Did A Flu Shot Make You Sick?

By Robert V. Potter, Jr. and Eric J. Brooks

It’s that time again. Fall brings us cooler weather, earlier sunsets, and—the flu shot. Millions of people in the U.S. receive the flu vaccine every year, and the vast majority suffer no ill effects. A small number, however, experience severe side effects. Fortunately, a little known federal program compensates those injured by vaccines, including the annual flu vaccine.

In the 1980s, the federal government enacted the National Childhood Vaccine Injury Act and established the National Vaccine Injury Compensation Program. The government recognized universal vaccination was critical to the nation’s health and safety and created the Compensation Program to encourage vaccine manufacturers and health care providers by partially shielding them from liability. The Compensation Program provides an efficient, no-fault, non-adversarial means by which individuals can seek compensation for any serious vaccination side effects. A person injured by a vaccine is required to first attempt to recover under the Program before pursuing another party via a civil suit. The Compensation Program operates in a markedly different fashion than the traditional legal system and it is often advisable that an injured party engage a lawyer to navigate the Program with them.

First, a petition must be filed with the U.S. Court of Federal Claims in Washington, D.C. The petition sets out the basic facts of the petitioner’s claim, including the vaccine believed to have caused the injury and the date it was administered, the exact injury claimed, a detailed description of the symptoms, and the nature and extent of the injury. To qualify for the Compensation Program, the residual effects or complications must last for at least 6 months or require inpatient hospitalization and surgical intervention. Supporting documentation from doctors and healthcare providers must be gathered, organized, and persuasively presented as part of the petition process. The required documentation includes three years of pre-vaccine medical records and all available post-vaccine records, plus affidavits from the injured person and sometimes from his or her physician and other relevant fact witnesses. The records required will vary depending on the particular circumstances of the injury or condition. It is critical that a person who believes he or she may have been injured by a vaccine research and locate all medical and financial records relating to the injury.

After gathering all the supporting information and records we submit them to the Court together with the petition.  The U.S. Department of Health and Human Services (“HHS”) then reviews the submittal and determines whether it includes all of the necessary documentation and information. If so, the petition proceeds through the two primary phases of the Program—entitlement and damages. Although the Compensation Program is defined as non-adversarial, HHS reviews and opposes those petitions it believes lack merit and it will be represented by an attorney from the U.S. Department of Justice. It should be anticipated that HHS will actively oppose petitions lacking factual and documented support.  Once a petition is submitted, the petitioner and HHS may also choose to pursue settlement at any stage of the Program.

If HHS opposes the petition, a Special Master (who serves the role of judge) must determine whether the petitioner has sufficiently demonstrated entitlement to compensation from the Program, that is, whether the vaccine, more likely than not, caused the adverse side effects. Certain side effects are well recognized and are listed as “Table Injuries.” The Vaccine Injury Table, found at 42 U.S.C. § 300aa-14, lists vaccines, side effects and the required time period for the first onset of symptoms. If a petitioner received a vaccine listed on the Table, suffered a side effect that appears on the Table, and first experienced symptoms within the prescribed time frame, causation is presumed. Unrecognized or frequently disputed side effects are called “off-table” injuries. Unfortunately, the “off-table” injuries still include severe and sometimes permanent side effects. If the petitioner has an off-table injury, the petitioner will have to convince the Special Master that the vaccine caused his or her injury. This is achieved by providing a medical theory causally connecting the vaccine with the injury, a logical cause-and-effect sequence between the vaccine to the injury, and a relationship in time between the vaccine and the injury. It should be noted that the majority of Compensation Program petitions involve off-table injuries.

If causation is successfully established, the petitioner must reach an agreement with HHS on damages or convince the Special Master of those damages. Persons suffering vaccine-caused side effects are entitled to four categories of compensation:  pain and suffering (maximum of $250,000), 100% of lost wages, 100% of past out-of-pocket non-reimbursable medical expenses, and 100% of actual future non-reimbursable medical expenses. Detailed documentation and supporting evidence are required to establish damages. In complicated cases this will likely require one or more experts, such as economists or life care planners.

Under the Compensation Program, petitioners do not pay attorneys’ fees or any percentage of their recovery to their attorneys, regardless of whether the petition ultimately results in recovery for the petitioner. In fact, the Compensation Program specifically prohibits attorneys from charging the petitioner an hourly rate or a contingent fee. Instead, the petitioner’s attorney must apply to the Program for payment, which then pays the attorney a reasonable fee for the work he or she performed.

Vaccine-related side effects are very rare. According to the Health Resources and Services Administration’s most recent report, billions of doses of vaccines have been administered (over 2.5 billion from 2006 to 2014). In terms of the seasonal influenza vaccine alone, 1,078,000,000 doses were administered between January 1, 2006 and December 31, 2014, but during that same period petitioners filed only 1,573 petitions claiming flu vaccine injuries. Some form of compensation was paid in 1,363 of those cases. So be healthy, be safe, get your flu shot, but know what to do if you or a loved one suffers a severe side effect.