Two North Dakota parents allege Essentia Health has sold and administered more than 100 time- and temperature-sensitive pharmaceutical products (TTSPPs), including medications and vaccines, that were handled and stored outside of their proper temperature ranges.
As a result of the storage and handling of the TTSPPs outside of their proper temperature range—called a “temperature excursion”—the medications and vaccines have suffered from reduced potency and caused an increased risk of vaccine-preventable diseases among proposed class members and their children, the 27-page proposed class action alleges.
According to the complaint, Essentia Health notified roughly 50,000 patients in Minnesota and North Dakota that medication or vaccines they received may have been compromised due to improper temperature storage on the part of a John Doe distributor Essentia has not named publicly. The suit alleges the plaintiffs and their minor children are among a proposed class of individuals who have been injured as a result of paying for affected medicines and associated medical visits at the defendant’s healthcare facilities “without receiving the benefit of the bargain.”
Though Essentia has offered to revaccinate affected individuals free of charge, proposed class members are entitled to refunds for medical visits during which they did not receive proper care, the lawsuit adds. The plaintiffs argue, however, that free vaccines are worthless to thousands of patients who received vaccines that cannot be re-administered, such as the 2017, 2018 and 2019 flu vaccines. Moreover, some patients may choose to get revaccinated outside of the Essentia Health system and therefore bear additional out-of-pocket costs, the suit says, noting the “additional pain and suffering” some many experience undergoing additional medical exams.
Per the case, the Centers for Disease Control and Prevention (CDC) requires vaccines be stored at proper temperatures from the time they’re manufactured until they are administered. Frozen vaccines, such as Varicella, MMRV and Zoster, must be kept in a freeze between -58 degrees and +5 degrees Fahrenheit, while other routinely recommended vaccines should be stored in a refrigerator between 35 degrees and 46 degrees Fahrenheit, the lawsuit says.
According to the suit, responsibility that vaccine quality is maintained is shared among manufacturers, distributors, public health staff and healthcare providers, with each entity sharing the load within a temperature-controlled cold supply chain that spans from manufacture to administration. So important is the cold supply chain that the CDC recommends that it is “better to not vaccinate than to administer a dose of vaccine that has been mishandled,” the complaint reads.
In or around February 2020, Essentia took over the management, storage and distribution process for medications from a John Doe distributor, the suit alleges. According to the complaint, it was at that time that Essentia came to learn the John Doe distributor stored certain vaccines and medications outside of their precise recommended temperature ranges.
“According to an alert on Essentia’s website, more than 100 refrigerated injectable medications could have been compromised,” the lawsuit says, noting that affected medicines and vaccines may date back to September 2017.
Ultimately, the plaintiffs and proposed class members are entitled to refunds for healthcare visits for which they did not receive proper care, the suit claims.
The lawsuit looks to represent all persons who were administered or paid, in whole or in part, for the “Affected Medications” at Essentia Health. The complaint notes the full list of affected medications will be made available upon discovery from Essentia Health.
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