Why anti-vaxers hate the NVICP (and just what is it, anyway?). –by Colin McRoberts

Jennifer Raff —  November 22, 2013 — 43 Comments

Orac is reporting that a planned Congressional hearing into the National Vaccine Injury Compensation Program has been canceled. This is unambiguously good news; the hearing was probably a political favor being done for anti-vaccine cranks who despise the NVICP. Their hatred for the Program can be confusing, given how much better it is for their position than the alternative.

The short version
What are we talking about? The NVICP is a special court set up by Congress for people who claim they were injured by vaccines. Instead of having to sue the vaccine makers, which is an incredibly expensive, difficult, and time-consuming process, those plaintiffs get fast-tracked through a non-adversarial system. That means that instead of making them fight with the vaccine makers’ lawyers, the government pays for the plaintiffs’ counsel and works with them to determine whether compensation is appropriate. Plaintiffs in the NVICP win their cases much more often than plaintiffs in the normal product-liability courts, and even if they lose they don’t have to pay for their own lawyers.

But despite those advantages, anti-vaxers are trying to pressure Congress to kill the program. On the surface, it doesn’t make sense—the NVICP is a much friendlier place to bring a claim of vaccine injury than normal courts. But there is a hardcore cadre of anti-vaxers who still believe that vaccines cause autism. The NVICP has rejected that claim on the strength of the evidence, and so those opinion leaders have set their sights on it. They hope that by destroying it, they can get their autism claims back into normal courts where they might get lucky with a sympathetic judge and jury.

Of course, this would be terrible for people who have actually suffered some side effect from vaccination—it’s rare, but it happens. Those people are much better off in the NVICP than in normal courts, where lawsuits are excruciatingly slow, hideously expensive, and incredibly uncertain. They would lose the NVICP, which is much faster, vastly cheaper, and far friendlier to legitimate claims of injury.

How it works

The NVICP is an attempt to manage the negative externalities—the costs incurred by patients, essentially—of vaccines. It is true that vaccines sometimes cause harmful side effects, although not to the extent alleged by anti-vaxers. Typically people who suffered harm because a vaccine was negligently designed or manufactured would sue, just as with any other product. (If it was a minor who was hurt, their parents would sue in their place.) This works well enough for trucks, cribs, microwaves, and all sorts of other products. But it can only take a few adverse jury verdicts to make it uneconomical to manufacture a product. That’s one thing if the product is a microwave. If it’s a DPT vaccine, though, then we’re all in trouble.

Vaccines provide a huge public service, protecting people from terrible but preventable diseases. To do that, enough people need to be vaccinated to provide herd immunity. If it isn’t economical to produce a vaccine, or is only economical for a few producers, then there probably won’t be enough doses available to achieve that. This nearly happened in the 1980s, when almost every manufacturer of the DPT vaccine took its product off the market following a series of jury verdicts for plaintiffs suing vaccine makers.

Congress acted to protect the public welfare by creating the NVICP, which created a new venue just for cases in which someone alleges that a child has been hurt by a vaccine. (That’s a little oversimplified, like most of this explanation—there is actually a list of covered vaccines.) Instead going to the same court they would with any other product, the plaintiff files a complaint with the United States Court of Federal Claims. The COFC’s Office of Special Masters handles the case. The plaintiff can’t go to a regular court, they must take their case to the Office of Special Masters. When we say “the NVICP,” we’re usually really referring to the Office of Special Masters.

There are eight Special Masters, appointed by the COFC. They hear the vaccine cases themselves, and are much more involved in the case than a normal judge would be. That’s because their role is not the same as a normal judge. Judges referee an adversarial process, in which plaintiffs and defendants fight against one another. The NVICP is designed to create a non-adversarial process. The Special Masters are charged with taking an active role in the process to help manage cases more quickly and fairly than would be possible otherwise. They essentially try to create a collaborative process to uncover the facts and determine a fair outcome. (This doesn’t work in most courts, because there are far too many cases for judges to get involved in the same way and the American judicial system has evolved different rules.)

One of the things that makes the system “non-adversarial” is that the vaccine makers aren’t really acting as defendants. If the plaintiff prevails, the money for their compensation comes from the Vaccine Injury Compensation Trust Fund, which gets its money through an excise tax on vaccines. This essentially puts all vaccine makers on the hook for compensating for vaccine injuries, without putting any one of them at excessive risk of being destroyed by litigation.

Benefits to plaintiffs

The NVICP is very favorable to plaintiffs. Among other benefits, they need only show that they have been injured and that they would not have been injured but for the vaccine. They don’t need to prove it beyond a shadow of a doubt, either, just show that the evidence makes it more likely than not. In fact, the Office of Special Masters maintains a table of injuries known to result from vaccines; if the plaintiff proves an injury on the table, that occurred within a specified amount of time after the vaccination, causation is presumed. That is enormously more favorable to plaintiffs than the rules in place in normal courts.

Plaintiffs also don’t have to jump through the hoops it takes to introduce scientific evidence in normal court—the Special Masters give them tremendous leeway in showing causation. (But not total leeway. Plaintiffs must still show a medical theory supporting the injury, and the NVICP determined in 2010 that the evidence was overwhelmingly against the hypothesis that vaccines containing thimerosal caused autism.)

How much of a benefit is this to plaintiffs? Dorit Rubenstein Reiss, a law professor at UC Hastings, wrote an excellent piece discussing a recent briefing anti-vaxers put on in anticipation of the now-canceled hearing. In it, she calculated that NVICP plaintiffs win approximately 26% of the time—substantially more than product liability plaintiffs in traditional courts (who win about 20% of the time).

Even the remaining 74% are benefiting. The NVICP pays for their lawyers even when they lose. In normal courts, plaintiffs who lose their case are still on the hook for their lawyers’ fees. Knowing this, lawyers are reluctant to take cases from plaintiffs who aren’t wealthy or who have borderline cases. Those plaintiffs benefit tremendously from the NVICP, since they might not ever get a day in court otherwise.

There are other benefits as well, such as the fact that the NVICP essentially sets up a strict-liability system. But as I’m not an expert in the court, it doesn’t make sense to try to break down every possible benefit. I think it’s enough, and plainly true, to say that the NVICP has been a tremendous boon to plaintiffs alleging they were injured by a vaccine.

So why kill it?

Professor Reiss raises a fascinating question—why are anti-vaxers trying to shut down the NVICP when it provides so many tremendous advantages to vaccine plaintiffs? She points out that really only two types of people would benefit: “plaintiffs who cannot prove causation and lawyers who would like more control of the fee structure.” Everyone else would get the short end of the stick.

The first category is the most interesting. The most visible plaintiffs who cannot prove causation are those who claim a vaccine caused their child’s autism. The NVICP is clearly on the side of science on that question, and acknowledges that the evidence does not support a link between vaccination and autism. If those plaintiffs could kill the NVICP and get back into normal trial courts, they would at least have a small chance of winning the lottery with a sympathetic judge and jury.

There are also the public figures and opinion leaders in the anti-vax camp, who are largely aligned on the autism issue. The NVICP is a convenient bogeyman for them, since it is the public-facing entity that is responsible for denying the claims of parents who believe vaccines caused their child’s autism. And the misguided autism warriors are the loudest voices in the anti-vaxer community. (The comments to Professor Reiss’s article bear witness to how misinformed and monomaniacal those voices can be.)

The interests of the vaccines-cause-autism brigade are diametrically opposed to those of people who suffer the real but rare side effects of vaccines. (Going by the NVICP’s numbers, about 3,500 compensable cases in over two decades, or less than two hundred out of the roughly 10 million childhood vaccines given each year). They are desperate to wring one last bit of life out of their dead, dry husk of a theory. Their gambit would cost people who have suffered actual harm from a vaccination their best chance at compensation.

It would also put vaccine manufacturers at renewed risk of being destroyed not by strong court cases—the most sensationalist anti-vax claims have long since been conclusively debunked—but by the costs of fighting those battles over and over again. Anti-vaxers are persistent and show no signs of updating their theories to match scientific evidence; they would certainly be in court tomorrow pushing their autism theories if they had the chance. This may be the ideal outcome for an interest group Professor Reiss did not mention: opinion leaders and public figures leading the anti-vax camp. But here, too, their goals would come at a terrible cost.

Colin McRoberts (@Kolyin) is a Texas attorney and consultant

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Jennifer Raff

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Scientist, fighter, reader. In pursuit of the extraordinary.

43 responses to Why anti-vaxers hate the NVICP (and just what is it, anyway?). –by Colin McRoberts

  1. 
    Charlotte Colvin November 22, 2013 at 6:06 pm

    Great post! Can I put it on my FB page (obviously with credit to you and the author?

    Sent from my iPhone

    >

  2. 

    Thank you, Mr. McRoberts, for this very clear explanation of the NVICP, and the harm caused by the anti-vax crowd. This article was otherwise so well written that I hesitate to mention this, but… I cringe a little every time I read something called a theory that is obviously not one (in a scientific sense). At best, the vaccines-cause-autism idea is a disproved hypothesis. At worst, it verges on unscientific quackery and woo.

  3. 

    “The NVICP is very favorable to plaintiffs. Among other benefits, they need only show that they have been injured and that they would not have been injured but for the vaccine. They don’t need to prove it beyond a shadow of a doubt, either, just show that the evidence makes it more likely than not.”

    That is what’s called the “standard of proof” or “burden of proof” and it is EXACTLY THE SAME as every other civil case. It is only criminal courts who require the higher standard of proof that it be beyond a reasonable doubt.

    The fact that you would try to pass this off as a benefit of the NVICP makes your entire article suspect. I know you tried to protect yourself by saying you’re not an expert in the court, but this is pretty egregious. You were clearly trying to mislead your reader, you should be ashamed.

    • 

      Thanks for your comment. You’re right that I confused the issue by trying to make a point with the “shadow of a doubt” standard, which would not apply in civil product liability cases. It’s not an attempt to mislead, just an oversimplification. (In particular I conflated the burden of proof with the standard of proof, which is a rookie mistake.) Similarly, you’ve oversimplified by claiming (wrongly) that the preponderance of evidence standard is the same in every civil case, and that the NVICP burdens of proof are the same as they would be in civil court. Neither is true, although the second one is the only one that really matters here.

      There are important distinctions between what an NVICP claimant has to prove and what they would have to prove as a plaintiff in normal courts without an NVICP. We can assume for now that they’d have to prove everything, in either court, by a preponderance of the evidence standard. But that’s not necessarily true in every state, and in every jurisdiction I’m familiar with they’d have to meet a higher standard if they wanted the kind of punitive damages anti-vaxers say they want.

      If the NVICP didn’t exist, plaintiffs would have launch a products liability suit in state or federal court. Even under “strict liability,” just about the laxest standard around, they’d have to prove causation in every case. I can’t begin to tell you how much of a pain in the ass that is. It’s enormously difficult and expensive, requiring very costly experts (sometimes teams of them) battling for months or even, in my personal experience, years. And even then plaintiffs aren’t done; adversarial defendants can raise affirmative defenses to win even if the tort plaintiff has proved causation. If the defense proved that a parent knew the relevant risks but got vaccinated anyway, for example, it could preclude recovery. (And none of this even touches the additional burdens of proof (and other complications, such as additional affirmative defenses) that would arise in a negligence jurisdiction. I don’t have enough products liability or pharma experience to know for sure whether such cases would arise under negligence standards, but I suspect it would vary from state to state.)

      But thanks to the NVICP, claimants not only get through their cases much (much, much, much) faster and more cheaply, they have a shallower hill to climb and thus recover much more often. Claimants only have to show causation if their injury isn’t on the table. (This is what the autism claimants failed to prove.) For table injuries, the claimants don’t need to prove causation! It’s presumed, under the statue. See Althen v HHS, 418 F.3d 1274, 1278 (Fed Cir 2004). Even off-table injuries are easier because there isn’t an adversarial defendant hammering away at every single case with affirmative defenses and delaying tactics.

      It’s true that I have no personal experience with the NVICP. But I have plenty with standard civil courts, and any rational plaintiff would kill to have the kinds of advantages NVICP claimants get. The deck isn’t stacked completely in their favor, but the argument that the NVICP isn’t favorable to plaintiffs is difficult to grasp given how many advantages they’re given.

      Why do you think otherwise? Why do you think I’m trying to mislead people, and what do you think the truth is?

  4. 

    Colin, thanks for your response. As a preface, I believe there are three sides to every story. When it comes to the VICP, it was created for three reasons, “The VICP was established to ensure an adequate supply of vaccines, stabilize vaccine costs, and establish and maintain an accessible and efficient forum for individuals found to be injured by certain vaccines.” So ultimately, it was created, as you alluded to in your article, to ensure that vaccines could be produced without the financial burden of civil litigation arising from product liability. It was never intended to protect individuals that were harmed by vaccines, it was intended to guarantee a supply of vaccines. In other words, it is for “the greater good”, not to protect individuals.

    More importantly, the compensation fund IS NOT paid for by vaccine manufacturers, it is paid for by an excise tax on the sale of vaccines. So the maker of the vaccine doesn’t pay for damages, I DO with every shot my kids get (I have four kids so I’ve contributed probably $100). They have absolutely NO RISK. (Btw, I think your explanation of this is misleading as well – you know full well that parents pay this tax, not the manufacturer).

    I think there are aspects to the VICP that make it beneficial, but I don’t believe it is as completely lopsided as you make it out to be. My suspicion is that those who want to do away with it probably want larger compensation (which they feel they could get at trial) or want the manufacturers to be held responsible. If the manufacturer was held responsible, it may make them more careful about the adverse reactions of their vaccines.

    I’m not sure why you would try to mislead someone, but it’s pretty clear that you did. Anyone with that much legal experience would not make such a basic slip up. I am not an attorney, but a few basic legal classes in college covered these topics thoroughly. And your explanation of how the compensation fund is handled makes it look like all the vaccine manufacturers are chipping in to pay claims. That’s bull; do you think that oil companies pay the excise tax on gasoline, or that you and I do?

    As it stands now, vaccine manufacturers have no liability and no risk – so they seem to have the most to gain by the system staying the same.

    In the end, the old saying “follow the money” is probably the most direct path to the truth.

    • 

      Michael, you seem to be looking for simple answers. That’s understandable, especially if you lack the facts necessary to really understand the question, which seems to be the case here given your confusion about excise taxes and how litigation works. But there’s such a thing as oversimplification. The NVICP was absolutely intended to compensate and protect people. If the only intent was to protect pharma, there would be much more efficient ways to do it. The government could have simply foreclosed vaccine litigation completely, either directly or indirectly (such as by imposing a six-month statute of limitations or setting a very low liability cap). Instead they set up a huge compensatory program that pays money to claimants. They do that because they *want* to pay money to claimants, to compensate them for vaccine injuries. The Act also

      As for the incentives, I think I understand your point—since the manufacturers aren’t paying the damages, you suggest, they have less inventive to worry about the safety of their goods. But first let’s correct a common misconception. The NVICP doesn’t prevent everyone from suing in normal state courts. There are three types of product liability: defective design, defective manufacturing, and failure to warn. The NVICP only preempts the first type of suit. If the claim is that the vaccine was improperly manufactured, or that the manufacturer failed to warn users of avoidable dangers, then the plaintiff can reject the NVICP’s ruling and proceed in state court. (Or possibly in federal district court, but I’m not sure about that.) At most, therefore, the NVICP reduces the litigation liability of vaccine manufacturers—it doesn’t eliminate it. In other words, they are still at risk.

      And litigation liability isn’t the only, or even the greatest, incentive to maximize safety. You can’t sue the post office for losing a package, for example, and yet they (like vaccine makers) have lots of incentives to not create harm. For vaccine makers, they need to demonstrate safety and efficacy to get approval, convince doctors to actually administer vaccines, and prevent a competitor from making a safer product and stealing market share. We can even test to see whether these incentives are sufficient by looking at the safety record of vaccines. The NVICP bends over backwards to make it easy for people to file compensation claims, yet out of the millions of vaccines given every year in the U.S. there are typically less than a thousand NVICP claims filed. (Even fewer of those succeed, even though the NVICP doesn’t require proof of compensation for table injuries so almost certainly pays on some margin of claims where the injuries weren’t actually caused by a vaccine.) That’s a safe product.

      You say that “anyone with that much legal experience would not make such a basic slip up,” but I’m not sure what you mean. Nothing in the paragraph you referenced is inaccurate. Referencing the “beyond a shadow of a doubt” standard was sloppy on my part, but the statement is true and not misleading. NVICP claimants are at an advantage over normal trial court plaintiffs, especially (but not only) if they have a table injury. While they operate under the preponderance of the evidence standard like most trial court plaintiffs, they have less to prove. They also face much less adversarial pressure and get free counsel. I’d certainly rather be in that system than state court, no matter what my claim.

      As for your contention that I mislead people by not telling people that “parents pay this tax, not the manufacturer,” you are oversimplifying again. I’m not sure you understand how the excise tax works. The government collects it from the manufacturer. The manufacturer can raise the product’s price somewhat to compensate, but they can only recover 100% of the tax from the consumer if demand is perfectly inelastic. That is obviously not the case with vaccines, where consumption rises and falls. Low profit margins are also a sign of elastic demand, and while I don’t know of any studies I suspect vaccine manufacturers eat a significant portion of the tax. I will do you the common courtesy you lack and assume that you aren’t trying to mislead people.

  5. 

    Wow Colin, that’s a lot to respond to. To the extent that I am over simplifying, I would argue that you are taking things to literally. For example, I didn’t intend to imply that protection of the vaccine manufacturers was the ONLY reason for the NVICP. But I do believe that the threat of pharma not supplying vaccines was the MAIN reason, and compensation was a political bone thrown to the public. They couldn’t just completely hold manufacturers harmless, after all.

    Or could they?

    This is from a 2011 article in the Christian Science Monitor about the Supreme Court verdict at that time (http://www.csmonitor.com/USA/Justice/2011/0222/Parents-can-t-sue-drug-firms-when-vaccines-cause-harm-Supreme-Court-says):

    “But compensation is only part of the Vaccine Injury Act’s purpose. Congress also sought to preempt lawsuits seeking open-ended money damages against vaccine manufacturers.

    The problem with the law is that Congress did not specifically spell out which lawsuits may move forward in the courts against vaccinemakers and which must be dismissed.

    The law says in part that no vaccine manufacturer shall be held liable for a vaccine-related injury or death “if the injury or death resulted from side effects that were unavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warnings.”

    End Quote

    So even if unintentional, the vaccine manufacturers have gotten quite a bit, if not entire, immunity from liability.

    As for their incentive to improve their products, how about this:

    According to Justice Sotomayor: “Manufacturers, given the lack of robust competition in the vaccine market, will often have little or no incentive to improve the designs of vaccines that are already generating significant profit margins,” Sotomayor wrote. “Nothing in the text, structure, or legislative history remotely suggests that Congress intended that result.”

    So while you may argue that it is not “literally” true, “the effect” of the National Childhood Vaccine Injury Act of 1986 is that it removes liability and the incentive to make safer drugs. I’m not an attorney, but I can clearly figure that out from actual events.

    I don’t have time to respond to everything now, so I’ll check back in later.

    • 

      The case that article refers to is Bruesewitz, which I discussed a bit above. Essentially the Court held that the Act preempts some suits against vaccine makers (those that go to the NVICP instead), but did not foreclose defective manufacturing or failure-to-warn cases.

      “Immunity from liability” is not some bizarre or unprecedented thing. Lots of institutions are immune from liability, de jure or de facto. Earlier I used the example of the post office, which is immune from litigation liability for (inter alia) losing packages. And yet, their track record for package delivery is pretty good. The threat of liability would be one incentive to achieve that record, but what matters is the record itself, not whether every possible incentive is in place. (I can’t think of any situation in which every possible incentive is in place.)

      Similarly, vaccines have a very impressive safety record. The removal of one type of possible liability isn’t actually very significant when (a) the safety record is still exceptionally good, and (b) people who are harmed by vaccines–since they can’t ever be 100% safe–are compensated.

      I take Justice Sotomayor’s comments seriously, and there isn’t one unanimous right position on these questions. But I’m skeptical that vaccine makers have no incentive to make better products–that ignores commercial realities–and see no truth whatsoever to the bizarre pretense that the NVICP somehow victimizes the claimants who benefit from its plaintiff-friendly structure.

  6. 

    for real. they have the all seeing eye in their logo… very trustworthy

    • 

      FYI, that’s not the logo of the NVICP. It’s the symbol of the Court of Federal Claims, which has heard money-damages claims against the federal government for the past 150+ years. The vaccine court is a group of “Special Masters” who are appointed by the CFC, and cases heard in vaccine court can be appealed to the CFC.

      So if you’re looking for some juicy freemason-style occult conspiracy, you can imagine robed Special Masters drinking plaintiffs’ blood from jeweled goblets under the all-seeing eye. If you must.

  7. 

    This is inaccurate. What about the fact that NVIPC is set up in favor of vaccine makers and that it is illegal to sue those vaccine companies on your own? NVIPC is made to look like it’s set up for protection, but it really is there to protect big pharma. Sad.

    • 

      Why should we believe you over what was written by a lawyer? Especially when you did not even use the correct sequence of letters, NVICP?

      To forward you argument that it is only to protect “big pharma”, can you give us the economic breakdown that compares letting every child in the USA suffer from measles versus providing each child two MMR doses. You can use Economic Evaluation of the Routine Childhood Immunization Program in the United States, 2009 as a guideline.

    • 

      Those aren’t what most people would consider “facts.” The NVICP is set up in favor of parents, and gives them (as explained in detail above) a better pathway to recovery than normal civil courts.

      Nor is it true that “it is illegal to sue those vaccine companies on your own.” The Act requires that people who want to sue under a “defective design” theory go through the NVICP. (There are two other types of products liability suit that aren’t affected–parents can still file those, as far as I’m aware.)

      And even those parents who go through the NVICP can still go to normal court. There are a couple of paths to that. They can appeal the ruling of the special masters to the Court of Claims. That’s an appellate court, not a trial court. If they want to go to trial, they can simply refuse to accept the judgment of the program and file civil suit anyway. See 42 USC 300aa-21, or section IX, chapter 3 of the Guidelines for Practice Under the NVICP.

      If there is some reason why those civil claims can’t be filed, I don’t know it. I’d love for you to explain why it’s an insufficient remedy; it seems to me like NVICP plaintiffs get the best of both worlds. They get to try for compensation in the Program, where they get free lawyers and lower hurdles to clear. And if they don’t like the result, they can refuse to accept it and file a civil lawsuit. Is that not true?

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    […] They say that the Vaccine Adverse Events Reporting System (and/or the “vaccine court”) proves that vaccines are harmful. It doesn’t. […]

  26. Jennifer RAFF: “Drodzy rodzice, jesteście okłamywani. Prawda o szczepionkach” | Wszystko co najważniejsze - October 24, 2014

    […] Podobno VAERS (Vaccine Adverse Events Reporting System – „trybunał szczepionkowy”) ma dowody na szkodliwość szczepień. Nie ma. […]

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