Injector device manufacturer dismissed from pharmacy immunization case

On the docket

 

Pharmacists are now able to administer immunizations in all states. This new role brings with it the potential for exposure to liability if harm is caused to a patient by a pharmacist-administered immunization. Fortunately, actual litigation against pharmacists has been very limited.

The United States District Court for the Northern District of Ohio recently dismissed a case against the manufacturer of an injector device alleging harm caused to a patient by a pharmacy immunization. The ruling in the case raises issues of interest to pharmacists who administer immunizations to patients, although the pharmacy was not a party to the lawsuit.

Background

On October 11, 2011, a patient went to a pharmacy to obtain an influenza vaccination. The patient was administered a needle-free injection in his upper arm without being asked whether he would prefer that the immunization be administered using a needle. The patient asserted that he experienced swelling, redness, and soreness at the site of the injection and was surprised to feel pain and see blood at the injection site, because “he was told the injection device was needle-less.”

The patient referred to a communication from FDA of October 21, 2011, sent to health professionals who administer influenza vaccine. The communication advised health professionals not to use injector devices to administer influenza vaccines and recommended that all vaccines, including influenza, be administered in accordance with their labeling.

The communication noted the following:

  • “Currently, there is only one vaccine, measles, mumps and rubella (MMR), that is approved for administration by jet injector.
  • “FDA has no data to support the safety or effectiveness of other vaccines delivered by jet injector.
  • “At this time, there are no vaccines for the prevention of influenza disease that are approved by FDA for administration by jet injector.”

The patient contended that the manufacturer should be held liable for damages caused to him by the needle-free injection device because the device was marketed to health professionals for the administration of influenza vaccine, although it was not approved by FDA for this purpose.

Reasoning

The court noted that the patient’s lawsuit was based primarily on the FDA communication and the patient’s conclusion from the communication that the manufacturer had failed to comply with requirements of the federal Food, Drug, and Cosmetic Act (FDCA). The court concluded, however, that FDCA does not provide a private right of action for violation of its provisions. Only FDA has the authority to enforce FDCA if it finds that a manufacturer has committed a violation. A private person cannot sue a manufacturer to enforce provisions of FDCA.

The patient also claimed that a violation of state consumer protection laws could serve as the basis of manufacturer liability. The court disagreed. For there to be liability under these state laws, there must be evidence that the patient relied on representations made by the manufacturer. The patient did not allege that he saw, or was even aware of, any alleged misrepresentations regarding the needle-free injection device before or during the administration of his influenza vaccine. Rather, the lawsuit made it clear that the patient went to a pharmacy to obtain an influenza vaccine and that his attorney later discovered advertisements by the pharmacy indicating that it would provide “needle-free” injections. The lawsuit referenced statements made on the manufacturer’s website, but it was clear that the patient was unaware of these statements at the time of the immunization, so they could not possibly have been relied on by the patient.

The case against the manufacturer was dismissed.

Discussion

Perhaps the most interesting aspect of this case is the patient’s expression of surprise at harm caused by what the patient apparently perceived to be a harmless device. Informed consent has become a cornerstone of medical practice, and as pharmacists expand their practice sphere into areas formerly occupied exclusively by physicians, they will need to adopt the risk management practices of physicians. One of the key purposes of informed consent is to prevent surprise by patients if a risk materializes following the provision of care.

In this case, there was no mention of a signed informed consent document describing the nature of the influenza vaccine, the manner in which it would be administered, or the risks of the vaccine and its administration. Effective risk management, and respectful patient care, require adherence to the principles of informed consent when vaccines are administered to patients.

Based on: Reeves v Pharmajet, Inc., 2012 U.S.Dist. LEXIS 14957 (February 3, 2012).