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The United States Center for Disease Control and Prevention reported on October 12, 2012 that 170 people have contracted fungal meningitis due to the recent outbreak resulting in 14 deaths so far. See CDC outbreak information. ABC News and other media outlets have reported that the fungal meningitis outbreak may have been caused by spinal injections of methylprednisolone acetate for back pain. See ABC News article. Tennessee, more than any other state, has been most affected by the outbreak where there are 49 cases of fungal meningitis that have been reported including six that have been fatal. See ABC News article. According to ABC News "meningitis affects the membranous lining of the brain and spinal cord. Early symptoms of fungal meningitis, such as headache, fever, dizziness, nausea, sensitivity to light, stiff neck, weakness or numbness, slurred speech and pain, redness or swelling at the injection site can take more than a month to appear." See ABC News article.
As a result of the outbreak that is growing by the day, significant questions must be addressed pertaining to potential liability for manufacturers, sellers, distributors, medical providers and physicians for this outbreak in Tennessee. The main cause of action in any litigation under Tennessee law would most likely be a products liability action under T.C.A. § 29-28-101 - 29-28-108. The "Tennessee Products Liability Act of 1978" is codified at T.C.A. § 29-28-102.
Under T.C.A. § 29-28-102 a Tennessee "Product Liability Action" is defined as follows:
“Product liability action” for purposes of this chapter includes all actions brought for or on account of personal injury, death or property damage caused by or resulting from the manufacture, construction, design, formula, preparation, assembly, testing, service, warning, instruction, marketing, packaging or labeling of any product. “Product liability action” includes, but is not limited to, all actions based upon the following theories: strict liability in tort; negligence; breach of warranty, express or implied; breach of or failure to discharge a duty to warn or instruct, whether negligent, or innocent; misrepresentation, concealment, or nondisclosure, whether negligent, or innocent; or under any other substantive legal theory in tort or contract whatsoever;
This act is intended to broadly encompass most if not all possible causes of action and legal theories for litigation pertaining to a defective product in Tennessee. The definition of product liability action in Tennessee is therefore very broad and is intended to include causes of action for many different product liability issues and in all likelihood would include litigation related to the fungal meningitis outbreak in Tennessee.
The definition of "manufacturer" under T.C.A. § 29-28-102(4) includes as "compounder" of a product which would include whatever entity compounded the drugs that are suspected to be the cause of the meningitis outbreak. The media has widely reported that the New England Compounding Center in Framingham, Massachusetts is being investigated by the U.S. Food and Drug Administration and CDC as the potential company responsible. The firm has apparently recalled their products and actually shut down operations. See CDC Outbreak information and ABC News article.
The next question is what other entities could be legally responsible in Tennessee for the fungal meningitis outbreak. Obviously, there are many other categories of entities that could be sued, including sellers, distributors, medical providers and physicians. However, the Tennessee Products Liability Act provides some protection for "sellers" of a product in Tennessee. A seller is defined under the act in T.C.A. § 29-28-102(7) as:
“Seller” includes a retailer, wholesaler, or distributor, and means any individual or entity engaged in the business of selling a product, whether such sale is for resale, or for use or consumption. “Seller” also includes a lessor or bailor engaged in the business of leasing or bailment of a product; and.
Seller’s of a product have specific protections found in T.C.A. § 29-28-106 from potential liability. T.C.A. § 29-28-106 provides as follows:
No product liability action, as defined in § 29-28-102, shall be commenced or maintained against any seller, other than the manufacturer, unless:
(1) The seller exercised substantial control over that aspect of the design, testing, manufacture, packaging or labeling of the product that caused the alleged harm for which recovery of damages is sought;
(2) Altered or modified the product, and the alteration or modification was a substantial factor in causing the harm for which recovery of damages is sought;
(3) The seller gave an express warranty as defined by title 47, chapter 2;
(4) The manufacturer or distributor of the product or part in question is not subject to service of process in this state and the long-arm statutes of Tennessee do not serve as the basis for obtaining service of process; or
(5) The manufacturer has been judicially declared insolvent.
It is likely that the main exception that may come into play could be number five where the manufacturer has been judicially declared insolvent. Obviously, we are very early in this outbreak, but the potential litigation and legal liability exposure for the manufacturer is massive in an outbreak of this scale. It is certainly not a stretch to assume this situation will cause significant financial stress on the manufacturer of the spinal injections in question. T.C.A. § 29-28-106 was actually amended effective October 1, 2011 and now provides greater protections for sellers of products then prior to the amendment of this statute. See my prior blog post on this issue here.
There is no doubt there will be litigation over the serious fungal meningitis outbreak in Tennessee. If particular entities or individuals know they could be implicated in litigation, I would strongly recommend they obtain counsel to begin the process of assessing potential liability. Further, insurance carriers should be put on notice immediately to inform them of potential exposure. Additionally, all records, documents and evidence should be maintained in order to formulate the best defense possible to litigation that may occur as a result of the fungal meningitis outbreak in Tennessee.
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