Flu Vaccines in Infants: Learning From a Case Report

I follow social media closely. One of the local Facebook "mom groups" that I follow recently had a very interesting discussion that I thought would be worthy of more investigation. A mom was asking for advice on whether she should switch pediatricians. Her child, an infant, was accidentally given 3 flu vaccines instead of 2. This was due to a combination of record-keeping errors and different caregivers taking the child to appointments. In this Facebook post, about 95% of hundreds of comments were very angry and many suggested a lawsuit.

I was in the minority with my opinion. This was my response: "I am going to go against the majority here. If you have had great experiences so far besides this, and you like the pediatrician, I would sit down with the pediatrician and office manager and figure out what happened. I do not believe you can claim negligence if no harm was done. If after sitting down with them you don't feel reassured then maybe I would look elsewhere, but I think you should find out more about how this happened and what they will do to prevent mistakes like this from reoccurring."

I thought I would investigate further, both on the effects to the patient and the legal aspect of what occurred.

I spoke with a pediatrician who was unrelated to this situation, Jeffrey Bienstock, MD, FAAP.

Dr Bienstock explained that each state has a registry where immunizations are tracked and can be accessed. He also explained that 3 flu vaccines in a year could occur, as this will happen for many infants or children as part of their routine schedule as outlined by the AAP and CDC. As an example, he noted that 2 flu vaccines need to be administered in one season for children 6 months-<9 years) for that infant/child to start a series of flu vaccines that will continue yearly well into adulthood. For an infant born on 7/23/16, the first vaccine would be given on or around 1/23/17 (at 6 months of age) and the second vaccine would be given on or around 2/23/17. This child would then need one shot in the next flu season, likely at the 15 month check up on or around 10/23/17. In this case, three flu vaccines are given in one year as recommended. In that case, Dr. Bienstock views the extra flu vaccine as protective, and not harmful.

What about the concerns about mercury? Dr Bienstock explained that the only flu vaccine that contains trace amounts of mercury/thimerosal are ‘multidose’ vials, which pediatricians do not use for infants or children. Therefore, mercury exposure is not an issue.

As mentioned, vaccine records are kept electronically in a statewide registry. In addition, each practitioner's office will have their own record keeping system: electronically in their EHR or on a paper card.

Dr Bienstock would first verify the timing of the 3 flu vaccines and the age of the infant. He would recommend a ‘sit down’ conversation with the practitioner this parent is most comfortable with and make sure that this becomes a learning/teaching moment for the doctor, group of doctors and staff.

Now that we have explored the medical aspect, I wanted to seek legal opinion on this matter to see the full picture. I spoke with Angelo Cifaldi, RPh, JD, and Satish Poondi, RPh, JD.* Both attorneys are pharmacist lawyers with many years of experience in medical/pharmacy law. They explained that to prove negligence, there needs to be proof that harm occurred to the patient. In this case, there is no damage and therefore nothing to sue for. Unless there is damage/injury to the child, there is no basis for a lawsuit and no case. However, Mr Cifaldi and Mr Poondi further explained that with injury to a minor, there is a statute of limitations.

This statute of limitations is 2 years in NJ and does not begin until the child is 18, and can possibly be extended even further with the discovery rule. Mr Cifaldi gives this example. Let's say, later down the road, it is discovered that getting 3 rather than 2 flu shots in one year causes all your teeth to fall out (again, this is strictly hypothetical) at age 30. Then the patient would have till age 32 (age 30 plus two more years) to bring forth a lawsuit. More than likely, none of this would apply, though. The bottom line is that, as of right now, there are no damages and therefore no case as negligence cannot be established.

What can we learn from this? Any health care professional can make a mistake. This does not mean it is immediate grounds to switch providers or look for a lawsuit. I know that I fully trust my pediatrician's office to keep records and do not keep my own records other than the ones the office provides. Perhaps I should be better at my own record keeping. Health care professionals of all types are extremely caring and trustworthy, and mistakes can happen. I think how we learn from our mistakes and prevent further mistakes is just as important.

What do you think of this case? Email me at karenmichelleberger@gmail.com.

*information from Mr Cifaldi and Mr Poondi is general information, not legal advice. Consult your lawyer for legal advice