Medical Malpractice Lawyer Cleveland OH

In July 2020, the U.S. Department of Health and Human Services (DHHS) proposed a rule change to the National Vaccine Injury Compensation Program (VICP) that, if adopted, would affect thousands of Americans who are injured by a vaccine. Traditionally, the national vaccine injury program provided compensation to individuals injured as the result of various categories of vaccines. Injuries that are recognized as compensable under the program are listed on tables published by DHHS. The so-called “table injuries” include shoulder injury related to vaccine administration (SIRVA) and vasovagal syncope. The proposed rule would remove these two injuries from the list of table injuries and require injury victims to pursue compensation through direct action against the hospitals, doctor’s offices, and pharmacies that administer vaccines.

SIRVA injuries, which include pain and/or weakness of an arm or shoulder following vaccination, can be devastating. As vaccine injury lawyers, we have represented clients who have sustained a SIRVA injury that resulted in virtually complete loss of use of the affected arm and hand. The arm is rendered too weak to open a door, reach overhead, or button one’s shirt. In many occupations, loss of use of one arm can render the individual unemployable.

Likewise, vasovagal syncope can have devastating effects. “Syncope” is medical jargon for dizziness, faintness, or loss of consciousness. Typically, an individual who experiences this complication of a vaccine will recover quickly and experienced no further symptoms or harm. However, in a subset of individuals, the symptoms can lead to a collapse, trip, or fall from fainting or feeling faint that results in severe injuries, such as traumatic brain injury (TBI), fractures, or other orthopedic injuries.

The Secretary of the Department of Health and Human Service’s proposed rule change would remove SIRVA and vasovagal syncope injuries from the tables of compensable injuries.  The proposed rule change is based on the Department’s review of medical literature related to these complications. This peer-reviewed medical literature establishes that SIRVA type injuries are related to improper administration of the vaccine in an area of the shoulder where nerve roots are exposed. Damage from the insertion of the needle into the nerve followed by administration of the caustic vaccine contents results in the permanent nerve injury, pain, and disability.

Likewise, the Department’s literature review showed that the most serious injuries associated with vasovagal syncope can be avoided through proper vaccine administration. The vasovagal response occurs shortly after administration of the vaccine. A well-trained and careful health care provider who administers a vaccine should monitor the vaccine recipient for signs of a vasovagal reaction. When the individual shows signs of faintness, the individual should be placed into a protected position in order to avoid serious injury from a fall.

How would this rule change affect Americans who sustain an injury as a result of a vasovagal reaction or shoulder injury following vaccine administration?  First, vaccine injury claims must currently be filed in the U.S. Court of Federal Claims in Washington, D.C.  If the proposed rule change is adopted, your lawsuit will likely be filed in state or federal court in the state where the injury occurred, rather than in the Federal Court of Claims.

Second, the National Vaccine Injury Compensation Program is a “no-fault” system. Participants are compensated once they meet the regulatory criteria established for participation. Participants need not establish the elements of negligence, medical malpractice or product liability claims in order to recover. If the rule is changed, an injured vaccine recipient would have to prove fault, specifically that the health-care worker who administered the vaccine failed to do so in a careful manner or failed to monitor the patient in a careful way after vaccine administration. Well-financed malpractice insurers and self-insured big box pharmacies will undoubtedly aggressively defend these cases. However, the extensive medical literature cited by the Department of Health in support of the proposed rule change is powerful evidence that these injuries can be avoided through proper care.

Another change will be the measure of damages that an injured individual can recover when they have a vasovagal reaction followed by a fall or a vaccine-related shoulder injury.  Under the vaccine injury program, damages are established by regulations that apply to all vaccine injury claims. If a vaccine program participant is not happy with a settlement offer from the government on their claim, they have a right to try the case. The trial is before a magistrate, which is a court-appointed decisionmaker, rather than to a jury. The vaccine program’s damages are subject to caps. By contrast, if the rule is changed, damages will be established by each individual state’s laws. Some of those damages are capped by state law, while others are not. In addition, if the claim cannot be settled out of court, trial will proceed before a jury. In general, the outcome of jury trials are less certain than trials before a magistrate, but they can result in larger damage awards.

Finally, there will be procedural changes along with any rule change. One procedural rule to keep in mind is that the federal vaccine injury program establishes a three-year statute of limitations, while the statute of limitations for negligent administration of a vaccine will vary from state to state.  In Ohio, these claims will be subject to a one-year statute of limitation.  A medical malpractice lawyer would be well-suited to handle one of these claims in state court and advise you about the other technical procedural changes that will apply if the rule change passes. Some vaccine injury lawyers will not handle vaccine-related SIRVA or vasovagal syncope injury cases if the rule passes, due the nature of the litigation.  The trial attorneys at Mishkind Kulwicki Law handle vaccine injury, medical malpractice, and pharmacy liability cases.  We are licensed in state and federal courts in Ohio and the U.S. Court of Federal Claims.  Call a medical malpractice lawyer Cleveland, OH residents recommend for a free consultation.