Rachael Zimlich is a freelance writer in Cleveland, Ohio. She writes regularly for Contemporary Pediatrics, Managed Healthcare Executive, and Medical Economics.
Vaccine-related injuries in adults are rising, but healthcare providers administering those vaccines rarely have to worry about liability claims.
The number of adults claiming injury from vaccine administration is on the rise, but providers rarely run the risk of liability.
Those who administer vaccines may fear legal recourse from patients injured in the process, but a federal program created to handle these claims adjudicates most cases through a trust fund.
The National Vaccine Injury Compensation Program (VICP) was created in the late 1980s to provide a no-fault alternative to traditional legal claims which, at the time, officials feared could threaten vaccine supply and vaccination rates.
Martin Kramer of the Health Resources and Services Administration (HRSA) under the U.S. Department of Health and Human Services (HHS) said about 80% of the compensation awarded through the VICP program is the result of negotiated settlements where program administrators have not concluded that vaccines caused the injury. Petitions may be awarded in this way when both parties recognize there is a risk of loss and to minimize the time and expense involved in litigation.
“The purpose of the VICP is to ensure that individuals injured by certain vaccines are provided with fair and efficient compensation, and to ensure a stable vaccine supply by limiting liability for vaccine manufacturers and vaccine administrators,” Kramer told Medical Economics.
Since the program’s inception, Kramer said 59% of the claims through VICP involved children and 41% involved adults. However, since 2006, the trend has started to shift, and 24% of claims since that time involved children while 76% where injuries occurring in adults.
The shift seems to coincide with more widespread uptake of the flu vaccine, which is also the vaccine most commonly alleged to cause injury, according to VICP records.
According to data from the Centers for Disease Control and Prevention (CDC) reported by HRSA, 2.8 billion doses of covered vaccines were administered in the U.S. between 2006 and 2015, and 4,528 claims were filed with VICP-2,962 of which were compensated. This breaks down to roughly a million-to-one chance of receiving compensation for a vaccine-related injury.
Since 1988, about $3.7 billion in damages has been awarded from the trust. A total of 18,426 petitions have been filed with VICP-16,555 were reviewed, 10,974 were dismissed and 5,581 of the cases resulted in compensation.
To be awarded compensation, a conclusion must be made through a thorough review of scientific and medical data that the injury in question was caused by a vaccine.
Compensation may include relief from past and future medical expenses caused by the injury, rehabilitation care, lost earnings, and pain and suffering. Both pain and suffering, as well as death benefits, are capped at $250,000 in the program, according to Kramer. The program also provides relief for attorney fees and costs whether the claim is compensated or dismissed as long as the court determines the claim was filed with on a reasonable and in good faith, Kramer said.
A vaccine table detailing possible injuries and reactions covered under the program is available, as well as settlement data. The average award in 2016, excluding attorney fees, was $334,021, and has risen to $385,979 in 2017, Kramer reported.
Most common claim
Maximillian J. Muller, Esq., of law firm Muller Brazil LLP specializes in vaccine-related injury claims and said about two-thirds of the cases he handles are shoulder injury claims.
Shoulder injury related to vaccine administration (SIRVA) accounts for the most claims filed through VICP, Kramer said, and is caused by improper administration of a vaccine rather than the vaccine’s components. SIRVA may be prevented through appropriate injection techniques, which include administering a vaccine into the shoulder’s deltoid muscle with a dart-like motion at a 90-degree angle, avoiding the upper third of the muscle. By lifting the patient’s arm slightly to the side during administration, the bursa will slide beneath the acromion process, reducing the risk of injury. SIRVA injuries often occur from physical damage from the needle when it goes through the deltoid to the shoulder joint or bursa, or when immune reactions occur.
SIRVA has become so common, that it is now one of the injuries for which a petitioner does not have to prove causation, but only provide documentation that new onset and acute, movement-related pain occurred within 48 hours of vaccine administration.
VICP has streamlined the management of these causes compared to the chaos that occurred before, Muller said.
“The program was created in 1986. Back then, the medical and legal community started to realize that certain reactions were happening after certain vaccines,” Muller said. “Before that, suits were all over the place.”
Some suits were filed against pharmaceutical companies, others against physicians and even drug stores. The government wanted to consolidate those efforts, he said. Now, drug makers pay a 75-cent tax on each vaccine dose they make, and those funds go into a trust from which HHS can award damages.
“If we can prove causation, individuals are entitled to full damages from that trust fund,” Muller said.
The good thing for providers, he said, is that the award of damages from this fund limit liability for providers. By statute, Muller notes, anyone directly involved in the administration of a vaccine cannot be sued.
When injuries do occur
In many cases Muller sees, there wasn’t anything that could be done to prevent vaccine-related injuries.
“We do shoulder injury cases and neuro-autoimmune injuries. There’s absolutely nothing they can do to prevent those types of injuries. There’s just an issue where certain people’s bodies are going to react in certain ways to having these vaccines injected into them,” Muller said.
In terms of shoulder injuries, there is an element of human error, but also of differences in anatomy.
“Typically, the injection is administered too high on the shoulder and can cause a bursa injury,” Muller said. “It just happens. You miss your spot by half an inch and this kind of thing can happen.”
When a vaccine-related injury occurs, Muller said physicians should provide treatment for the injury, then direct patients wishing to pursue legal recourse to the VICP program.
In some cases, Kramer said injured parties may still pursue action against providers and manufacturers of vaccines, but it is a long road to get to that point.
“Generally, persons with petitions of vaccine-related injuries or deaths resulting from VICP-covered vaccines must first file a claim with the VICP and exhaust their remedies under the VICP before they can pursue legal actions against vaccine administrators and manufacturers,” Kramer said.
Petitioners must withdraw VICP petitions to pursue other legal relief, and this often occurs only if the U.S. Court of Federal Claims fails to issue a decision within the time provided under the Vaccine Act, or if a claim is rejected by VICP.
“While the VICP affords liability protections to vaccine administrators who administer covered vaccines in many circumstances, these protections are not absolute,” Kramer said.
He said there are some instances, like when petitions are filed seeking damages of $1,000 or less, that healthcare providers administering vaccines would not be protected from liability. In those cases, civil suits may be filed in either state or federal court without initial filing with the VICP.