VACCINE LITIGATION

by Lou Addington, RN, CLNC

Nurses and Immunizations 

     In order for the legal nurse consultant to effectively work in the field of vaccine litigation, they must have a good understanding of all of the issues related to vaccines. A working knowledge of the National Childhood Vaccine Injury Act of 1986, the Vaccine Adverse Event Reporting System (VAERS), as well as how vaccines are developed and tested is imperative to the accurate assessment of vaccine injuries.  As nurses, the administration of vaccines (tetanus, flu shots, and childhood immunizations) is a routine duty performed throughout the course of our clinical work.  And, of course, in order to keep us safe in our duties as nurses, we are subjected to numerous immunizations ourselves. 

     As parents, we try to stick to the rigid immunization schedules dictated by the government and medical community, so that our children are "up to date" on all of their shots.   We have been programmed to believe that this is the key to living a long and healthy life.   

     So much emphasis and education is focused on making sure that everyone is immunized according to the schedules, that there is very little room allowed for deviations.  As nurses, we recognize that patients vary and their reactions to drugs and treatments are so individualized, that we routinely assess signs and symptoms and titrate dosages of medications accordingly.  We obtain detailed histories so that we can make the best decisions in caring for our patients.  We have been taught and we recognize that what works for one patient may not work for another, and we constantly monitor our patients to assess the effectiveness of our treatments and to adjust them accordingly.  In the specter of vaccine administration, can we honestly say that we apply the same standards?   

     As nurses, how much education and training have we received regarding immunizations other than the emphasis that's placed on following the schedules?  Are we aware of what questions to ask to determine who should not be immunized according to the protocols?  Are we trained to recognize the symptoms of adverse vaccine events, and do we know what to do when one has occurred?  Can we recognize the signs of problems that dictate a closer look at the situation before subsequent doses are administered?   

     When a reaction does occur and is recognized, can we reliably determine which vaccine caused the problem so that, further doses can be withheld?  The chances are high that we cannot because the child may have received 3, 5, 7 or more different immunizations in one day.  (Today, an American child receives up to 39 doses of 12 different vaccines, most given during the first two years of life.)  Aside from the toxins in each vaccine, they are preserved and filled with adjuvants (to make them work better), such as mercury, formaldehyde, aluminum and MSG (yes, Mono Sodium Glutamate, the same stuff you ask them to hold from your Chinese food).  Some vaccines contain live viruses, as well as human, animal and plant genetic materials.  If an adverse reaction does occur, we may assume it was from say the Pertussis (which has a long history of problems), and we may withhold further doses of Pertussis, only to find that the child has a similar or worse reaction with the next dose of vaccines.  Perhaps the problem after all was not with the Pertussis, but in one of the additives that was found in the other vaccines. 

     As nurses, we have a duty to teach and educate our patients and their families about what we are injecting into their systems.  Unfortunately, the answers to most of these questions are that we have not been taught enough, and we do not know the correct answers, therefore, we place our patients in jeopardy. 

Vaccine Litigation and the National Childhood Vaccine Injury Act 

     The National Childhood Vaccine Injury Act of 1986, Public Law 99-660, was signed by President Reagan in November 1986, but did not contain a funding mechanism to enable the compensation system to operate.  In 1987, Congress passed amendments to the law and developed a plan to fund the system, which comes from a surcharge on each mandatory vaccine.  The main elements of the law were to create safety provisions for the administration of vaccines to help prevent future vaccine injuries, to promote the improvement of existing vaccines and develop safer vaccines.  Another purpose was to create a no-fault compensation system alternative to suing vaccine manufacturers and physicians on behalf of injured or deceased individuals from reactions to mandated vaccines.  Children and adults injured or killed from these vaccines are divided into two categories, those who were damaged before October 1, 1988 and those who were damaged after that date.  We will discuss the act as it applies to injuries occurring after October 1, 1988 for the purpose of this article. 

     The safety reforms of the act, require doctors to keep a record of the date of each vaccination administered, the manufacturer's name, lot number, the signature and professional title of the person administering the vaccine, and the address where the vaccine was administered.  The law requires that all doctors who administer vaccinations report vaccine reactions to federal health authorities, and to record the vaccine reactions in an individual's permanent medical record.  Another requirement is that doctors provide parents with information about childhood diseases and vaccines prior to vaccination. 

     In response to the law, in 1990, the FDA and the CDC developed the Vaccine Adverse Event Reporting System (VAERS), which allows public and private physicians to use one standard reporting form to report reactions.  If the doctor or health official does not report the event following a mandated vaccine, parents are allowed to file their own report.  (VAERS forms may be obtained by calling 1-800-822-7967.)  It is estimated that only about 10% of reactions even do get filed. The government states that the primary purpose for maintaining the database is to serve as an early warning or signaling system for adverse events not detected during pre-market testing.  Both the CDC and the FDA review data reported to VAERS.  The CDC focuses on collective reports, attempting to detect unusual epidemiologic trends and associations.  The FDA reviews individual reports, assessing whether a reported event is adequately reflected in product labeling, and also closely monitors reporting trends for individual manufacturers and vaccine lots. 

     The FDA has the authority to recall a vaccine from use if they feel it represents a risk to the American public.  Over the past 10 years, there have been only three vaccine recalls.  One was recalled after the FDA found impurities in the vaccine, another was mislabeled, and the third batch was recalled because a FDA inspection found substandard conditions at the production plant.  I am compelled to add at this point that despite a high incidence of VAERS reports on certain lots, since 1990, little intervention has been noted by the FDA.  The first two doses of DPT vaccine received by my daughter were from the same lot number.  After my daughter was injured by her immunizations, my investigation led me to discover that the lot she received had killed 7 children before her first round with it, and 2 more children had died by the time she received her second dose two months later.  The final VAERS reports on that lot revealed 13 deaths and 69 severe injuries (and remember that only 10% are reported).  When the FDA was questioned by a parent of an injured child about this same lot number and why it had not been pulled from the market, their response was that "you would expect that number of injuries to occur from a lot that size", but when questioned about the size of the lot, the response was that that was "confidential information".  Per the government reports, some lots contain as many as 700,000 doses, while others as few as 20,000 doses.  Even if this particular lot number had the 700,000 doses, isn't the death of 13 children significant enough for a recall?  No death should be acceptable.  

     Any individual or the legal representatives of children who have died or been permanently injured by a mandated vaccine can apply for federal compensation.  The injuries must have lasted for at least six months in order to be eligible for compensation.  Claims for federal compensation must be filed within 24 months after the death and 36 months after injury, in the U.S. Claims Court in Washington, D.C.  If the compensation claim is denied or the amount of compensation is not acceptable to the individual or his legal representative, a lawsuit may be filed against a vaccine manufacturer or physician.  However, there are more restrictive standards for actions alleging injury from these covered vaccines in cases that are brought to the tort system and a three-step procedure must be followed.  In the first trial it must be proven that the vaccine caused the injury and that the vaccine manufacturer was liable for the injuries or death because the manufacturer produced an unreasonably dangerous product or was negligent in the manufacture of the product.  In the second trial, it must be established what the past financial expenses have been and what the future financial needs will be, to provide adequate care for the remainder of life.  In order to obtain punitive damages, a third trial must prove that the vaccine manufacturer did not adhere to FDA standards in making the vaccine. This is nearly impossible to do, since all vaccines must pass FDA tests before being released for public use.  Punitive damages are virtually eliminated unless the manufacturer engaged in fraud, intentional withholding of information, or criminal activity relating to the safety and effectiveness of the vaccine. 

     The law requires that any attorney who is consulted about a vaccine injury or death, to inform the injured person or his legal representative of the availability of federal compensation.  The law provides for court-awarded attorneys' fees for all claims, which are paid by the Court, separately from the compensation award.  Expenses for filing a claim, expert witnesses, life care plans (perfect for LNC/Life Care Planners), travel, preparation and completion of the claim may also be paid by the Court.  If it is deemed by the Court that the injury or death is not vaccine related, but is determined that the petition was filed in good faith and there was a reasonable basis for the claim, the Court may award attorney's fees even though compensation is not awarded. 

     The vaccine compensation program is administered jointly by the United States Claims Court, the Department of Health and Human Services (DHHS), and the Department of Justice (DOJ).  When an individual claiming injury from a vaccine files a petition for compensation with the U.S. Claims Court, a copy is also sent to the DHHS.  Specific information and documentation outlined in the law must accompany the petition. This information should include prenatal, delivery and newborn records; a vaccination record; records of injuries that the child suffered before or after the vaccination; medical records from emergency rooms, hospitals, clinics or physicians; death certificates and autopsy reports; and records of any developmental evaluations performed.   

     A physician (usually a pediatrician or pediatric neurologist), at the Division of Vaccine Injury Compensation, DHHS reviews each petition to determine whether it meets the criteria for compensation.  The DHHS uses the Vaccine Injury Table contained in the law as one of the guidelines to determine whether or not an injury or death is vaccine related.  The Vaccine Injury Table was most recently amended by law on December 18, 1999, and is very limited as to the range of illnesses, disability, injury or conditions covered, as well as the time frame for the onset of symptoms. The most common reaction covered is anaphylaxis or anaphylactic shock occurring within four hours of immunization.  Some vaccines have more specific injuries covered, such as Brachial Neuritis occuring 2-28 days after a vaccine containing tetanus; Encephalopathy 72 hours after a vaccine containing pertussis; Encephalopathy occurring 5-15 days or chronic arthritis occurring 7-42 days after a vaccine containing any of the components of MMR; Thrombocytopenia purpura occurring 7-30 days after MMR.  The full table may be viewed on line at http://bhpr.hrsa.gov/vicp/table.htm.   

     Although not binding, the DHHS physician's recommendation is provided to the Claims Court through a report filed by the DOJ.  The DHHS recommendation is represented by an attorney from the DOJ in hearings before a "Special Master" (an attorney appointed by the judges of the Claims Court).  The Special Master is authorized to require the production of relevant documents and testimony, and makes the initial decision for compensation under the program.  Decisions may be appealed to the U.S. Claims Court and then to the Federal Circuit Court of Appeals and then to the Supreme Court. 

Problems with the Compensation Program 

     The Secretary of Health and Human Services has been granted by Congress, broad discretionary authority to alter the injuries table.  Unfortunately, the secretary has used her authority to remove or redefine permanent injuries long recognized by the medical community as being associated with vaccine reactions.  For example, residual-seizure disorders, a well known DPT related side effect, and one of the most highly compensated injuries was removed from the compensable-injuries table, while other injuries much less frequently reported and complained of have been added.   

     The Compensation System, which was intended to be fair and non-confrontational, has become highly adversarial, with three out of four claims being rejected.  Cases can take up to nine years for completion.  Even after the court rules in the parents' favor, it can take years to receive compensation.  Many attorneys working in this system no longer accept cases because they cannot afford to represent clients without any compensation for years.  Some lawyers are threatening to go back to civil court to pursue lawsuits against the manufacturers, which is exactly what the act was intended to prevent.  

Vaccines and the Injuries They Cause 

     There is tremendous controversy over what injuries are caused by vaccines.  The most basic problem is that there has not been a single safety study ever done on the short or long-term effects of the interaction of vaccines on the developing brain and immune systems of our children.  Manufacturers' safety studies range from a few days of surveillance to a couple of weeks.  The government experts say there is no scientific evidence to prove that vaccines cause chronic diseases, but no research has been done to prove or dis-prove this.  Federal immunization policy is determined by two advisory committees: the FDA's Vaccines and Biological Products Advisory Committee who determine whether new vaccines are safe and effective, and the CDC's Advisory Committee on Immunization Practices who recommend which vaccines should be included on the national Childhood Immunization Schedule.  One may question how and why vaccines meet with the approval of these committees in the absence of adequate safety studies.  Representative Dan Burton of Indiana, Chairman of the House Government Reform Committee reported last summer that his staff had found that the chairman and members of both committees own stock in vaccine manufacturing companies, and some members of the committees own patents for vaccines affected by the decisions of the committee.  Surely a conflict of interest exists, but the FDA justifies assignment of the committee members saying they are the top scientists in the field. 

     There are many differences of opinion when assessing whether an injury, was caused by the vaccines, or not.  Even with over one billion dollars being paid out under the compensation program, health officials insist that just because someone wins compensation in the system does not necessarily mean a vaccine caused the condition.   

     The list of injuries claimed is extensive and cannot be adequately covered for the purpose of this article.  The most common injuries noted in the past were brain damage and seizure disorders.  Other common injuries complained of include: Guillain-Barre Syndrome; optic neuritis; acute and chronic arthritis; viral infections; vaccine strain polio, measles and chicken pox; chronic fatigue syndrome; asthma; ADD, ADHD and learning disabilities; paralysis; thrombocytopenia purpura; early-onset Hib disease; allergies; SIDS; brain tumors and cancer.  Autoimmune diseases are more frequently being associated with vaccine injuries today by parents and scientists.  As autism rates continue to multiply, many relate the onset with the MMR vaccine, and to the high levels of mercury found in the vaccines.  (In 1999, the FDA acknowledged that vaccines expose infants in the first six months of life, to levels of mercury considered unsafe by the Environmental Protection Agency (EPA).)  Other autoimmune diseases being linked to vaccines are diabetes mellitus in children, lupus, rheumatoid arthritis and other rare diseases.  There have been some recent court cases where parents were accused of shaken-baby syndrome, and the defense used was that the injuries were related to immunizations received in the prior 24 to 48 hours. 

Contraindications to Vaccination 

     Although not universally accepted, the most common are: personal or family history of convulsions or neurological disease; having a family member who reacted to a DPT shot; history of cerebral irritation; history of severe allergies; premature and low birth weight babies; chronic illness or recent severe illness; immune system disorders, or history of adverse reaction to other vaccines.   

How Can the LNC be Most Effective in Investigating Vaccine Injuries 

     Careful review of the medical records and autopsy results is crucial along with a thorough review of the family histories.  Particular attention must be focused on the health of the individual when the vaccines were administered, and what vaccines were given.  How many vaccines were given that day?  How long since a previous dose of each vaccine had been given?  Had the individual experienced any problems with prior doses?  Determine any changes that were noted in the individual, by the caregivers after each dose was administered.  Examine all aspects of the injuries and identify any other causes.  Read the package inserts and consult with the PDR for reported adverse effects.  Investigate the lot numbers received and obtain the VAERS reports for the lots provided, to determine the frequency of injuries reported and types of injuries reported.  Determine if the safest forms of the vaccines administered were available and used, such as mercury free vaccines, DTaP instead of DTP and IPV instead of OPV.   Assist the attorneys in locating experts to opine and testify, and life care planners.  Assist the attorneys in obtaining all pertinent records. 

     Another important aspect to consider is whether or not the physician and nurses used good judgment in their actions and treatment, or were their actions so grossly negligent that a medical malpractice lawsuit should be considered.  A good example of this would be re-immunizing a child when it is obviously contraindicated, or immunizing when the child is sick and has a fever. 

     The problems that families are facing in regards to immunizations are numerous.  Some parents have been accused of abuse for subjecting the child to extra injections by insisting on "split" doses of the vaccines (i.e., just measles this month, mumps next month, etc.).  Others have been threatened with having their children removed from their custody for refusing to immunize.  In some areas, insurance coverage is being denied to non-immunized individuals, and some states are looking at limiting access to welfare, WIC and other programs if the children are not kept up to date on their immunizations.  The LNC can be effective in assisting attorneys and their clients in all of these areas by using their research, assessment and teaching skills.  

Personal Experience 

     As the mother of a vaccine injured child, I have had the opportunity to get an intimate view of how the system works.  After my daughter's injury, it took me two years to find an attorney to represent us in filing a claim for compensation.  It took another six years to get through the system and to be denied compensation.  Ours was the first case in which Daubert was used in reaching their conclusion.  The injuries that my daughter sustained are well documented and were even listed in the product inserts in the 1970's, but had been removed by the 1980's even though the product had not changed. 

     The cost of caring, for Katie's injuries are astronomical.  Her IV medications alone can be close to $10,000 per month and sometimes more, and that's with me doing the infusions at home.  Her life and ours has been devastated, and at ten years old, she has already outlived her doctors' predictions for her life expectancy. 

     They say that vaccine injuries are rare and that the risk of the diseases is greater than the risk of injury from the vaccines.  I've looked into the eyes of hundreds of parents of injured and dead children, and I know first hand that when your child is affected, the risks are 100%.  Winning compensation doesn't change what happened, but it can make a big difference in the level of care that can be provided to help make that child's life as good as possible. 

     I encourage LNC's to actively investigate the relationship of vaccines and injuries in the cases they handle.  I pray that as nurses we recognize the seriousness of our actions as we administer these sometimes toxic brews and educate ourselves enough to recognize the right questions to ask and the correct information to provide so that our patients can truly sign informed consents.  

References

Full Committee Hearings 106th Congress (1999-2000).  Found on line at http://www.house.gov/reform/hearings/ 

Koch, Kathy.  (8-25-00)  Vaccine Controversies. The CQ Researcher Volume 10, No. 28, 641-672.

National Vaccine Information Center. (1998).  The Compensation System and How it Works.  Vienna, VA. http://www.909shot.com/

National Vaccine Injury Compensation Program (VICP), Public Law 99-660.  Found on line at http://bhpr.hrsa.gov/vicp/ 

Other helpful web sites include:

http://www.safeminds.org

http://www.immunizationinfo.org/

ALL INFORMATION, DATA, AND MATERIAL CONTAINED, PRESENTED, OR PROVIDED HERE IS FOR GENERAL INFORMATION PURPOSES ONLY AND IS NOT TO BE CONSTRUED AS REFLECTING THE KNOWLEDGE OR OPINIONS OF THE PUBLISHER, AND IS NOT TO BE CONSTRUED OR INTENDED AS PROVIDING MEDICAL OR LEGAL ADVICE.  THE DECISION WHETHER OR NOT TO VACCINATE IS AN IMPORTANT AND COMPLEX ISSUE AND SHOULD BE MADE BY YOU, AND YOU ALONE, IN CONSULTATION WITH YOUR HEALTH CARE PROVIDER.