An Act To
Maine Legislature, Session 126, LD 1331
Committee Amendment CA_A_S163 (Senate)
Amends: 14 MRSA §221

COMMITTEE AMENDMENT A " 
to S.P. 462, L.D. 1331, Bill, "An Act To 
Amend the Law Pertaining to Defective or Unreasonably Dangerous Goods" 
Amend the bill by striking out the title and substituting the following: 
'An Act To Amend the Law ]i»ertaining to Defective or Unreasonably Dangerous 
Implantable Medical Devices: and Pharmaceuticals' 
Amend the bill by striking out everything after the enacting clause and before the 
summary and inserting the following: 
'Sec. 1. 14 MRSA §221, as enacted by PL 1973, c. 466, §1, is amended to read: 
§221. Defective or unreasonably dangerous goods 
One who sells any goods or products in a defective condition unreasonably dangerous 
to the user or consumer or to fti.s the user's or consumer's property is subject to liability 
for physical harm thereby caused to a person whom the manufacturer, seller or supplier 
might reasonably have expected to use, consume or be affected by the goods, or to his the 
user's or consumer's property, if the seller is engaged in the business of selling such a 
product and it is expected to and does reach the user or consumer without significant 
change in the condition in which it is sold. This section applies although the seller has 
exercised all possible care in the preparation and sale of his the product and the user or 
consumer has not bought the product from or entered into any e9Btraetlffill contractual 
relation with the seller. A civil action to enforce this section against a seller of a 
pharmaceutical or implantable medical device must be commenced within 6 years after 
the date that both that injury and its cause are known or should have been known by the 
exercise of reasonable diligencl~. 
As used in this section, the following terms have the following meanings. 
1. Implantable medical device. "Implantable medical device" means a medical 
device that is intended to be surgically or medically introduced into the human body and 
is intended to remain in the human body after the surgical or medical procedure. 
COMMITTEE AMENDMENT 
~. 
'i;. 
COMMITTEE AMENDMENT A 
"to S.P. 462, L.D. 1331 
2. Medical device. "Medical device" means an instrument, apparatus, implement, 
machine, contrivance, implant, in vitro reagent or other similar or related article, 
including any component part or accessory. 
3. Pharmaceutical. "Pharmaceutical" means: 
A. 
Articles recognized as drugs in the official United States Pharmacopeia and 
National Formulary or other drug compendiums or any supplement to any of them; 
B. 
Articles intended for use in the diagnosis, cure, mitigation, treatment or 
prevention of disease in humans or other animals; 
C. Articles, other than food, intended to affect the structure or any function of the 
body of humans or other animals; and 
D. Articles intended for use as a component of any articles specified in paragraphs A 
to C.' 
SUMMARY 
The bill requires a user or consumer who has been injured by defective or 
unreasonably dangerous goods or products to bring a civil action within 6 years after the 
date that both that injury and its cause are known or should have been known by the 
exercise of reasonable diligence. This amendment, which is the majority report of the 
committee, limits the type of civil actions subject to the 6-year limitation to actions 
against sellers of pharmaceuticals or implantable medical devices and provides 
definitions of those tenns. 
FISCAL :\OTE I~EQllRED 
(See attached) 
COMMITTEE AMENDMENT 
• 
Approved: OS/27/13 
~ac:. 
LD 1331 
LR 1626(02) 
An Act To Amend the Law Pertaining to Defective or Unreasonably Dangerous Goods 
Fiscal Note for Bill as Amended by Committee Amendment ~'fs -((.03 ) 
Committee: Judiciary 
C'::' 
Fiscall Note Required: Yes 
:Fiscal Note 
Minor cost increase - General Fund 
Minor revenue increase - General Fund 
Correctional and Judicial Impact Statements 
Increases the number of civil suits. 
The collection of additional filing fees may also increase General Fund revenue by minor amounts. 
LR1626(02) - Fiscal Note - Page 1 of 1