Supreme Court Gives Big Pharmaceuticals a Vaccination Against Lawsuits

This post comes as a reaction to an Editorial entitled, “Vaccine Safety: Misinformation About Vaccine Risks is Making Us Less Safe,” by Dr. Sandeep Rao. In his Editorial, Dr. Rao charges that lawyers are “intent on creating a mini-industry out of lawsuits against vaccine makers,” and he rebukes families for “pursuing their claims of disability through available legal channels.” This mini-industry of “litigation tied to junk science,” Dr. Rao says, fosters an irrational fear against vaccines and threatens the supply of vaccines to the public- presumably because some manufacturers will pull out of the market for fear of being sued. Dr. Rao cites Bruesewitz v. Wyeth LLC, in which the Supreme Court ruled (6-2) that parents whose children have been harmed by vaccines must seek compensation from a special tribunal commonly called the ‘Vaccine Court.’ Specifically, the Court holds that the National Childhood Vaccine Injury Act (NCVIA), which implements the Vaccine Court, preempts all design-defect claims against vaccine manufacturers brought by plaintiffs who seek compensation for injury or death caused by vaccine side effects. Dr. Rao quotes Justice Scalia, saying that NCVIA “reflects a sensible choice to leave complex epidemiological judgments about vaccine design to the FDA and the National Vaccine Program rather than juries.”

Dr. Rao uses the Bruesewitz decision to buttress his argument that misinformation about vaccines is making us less safe. I disagree with his interpretation of the decision. Bruesewitz has nothing to do with the proposition, ‘good science makes good law;’ and it has nothing to do with juries being persuaded by ‘junk-science.’ Reading the Bruesewitz decision, it becomes quite clear that the preemption holding is a pretense for safeguarding the financial interests of the $20 billion dollar vaccine industry- an industry which (in case anybody doesn’t know) has a long history of hiding its products’ risks.

Vaccines are a type of ‘unavoidably unsafe’ product; that is, a vaccine is a product that is incapable of being made safe for its intended and ordinary use. The Court in Bruesewitz notes that NCVIA expressly eliminates liability for a vaccine’s unavoidable, adverse side effects:

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.” 42 U.S.C.A. § 300aa-22(1).

And so, the Court engages in bottom-up thinking, reasoning backwards from its desired outcome. The Court takes as true the premise that vaccines are unavoidably unsafe.  Since the government mandates the use of an unavoidably unsafe product, it is reasonable to believe that some people will be injured it. Vaccine makers will take a big hit if everyone that is injured sues, and an even bigger hit if plaintiffs are successful- since vaccine makers will then be obligated to compensate their victims. The Court sees this as a bad result.  On the other hand, the Supreme Court finds that a good result is reached by shielding vaccine makers from liability when their vaccines cause debilitating injuries and death.  Now that the Court has decided how it wants the case to turn out, the Court must pick the principle that will precipitate the desired result: NCVIA preempts state tort actions that allege negligent design defects.

The disposition of this ruling yields rather harsh results for Hannah Bruesewitz who, after receiving a mandated DPT vaccine, now suffers from a severe brain injury, developmental delays, and a lifelong seizure disorder. After being denied compensation by the Vaccine Court, Hannah turns to the American civil court where she offers evidence that Wyeth-Lederle, the DPT vaccine manufacturer, had the technology to produce a less reactive, purified vaccine but declined to do so.  With its ruling, the Supreme Court declares that Hannah’s lawsuit cannot go forward.

“This is a sad day for all Americans forced by law to use dozens of doses of vaccines or be barred from school or health insurance or employment.” NVIC Cites “Betrayal” of Consumers by U.S. Supreme Court Giving Total Liability Shield to Big Pharma. In dissent, Justices Sotomayor and Ginsburg argue that the threat of lawsuits provides an incentive for vaccine manufacturers to constantly monitor and improve their products. Supreme Court Rules Vaccine Makers Protected From Lawsuits. As Justice Sotomayor writes, the Bruesewitz decision

leaves a regulatory vacuum in which no one- neither the FDA nor any other federal agency, nor state and federal juries- ensures that vaccine manufacturers adequately take account of scientific and technological advancements… The vaccine market will often have little or no incentive to improve the designs of vaccines that are already generating significant profit margins. Nothing in the… legislative history remotely suggests that Congress intended that result.”


  1. This is very well put… “And so, the Court engages in bottom-up thinking, reasoning backwards from its desired outcome. The Court takes as true the premise that vaccines are unavoidably unsafe” …and succinctly addresses the insanity of this issue.

  2. Good analysis. Glad you wrote about it, explained what actually occurred behind the scenes, and the legal and social ramifications. This reminds me of the Ford Pinto situation in which Ford made decisions that profited their corporation, at the cost of human lives…

  3. […] We’re doing something wrong. It might not be so simple figuring out what, but we can start with the obvious: healthcare. Even when you get it it’s not that great. According to the U.S. iatrogenic report, over 100,000 Americans die of taking appropriate dosages of prescription drugs each year and we’re five times more likely to die at the hands of our doctors than in a car accident. And no other developed country mandates as many shots as a requirement for attending school: 71 doses of 16 vaccines between birth and 18. Furthermore,  consumers can’t sue no matter what happens following vaccination and the Supreme Court has declared the technology “unavoidably unsafe.” […]

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