The World Needs a Balanced View of Vaccine Policy and Litigation, Not Pro-Vaccine Zealotry
A rational critique of "Vaccines in the Courts: A COVID-19-Induced Litigation Influx". Product litigation has led to safer products. The 1986 Act has created judicial tyranny.
Manufacturers, distributors, shops, hospitals, and medical providers are not able to evade liability for harms resulting from their products. Pharmaceutical companies are also liable for harm from their drugs. The legal process ultimately encourages these products to be safer - often with only a few lawsuits and some math demonstrating that the total cost would be too much if the products are not pulled from the market and made safer. Why should this process not apply in the context of vaccines?
-GRAB A COFFEE OR TEA AND GET READY. THIS IS ONE TO SEND TO YOUR REPRESENTATIVES - jlw
In the realm of public discourse, particularly concerning vaccine policy and litigation, it is crucial to approach the conversation with a balanced perspective that weighs the benefits of costs of alternative viewpoints. A Health Affairs Forefront article, “Vaccines in the Courts: A COVID-19-Induced Litigation Influx,” presents us with an opportunity to examine the assumptions and representations that influence the understanding of issues in vaccine-related legislation. It also allows us to consider the presumption of public health authority as an obvious necessity that is so essential that individual rights can - and as implied by the article authors, should be - tread upon with hardly a second thought.
In this article, we examine these issues, and indeed whether The National Vaccine Injury Compensation Program (NVICP) and the Countermeasures Injury Compensation Program (CICP), both administered by the US Department of Health and Human Services (HHS), should exist at all.
Revisiting the Premise of Vaccine-Related Bills
The authors of the Health Affairs Forefront article assert that recent state legislature bills before the COVID-19 pandemic were designed to undermine public confidence in vaccines. This bold assertion warrants a critical examination. Contrary to this claim, a closer look reveals that many of these bills were, in fact, aimed at preserving individual rights to make informed choices regarding vaccinations in response to bills aimed at stripping those rights away.
These legislative efforts sought to uphold and reinforce the freedom to accept or decline vaccines based on valid medical, religious, or philosophical reasons, rather than to impede access or erode public confidence. I know this first-hand because in 2017-2019 I traveled to many states to testify on the balance of the science on vaccine safety to legislative bodies contemplating bills designed to strip away rights people granted themselves for protection of body, mind, and soul against the effects of vaccination.
The Language of Legislation and Public Perception
The language used to describe vaccine-related bills is of paramount importance. Labeling bills that protect the right to informed vaccine choice as "anti-vaccine" is a distorted misrepresentation that carries significant emotional weight and is an attempt to skew public perception.
The article title itself is misleading: “Vaccines in the Courts: A COVID-19-Induced Litigation Influx” should be “Vaccines in the Courts: A COVID-19-VACCINE Induced Litigation Influx”.
The article's very first sentence also contains the falsehood:
"Every year, in the decades before the COVID-19 pandemic, tens of bills were introduced in states legislatures aimed at undermining public confidence in and access to vaccines…”
Their language misrepresents the intent of the bills.
The bills are not “aimed at” limiting access of others to get vaccines, nor is their aim to “undermine public confidence in vaccines.” The bills are, actually, aimed at ensuring the right of individuals to have free choice over what is injected into their bodies, specifying valid medical, religious, or philosophical reasons to disagree with government recommendations.
A bill protecting consumer rights to know about Toyota’s previous failed brake issues and choose what car to purchase (or to avoid cars altogether) would not ever be misrepresented as “undermining public confidence in automobiles.” Bills passed to improve the safety of infant car seats would never have been represented as “anti-car seat”; they are, instead pro-child safety.
The first article they cite in support of their distortion does not note any intent on the part of the bill writers/supporters to “undermine public confidence and access to vaccines,” as the authors wrongfully claim.
Reassessing the Safety and Efficacy of Vaccines in General
The assumption that all CDC-recommended vaccines are sufficiently safe and effective to warrant mandates is far from universally accepted and represents a point of contention. The recent experiences with COVID-19 jabs, which have faced severe challenges in terms of efficacy and safety, underscore the importance of maintaining a no-vaccine-mandate policy. It is reasonable to question whether other vaccines have been subject to similar overestimation of their benefits and safety.
Workplace mandates of the COVID-19 jabs fell apart due to clear evidence of no protection against transmission. The article in question also misrepresents facts of childhood vaccine efficacy and the concept of herd immunity, and thus these topics also requires scrutiny.
The history of vaccines, including those for COVID-19, pertussis, and influenza, has shown that the prevention of infection and transmission is not absolute. For instance, the chickenpox vaccine, while reducing the incidence of chickenpox, does not confer herd immunity, and has been associated with shingles in some cases. Even with 100% vaccination, as the vaccine is a live-virus vaccine, and children who have received it can still develop shingles down the road — which would make them contagious for chicken pox.
While a study published in AAP may claim that the risk of shingles is lower in vaccinated children, there are some very troubling facts surrounding this finding:
(1) The lead author plus two others disclosed that they received funding from Merck, manufacturers of the chicken pox vaccine.
(2) There is no way to know whether the vaccine truly reduced the future risk of shingles because most people who get shingles are typically over 50, while the chickenpox vaccine was not introduced until 1995, making the first cohort of children who got the vaccine only 28 years old today.
(3) In some cases, there is documentation that chickenpox vaccination has caused shingles.
The pertussis vaccine is widely understood to be a “failed vaccine” because it merely masks symptoms, leading to asymptomatic transmission of the pertussis bacteria by the vaccinated. These nuances are critical to understanding the complex interplay between vaccination and public health outcomes.
Then there is Merck’s Measles, Mumps and Rubella vaccine (MMR and MMRV). The evidence that the MMR has lost efficacy in preventing the transmission of the mumps became quite clear prior to 2020 as outbreaks were occurring in schools that were fulling vaccinated; recall in 2019 that the USS Fort McHenry was quarantined at sea for months due to a mumps outbreak among the fully vaccinated and up-to-date crew (See AHPR: MMR Vaccine Caused Viral Mumps Outbreak on U.S Navy Warship – Alliance for Human Research Protection (ahrp.org) and CNN: US warship quarantined at sea due to virus outbreak).
The second article the authors cite labels every bill aimed at protecting the right to choose which vaccines, when, how, and why as “anti-vaccine”, which is simply a dishonest presentation. If someone wants to choose prescription medication for a headache, or acetaminophen or ibuprofen, or even nothing at all, they are not labeled as “anti-pill” or “anti-medication.” There are no valid reasons to apply the pejorative label “anti-vaccine” here; no law professor should deliberately choose emotionally charged language instead of sticking to simple facts.
The well-documented history of the failure of childhood vaccines to prevent infection and/or transmission of Covid19, pertussis, mumps and influenza refutes Reiss's and Hughes' claim that the viewpoint of vaccine policy critics would “undermine herd immunity”: vaccinating more people with failed vaccines will not provide herd immunity, and thus just as court ruling after court ruling has found for COVID-19 jabs: vaccine mandates are capricious and arbitrary.
The Integrity of Research
The integrity of vaccine research is another area of concern, especially when financial conflicts of interest are present. Studies funded by vaccine manufacturers, such as those related to all childhood vaccines and COVID-19 injections must be examined with a discerning eye, considering the great potential for bias. The long-term effects of vaccines, including the risk of shingles post-vaccination, and the public health effects of misguided and failed endeavors like the COVID-19 jabs are now becoming apparent. Vaccine zealots have grossly impaired the public’s perception of vaccine efficacy and long-term safety, using, exclusively, retrospective studies that are relatively easy to manipulate.
Given especially the unusual methodology in studies on COVID-19 injection safety and efficacy, the claims of safety and the prevention of cases, hospitalizations, and deaths have been soundly challenged: cases, adverse events, and hospitalizations were not counted until two weeks after the second injection, initially five weeks after the first jab, and then, later, eight weeks after the first jab. Both I (in 2021) and Norman Fenton (in 2023) have published on this cheap trick.
The Authors' Backgrounds and Clear Biases
The professional backgrounds of the authors of the original article—particularly their affiliations with vaccine manufacturers and policy strategy firms—raise glaring questions about potential biases. It is essential for readers to be aware of these affiliations as they may influence the framing of vaccine policy and litigation issues.
The first author has been attacking individual rights for a long time, using ad hominem attacks, ridicule of parents of children with severe vaccine injuries, misrepresentation of intentions and facts, and distortions of logic to misrepresent intentions and meanings. She even wrote a paper that proposed that are “benefits” of Regulatory Capture. (See: Dorit Rubinstein Reiss and the Benefits of Agency Capture: The Latest Vaccine Industry Advocate - AGE OF AUTISM). Ms. Reiss seems to hold the singular belief that forebears who took the time to specifically place legislation in place to protect individuals from harm from vaccination with philosophical exemptions did not have any reason to do so. The exemptions came through painful human experiences of people losing children and other loved ones to vaccines: families who have such experiences will never agree to vaccinate other members, no matter what the state or federal laws say, and to expect them to do so it inhumane.
The second author of the Health Affairs article was a former vice president of policy at Moderna, “guiding the company’s policy strategy during the COVID-19 pandemic. Previously, he was managing director at Avalere Health, where he founded and led the firm’s vaccine group.” Note that Avalere Health is a healthcare business consulting firm; they do not themselves provide health care. Here is a statement on their website:
"Count on us to help you evaluate and manage risk, determine and optimize provider partnerships, expand into new business lines and markets, and prepare for future changes that will impact your business."
The Legal Landscape and the Future of Public Health Authority
The Health Affairs Forefront article correctly noted that we have witnessed an uptick in vaccine-related litigation. It is indeed crucial to consider the trajectory these cases may take and their potential to reach the highest judicial authority in the United States: The Supreme Court. The implications of such a development are profound, not only for the immediate cases at hand but also for the foundational principles of public health policy.
According to the authors, recent comments from a Supreme Court justice suggest a judicial appetite for reevaluating the scope of state vaccine mandates and of public health authority which has been debated for over a century. This can only be good news because distortions of reality over public health issues do not replace the reality of public health issues.
Liability Enhances Product Safety
Litigation over harm has long been a driving force in improving commercial product safety. It serves as a crucial check on corporations, ensuring they are held accountable for the safety and efficacy of their products. This legal mechanism often leads to enhanced safety protocols, product recalls, and the development of safer goods for consumers. The history of product liability cases is rich with examples where litigation has prompted significant improvements in consumer products.
Reassessing Vaccine Liability: A Call for Wholescale Judicial Reform for Enhanced Product Safety
In the complex landscape of public health, vaccine liability in the United States stands as a contentious and critical issue. Central to this discourse are the National Vaccine Injury Compensation Program (NVICP) and the Countermeasures Injury Compensation Program (CICP), both administered by the Department of Health and Human Services (HHS). This article posits that the dual role of HHS, serving as both the administrator and the defendant in vaccine injury cases, has precipitated a form of judicial tyranny. This duality undermines the integrity of the compensation process and impedes the essential safety feedback mechanisms inherent in product liability.
Operational Challenges and HHS's Unconstitutional Dual Role
Established with the intent to provide a streamlined compensation process for vaccine-related injuries, the NVICP and CICP have faced significant operational challenges. The high burden of proof and limited public awareness have been notable barriers. However, a more insidious issue lies in the dual role of the Department of Health and Human Services (HHS). As both the administrator of these programs and the defendant in vaccine injury cases, HHS is positioned in a conflict of interest of the highest order that not only abjectly and plainly biases the compensation process: it also violates the separation of powers clause.
This arrangement has led to innumerable instances where claims are denied despite clear evidence of vaccine-related injuries, as illustrated by various case studies (See Mary Holland, Louis Conte, Robert Krakow, and Lisa Colin, Unanswered Questions from the Vaccine Injury Compensation Program: A Review of Compensated Cases of Vaccine-Induced Brain Injury, 28 Pace Envtl. L. Rev. 480 (2011)
DOI: https://doi.org/10.58948/0738-6206.1681
Available at: https://digitalcommons.pace.edu/pelr/vol28/iss2/6).
In some cases, the Special Master’s only reason for favoring HHS MD testimony over petitioner’s testimony had nothing to do with the validity of the testimony at all; instead, breaking their own rules, they have cited prior rulings (e.g., about aluminum in vaccines) and could only resort to ad hominem attack by the Special Master of an expert witness with 20 years’ experience in biomedical research with a peer-reviewed publication record on that very topic about which he was testifying. The decision in that case revealed the Special Master’s contempt of science, favoring the defendant at all costs, including the cost of the reputation of the NVICP.
The US Constitution Did Not Restrict the Right to Indemnity Protection - and Guaranteed and Protected Life, Liberty & the Pursuit of Happiness
Rights not restricted by the US Constitution are safeguarded by it. Thus, when Congress passed and when Reagan signed into the law the 1986 Act, they overstepped and signed into law an act that would guarantee harm to some citizens. They committed a tort (a wrongful act or an infringement of a right (other than under contract) leading to civil legal liability). When vaccines hurt, maim, or kill, they not only cause personal damage: attendant consequences of harm almost always lead to financial costs - sometimes hefty costs - including loss of income, medical care, costs associated with debts … it’s a long list. A humanitarian USA would never place the burden of one person’s health - in theory, or otherwise - on the back of another’s well-being. The vaccine injured - and their relatives who have shouldered the cost - deserve to be made whole. And the protection from liability hoists on these families the externalized cost of vaccine manufacturers’ savings from having to attend to the risks of their products by making them relatively safer than they were in the past.
HHS’s Judicial Tyranny and Its Impact
The term "judicial tyranny" aptly describes the current state of vaccine injury compensation in the U.S.; victims face formidable barriers in obtaining compensation, often finding themselves entangled in a web of bureaucratic and legal complexities with little recourse. The broader implications are profound, affecting public trust and potentially impacting hundreds of thousands of individuals.
The Role of Product Liability: Comparative Analysis with Other Industries
In industries such as the automotive and infant product industries, product liability has played a pivotal role in enhancing safety standards. Litigation in these sectors has not only provided quality assurance but also ensured consumer protection. In contrast, the vaccine industry lacks similar accountability. This absence of liability for vaccine manufacturers stands in stark contrast to the robust safety feedback loops that liability provides to other industries.
Numerous case law examples support the act that liability litigation in action is essential for bringing about safer commercial and medical products.
Brochu v. Ortho Pharmaceutical Corp
The case of Brochu v. Ortho Pharmaceutical Corp. (642 F.2d 652) was decided by the United States Court of Appeals, First Circuit, on March 3, 1981. The plaintiffs, Judith Brochu and her husband Emmanuel, residents of New Hampshire, filed a civil action against Ortho Pharmaceutical Corporation. The lawsuit was grounded on four theories: negligence, strict liability, fraudulent misrepresentation, and negligent misrepresentation. The negligence claims were withdrawn before the case went to the jury.
Key Facts:
- Judith Brochu began using Ortho-Novum 2 mg., an oral contraceptive manufactured by Ortho, in 1967.
- She suffered a cerebral thrombosis in 1971, resulting in serious bodily injuries, including paralysis, seizures, depression, and difficulty in breathing and swallowing.
- The lawsuit claimed that the oral contraceptive was defectively designed and unreasonably dangerous due to its high estrogen content.
Claims and Legal Issues:
1. Strict Liability in Tort: The plaintiffs alleged two claims under strict liability:
- The Ortho-Novum 2 mg. pill was defectively designed and unreasonably dangerous due to its high estrogen level.
- Ortho failed to warn physicians about the higher risk of cerebral thrombosis associated with this product compared to other lower-estrogen-dosage products.
2. Design Defect: The court considered whether the high estrogen content in Ortho-Novum 2 mg. made it unreasonably dangerous, constituting a design defect under New Hampshire law.
3. Warning: The case also involved the adequacy of warnings provided to physicians about the risks associated with the drug.
Court's Decision:
- The court did not categorically rule out the possibility that a drug could be classified as unreasonably dangerous under New Hampshire's balancing test.
- The evidence presented allowed the jury to find that the increased health risk posed by the 100 mcg. pill outweighed its advantages over lower dosages.
- The case also discussed the duty of drug manufacturers to warn the medical profession of dangerous side effects.
The case is significant in exploring the application of strict liability and design defect theories in the context of pharmaceutical products, particularly in relation to ethical drugs. The decision reflects a nuanced approach to balancing product utility against potential dangers.
Patterson v. Foster Forbes Glass Co. (1984)
In the case of Patterson v. Foster Forbes Glass Co., the plaintiff, Mary Patterson, filed a lawsuit against Foster Forbes Glass Co. following an incident where a baby bottle manufactured by the defendant exploded. The explosion resulted in injuries to the plaintiff, including cuts and severed tendons in her hand. The case was heard by the Missouri Court of Appeals in 1984.
Key Points of the Case:
- The incident occurred in July 1979, approximately one year after the plaintiff purchased the glass baby bottle.
- The bottle exploded when the plaintiff picked it up from a table, after it had been used and was empty.
- The explosion caused significant injuries to the plaintiff's hand.
- The plaintiff's evidence included details about the careful handling and usage of the bottle since its purchase, suggesting that the bottle had not been mishandled or subjected to abnormal conditions.
- Foster Forbes Glass Co. was identified as the manufacturer of the bottle based on the logo found on the bottle.
- The plaintiff did not present expert testimony, and the defendant did not present any evidence.
Legal Aspects:
- The case was based on Section 402A of the Restatement of Torts Second, which deals with liability for selling products in a defective condition that are unreasonably dangerous.
- The court considered whether the evidence was sufficient to establish that the bottle was defective and that it had not been mishandled after leaving the defendant's control.
- The court found that the evidence was sufficient to establish the defendant as the manufacturer and that the bottle reached the consumer without substantial change in condition.
- The court also found that the explosion of the bottle could be considered a strong circumstance inferring a defect in the product.
Outcome:
- The jury verdict was in favor of the plaintiff, awarding her $50,000 in damages.
- The defendant's appeal that the plaintiff failed to make a submissible case and that the verdict was excessive, was denied.
This case is significant as it provides a demonstration of the role of product liability litigation in holding manufacturers accountable for the safety of their products. The court's decision underscores the principle that compliance with standards does not necessarily equate to safety and that litigation can reveal inadequacies in product standards, leading to improved safety measures.
Greene v. Gerber Products Co.
The case of Greene v. Gerber Products Co. involved plaintiffs Jeremy Greene, Cetaria Wilkerson and Wendy Manemeit who filed class action lawsuits on March 8, 2016, and on January 6, 2017 against Gerber Products Co., alleging violations of various consumer protection acts. The plaintiffs claimed that Gerber's advertising and marketing of its "Good Start" line of infant formula were misleading. They argued that Gerber misrepresented the formula's ability to reduce the risk of infants developing allergies and falsely claimed that the Food and Drug Administration (FDA) endorsed the formula for reducing allergy risks.
The lawsuit sought actual, statutory, and punitive damages, as well as restitution, disgorgement, and injunctive relief. The plaintiffs' allegations were based on Gerber's claims about the formula containing partially hydrolyzed whey protein, which was purported to reduce allergy risks. The FDA had previously denied Gerber's petition for approval of a health claim related to this. The court's decision involved various aspects of the case, including the dismissal of some claims and the denial of the motion to dismiss others.
The court found that the class certification was warranted. The court held that the claims of consumers' protection violations were sufficiently pled under North Carolina and New York laws. The court also found favorably that plaintiffs sufficiently asserted claims for intentional and negligent misrepresentation of the Gerber Formula's ability to reduce allergy risks.
The plaintiffs suffered no actual physical injury in this case. Damages were limited to not receiving the full benefits of the advertised Gerber products' use of whey protein. This alone was sufficient for these multi-state class action lawsuits to move forward.
Geiser v. Simplicity, Inc.
In the case of Geiser v. Simplicity, Inc., the United States District Court for the Northern District of West Virginia dealt with a product liability claim related to the wrongful death of an infant arising from the manufacture and sale of a defective crib by Simplicity, Inc. The case involved complex legal issues, including insurance coverage disputes and the interpretation of policy exclusions.
Key aspects of the case include:
- The plaintiff's minor son tragically died in his crib when his head and neck became wedged between the headboard and the first rail of the stationary side of the crib.
- The crib had been subject to a recall due to issues with the drop-side rail, which could detach and create a gap leading to entrapment.
- The plaintiff filed a wrongful death suit alleging negligent design, construction, and manufacturing of the crib against Simplicity, Inc. and Walmart.
- James River Insurance Company, the insurer of Simplicity and Walmart, intervened in the case to resolve disputes regarding its obligation to indemnify filed for summary judgement to defend against liability for the damages claimed by the plaintiff.
- James River contended that it was not obligated to indemnify Simplicity due to a "Recalled Products Exclusion" in the insurance policies.
- The court granted James River's motion for summary judgment, finding that the insurance policies clearly excluded coverage for liability in the matters contained in the relevant claims brought against the defendants by the plaintiff.
- The court's summary judgment in favor of James River meant that simplicity and Walmart were directly liable to the plaintiff in this case.
- Following this decision, Walmart filed for summary judgement. Walmart claims there is insufficient evidence to establish Walmart's negligence or strict liability, the plaintiff engaged in spoilation of evidence, and plaintiff had not sufficiently pled for punitive damages.
- The court found there was enough evidence to hold Walmart strictly liable for design defect and use defect despite the evidence of the crib being destroyed. The recall provided sufficient evidence that the crib was defective, and Walmart was the distributor of the defective crib.
This case ultimately shows that in traditional products' liability, even distributors cannot evade responsibility. It also shows that insurance alone does not protect manufacturers or distributors from being fiscally responsible for defective products.
Vitali v. Bankers Securities Corp.
The case of Vitali v. Bankers Securities Corp. involved a negligence claim against a department store for injuries sustained due to a defective baby stroller. The incident occurred on February 22, 1956, when Mrs. Eleanor Vitali, accompanied by her niece and two babies, entered the Snellenburg Department Store in Philadelphia. Mrs. Vitali was provided with two baby strollers by the store, one of which she used for her three-year-old daughter, Bernadette. While descending a stairway in the store, the handle of Bernadette's stroller detached from the shaft, causing the stroller to fall down the stairs and seriously injure Bernadette.
The Supreme Court of Pennsylvania, in its decision on January 18, 1960, held that the department store was negligent. Key points from the case include:
1. Negligence of the Department Store: The court found that the department store was negligent in providing a defective baby stroller. The store failed to produce evidence of any inspections of the strollers and could not demonstrate that the handle's detachment was an unforeseeable event.
2. Incontrovertible Physical Facts Rule: The court ruled that this rule was inapplicable in this case. The rule is only relevant in clear cases without variables or doubtful estimates, which was not the situation here.
3. Duty to Inspect: The court emphasized that the store had a duty to inspect the strollers to ensure they were in safe condition, especially given their use by infants. The store failed to show that it conducted any such inspections.
Outcomes:
The jury awarded $8,000 (worth $90,500 in 2023 in damages to Bernadette and $200 (current worth $2,200) to her sister, Nancy, who was slightly injured. The parents received no award. The store's motions for judgment notwithstanding the verdict and for a new trial were dismissed.
The court noted that the store, by providing strollers as part of its service to customers, assumed the responsibility to ensure their safety. Mrs. Vitali, as a customer, had the right to expect that the equipment provided was in a reasonably safe condition.
The court also rejected the store's arguments that the physical evidence contradicted the plaintiffs' version of events and that the mother's use of the stroller constituted intervening negligence.
The case highlights the legal responsibilities of businesses in ensuring the safety of products they provide to customers, especially when those products are used by vulnerable individuals such as children, and the evidence that is presented should be weighed in accordance with its value to the decision, not its threat to the corporation.
Burks v. Abbott Laboratories
The case of Burks v. Abbott Laboratories involves a products liability claim under the Louisiana Products Liability Act (LPLA) related to the consumption of powdered infant formula. The plaintiffs, Evan Burks and his parents, Rockland and Adrienne Burks, brought the action against Abbott Laboratories, Bristol-Myers Squibb Company, and Mead Johnson Company, alleging that the powdered infant formulas Similac and Enfamil were responsible for Evan's severe brain damage due to neonatal Enterobacter sakazakii meningitis.
Key points from the case:
1. Background: Evan Burks was born full term and initially had a normal immune system. The parents received and purchased the powdered infant formulas Similac and Enfamil. After consuming these formulas, Evan was diagnosed with neonatal E. sakazakii meningitis, leading to severe brain damage. The plaintiffs allege that the formulas were the source of the bacteria causing the illness.
2. Claims: The plaintiffs filed claims under the Louisiana Products Liability Act (LPLA), asserting that Similac and Enfamil were unreasonably dangerous in composition, construction, or design, because of inadequate warning, and for failure to conform to an express warranty.
Outcomes:
The court's review focused on whether the plaintiffs adequately pled their claims under the LPLA. The court considered the standards for a product being unreasonably dangerous in construction or composition, in design, because of inadequate warnings, or due to nonconformity to an express warranty.
The court granted in part and denied in part the defendants' motions to dismiss the Complaint for failure to state a claim.
The court found the plaintiff sufficiently argued that the infant formula was unreasonably dangerous because of inadequate warnings.
This ruling was favorable to the plaintiff and led to several other motions allowing plaintiff's evidence and experts to be admitted. The case was originally set for a jury trial, but the defendants ended up settling with the plaintiffs prior to the trial. The case was resultingly dismissed with prejudice by stipulation of the parties. (See docket: 0:08cv03414).
This case shows that even an order denying in-part the defendant's motion for summary judgment dismissal of the case would be favorable to plaintiff. The defendants did not want to risk going to trial and decided to accept loss. The defendants also took corrective action. In the year the case settled, Abbott labs decided to issue a recall of its products containing imported milk products from China. (Source: https://www.Bizjournals.Com/chicago/news/2013/08/07/abbott-labs-double-whammy-in-china.Html).
Birchfield v. Texarkana Memorial Hospital
In the case of Birchfield v. Texarkana Memorial Hospital, a child, Kellie Birchfield, was harmed due to complications arising from her premature birth. She was born with a non-functioning right eye and later developed retrolental fibroplasia (RLF) in her left eye, which led to total blindness. RLF, now more commonly known as retinopathy of prematurity (ROP), is a disease that affects prematurely born babies. It is thought to be caused by disorganized growth of retinal blood vessels which may result in scarring and retinal detachment.
The plaintiffs in the case alleged that the negligence of the treating physicians and the hospital in failing to properly monitor and treat the condition led to Kellie's blindness. Specifically, they claimed that the hospital did not adequately monitor arterial blood gases in premature infants, a factor that was known to be associated with the development of RLF. The jury found Dr. Jon Hall, Dr. Noel Cowan, Dr. Betty Lowe and the Wadley Hospital. Further, the WADLEY hospital was also found grossly negligent and in violation of the Deceptive Trade Practices Act.
Key points from the case include:
1. Negligence and Gross Negligence: The jury found the individual doctors negligent and Wadley both negligent and grossly negligent in failing to properly treat Kellie. The hospital was accused of not adequately monitoring arterial blood gases in premature infants, despite warnings from the medical community about the risks of RLF.
2. D.T.P.A. Violation: The jury also found that Wadley violated the D.T.P.A. by misrepresenting its capability to handle premature babies.
Outcomes:
The Birchfields were awarded $2,109,500 in actual damages against all defendants, jointly and severally, and $4,219,000 in exemplary damages against Wadley hospital.
The trial court's judgment was initially affirmed by the court of appeals but was later reversed and remanded for trial. The Supreme Court of Texas reversed the judgment of the court of appeals and rendered judgment for the Birchfields.
The case addressed the definitions of negligence and ordinary care, and the applicability of the locality rule in defining these terms.
The case highlights complex issues surrounding medical negligence, the role of hospital facilities in patient care, and the legal processes involved in such litigation.
Wholescale Systemic Reform Requires Reinstating Vaccine Manufacturer Liability
None of the important, nuanced issues raised in the sample of liability cases and addressed by the courts and juries are allowed to be addressed when a vaccine injures or kills as an infant, toddler, child, teen, or adult. The NVICP is gamed against plaintiffs, and the CICP is even more so.
Imagine in the case of car seats, bottles, strollers, and cribs if new cases were not allowed to cite past cases to establish precedent in spite of past findings of fault and awards.
That’s the NVICP and CICP.
Imagine if lawyers and experts were goaded into providing specific types of testimony and arguments - and not others - on the basis of whether a judge - who works for the defendant - is likely to compensate them for their time.
That’s the NVICP and CICP.
Imagine if in clear cases of liability, causality had to be established - even in the absence of any other evidence of any other potential cause of injury or death - and no precedents could be cited.
That’s the NVICP and CICP.
There are two fairly well-known instances in of NVICP Special Masters who break the rules of cited their own past determinations as justification of new determinations to deny compensation.
In the NVICP complaint of Gamboa-Avila v. Secretary of the Department of Health and Human Services, No 12-925V), Special Master Corcoran wrote in his dismissal:
“Having reviewed the above plus the filed medical records, expert reports, and associated literature, I hereby deny an entitlement award. As discussed in greater detail below, Petitioner has not preponderantly established that the pneumococcal vaccine can cause GBS—and this alone is a sufficient basis for dismissal. I have reached the same determination in several prior Program cases, based on a comparable theory, and nothing advanced by Petitioner in this case supports an alternative finding, or reflects new scientific/medical developments that would provide the occasion to reconsider my prior reaction to the theory”.
Since Petitioners are not allowed to cite precedent, placing the burden of proof of victims of vaccine injuries, this Special Master’s citation of his own prior determinations is an example of judicial tyranny. Special Masters are neither scientists nor physicians, and their ability to assess causality is imperfect. Their reliance on their own inexpert opinions on these matters is, to say the least, problematic.
Similarly, Chief Special Master Vowell, who denied all of 20 cases in a Hepatitis B / Type 1 diabetes omnibus (e.g., Bryant v. Secretary of the Department of Health and Human Services, No 12-480V) has used the same argument without calling for medical expert testimony in complaints of Merck’s Gardasil(TM) vaccine causing Type 1 diabetes. Other Special Masters have found in other petitions sufficient evidence of causality in other cases. The inability of petitioners to cite precedent inherent inequity strains logic, reason, and any sense of fairness in justice.
Imagine of doctor expert witnesses in cases of injury and death working for the corporations were allowed to re-diagnose standing diagnoses - determined by attending physicians via examination, biomarkers and the practice of medicine or by autopsy - and without ever ordering a new test, or ever examining the patient, the physician working to defend the corporation could change the fundamental nature of the case via diagnostic substitution.*
That’s the NVICP and CICP.
[FROM JLW: This happened in two cases in which I was involved, prior to a Special Master’s attempt to bribe me to change my testimony - upon which I immediately reported the crime and refused any payment whatsover. The case derailed by the bribery attempt was dismissed by the offending Special Master. I have not participated and will never participate in this corrupt simulation of a judicial system due to its inherent corruption.]
The current state of vaccine liability in the U.S. requires a thoughtful reassessment. Balancing public health goals with individual rights and product safety is not just a legal imperative but a moral one. The need for legal and policy changes to address the current shortcomings in vaccine liability is clear. This call to action is directed at legal professionals, policymakers and lawmakers, urging them to engage in meaningful reform for the betterment of public health and justice.
The reinstatement of liability for vaccine manufacturers is imperative for ensuring product safety. Liability serves as a critical quality control feedback mechanism, prompting manufacturers to prioritize safety. Counterarguments concerning the potential stifling effect of litigation on vaccine innovation and availability must be addressed. However, the balance between innovation and safety is a cornerstone of consumer protection and public health.
To address the shortcomings in the NVICP and CICP, abolition is the only logical solution that could reinstate liability and provide the industry with real accountability on product safety. Legal pathways for reintroducing balanced liability in vaccine manufacturing not only should but must be explored. Advocacy for greater public and professional awareness of these issues is also crucial.
The current state of vaccine liability in the U.S. requires a thoughtful reassessment. Balancing public health goals with individual rights and product safety is not just a legal imperative but a moral one. The need for legal and policy changes to address the current shortcomings in vaccine liability is clear. This call to action is directed at legal professionals and policymakers, urging them to engage in meaningful reform for the betterment of public health and justice.
Take, for instance, the case of infant car seats. In Hinson vs. Dorel Juvenile Group the family of a 4 year-old boy who was paralyzed in a car accident while sitting in a forward-facing car seat while under 2 years of age has been awarded $34 million by a federal jury. Dorel Juvenile Group was found negligent for failing to warn about the dangers of putting children under two years old in forward-facing car seats.
The award provided motivation for all car seat manufacturers to adhere to the duty-to-warn principle, something that was also distorted by the 1986 Act. Now car seats are safer for millions of infants and children worldwide, but vaccines are merely promoted as safe.
In the realm of infant nutrition, the Similac and Enfamil lawsuits in the early 2000s highlighted issues with certain baby formulas that were linked to severe health problems in infants. These cases not only resulted in financial compensation for affected families but also prompted formula manufacturers to conduct more thorough testing and improve labeling on their products.
The realm of infant and child safety saw further litigation-led improvements with the case of Consumer Product Safety Commission (CPSC) v. Playskool Inc. in 1997, where the company's infant cribs were found to be hazardous. The resulting product recall and the CPSC's subsequent regulations led to the development of safer cribs, with more stringent manufacturing standards to prevent accidental injuries.
The Value of Litigation in Enhancing Product Safety
October, 2010. Graco recalls two million strollers after four babies strangled | National Post
There are uncountable numbers of additional examples of how consumers are protected, and how commercial products can be made safer by liability litigation. The multidistrict litigation In re: Bisphenol-A (BPA) Polycarbonate Plastic Products Liability Litigation, MDL No. 1967, consolidated in 2008, addressed the health risks posed by BPA in baby bottles. The litigation led to a voluntary phase-out of BPA in baby bottles by major manufacturers and the eventual ban of BPA in baby bottles and sippy cups by the FDA in 2012.
There is no reason why unsafe components of vaccines cannot similarly be phased out using plain-language liability findings and enforceable court orders. Phasing out of aluminum can, in the professional opinion of many scientists and doctors, should be done. A study published in 2020 found that infants in the first year of life experience chronic whole-body aluminum toxicity on the CDC pediatric vaccine schedule, and that on the first day of life, infants whose parents accept the HepB vaccine experience 15 times the safe level determined by FDA for adults, adjusted per body weight (See: Acute exposure and chronic retention of aluminum in three vaccine schedules and effects of genetic and environmental variation).
Ethical and rational observers often view litigation as a valuable and necessary mechanism to prevent the externalization of costs by corporations. When companies fail to ensure the safety of their products, it is often the public that bears the cost, both financially and in terms of health and well-being. A report by IPAK, The Institute for Pure and Applied Knowledge, found that aluminum hydroxide, the same compound used in over 60% of childhood vaccines, is routinely and reliably used to induce autoimmune conditions in mice and rats at per body weight doses that are lower than infants are exposed to via the CDC recommended vaccine schedule in the first year of life.
The Final Question
The question then arises: why have vaccine manufacturers been granted special dispensation from such liability? The National Childhood Vaccine Injury Act of 1986 established the National Vaccine Injury Compensation Program (VICP), effectively shielding vaccine manufacturers from most liability related to vaccine injuries unless fraud can be demonstrated in the NVICP proceedings or in the case of fraud by the vaccine manufacturers. In spite of a massive amount of evidence of intentionally biased science use to make vaccines appear safer and more effective, NVICP lawyers do not use the evidence of mass fraud perpetuated by the CDC and the vaccine makers to appeal vaccine injury cases that fail to yield awards.
This unique legal protection was justified by the government as a means to stabilize the vaccine market and ensure a steady supply of vaccines, which were considered vital to public health. This absurd arrangement begs the question of safety and efficacy and has become a travesty of justice.
The 1986 Act removed a key incentive for vaccine manufacturers to improve the safety of their products. The absence of traditional legal pressures that have led to enhanced safety in other industries may lead one to question whether vaccine manufacturers are being held to the same standards of accountability.
The role of the judiciary in this context is not merely to interpret the law in a vacuum but to consider the broader implications of its decisions on public health and individual rights. The courts serve as a critical balance, ensuring that public health measures are not only legally sound but also ethically and scientifically justified. This judicial oversight is essential in maintaining public trust and ensuring that policies are implemented fairly and effectively. Special Masters who participate in the NVICP should take an inventory of their personal morality and their obligation to humanity to act on behalf of people first. Otherwise, they are complicit. With every biased reinforcement of the false narrative of safety of mercury and aluminum, for example, they undermine their authority and write the long-term legacy. History will remember.
Similarly, authority vested in public health institutions by the public should not be taken as an immutable given. It must be earned and maintained through a demonstrated track record of integrity, transparency, and efficacy. Public health measures must be continually assessed for their impact on the community and their respect for individual autonomy. The balance between protecting public health and upholding human rights and dignity is delicate and must be navigated with care and consideration.
In light of these considerations, it becomes clear that public health authority is contingent upon its ability to adapt and respond to new challenges. It must be informed by the latest scientific evidence, guided by ethical principles, and committed to transparency, human rights, and human dignity in its decision-making processes. Only by upholding these standards can public health institutions hope to maintain their authority and the public's trust.
As we move forward, it is imperative that we support a legal and public health framework that respects both the collective welfare and individual rights. The tools of public health are powerful and necessary, but their implementation must always be weighed against the fundamental principles of human rights and dignity. The courts, in their role as interpreters of the law, are a vital component of this process, ensuring that public health policy is not only effective but also just.
Moving Forward with a Professional and Informed Dialogue
It has been the habit of vaccine proponents to attack and attempt to belittle those who have been skeptical of the practiced patterns of deception used to bolster the public’s impression of vaccine safety. Special Masters even routinely threaten to not compensate witnesses and lawyers unless they adopt the views of the program. In one case, Dr. Lyons-Weiler overtly refused a recorded bribe from one Special Master to change his testimony regarding the risks of autoimmunity and other harms from aluminum hydroxide. These are not professional tactics: they are bullying and tyrannical actions deserving of both civil and tort liability actions themselves.
In light of these revelations, it is clear that the dialogue surrounding vaccine policy and litigation must be grounded in a nuanced understanding of both the legal and scientific landscapes and it must be raised to a professional standard. We must remain open to evolving evidence, ensure that public health policies are adaptable, and recognize the value of legal challenges in refining and upholding these policies.
As we continue to navigate these complex issues, let us commit to a discourse that is informed, inclusive, objective, and reflective of the multifaceted nature of public health, medicine, and the goals of science. Our collective goal should be to foster an environment where vaccine policies are developed and implemented with transparency, scientific integrity, and respect for individual autonomy.
DR. LYONS-WEILER IS AVAILABLE FOR INTERVIEWS VIA media@ipak-edu.org
Cases Referenced:
Brochu v. Ortho Pharm. Corp., 642 F.2d 652 (1st Cir. 1981)
Patterson v. Foster Forbes Glass Co., 674 S.W.2d 599 (Mo. App. E. Dist. 1984)
Greene v. Gerber Products Co., 262 F. Supp. 3d 38 (E.D.N.Y. 2017)
Geiser v. Simplicity, Inc., No. 5:10CV21, 2011 WL 2413668 (N.D.W. Va. June 10, 2011); 2012 WL 174951 (N.D.W. Va. Jan. 20, 2012)
Vitali v. Bankers Securities Corp., 157 A.2d 633 (Pa. 1960)
Burks v. Abbott Laboratories, No. CIV 08-3414 JRT/JSM, 2010 WL 1576779 (D. Minn. Apr. 20, 2010)
Birchfield v. Texarkana Meml. Hosp., 747 S.W.2d 361 (Tex. 1987)
FROM 11/29/2023 - Dr. James Lyons-Weiler’s lecture on this topic in Wayne Rohde’s course on the NVICP AND CICP at ipak-edu.org - THE VALUE OF VACCINE LIABILITY LITIGATION
IF YOU ARE INTERESTED IN TAKING A COURSE ON VACCINE LAW, EMAIL US AT INFO@IPAK-EDU.ORG
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Excellent! Extremely well written.
Thank you.
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Well done! It is critical that vaccinology be held to the same standard as industries. Actual legal cases would allow for discovery - something that the NVICP and CICP programs do not allow. If there is really solid safety science here, then the public should be allowed to see it.