Sunday, December 12, 2010

Bruesewitz v. Wyeth : Unavoidable Outcome

Flickr Photo by dbking
As I have talked above a few times before, there is a vaccine injury case - Bruesewitz v. Wyeth - currently being decided by the U.S. Supreme Court.  If you are interested in reading the filings and arguments before the court or would like to read a summary written by someone who actually understands the legal issues, I would refer you to the excellent page on SCOTUSblog.

The arguments before the court were heard about a month and a half ago and, while I was planning to write about it at the time, I never had the chance to do so.  But now, since a decision from the court might be handed down in the next few weeks, I thought it might might be a good time to talk about the case again.

First let me say that I am not a lawyer nor do I play one on the internet.  I have read the filings and the transcripts from the the case several times and have attempted to understand the legal issues involved.  I think I understand the basics but my knowledge in this area is extremely limited and I could very easily be misunderstanding what is involved.

However, having said all of that, it is my opinion that Bruesewitz is going to lose their appeal.  I think that the Supreme Court is going to basically say that vaccine manufacturers cannot be sued in civil court for any injuries that could be reasonably be expected to occur after being given a vaccine.  The Court is going to find that the only venue for these sorts of claims is the so-called vaccine court.

The reasons I say this have absolutely nothing whatsoever to do with any debate surrounding vaccines or vaccines and autism but rather are completely based on what the relevant laws are.  In this case, the controlling law is the one that created the National Vaccine Injury Compensation Program in the first place.  This law created the Office of Special Masters inside the US Court of Federal Claims - the so-called vaccine court, established how that program should work, and set the terms under which vaccine injury claims could be heard by civil courts.

So the central issue in Bruesewitz  v. Wyeth is about how this law should be interpreted in general, and more specifically, what this section of the law means -
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.
While at first glance this passage seems to be as clear as mud, when you consider the backdrop of how product liability works it starts to make a certain kind of sense.

Product liability is the area of law that deals with how manufacturers (and others) should be held responsible for injuries that their products cause.  There are a few different types of liability but the relevant one for this case is strict liability.  Strict liability is the idea that a company is responsible for damage caused by their products regardless of any fault on their part.

Strict liability is different than other types of product liability, such as negligence, in that it doesn't matter how careful the company is or what steps it takes to prevent problems.  If it can be proven that a company's product caused the damage then the company can be held liable.  With this type of liability there are three basic types of claims that can be made.

The first type of claim is called a "manufacturing defect" and deals with injuries that are caused because of problems during the manufacturing process.  For example, if a vaccine was contaminated by something while it was being made or if a worker didn't add some ingredient when they should have then that would be considered a manufacturing defect.

The second type of claim is called "failure to warn" and deals with injuries that occur because a company failed to warn about a non-obvious danger where the injury might have been able to have been avoided if the user knew about the risk.  An example here would be the warning about kickback that comes on every chainsaw.  Kickback is what happens if you get the tip of a chainsaw too close to an object, such as the ground - the blade has a chance of kicking back (rebounding) in the direction of your body and causing serious harm.  A novice user might not realize the danger of that happening, hence the warning.

The final type of claim is called a "design defect" and deals with injuries caused by products that have a defective by design or products that cannot be made safe no matter what the design.  A example here might be a chair that was designed to only have three legs instead of four or a car whose brakes would fail to work when the car is going faster than 15 mph.

Now, if you look back at the snippet of the law above, you can see that it mentions all three types of liability I just talked about.  The question is how should the law be interpreted and what exactly was the intent of Congress in writing the law.

The laws says that if an side effect occurs even though a product was properly prepared (manufactured) and accompanied by proper directions and warnings then the company is not liable for that injury if it were unavoidable.

So, the case basically comes down to what an "unavoidable" side effect is.  My opinion is that the Supreme Court is basically going to find that a side effect is "unavoidable" if it is known that it can happen as a result of the vaccination and that there was no way to change the vaccine to prevent the injury.

Or to put it another way, if the product was properly manufactured and the possible risks are disclosed to the end user (or their parents) that the company is not liable if one of those side effects happens.

Bringing it all the way back to the current case, the seizures that Bruesewitz had were certainly a known side effect of the DTP vaccine as it was listed in the vaccine injury table of the original 1986 National Vaccine Injury Act and was still there up until a month before the Bruesewitz's initial claim was filed with the vaccine court in 1995.  There were no changes to the then-current vaccine that could have been made to prevent the injury.  Hence the possibility of seizures was an "unavoidable" side effect of using the vaccine.

Now, there is the second part of the argument - that Wyeth had a different type of vaccine that it could have used and that type of vaccine might have been able to avoid the seizures.  But that argument ignores the fact that the current vaccine was approved by the relevant agencies, was used properly, and (presumably) had the proper disclaimer pamphlet with it while the other vaccine was nothing more than vaporware.  The mere possibility that another type of vaccine existed did not make the side effect of this one avoidable.

As a result, I think the Supreme Court will look at the evidence, decide that the seizures were "unavoidable", and uphold the decision of the 3rd circuit court.  The only question for me is how far they will take it.  Will the ruling be a narrow one limited to only this case or will the Court attempt to set a general precedent that vaccine manufacturers have broad based immunity and the only forum for hearing injury complaints is the vaccine court?

Time will tell.


  1. You said that the court will decide that the seizures were unavoidable. The hitch with this is that the vaccine court decided that the seizures were not a vaccine side-effect. So, if the seizures were a vaccine side effect (but an unavoidable one), the vaccine court erred in not paying the family. If the seizures were not a vaccine side-effect at all, then of course the family have no claim.

    But the Supreme Court cannot decide that the seizures were caused by the vaccine without making the vaccine court look slimy.

  2. I think the scope of what the Supreme Court is deciding is somewhat limited. I don't believe that they are considering whether the vaccines did in fact cause the seizures nor are they reviewing the ruling of the vaccine court.

    The issue that the Court will decide, as far as I can tell, is whether vaccine makers have immunity from design defect cases (i.e. cases automatically dismisssed) or whether the design claims have to be evaluated on a case by case basis.

  3. I agree with you. The law applied strict liability in the 'vaccine court' and actually with less prove than in a civil court.

    If the manufacturer messes up the vaccine by making it improperly, they can be sued.

    But if they make the vaccine as they are supposed to and include the FDA required warnings, they are off the hook.

    A return to the courts for vaccines that weren't as good as they might have been could easily scare the vaccine makers off.

    Because there are all those thimerosal based cases that had their hearing in the Omnibus Autism Proceedings and lost.