At trial, several experts testified about the Prevnar 13 vaccine. An infectious disease expert said that Prevnar 7 vaccination protected against the seven serotypes of pneumococcus that caused 80% of pneumococcal disease in infants. However, when asked about the standard of care, the expert stated that Prevnar 13 should have been administered to Joe at his 24-month or 36-month well-child visit. All the other experts testified that the Prevnar 13 vaccine would likely have protected Joe from meningitis had it been given to him. They noted that the vaccine was approved by the FDA in February 2010, and that the vaccine was readily available by the May 2010 well-child visit, when Joe was 18 months old.
Ms P was called to testify about the three well-child visits, and she was forced to admit that she was unaware of the updated vaccine at the time of the visits and that she was following the template provided by the office, which only listed Prevnar 7.
The case went to the jury, and after several hours of deliberation, they returned a verdict for the plaintiff.
In this particular case, Ms P was not sued personally. Instead, it was the practice, and the physicians, who were actually sued. While nurse practitioners do get sued personally, they are sued far less often than physicians. This is due to several reasons, but one major one is the common notion that physicians have “deep pockets” and are thus better candidates for a lawsuit.
This case was based on facts which took place between March 2009 and February 2012, a period of time during which the FDA approved the use of pneumococcal conjugate vaccine Prevnar 13. Prior to February 2010, only the Prevnar 7 vaccine was available, which provided less protection than Prevnar 13.
The case illustrates what can happen when a medical practice has no process in place to update immunization policies; it was primarily a result of system failure. The pediatric practice did not have a written office policy assigning a specific person the responsibility for updating immunization procedures to ensure compliance with FDA and AAP recommendations. Thus, when the new vaccine came out, the practice was still using printed well-child forms that had not been updated to reflect the new recommendations. Whichever NP was conducting the well-child appointment would only see Prevnar 7 as a choice; therefore, the practice failed in keeping immunization tracking up to date.
How could this have been avoided? The practice should have assigned someone to routinely check and update the practice’s immunization policy with up-to-date immunizations. Ms P should have been following FDA updates via professional publications or the FDA website, particularly those that affect her client base—children. And finally, the physicians should not have been blindly signing off on well-child forms without reviewing immunization information and making sure that it was up-to-date.
In today’s Internet-savvy world, it is inexcusable to be uninformed about FDA-approved immunizations.
Ms Latner, a former criminal defense attorney, is a freelance medical writer in Port Washington, N.Y.