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55-442: The Office of Special Masters of the U.S. Court of Federal Claims , popularly known as " vaccine court ", administers a no-fault system for litigating vaccine injury claims. These claims against vaccine manufacturers cannot normally be filed in state or federal civil courts, but instead must be heard in the U.S. Court of Federal Claims , sitting without a jury. The National Vaccine Injury Compensation Program ( VICP or NVICP )

110-460: A no-fault system for resolving vaccine injury claims. Compensation covers medical and legal expenses, loss of future earning capacity, and up to $ 250,000 for pain and suffering; a death benefit of up to $ 250,000 is available. If certain minimal requirements are met, legal expenses are compensated even for unsuccessful claims. Since 1988, the program has been funded by an excise tax of 75 cents on every purchased dose of covered vaccine. To win an award,

165-399: A causal relationship. In 2008, the federal government settled a case brought to the vaccine court by the family of Hannah Poling , a girl who developed autistic-like symptoms after receiving a series of vaccines in a single day. The vaccines given were DTaP , Hib , MMR , varicella , and inactivated polio . Poling was diagnosed months later with encephalopathy (brain disease) caused by

220-455: A claim with the Court of Federal Claims requires a $ 402.00 filing fee, which can be waived for those unable to pay. Medical records such as prenatal, birth, pre-vaccination, vaccination, and post-vaccination records are strongly suggested, as medical review and claim processing may be delayed without them. Because this is a legal process most people use a lawyer, though this is not required. By 1999

275-419: A claimant must have experienced an injury that is named as a vaccine injury in a table included in the law within the required time period or show a causal connection. The burden of proof is the civil law preponderance-of-the-evidence standard, in other words a showing that causation was more likely than not. Denied claims can be pursued in civil courts, though this is rare. The VICP covers all vaccines listed on

330-603: A course of treatment and would have declined the medical treatment had proper information been provided in advance. The Supreme Court of the United Kingdom decided in 2018 that the duty of care extended to information given to patients by clerical staff of a healthcare provider, such that a medical negligence case might be predicated upon an administrative mistake. A patient at Croydon Health Services NHS Trust 's emergency department had severe brain damage having been given misleading information by staff at reception. He

385-609: A mitochondrial enzyme deficit, a mitochondrial disorder ; it is not unusual for children with such deficits to develop neurologic signs between their first and second years. There is little scientific research in the area: no scientific studies show whether childhood vaccines can cause or contribute to mitochondrial disease, and there is no scientific evidence that vaccinations damage the brains of children with mitochondrial disorders. Although many parents view this ruling as confirming that vaccines cause regressive autism, most children with autism do not seem to have mitochondrial disorders, and

440-461: A no-fault compensation scheme to stabilize a vaccine market adversely affected by an increase in vaccine-related lawsuits, and to facilitate compensation to claimants who found pursuing legitimate vaccine-inflicted injuries too difficult and cost prohibitive. A form of strict liability has been supported in law in the Netherlands since the early 1990s for bicycle-motor vehicle collisions. In

495-464: A nutshell, this means that, in a collision between a car and a cyclist, the driver is deemed to be liable to pay damages and his insurer (motor vehicle insurance is mandatory in the Netherlands, while cyclist insurance is not) must pay the full damages, as long as 1) the collision was unintentional (i.e. neither party, motorist or cyclist, intentionally crashed into the other), and 2) the cyclist

550-445: A patient. The negligence might arise from errors in diagnosis, treatment, aftercare or health management. An act of medical malpractice usually has three characteristics. Firstly, it must be proven that the treatment has not been consistent with the standard of care , which is the standard medical treatment accepted and recognized by the profession. Secondly, it must be proven that the patient has suffered some kind of injury due to

605-530: A petitioner either establishes a "Tabled Injury" or proves "causation in fact" by proving three prongs: This ruling held that tetanus vaccine caused a particular case of optic neuritis , even though no scientific evidence supported the petitioner's claim. Other rulings have allowed petitioners to gain awards for claims that the MMR vaccine causes fibromyalgia , that the Hib vaccine causes transverse myelitis , and that

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660-604: A process through which documents such as medical records are exchanged, and depositions are taken by parties involved in the lawsuit. A deposition involves the taking of statements made under oath about the case. Certain conversations are not discoverable due to issues of privilege , a legal protection against discovery,  but most conversations between the parties and witnesses are discoverable. Consequences for patients and doctors vary by country. A no-fault system may provide compensation to people who have medical outcomes that are significantly worse than would be anticipated under

715-620: A vaccine, so it does not fall under the provisions of the vaccine act. The claims that vaccines (or thimerosal in vaccines) caused autism eventually had to be filed in the vaccine court as part of the Omnibus Autism Proceeding . The scientific consensus , developed from substantial medical and scientific research, states that there is no evidence supporting these claims, and the rate of autism continues to climb despite elimination of thimerosal from most routine early childhood vaccines. Major scientific and medical bodies such as

770-475: Is also found in criminal law. Strict liability often applies to vehicular traffic offenses: in a speeding case, for example, whether the defendant knew that the posted speed limit was being exceeded is irrelevant; the prosecutor need only prove that the defendant was driving the vehicle in excess of the posted speed limit. In the United States, strict liability can be determined by looking at the intent of

825-565: Is inherently dangerous, as specified under the "ultrahazardous" definition, the defendant is then strictly liable for any damages caused by such possession, no matter how careful the defendant is safeguarding them. In the field of torts , prominent examples of strict liability may include product liability , abnormally dangerous activities (e.g., blasting ), intrusion onto another's land by livestock , and ownership of wild animals . Other than activities specified above (like ownership of wild animals, etc), US courts have historically considered

880-564: Is normally based on the tort of negligence . Although the law of medical malpractice differs significantly between nations, as a broad general rule liability follows when a health care practitioner does not show a fair, reasonable and competent degree of skill when providing medical care to a patient. If a practitioner holds himself out as a specialist a higher degree of skill is required. Jurisdictions have also been increasingly receptive to claims based on informed consent , raised by patients who allege that they were not adequately informed of

935-624: Is proved. Absolute liability, however, requires only an actus reus . In the United States courts have applied strict liability to vaccines since the Cutter incident in 1955. Some vaccines (e.g. for Lyme disease ) have been removed from the market because of unacceptable liability risk to the manufacturer. The National Childhood Vaccine Injury Act (NCVIA) was enacted in 1986 to make an exception for childhood vaccines that are required for public school attendance. The NCVIA created

990-610: Is specified, under the Model Penal Code (MPC), the default mens rea requirement is recklessness, which the MPC defines as "when a person consciously disregards a substantial and unjustifiable risk with respect to a material element". Strict liability laws can also prevent defendants from raising diminished mental capacity defenses, since intent does not need to be proven. In the English case of Sweet v Parsley (1970), it

1045-403: Is the rule Rylands v Fletcher , where it was held that "any person who for his own purposes brings on his lands and collects and keeps there anything likely to do mischief if it escapes, must keep it in at his peril, and, if he does not do so, is prima facie answerable for all the damage which is the natural consequence of its escape". If the owner of a zoo keeps lions and tigers, he is liable if

1100-578: The Institute of Medicine and World Health Organization , as well as governmental agencies such as the Food and Drug Administration and the CDC reject any role for thimerosal in autism or other neurodevelopmental disorders. As of May 2023, nearly $ 4.6 billion in compensation and $ 450 million in attorneys’ fees have been awarded. The following table shows the awards by main classes of vaccines made to victims in

1155-414: The U.S. Fifth Circuit Court of Appeals ruled that plaintiffs suing three manufacturers of thimerosal could bypass the vaccine court and litigate in either state or federal court using the ordinary channels for recovery in tort . This was the first instance where a federal appeals court has held that a suit of this nature may bypass the vaccine court. The argument was that thimerosal is a preservative, not

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1210-434: The hepatitis B vaccine causes Guillain–Barré syndrome , chronic demyelinating polyneuropathy, and multiple sclerosis . In the most extreme of these cases, a 2006 petitioner successfully claimed that a hepatitis B vaccine caused her multiple sclerosis despite several studies showing that the vaccine neither causes nor worsens the disease, and despite a conclusion by the Institute of Medicine that evidence favors rejection of

1265-697: The MMR vaccine and autism. Many studies have failed to conclude that there is a causal link between autism spectrum disorders and vaccines, and the current scientific consensus is that routine childhood vaccines are not linked to the development of autism . Several claimants have attempted to bypass the VICP process with claims that thimerosal in vaccines had caused autism, but these were ultimately not successful. They have demanded medical monitoring for vaccinated children who do not show signs of autism and have filed class-action suits on behalf of parents. In March 2006,

1320-563: The NHS to court. In 2019/20 11,682 medical negligence claims and reported incidents were received by the NHS – an increase of 9.3% on 2018/19. In the same time, the total value of clinical negligence claims under the CNST scheme reduced from £8.8 billion, to £8.3 billion. In many jurisdictions, a medical malpractice lawsuit is initiated officially by the filing and service of a summons and complaint . The parties subsequently engage in discovery ,"

1375-578: The National Vaccine Injury Compensation Program (VICP) in 1988 to compensate individuals and families of individuals injured by covered childhood vaccines. The VICP was adopted in response to concerns over the pertussis portion of the DPT vaccine. Several U.S. lawsuits against vaccine makers won substantial awards. Most makers ceased production, and the last remaining major manufacturer threatened to do so. The VICP uses

1430-413: The VICP comes as result of a negotiated settlement between the parties in which HHS has not concluded, based upon review of the evidence, that the alleged vaccine(s) caused the alleged injury". Cases are settled to minimize the risk of loss for both parties, to minimize the time and expense of litigation, and to resolve petitions quickly. Of the remaining cases, in the vaccine court, as in civil tort cases,

1485-401: The VICP comes as result of a negotiated settlement between the parties in which HHS has not concluded, based upon review of the evidence, that the alleged vaccine(s) caused the alleged injury". Cases are settled to minimize the risk of loss for both parties, to minimize the time and expense of litigation, and to resolve petitions quickly. The U.S. Department of Health and Human Services set up

1540-540: The VICP. Of these claims, 925 (see previous rulings ), were compensated, with 1,158 non-autism and 350 autism claims dismissed, and one autism-like claim compensated; awards (including attorney's fees) totaled $ 847 million. The VICP also applies to claims for injuries suffered before 1988; there were 4,264 of these claims of which 1,189 were compensated with awards totaling $ 903 million. As of October 2019, $ 4.2 billion in compensation (not including attorneys fees and costs) has been awarded. As of December 2020, filing

1595-581: The Vaccine Injury Table maintained by the Secretary of Health and Human Services; in 2007 the list included vaccines against diphtheria , tetanus , pertussis (whooping cough), measles , mumps , rubella (German measles), polio , hepatitis B , varicella (chicken pox), Haemophilus influenzae type b , rotavirus , and pneumonia . From 1988 until January 8, 2008, 5,263 claims relating to autism, and 2,865 non-autism claims, were made to

1650-413: The average claim took two years to resolve, and 42% of resolved claims were awarded compensation, as compared with 23% for medical malpractice claims through the tort system. There is a three-year statute of limitations for filing a claim, timed from the first manifestation of the medical problem. More than 5,300 petitions alleging autism caused by vaccines have been filed in the vaccine court. In 2002,

1705-494: The beneficial effect of simplifying and thereby expediting court decisions in these cases, although the application of strict liability may seem unfair or harsh, as in Re Polemis . Under the English law of negligence and nuisance , even where tortious liability is strict, the defendant may sometimes be liable only for the reasonably foreseeable consequences of his act or omission. An early example of strict liability

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1760-432: The big cats escape and cause damage or injury. In strict liability situations, although the plaintiff does not have to prove fault, the defendant can raise a defense of absence of fault, especially in cases of product liability , where the defense may argue that the defect was the result of the plaintiff's actions and not of the product, that is, no inference of defect should be drawn solely because an accident occurs. If

1815-534: The burden of proof is a preponderance of evidence , but while in tort cases this is met by expert testimony based on epidemiology or rigorous scientific studies showing both general and specific causation, in the vaccine court, the burden is met with a three prong test established in Althen , a 2005 United States Court of Appeals for the Federal Circuit ruling. Althen held that an award should be granted if

1870-503: The case of a minor). The trend toward strict liability in the United States during the mid to late 20th century nearly destroyed the small aircraft industry by the mid 1990s. Production had dropped from a peak of 18,000 units per year in 1978 to under only a few hundred by 1993. With a concurrent increase in the cost of liability insurance per airplane rising from $ 50 in 1962 to $ 100,000 in 1988, and many underwriters had begun to refuse all new policies. The concept of strict liability

1925-463: The case was settled without proof of causation. With the commencement of hearings in the case of Cedillo v. Secretary of Health and Human Services (Case #98-916V), the argument over whether autism is a vaccine injury moved into the vaccine court. A panel of three special masters began hearing the first cases of the historic Omnibus Autism Proceedings in June 2007. There were six test cases in all, and

1980-448: The circumstances, or where there is proof of injury resulting from medical error, without regard to whether or not malpractice occurred. Some no fault systems are restricted to specific types of injury, such as a birth injury or vaccine injury . Medico-legal action across multiple countries is more common against male than female doctors ( odds ratio of 2.45). A 2016 survey of US physicians found that 8.2 percent of physicians under

2035-441: The court instituted the Omnibus Autism Proceeding in which plaintiffs were allowed to proceed with the three cases they considered to be the strongest before a panel of special masters. In each of the cases, the panel found that the plaintiffs had failed to demonstrate a causal effect between the MMR vaccine and autism. Following this determination, the vaccine court has routinely dismissed such suits, finding no causal effect between

2090-439: The entire record of the cases is publicly available. The lead petitioners, the parents of Michelle Cedillo, claimed that Michelle's autism was caused by a vaccine. Theresa and Michael Cedillo contended that thimerosal seriously weakened Michelle's immune system and prevented her body from clearing the measles virus after her vaccination at the age of fifteen months. At the outset Special Master George Hastings, Jr. said "Clearly

2145-414: The failure to properly diagnose a disease or medical condition, the failure to provide appropriate treatment for a medical condition, and unreasonable delay in treating a diagnosed medical condition. In some jurisdictions a medical malpractice action may be allowed even without a mistake from the doctor, based upon principles of informed consent , where a patient was not informed of possible consequences of

2200-471: The following activities as "ultrahazardous": On the other hand, US courts typically rule the following activities as not "ultrahazardous": parachuting, drunk driving, maintaining power lines, and letting water escape from an irrigation ditch. In the English system, in reality, responsibility is tailored to the evidentiary system: that is, to the admissibility of defenses and excuses capable of neutralizing

2255-431: The legislature. If the legislature seems to have purposefully left out a mental state element ( mens rea ) because they felt mental state need not be proven, it is treated as a strict liability. However, when a statute is silent as to the mental state ( mens rea ) and it is not clear that the legislature purposely left it out, the ordinary presumption is that a mental state is required for criminal liability. When no mens rea

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2310-462: The loss of herd immunity . Between its inception in 1986 and May 2023, it has awarded a total of $ 4.6 billion, with the average award amount between 2006 and 2020 being $ 450,000, and the award rate (which varies by vaccine) being 1.2 awards per million doses administered. The Health Resources and Services Administration reported in July 2022 that "approximately 60 percent of all compensation awarded by

2365-408: The negligence. In other words, an injury without negligence or an act of negligence without causing any injury cannot be considered malpractice. Thirdly, it must be proven that the injury resulted in significant damages such as disability , unusual pain , suffering , hardship, loss of income or a significant burden of medical bills . In common law jurisdictions, medical malpractice liability

2420-421: The petitioner. This is "to ensure that vaccine claimants have readily available a competent bar to prosecute their claims". The Homeland Security Act of 2002 provides another exception to the exclusive jurisdiction of the vaccine court. If smallpox vaccine were to be widely administered by public health authorities in response to a terrorist or other biological warfare attack, persons administering or producing

2475-499: The plaintiff can prove that the defendant knew about the defect before the damages occurred, additional punitive damages can be awarded to the victim in some jurisdictions. The doctrine's most famous advocates were Learned Hand , Benjamin Cardozo , and Roger J. Traynor . Strict liability is sometimes distinguished from absolute liability . In this context, an actus reus may be excused from strict liability if due diligence

2530-631: The punishability of the actus reus; and therefore the different forms of strict liability can be differentiated according to the defenses allowed by the individual legal systems. In tort law, strict liability is the imposition of liability on a party without a finding of fault (such as negligence or tortious intent). The claimant need only prove that the tort occurred and that the defendant was responsible. The law imputes strict liability to situations it considers to be inherently dangerous. It discourages reckless behaviour and needless loss by forcing potential defendants to take every possible precaution. It has

2585-406: The risks of medical procedures before agreeing to treatment. As law varies by jurisdiction, the specific professionals who may be targeted by a medical malpractice action will vary depending upon where the action is filed. Among professionals that may be potentially liable under medical malpractice laws are: Among the acts or omissions that may potentially support a medical malpractice claim are

2640-483: The story of Michelle's life is a tragic one," while pledging to listen carefully to the evidence. On February 12, 2009, the court ruled in three test cases that the combination of the MMR vaccine and thimerosal-containing vaccines were not to blame for autism. Hastings concluded in his decision, "Unfortunately, the Cedillos have been misled by physicians who are guilty, in my view, of gross medical misjudgment." The ruling

2695-574: The vaccine would be deemed federal employees and claims would be subject to the Federal Tort Claims Act , in which case claimants would sue the U.S. Government in the U.S. district courts, and would have the burden of proving the defendants' negligence, a much more difficult standard. Notably, the Health Resources and Services Administration reported in July 2022 that "approximately 60 percent of all compensation awarded by

2750-486: The years 2006-2017. This shows that on average 1.2 awards were made per million vaccine doses. It also shows that multiple vaccines such as MMR do not have an abnormal award rate. * This covers the vaccinations known by the abbreviations DT, DTaP, DTaP-HIB, DTaP-IPV, DTap-IPV-HIB, Td, Tdap Self representation is permitted, although the NVICP also pays attorneys fees out of the fund, separate from any compensation given to

2805-411: Was appealed to the U.S. Court of Appeals, and upheld. On March 13, 2010, the court ruled in three test cases that thimerosal-containing vaccines do not cause autism . Special Master Hastings concluded, "The overall weight of the evidence is overwhelmingly contrary to the petitioners' causation theories." Strict liability Under the strict liability law, if the defendant possesses anything that

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2860-544: Was established by the 1986 National Childhood Vaccine Injury Act (NCVIA), passed by the United States Congress in response to a threat to the vaccine supply due to a 1980s scare over the DPT vaccine . Despite the belief of most public health officials that claims of side effects were unfounded, large jury awards had been given to some plaintiffs, most DPT vaccine makers had ceased production, and officials feared

2915-442: Was held that where a statute creating a crime made no reference to intention, then mens rea would be imputed by the court, so that the crime would not be one of strict liability. Medical malpractice Medical malpractice is a legal cause of action that occurs when a medical or health care professional, through a negligent act or omission, deviates from standards in their profession, thereby causing injury or death to

2970-418: Was not in error in some way. Even if a cyclist made an error, as long as the collision was still unintentional , the motorist's insurance must still pay half of the damages. This does not apply if the cyclist is under 14 years of age, in which case the motorist must pay full damages. If it can be proved that a cyclist intended to collide with the car, then the cyclist must pay the damages (or their parents in

3025-482: Was told that he would be seen by a doctor in four or five hours and left the hospital, when actually he would be seen inside 30 minutes by a triage nurse. £1.7 billion was spent on clinical negligence claims by the NHS in 2016/17. 36% of that was legal costs. In January 2018, NHS England announced that NHS hospitals in England would no longer provide office or advertising space for lawyers who encourage people to take

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