11 Indiana Patients Have Contracted Fungal Meningitis After Epidural Injections
Oct. 24, 2016
Northwest Indiana personal injury lawyer discusses who may be responsible for the fungal meningitis outbreak that has infected 11 Indiana patients.
The fungal meningitis outbreak continues to spread. Eight patients have died and over 100 other patients have contracted fungal meningitis, which reports point to steroid injection made by compounding pharmacists at New England Compounding Center (NECC). All the patients who contracted meningitis received an injection of the steroid in their back for treatment of back pain.
The reports suggest that the steroids shipped to healthcare providers were contaminated with a fungus that led to meningitis. The brain and spinal cord (central nervous system) is covered with three layers of lining called the meninges. The inner most layer is the pia mater, the middle layer is the arachnoid mater and the outer layer is called the dura mater. Meningitis is an infection of the meninges. Fungal meningitis is quite rare but can lead to death or severe injury.
WHO HAS LEGAL RESPONSIBILITY FOR THIS OUTBREAK?
A full investigation into the facts and circumstances of the steroid production and shipment will be required to fully answer this question. The Centers for Disease Control is coordinating the multi-state investigation into the fungal meningitis outbreak and will help get to the bottom of the matter from a scientific standpoint. The Indiana Health Department is also investigating the outbreak. Currently, the CDC has reported 105 cases in 9 states with 8 people dying from the infection. At this point, the CDC has not definitively found that the steroid is the source of the infection.
11 cases have been reported in Indiana with no deaths. If a patient has contracted this form of meningitis from an epidural steroid injection prepared by NECC, he or she does not have to prove that the infection definitely came from NECC's steroid. Under Indiana law, the injury victim will have to show by a preponderance of the evidence or more likely than not that the steroid was the source of the fungal meningitis.
What Does Indiana Law Say?
I am just analyzing this matter based on the limited number of facts and this is how the analysis would go if somebody came into my office to discuss this issue. Indiana law would apply to patients injured while receiving the epidural injection in Indiana by an Indiana physician in an Indiana facility or office. .
If Indiana law applies; and if the steroid is found to have been contaminated during the manufacture by NECC, then we would analyze the case under Indiana products liability. First, we would look to IC-34-20, which is the products liability statute. Indiana products liability law is as follows:
a person who sells, leases, or otherwise puts into the stream of commerce any product in a defective condition unreasonably dangerous to any user or consumer or to the user's or consumer's property is subject to liability for physical harm caused by that product to the user or consumer or to the user's or consumer's property if: (1) that user or consumer is in the class of persons that the seller should reasonably foresee as being subject to the harm caused by the defective condition; (2) the seller is engaged in the business of selling the product; and (3) the product is expected to and does reach the user or consumer without substantial alteration in the condition in which the product is sold by the person sought to be held liable under this article.
The law goes on to define defective condition:
A product is in a defective condition under this article if, at the time it is conveyed by the seller to another party, it is in a condition: (2) that will be unreasonably dangerous to the expected user or consumer when used in reasonably expectable ways of handling or consumption.
So, if NECC or another manufacturer allowed the steroid to be contaminated with a fungus during its manufacturer they could be strictly liable to the injured person for the injuries.
However, the injured person will have to show that the steroid was actually contaminated or contained a contaminant when it left the manufacturer. The CDC and Indiana Health Department investigations will shed some light on this issue as time goes on.
Would the Healthcare Provider, Surgery Center or Hospital Have Responsibility?
The next part of the analysis would require us to look at the actions of the healthcare provider. We would have to look at the person or facility who administered the injection under the Indiana Medical Malpractice Act as opposed to products liability law.
If we were to assume the following – I see no liability on the healthcare provider(s):
The healthcare provider was allowed to purchase the steroid from the manufacturer
The healthcare provider stored the product correctly
The patient needed the steroid injection – the treatment was medically necessary
The healthcare provider acted appropriate when he/she administered the epidural injection
The healthcare provider gave the patient proper informed consent regarding the procedure
If the above facts that I assumed are correct, the healthcare provider would most likely not be responsible for the injury because he/she did everything right. A healthcare provider is not in a position to look at a vial of steroid and determine that the medicine is contaminated with an infective agent.
This outbreak is an unforeseen event but it appears based on the reports from the CDC and Indiana Health Department that it was preventable. The legal analysis is based on the assumptions stated and in no way attempts to give legal advice only to show how a lawyer would look at the issue.
As you can see, Indiana law regarding defective medical products and medical malpractice can be complex. If you have any questions about a problem with an epidural steroid injection or the fungal meningitis outbreak.