The Supreme Court rules on Bruesewitz v. Wyeth and vaccine injury cases

Hard as it is to believe, it’s been nearly a year since I first learned that the Supreme Court agreed to hear a case regarding the legitimacy of the vaccine court. The long version can be found here, but the short version is that last March SCOTUS agreed to hear a case regarding the constitutionality of the law that set up the Vaccine Court back in the 1980s. As you might recall, the National Childhood Vaccine Injury Act was passed in 1986 in order to establish a no-fault compensation system for children who suffer vaccine injury. The NCVIA was necessary because a flood of lawsuits in the wake of a muck-raking, sensationalistic, and, in retrospect, totally inaccurate TV special, Vaccine Roulette, had fired up a fear mongering campaign about the DTP (diptheria-pertussis-tetanus) vaccine to the point where there was a very real danger of pharmaceutical companies in the U.S. giving up on vaccines altogether. The liability had become just too high. Several large jury awards convinced pharmaceutical companies that the risk of producing vaccines was just too high relative to the potential profit.

Due to the fear that litigation might well drive vaccine manufacturers either out of business or leave them no choice but to stop up manufacturing vaccines due to liability concerns, Congress was forced to act. It should be remembered, 25 years later, that these fears were not unfounded. All but one DPT manufacturer stopped manufacturing the vaccine, and the last one was threatening to do so at the time the NCVIA was passed. As I mentioned above, this law established a no fault compensation system for children injured by vaccines. To administer the compensation, the NCVIA established what is now known as the Vaccine Court, administered by the Office of Special Masters in the U.S. Court of Federal Claims. Claims against vaccine manufacturers for vaccine injury can’t be initially filed in state or federal court; they must first go through the Office of Special Masters, where special judges known as Special Masters adjudicate the claims. As a result, the bleeding stopped; the vaccine supply was safeguarded; and parents of children with legitimate injuries caused by vaccines can be compensated fairly rapidly. Indeed, it’s likely that many children who did not have a true vaccine injury were also compensated. This is because the Vaccine Court uses looser rules of evidence and not requiring the Daubert standard for scientific testimony and evidence. Also, there is a list of “table injuries” that are assumed, for all intents and purposes, automatically to be due to vaccines, which is why compensation is more or less automatic for table injuries. Compensation covers medical expenses, legal expenses loss of future earning capacity, and others. Even for unsuccessful claims, legal expenses are often covered. Moreover, claimants can sue in federal court after losing in Vaccine Court. The problem with doing so, however, is that the standard of evidence is more stringent in federal court, and, having lost in Vaccine Court is a very high bar for plaintiffs to overcome. Still, that hasn’t stopped plaintiffs from trying, particularly given that damages for pain and suffering are capped in Vaccine Court.

Then, in March 2010, SCOTUS agreed to hear Bruesewitz v. Wyeth. The case involves Hannah Bruesewitz, who was born in 1991. Hannah received the first three shots of DPT, and after the third injection developed seizures. The parents presented a claim in Vaccine Court, but lost. As a consequence, they decided to sue in Pennsylvania state court for what they argued was a preventable injury due to a “design defect” in the vaccine. Even though the federal Third Circuit Court of Appeals ruled for the vaccine manufacturer in the case, concluding that the legislative history of the NCVIA indicated a clear intent by Congress to preclude suing for claims of preventable injuries due to poor design, the case went to the Supreme Court because vaccine manufacturers and the Obama Administration requested it for clarity. They wanted a ruling once and for all whether the NCVIA preempted lawsuits based on design defect claims in state courts, given that clearly trial lawyers were now trying to bypass the Vaccine Court using such arguments. The case basically boiled down to three questions:

  • whether the Act preempts all design defect claims against the manufacturer of a vaccine
  • whether the plaintiffs demonstrated that the manufacturer failed to adequately warn the plaintiffs of the risks associated with the vaccine
  • whether the plaintiffs provided sufficient evidence of a manufacturing defect to survive the defendant’s motion for summary judgme

At the time, I was a bit worried, viewing such a request as a risky move. In retrospect, I needn’t have worried, as SCOTUS ruled 6-2 against the plaintiffs:

The justices, voting 6-2, said a 1986 federal law preempts claims that a drugmaker should have sold a safer formulation of a vaccine. The law, designed to encourage vaccine production by limiting patient suits, channels most complaints into a company- financed no-fault system that offers limited but guaranteed payments for injuries shown to be caused by a product.

“The vaccine manufacturers fund from their sales an informal, efficient compensation program for vaccine injuries,” Justice Antonin Scalia wrote for the majority. “In exchange they avoid costly tort litigation and the occasional disproportionate jury verdict.”

The ruling is a victory for the four companies that supply vaccines for the U.S. market — Wyeth, GlaxoSmithKline Plc, Merck & Co. and Sanofi-Aventis SA. A ruling letting the parents sue Wyeth might have allowed suits by thousands of families that say vaccines caused autism in their children. Since 1988, the no-fault process has led to almost $2 billion in compensation to more than 2,500 families.

The issue for the Supreme Court was whether the 1986 law leaves open the possibility that patients can sue manufacturers when the side effects were avoidable. The Obama administration joined Wyeth, acquired in 2009 by New York-based Pfizer, in urging the justices to bar those types of suits.

Courtesy of our “friends” at the anti-vaccine crank blog Age of Autism, you can find the full text of the SCOTUS decision here.Justice Scalia wrote the decision, and Justice Breyer submitted a concurring statement, while Justice Sotomayor wrote the dissent. Basically, it’s a resounding victory for the NCVIA and the Vaccine Court. I will admit to being somewhat concerned about how this case was argued, though. Everything seemed to hinge on whether or not the Vaccine Act (i.e., the NCVIA) completely preempts design defect claims in which it is argued that a vaccine manufacturer could have formulated a safer version of a vaccine. The relevant portion of the NCVIA states:

[n]o vaccine manufacturer shall be liable in a civil action for damages arising from a vaccine-related injury or death associated with the administration of a vaccine after October 1, 1988, 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.

The case appears to have hinged upon what the intent of Congress was in writing the law, and SCOTUS concluded:

Design defects do not merit a single mention in the Act or in Food and Drug Administration regulations that pervasively regulate the drug manufacturing process. This lack of guidance for design defects, combined with the extensive guidance for the two liability grounds specifically mentioned in the Act, strongly suggests that design defects were not mentioned because they are not a basis for liability. The Act’s mandates lead to the same conclusion. It provides for federal agency improvement of vaccine design and for federally prescribed compensation,which are other means for achieving the two beneficial effects of design-defect torts–prompting the development of improved designs, and providing compensation for inflicted injuries.

In other words, the Vaccine Act excluded design defects by intent. At least that’s how SCOTUS interpreted it. If design defects are to be an exception, Congress will have to amend the law or pass a new law.

Does this mean that there is no recourse for parents who have evidence that their child was injured by vaccines? Certainly, the anti-vaccine movement seems to think so, but, as usual, they go way over the top. For example, right on cue, Louise Kuo Habakus cranked up the fear mongering to 11 in a quote cited in a post over at the anti-vaccine crank blog Age of Autism entitled Court Protects Vaccine Manufacturers, Not Injured Children:

According to vaccine safety advocate Louise Kuo Habakus, “The Court is telling parents that they’re on their own. Parents know that 4 out of 5 cases of vaccine injury do not get compensation in the misnamed Vaccine Injury Compensation Program. The Supreme Court has slammed the courthouse doors shut.” Because the federal government recommends 70 doses of 16 “unavoidably unsafe” vaccines, and states compel 30-45 doses for school attendance, this issue affects all children.

This is, of course, a load of fetid dingos’ kidneys. Not only do parents who think their children have been injured by a vaccine have recourse to the Vaccine Court, where, win or lose, their attorneys’ fees are paid by the government. Then, if they fail in Vaccine Court, they still have recourse to federal courts. Habakus is also parrotting the same anti-vaccine exaggerations, with “70 doses.” What happened to the usual nonsense about “36 vaccines”? Apparently that number isn’t big enough to be as frightening as Habakus wants. In any case, the courthouse doors are in no way “slammed shut.” The Vaccine Court exists. It is intentionally set up to make pursuing claims easier than in state or other federal courts, and the standard of evidence for what scientific evidence may be presented in Vaccine Court is looser than it is in other federal courts. Moreover, there still exists a list of known and possible vaccine injuries for which compensation is virtually automatic. Finally, even if the Vaccine Court denies a claim, as I’ve pointed out, there are still federal courts. The law only mandates that claims for vaccine injury have to go through the Vaccine Court first. Moreover, ask this question: The Vaccine Act states that claimants have to go through the Vaccine Court if “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.” What if the vaccine was not “properly prepared”? What if it was not accompanied by “proper directions and warnings”? Presumably, if that were the case, parents could still bypass the Vaccine Court and sue directly in state or federal court.

Despite their resounding defeat, the anti-vaccine movement can still find a crumb to console itself with in the dissent written by Justice Sonia Sotomayor, which seems to buy somewhat into some of the anti-vaccine arguments, accusing the majority of writing a “policy-driven,” rather than a law-driven, decision:

Respondent notes that there are some 5,000 petitions alleging a causal link between certain vaccines and autism spectrum disordersthat are currently pending in an omnibus proceeding in the Court of Federal Claims (Vaccine Court). Brief for Respondent 56-57. According to respondent, a ruling that §22(b)(1) does not pre-empt design defect claims could unleash a “crushing wave” of tort litigation that would bankrupt vaccine manufacturers and deplete vaccine supply. Id., at 28. This concern underlies many of the policy arguments inrespondent’s brief and appears to underlie the majority and concurring opinions in this case.

Actually, she has a point. The law is the law, and it shouldn’t matter how many people are suing based on the law. If the law is producing bad policy, then the law needs to be changed. Here’s where Justice Sotomayor goes off the rails:

Trial courts, moreover, have considerable experience in efficiently handling and disposing of meritless products liability claims, and decades of tort litigation (including for design defect) in the prescription-drug context have not led to shortages in prescription drugs.

What planet is she on? As Sullivan points out, the very reason that the NCVIA was passed and the Vaccine Court created was because of a–dare I say?–tsunami of lawsuits based on claims that the DPT caused neurological injury, claims that were not supported by later studies. The number of manufacturers of vaccines was declining precipitously, raising real fears that the U.S. vaccine system would collapse. Another example is the furor over silicone breast implants, which in the 1980s and 1990s were blamed for autoimmune diseases, cancer, and various other systemic diseases, claims that were later demonstrated by epidemiological studies to be without a scientific basis. The lawsuits based on these claims drove Dow Corning into bankruptcy. No, I’m afraid Justice Sotomayor borders on the delusional when she blithely proclaims that courts are so good at efficiently disposing of meritless product liability claims. Unfortunately, the converse is also true; the courts aren’t so good at efficiently compensating victims suing based on meritorious product liability claims, either.

Perhaps the paragraph in the majority opinion ruling that stands out the most is this one:

These provisions for federal agency improvement of vaccine design, and for federally prescribed compensation, once again suggest that §300aa-22(b)(1)’s silence regarding design defect liability was not inadvertent. It instead reflects a sensible choice to leave complex epidemiological judgments about vaccine design to the FDA and the National Vaccine Program rather than juries.

Imagine that! Leave the science to scientists, the FDA, and the National Vaccine Program, rather than the juries. What a radical concept! It’s a concept entirely lost on the anti-vaccine movement in general and Mike Adams in particular, who couldn’t wait to chime in either, this time in a typically histrionic screed entitled U.S. Supreme Court denies parents of vaccine damaged children their right to seek justice. One can’t help but chuckle and point out that the parents were so denied justice that they managed to take their case all the way to the Supreme Court of the United States. Here’s a hint, Mike: Just because a SCOTUS decision didn’t go your way doesn’t mean that justice was denied. That doesn’t stop Mike from making some truly disturbing statements, for example:

The vaccine industry is killing children. It is maiming them, destroying their nervous systems and causing permanent harm. These are acts of medical violence committed against children. Even the vaccine court admits this link through its own cash payouts to parents of damaged (or dead) children.

And yet, the U.S. government continues to endorse these acts of violence against children. It even goes so far as to excuse them by providing immunity to the corporations whose products harm these children.

It doesn’t take a genius to realize that this blanket immunity takes away any incentive of safety from the vaccine manufacturers. With no liability, what motivation do they have to improve the safety of their products? They have none. No wonder vaccines continue to be so dangerous, manufactured with mercury, aluminum and formaldehyde among other neurotoxic ingredients.

This entire situation is nothing less than extraordinary. The vaccine industry gets blanket immunity. The government denies parents their Constitutional right to due process. The children continue to be harmed and killed by vaccines, and yet the parents have no means by which they can seek justice.

While Adams has a germ of a point (namely that giving the industry too much immunity might remove incentives for improving vaccine safety), as usual, he takes it straight off the cliff into Crazy Ocean. Adams then goes on to proclaim the vaccine program as “state-sponsored terrorism against children,” after which he wonders what recourse parents now have. His answer is what is disturbing:

This is where acts of violence will no doubt enter the picture. Violence is the last, desperate option for those who have been denied all other options to resolve their grievances peacefully. When the courts, the government and the corporations have conspired against you to harm your children and then deny you any legal recourse, it is only a matter of time before some parent of a vaccine-damaged child decides to take matters into their own hands through acts of violence committed against those who damaged their children.

Do not misinterpret this as an endorse of such actions. NaturalNews has consistently and repeatedly decried the use of violence to resolve problems. Yet we cannot deny that in this legal / pharma / government conspiracy that causes children to be harmed while denying parents any legitimate legal recourse, it is inevitable that angry, disenfranchised parents will sooner or later reach a boiling point and decide to pursue justice in the only way left available to them.

Mike’s not advocating violence, you know, but he understands and is down with the anti-vaccine movement, so much so that he thinks there should be an “uprising” against what he calls the “vaccine state,” just like how the people of Egypt, Libya, and Iran took to the streets to protest tyranny.

Then, while decrying the possibility of violence, which, while claiming he opposes it, Adams spends a lot of time describing and labeling the “vaccine pushers” as having blood on their hands, he concludes:

When the People are suppressed, with their children are maimed by the state, when their rights are denied by the courts, and when they feel as if they have no options remaining to them, they will sooner or later take to the streets with sticks, or stones, or bullets. One way or another, they will seek the justice that has been denied them by the corrupt state, operating in a criminal conspiracy with the vaccine industry.

I pray for America. And I pray for the victims of the vaccine industry. I pray, but I do not dare hope, that this grave injustice can be resolved without eventual bloodshed committed by those who have been driven to desperation by a corrupt, criminally-operated system of medical violence against children.

I can’t help but note that Adams appears to use bold type in the same way that Internet cranks used to use all caps on Usenet. In any case, here’s a hint: We are a nation of laws. The law creating the Vaccine Court was passed constitutionally by our duly elected representative and signed by the President (who, at the time, was Ronald Reagan). SCOTUS has ruled on how the law should be interpreted. Don’t like it? Try to get it changed! Petition your lawmakers. Try to elect anti-vaccine lawmakers to Congress. Engage in democracy. But don’t use thinly veiled, disingenuously denied threats of violence. Besides, if the revolution were ever actually to come, my guess is that Adams would probably be hiding in his home in Arizona and not out there storming the barricades.

In the meantime, the anti-vaccine movement rolled the dice and lost. Big time.