As the recent fungal meningitis outbreak in the United States associated with contaminated epidural steroid injections produced by the New England Compounding Center (NECC) since May 21, 2012 spreads to more people in more states, one issue that will need to be resolved, and which may be resolved differently depending on differing laws in different states, is whether the claims of the fungal meningitis victims will be determined based on medical malpractice law and/or product liability law. The answer is important because the standards of proof are different for medical malpractice cases and for product liability cases.
If the contaminated vials of the steroids that were injected into patients that led to their fungal meningitis are determined to be “products,” the doctors and clinics that used the products could be held responsible under product liability laws that impose strict liability that does not consider the intent to cause harm. If the steroid injections are considered to be a service provided by the doctors who provided the injections, then medical malpractice law would require proof of the doctors’ negligence, such as establishing that the doctors had a duty to determine the safety/purity of the injections, that the doctors breached that duty, and that the breach of duty caused the patients the harms that they suffered. It may be much more difficult to prove negligence rather than to rely on the strict liability afforded by product liability laws.
In New Jersey, where lawsuits arising out of the fungal meningitis outbreak have already been filed, the alleged claims include negligence by the doctors who performed the injections and product liability claims against the clinics where the injections were performed, claiming that the clinics sold a defective product (it would be irrelevant if the clinics knew or should have known that the injections were defective because they would be held strictly liable as long as they sold the products and the products were defective).
Medical malpractice lawyers and product liability lawyers who are involved in fungal meningitis claims may look to the medical bills received by their clients to determine if there was a separate charge for the injectable steroid itself or if the patient was billed one price for the procedure (which would include the injection material and the service fee from the doctor who performed the injection). If there is a separate bill for the injection material, then the argument may be stronger that product liability law should apply. If there is only one charge for the doctor’s service that does not itemize a separate charge for the injection material itself, then it may be more difficult to argue that product liability law applies.
The fact that the investigation into the fungal meningitis outbreak is continuing and that lawsuits arising out of the situation are just beginning to be filed in various states, which may have different laws regarding whether product liability law and/or medical malpractice law applies to the situation, makes it too early to determine with any reasonable level of confidence which law(s) will apply to fungal meningitis claims.
If you or someone you know have been affected by fungal meningitis in the United States, you or the effected person should promptly contact a local medical malpractice attorney or a local product liability attorney to investigate your possible claims and to learn about your legal rights.
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