Day 221: Residual reasoning

The cross-examination of Stephen L. Young, PhD, CPE, of Ann Arbor Michigan began late Monday afternoon. After circling around the same arguments and the same documents for another full day, it finally ended, and after a few questions from Mr. Lockwood, the most interesting questions once again came from Justice Riordan. Mr. Young is now free to go back to Michigan.

Pierre Boivin began his cross-examination with a zinger of a hypothetical question, “If I want to sell a new product that will kill half its customers if used as intended, what I do?” Mr Young’s answer was clear, “You would not sell it unless you went to the government and public health authorities to determine whether benefits outweighed the costs or risks.” Once again, Mr. Young demonstrated his feeble grasp of the meaner realities of corporate life here on Earth.

All tobacco-related risks are residual risks

When asked if the risk of lung cancer from tobacco use was a residual risk, Mr. Young said that all tobacco-related risks are residual risks. In Mr. Young’s expert opinion, manufacturers do not warn consumers about the residual risks of their products but leave that task to public health officials.

In another hypothetical situation, Mr. Boivin asked whether, if a manufacturer knew about cancer risks in its product, it should warn people. Mr. Young replied, consistently, that he would expect the manufacturer to go to the public health officials who would deal with it. And would the manufacturer contradict the message the government wanted it to provide? “I would expect the manufacturer to be consistent with the government’s message”. And if the government wants a message on the product to say cigarettes cause lung cancer, and the manufacturer complies, but takes out a full-page ad saying the government is wrong, is that proper? Mr. Young was not sure about that; it was not what he had looked at. Certainly, he said, the manufacturer’s information should be consistent with government policy regarding health risks.

And with a little housekeeping of schedules, Monday’s session was over.

Exploring the literature on effectiveness of warnings

With the only-in-Montreal admonishment to the courtroom to “Close your cell phones” and the arrival of Justice Riordan in his red and black robes, another day began.

Mr. Boivin’s first questions were about a study by Ho et al: had Mr. Young read it? Yes. Thoroughly? Yes. It was pointed out that the statements concerning addiction were at odds with Mr. Young’s statement in his report. His explanation? I made an error in including it in my list of references. And he continued, “I seem to have ignored this.” That made me wonder if he had not read his own report, or if he had even written much of it himself.

Another of Mr. Young’s source documents was presented, Curbing the Epidemic: Governments and the Economics of Tobacco Control, a report by the World Bank. Asked who the World Bank is, Mr Young replied “I don’t know who the World Bank is.” But you use it as a source, offered Mr. Boivin. Mr. Young asked, Can you point to where I used it as a source? You don’t remember? I don’t. It’s on page 18 of your report, Mr. Young. (It is one of the sources for a table of smoking control activities by decade.) Mr. Young was asked what parts of the World Bank document he had read and answered, “The parts cited in our report”. (Note that was “our” report not “my” report). Mr. Young seemed to be getting more defensive and was becoming redder in the face as the morning went along.

I agree they said that

Mr. Boivin read a passage indicating that health warnings were part of the effective strategy governments had employed and asked Mr. Young if he agreed. “I agree they said that,” was his first reply. Asked again, he said he did not entirely agree, since, in his opinion, warnings are not effective.

Next, Mr. Boivin presented an Australian report and asked if Mr. Young had read it. Yes, he had read it entirely, but did not remember how he used it in his report. Further, he said he’d have to “look and see why they referenced this in the report.” In any case, it concerned government warnings, not manufacturers’ and so was not in his area. Also it was much later, in 2008.

In a single-sentence paragraph, the Australian study states, “There is no doubt that warnings have an impact on smokers.” Mr. Young said he did not know what they meant; these studies do many things. When asked if he had read this page, Mr. Young said he might have. In any case, he appeared not to be convinced by the studies in this report and said he would be willing to bet that they did not measure actual behaviour but only behavioural intent. That opinion was based on his review of the literature on smoking and warnings.

Mr. Young does not agree

Mr. Young was asked if he had read the WHO Report on the Global Tobacco Epidemic, 2011: Warning about the dangers of tobacco. He had read some WHO documents but was not sure about this one. Did he consider WHO a reliable source regarding tobacco warnings? He hadn’t evaluated it so he had no opinion. Was he aware of the Framework Convention on Tobacco Control when he wrote his report? He did not recall, but he understood that some countries had joined together to do something about tobacco. The FCTC, an evidence-based treaty, stated “health warnings encourage tobacco users to quit and help keep young people from starting”, but Mr. Young said it might be true or untrue, because he did not know what evidence they used and repeated his opinion that intent is what is being measured, not behaviour itself.

What the WHO report said	What Mr. Young said about it
After Canada became the first country to introduce large, graphic health warning labels on cigarette packages in 2001, smokers who had read, thought about and discussed the labels were more likely to have quit, made a quit attempt, or reduced their smoking (29). About three in 10 former smokers reported that the labels had motivated them to quit and more than a quarter said that labels helped them remain abstinent (41). In another Canadian study, about a fifth of smokers reported reducing their consumption as a result of seeing the pack warning labels (42).	It would be a good thing if warnings actually changed behaviour. But it can’t be determined. I don’t have references to tobacco warnings in my report but I do say intent and self-reported behaviour are not accurate measures of behaviour. I would be very surprised if warnings actually had a behavioural influence on them. This reported reduction is not accurate (it may be true they said it or thought it).
Youth respond to graphic health warning labels similarly to adults (16). Graphic warning labels are more likely to prevent adolescents from initiating smoking (47) or, if they are already smokers, to think about cutting down or quitting (48).	I don’t believe that.

Mr. Young said he has never done this kind of research because it is too complex and there are too many influences on behaviour. He implied that it would be next to impossible. All the research he had ever seen says other factors are always more important than warnings.

Mr. Young is obviously not up-to-date on this field of research: we could send him a few good reports (here and here)!

What was on Mr. Young’s reference list?

Further questions covered other references used by Mr. Young (and his assistants) in producing the report.

Had Mr. Young read the Hammond report? Yes, but it wasn’t relevant to his mandate. His staff did the searches and selected reference documents. “I don’t know what they found.” Had Mr. Young read all Hammond’s references? He did not know, but he had read a lot of them. Asked about a number of specific references, he had two answers. Either he had read a paper but did not include it because it was not relevant to his mandate or he did not recall. Some other papers dealing with the same topics had not been read.

Personal watercraft take us to Australia

Plaintiff lawyer Philippe Trudel took over, and after a moment spent arranging his laptop on one of the many stacks of file boxes, set off on a new course. After a detour through explosive Ford Pintos and defective baby cribs, in order to separate residual risks from product risks, Mr. Trudel wanted to discuss an Australian instructional booklet about personal watercraft safety. (Mr. Young has worked on safety information for personal watercraft.) The warnings told people what to do or not do. It was a product risk and not a residual risk, said Mr. Young. Do you need to warn people that injury may result from using the product? Mr. Young’s answer was No; we told them to avoid these specific things, which are product risks people can avoid. In such cases, the manufacturer warns.

Wiping out the public health authorities--- just hypothetically, of course

Finally, cigarettes entered the conversation. The possibility that filters make cigarettes less dangerous was introduced; if that is true, what should a manufacturer do? Mr. Young said it was inappropriate to suggest manufacturers should do something just because it can be done. And if this were going to kill fewer people? Same answer. If it would kill 50,000 fewer people in Canada? No answer. After some objections that Mr. Young was being asked for a legal opinion, and reassurance from the judge that the expert understood that his domain is warnings and science, not the law, Mr. Trudel rephrased his question: In a hypothetical situation where there were no public health authorities, if cigarettes with filters cause fewer deaths than those without, should manufacturers advise the public? Mr. Young insisted that it must be the public health authorities who do that, but that he was not in a position to imagine public health authorities not existing. He had no recommendation in this scenario. The next series of questions relied on the absence of such authorities, and if a manufacturer wanted to sell a product with only residual risk in such a situation, Mr. Young would not approve.

Which risks is a manufacturer bound to disclose? Things a consumer must do or not do to use a product safely, in Mr. Young's opinion.

Still in the hypothetical universe with no public health authorities, Mr. Trudel asked whether, if it were possible to make a cigarette without nicotine, which would not be addictive. Mr. Lockwood and his learned friends objected to the hypothesis, but Justice Riordan allowed the question. Mr. Young’s answer was consistent: There is no automatic need to provide a warning, but it might or might not be appropriate, and I would lean towards not recommending a warning. Manufacturers are not required to warn about residual risk and generally do not. All tobacco-related risks are residual.

Avalanches and Bear Country

Mr. Trudel probed further into Mr. Young’s insistence that warning have no effect on behaviour. If skiers see a sign warning of high risks of avalanche and they do not go skiing that day, did the sign affect their behaviour? Mr. Young had no idea whether the sign has any effect at all. You could interview the people and find out why they didn’t go, whether the saw the sign, and what other ways they had learned about the avalanche risk. Unsatisfied, Mr. Trudel tried another outdoorsy scenario.

Suppose a hiking path forks and one branch has a sign warning about bears. No one goes on the path with the bear warning. Mr. Young allowed that it was reasonable to assume that the sign might have had an effect. He said that if people see a sign and act accordingly, the sign is effective. It’s easier to attribute the change in behaviour to the sign in the bear situation, rather than in the skiing situation where there are many other warnings around, such as radio. So, asked Mr. Trudel, is there a good chance behaviour was changed by the warning sign? Mr. Young agreed that in the scenario presented it was not only a reasonable assumption it was a required assumption.

Thus, Mr. Young had made an exception to his rigid statement that warnings are always ineffective, and he even hinted he might agree with the more commonplace definition of “effective”.

A long discussion ensued about the information provided with prescription and over the counter drugs. The questioning wandered into the borderland between expert opinion and legal opinions, without ever mentioning manufacturer’s liability. That would come later.

Skepticism and extreme cherry-picking

Even though Mr. Young appeared to have relied heavily on his staff to prepare the research for his paper, he was quite adamant in his scepticism regarding other people’s research. Here’s an example:

When shown a table of the ages people start smoking, he admitted he could read the numbers but did not know if they were accurate. He had no opinion. He did not know.

And did he think the World Bank reports were credible? He said he did not assess credibility of all the documents; he just used the part about benefits. A further question: If you choose to use documents from an organization, you are choosing to believe they are credible. Answer: I look at whether the data is relevant and useful to my research. I do not evaluate the credibility of the authors or organizations. I assume that peer-reviewed articles are credible and most by the organizations are probably credible.

In short, asked Mr. Trudel, you use one page for your purposes and throw the rest away? No, said Mr. Young, I just have no use for the rest. For the rest of the cross-examination, his most frequent utterances were “I don’t know” and “I have no opinion”.

The witness looked somewhat relieved when Mr. Lockwood returned for redirect. The lawyer representing a tobacco company found himself asking this question: Given that all tobacco-related risk is residual risk, are you aware of any safe way to smoke cigarettes? His witness answered clearly: There is no way to avoid the risk except by not smoking. After some discussion of the narrowness of his mandate and his firm conviction that warnings do not work, it was time for the witness to face Justice Riordan.

The best questions come from the bench

Beginning conversationally, and assuming--as we all would--that the witness was not a Harley rider, Mr. Riordan mentioned that in New Hampshire some motorcycle riders wear helmets while others don’t, although they would have all been exposed to the same informational warnings. Mr. Young said this was because there are many factors other than simple information that affect people’s behaviour.

He asked Mr. Young if warnings are used to protect manufacturers against legal problems. The witness said it was not relevant and that he did not consider legal liability. The judge pursued the point: Is there a relationship between warnings and legal liability? Mr. Young said he was aware of some relationship and that liability does enter into the failure to warn or failure to warn adequately.

Could the judge assume there is a body of theory on warnings and legal liability? Mr. Young did not know. Surprised, the judge asked whether, in 25 years of working on warnings, Mr. Young had never considered that. His answer was that if the warnings are well designed they should stand up in court.

And when Mr. Young worked with the personal watercraft manufacturers, did no one raise the issue of legal liability? Mr. Young volunteered that he had addressed liability in litigation concerns but not while performing his design work. He had never put it together with design. I had to restrain myself from an unbecoming comment on the disingenuousness of this answer, but Justice Riordan took it more calmly than I did and made the clarifying suggestion that legal considerations were parallel to the design process but not connected. The witness agreed.

The final question: isn’t cigarette smoking such a special case that warnings have a different place? Mr. Young mentioned other public health strategies and that the ways over the counter drugs are sold is another special case among consumer products, but concluded by repeating that tobacco is probably the only product whose risk is entirely residual.

The court will not sit Wednesday, and Thursday will be a document day with no witnesses. At 5:02 p.m. the witness was dismissed and the judge wished everyone happy spring. (We are still waiting for the temperature in Montreal to get above freezing.)

Visitors in the audience

In the afternoon, there were new observers. One was a woman (whose name I missed) studying courts’ and judges’ use of technology; she was impressed with the smooth and mostly paperless operation of this court. The others were filmmaker Nadia Collot and her partner. Here’s a trailer for her film The Tobacco Conspiracy.

Day 220: A very different view of the world

Today, a man whose business is to design warnings and product information notices and whose academic career is based on evaluating such warnings and notices told the court that warnings have no effect on behaviour. He also said he expected any manufacturer of a dangerous product would immediately, on discovering the danger, go to the government’s public health authorities to report it and work on mitigating the danger to the public. Many in the court were scratching their heads in puzzlement. What planet was he from?

In fact, he is from the state of Michigan, Ann Arbor to be exact. Stephen L. Young, PhD, CPE, is a senior consultant with Applied Safety and Ergonomics, Inc. He explained that CPE means Certified Professional Ergonomist, a qualification certified by the Board of Certified Professional Ergonomists, and that ergonomics is also known as engineering psychology. He sits on various committees of the American National Standards Institute (ANSI, a body linked to ISO) and helps set standards for information and warnings in terms of colour, labelling and symbols, both in occupational settings and for consumer products.

Voir dire: qualifying the expert witness
Pierre Boivin began the voir dire questioning. Mr. Young had never considered the tobacco issue before, but applied the same principles he would use to assess warnings on ladders, lifejackets and personal watercraft. He was unaware of most research into the effectiveness of tobacco warnings (of which there is an abundance), although he had read some of the literature.

What did Mr. Young think of the Supreme Court of Canada’s statement (Exhibit 75-A, Para 135), “Further, both parties agree that past studies have shown that health warnings on tobacco product packages do have some effects in terms of increasing public awareness of the dangers of smoking and in reducing the overall incidence of smoking in our society.”? Mr. Young said this was not relevant for his purposes.

Mr. Boivin quoted again from the Supreme Court decision, “A mass of evidence in the intervening years supports this conclusion”. Mr. Young said he had seen this sort of statement but didn’t care.

Philippe Trudel picked up the thread and asked Mr Young how many documents he and his staff had considered before selecting the 195 referred to in his report. The witness took a long time to make his guess, some 200 to 300. Why did Mr. Young not ask his client for information from the industry? It was not in his mandate and he was confident he could figure out what a manufacturer would do. And had Mr. Young come to the conclusion that manufacturer’s warnings were unnecessary? Indeed, warnings were only necessary because the government believed them to be. For manufacturers, they were unnecessary in the past and continue to be today.

Warning: you may wandering off-topic
At this point, the defence objected that the plaintiffs’ lawyers were straying from the purpose of the voir dire but the judge agreed that asking about Mr. Young’s lack of knowledge about tobacco was not unfair. Mr. Trudel agreed to restrain himself, and asked about Mr. Young’s knowledge of tobacco warnings in the 1960s and 1970s and whether the public was aware of addiction issues in the 1970s. Mr. Young stated that some warnings in 1969 mentioned dependency, which he considered the same as addiction, but added that he was not an expert in that issue and not an “awareness historian”. (Hmm, said the observers, what is an awareness historian? But that question was unanswered.) Then there was another objection and the plaintiffs’ side was asked to leave this line of questioning for its cross-examination.

Mr. Trudel asked how a warning’s effectiveness is determined. Mr. Young replied that warnings convey information through their design and content. A warning is effective when people get the information; it has nothing to do with their behaviour. And how do you know people are getting the message? If the language is plain and the content is simple, it is not necessary to evaluate. If it is more complex, it is evaluated by interviews and focus groups who say what the message means to them. Once again, he said assessment has nothing to do with behaviour. Mr. Young was quite calm and stood with one or both hands in his pockets most of the time.

The next question was about measuring compliance. Mr. Young insisted warnings were not relevant to behaviour. Warnings, he said, convey information and they do not, should not and cannot influence behaviour. In a few more answers, he once again appeared to pride himself on his lack of knowledge about the history of tobacco warnings in Canada.

At the end of this voir dire questioning, the judge asked if the witness was acceptable. The plaintiffs said he had flaws in knowledge and methodology, but Justice Riordan agreed to accept the expert opinion, because he had access to actual documents even if his assistants did the research. In the end, the plaintiffs’ arguments were noted but the witness was not excluded. The probative value of his testimony will be weighed.

And then, while the concept that warnings have little or no influence on actual behaviour was echoing through the courtroom, Mr. Lockwood (supported by an unusually quiet Deborah Glendinning) began his direct examination of Mr. Young. 

An expert report can be a risky undertaking
First, what sort of documents did he look at in his research? Mr. Young did not intend to do a comprehensive study, but to establish the context, and can state that smoking was managed as a public health risk by the Government of Canada, which used varied methods over time. When was this? Not much before 1963, but the government started public education and research in earnest that year. For example it used books, posters, ads, toolkits and other educational items. Mr. Young did not specifically study public awareness but, he said, he became aware of it. He simply analyzed the sources of information and risk management strategies that were available. What is a public health risk? asked Mr. Lockwood. Mr Young’s reply: Public health officials implement interventions to reduce risk. (The observers wondered: Is that an answer? The next Q&A made more sense.) To the question Is smoking a public health risk, Mr. Young clearly replied that (1) it is managed as a public health risk and (2) the government has said it is a public health risk since 1963. Can public health risks involve products? Certainly. Alcohol and drunk driving, seat belts and their use, and obesity and food labelling were given as examples. Typically, the “authorities” use various means to manage risks, including education, regulation, taxation, enforcement and penalties. Public health officials within the government are the best placed to manage risks related to smoking; they have tools available that the manufacturers do not. And did Mr. Young see evidence of risk management in Canada related to smoking? Indeed, in the Isabelle report there are two sections dealing with the contribution made by tobacco growing and manufacturing to the Canadian economy. Thus, a balance was sought between the costs and benefits to society. The public must be protected, and the interests of various segments of the tobacco industry must be protected.

What is an acceptable risk (or a tolerable risk, as Mr. Young used the terms interchangeably)? It is a level of risk that can be tolerated by the society despite its existence (cars, for example). Governments establish acceptable risk by judging cost/benefit ratios, which may change over time. There are differences in acceptable levels of risk between societies as well, such as differing levels of blood alcohol tolerated in divers in various countries, or varying speed limits and seat belt legislation, all based on what is important to a society. Here we a number of charts, graphs, maps and pictures taken from his report –all were either grey-scale or fuzzy--to demonstrate differences. The tools government public health authorities use are media, legislation, regulation, enforcement and penalties. Warnings are also used, but Canada does not use on-product warnings for a number of risky products such as alcohol or fatty foods. Here Justice Riordan interrupted: is the nutritional information on food not a warning? The answer was No, it isn’t.

Mr. Lockwood and Mr. Young went over more examples from the latter’s expert report, summing up that typical product warnings provide people with information so they can manage risks themselves.
Residual risk is the only kind of risk for smoking

One important concept for Mr. Young is residual risk. What is it? Once you have managed all the likely risks, other risks still exist despite your actions. For instance you may be a good driver and your car in excellent condition, but someone else can drive dangerously and cause you harm. Do manufacturers deal with residual risk? Not usually: they warn about things you can control while using the product as it was intended. There is little utility in warning about residual risks. How do people become aware of residual risks? People just know. (At that statement, some eyes began rolling.) Has the Canadian government managed residual risk? Public health authorities will begin to manage residual risk when it reaches a certain level. As an example, with more concern about obesity, the food guide and labelling are used. Warnings are not put on butter.

Justice Riordan asked: how can people avoid residual risk? Mr. Young answered that the only way to avoid it is to avoid using the product.

Mr. Lockwood continued. Residual risk is present when a product is used as intended. Does this apply to smoking? Mr. Young answered that all the health risks associated with smoking are residual. The Department of National Health and Welfare wanted people to stop or not begin to use the product and the early warnings told people to “avoid inhaling”. Is “avoid inhaling’ related to residual risk? Yes it is. It is not a practical suggestion with regard to the intended use of the product.

Justice Riordan intervened, asking about moderation. Mr. Young said it was not a government position. The judge continued, referring to government advice that if people can’t stop smoking, they should smoke less. Mr. Young said that was not reasonable. And could the manufacturers say something different from the government message? Answer: that would be inconsistent with public health policy and the manufacturers should not do that. (This is the point some observers began to speculate about possible extraplanetary origins.) Justice Riordan continued: if McDonald’s advertises fatty foods in super sizes, is that inconsistent with public health? Mr. Young said he did not know, not being an advertising expert; he knows nothing about awareness.

Mr. Lockwood resumed his questioning asking whether it would be improper for a manufacturer to adopt a warning that is inconsistent with the government’s public health values. Definitely, said Mr. Young, I would not expect a manufacturer to do things that subvert warnings. I would not recommend that manufacturers warn independently from the public health authorities about residual risks, if those authorities are already addressing it. And what if the risk is known only to the manufacturer? Mr. Young would still not expect the manufacturer to issue a product warning, but would expect them to take the problem to the public health authorities. It would be irresponsible for the manufacturer to warn people before going to the authorities. (One wonders about his real-world experience!)

Some public health risks have been managed without warnings and the government felt successful. In 1972 only two other countries had cigarette warnings. Public health authorities say there is value in warnings, but Mr. Young does not think it is necessary or appropriate for manufacturers to warn about residual risk.

Here the judge asked for clarification. Mr. Young said that norms have changed and manufacturers were previously not expected to give warnings.

At this point, with everyone feeling a little dizzy from all this alternate reality, a lunch break was declared.

Is moderation advisable?
Mr. Lockwood resumed after the break: Suppose manufacturers warned people to smoke in moderation. Mr. Young could not agree with that because it would leave off the part of the message the government wished to deliver, i.e., stop smoking. The manufacturer could advise moderation but it would not be acceptable to Mr. Young.

To the question of whether product warnings typically provide statistics about health outcomes, Mr. Young’s simple answer was No. And what would be the downside of such information? Mr. Young said it was an issue of probabilities and when people see a range of risks, they tend to perceive their own risk at the lower end of the range. For pharmaceutical products, consumer information has some details but is considerably less than the monographs supplied to doctors. As for cigarette warnings about addiction, these were considered as early as the Isabelle report but were not implemented until 1994, and there are still none in the U.S.

Mr. Young said several times that warnings have no effect on behaviour, yet he was able to chart responses showing how a typical consumer interacts with warnings. In these stages, the manufacturer can only control the exposure to the message and its ease of comprehension. Those are the areas Mr. Young and his colleagues concentrate on. The stages from perception of a warning to acting upon it can be interrupted at various points. Some people may think they already know the information and so ignore it. Others may reject it because of cognitive dissonance. Some may read and forget, and some may ignore it because of peer pressure and other societal contexts.

Why have warnings at all? Why spend your career designing them?
Mr. Lockwood asked Mr Young directly about the effects of warnings. The reply was that warnings are generally not effective; it is unreasonable to expect people to change their behaviours. Have there been studies of the effects of warnings on behaviour? Yes, there have been tests and reports in the literature. People overestimate the power of warnings, predicting that the clearer and more eye-catching warnings will be more effective, but they are not. People underestimate the other background factors and make faulty assumptions about other people’s behaviour.

In terms of smoking, do factors other than warnings (non-warning factors include peers, parents, image, price and restrictions) have an influence to reinforce or negate the warning? Both, said Mr. Young.

While some of Mr. Young’s statements seemed counter-intuitive, he did have one observation that was stunning in its predictability: use of motorcycle helmets is much more frequent in jurisdictions where it is required by law and the law is enforced. (Imagine that!)

The cross-examination did begin Monday afternoon, but I will report on that when it is complete on Tuesday. I leave you with a final warning:

Warning:   Do not read this warning.  It may give you information that you do not need because you should have known everything that you need to know already because the government should have told you and you should have been listening, and if you weren’t listening, that is your fault, and if we stated or implied something to the contrary, you should not have listened to what we said.