A well-working vaccine against COVID-19, for everyone, is eagerly awaited throughout the world. It is seen as the coveted entrance ticket that will give back access to a vibrant and active life outside the walls of one's home. Early reports are encouraging. For example, the newspapers recently headlined: ‘Spring 2021 the light will shine again’ and ‘Pfizer corona vaccine meets safety and effectiveness FDA requirements’.
From the rain into the drizzle
Let us hope that the vaccines will indeed do what they promise and prevent new, unnecessary casualties. Still, it is important to keep a cool head and think about the legal position of those who suffer personal injury because of a potentially defective vaccine against COVID-19. This is not entirely unthinkable, history shows. For example, Beer advocaten is currently assisting several victims who have suffered a severe sleep disorder called ‘narcolepsy’ as a result of a defective swine flu vaccine, Pandemrix mentioned.
As in any personal injury case, sometimes multiple parties can be held liable (side by side) for occurred personal injury. Thus, if vaccine action is deficient, the producer or supplier of the vaccine are liable, as well as the physician if the vaccination is by medical negligence is given incorrectly. The state that considers the vaccine ‘safe’ and includes the vaccination in the National Vaccination Program, for example, may also be liable. In this blog, I will discuss producer liability in more detail. In a subsequent blog, my office colleague Laura-Jean van de Ven deepen the liability of others than the producer.
In the event that a vaccine causes damage, the manufacturer is only liable if the product can legally be said to be ‘defective. This requires consideration of what level of safety the vaccinated person was entitled to expect from the vaccine. The mere fact that the vaccine causes side effects is for liability insufficient. However, the risk of (serious) side effects will of course have to be proportional to the risk against which it protects (COVID-19). Also, the manufacturer must properly research the vaccine's side effects and inform potential users about them as fully as possible.
Unforeseen side effect
It is just that, also given the pressure to bring a working vaccine to market as soon as possible, it is not inconceivable that the corona vaccine could become a unforeseen side effect will have. The question then is whether this risk is for the producer's account and risk. In The Netherlands, if the most advanced insights of science and technology made it impossible for the manufacturer to discover the side effect, he is off the hook. If the manufacturer failed to do this advanced research into the vaccine, for example in order to be able to market a vaccine as quickly as possible, then a defect will in principle be attributable to him. This is different if the defect is a consequence of compliance with mandatory government regulations. Importantly, a manufacturer must continue to investigate possible side effects and communicate these new findings.
How unique is this crisis?
The question is whether the corona crisis is so unique as to warrant a departure from these main rules. Some legal scholars believe that this is an exceptional situation because there is a lot of pressure on the pharmaceutical industry to make vaccines available more quickly than regular vaccines. In their view, this would justify that society in the form of the government should (partially) help pay for possible damage claims. They also raise the possibility of a special damage fund, in which the government and manufacturer both contribute financially. What is central for me is that - should it come to that - duped vaccinated people with health damage do not themselves end up from the rain in the drip, but can recover their damage from the party responsible for it. Let's hope it will never be necessary.
Amsterdam, December 17, 2020
If you have questions about this blog, please contact the author, Irene Timmermans.