History of Vaccine Liability and Legal Issues in the United States
This presentation discusses the history of vaccine liability and legal battles in the United States, covering events such as the Cutter Incident, the Swine Flu vaccine campaign, and cases like Berkovitz v. U.S. It explores the challenges, consequences, and legal defenses surrounding vaccine-related injuries, highlighting shifts in public perception and regulatory responses over time.
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Presentation Transcript
Suing the Federal Government FTCA II
Polio Vaccine Salk vaccine Dead virus - supposedly Sabin vaccine Live, attenuated vaccine Gives a mild infection Can spread to others - which is good What if someone is immunosuppressed?
Cutter Incident During the first wave of vaccinations when the vaccine became available in 1955 Some vaccine was not killed and children became infected Remember, there is still polio in the community at this time First vaccine litigation Real injuries, but a real benefit
Post Cutter Incident Undermined confidence in vaccines 1965 - 402 A made vaccine cases easier to prove There was some natural spread from Sabin virus
Swine Flu 1974-75 flu season New strain of flu that was thought to resemble the 1918-1919 Spanish Influenza Feds did a massive vaccine campaign Companies demanded immunity for lawsuits Congress let plaintiffs substitute the feds as plaintiff, and allowed strict liability theories
Swine Flu - Legal Consequences Huge incentive to find injuries Diagnosis of Guillain-Barre syndrome was ambiguous No lab test vague finding in all but the extreme cases Docs were encouraged to make the diagnosis Maybe the first big injury case where plaintiff's attorneys shaped the epidemiology and perception of the disease Berkovitz happened in this climate - 1979
Berkovitz by Berkovitz v. U.S., 486 U.S. 531 (1988) What was the product in Berkovitz? What did the FDA regulations require? What did the plaintiffs claim the FDA failed to do? What was the FDA s defense?
Varig Airlines (in Berkovitz) What was the injury in Varig Airlines? What did the enabling act require the agency to do? What did the regs require? How are the regs in Berkovitz different from those in Varig Airlines?
Agency Liability Why was the FDA liable in Berkovitz? How could the FDA have worded the regulations to avoid this sort of liability? Why might that have raised a red flag during notice and comment?
Epilog National Childhood Vaccine Injury Compensation Act Autism Scam Based on fraudulent research Tries to get around the act by blaming the preservative Attacks on adult vaccines like anthrax Undermined the vaccine law system
Pandemic Flu Vaccines What are the legal issues? How can the feds deal with these? What about rolling out an experimental vaccine? What if the feds make you take the experimental vaccine? And it harms you? What does Allen tell us? Public Readiness and Emergency Preparedness Act Creates broad immunity for government and private contractors
Raw Oysters What do oysters eat? Hepatitis A - traditional Liver disease some die vibrio vulnificus - the new threat acute liver disease and failure various other nasty vibrios This is why God made deep fat fryers 14
State Warning THERE MAY BE A RISK ASSOCIATED WITH CONSUMING RAW SHELLFISH AS IS THE CASE WITH OTHER RAW PROTEIN PRODUCTS. IF YOU SUFFER FROM CHRONIC ILLNESS OF THE LIVER, STOMACH OR BLOOD OR HAVE OTHER IMMUNE DISORDERS, YOU SHOULD EAT THESE PRODUCTS FULLY COOKED. 15
The Oyster Industry and Warnings Did they support the reporting regulations? What was their concern? What would you tell them as a products liability lawyer? How did their position affect the final form of the law? What should it really say? Is this like fugu - puffer fish - sushi? 16
Where Does the Warning Have to be Posted?? Section 23:006-4 of the Sanitary Code requires that all "establishments that sell or serve raw oysters must display" a prescribed warning "at point of sale." The establishment has discretion in determining what method may be used to convey the warning because the warning can be conveyed by a sign, menu notice, table tent or other clearly visible message. What is the critical language? 17
Gregor v. Argenot Great Central Insurance Co., 851 So.2d 959 (La. 2003) What happened to plaintiff? Preexisting illness? What if he did not have a preexisting illness? Where was the sign posted? Where did plaintiff eat? Did he see the sign? 18
The Claims Who did the plaintiff sue? What was the comparative fault assessment? What is the plaintiff's negligence theory against the state? What is the causation issue? Why was DHH assessed so much fault? What is the state's defense? How does plaintiff attack this defense? 19
State Immunity Sovereign immunity was abolished How does this change the construction of the immunity provision as compared to the construction of the FTCA? The Discretionary Authority Statute: "Liability shall not be imposed on public entities or their officers or employees based upon the exercise or performance or the failure to exercise or perform their policymaking or discretionary acts when such acts are within the course and scope of their lawful powers and duties. La. R.S. 9:2798.1 20
What is the purpose of La. R.S. 9:2798.1? Section D of La. R.S. 9:2798.1 explains that its purpose "is not to re-establish any immunity based on the status of sovereignty but rather to clarify the substantive content and parameters of application of such legislatively created codal articles and laws and also to assist in the implementation of Article II of the Constitution of Louisiana."
Court's Analysis The Court's use of Berkowitz is confusing. It rejects the Fowler's court's reliance on Berkowitz because the LA statute is different It then appears to use an analysis that is consistent with Berkowitz and other FTCA cases in its resolution of the case How is this case like Berkowitz? What is the role of the regulation? How is the agency arguing that the reg does not apply? 22
What was the Real Negligence of DHH? Did it really allow inspectors to decide what point of sale meant? DHH had a mandatory duty to properly enforce the sanitary code. La. R.S. 40:4A. We find that DHH was negligent in failing to properly train its sanitarians and failing to properly provide them with interpretations of the Sanitary Code terminology, specifically as to what the term "point of sale" means. Was the restaurant also liable? Bad oysters or bad warning? How did the court modify the allocation of fault? 23
Public Health Risks Does the health department have a duty to warn about risks it knows of? What if it warns physicians, but not the public? Should it be liable for not abating a risk to the public? What about testing the oyster beds? What did the health department find about the origin of the oysters in this case that should worry you? 24
Hepatitis in Bathhouses Data from health studies in the mid-1970s showed a huge risk of hepatitis b in bathhouses Should the health department have warned the public? Should they have closed down the bathhouses? What about AIDS in the bathhouses? What if the statute says the government shall protect the public? What does the public assume from government inaction? 25
