At least one patient has died after being injected with an IV saline solution and dozens more have been sickened. The IV solution, made by Wallcur LLC, is intended for training purposes only. Dangerous drug lawyers at Pintas & Mullins Law Firm warn patients receiving saline injections to keep this alert in mind.
Wallcur is a medical training product company based in San Diego. Its medical-grade versions of 0.9% sodium chloride (also called normal saline) were shipped to health clinics, surgical centers and urgent cares in seven states. These states are Colorado, Florida, Georgia, Idaho, Louisiana, New York, and North Carolina.
The solutions are labeled as Practi IV Solution Bags. Medical personnel were unaware that the products were for simulation only, and have been using the mock-solution for serious cases of dehydration and other medical conditions.
Because the IV solution is intended for training only, the seriously ill patients did not receive the treatment they desperately needed. Some patients have been hospitalized, and one has died. Patients are displaying symptoms such as:
• Fever • Chills • Tremors • Headaches
The FDA released a Safety Alert on January 10, 2014 warning medical centers not to inject patients with Wallcur’s training solution. Before administering any IV solution to patients, the FDA advises medical personnel to carefully check the labels to confirm they are not intended for training. Wallcur’s products often include the language “for clinical simulation.”
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The FDA and CDC are currently working with Wallcur and its distributors to determine how many products entered the supply chain. According to Reuters, medical-grade versions of this normal saline solution have been in short supply. For this reason medical clinics have likely brought out older stocks to keep up with demand, not realizing Wallcur’s solution were for simulation only.
FDA’s Adverse Event Reporting System
Anyone suspecting that any Wallcur training IV products may have been injected into patients should report the incident to the FDA’s MedWatch Adverse Event Reporting program, located here. This should be done whether or not there was an injury suffered.
This system allows the government to gather information on the side effects of prescription drugs and devices. The system is voluntary and can be used by anyone, from the public to drug companies to doctors. Drug makers file the highest number of side effect reports – close to 97% of all reports in the system. Not surprisingly, the drug companies often file with incomplete information in efforts to underplay the seriousness of some drug side effects.
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In reports involving the death of a patient, for example, many filed by drug makers do not include the cause of death or the possible role of a medicine. This is a serious problem because the FDA Reporting system is the most important tool we have to keep track of medicine safety. Virtually every prescription has its own set of side effects; it is literally a matter of life and death that we know how many people are harmed and by what drugs.
Medical experts believe the FDA’s current program is outdated and has not kept up with how drugs are manufactured and marketed. The agency needs to develop new tracking systems for drugs and patient side effects. Particularly in a country where 70% of the population is on at least one prescription drug, systemic monitoring should be of utmost importance. Safety information should not rely on what the public and drug makers choose to provide.
Our team of dangerous drug lawyers is currently investigating cases of serious injury and death from prescription drugs and medical devices. If you or someone you love was harmed by a drug or device, contact us immediately for a free case review. Our services are offered free of charge to injured victims nationwide.