228 • Impacts of Applied Genetics — Micro-Organisms, Plants, and Animals 
defendant’s actions in fact caused the injury, 
and 3) the injury was not one for which com- 
pensation should he denied or limited because 
of overriding policy reasons. 
Because of the newness of genetic technol- 
ogy, legal standards of conduct (e.g., what con- 
stitutes unreasonable risk) have not been ar- 
ticulated by the courts. If a case were to arise, a 
court would undoubtedly look first to the 
Guidelines. Even if a technique other than rDNA 
were involved, they would provide a general 
conceptual framework for good laboratory and 
industrial techniques. Other sources for stand- 
ards of conduct include: 1) CDC’s guidelines for 
working with hazardous agents; 2) specific Fed- 
eral laws or regulations, such as those under the 
Public Health Service Act covering the inter- 
state transportation of biologic products and 
etiologic agents; and 3) industrial or profes- 
sional codes or customary practices, such as 
generally accepted containment practices in the 
pharmaceutical industry or in a microbiology 
laboratory. Compliance with these standards, 
however, does not foreclose a finding of neg- 
ligence, since the courts make the ultimate judg- 
ment of what constitutes proper conduct. In 
several cases, courts have decided that an entire 
industry or profession has lagged behind the 
level of safe practices demanded by society.* 
Conversely, noncompliance with existing stand- 
ards almost surely will result in a finding of 
negligence, if the other elements are also pres- 
ent. 
Causation may be difficult to prove in a case 
involving a genetically engineered product or 
organism. In the case of injury caused by a path- 
ogenic micro-organism— e.g., it may be difficult 
to isolate and identify the micro-organism and 
virtually impossible to trace its origin, especially 
if it had only established a transitory ecological 
niche. In addition, it might be difficult to 
reconstruct the original situation to determine 
if the micro-organism simply escaped despite 
•For example, see: The T. J. Hooper, 60 F. 2d 737 (2d Cir. 1932), 
concerning tugboats; and Helling v. Carey, 519 P. 2d 981 (1974), 
where the court held that the general practice among ophthalmo- 
logists of not performing glaucoma tests on asymptomatic patients 
under 40 (because they had only a one in 25,000 chance of having 
the disease) would not prevent a finding of negligence when such 
a patient developed the disease. 
precautions or if culpable human action was in- 
volved. On the other hand, if a micro-organism 
or toxin is identified, it may be so unique 
because of its engineering that it can he readily 
associated with a company known to produce it 
or with a scientist known to be working with 
it.** 
The law recognizes that not every negligent 
act or omission that causes harm should result 
in liability and compensation— e.g., the concept 
of "foreseeable” harm serves to limit a de- 
fendant’s liability. The underlying social policy 
is that the defendant should not he liable for in- 
juries so random or unlikely as to he not rea- 
sonably foreseeable. This determination is made 
by the court. In the case of a genetically en- 
gineered organism, extensive harm would prob- 
ably be foreseeable because of the organism’s 
ability to reproduce; how that harm could occur 
might not be foreseeable. 
Unlike negligence, strict liability does not re- 
quire a finding that the defendant breached 
some duty of care owed to the injured person; 
the fact that the injury was caused by the de- 
fendant’s conduct is enough to impose liability 
regardless of how carefully the activity was 
done. For this doctrine to apply, the activity 
must be characterized as "abnormally dan- 
gerous.” To determine this, a court would look 
at the following six factors, no one of which is 
determinative:"*^ 
1. existence of a high risk of harm, 
2. great gravity of the hai in if it occurs, 
3. inability to eliminate the risk by exei’cising 
reasonable care. 
•’ll' several companies were working with Ihe micro-organiMn 
it could be impossible to pro\-e which company prodm ed Ihe par 
ticular ones that caused the harm. V recent ( alilornia Supreme 
Court case, Sindell v. Ahholl l.ahoratories, 26 ( al 3d 5HK l9Mtl 
could pro\'ide a way around this |)roblem it the new lheor\ ol 
liahility that it establishes hecomes widely accepted Iw coiii ls m 
other jurisdictions. Ihe Court ruled Ih.it women whose mothiTs 
had taken diethylstilbestrol. a drug that allegedly c.iiised c.iiii ei m 
their daughters, could proceed to trial .igainst m.iiuit.iclurers ol 
the drug, even though most ol Ihe plaintitls would not be .ihle to 
show which |)arlicular manutaclurers produced Ihe drug I he 
Court said that wh(>n the delendani manut.iclurers h.id ,i suhslaiv 
tial share of Ihe product market, liahililv it lound would he ap 
portioned among the defendants on Ihe h.isis ol their m.irkel 
share, A particular defendant could esc.ipe li.ihilil\ oiiK h\ 
proving it could not ha\c made Ihe drug 
^^Restatemenl (Second) of Torts §5211 1 19761 
