Index
A
Abortifacient, 143
Accident investigation, 74
commercial aviation, 116-117
Accidents
automotive, 98-99
in commercial aviation, 114, 118
in general aviation, 74
Air bags, 18 n.4
Aircraft industry. See Commercial aviation;
General aviation
Airworthiness Directive (AD), 116
American Bar Association, 7, 17, 41, 42
American Legislative Exchange Council (ALEC), 33
American Tort Reform Association (ATRA), 33
Antilock braking system, 18 n.4, 93
Antitrust law, 71
Arbitration, 42
Asbestos-related injury claims, 18 n.1, 135
Automotive industry, 1, 10-11, 13, 72ff., 82ff
causes of vehicular injury, 11, 98-99, 110nn.52-54
defense strategies in liability cases, 89-90
engineering practice, 78-79
fuel tank design, 86
Intelligent Vehicle Highway System (IVHS) technologies, 98
legal environment, 87-88, 95-96
liability environment, 77-78, 83-87, 88
motivation for safety in, 94-95
opportunity for innovation in, 92-94
in public opinion, 87
regulation of, 99-101
safety innovation in, 80
tort reform and, 105-106
trial outcomes, 90
Aviation industry. See Commercial aviation;
General aviation
B
Birth defects. See Bendectin;
Thalidomide
Bullet-resistant vests, 51-52
C
Chemical industry, 47 ff.
benefits of technical innovation in, 47
effects of product liability system in, 13
inhibition of innovation in, 49-52
risk management in, 47-49
risks in, 48
See also Materials suppliers
Chernobyl accident, 170
Class action suits, 18 n.1, 152
Clinical trials, 123-124
Cognitive processes
belief maintenance, 165
consumer's, as design factor, 15, 162-164, 183-184
individual inconsistency in, 169
information sources in, 165-167
in injured parties, 159
in law vs. engineering, 28
product-usage instruction, 180-182
in risk management experts, 169-171
in risk perception, 164-171, 179-180, 181
simplification, 164-165
in value-of-information analysis, 178
Commercial aviation, 11-12, 13, 113 ff.
accident investigation, 116-117
causes of accidents, 116
development of, 113-114
excessive inspections, 118-119
motivation to safety innovation, 118
number of airplanes in, 116
pilot training, 115
product development in, 114-116
product liability system impacts, 118-119
protection against liability, 119
See also General aviation
Competition
in general aviation industry, 71, 75
international, 6-7, 13, 26, 34-35, 58, 75
in medical device manufacture, 58
product liability-related costs and, 40
product liability system and, 3, 43
tort reform and, 34-35
Comprehensive Environmental
Response, Compensation, and
Liability Act (CERCLA), 56
Controlled flight into terrain (CFIT), 116, 119 n.3
Conciliation, 42
Costs
general aviation engineering process, 64
general aviation insurance, 142
general aviation liability claims, 142
health care, 38
in incentive-based regulation, 155
insurance, 26, 68, 69, 146-147
legal, 9, 17, 18 n.3, 24, 40, 42, 49-50, 126, 135
new drug development, 12, 123, 125
of noncritical performance compliance, 66-67
punitive damage awards, 136-137
retail, product liability factors in, 3, 12, 40, 67, 75
of zero-risk, 27
D
Dalkon Shield, 18 n.1, 33, 125
Daubert v. Merrell Dow Pharmaceuticals, 91, 144-145
DDT, 170
in automotive industry, 80
documentation for legal defense, 65-66
materials supplier liability in, 50-51
protection against, 27, 72-73, 182-183
risk of, 26-27, 84-85, 174, 175
in tort reform, 34
Defect of manufacture, 6, 30-31, 84, 174
Discovery procedures, 17, 42, 63-64, 71-72, 90, 96
Documentation
company meeting notes, 72
corporate communication practices, 72, 118
destruction of, 65
for emergency situations, liability in, 66
in general aviation industry, 63-65, 72
legal interpretation of, 64
user manuals, 66
Drug industry. See Pharmaceutical industry
E
Elixir Sulfanilimide, 122
Engineering
automotive, 10-11, 78-79, 85-88
chemical industry, 47-48
commercial aviation, 119
corporate liability in, 85
engineers' perception of product liability, 92-93
future of, 82-83
innovation process and, 25, 73
law and, 28
national interest and, 106
product liability defense in, 11, 13, 27, 64
in product liability system reform, 97, 101
resource allocation issues, 63-64
response to litigation in, 72-73, 91
risk management in, 91-92, 175
user behavior as design factor, 160, 162-164
Enterprise liability, 103
Environmental Protection Agency, 155, 181
European Community Directive, 7, 35, 41, 44 n.13
Expert witnesses, 74, 90-91, 127, 145-146
Express warranty, 6, 31-32, 174
F
continuing responsibility, 32-33
lack of legal standards in, 84
language issues, 32
legal interpretation of, 32-33
product-related publications and, 66
protection against, 173, 177-180
state-of-the-art defense, 32
in tort reform, 34
Federal Aviation Administration, 65, 66, 71, 74, 114, 115-116
Federal law
automotive industry regulation, 85
food and drug oversight, 122-123, 124
fund for victims of product defects, 17, 61
Federal Motor Vehicle Safety Standards, 85
Federal Tort Claims Act, 147, 150 n.17
Financial management issues, 70-71
Food and Drug Administration, 57, 60-61, 122-123, 124, 127, 172, 184 n.1
Frye v. United States, 141
Fuel tank design, 86
G
General aviation, 1, 9-10, 62 ff., 68 ff.
accident investigation, 74
aftermarket manufacturers, 71
aircraft certification rules, 66
component industry, 68-69, 70-71
corporate communications in, 72
corporate practice, 70-72, 73-74
effects of product liability system in, 13, 67, 70-74
engineering environment, 63
engineering resource allocation in, 63-64
expenditures in noncritical areas, 66-67
industry status, 62, 68-69, 70, 142
international competition in, 75
kit planes, 69-70
manufacturer-regulator relationship in, 71
See also Commercial aviation
H
Halcion, 126
Hawaii, 35
Health care system, 17, 38, 105, 127
Hiring practices, 74
I
Incentive-based regulatory statutes, 155, 157
automotive, 98-99, 110 nn.52-54, 111 n.55, 118
commercial aviation, 118
consumer product-related, 38
pertussis, 140
Innovation. See Obstacles to innovation;
Safety innovations;
Technical innovations
Innoculations. See Vaccines
Insurance, 113 ff.
for component/materials suppliers, 71
damage awards and, 136-137, 139
general aviation industry, 68, 69
joint-and-several liability, 134, 139
legal environment and, 135-136, 143, 148-149
liability principles, 134
product liability system and, 14, 131-132
against punitive damages, 89
regulatory environment, 146-147
in resolution of liability cases, 89
scientific knowledge and, 135
scientific testimony and, 139-142
state law, 133-134
swine flu vaccine program, 136
systemic reform, 146-147
trends, 2-3
underwriting practices, 132-133
Insurance Services Office, 132-133
International comparisons
automobile industry regulation, 85
automotive safety and liability system, 80
product liability law, 7, 34-35, 50, 82
product liability system trends, 41, 89-90, 148-149
research needs, 16
safety innovation, 10
vehicle design, diversity in, 92
Investigational New Drug Application (IND), 123
Investor liability, 71
J
Junk science, 14, 91, 127, 135, 138 ff.
L
Larsen v. General motors, 153
Legal process
alternative settlement mechanisms, 42
automotive liability cases, 89-90
bases of product liability cases, 6, 30-33
behavioral research and, 171-176
cognitive style in, 28
corporate approaches to liability protection, 143-144
corporate communication practices and, 72, 118
corporate preparation for, 74-75
cost of, 9, 17, 18 n.3, 24, 40, 42, 49-50, 126
court-led reform, 95-96, 103-107
defense strategies in automotive cases, 89-90
discovery procedures, 17, 42, 63-64, 71-72, 90, 96
engineering documentation in, 27, 63-65
enterprise liability, 103
in expanded regulatory system, 154-156
general aviation industry defendants, 69
institutional differentiation in, 106-107
interpretation of outcomes, 25-26, 86, 171-172
investment of engineering resources in, 72-73
joint and several liability, 5, 7, 134, 139
jury sympathy in awards, 134
number of tort cases, 39
pharmaceutical industry as defendant, 125-126
precedent vs. lawmaking in, 33, 83, 102
problems of, 95-97
producer indemnification, 146
scientific testimony in, 14, 17, 28, 74, 90-91, 127, 135, 139-142, 144-146
statute of repose, 35
theoretical basis of tort law, 24, 83-84
tort system vs. statutory system, 152-154
U.S. tradition, 37-38, 43, 83-84
See also Obstacles to innovation;
Tort reform
M
Manufacturing processes, 30, 47-48, 73
Marketing
express warranty issues in, 31, 32
legal risk in, 72
new drug application process and, 124
risk management in, 173
Materials suppliers, 1, 8-9, 13
in commercial aviation, 114
diminishing number of, 59, 69, 70-71
in general aviation industry, 68-69, 70-71
inhibition of innovation in, 49-52
legal indemnification for, 60, 61
in medical device manufacturing, 50-51, 58-61
societal interests and, 53
See also Chemical industry
Mediation, 42
Medical device manufacture, 1, 9, 13, 54 ff.
advances in, 54-55
biological challenges in, 55
component/materials suppliers in, 50-51, 58-61
future of, 60-61
improving liability environment for, 60-61
inhibition of innovation in, 50-51
public expectations, 60
supply of quality materials for, 59
Misrepresentation, innocent, 6, 31-32, 174
Mississippi, 33-34
Multi-Door Courthouse, 42
N
National Transportation Safety Board, 74, 117
Negligence
contributory, 5-6
regulatory standards and, 157
New Drug Application (NDA), 124
North Dakota, 33
O
Obstacles to innovation
in automotive industry, 10, 13, 78-79, 92-94
in chemical industry, 50-52
in commercial aviation, 118
destruction of unnecessary documentation, 65
engineering environment, 72-73
in general aviation, 10, 13, 62, 67
industry-specific differences, 12-13
in insurance industry, 138
legal environment as, 14, 49-50, 53, 142-143, 151
in medical device manufacturing, 9, 13, 50-51, 58, 59-61
open-ended liability, 34
in pharmaceutical industry, 12, 13, 121, 125, 143
in regulatory environment, 100, 121
Occupational Safety and Health Act, 155
P
Peer review, 145
Personal injury awards
limitation of, 147
reform recommendations, 17, 41
in regulatory system, 156
terms of, 96-97
tort reform, 33
See also Punitive damages
Personnel policies, 73-74
Pertussis vaccine, 140
Pharmaceutical industry, 11, 12, 120 ff.
express warranty issues in, 31
insurance in, 136
in litigation, 125-126
new drug development, 120-121, 123-125, 184 nn.1-2
obstacles to innovation in, 143
regulatory environment, 120, 121-123, 127-128
tort reform and, 127
Pharmaceutical Manufacturers Association, 127
Policymaking, institutional differentiation and, 106-107
Probabilistic risk assessments, 177
Product development
in automotive industry, 78-79
in chemical industry, 48-49
in commercial aviation, 11-12, 13, 114-116
consumer behavior as design factor, 5, 160, 162-164, 183-184
corporate transactions and, 70-71
inhibition of innovation in, 50-52, 78
in medical device manufacture, 55-57
in pharmaceutical industry, 12, 120-121, 123-125
process, 172-174
Product liability system
automotive industry and, 83-87, 88, 92-94
commercial aviation and, 118-119
conflicting assessments of, 3-4, 26, 28-29, 151, 163-164
corporate practice and, 8-13, 12-13, 40-41, 70-72, 73-74, 143-144
course of reform, 16-17
general aviation industry and, 63, 67
good qualities of, 7-8, 41, 43
insurance industry and, 131-132, 148-149
insurance trends, 138
international comparison, 7, 10, 34-35, 38
legal trends, 5-6, 16, 24, 30, 31, 32, 33-34, 36, 39-40, 50, 83-84 , 95-96, 125-126
misperceptions of, 39-41
as motivation for safety innovation, 10-11, 41, 63, 75-76, 80
opportunities for improvement, 41-43
pharmaceutical industry and, 120, 125-126
problems in, 75-76
public concern, 1-2
schema, 174-175
societal expectations in, 15, 17-18, 24, 60
trends, 2-3, 15-16, 40-41, 87-88
Product stewardship, 48-49
Prozac, 125
Public concern, 1-2, 17-18, 168-169
commercial aviation safety, 119
as motivation to safety improvement, 11-12
Punitive damages, 134
insurance against, 89, 136-137, 139
limitation of, 147
role of, 88
in tort-regulatory reform, 33-34, 154
trends, 39
R
Recalls of products, 33
Refused take-offs (RTOs), 116, 119 n.2
Regulatory system, 151 ff.
aircraft certification, 66, 115
automotive industry, 85, 99-101
aviation industry, 114, 115-116
impact on innovation, 100
insurance industry, 146-147
legal liability and, 14-15
manufacturer-regulator relationship and, 71
medical devices, 55-57
pharmaceutical industry, 120, 121-123, 127-128
as source of liability claim, 65
tort system and, 99-101, 126, 148, 152-156
U.S. tradition, 37-38
victim compensation in, 156, 157
Research and development (R&D), 50-51, 59-60, 65, 91, 114-115, 123 -124, 157
Risk assessment
in chemical industry, 49
consumer behavior as factor in, 15, 160, 161, 162-164, 176-184
definition of risk in, 167-168
experts, 169-171
individual cognitive processes in, 164-171
in insurance underwriting, 14, 132-133, 138-139
manufacturer liability, 34
new aviation products, 114-115
of potential product-use problems, 176-177
probabilistic, 177
swine flu vaccine, 136
tort system uncertainty and, 133
in unknown technologies, 170-171
Risk comparison, 179-180
Risk management
in chemical industry, 47-49
in commercial aviation, 115-119
consumer behavior as factor in, 15
consumer role in, 163-164
in corporate communications, 72, 118
corporate practice in, 13, 72, 74-75, 118
in design process, 26-27, 72-73
in general aviation engineering, 63-67
as good business practice, 48
insurance as, 14
in insurance industry, 134
in new product development process, 173-174
in pharmaceutical regulation, 121-124
strategies for, 16
RU-486, 143
S
Safety innovation
in automotive industry, 80, 94-95
behavioral focus in, 15, 98-99
in commercial aviation, 113-114, 118
in general aviation industry, 63
motivation for, 10-11, 12, 41, 75-76, 80, 94, 118
risk homeostasis and, 183
Schuck, Peter, 106-107
Schwartz, Gary T., 87-88, 99, 104
Scientific testimony, 14, 17, 74, 90-91, 127, 135, 144-146
insurance and, 139-142
Silkwood v. Kerr McGee, 156
Social services system, 17, 38, 104-105, 127
in definition of risk, 167-168
in technology risk trade-offs, 23-24
State law
inconsistency in, 133
insurance regulation, 134
interstate commerce and, 6
tort reform, 33-34, 41, 102-103
trends, 3
State-of-the-art knowledge, 3, 5, 17, 25, 32, 35, 52
in insurance underwriting, 135
Statute of limitations, 34
Swine flu vaccine, 136
T
Technical innovation
in chemical materials, 47
in commercial aviation, 114-116
insurability of, 135
in medical device manufacture, 54-55
public evaluation of, 165-166
speed of, 79
vs. technical correction, 10, 79
See also Obstacles to innovation;
Safety innovation
Three Mile Island, 170
Tort reform
call for federal standards, 6-7, 127
contract law in, 147-148
damage award limits, 147
engineers in reform of, 97, 101
expanded regulation vs., 99-101
express warranty issues in, 32
federal initiatives, 34
general aviation industry and, 76
incentive-based regulatory statutes, 155-156, 157
insurance and, 137
international competition and, 34-35
meaning of, 111 n.61
pharmaceutical industry, 127
public understanding, 2
regulatory reform vs., 126, 148
research needs, 42
scientific evidence, 14, 17, 127
social insurance system and, 104-105, 127
state initiatives, 33-34, 102-103
statute of limitations, 34
statutory reform vs., 152-154
TXO Production Corporation v. Alliance Resources, 88
U
University research, 65
V
W
Waller, Patricia, 92-93
Warranty cards, 32-33
Whooping cough, 140
Workplace injuries/fatalities, 23, 100
baseline risk standards, 153
express warranty issues in, 31
Z
