIEF SPECIAL MASTER GOLKEWICZ: I have to concede. I’m one of those that does not understand how you have close calls go to one side or the other because the standard of proof in the statute is a preponderance of evidence which by definition is 50.1 percent. So you have to find 50.1 percent for one side or the other.

And then also is the burden of proof is on the moving party, the petitioner. And there’s a lot of case law out there. But if you find the evidence is equal, 50-50, the moving party loses. So those two concepts, 50-50, moving party loses, and to win you have to prove 50.1 percent. I honestly don’t know how you deal with close calls go to the petitioner. I just don’t understand it. I’m sorry.

MR. SCONYERS: Thank you very much for being here with us today and for your carefully considered remarks, and I very much appreciate it.

We are at our break time. We’re going to commence as close to 3:20 precisely as we can. So let’s take an approximate ten-minute break.

Back to: ACCV Meeting - March 6-7, 2008 Minutes

This information reflects the current thinking of the United States Department of Health and Human Services on the topics addressed. This information is not legal advice and does not create or confer any rights for or on any person and does not operate to bind the Department or the public. The ultimate decision about the scope of the statutes authorizing the VICP is within the authority of the United States Court of Federal Claims, which is responsible for resolving claims for compensation under the VICP.