Analysis: A manufacturer or seller’s compliance with federal
or state statutes and regulations can have a significant impact on a product
liability cause of action. Compliance
with statutes and regulations pertaining to the product can provide a
rebuttable presumption that the product is not in an unreasonably dangerous
condition for the matter specifically covered in the statute or
regulation. This is limited to
situations where the statute or regulation pertains to the “design, inspection,
testing, manufacture, labeling, warning or instructions for use of a product.” T.C.A. § 29-28-104(a) provides as follows:
(a) Compliance by
a manufacturer or seller with any federal or state statute or administrative
regulation existing at the time a product was manufactured and prescribing
standards for design, inspection, testing, manufacture, labeling, warning or
instructions for use of a product, shall raise a rebuttable presumption that
the product is not in an unreasonably dangerous condition in regard to matters
covered by these standards.
An amendment to this statute that took
effect October 1, 2011 provided additional protections to manufacturers or
sellers that comply with product specific statutes and regulations. A manufacturer or seller (other than the
manufacturer of a drug or device) is not liable for exemplary or punitive
damages if:
(1) The product alleged to have caused the harm was designed,
manufactured, packaged, labeled, sold, or represented in relevant and material
respects in accordance with the terms of approval, license or similar
determination of a government agency; or
(2) The product was in compliance with a statute of the state or the
United States, or a standard, rule, regulation, order, or other action of a
government agency pursuant to statutory authority, when such statute or agency
action is relevant to the event or risk allegedly causing the harm and the
product was in compliance at the time the product left the control of the
manufacturer or seller.
(See T.C.A. § 29-28-104(b)). This exemption from exemplary or punitive
damages will not apply if the product was ordered to be removed from the market
by the government prior to the time of the incident in question. (See T.C.A. §
29-28-104(c)(1)) Further, if information
was withheld or misrepresented to the government and that information is
relevant to the harm caused in the incident in question, then this exemption
from exemplar and punitive damages will also not apply (See T.C.A. §
29-28-104(c)(2)).
As a result, when dealing with a products
liability action in Tennessee from the defense side, statutes and regulations
that pertain to the product should be carefully reviewed. If there are statutes and regulations that
provide requirements for the product, then you need to consider whether they
can provide a defense to the cause of action under T.C.A. § 29-28-104
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