FARGO — Two mothers have filed a lawsuit against Essentia Health for administering injectable medications and vaccines to almost 50,000 patients in Minnesota and North Dakota that lost their potency because of improper temperature storage.
The lawsuit, filed July 10 in U.S. District Court in Fargo, seeks certification as a class action on behalf of the affected patients, who were notified in April by Essentia that 100 types of injectable medications and vaccines had not been stored at proper cold temperatures.
The medications and vaccines were administered in 2017, 2018 and 2019. Essentia said the medicines were stored improperly by a distributor that it has not named, and that the health system assumed storage responsibility in February.
Two Fargo mothers are named as plaintiffs in the lawsuit, filed on their behalf and on behalf of their five children and potential class members, if a judge decides to allow the lawsuit to proceed as a class action.
Jessica Kraft received a flu vaccine at Essentia South University Clinic in Fargo on Jan. 31, 2017. On the same day, a daughter received three other vaccines, including for diphtheria, tetanus and whooping cough as well as rotavirus and pneumonia, according to the lawsuit. Two other children received flu vaccines.
Shelli Schneider of Fargo received notice that vaccines given to her children for diphtheria, tetanus and whooping cough as well as for hepatitis and influenza might have been compromised by improper temperature storage.
Mothers of children who were given vaccines that were improperly stored now must face the possibility their children could acquire a preventable disease or might have been injected with something inappropriate, said Elizabeth Fegan, a Chicago lawyer who is representing the plaintiffs.
“That is a really scary thing to contemplate as a mother,” Fegan said Tuesday, July 14. “Obviously vaccines play a huge role in ensuring that our kids stay healthy.”
Essentia declined comment through a spokeswoman on Tuesday, who said the lawsuit has not yet been served. “Thank you for your inquiry but Essentia Health does not comment on litigation matters,” said Tara Ekren, an Essentia spokeswoman.
In Essentia’s West Region, the vaccines and medications were given to patients seen at clinics including Fargo, Jamestown and Valley City in North Dakota and including Moorhead, Detroit Lakes and Ada in Minnesota.
The problem was discovered in February, when Essentia took over management and storage of medications from a former distributor, Essentia said in April. No “shelf stable” medications were at risk from the improper temperature storage, Essentia said then.
Although Essentia has offered to revaccinate free of charge, “plaintiffs and class members are entitled to refunds for visits for which they did not receive proper care,” the lawsuit said. “Moreover, free vaccines are worthless to the thousands of patients who received vaccines that cannot be re-administered, such as annual flu vaccines for the 2017, 2018 and 2019 flu seasons.”
Also, the lawsuit contended, Essentia has refused to identify the distributor or the steps it has taken to ensure that proper storage and handling of the vaccines and medications is now in place.
The Centers for Disease Control and Prevention advises that vaccines exposed to temperatures outside proper ranges “may result in reduced vaccine potency and increased risk of vaccine-preventable diseases.”
As a result, the CDC recommends, “It is better to not vaccinate than to administer a dose of vaccine that has been mishandled.” Also, the CDC as well as the Minnesota and North Dakota health departments recommend that any vaccine subject to improper temperature storage be set aside and marked “Do Not Use,” according to the lawsuit.
Essentia Health, based in Duluth, serves patients in Minnesota, Wisconsin and North Dakota in 13 hospitals, 69 clinics, six long-term care facilities, three assisted-living facilities, three independent-living homes, five ambulance services and a research institute.