Bruesewitz v. Wyeth: What it means for those who suffered a vaccine injury

If you or someone you love is injured you can bring a lawsuit against the person who injured you. During that lawsuit you (and your lawyer) must prove that the person who injured you had a responsibility to not hurt you. This is called duty in legal terms. After you prove duty, you must next show that the person who injured you violated that duty. This is called breach of duty in legal terms. The third item you must prove is that you were injured because of the breach of duty. The final item you must prove is that you suffered some loss as a result of that injury. This is called damages in legal terms.

Manufacturers have a duty to not hurt consumers with their products. The following are their three main duties:

  • To not place a product on the market without a warning, which when used normally puts the consumer in danger of injury (defect in warning label);
  • To not place a product on the market that could have been designed safer (design defect); and
  • To not place a product on the market that is not manufactured correctly (manufacturing defect).

What was available to people who suffered vaccine injuries before Bruesewitz:

Before the Bruesewitz decision, a person injured by vaccine could bypass the vaccine court when:

  1. A vaccine manufacturer fails to put a warning in the label; and
  2. A vaccine manufacturer fails to manufacture the vaccine properly, i.e. in accordance with the federal rules.

After a decision in the vaccine court, an injured person could decline to accept the decision and file a lawsuit in state court based on the manufacturers failure to design the product in a safer manner, or design defect.

Vaccines are susceptible to design defect claims because manufacturers are slow to adopt new and safer technologies in the design of their vaccine products.

What is available after Bruesewitz:

Based on the ruling made on February 22, 2011, the Supreme Court has now taken away the ability to sue a vaccine manufacturer based on design defect. So, at the end of your case in vaccine court, you no longer have the option to sue a manufacturer in state court based on design defect.

What about failure to warn and/or manufacturing defects?

There is a strong presumption that the labeling and manufacturing processes are adequate if the manufacturer follows all the rules.

In a vaccine injury case you would focus on failure to warn as a means to sue the manufacturer instead of proving problems with the manufacturing processes. Unfortunately, manufacturers follow the labeling rules. The FDA will tell the manufacturer what needs to be in the label. As long as those items are in the label, the manufacturer is largely immune from a lawsuit.

If we suspect that the company is hiding something or failing to warn about certain adverse events, lawsuits are stopped before we can get into the company and figure out if it’s true or not. There usually has to be fraud that is out in the open for this tactic to work (or a judge willing to listen).

What can we do now?

This situation is not without precedent. The Supreme Court took away people’s right to sue certain medical device manufacturers. This left thousands of people who died or were physically maimed by recalled medical devices without any compensation. Here we at least have a program that can at least provide some compensation, but limited access to the manufacturer.

Nonetheless the only way to change this outcome is to write your State Senator and Congress member and appeal for a bill to overturn this ruling. We will be placing a draft letter on this website for your convenience and a step-by-step guide on getting this information to the right member of congress.


You Only Have Three Years To File Your Claim

The first step in helping yourself or a loved one after a serious vaccine related injury is to contact us for a free review of your case.

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