Ch. 7— The Use of Animals in Testing • 167 
in the Toxic Category Table, which contains five 
categories of hazards based on an LC S0 test for fish, 
an oral LD S0 for rats, an inhalation LC S0 for rats, 
and a dermal LD S0 for rabbits. 
Some State laws do not explicitly provide for har- 
monization with Federal requirements regarding 
the identification and classification of toxic sub- 
stances. Under the California Air Pollution Laws 
(California Air Pollution Control Laws, 1979 Edi- 
tion), the California Air Resources Board and the 
State Department of Health Service are to prepare 
recommendations for substances to be regulated 
and to consider all relevant data. State officials may 
request information on any substance under evalu- 
ation, although they do not have the authority to 
require testing. However, any person who wishes 
the board to review one of its determinations must 
specify additional evidence that is to be consid- 
ered. Similarly, the California Hazardous Waste 
Control Act (California Health and Safety Code, 
Div. 20, chs. 6.5, 1039; California Administrative 
Code, Title 22, div. 4, ch. 30) directs the California 
Department of Health Services to prepare lists of 
hazardous waste and extremely hazardous waste 
and to develop regulations for their management. 
PRODUCT LIABILITY CONSIDERATIONS 
Toxicological testing and research play an im- 
portant role in the law of product liability. Manu- 
facturers are responsible for knowing what dan- 
gers their products may present and must pay for 
any damages these products cause. Animals are 
used to discover possible dangers, and courts may 
award damages to a party whose injuries could 
have been prevented with additional testing or re- 
search (see ch. 11). 
This discussion of product liability law focuses 
primarily on drugs because animal use plays such 
an important role in determining safety . Drugs are 
also an interesting case study because they are re- 
viewed for safety and effectiveness by the Food 
and Drug Administration before they are mar- 
keted, and yet satisfying FDA’s testing require- 
ments does not necessarily fulfill the manufac- 
turer’s duty to test. 
The Manufacturer's Duty to Produce 
a Safe Product 
In general, a manufacturer has a duty to pro- 
duce a safe product with appropriate warnings 
and instructions. This is based on an individual’s 
responsibility to exercise care to avoid unreason- 
able risks of harm to others . The duty extends to 
all persons who might foreseeably be injured by 
the product manufactured. Under the Uniform 
Commercial Code— a law governing commercial 
transactions involving goods, which varies only 
slightly from State to State— failure to produce a 
safe product results in liability for the manufac- 
turer for the damages thereby caused. 
Generally, an injured plaintiff must prove that 
the drug in question was unreasonably danger- 
ous, that the defect existed at the time the drug 
left the manufacturer’s control, that the consumer 
was injured or suffered damages from the use of 
the drug, and that the defect in the drug was the 
proximate cause of the injury (13,37). 
Product liability law in most jurisdictions follows 
the "strict liability" standard— that is, no matter 
how careful a manufacturer is, it is liable for inju- 
ries caused by its products. Some jurisdictions only 
hold the manufacturer to a high standard of care, 
and many that do have strict liability standards 
also have exceptions. 
One exception is for drugs that are necessary 
but that cannot be made safe. Some have a high 
risk of harmful side effects but treat conditions 
that are even more harmful if left untreated , such 
as rabies (57). (Conversely, when the advantages 
a product offers are small, such as where vaccines 
were combined instead of using multiple injections, 
the manufacturer is more likely to be held liable 
(51).) Another exception is for products for which 
no developed skill or foresight could have avoided 
the harm (14). Even though a toxic effect might 
not have been tested for using existing methods 
with animals, a manufacturer must not ignore in- 
