Friday, December 13, 2013

Mandatory Flu Vaccination: In My House It's the Law

Today marks the last day of National Influenza Vaccination Week, and in keeping with my standard M.O., I've waited until the very last minute to talk about the influenza vaccine. (Luckily, this didn't extend to the vaccine--my kids were vaccinated in August and I got mine in early November).

Over at Shot of Prevention, Voices for Vaccines Parent Advisory Board member and leader of Nurses Who Vax, Melody Butler reminded readers what, exactly, is at stake when it comes to children and the flu. Last year, 169 children died from flu. "To put that number in perspective," Melody wrote, "that's more than six kindergarten classes." 

Opponents of vaccination would quickly point out that those deaths likely represent children who had an underlying condition or were immune-deficient, that most healthy children can fight the flu. The brutality--and the astounding ignorance--of such a statement is likely self-evident, but let's unpack it anyway.

First, those children with underlying conditions or who were immunocompromised are the very reason we should vaccinate our healthy children. By cocooning these kids who are battling illnesses, like cancer, we can reduce the chances that they will contract the flu, which, for them, can be extremely serious. 

Second, opponents of vaccination are caught in a double-bind--they aim to convince as many people as possible not to vaccinate their children, yet the health of their own unvaccinated children is utterly dependent on high vaccination rates. 

But what about the canard that the flu vaccine doesn't work? Is it perfect? Of course not. The nature of the flu itself makes a universal vaccine an exceptionally complex proposition (though it may be on the way). But if you could reduce your child's chances of suffering--and believe me, dealing with influenza comes with a great deal of suffering, whether you're a child or an adult--by any percentage point, even one, wouldn't you do so? Apparently, in some circles, the answer is no. And I find that hard to wrap my mind around. 

So here's my yearly plea: whether flu vaccine reduces your child's chance of getting the flu by 60% or 6%, it's worth the trip to the pediatrician's office, the local big box minute clinic, the local pharmacy, etc. 

And a last note: in my house, vaccinations are mandatory--and my kids are getting old enough now to understand why. Yes, they don't want to get sick, but what fills me with pride is that they care even more about keeping their friends and family healthy as well. They understand how vaccines function in this regard. They are not old enough to fully understand why parents might not vaccinate their children (frankly, I'm not either), but they have been told that these unvaccinated children are in need of protection as well, that these peers of theirs are, in a sense, immunocompromised themselves. Choosing vaccination because you care about your own health, as well as the health of the community, is a lesson in compassion and community all children should learn. 

Wednesday, December 4, 2013

In the Media, A Bad Day for Vaccines

By Karen Ernst

I write this at the end of a bad day in the media for vaccines. It’s not that there was bad news about vaccines; it’s that the good news was ignored in lieu of anti-vaccine misinformation. The most disappointing of these media stories occurred on Katie Couric’s daytime talk show, Katie.

For weeks, the Canary Party (a group of anti-vaxxers who have actually formed a political party based on being anti-vaccine) have been shopping around an anti-HPV vaccine video on the heels of the cancellation of Congressional Oversight Committee hearing they had so hoped for. Katie Couric and her producers, in a cynical attempt to buoy her dismal ratings, bit.

To say I am disappointed in Couric would be an understatement. Since losing her husband to colon cancer 15 years ago, Couric has championed cancer prevention through colonoscopies. That she would allow a ratings ploy to trump journalistic integrity on the subject of a vaccine that prevents tens of thousands of HPV-related cancers each year in the U. S. boggles the mind.

The segment began with Canary Party Executive Committee member Emily Tarsell describing the death of her daughter, Christina, eighteen days after she received the Gardasil vaccine. Truly, nothing is as traumatic and devastating as losing a child in the prime of her life. The need for answers is more than understandable, it is necessary; and I can even understand parents seeking answers in and holding fast to a theory that makes sense to them, even if the theory doesn’t hold up scientifically. I want to be absolutely clear that I do not blame those parents for this. Instead, I blame the anti-vaccine movement for exploiting their stories in order to support their own wrong-headed ideas about immunization.

But because she brought her daughter’s story to a large, public forum, it is fair to investigate it to see if Emily Tarsell’s account holds up to scrutiny. Many facts surrounding Christina’s death are unavailable because Emily Tarsell is seeking compensation from the National Vaccine Injury Compensation Program. However, this court order from the NVICP judge indicates that the story does not support the theory that Christina died from an HPV-vaccine reaction. In it, the judge notes that despite Emily’s recall of her daughter’s unusual fatigue, “there is no evidence suggesting that Christina was so tired (or fatigued) that her health affected her daily activities.  For example, none of [those] who observed Christina while she was in Maryland . . . asserts that she changed plans due to tiredness.”

In fact, the findings note that Christina seemed anything but fatigued: “While in New York, Christina worked her part-time job for 18.75 hours.  On Thursday, June 17, 2008, Christina stayed up until midnight or 1:00 A.M. having dinner with her apartment mates.  Her apartment mates did not tell the police officers investigating Christina’s death that she appeared unusually tired.  Her apartment mate’s recollections suggest that, to their knowledge, Christina was normal.” In this document, there is also evidence that Christina may have suffered from a preexisting heart condition, but there was never a definitive cause of death.

Next up on Katie, Couric handed the floor over to Dr. Diane Harper, who made a number of spurious claims about HPV vaccines. The first claim was that HPV vaccines only offer protection for five years. Initial studies, however, do not support Dr. Harper’s claim, some showing that an HPV vaccine can offer protection for at least 8.5 years. And we may find that the vaccine offers protection for much longer as more evidence rolls in.  

Dr. Harper also asserted that pap smears are sufficient in detecting pre-cancerous cells which, she claimed, are 100% curable. However, between 2004 and 2008, 26,000 HPV-related cancers were diagnosed each year in the United States. 11,500 of these cancers were cerivcal cancers. In 2010, nearly 12,000 women died from cervical cancer. Despite Dr. Harper’s optimistic view of cervical cancer screening, it is far from perfect, and it would be vastly better to prevent infection than to try to cure the results of it.

Dr. Harper’s subsequent instructions that parents weigh the benefits and the risks of the vaccine is only sage advice if parents are receiving accurate information about the benefits and risks. The benefits, of course, are preventing cancer and death. The risks, as Couric presented them, were completely out-of-whack. A study of nearly one million girls who had received HPV vaccines found no significant health risks involved.

And it only got worse.  After talking to Dr. Harper, Couric provided air time to yet another anti-vaccine leader--this time SaneVax director Rosemary Mathis. SaneVax has a history of promoting misinformation and particularly horrible science. Inviting Mathis as a guest on a show about vaccination is the equivalent of inviting my kindergarten-age son as an expert on Tokyo because of his interest in Godzilla.

But it couldn’t all be a big commercial for anti-vaccine propaganda could it?  There must be hope because this is Katie Couric, right? As somewhat of a reprieve, Dr. Mallika Marshall provided some wonderful and accurate information about HPV and its vaccine. And she was brilliant. She was followed by a mother-daughter pair who endorsed the HPV vaccine.

The segment ended with Dr. Harper encouraging parents to get their daughters gift certificates for pap smears for their 21st birthday and Dr. Marshall encouraging parents to vaccinate.

Couric may have considered this balanced coverage since she presented two sides about this vaccine. But you probably know that I’m not going to let her off the hook that easily.

In 1998, Andrew Wakefield hoodwinked journalists into reporting on a shiny new theory about vaccines causing autism. As you might remember, it was all a grand fraud from which Wakefield continues to profit. And the media helped him, even after studies were rolling in discrediting the theory that vaccines cause autism, the media continued to structure their news stories to create balance. On one side, a family that claimed their children became autistic because of vaccines. On the other side, people in lab coats saying this just could not be the case. The anecdote too often trumped the evidence, as often happens in cases of false balance. CJR’s Curtis Brainard discussed how these “subtly bad” media reports perpetuate myths about vaccines. These myths threaten us all.

Katie Couric’s television show threatened the lives of young girls and boys. Because their parents are being frightened away from a safe and important vaccine, there will be men and women in the future who will die from HPV-related cancers, and who could pass HPV on to unwitting partners. Today, Katie Couric gave the anti-vaccine movement a huge forum, and I am already mourning the lives that will be affected because of it.

The Costs of the Fight Against the HPV Vaccine

By Dorit Reiss

This post stems from an HPV thread on the Katie Couric show. When I joined it, was a series of heart-rending stories by parents about the harms they believe the HPV vaccines caused to their daughters. There’s not a lot you can say to stories like these that will not sound heartless and cruel. But, after reading some, I felt that I had to try and speak up. This decision resulted in me spending several hours a day, from the Wednesday before Thanksgiving and through the weekend, commenting and, especially, responding to comments.

The thread on the Katie website is still going strong. I concluded that rather than engaging further I should write a more systematic explanation of why we need to speak up and respond to the claims of harm made against this vaccine, however painful it might be to the parents commenting to hear someone say there is no evidence that the vaccine caused their daughters’ illnesses, and however unpleasant the discussion becomes. Because as real as the pain of these parents and daughters is, without objective evidence of causation, their belief that this vaccine is to blame does not justify rejecting it in the face of substantial scientific evidence supporting its safety.

Let’s start with the basics. The HPV vaccines prevent infection with several strains of a virus that, at worst, can cause cancer. The virus is responsible for nearly all the cervical cancers in the United States and for “90% of anal cancers, 40% of vulvar, vaginal, or penile cancers, and 12% of oral and pharyngeal cancers. (all data is available here.)

Most HPV infections clear up on their own. Infections can be detected and cancer prevented early with regular pap smears. But HPVis still responsible for tens of thousands of cancers a year and over three thousand deaths a year in the United States alone. Preventing those cancers and deaths seems like a good, important goal.

The vaccines were tested in clinical trials with over 30,000 women for over 7 years and found to have high rates of effectiveness and no serious problems. They cover strains responsible for a large percentage of those cancers. It has already reduced infections. You can find more in depth discussion of the HPV vaccines in a series of excellent posts by the Skeptical Raptor.

Why oppose something that can do so much good? Well, part of the opposition stems from religious objections having to do with a perceived connection between the vaccine and sex. But that was not what this battle was about.

Shortly after the vaccine came out, several parents of girls who suffered medical conditions or died claimed that the causes of their deaths or harm was the vaccine. The stories are both scary and heartrending. And as these stories became public, more parents heard them and started associating their daughters illnesses with the vaccine. I do not doubt the real suffering and distress of these families. My heart goes out to them. How can one not sympathize with a parent grieving because a 17-year-old girl is dead, or a teenager in constant pain? 

But feeling for hurting girls, and hurting families, does not mean that one uncritically accepts claims that the vaccine was the cause of their suffering. In fact, the causation claims behind these stories are often extremely problematic. Sometimes, even the temporal connection is weak (e.g. Gabi Swank developing symptoms weeks after the vaccine). The problem is that bad things happen to teenage girls regardless of the vaccine. They can suffer a variety of medical conditions, and sometimes, healthy teens do die. The question in each case like this is: do we have evidence that the vaccine caused the harm? And the answer in these cases is often no. These stories generally do not have medical evidence supporting the connection between the vaccine and the alleged harm. Nor do they suggest a plausible biological mechanism by which the vaccine could cause the harm.

Is there anything supporting them besides the parents belief in the harm? Well, a small number of studies looking at a tiny number of cases and conducted by anti-vaccine scientists supported the claims. Each of them when analyzed by scientists was found incredibly flawed. For example, this study by two anti-vaccine activists, looking at the deaths of two girls. This study, by a doctor, looking at one single case, ignoring other possible causes of the harm to the girl in question. Another study was addressed here.

In contrast, not only did the clinical trials – ongoing since at least 2001, covering tens of thousands of participants – not find serious risks, but two large studies addressing the question found none: A Kaiser study with almost 190,000 young women given 350,000 doses of the vaccine that compared harms in vaccinated women to the general rates in the population found no difference; and a Swedish study with hundreds of thousands young women comparing vaccinated and unvaccinated found similar rates.  Over forty million doses of the vaccine have been administered in the United States alone with no clear evidence of problems. Scientists’ best assessment is that the only side effect consistently connected with the vaccine is fainting on the day the vaccine is administered, and local reactions.  

This evidence paints a picture of a very safe vaccine. But the only way to make that point is to point out the weak evidence for the parents’ claims that the vaccine caused harm. This is bound to offend those parents: their belief in the evils of the vaccine is very strong, and they are may have difficulty considering that they may be wrong. In fact, they have been told in no uncertain terms that they are right. In the thread itself, they received support from anti-vaccine activists who rallied to their support, using the tried and true tactic of personal attacks on anyone speaking in support of the vaccine, accusing them of being heartless, shills, trolls, ignorant, Hitler, and so forth. I’m mentioning this as fair warning to parents who may want to jump in: this discussion is often conducted with high levels of vitriol (it’s even worse than French Revolution discussions; and people could be very passionate about the French Revolution).

Most pro-vaccine people do not enjoy dealing with vitriol or having their workplaces contacted, though I am sure there are some people who enjoy the conflict for conflict’s sake. And nobody that I know wants to hurt parents who have already been through so much with their suffering daughters, or who lost a child. But we are not going to stop speaking. And I think it is important for many of us to speak up about the HPV vaccines. It’s the same reason that you should speak up for vaccines generally, but let’s make it specific.

The grieving parents want us to accept their word that it was the vaccine that caused their daughters’ suffering. It is more than natural for them to look for a cause for their misfortune, and the vaccine is an easy target. But most of them have no medical evidence behind their belief the vaccine caused the harm. In some cases there are alternative explanations that their doctors pointed out. Explanations the parents, in their grief and pain, reject. The problem is that with these stories they want to convince other parents to reject the vaccine—that is, to choose not to protect their children against a virus that has been proven to cause cancer.

When that is what we are asked to do, a responsible parent not only can but should demand hard, credible data that the vaccine actually causes the alleged harm. Because there is a cost to not taking the vaccine. A cost in suffering and lives.
And there is no such hard evidence.

When it’s my child for whom I’m making the decision, rejecting a vaccine that can save him or her from needless suffering is a dereliction of duty. I owe my child the best protection available against dangers, health, and otherwise. There are too many things I can’t protect him against. But modern medicine offers a safe, effective prevention against some of the most dangerous types of HPV infections. My child deserves it.

There is a reason to speak up for the sake of these grieving parents, too: they do not deserve to feel guilty for vaccinating their children, or feel betrayed by the system, when the evidence does not indicate that the vaccine caused the illness. We should explain the evidence in the hope of reducing their guilt and anger. And hope some will listen.

Arguing for the safety of vaccines is worth the time and effort it takes, because it’s about our children, their health, and welfare. Vaccines protect them. They’re not perfect, and not 100% risk-free. No medicine is. But vaccines are remarkably effective and compared to pretty much every other drug we have, extremely safe.

So we need to keep asking, and pushing, and demanding. When a parent says the HPV vaccine harmed her child, we must ask for evidence that the harm came from the vaccine. Especially when the story is followed by a warning not to get the vaccine for your child. If someone asks you to leave your child unprotected against a dangerous virus that is completely preventable, tell him or her "I'm sorry, but I can’t make such a choice based on your belief, scientifically unsupported, that the vaccine hurt your child."

For my children’s best interests, I need to follow the data. I don’t want my child to become a cancer statistic.

Dorit Reiss is a professor of law at University of California. She has published writings on administrative law, and recently wrote "Compensating the Victims of Failure to Vaccinate: What are the Options?" Dorit is a member of Voices for Vaccines' Parent Advisory Board.

Wednesday, November 13, 2013

We Need You Today: Speak Up Against Anti-Vaccine Activists Trying to Dismantle VICP

The voices of pro-vaccine advocates need to be heard today!  

Anti-vaccine groups have convinced the Congressional Oversight Committee to hold a hearing about the Vaccine Injury Compensation Program.  Their intent in pressing for this hearing is to dismantle the program in hopes that they can revive arguments about vaccines that science has already thoroughly disproven. Despite the clear science that vaccines do not cause autism, chronic disease, allergies, ADHD, etc., the anti-vaccine movement wants to use politics and the court system to support their unsupportable claims.  

Dismantling VICP and holding public hearings poses a real threat to our children who are currently protected from such scourges as measles, polio, and other vaccine-preventable diseases. First, the VICP insures that vaccine manufacturers are not inundated with lawsuits so that they are able to afford continued production of our vaccines. The hearing also serves as a very public platform for anti-vaccine activists to receive new publicity on their old and debunked message.

The Vaccine Injury Compensation Program (VICP) benefits the children who suffer very rare adverse reactions.  These reactions are sometimes so rare that it is difficult to prove that vaccines caused the reaction. However, the benefit of the VICP to these parents is that the burden of proof there is far lower than it would be in small claims court. In fact, they are far more likely to receive compensation through "Vaccine Court" than they would anywhere else. Thus, the VICP benefits not only the health of our communities but also the children who may have suffered a serious side effect from a vaccine. The anti-vaccine movement is angry because autism is not included among the reactions for which the court will compensate parents. The Autism Omnibus proceedings found that vaccines cannot be held liable for autism.

Today, we need you to write the representatives on this committee who serve [STATE]. We recommend sending you either email or fax their offices. If you are short on time, a phone call may also be useful.  

In the letter, voice your own opinions on vaccines.  A few points to consider including:

  • That you are a resident of [STATE].  If you are also a constituent, say so.
  • The story about why vaccines are important to you and how your family and community are positively improved by immunization. Be as personal and detailed as you like.
  • Support for the Vaccine Injury Compensation Program, which both insures a steady supply of vaccines for our children while fairly compensating those who experienced a serious side effect from a vaccination
  • An understanding that vaccines do not cause autism or most of the other health problems claimed by the anti-vaccine movement
  • A request that the hearing include an expert in the Autism Omnibus Proceedings (why they were fair and balanced); an expert on how the NVICP actually works; and an expert on torts and product liability litigation (to talk about how the vaccine-injured would be worse off in a non-NVICP world).

If you are interested, you can read more about the VICP here and here. More about the upcoming hearings can be found here and here. If you'd like background on the Autism Omnibus Proceedings, you can find that here.

Please pass along this request to your friends, family members, and co-workers by linking to this post, copying and pasting it (or your letter) on social media, and blogging about it. The more pro-vaccine advocates we have writing to their representatives, the better off we will be.

A full listing of the committee members with their contact and biographical information is available here:

Sunday, November 10, 2013

Science Illiteracy in the Daily Paper

As a former journalist, I find myself embarrassed by my profession more and more these days--and more and more grateful for the handful of news outlets that still adhere to journalistic ethics and a true understanding of "balance" in the discipline.

Today, November 10th, 2013, the Concord (NH) Monitor-News chose to accept an advertisement (and payment) from National Vaccine Information Center, the most notorious anti-vaccine group in the country, to run this embarrassment.

If you don't know why it's an embarrassment, that's okay--the unfortunate reality is that most people wouldn't, and that's what makes it so insidious. The whole "the flu shot gave me the flu" canard is pretty well entrenched in this country.

The flu shot does not give you the flu. It can't. It's physically impossible. Why? Because flu vaccines administered by needle are made with inactivated flu viruses (not infectious--dead) or no flu vaccine virus at all, which is how recombinant influenza vaccines are made.

That's what makes this advertisement from NVIC so laughable. It's like saying that the earth is warming because the American Girl Company is retiring "Molly, 1944." It's actually not laughable. It's maddening. It's maddening because I'm of the opinion that NVIC actually knows this is inaccurate information, but knows that it builds on an existing misconception that can bloom, for them, into general distrust of vaccines: their end-goal.

But I'm truly sickened by the editorial standards at the Concord Monitor-News. That it would allow such bald scientific illiteracy into their pages speaks volumes about the paper's approach to truth. And for a journalistic outlet, that is shameful. I've made my opinion known via Twitter this evening, and plan on following up with a letter tomorrow. I recommend you do the same. The Concord Monitor-News' Twitter handle is @ConMonitorNews.

If you'd like more information on the flu vaccine, check out the CDC's primer on the vaccine.

If you'd like to know why it's so crucial for children, in particular, to get the flu vaccine, check out this story in USA Today.

NOTE: I just noticed that an ad is playing on this site. I have no idea why and am working to sort it out. I apologize for this.

Wednesday, November 6, 2013

Speak Out Against Legislative Hearing on Vaccine Injury Compensation Program

Editor’s Note: Anti-vaccine organization Age of Autism has been working overtime to dismantle the federal government’s Vaccine Injury Compensation Program because they are frustrated that claims of vaccine injury in the form of autism have not been found valid by that program. Instead, they want to try to sue by taking their “case” to small claims court, where they can attempt to convince a jury of peers (read: most likely individuals not trained in science or medicine) that vaccines caused their child’s autism. They have been pressuring legislators to support their goals and have instructed members to contact their local representatives about this matter. They have succeeded in getting a hearing in the U.S. House of Representatives.

We’d like for parents and providers to speak out against this by writing e-mails to their state representatives today. Below is an example written by one parent to her local state representative. You can find your representatives here. To be effective, your note or phone call should be made today or tomorrow (11/6 and 11/7). Please note that Age of Autism has asked its members to call legislators today to urge them to attend this meeting, in which parents of children with autism will be testifying about how they believe their children received autism from a vaccine--a claim that has been proven, again and again, to be without merit.

Dear [Legislator]:
The anti-vaccine group Age of Autism intends to hold a hearing tomorrow about the Vaccine Injury Compensation Program.  Their intent is to dismantle the program so that they can bring their case to small claims court in hopes that a jury will find for them what science has already thoroughly disproven.  Despite the clear science that vaccines do not cause autism, chronic disease, allergies, ADHD, etc., it's always possible that a jury not savvy in the science would give out an award, which would threaten our immunization program.  Of course, this poses a real threat to our children who are currently protected from such scourges as measles, polio, and the like.
The Vaccine Injury Compensation Program benefits the children who, because of very rare bad luck, suffer an adverse reaction from vaccines.  These reactions are sometimes so rare that it is difficult to prove that vaccines caused the reaction. However, the benefit of the VICP to them is that the burden of proof there is far lower than it would be in small claims court. They are far more likely to receive compensation through "Vaccine Court" than they would be anywhere else.  Thus, the VICP benefits not only the health of our communities but also the children who may have been injured by a vaccine. 
A University of California-Hastings Law Professor writes on these issues in far more depth than I can cover here.  If you are interested, you can read more about the VICP here: [].  And you can read more about the term "unavoidably unsafe," which is often misused, here: [].
Thank you so much for your time.

[Your Name and City]

Sunday, November 3, 2013

Vaccines and "Unavoidably Unsafe Products"

By Dorit Reiss

Those of us engaged in vaccine-related discussions online often hear vaccine critics claim the Supreme Court has declared vaccines “unavoidably unsafe” and thus incredibly dangerous. The critics are doubly wrong. First, the Supreme Court has said no such thing. Second, in the law’s eyes, an unavoidably unsafe product is not a “super-dangerous” product.  Quite the opposite, an unavoidably unsafe product is a product whose tremendous benefits justify the reasonable risks it poses.

What is an "unavoidably unsafe” product?

Normally, in the United States, a person only has to pay damages if they caused harm to someone else with fault—in other words, if they acted negligently or intentionally. In the area of products liability, however, the United States adopted a different approach.

In 1965 the American Law Institute published the Restatement (Second) of the Law of Torts, §402A. Section 402A was an attempt by the ALI – a nonprofit organization of lawyers, judges and academics - to rationalize a growing number of court decisions holding manufacturers and sellers of defective products liable to the consumers their defective products injure.  It adopted a standard of liability without fault when a business sells a product “in a defective condition unreasonably dangerous to the user or consumer or to his property.”

The qualification was important: not every product that causes harm is defective.  Well-made knives can cut fingers, and even the best whiskey can get you drunk!   To be defective, a product had to be unreasonably dangerous, either because it was poorly made, or because consumers weren’t aware of its dangers, or because a different design could have made the product safer.

Restatements are very influential (though not binding), and section 402A was quickly adopted by pretty much every state.

The Restatement’s drafters wanted to provide certain products with additional protection against liability, because although those products, too, carried risks, they provided especially high benefits.  The Restatement’s drafters expressed this idea in a comment to section 402A; namely, comment k:

Unavoidably unsafe products: There are some products which, in the present state of human knowledge, are quite incapable of being made safe for their intended and ordinary use. These are especially common in the field of drugs. An outstanding example is the vaccine for the Pasteur treatment of rabies, which not uncommonly leads to very serious and damaging consequences when it is injected. Since the disease itself invariably leads to a dreadful death, both the marketing and the use of the vaccine are fully justified, notwithstanding the unavoidable high degree of risk which they involve. Such a product, properly prepared, and accompanied by proper directions and warning, is not defective, nor is it unreasonably dangerous.

The last sentence is the important one: A vaccine whose benefits outweigh its risks is not unreasonably dangerous or defective – even if the risks are as frightening as those attributed to the Pasteur vaccine, let alone modern vaccines, with their much lower risks.

In retrospect, the Restatement’s drafters could have chosen better language to capture the idea that a product or a drug can be valuable even it if poses some risk to its users (and indeed, the drafters of the Restatement (Third) of Torts: Product Liability did away with the “unavoidably unsafe” language while preserving the same idea:   

Saying a product is “unavoidably unsafe” makes it sound like the product is a bad one, when what the drafters meant was precisely the opposite: the comment was meant to apply only to ethical drugs or vaccines, i.e. where the benefits outweigh the risks.  But courts understood.  Some courts (California, New York, Alabama) adopted comment k wholeheartedly, exempting all properly manufactured prescription drugs and vaccines from strict liability.  Others applied comment k selectively, requiring a case-by-case determination that there is no safer alternative design for a drug or vaccine before finding the risk unavoidable (Idaho, Colorado, Hawaii).  Some courts, inevitably, are unclear or take an intermediate position (Florida, Georgia, Indiana). 

The message comes through clearly: these products are beneficial enough that society wants to encourage their manufacturing. Therefore, while strict liability would be applied to most products, a manufacturer that prepared a drug or vaccine carefully and warned consumers of its risks should not have to pay for the side effects of a drug or vaccine whose benefits outweigh the risks unless that manufacturer can be shown to have been negligent.

In other words,  “unavoidably unsafe” is the opposite of “unreasonably dangerous” in the Restatement’s categorization. It justifies a more favorable treatment because of those products’ extraordinary benefits.

What Did the Supreme Court say in Bruesewitz?

Regardless of the real meaning of the term “unavoidably unsafe,” it is understandably disturbing to parents to hear that the Supreme Court described the vaccines given to their children using that scary term. Fortunately, it didn’t.

In a case from 2011, Bruesewitz v. Wyeth , the Supreme Court discussed whether the National Childhood Vaccine Injury Act of 1986 (NCVIA) preempts tort suits for product design defects at the state level. The NCVIA created an administrative compensation scheme, in many ways quicker and easier than a court procedure. The question was whether a plaintiff who claims that she was injured because the vaccine was designed in an unsafe manner is limited only to the special compensation scheme, or can also sue in state courts (specifically, plaintiff claimed that she should have been given the shot with the acellular pertussis vaccine, rather than the whole cell pertussis vaccine).

While section 402A of the Restatement (Second) Torts did not distinguish between types of defects directly, today’s product liability jurisprudence distinguishes between three types of defects a product might have. Manufacturing defects are situations where the product is not up to the standard set by the manufacturer itself: when it deviates from its intended design. In the vaccine content, an example is the infamous Cutter Incident, in which a polio vaccine supposed to contain an inactivated virus ended up containing a live virus, paralyzing 200 children and killing ten. The product was designed to have an inactivated virus; it had a live one; the manufacturer did not meet its own standards. For manufacturing defects, the courts apply strict liability.

Another type of defects is a design defect. Under this theory, a plaintiff must prove that there is an alternative design that is safer than the current design. In the vaccine context, plaintiff may claim that using the Oral Polio Vaccine (OPV) that includes a live virus and carries a small risk of paralysis is less safe than using the Inactivated Polio Vaccine (IPV) which does not carry that risk. To make a long story short, while some courts still talk about strict liability when handling these kinds of suits, they are currently handled under negligence principles.

The last type of defects is a warning defect, also handled under negligence principles. A warning defect, for example, would be not warning that a product needs to be stored in a certain temperature, or not warning against a risk.

The NCVIA clearly allows children injured by a vaccine to sue the manufacturer in the regular courts if the vaccine was poorly made or lacked appropriate warnings.  Does it also allow children to sue in state court if the vaccine was poorly designed?

The question was how to interpret §300aa-22(b)(1) of the act, which says:

“No 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 plaintiffs – and two dissenting Justices – argued that when Congress used the word “unavoidable,” it meant to invoke comment k’s concept of the “unavoidably unsafe” product, as interpreted by courts applying it using a case-by-case approach.  Under this approach a product isn’t unavoidably unsafe if there’s a way to design the product that would eliminate the risk of side effects.  Therefore, the plaintiffs claimed Congress meant for plaintiffs to have the opportunity to sue a vaccine’s manufacturer if they could prove that an alternative design would have eliminated the risk of harm.

The majority of the Supreme Court, in a five-justice decision written by Justice Scalia, disagreed.   What Congress meant when it said manufacturers are not liable for side effects that were “unavoidable” was that manufacturers are not liable for the side effects of vaccines that are properly prepared and accompanied by proper directions and warnings.  As Justice Breyer explained in a concurring opinion, Congress deliberately decided that if plaintiffs could sue manufacturers over the way vaccines were designed, drug manufacturers threatened by frequent lawsuits would stop making needed vaccines. Congress was not willing to accept that result.

The majority opinion in Bruesewitz expressly rejected the idea that by using the word “unavoidably” Congress meant to invoke comment k:

“… there is no reason to believe that [the Act] was invoking [comment k]. The comment creates a special category of ‘unavoidably unsafe products,’ while the statute refers to ‘side effects that were unavoidable.’ That the latter uses the adjective ‘unavoidable’ and the former the adverb ‘unavoidably’ does not establish that Congress had comment k in mind. ‘Unavoidable’ is hardly a rarely used word. Even the cases petitioners cite as putting a definitive gloss on comment k use the precise phrase ‘unavoidably unsafe product’; none attaches special significance to the term ‘unavoidable’ standing alone.” 

The court is very clear: it’s rejecting the application of the term “unavoidably unsafe” to the Act.  Neither Congress nor the Court thinks vaccines are “unavoidably unsafe” in the way vaccine critics mean to suggest.


Comment k does use the Pasteur rabies vaccine to illustrate what it means by “unavoidably unsafe” and the dissenters in Bruesewitz v. Wyeth do rely on comment k to argue Congress meant for plaintiffs to have a chance to prove that an alternative design would have made the vaccine safer.  What the vaccine critics have missed -as Justice Breyer’s concurring opinion in Bruesewitz explains – is the principle behind comment k.  If a product – like a vaccine or a drug – is “unavoidably unsafe”, the product is NOT defective, and the product’s manufacturer is not liable for the products’ inherent risks (though the plaintiff may still be eligible for compensation through the administrative program). “Unavoidably unsafe” products are products that are so valuable – have so many benefits – that the risk associated with their use is justified.  If the Supreme Court had applied this term to vaccines, it would have reaffirmed what most scientists and doctors know: the benefits of vaccines far, far outweigh their small risks.

Author's Note: I am very grateful to the people who read my post for accuracy and for grammatical edits: Marsha Cohen, David Jung, David Levine, Kathy McGrath, Paul Offit, Robert Schwartz, Madeleine Ware, Alice Warning Wasney and Kelly Wessel. All errors are, of course, my own.

Tuesday, October 29, 2013

Call for Action: AB 2109 (or: Pro-Vax Parents and Providers Needed!)

Editor's Note: The religious exemption form was released last week. It can be found by clicking here

By Dorit Reiss

On September 30, 2012, California Governor Jerry Brown signed into law Assembly Bill 2109, which goes into effect January 2014. This law will require a parent or guardian seeking a personal belief exemption (PBE) from the immunizations required for their child to attend school to first obtain a document signed by a licensed health care practitioner that verifies that the practitioner has informed the parent or guardian of the benefits and risks of immunization and the risks of the diseases we immunize against.

Unfortunately, the Governor, in his signing statement, also instructed the Health and Human Services Agency to add a religious exemption to the form. Several commentators addressed the problems with these instructions and I analyzed the legal implications.

A draft form of the bill had been provided to anti-vaccination group. It includes the following language: “Religious beliefs: I am a member of a religion which prohibits me from seeking medical advice or treatment from health care practitioners. (Signature of a health care practitioner not required in Part A.)”

Anti-vaccination activists are concerned that this language does not go far enough. We should be concerned for other reasons: that it may allow people to be exempt from immunization, leaving their children and others at risk, without good reason.

We should not allow the anti-vaccination voice to be the only parent voice heard. Speak up and let the health authorities know that you want the children of California protected against vaccine preventable diseases. You can contact: 

Ron Chapman, MD, MPH, Director and State Health Officer, at

Diana Dooley, Secretary of the Health and Human Services Agency, at:

Governor Brown's office, at:, or by phone, at 916-445-2841, fax at 916-558-3160

Donna Campbell, Deputy Secretary for Legislative Affairs at CHHS, at (note: only one L in Campbel), or by phone at 916-654-0572

Janne Olson-Morgan, Assistant Secretary, CHHS, at, or by phone at 916-651-8060

Editor's Note: You do not need to be a California resident to speak out on this issue. Be assured that the anti-vaccine forces responsible for the religious exemption loophole garnered forces from all over the country, as they do in most state immunization rule discussions. 

Dorit Reiss is a professor of law at University of California. She has published writings on administrative law, and recently wrote "Compensating the Victims of Failure to Vaccinate: What are the Options?" Dorit is a member of Voices for Vaccines' Parent Advisory Board.