Compensating Adverse Flu Vaccine Reaction Victims

As the US flu vaccination program rolls out, the numbers are also growing for those who have reported adverse consequences from the H1N1 vaccine. The victims and their families are also lining up for benefits available in the workers’ compensation system as well as the Federal program. The existence of these programs have received little publicity and may be difficult for the public to navigate without adequate representation. 

The US Centers for Disease Control and Prevention (CDC) announced this week that pandemic activity has now increased in the US. Tom Frieden, MD, director of the CDC, said, "We have had up until now many millions of cases of pandemic influenza in the U.S. And the numbers continue to increase." President Obama signed an Executive Order declaring the Swine Fu as a national emergency. Hospitalization and death rates have increased, yet again. Over 60 million have been immunized early for seasonal flu, so that providers would be available to administer  H1N1 vaccine when it becomes available. . 

Even though the supply has been tardy for the H1NI vaccine, the companies that supply the product have promised an additional flow of supply to meet the demand. The European pharmaceutical companies, Novartis’s Focetria, GlaxoSmithKline’s (GSK’s) Pandemrix, and Baxter’s Celvapan are under contract to supply a huge volume of vaccine to the US. Novartis alone has a $979 million contract to supply H1N1 vaccine to the US Department of Health and Human Services (HHS) which amount to 251 million does and the total 35% projected US supply. It is anticipated that the US supply may not arrive until the first quarter of 2010.

A recent Washington Post-ABC News Poll reflects that Americans are more worried than ever about the H1N1 flu. In a matter of weeks, from August 2009 to October 2009 those reportedly worried about getting the H1N1 flu increased from39% to 52%.  The CDC has been reluctant to advertise the need to about the vaccine because the supply has been limited and they were attempting to avoid public panic. Their program will pick up as the supply becomes increasingly available.

Adverse effects from the flu vaccine already are being reported. Deaths have been reported associated with the deaths of at least four nurses with 2009 H1N1The Vaccine Adverse Event Reporting System (VAERS) is a national vaccine safety surveillance program co-sponsored by the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA). VAERS is a post-marketing safety surveillance program, collecting information about adverse events (possible side effects) that occur after the administration of vaccines licensed for use in the United States. The data is publically available through the CDC WONDER on-line database.

Workers’ Compensation programs have provided compensation benefits in the past resulting from adverse reactions to vaccines. In many jurisdictions, vaccinations afforded to employees resulting in a benefit to the employer against possible disastrous business consequences, have been considered to be “a mutual benefit.” Therefore, any disease arising from such vaccination has been deemed compensable.

Additionally, a Federal program has been established to shield the vaccine producers from liability claims. On October 1, 1988, the National Childhood Vaccine Injury Act of 1986 (Public Law 99-660) created the National Vaccine Injury Compensation Program (VICP). The VICP was established to ensure an adequate supply of vaccines, stabilize vaccine costs, and establish and maintain an accessible and efficient forum for individuals found to be injured by certain vaccines. The VICP is a no-fault alternative to the traditional tort system for resolving vaccine injury claims that provides compensation to people found to be injured by certain vaccines. The U. S. Court of Federal Claims hears the claims.

As of July 1, 2005, trivalent influenza vaccines have been added to the Table under this Category. Trivalent influenza vaccines are given annually during the flu season either by needle and syringe or in a nasal spray.  All influenza vaccines routinely administered in the U.S. are trivalent vaccines covered under this Category.  

The criteria for filing a claim under the VICP are the following:

• You may file a claim if you received a vaccine covered by the VICP and believe that you have been injured by this vaccine.
• You may also file a claim if you are a parent or legal guardian of a child or disabled adult who received a vaccine covered by the VICP and believe that the person was injured by this vaccine.
• You may file a claim if you are the legal representative of the estate of a deceased person who received a vaccine covered by the VICP and believe that the person’s death resulted from the vaccine injury.
• You may file a claim if you are not a United States citizen.
• Some people who receive vaccines outside of the U.S. may be eligible for compensation. The vaccines must have been covered by the VICP and given in the following circumstances:
• the injured person must have received a vaccine in the U.S. trust territories; or
• if the vaccine was administered outside of the U.S. or its trust territories:
1. the injured person must have been a U.S. citizen serving in the military or a U.S. government employee, or have been a dependent of such a citizen; or
2. the injured person must have received a vaccine manufactured by a vaccine company located in the U.S. and returned to the U.S. within 6 months after the date of vaccination.
• In addition, to be eligible to file a claim, the effects of the person’s injury must have:

1. lasted for more than 6 months after the vaccine was given; or
2. resulted in a hospital stay and surgery; or
3. resulted in death.

The VICP program has paid over $1.8 billion dollars from 1989 through 2009. Over 2,300 families have been paid to date with over 2,200 attorneys representing clients in such matters. "Compensated" are claims that have been paid as a result of a settlement between parties or a decision made by the U.S. Court of Federal Claims (Court). Approximately 18% of the benefits were paid to adults who received vaccines during the existence of the program. Since the program was expanded to adults who received vaccinations, the proportion of benefits to adults under the program has  increased proportionally. Nearly 52% of program awards in 2007 and 2008 went to adult vaccine recipients.

As the H1N1 vaccination program unfolds, those who suffer adverse reactions will be seeking benefits from both, the State workers’ compensation programs, as well as the VICP. Adequate dissemination of information concerning eligibility and procedural access to the programs will be of great benefit to the victims and their families.

For more articles on Workers' Compensation and the Flu Pandemic click here. 

CDC Issues H1N1 Flu Guidance to Healthcare Personnel-"stay home"

In an urgent need to protect healthcare workers from H1N1 Flu, the today CDC has issued guidance on infection control measures to prevent transmission of 2009 H1N1 influenza in healthcare facilities. The CDC continues to recommend that healthcare workers take time away from work if they are ill. The issue unanswered is whether workers' compensation insurance will pay temporary disability benefits for the absence?


The CDC has defined healthcare personnel as, "....For the purposes of this guidance, healthcare personnel are defined as all persons whose occupational activities involve contact with patients or contaminated material in a healthcare, home healthcare, or clinical laboratory setting. Healthcare personnel are engaged in a range of occupations, many of which include patient contact even though they do not involve direct provision of patient care, such as dietary and housekeeping services. This guidance applies to healthcare personnel working in the following settings:  acute care hospitals, nursing homes, skilled nursing facilities, physician’s offices, urgent care centers, outpatient clinics, and home healthcare agencies.  It also includes those working in clinical settings within non-healthcare institutions, such as school nurses or personnel staffing clinics in correctional facilities. The term “healthcare personnel” includes not only employees of the organization or agency, but also contractors, clinicians, volunteers, students, trainees, clergy, and others who may come in contact with patients."

Healthcare personnel who develop a fever and respiratory symptoms should be:
• Instructed not to report to work, or if at work, to promptly notify their supervisor and infection control personnel/occupational health.
• Excluded from work for at least 24 hours after they no longer have a fever, without the use of fever-reducing medicines.

For more articles on Workers' Compensation and the Flu Pandemic click here.

The Urgent Need for Workers Compensation Flu Pandemic Planning

The 2009 influenza pandemic (flu) has created a new framework of acts and regulations to respond the World Health Organization’s (WHO) phase 6 pandemic alert. Governmentally imposed employment disruptions resulting from regulatory work disruptions to prevent the spread of disease maybe massive. While workers’ compensation was envisioned as a summary and remedial social insurance program, the challenges facing the workers’ compensation system to deliver benefits as promised may be seriously burdened.

There has been a global reaction to the 2008 influenza pandemic. On April 25, 2009, the WHO director-General Dr. Margaret Chen declared the H1N1 virus outbreak as a “Public Health Emergency of International Concern.” The international declaration indicated that a coordinated international response was potentially necessary to prevent curtail the spread of the disease that was perceived as a public health risk. Recommendations to restrict both trade and travel may follow.

The United States has structured its response on both a State and Federal level to the 2009 influenza alert. The Public Health Service Act (PHS) permits the Secretary of Health and Human Service (HHS) to access a special emergency fund, allows or the use of unapproved medical treatments and tests, and allows waiver of certain reimbursement of Medicare and Medicaid expenses, and waives penalties and sanctions for violation of the HIPAA Privacy Rule requirements. Additionally, the President may issue an emergency declaration under The Stafford Act to co-ordinate emergency relief under State and Federal programs, ie. use and distribution of anti-viral medications.

The Federal government has sweeping powers under the PHS that could disrupt employment throughout the country. Recommendations for school closings will impact children and staff well beyond the approximate 700 facilities that were closed in the Spring of 2009 during the H1N1 initial outbreak. The Federal government under the PHS has authority to quarantine (interstate and border) and to isolate. An Executive Order (E.O. 13375, April 2005) enumerates the “quarantainable diseases.” Travel restrictions may be imposed to limit the spread of a communicable disease. Employees may not be permitted to board flights under either voluntary airline restrictions or through the Federally imposed “Do Not Board” lists.

These closings and restrictions have raised issues as to what programs, if any, will be able to provide benefits to the employees because of the involuntary nature of the closings and disruptions. A recent Harvard School of Public Health study reveals that 80% of businesses foresee severe problems in maintaining operations if there is an outbreak. The workers’ compensation system could be requested to provide temporary disability benefits for occupational disease absences on a massive scale never before experienced. Pre-emption by superseding emergency regulatory actions may curtail employment that will trigger the implementation of State workers’ compensation benefits. The employer and the workers’ compensation insurance carriers will be required to pay temporary disability and medical benefits as a direct consequence of efforts to prevent the spread of a communicable disease. The carefully crafted employee-employer notification structure integrated into the workers’ compensation system may be partially or entirely disrupted by the consequences and chaos of the global health emergency.

Workers’ Compensation claims arising out of the influenza pandemic of 2009 will need to fit into the convoluted framework statutory acts and regulation. Reimbursement from the usual collateral third-party reimbursement sources may be restricted. In addition to the Doctrine of Sovereign Immunity, enjoyed by the Federal and State governments, other legislation including The “Public Readiness and Emergency Preparedness Act" (PREP Act) limits liability of others under certain specific emergency circumstances.

The enormity of the Pandemic presents a new and novel challenge to the system and one that must be considered by both Federal and State planners. Workers’ Compensation programs have adapted to emergencies before including natural disasters and terrorist attacks. The urgency of the situation requires that the system be vaccinated now.

For more articles on Workers' Compensation and the Flu Pandemic click here.

Federal Government Alerts Employers to Prepare for Flu Outbreaks

The Federal government has now taken action to alert employers and business as to what precautions should be taken in anticipation of the anticipated fall Flu outbreak. Yesterday the government revealed that deployment of vaccines would be too slow to prevent or restrain further spread this fall.

In a joint letter from the Secretaries of Commerce, Health and Human Services, Homeland Security and Labor, the Federal government has alerted employers and business of a new web site directed to encouraging prevention and containment for a resurgence in the months ahead of H1N1 Flu.

For more on this topic and workers' compensation benefits, visit the Workers Compensation Blog.

Employer Responsibility in the Flu Pandemic

The threat of the spread of flu this fall in the US is a major concern to infectious disease specialists. Healthcare workers are extremely apprehensive as the disease is beginning to spread and employers have not instituted adequate protections for workers.

In the US alone there have been 6,506 hospitalizations of H1N1 Flu patients. The CDC has reported that there have been 436 reported to date because of the novel flu infection. The World Health Organization (WHO) declared the virus a Phase-6 pandemic, the highest level of concern. Over 1,154 deaths have been reported worldwide.

The CDC has issued an Interim Guidance for controlling the spread of infection in healthcare facilities including hospitals, long-term care and outpatient facilities and other settings where healthcare is provided.

Healthcare workers have rallied to protest the firing of a co-worker who disclosed that a healthcare facility was not taken appropriate action to prevent the spread of flu at its work site. The major national unions in April 2009 warned in a report that employers were not taking adequate precautions to protect healthcare workers.

Most recently a task force of the Institute of Medicine (IOM) charged with the responsibility of making recommendations on how to protect workers from the H1N1 flu heard evidence that actions by employers could reduce the spread of the disease. It was reported the use of N95 masks provided 75% protection against lab-confirmed flu.

Workers' remedies from the residuals of the illness have now been limited. The Federal vaccination compensation program will shield the vaccine makers from liability claims. Employers will be protected against civil law suits by the exclusivity provisions of the workers' compensation system. Workers' Compensation does not encompass a roll in prevention of disease. OSHA has alerted employers to take action, but cannot compel them to do so.

It is time for employers to act to prevent unnecessary illness and death in the workplace. Simple educational and enforcement actions by employers will go along way to protect workers from the consequences of this unprecedented pandemic. While time is short and the clock is ticking away as the US flu season formally approaches, time still remains for employers to act and mandate protocols and procedures that will prevent the spread of the disease and will save lives.

..........

For more on workers compensation and the flu pandemic visit the Workers' Compensation Blog.

US Congress to Hold Hearing on Helping Schools and Workplaces Prepare For Flu Virus

Taking urgent actions in light of the threat of a pandemic, The Hon. George Miller, Chairman of the Committee on Education and Labor has scheduled a hearing this week.

On Thursday, May 7, the Committee will hold a hearing to examine how federal agencies can help child care, schools, colleges and workplaces prepare for the H1N1 flu virus and future pandemics. The hearing will also provide an update on how schools and workplaces are being affected by and responding to the current outbreak.

WHAT: Hearing on “Ensuring Preparedness Against the Flu Virus at School and Work"

WHO:
Jordan Barab, Acting Assistant Secretary, Occupational Safety and Health Administration, Washington, DC

Ann Brockhaus, Occupational Safety and Health Consultant, ORC Worldwide, Washington, DC

Jack O'Connell, Superintendent of Public Instruction, California Department of Education, Sacramento, CA

Miguel Garcia, Registered Nurse and member, American Federation of State, County and Municipal Employees, Los Angeles, CA

Bill Modzeleski, Associate Assistant Deputy Secretary, Office of Safe and Drug-Free Schools, Department of Education, Washington, DC

Dr. Anne Schuchat, Deputy Director for Science and Program (Interim), Centers for Disease Control, Atlanta, GA

WHEN: Thursday, May 7, 2009 10:00 a.m. ET
Please check the Committee schedule for potential updates »

WHERE: House Education and Labor Committee Hearing Room 2175 Rayburn House Office Building Washington, D.C.

California Workers Compensation Fund Alerts Employers and Employees as to Flu

The California Workers' Compensation Fund has taken the initiative of alerting employers and employees as to preventative measures that should be taken to prevent the spread of Swine Flu. 

"To protect California workers and businesses, State Fund advises employers to educate their employees about swine flu facts, symptoms, and preventative measures and to prepare their business operations should a pandemic outbreak significantly reduce their workforce or disrupt their business operation. "

As of today there are 403 reported cases and one death according to the CDC. Numbers are expected to rise as testing has now been shifted from the CDC to the States. California has 49 reported cases.

The novel influenza outbreak (H1N1) has given rise to concern on the impact what a pandemic would cause. The Department of Homeland Security has posted information that workers' compensation programs would probably become involved in responding to the emergency. NIOSH has issued an alert concerning the impact upon psychological and social workers comparing a potential pandemic to the 911 tragedy.

CDC Issues A Safety Alert For Laboratory Workers

The safety of laboratory workers involved in testing for the Swine Flu Virus (H1N1 Influenza Virus) is the subject of a alert issued by the US Centers for Disease Control (CDC). The guidance is aimed at laboratory workers who may be processing or performing diagnostic testing on clinical specimens from patients with suspected H1N1 influenza virus infection, or performing viral isolation.

The Compensability of a Swine Flu Pandemic

The US Centers for Disease Control (CDC) has issued an alert for the spread of human swine flu virus. Employers and employees will now need to be alerted to preparations and the reactions that may occur.

In preparation for a Smallpox epidemic, the US government, several years ago, issued rules concerning illness flowing from the distribution of smallpox vaccine. Now the focus will switch from not only compensable conditions flowing from preparation to compensable and contagious diseases in the workplace.

The federal government established a no-fault program entitled the Smallpox Emergency Personnel Protection Act of 2003 (SEPPA) in an effort to provide benefits and/or compensation to certain individuals, including health-care workers and emergency responders, who are injured as a result of the administration of smallpox countermeasures including the smallpox (vaccinia) vaccine. The Department of Health and Human Services, under rule making authority, established a vaccine injury table and procedural process for filing a request for benefits and/or compensation under the Program.

Already the CDC reported today, "Human cases of swine influenza A (H1N1) virus infection have been identified in the U.S. in San Diego County and Imperial County, California as well as in San Antonio, Texas. Internationally, human cases of swine influenza A (H1N1) virus infection have been identified in Mexico."

The CDC has reported that Swine flu has impacted the US in the past: "Like seasonal flu, swine flu in humans can vary in severity from mild to severe. Between 2005 until January 2009, 12 human cases of swine flu were detected in the U.S. with no deaths occurring. However, swine flu infection can be serious. In September 1988, a previously healthy 32-year-old pregnant woman in Wisconsin was hospitalized for pneumonia after being infected with swine flu and died 8 days later. A swine flu outbreak in Fort Dix, New Jersey occurred in 1976 that caused more than 200 cases with serious illness in several people and one death."

As new cases become suspect, concern will focuss on the spread of the disease in the workplace environment. Over 75 students are being tested in New York City. The Governor of California has issued an alert. As of now the Federal government is directing individuals to their local workers' compensation programs. Since a pandemic could be considered a challenge to Homeland Security, the federalization of prevention, treatment and compensation may ultimately result in expansion of a nationalization of the program.
......
To read more about compensation for the flu click here.