Vaccine Liability: How Vaccines fit into the Legal Picture

We often hear people in movies say things like, “I’ll sue you,” or see scenes of our hero meeting with lawyers and using the system to get justice. But, what do the words, “I’ll sue you,” really mean in the context of pharmaceuticals and vaccines?

You may have heard about the recent lawsuits against Johnson and Johnson or Bayer’s subsidiary Monsanto due to evidence that their products cause cancer. The damages for these claims total over 11 billion dollars. Both of the items in question are household products, used for years. One, a talcum powder used for baby diaper rashes, and the other a weed killer. Things the average American doesn’t give any thought to using.

If this is the case with ordinary products with a history of long-time use, what about things that play a much larger chemical role in our lives? If a drug causes someone injury, how does that person get redress?

There are a couple of ways this is done. Most of the time, when a drug has harmed someone, that person can file a personal injury claim. This is different than a medical malpractice suit, which is specifically filed to sue a particular health care provider or pharmacist. A personal injury claim, in the case of pharmaceuticals, is much like a product liability claim. The short of the long of it is, the plaintiff (or the person who is claiming injury/defect) can file a suit against the manufacturer of the product to get redress for harms done.

A Preponderance of Evidence

In that suit, the plaintiff has the responsibility to show by “a preponderance of evidence” that the pharmaceutical product is to blame for their injury. Now, let’s explain a little more what the phrase “a preponderance of evidence” actually means. Here is an explanation from one website that provides “free legal information:”

“However, a plaintiff in a civil case — including personal injury claims — has a much lower burden of proof: the plaintiff must convince the jury that it is “more likely than not” that the facts are what he or she says they are. “More likely than not” (or “by a preponderance of evidence”) essentially means the jury thinks the chance the plaintiff’s version of the facts are true is at least 51%, while the chance they are false is no more than 49%. Fifty-fifty odds are not good enough.”

The idea stated here is that the plaintiff just needs to tip the scales, or as stated above, prove that is “more likely than not,” that the product played a role in their injury. This burden of proof does vary depending on what kind of injury claim you are making about the product in question. When it comes to pharmaceuticals the claim most often filed is, “failure to warn,” or some type of marketing defect, but there are others like design defects or negligence which may or may not hold a higher burden of proof or require the manufacturer to take on the burden of proof.

However, for most cases, and torts in general, “a preponderance of evidence,” or that 51% rule applies to the plaintiff. It is all about the fact of whether or not it is more likely that the drug was a contributing factor than not.

There are two instances, in which these rules do not apply. One, a product. The other, a time frame.

Vaccine Liability

The product where a preponderance of evidence doesn’t apply is vaccines. Yes, believe it or not, vaccine manufacturers do not take liability for any kind of damage their product may produce.

That can’t be true!

It is.

Prove it!

Okay, here it goes–in 1986, Ronald Reagan passed the National Childhood Vaccine Injury Compensation Act.

This is what is stated about vaccine liability,

“Provides that no vaccine manufacturer shall be liable in a civil action for damages arising from a vaccine-related injury or death: (1) resulting from unavoidable side effects; or (2) solely due to the manufacturer’s failure to provide direct warnings.”

Here is what a manufacturer may be held liable for, according to the law:

“Provides that a manufacturer may be held liable where: (1) such manufacturer engaged in the fraudulent or intentional withholding of information; or (2) such manufacturer failed to exercise due care. Permits punitive damages in such civil actions under certain circumstances.”

But wait, you said that they cannot be held liable for any damages?

You’re right, I did, and that is still one hundred percent accurate.

The provisions here, including “fraudulent or intentional withholding of information” and “due care” are nearly impossible to meet. To show an intentional withholding of information, you would have to be able to prove:

1. That said information actually existed, which means you would have to get access to this information somehow, and
2. you have to show that it was INTENTIONALLY withheld. How do you prove intent? This would require some kind of document combined with a whistleblower showing intent to withhold said information. Even that, may not be enough.

The second part that makes it impossible to get standing under these conditions is the big old caveat at the end, “Permits punitive damages in such civil actions under CERTAIN CIRCUMSTANCES.” What kind of circumstances? The law is unusually vague. It would be very difficult to prove that, the plaintiff’s case is a circumstance that allows for damages.

This is why, since this law has been passed, there has never been a case against a vaccine manufacturer that has actually made it through to civil court.

So, if vaccine manufacturers cannot be sued for any damages caused by their product, is there a place a plaintiff could go to for redress?

Yes. The US Government. This same law provided for a compensation program to be enacted wherein a plaintiff could sue the US Government in hopes of getting redress. However, it doesn’t look like a regular court, per se.

Structure of the Vaccine Court

There is no judge nor jury in this court. A lawyer from health and human services is chosen by the department of justice to be the “special master” of the court. (Yes, they are actually called special masters, I am not being facetious.)

This special master is the one who gets to decide whether the plaintiff will get compensated and how much the department of health and human services owes the plaintiff. The funds for this program come through a tax on each vaccine that is produced.

Sometimes, the plaintiff gets only to submit the documentation of their injury to see if it meets the requirements of whether they get compensation.

Other times there is an actual hearing. The plaintiff’s personal injury lawyer gets to show their case or evidence and the defendant, another health and human services lawyer, gets the chance to show why that evidence is faulty.

Burden of Proof and Statute of Limitations

The burden of proof in these cases is quite high. Higher than the “preponderance of evidence” we talked about earlier. The plaintiff must meet stringent medical requirements of what is and what is not covered by this program. Along with having to meet particular definitions of what these conditions look like, each of these has a very particular timeframe within which the injury must have happened after the administration of the vaccine (most within 24-48 hours of administration).

The reason that this is notable is that any other pharmaceutical product has neither this level of burden of proof nor such a strict time frame. For example, if you were to develop liver spots 3, or even 6, years after taking a certain medication, you still may be able to get redress for that grievance from the manufacturer. However, with a vaccine, if you were to get encephalopathy one day outside of the set timeframe you would not be able to get compensation, even if you could prove that the vaccine was the cause of the encephalopathy.

This also affects the statute of limitations. Under most state laws, the statute of limitations, (or the time that you have to file a lawsuit after an injury has occurred), does not start to expire until the plaintiff has discovered their injury. However, under the 1986 act, the statute of limitations starts as soon as any symptoms may have started or vaccination took place. Plaintiffs have 36 months to file after that.

There are no exceptions. Even if the doctor did not connect the dots between the injury and the vaccine or the plaintiff did not realize what their symptoms were until it was too late.

The Accepted Injuries Table

As I stated earlier, only certain injuries and conditions meet the requirements of the compensation program. You can check out the table yourself as well as the newly revised provisions on the HRSA.gov page.

This table has gone through many revisions over time. Most revisions have taken injuries off the table, although some injuries and acceptable vaccines have been added. HHS does not have to give a reason for changing the table nor the injuries on it. They do give notice of deletion and recently have moved to let the public comment on their choices to delete certain injuries.

The most recent changes took place in 2017. You can compare it to the 2015 version from the HRSA.gov website as well.

Vaccine Injury in Numbers

This site also provides data on how many injuries have been compensated through the program, those that have been dismissed, as well as the amounts that were paid to plaintiffs.

So how much has been paid out for injuries since 1989 when the program was put into place?

4.48 billion dollars.

How many injuries have been compensated in total? Out of 22,507 petitions filed, 7,666 have been compensated. Although only 7,630 have actually been compensated.

The three tables above are where the often quoted statement that “one in a million are injured by a vaccine,” originated. If you look at the CDC and other sources that state this, you will find that the citation always comes back to this data. This statistic comes from this graph.

The math can be seen more easily in the table above. 3,700 compensable settlements/ 3,761,744,351 (number of doses distributed) = .00000098 (or about .000001). In other words one in a million.

There are a couple of things about this data that I would like to point out as it pertains to the claim of “one in a million.”

1) The data here is taken from a period of the compensation program from January 1, 2006, to December 31, 2018. This is not the full data of cases compensated or doses of vaccines given. It excludes a very heavy period of cases at the beginning of the 1990s.

2) The idea that compensated cases are equal to the amount of vaccine injury is a misnomer. Just because a case meets the criteria set by health and human services, does not mean that other cases did not result in vaccine injury.. It also does not account for those who realized their injury after the statute of injury was up or that did not have the finances to sue the US government.

Another note on this is that the CDC commissioned Harvard Pilgrim to do a study in 2007 to find out how much vaccine injury goes unreported. According to this study, less than 1 percent of vaccine injury is reported.

Last year, there were a little over 60,000 adverse reactions reported to VAERS. So, if this study is correct and less than 1% of those are reported, that would mean that there were more like 6 million adverse reactions last year.

Of course, we cannot be sure that all adverse reactions reported were caused by a vaccine and that these adverse reactions have varying degrees of injury. However, even if only half of them were caused by a vaccine that is still about 3 million adverse events a year.

This study also brings in to question the statement on the VAERS website that physicians are encouraged to report injuries even if they do not believe it is caused by a vaccine. If less than 1% of these events are reported, it is unlikely that many doctors are reporting these events or know how. I have personally talked to a few doctors that do not even know that VAERS exists.

3) They are using doses of vaccines as the standard of one in a million. This is a deceiving number, as it does not show the risk relative to groups nor does it show the risk as to how many times someone is vaccinated. Most people will get more than one dose of a vaccine in their lifetime and often in the same year, so saying that the chance of injury is “one in a million” according to the number of doses given in the US, is not telling the whole story and has diluted the true number to a great extent.

Issues with Lack of Vaccine Liability

Although the court has helped many people who have been injured, the lack of vaccine liability lying with the manufacturer does present a couple of potential problems.

1. Lack of incentive for manufacturer attention to safety.

Liability is essentially incentivizing all private entities to produce safe products. Even with this incentive, products, even stringently approved products, do cause harm. There are hundreds of injury lawsuits against pharmaceutical companies for this very reason. Here is a list of a few heavy hitters.

Although the FDA does still review the manufacturer’s clinical trials before approving a vaccine, vaccines do not have to go through the same process as other pharmaceuticals do. (There will be a future post about this.) Vaccines are not classified as a drug but as a biologic. This is why flu shots can be tested and sent out all in one year. The criteria are different for a vaccine.

Because of the lack of liability, there is a possibility that vaccines could cause more injury than we are seeing, as has been suggested by the previous study, without accountability to their consumers. This may be part of the reason why vaccination is now a 60 billion dollar industry.

2. Government incentive to reduce the compensation of vaccine injury.

The government is seen as having a duty to keep its citizens safe. Vaccines are seen as one of the most important public health interventions ever invented. If the government were to admit a larger amount of injury from vaccines and some of the public were to stop vaccinating, this may reflect badly on the government and start a larger panic. Therefore, the government is incentivized to keep its accepted and compensated injury low regardless of how many injuries there may be.

The government is also now the one taking on the liability of each of these suits. Therefore, the government is also incentivized to keep compensated injury low to maintain its budget. If more people were aware of potential injury, this could create more lawsuits than the court could handle or properly compensate.

Just like any company, they, most likely, do not want their constituents to feel unsafe or see any major losses due to their holding liability. They need to save face, which is probably why you may have never heard of this information before. And why it is difficult to find the compensation program or the data surrounding it.

Why and What?

So, why? Why did the government take on vaccine liability claims in the first place? And what is the other circumstance in which persons cannot file an injury claim against a pharmaceutical company?

Read my next posts, to find out.