WEBVTT 00:01.580 --> 00:06.920 Prof: Okay, so heretofore in this course we 00:06.923 --> 00:11.723 have treated government as one of two things: 00:11.721 --> 00:15.111 either, as in de Soto's frame of 00:15.110 --> 00:18.070 reference, a guarantor of property rights; 00:18.070 --> 00:27.070 or as just background material, as with Smith, 00:27.070 --> 00:32.190 where the gravamen of Wealth of Nations and the invisible 00:32.189 --> 00:36.339 hand story is to encourage governments to allow free 00:36.335 --> 00:38.525 markets and free trade. 00:38.530 --> 00:42.910 There's not much talk about governments and how they behave. 00:42.910 --> 00:46.730 And today I wanted to correct that deficiency a little by 00:46.733 --> 00:49.673 talking about government, and in particular, 00:49.669 --> 00:52.809 about the government of the United States. 00:52.810 --> 01:00.020 Then turning to the Vioxx, the Merck-Vioxx case, 01:00.020 --> 01:07.060 and looking at a little bit of video of Mark Lanier who is the 01:07.061 --> 01:13.991 main trial lawyer litigant nationally in the Merck matter. 01:13.989 --> 01:22.809 Now the United States is a very unusual political system. 01:22.810 --> 01:29.580 It is a so-called presidential system often copied. 01:29.580 --> 01:33.610 There are probably--I haven't counted them, 01:33.610 --> 01:37.460 there are probably twenty, perhaps twenty-five countries 01:37.464 --> 01:41.884 with regimes that look on the surface like the American one, 01:41.879 --> 01:45.959 and they have in common that almost every one of them has 01:45.962 --> 01:46.622 failed. 01:46.620 --> 01:50.290 Almost every one of them is wildly unstable. 01:50.290 --> 01:58.480 The organic growth of the very complex American Constitutional 01:58.477 --> 02:05.347 order is essentially unique, and it begins with what I think 02:05.352 --> 02:10.782 of as the genius of the founding fathers expressed particularly 02:10.776 --> 02:14.186 in Federalist 10 and Federalist 51, 02:14.188 --> 02:21.248 where the object is to create a complex system; 02:21.250 --> 02:27.470 system which makes it hard for people to put together winning 02:27.470 --> 02:31.410 coalitions in favor of new policies; 02:31.408 --> 02:37.798 which gives enormous advantage to those defending existing 02:37.797 --> 02:40.377 policies; which, by the scale and 02:40.377 --> 02:43.967 complexity of so large a system, and they thought, 02:43.967 --> 02:48.197 when they began, of the thirteen colonies as a 02:48.198 --> 02:52.218 huge republic, and it was a huge republic. 02:52.220 --> 02:58.700 What came after is the largest complex republic the world has 02:58.699 --> 03:04.639 known, and probably it is as large as is feasible with a 03:04.638 --> 03:08.308 republican form of government. 03:08.310 --> 03:11.950 The combination of federalism--so there are two 03:11.953 --> 03:17.053 major layers of government, and the expected diversity of 03:17.051 --> 03:22.781 so large a country make it hard to form majority coalitions. 03:22.780 --> 03:26.780 Even when you form majority coalitions, 03:26.780 --> 03:30.830 the system of checks and balances in the Constitution, 03:30.830 --> 03:34.740 augmented by the later emergence of the committee 03:34.744 --> 03:39.234 system in the House and Senate at the federal level, 03:39.229 --> 03:46.099 make putting together a winning majority very difficult. 03:46.098 --> 03:51.778 Arguably the last presidential and congressional elections 03:51.776 --> 03:58.246 created a winning coalition for some form of healthcare reform. 03:58.250 --> 04:01.930 Though one would have to admit that listening to the election 04:01.925 --> 04:05.045 wasn't much specificity about what that might be. 04:05.050 --> 04:11.210 If you watch what's happened since, the powerful resistance 04:11.207 --> 04:16.937 to change which is built into the system has manifested 04:16.942 --> 04:18.112 itself. 04:18.110 --> 04:22.200 Now from the point of view of capitalism, it is generally 04:22.202 --> 04:24.472 supposed that this is a plus. 04:24.470 --> 04:32.680 That the stability of economic policy and the endurance of laws 04:32.680 --> 04:39.280 relating to property patents, commerce, that the relative 04:39.283 --> 04:44.103 stability of all that owes something to the fact that no 04:44.098 --> 04:49.438 mere short-lived majority can transform the American political 04:49.440 --> 04:51.980 system and its policies. 04:51.980 --> 04:54.150 I think that's broadly true. 04:54.149 --> 05:01.289 The only contingency in which one would fear for the American 05:01.290 --> 05:04.950 republic, and there are people--New 05:04.954 --> 05:07.994 York Times columnist Frank Rich, 05:07.990 --> 05:11.560 for example, New York Times columnist 05:11.555 --> 05:14.535 David Brooks for another example, 05:14.540 --> 05:21.700 who fear that we've come to that difficult position, 05:21.699 --> 05:26.119 and that position is this: if the existing status quo is 05:26.115 --> 05:29.915 unsustainable, as one might have thought the 05:29.922 --> 05:34.972 status quo on the regulation of banking and mortgages was six 05:34.973 --> 05:38.583 months or a year ago, and as some argue the 05:38.576 --> 05:42.586 healthcare system is now, then all the checks and 05:42.593 --> 05:47.883 balances which make change difficult may make it impossible 05:47.877 --> 05:52.337 to escape from that very difficult status quo. 05:52.339 --> 05:59.049 Now I am personally an optimist about the ingenuity and 05:59.050 --> 06:06.880 resilience of the American and political and economic order, 06:06.879 --> 06:11.879 but it's important right now to begin what we're doing today, 06:11.879 --> 06:18.919 understanding that changing public policy is a heroic 06:18.915 --> 06:20.805 undertaking. 06:20.810 --> 06:23.700 The change of public policy, which will be in the background 06:23.697 --> 06:25.457 in the Vioxx case, is tort reform. 06:25.459 --> 06:32.619 Part--which plays a huge role in the Vioxx case, 06:32.620 --> 06:37.230 tort law does, and is in the background as a 06:37.225 --> 06:43.865 major factor in the healthcare reform story because the risk to 06:43.865 --> 06:49.435 medical practitioners from surgeons to nurses that is 06:49.435 --> 06:55.535 presented by tort law is very great and we'll try to cover 06:55.540 --> 07:00.360 some of that using Vioxx as our case. 07:00.360 --> 07:04.350 When Vioxx was in the testing stage I went to my internist and 07:04.350 --> 07:08.340 tried to talk him into getting me into the trial because I was 07:08.341 --> 07:12.991 still playing tennis then, and Vioxx allowed me to--Vioxx 07:12.992 --> 07:15.442 seemed like a miracle drug. 07:15.439 --> 07:20.619 The merit of it, a Cox-2 inhibitor, 07:20.620 --> 07:25.790 was that it seemed to reduce inflammation in your joints and 07:25.788 --> 07:30.608 therefore reduced pain without creating inflammation and 07:30.608 --> 07:33.148 erosion in the intestine. 07:33.149 --> 07:40.299 Aspirin and other similar drugs reduce inflammation in the 07:40.295 --> 07:46.935 joints, but, as a byproduct, tear at the intestine. 07:46.940 --> 07:51.080 He was wise enough to say, "You know, 07:51.079 --> 07:55.539 not every innovation is what it appears to be, 07:55.540 --> 07:57.600 and I would urge you not to be in the trials." 07:57.600 --> 08:02.910 Being a compliant fellow I took his advice, and in retrospect, 08:02.906 --> 08:04.556 I guess I'm glad. 08:04.560 --> 08:09.130 The American system, and this is not part of the 08:09.130 --> 08:13.670 original design, has built up an enormous 08:13.673 --> 08:20.523 practice in lobbying and high powered lawyering at the federal 08:20.516 --> 08:24.896 level, and K Street is to lobbying 08:24.901 --> 08:28.771 what Wall Street is to finance. 08:28.769 --> 08:34.269 The existence of trade associations for every 08:34.267 --> 08:41.887 imaginable thing is a leading factor in American politics, 08:41.889 --> 08:46.749 and whomsoever would seek to control or create some new 08:46.753 --> 08:51.803 efficiency or new form of justice in public policy has to 08:51.797 --> 08:55.577 fight her or his way through K Street. 08:55.580 --> 09:03.210 The--I'm about to give you a series of generalizations which 09:03.211 --> 09:07.121 are broadly true, each admits of exceptions, 09:07.124 --> 09:10.184 but they are about what are the advantages if we want to play 09:10.179 --> 09:11.249 the K Street game? 09:11.250 --> 09:16.110 One is concentrated interests, where a particular class of 09:16.110 --> 09:19.860 individuals or companies have a lot at stake, 09:19.863 --> 09:21.913 is a huge advantage. 09:21.909 --> 09:23.239 Why is it a huge advantage? 09:23.240 --> 09:27.540 Because it will provoke them to spend money on lobbying and 09:27.537 --> 09:30.647 influence, and they will have the money. 09:30.649 --> 09:34.429 Whereas, as disbursed interests, where there are 09:34.426 --> 09:39.246 perhaps tens of thousands or even millions of people who have 09:39.248 --> 09:44.228 small stake in an outcome will not readily form a well financed 09:44.230 --> 09:49.130 interest association, and will therefore be less 09:49.128 --> 09:55.238 strong than a concentrated set of interests which form a well 09:55.239 --> 09:57.479 financed coalition. 09:57.480 --> 10:01.630 It goes with the second point as a truism. 10:01.629 --> 10:06.219 Well-financed causes trump poorly financed ones. 10:06.220 --> 10:12.020 There are exceptions to that but not a lot. 10:12.019 --> 10:18.379 Remember that it is a market society, and money talks. 10:18.379 --> 10:23.719 It is a market society in which the first amendment gives money 10:23.724 --> 10:27.054 rights; that is, if I want to spend 10:27.054 --> 10:32.924 money putting forth a point of view and you want to regulate my 10:32.922 --> 10:37.122 right to do that, my first recourse of defense 10:37.120 --> 10:41.860 for the right will be to go to the courts and say that you're 10:41.860 --> 10:45.180 infringing my right of self expression. 10:45.178 --> 10:49.038 And the courts have often, not unambiguously, 10:49.035 --> 10:52.625 but often, ruled in favor of that view. 10:52.629 --> 10:56.709 Defending the status quo is a hell of lot easier then changing 10:56.705 --> 10:57.035 it. 10:57.038 --> 11:02.058 The legislative process is full of veto points. 11:02.058 --> 11:06.208 The commonest result for legislation introduced in the 11:06.214 --> 11:11.004 House of Representatives is that it is assigned to a committee 11:10.995 --> 11:13.265 and nothing else happens. 11:13.269 --> 11:16.779 It's assigned to a committee and nobody brings it to the 11:16.778 --> 11:17.988 floor for a vote. 11:17.990 --> 11:20.290 The committee may not even hold hearings. 11:20.288 --> 11:24.078 If the chair of the committee is hostile to it, 11:24.080 --> 11:27.600 he probably--hostile to it and he thinks it might have support, 11:27.600 --> 11:34.180 he will refuse to hold hearings in a way that's not really the 11:34.176 --> 11:40.016 subject of this course, the succession of ways in which 11:40.022 --> 11:44.442 you can kill new legislation is spectacular. 11:44.440 --> 11:49.500 Another issue, the one about agency--agency 11:49.496 --> 11:52.986 capture is a big advantage. 11:52.990 --> 11:58.880 By this we mean that if you are in the airline business, 11:58.879 --> 12:03.269 let us say, and there is a Civil Aeronautics Bureau, 12:03.269 --> 12:08.779 which is assigned the task of regulating your industry, 12:08.778 --> 12:13.078 if your industry can make an alliance with that agency 12:13.077 --> 12:16.217 itself, can capture the agency, 12:16.224 --> 12:22.014 that can be worth an enormous economic sum because it will 12:22.009 --> 12:28.099 allow you to structure public policy in a way which suits the 12:28.097 --> 12:32.257 combined interests of your industry. 12:32.259 --> 12:35.579 Something of the same is said to be at play, 12:35.578 --> 12:39.518 and almost certainly is at play, in the relationship 12:39.515 --> 12:43.525 between the pharmaceutical interest and the FDA. 12:43.529 --> 12:50.909 I've just said that and that at the same time. 12:50.908 --> 12:57.338 The CAB, Civil Aeronautics Bureau, ruled the airline 12:57.340 --> 13:03.770 industry from its inception until the late 1970s. 13:03.769 --> 13:06.249 In the late 1970s it was repealed. 13:06.250 --> 13:15.700 The regime it created assigned routes to particular companies, 13:15.700 --> 13:17.930 so you would apply to the government for the right to fly 13:17.927 --> 13:21.717 from LaGuardia in Chicago to-- LaGuardia, New York to Midway 13:21.720 --> 13:25.240 in Chicago, or from Midway in Chicago to 13:25.241 --> 13:25.671 LAX. 13:25.668 --> 13:31.608 The agency would assign routes to make sure that there was not 13:31.607 --> 13:34.137 undue price competition. 13:34.139 --> 13:39.759 It would protect oligarchical pricing, and that is to say 13:39.759 --> 13:42.569 highly profitable pricing. 13:42.570 --> 13:45.940 It would work the Porter Forces, if you will, 13:45.936 --> 13:49.376 to the advantage of the incumbent airlines. 13:49.379 --> 13:55.329 New entrants could be frozen out, price competition was 13:55.327 --> 13:58.237 minimal, most of the competition had to 13:58.238 --> 14:02.308 do with amenities, most famously with airline 14:02.313 --> 14:07.753 attendants averaging twenty-five years of age, 14:07.750 --> 14:11.380 and all women and none married. 14:11.379 --> 14:20.539 The air travel business was restricted and wildly 14:20.538 --> 14:23.208 inefficient. 14:23.210 --> 14:29.580 What killed this arrangement was the observation made by some 14:29.582 --> 14:35.532 law and economics people that the airlines which were not 14:35.530 --> 14:39.110 subject to it, and the only airlines that 14:39.105 --> 14:42.325 weren't subject to this regulation were ones which flew 14:42.333 --> 14:46.633 entirely in one state, and the most famous case was 14:46.630 --> 14:52.120 the flight between the San Francisco/Oakland area and the 14:52.115 --> 14:56.315 LA/San Diego area, where fares were low, 14:56.316 --> 15:01.576 they were less than half comparable fares on interstate 15:01.577 --> 15:02.647 flights. 15:02.649 --> 15:09.559 A similar story in Texas from Love Field, 15:09.558 --> 15:13.338 Dallas in a hub pattern around the state of Texas, 15:13.340 --> 15:16.490 fares were lower, safety was just as good, 15:16.490 --> 15:21.140 service wasn't quite as good, but there was genuine price 15:21.138 --> 15:22.298 competition. 15:22.298 --> 15:27.378 This group came to the fore and created a national coalition to 15:27.379 --> 15:29.509 deregulate the airlines. 15:29.509 --> 15:35.769 The effect was well let's take somebody at random. 15:35.769 --> 15:42.409 Who's had--how many of you look forward to air travel? 15:42.408 --> 15:50.148 Somebody want to give us a thirty second essay on why it's 15:50.153 --> 15:57.493 hard to--why it's not a lot of fun to travel by air? 15:57.490 --> 15:59.650 I'll save us time. 15:59.649 --> 16:04.199 It's because flights are by and large full and the 16:04.201 --> 16:08.571 Transportation Safety Administration provides an 16:08.566 --> 16:16.516 initial indignity on each trip, and because service is totally 16:16.517 --> 16:17.897 minimal. 16:17.899 --> 16:21.489 You have to buy your own graham crackers for lunch. 16:21.490 --> 16:34.580 It's not--unless you fly first class or business class, 16:34.580 --> 16:37.420 which Yale does not allow except for the very highest 16:37.418 --> 16:40.038 ranking officers at the university right now, 16:40.038 --> 16:45.548 and then only on very long flights. 16:45.548 --> 16:50.598 Air travel isn't fun at all, but what it is is efficient and 16:50.604 --> 16:55.324 it is in real terms vastly cheaper than it was under the 16:55.315 --> 16:57.195 regulatory regime. 16:57.200 --> 17:01.540 And I bring it up just to point out the advantage of regulation 17:01.538 --> 17:05.248 under the old CAB regime from the point of view of the 17:05.250 --> 17:09.590 airlines and not from the point of view of the passengers. 17:09.588 --> 17:15.168 The effect of deregulation was a long series of bankruptcies in 17:15.170 --> 17:18.680 which the legacy carriers went broke. 17:18.680 --> 17:22.300 Those which have survived, they had gotten so fat under 17:22.301 --> 17:24.721 the old regime, that they were wildly 17:24.715 --> 17:25.785 inefficient. 17:25.788 --> 17:30.508 And most of them died off and those which survived had to go 17:30.506 --> 17:35.616 through convulsive change to get their operating costs low enough 17:35.623 --> 17:40.183 to compete with the new wave carriers such as Southwest or 17:40.180 --> 17:41.300 JetBlue. 17:41.298 --> 17:48.678 Well the FDA is, from a strategic point of view, 17:48.681 --> 17:53.551 broadly analogous to the CAB. 17:53.548 --> 18:00.288 The FDA is a huge regulatory jungle which creates powerful 18:00.289 --> 18:06.109 obstacles to new entrants, and which requires drug 18:06.114 --> 18:12.154 companies to be extremely well financed in order to get new 18:12.151 --> 18:15.171 products through the mill. 18:15.170 --> 18:22.430 The impact of that has been to create a relatively small number 18:22.426 --> 18:27.106 of gigantic pharmaceutical companies, 18:27.108 --> 18:32.338 many of them very well run, and to induce those 18:32.343 --> 18:38.603 pharmaceutical companies to aim at blockbuster drugs. 18:38.599 --> 18:42.619 Merck is one of those companies. 18:42.618 --> 18:48.648 It's--I've shown you this diagram about combining know-how 18:48.648 --> 18:54.148 with capital and motivation to get something done. 18:54.150 --> 18:58.920 In a highly regulated environment you've also got to 18:58.923 --> 19:04.823 worry about the regulatory and legal apparatus in a big way, 19:04.818 --> 19:07.898 and these companies are really good at that. 19:07.900 --> 19:11.200 They have adapted to the regime of the Food and Drug 19:11.195 --> 19:16.105 Administration, and are terrifically good at 19:16.114 --> 19:23.624 that, and they are able to put up pretty high barriers to 19:23.624 --> 19:28.054 competition from new entrants. 19:28.048 --> 19:34.408 The typical outcome for somebody--for a small firm which 19:34.405 --> 19:39.605 has a drug candidate, is that they get to a certain 19:39.605 --> 19:44.455 stage in the preliminary phases of testing and then sell or 19:44.455 --> 19:49.135 license the drug to one of the major pharmaceuticals. 19:49.140 --> 19:55.530 I'll post this slide. 19:55.529 --> 20:00.049 It's the history of Merck's interaction with government and 20:00.045 --> 20:02.765 government's road toward the FDA. 20:02.769 --> 20:06.229 The interesting thing, it's in the case about Merck, 20:06.230 --> 20:08.380 is that it's property was seized during World War I, 20:08.380 --> 20:12.390 and for the American government to seize the property of a 20:12.394 --> 20:14.934 corporation is a very rare event, 20:14.930 --> 20:17.650 but the problem was of course World War I, 20:17.650 --> 20:19.450 the Germans were the bad guys. 20:19.450 --> 20:23.380 They ended up having to buy their property back on loans 20:23.381 --> 20:24.741 from Wall Street. 20:24.740 --> 20:27.980 The reason they got the loans is that Merck was a great 20:27.980 --> 20:31.160 company, a great company with centuries of history. 20:31.160 --> 20:37.170 The two legislative acts which are perhaps important to the 20:37.173 --> 20:43.503 background of this case are the Prescription Drug User Fee Act 20:43.500 --> 20:48.790 of 1992 and the FDA Modernization Act of 1997, 20:48.788 --> 20:55.128 both of which gave--put the drug companies in the position 20:55.130 --> 20:59.800 of funding the FDA's investigation of their 20:59.801 --> 21:01.361 proposals. 21:01.358 --> 21:04.938 Now in looking for a blockbuster drug, 21:04.936 --> 21:10.346 think of the green square as a space representing all the 21:10.352 --> 21:14.512 possible diseases that drugs could fix. 21:14.509 --> 21:18.779 They range on the vertical scale from acute at the bottom 21:18.784 --> 21:22.454 to chronic on the top, from rare on the bottom to 21:22.448 --> 21:24.278 common on the right. 21:24.278 --> 21:28.648 I said chronic up here, or I meant chronic up here. 21:28.650 --> 21:32.310 It is obvious to you where the money is to be made in the 21:32.306 --> 21:34.066 pharmaceuticals business? 21:34.069 --> 21:37.539 Yes back left. 21:37.538 --> 21:38.528 Student: Common and chronic. 21:38.529 --> 21:39.589 Prof: Pardon. 21:39.588 --> 21:39.708 Student: Common and chronic. 21:39.710 --> 21:43.320 Prof: Common and chronic, because if acute, 21:43.318 --> 21:46.808 the customer may not stay alive long enough to be truly 21:46.806 --> 21:52.716 profitable, and common is--has its obvious 21:52.717 --> 21:54.217 benefit. 21:54.220 --> 22:00.820 The idea of a Cox-2 inhibitor, the business plan behind the 22:00.823 --> 22:07.313 Cox-2 inhibitor was to advertise the hell out of it and to 22:07.311 --> 22:14.031 capture a huge generation of people forty and older with bad 22:14.028 --> 22:16.978 knees, tennis elbow, 22:16.981 --> 22:21.241 all those stiff necks, all those things which go on 22:21.240 --> 22:24.320 for decades, during the seventeen year 22:24.323 --> 22:28.953 patent to make billions upon billions of dollars. 22:28.950 --> 22:33.170 Blockbuster drugs, in fact, do make billions upon 22:33.167 --> 22:37.767 billions of dollars, and there is a market failure 22:37.772 --> 22:42.502 problem with this model, which has to do with less 22:42.497 --> 22:45.577 common and more acute diseases. 22:45.578 --> 22:50.298 Many, many small disease populations get 22:50.297 --> 22:56.467 disproportionately small investment in drug research 22:56.465 --> 23:02.025 because of the logic of blockbuster drugs. 23:02.028 --> 23:10.708 Merck has had two really famous CEOs in recent time. 23:10.710 --> 23:15.490 This is Roy--I've had both these guys in my classroom to 23:15.491 --> 23:20.711 teach this case at one time or another, Roy Vagelos was a--is 23:20.710 --> 23:23.580 an M.D., and a brilliant M.D. 23:23.579 --> 23:25.039 and an idealist. 23:25.038 --> 23:29.158 He at one point--I don't know if this--is river blindness drug 23:29.164 --> 23:30.184 in this case? 23:30.180 --> 23:33.010 Yeah, the river blindness drug is one where he-- 23:33.009 --> 23:37.499 the government wouldn't pay to distribute the drug in Africa, 23:37.500 --> 23:41.410 but he just had Merck pay, and thinks he got his money 23:41.411 --> 23:44.881 back in the motivation of his research staff. 23:44.880 --> 23:47.290 Ray Gilmartin, who succeeded him, 23:47.292 --> 23:52.052 and comes in for great abuse in the Mark Lanier video we'll look 23:52.046 --> 23:55.866 at, Ray Gilmartin is an MBA, 23:55.869 --> 24:02.619 worse yet a Harvard MBA, and was hell for leather 24:02.621 --> 24:03.981 marketer. 24:03.980 --> 24:08.840 He looked at the Cox-2 inhibitor market as the best 24:08.837 --> 24:14.567 single market available in the generation to Merck and put a 24:14.569 --> 24:19.269 huge sales force out there, and went full stop, 24:19.271 --> 24:22.541 and sometimes a little over the line, 24:22.538 --> 24:28.548 with the ethics of inducing doctors to prescribe the drug. 24:28.548 --> 24:33.308 Sometimes by straightforward favor giving, 24:33.308 --> 24:39.398 sometimes by invitation to so-called research conferences, 24:39.400 --> 24:44.510 which were in actual fact golfing holidays of the kind-- 24:44.509 --> 24:48.279 now what's wrong with a golfing holiday aimed at M.D.'s, 24:48.279 --> 24:49.569 if we remember Sharon Oster? 24:49.569 --> 24:51.949 Do we remember? 24:51.950 --> 24:57.910 Yes. 24:57.910 --> 25:05.590 25:05.588 --> 25:06.538 Student: If I remember correctly, 25:06.538 --> 25:08.538 she said it was that if the doctor was willing to go on 25:08.544 --> 25:10.834 golfing holiday, that means the opportunity cost 25:10.825 --> 25:14.845 he's losing is not that high, so it's probably not a doctor 25:14.852 --> 25:16.292 that sees a lot. 25:16.288 --> 25:18.858 Prof: Okay, so the doctors with the lowest 25:18.859 --> 25:21.109 opportunity costs were going to Hawaii, 25:21.108 --> 25:23.318 go to Hawaii, and they're not the people 25:23.315 --> 25:24.725 you're trying to reach. 25:24.730 --> 25:29.950 That's certainly true of the heart technology, 25:29.950 --> 25:34.670 maybe a little less true of Vioxx, where a very low key 25:34.666 --> 25:40.166 practice where you just casually advise people to take this drug 25:40.171 --> 25:42.531 would be very valuable. 25:42.529 --> 25:48.839 The common law tradition, the English common law is 25:48.838 --> 25:54.768 derived not from legislation but from cases, 25:54.769 --> 26:01.599 and builds up through precedent where each new case is analyzed 26:01.602 --> 26:08.102 by its analogy or lack thereof to earlier cases which raised 26:08.104 --> 26:10.974 the same legal issues. 26:10.970 --> 26:18.050 This tradition goes back a thousand years, 26:18.048 --> 26:23.228 or nearly a thousand years, and came to the United States 26:23.232 --> 26:28.882 with the immigrants who came to New England in the seventeenth 26:28.877 --> 26:34.707 century and is a dominant part of the American Legal Code, 26:34.710 --> 26:39.280 which is largely separable from Congress and the Legislative 26:39.284 --> 26:40.064 process. 26:40.058 --> 26:47.588 And central to it is the idea that courts should make the 26:47.590 --> 26:53.370 victims of careless, reckless, or fraudulent 26:53.374 --> 26:58.104 products whole; should make them--should bring 26:58.097 --> 27:02.507 them back to a situation as good as they would have been in if 27:02.506 --> 27:05.466 they had not received the bad product. 27:05.470 --> 27:10.490 Beyond that, often punitive damages, 27:10.490 --> 27:14.680 where if we say this person was harmed to the extent of $100,000 27:14.681 --> 27:18.741 so we'd pay him the $100,000 at the expense of the company. 27:18.740 --> 27:21.820 We then say, this is a huge company, 27:21.817 --> 27:26.647 $100,000 means nothing to this company so let's say $100 27:26.653 --> 27:27.713 million. 27:27.710 --> 27:31.570 Most of the $100 million is punitive damage, 27:31.566 --> 27:36.766 which nonetheless goes to the victim, but is meant to teach 27:36.767 --> 27:39.007 the company a lesson. 27:39.009 --> 27:43.649 Well from the point of view of business, punitive damages are 27:43.653 --> 27:44.663 very scary. 27:44.660 --> 27:49.480 And the American legal landscape is a particularly 27:49.480 --> 27:54.500 complex one for that reason because with federalism, 27:54.497 --> 27:55.477 Ghen v. 27:55.480 --> 27:59.020 Rich, you remember it, Ghen v. 27:59.022 --> 28:04.732 Rich is about tort law, and about setting incentives in 28:04.729 --> 28:10.139 a way that works well for society as a whole, 28:10.140 --> 28:14.230 and the problem with Merck Vioxx is similarly that. 28:14.230 --> 28:20.240 I'll give you one more common law case to get the feel of 28:20.238 --> 28:20.988 this. 28:20.990 --> 28:26.610 At the close of World War II, the guy who owned this property 28:26.606 --> 28:32.316 near an airport sued the airport for the noise of planes going 28:32.318 --> 28:34.658 through his airspace. 28:34.660 --> 28:39.440 He said I own the airspace; they can only come through if 28:39.443 --> 28:43.343 they have my permission or pay me rent on the use of my 28:43.343 --> 28:44.213 airspace. 28:44.210 --> 28:52.200 The plaintiff had a very strong common law precedent. 28:52.200 --> 28:58.160 The common law theory of airspace was that you make a 28:58.162 --> 29:02.412 projection from the-- after people were sure the 29:02.406 --> 29:06.456 world was round, it's a spherical projection, 29:06.463 --> 29:11.853 to the ends of the universe, you owned everything that is in 29:11.848 --> 29:14.868 that spherical projection over your land. 29:14.868 --> 29:23.578 Now you were--you're a judge, its 1947, the airline industry 29:23.583 --> 29:31.413 is just getting strong, and you're presented with this 29:31.410 --> 29:32.740 case. 29:32.740 --> 29:42.780 Tal, how would you decide it? 29:42.779 --> 29:46.299 Student: Well, since the airline industry is 29:46.297 --> 29:50.367 just getting strong I might want to incentivize them to keep 29:50.365 --> 29:53.465 flying and keep > 29:53.470 --> 29:56.450 which would obviously be very difficult if I let every single 29:56.452 --> 29:58.852 person-- it would obviously be very 29:58.853 --> 30:02.953 difficult to let the airline industry form if I let every 30:02.951 --> 30:07.491 single person who owns property control the airspace over their 30:07.489 --> 30:10.929 property because then they would have to-- 30:10.930 --> 30:14.280 the transaction costs would be huge to negotiate with each and 30:14.280 --> 30:15.490 every single person. 30:15.490 --> 30:16.740 Prof: Absolutely. 30:16.740 --> 30:18.430 That nails the question. 30:18.430 --> 30:21.850 A flight--a little flight from Chicago to Milwaukee or from 30:21.846 --> 30:24.506 Milwaukee to Madison, Wisconsin or from Madison, 30:24.506 --> 30:27.416 Wisconsin to Minneapolis, would involve thousands of 30:27.421 --> 30:31.161 transactions and license fees with the owners of all the land 30:31.161 --> 30:35.731 you're going to traverse, and the airline industry would 30:35.730 --> 30:38.490 be stillborn for that reason. 30:38.490 --> 30:44.690 In the background of this case, just as in the background of 30:44.689 --> 30:45.949 Ghen v. 30:45.950 --> 30:50.630 Rich, is creating incentives for those who are 30:50.628 --> 30:55.208 prepared to invest in the generation of value and 30:55.212 --> 31:00.182 ultimately of wealth for the society as a whole. 31:00.180 --> 31:04.090 Mr. Justice Douglas, in May of 1946, 31:04.094 --> 31:07.234 wrote the opinion in U.S. 31:07.226 --> 31:07.446 v. 31:07.450 --> 31:13.830 Cosby, which decided the case in favor of the airlines 31:13.825 --> 31:17.735 and against the landowners. 31:17.740 --> 31:24.300 Now the plaintiff bar--let's not do the summaries. 31:24.298 --> 31:26.448 Let's see if I can remember how we're going to do this. 31:26.450 --> 31:34.940 DVD stage, play, this is a set of interviews we 31:34.942 --> 31:37.502 sent a-- this is Mark Lanier: 31:37.500 --> 31:39.170 "I think Merck ultimately has to settle, 31:39.170 --> 31:42.760 maybe not all of the cases, but Merck certainly needs to 31:42.761 --> 31:44.331 settle the good cases. 31:44.328 --> 31:50.858 What Merck needs to do is wait until the statute of limitations 31:50.862 --> 31:51.602 runs. 31:51.598 --> 31:54.908 What that means is that there's a time period after you're 31:54.910 --> 31:57.640 damaged where you have to file your lawsuit, 31:57.640 --> 32:01.210 and if you don't file within that time period your rights are 32:01.212 --> 32:01.632 gone. 32:01.630 --> 32:05.370 Merck needs to go ahead and wait and let that time period 32:05.372 --> 32:08.232 run, so that there is a fixed 32:08.227 --> 32:11.467 denominator, how many cases are out there, 32:11.467 --> 32:13.987 and then the numerator, how many of those is Merck 32:13.992 --> 32:15.752 going to settle, can be determined. 32:15.750 --> 32:18.280 I'm not sure that Merck needs to settle every case out there. 32:18.278 --> 32:21.578 These cases are expensive to fight and they're hard to fight, 32:21.578 --> 32:27.778 and so Merck can satisfactorily settle the difficult cases of 32:27.778 --> 32:31.798 serious injury, where really I think all of us 32:31.795 --> 32:34.665 ultimately agree Merck owes the money, 32:34.670 --> 32:38.630 and then Merck can take those cases of lesser liability and 32:38.632 --> 32:42.382 ultimately tell the lawyers, 'You want us, come get us.' 32:42.380 --> 32:45.330 That's where this has got to end up I think." 32:45.328 --> 32:51.088 I think there are probably about 25,000 to 30,000 cases 32:51.086 --> 32:55.986 that ultimately will be filed against Merck. 32:55.990 --> 32:59.480 Out of those 25,000 to 30,000 how many of them are good cases? 32:59.480 --> 33:04.190 I would guess probably--you've got different degradations of 33:04.191 --> 33:04.751 good. 33:04.750 --> 33:07.260 It's like students, there's A good and there's B 33:07.259 --> 33:10.359 good, then there's C not so good, and then there's D and F, 33:10.356 --> 33:11.796 really not good at all. 33:11.798 --> 33:15.548 How many A/B cases in that grouping? 33:15.548 --> 33:18.778 Over half of them I think are probably A/B cases. 33:18.779 --> 33:21.189 How many of those are C's? 33:21.190 --> 33:24.360 Maybe a third; how many of them are D and F? 33:24.358 --> 33:26.658 Maybe about 25%, I don't know, 33:26.661 --> 33:31.191 my percentages may not add up, but it's something in those 33:31.185 --> 33:33.245 ranges at least." 33:33.250 --> 33:42.300 My guess is $12 to $15 billion dollars for liability for Merck. 33:42.298 --> 33:46.878 I think if Ken Frazier, the general counsel for Merck, 33:46.880 --> 33:49.430 came to me and said, 'Lanier here's $12.5 billion 33:49.425 --> 33:51.495 dollars, make my headache go away,' I 33:51.502 --> 33:53.962 could come pretty close to resolving all of his 33:53.955 --> 33:54.805 issues." 33:54.808 --> 34:00.878 "There's a great deal of difficulty in trying to set up a 34:00.878 --> 34:04.758 jurisdiction for hearing these cases. 34:04.759 --> 34:09.409 The way the law is set up, philosophically the plaintiff 34:09.407 --> 34:12.977 who has a burden of proof, the plaintiff has to prove 34:12.980 --> 34:15.280 their case, and a tie goes to the defendant 34:15.280 --> 34:16.010 if you will. 34:16.010 --> 34:19.900 The plaintiff with a burden of proof is supposed to get a pick 34:19.898 --> 34:20.598 of forum. 34:20.599 --> 34:24.439 By that it means if you've got to prove your case you should be 34:24.443 --> 34:27.733 allowed to choose in which court you want to do it. 34:27.730 --> 34:29.840 Realistically, in America, all of our courts 34:29.835 --> 34:32.295 are supposed to be fair, but practically, 34:32.300 --> 34:36.080 we recognize that some are more plaintiff friendly, 34:36.079 --> 34:38.409 and some are more defense friendly, 34:38.409 --> 34:42.279 and so the plaintiffs naturally try to find those courts that 34:42.277 --> 34:43.887 are plaintiff friendly. 34:43.889 --> 34:48.019 The defendants want defense friendly courts. 34:48.018 --> 34:50.588 We tried the first case in Texas. 34:50.590 --> 34:53.510 Texas has a reputation for being plaintiff friendly, 34:53.512 --> 34:55.982 realistically I think at this point in time, 34:55.978 --> 34:57.238 it's probably not. 34:57.239 --> 35:01.019 Our judge was appointed to the bench by George Bush when he was 35:01.019 --> 35:02.239 Governor of Texas. 35:02.239 --> 35:04.089 George Bush, President Bush, 35:04.090 --> 35:06.970 is certainly no friend to trial lawyers. 35:06.969 --> 35:11.979 We have an appellate court system in Texas that is entirely 35:11.976 --> 35:13.096 Republican. 35:13.099 --> 35:16.909 There will not be a Democratic judge that will ever see the 35:16.911 --> 35:19.341 Vioxx case we have, we tried in Texas, 35:19.342 --> 35:22.632 or the ones pending right now to my knowledge. 35:22.630 --> 35:26.110 In New Jersey you've got a different scenario. 35:26.110 --> 35:29.930 You've got a court system that's very friendly, 35:29.931 --> 35:33.421 ideologically at least, with big pharma. 35:33.420 --> 35:36.890 Pharma has a home in New Jersey, has great tort reform in 35:36.891 --> 35:39.601 New Jersey, and until we got the punitive 35:39.596 --> 35:43.116 damage finding against Merck, had never been held responsible 35:43.117 --> 35:45.977 for punitive damages in New Jersey under the current state 35:45.983 --> 35:46.993 of the law." 35:46.989 --> 35:52.119 Prof: If you Google "judicial hell-hole" 35:52.123 --> 35:57.073 you will find a map showing the most plaintiff friendly 35:57.074 --> 36:00.104 jurisdictions in the country. 36:00.099 --> 36:06.509 The huge ideological battle and political battle which is in 36:06.509 --> 36:12.589 progress, about federalizing and capping tort law awards, 36:12.592 --> 36:14.442 is out there. 36:14.440 --> 36:16.800 Just go "tort reform" or "judicial 36:16.795 --> 36:18.955 hell-holes" and you'll get the flavor of 36:18.956 --> 36:19.296 it. 36:19.300 --> 36:22.290 Mark Lanier: "So New Jersey is 36:22.289 --> 36:26.069 somewhere that I think Merck would like-- 36:26.070 --> 36:46.650 36:46.650 --> 36:49.720 " "The Harvard Business School slide that I've 36:49.724 --> 36:51.964 put was not the first slide I showed, 36:51.960 --> 36:54.580 but it certainly was in my opening statement. 36:54.579 --> 36:59.179 I wanted the jury to understand that when-- 36:59.179 --> 37:01.399 before Ray Gilmartin came on board, 37:01.400 --> 37:06.830 Merck--which was 1994, Merck was run basically by a 37:06.833 --> 37:10.533 CEO named Dr. Vagelos and Dr. 37:10.530 --> 37:15.130 Vagelos is a world-renowned doctor, phenomenal doctor. 37:15.130 --> 37:19.360 When Ray Gilmartin came on board Merck didn't hire a 37:19.356 --> 37:22.916 world-renowned doctor to run the company. 37:22.920 --> 37:26.640 Merck didn't hire a world-renowned chemist, 37:26.635 --> 37:29.905 or even a nationally known chemist. 37:29.909 --> 37:31.609 Heck, I'd have taken a local chemist. 37:31.610 --> 37:36.390 They didn't hire a pharmacist, someone who had experience with 37:36.389 --> 37:40.539 pills and medicines on even a local level, much less a 37:40.541 --> 37:42.031 national level. 37:42.030 --> 37:46.210 What Merck did is they took a different direction. 37:46.210 --> 37:49.110 They changed directions from the Vagelos days, 37:49.110 --> 37:52.600 Dr. Vagelos days, and they hired an MBA which I 37:52.596 --> 37:57.326 have a lot of respect for MBA's, but I think we need to put into 37:57.333 --> 38:00.953 context what it was speaking to within the Merck culture. 38:00.949 --> 38:04.489 It was saying no longer is science running our company, 38:04.489 --> 38:07.979 we're now going to run this company along economic terms as 38:07.978 --> 38:10.738 a business, and Ray Gilmartin came in, 38:10.742 --> 38:15.352 as a Harvard trained MBA, who had really no science 38:15.353 --> 38:17.763 background whatsoever. 38:17.760 --> 38:24.760 It was an--I put the Harvard Business School slide up to put 38:24.762 --> 38:31.882 a visual image to go with the intellectual concept that Merck 38:31.882 --> 38:39.362 was choosing to be a business first company not a patient-- 38:39.360 --> 38:43.240 When we tried the Ernst case, I was stunned at the opening 38:43.242 --> 38:44.472 that Merck gave. 38:44.469 --> 38:48.779 Understand Bob Ernst died from what's called sudden cardiac 38:48.775 --> 38:49.365 death. 38:49.369 --> 38:53.819 Sudden cardiac death means you are dead by the time you're in 38:53.815 --> 38:58.105 the hospital and the cause is not something they can easily 38:58.114 --> 39:00.364 trace, but it's clearly a heart 39:00.355 --> 39:00.885 problem. 39:00.889 --> 39:05.379 The sudden cardiac death was attributed to an arrhythmia, 39:05.380 --> 39:07.930 which is a ventricular fibrillation for him, 39:07.929 --> 39:11.199 his heart was quivering, and the question ultimately 39:11.202 --> 39:13.432 becomes, what caused that heart 39:13.434 --> 39:14.964 quivering arrhythmia? 39:14.960 --> 39:17.020 Most typically, according to the Merck 39:17.018 --> 39:20.058 Manual, it's caused by a heart attack, 39:20.056 --> 39:23.376 but it can be caused by an electrocution, 39:23.380 --> 39:28.980 it can be caused by inhaling a lot of salt water in a drowning, 39:28.980 --> 39:33.800 and it can be caused by being exposed to hypothermia. 39:33.800 --> 39:38.370 Clearly none of those is what had happened to Bob Ernst. 39:38.369 --> 39:40.319 Bob Ernst had had a heart attack. 39:40.320 --> 39:45.120 I was stunned in opening when the Merck lawyer stood up and 39:45.121 --> 39:48.161 told the jury, disingenuously I believe, 39:48.159 --> 39:52.139 that if the jury looked at the coroner's report they would see 39:52.137 --> 39:56.307 that they coroner said Bob Ernst had not had a heart attack, 39:56.309 --> 39:59.739 Bob Ernst had died from arrhythmia secondary to 39:59.744 --> 40:01.094 arthrosclerosis. 40:01.090 --> 40:05.660 Well, those are both caused by a heart attack. 40:05.659 --> 40:13.049 Someone may have died from a loss of blood okay, 40:13.050 --> 40:15.760 but if someone was shot, and it was the gunshot that 40:15.759 --> 40:18.149 caused the bleeding and the loss of blood, 40:18.150 --> 40:20.180 it's disingenuous to stand up and tell a jury, 40:20.179 --> 40:22.079 well they didn't die from the bullet, 40:22.079 --> 40:24.269 they died from loss of blood." 40:24.268 --> 40:27.318 I was shocked by that because I thought it was a 40:27.324 --> 40:29.824 misrepresentation, and I think Merck did it 40:29.822 --> 40:32.612 thinking they could get away with it because no one had ever 40:32.608 --> 40:35.488 been able to find the coroner and ask her what she meant, 40:35.489 --> 40:39.169 and so I don't have any testimony to the contrary, 40:39.170 --> 40:40.510 we just have a report. 40:40.510 --> 40:43.280 I went back to my office and I said, 'I want the coroner.' 40:43.280 --> 40:44.840 And they said 'We can't find the coroner.' 40:44.840 --> 40:48.360 I said 'We can find anybody except Bin Laden, 40:48.360 --> 40:49.960 find the coroner.' 40:49.960 --> 40:53.780 We hired a couple of PI's, we found the coroner doing 40:53.779 --> 40:57.819 pathology work in the United Arab Emirates Abu Dhabi. 40:57.820 --> 41:01.400 I shot her an email asking her if she would mind if I spoke 41:01.400 --> 41:02.080 with her. 41:02.079 --> 41:05.729 She emailed back and said she'd be glad to speak with me. 41:05.730 --> 41:09.090 I called her on the phone and I said, here is what was said 41:09.094 --> 41:12.464 about this case in opening, here is what your autopsy said, 41:12.460 --> 41:13.680 tell me about it. 41:13.679 --> 41:17.149 She said 'Well he died, under an autopsy I have to put 41:17.148 --> 41:20.118 the physical cause, physical cause it was a sudden 41:20.121 --> 41:21.911 cardiac death with an arrhythmia, 41:21.909 --> 41:23.699 secondary to arthrosclerosis.' 41:23.699 --> 41:25.059 I said 'Well how does that kill you'? 41:25.059 --> 41:26.699 She said 'Easy, you have a heart attack.' 41:26.699 --> 41:28.419 I said 'Really?' 41:28.420 --> 41:30.530 She said 'Of course, that's the only thing that 41:30.528 --> 41:31.078 causes it. 41:31.079 --> 41:33.789 Arthrosclerosis causes a heart attack; 41:33.789 --> 41:35.889 the heart attack causes an arrhythmia.' 41:35.889 --> 41:37.999 She said 'Unless he was electrocuted," 41:38.001 --> 41:39.661 she said 'Was he electrocuted?' 41:39.659 --> 41:40.869 I said 'No.' 41:40.869 --> 41:42.279 She said 'Okay.' 41:42.280 --> 41:44.250 I said 'Would you come over and explain that to the jury?' 41:44.250 --> 41:46.880 She said 'I would be glad too,' so she came over. 41:46.880 --> 41:50.390 Well Merck threw a fit because Merck says we never would have 41:50.393 --> 41:53.793 told the jury what we did if we'd known Lanier was going to 41:53.789 --> 41:56.599 be allowed to tell the truth about it." 41:56.599 --> 42:03.469 Prof: That film is almost an hour long. 42:03.469 --> 42:07.639 We had it made for the MBA's a couple of years ago. 42:07.639 --> 42:20.489 Mary Pat, you're not the coroner but if I asked you, 42:20.489 --> 42:24.529 is there--is another set of relationships that involve 42:24.532 --> 42:28.122 Merck, that were behind the scenes in 42:28.117 --> 42:31.647 all this, and what you know about it, 42:31.650 --> 42:32.840 help me out. 42:32.840 --> 42:34.150 Student: Sure. 42:34.150 --> 42:37.910 Well in addition to all the plaintiffs who brought cases 42:37.907 --> 42:40.807 against Merck, Merck also had taken out 42:40.811 --> 42:45.311 insurance policies for product liability and liability exposure 42:45.313 --> 42:48.153 insurance, and they took them from a bunch 42:48.148 --> 42:51.428 of companies like Munich Reinsurance and at the same time 42:51.431 --> 42:53.721 that all these cases were going on, 42:53.719 --> 42:55.969 Merck was trying to collect on those policies. 42:55.969 --> 42:59.949 Basically they wanted money because they had to pull Vioxx 42:59.951 --> 43:03.581 and all the exposure, they were losing a lot of money 43:03.583 --> 43:05.263 in profits that way. 43:05.260 --> 43:08.410 These insurance companies were saying, 43:08.409 --> 43:11.789 "Well you are exercising a breach of warranty, 43:11.789 --> 43:15.609 because when you took out these policies you basically told us 43:15.605 --> 43:18.415 that this sort of a thing wouldn't happen, 43:18.420 --> 43:20.640 but we're saying that you knew something like this would 43:20.635 --> 43:21.235 happen." 43:21.239 --> 43:26.899 Prof: Did the company your close relative represented 43:26.902 --> 43:29.112 end up paying or not? 43:29.110 --> 43:32.790 Student: They paid some of the damages but not all. 43:32.789 --> 43:36.209 Prof: Some sort of a negotiated settlement? 43:36.210 --> 43:41.620 Student: Yeah. 43:41.619 --> 43:44.299 Prof: Let me finish this. 43:44.300 --> 43:50.910 The ultimate outcome was a negotiated settlement amounting 43:50.911 --> 43:57.991 not to $12.5 billion dollars as Mark Lanier thought or claimed 43:57.987 --> 44:01.697 to think, but $4.85 billion. 44:01.699 --> 44:06.379 What happens is the Court system creates a class action 44:06.384 --> 44:11.334 suit and then settles the class action suit in a way which 44:11.329 --> 44:15.579 creates a scoring system for the plaintiffs, 44:15.579 --> 44:17.659 the tens of thousands of plaintiffs. 44:17.659 --> 44:24.399 The score you get depends on how long you used the drug, 44:24.400 --> 44:29.870 and how severely you suffered, and how plausible the causal 44:29.869 --> 44:35.339 connection between what happened to you and the drug is. 44:35.340 --> 44:40.240 For example, if you took Vioxx for a short 44:40.235 --> 44:45.965 period of time but were a 280 pound diabetic, 44:45.969 --> 44:51.319 with a major smoking problem, and a quart a day bourbon 44:51.320 --> 44:54.150 problem, the odds were that you weren't 44:54.150 --> 44:57.170 going to get a lot of money out of the settlement, 44:57.170 --> 44:58.900 so it's a mechanical system. 44:58.900 --> 45:04.760 And I personally believe that when used within reasonable 45:04.759 --> 45:10.619 limits common law is a way of protecting relatively small 45:10.617 --> 45:14.277 people against large companies. 45:14.280 --> 45:18.450 The adjudication of that boundary, which is now in 45:18.447 --> 45:20.997 progress, is very important. 45:21.000 --> 45:27.160 The killer for large companies is the transaction costs of 45:27.163 --> 45:33.113 settling so many cases can themselves be prohibitive. 45:33.110 --> 45:38.400 Okay, exam on Wednesday and back to work on Monday. 45:38.400 --> 45:43.000