Thursday, 27 March 2014

Day 222: There were no witnesses

Today’s session was a less formal affair, with the judge and lawyers in suits instead of gowns. Justice Riordan bounced in, ready for the game. The focus was on documents and getting some agreement between the parties.

A very special exemption

First, there was a request from JTI lawyer, Catherine McKenzie, to have a special exemption from the non-cell phone rule for her colleague Patrick Plante, whose partner was about to give birth. Justice Riordan’s first response was, “Why are you here, Mr. Plante?” and readily agreed to the exemption.

Naturally, Mr. Plante was the first presenter. He had new CDs full of exhibits to exchange for previous versions. The exhibits were numbered in the 3000s and 4000s, and there were no arguments.

When Mr. Plante was done, the judge began to greet Nancy Roberts who had arrived from Toronto. But Mr. Trudel jumped up with an urgent matter. He and Mr. Potter had been trading testy remarks before the judge came in. Mr. Trudel objected to an email Mr. Potter had sent to all concerned.

Mr. Potter explained that he was “apologizing for the labyrinthine changes made by the plaintiffs” and thought a table would help everyone find their way. Mr. Trudel jumped up again, and said he would be arguing about individual members of the class. The judge calmly replied that class members (membres désignés) cannot be added to Létourneau, but they could be in Blais. He admonished the defendants that there was no use rehashing all the steps taken since February 2011, and that we should just go from where we are now.

Judgement on amendments

Then, playing his trump card and settling the argument, Justice Riordan read out his judgement on this matter. The Létourneau statement of claim was accepted as amended in February 2014 and the notion of punitive individual damages was put back into the Blais claim.

Back to the CD Exchange

Ms. Roberts and Ms. Grand’pierre had more CDs to exchange, these ones with the 21000 series of exhibits. Everyone agreed.

Ms. Roberts presented some exhibits to be removed from the 2870 list, and all documents were agreed to. Ms. McKenzie said there were only 3 documents left to debate from JTI, but actually there were a few more than that. There was an exhibit (40366) related to Dr. Gentry’s testimony, a scientific paper where one author was dead and the other three had left the country. A rule had been established earlier for scientific articles, and the objection was withdrawn.

Ms. Roberts got her chance to speak and wanted to mention to the court a few documents that would be losing their 2870 suffix. When she finished her brief list, in about two minutes, the judge asked, “You came in from Toronto for that?” She assured him there was more to come.

Then Mr. Bouchard said that RBH’s fact witness, Mr. Chapman, had more documents that needed to be entered. Their numbers were from 30243 to 30316 and included some with .1, .2 suffixes that were from the plaintiffs. Everyone agreed and made changes to their lists. Next, several 2M exhibits were changed to “AUTH”, meaning authentic. Both sides agreed.

Such a lot of agreement! Remarkably, over 200 documents had been admitted as exhibits. “Have all the uncontested documents been filed, Mr. Bouchard?” asked Justice Riordan. Indeed they had. The plaintiffs were ready to debate a few others.

Colour-coded lists

Plaintiff lawyer Gabrielle Gagné had prepared a list and colour coded the debatable and agreed-to documents. Because she usually operates the computer that we see on the screen while her colleagues are talking, there was no one to assist her as she made her presentation. The judge found some colours hard to read, but the technical difficulties were overcome at last.

Numbering such a vast collection of documents, both real and potential exhibits, has been quite a challenge. The judge and many others have worked hard to eliminate duplicate entries and remove exhibits that have been rejected. This list had them arranged in tabs, and the debate was about tabs 18, 19 and 21.

The first was a speech given by Health Minister Judy LaMarsh in 1965, directed to youth. It mentioned a conference, and the plaintiffs wanted to introduce documents about preparations for that meeting. Ms. Roberts argued that the responding or responsive documents had to “complete, clarify or contradict” the initial exhibit. Ms. Gagné replied that the definition of responsive was not the same on both sides of the court. Ms. McKenzie said that this was not a complementary document, but a tangent or even a Trojan horse. Mr. Trudel added an observation as well.

Calmly, the judge said he would listen to all the arguments and decide at the end.

On the next exhibit, Ms. Roberts once again objected that it did not complete, clarify or contradict the initial document, and Ms. Gagné replied that it was related. The judge said he thought “related” was fine. But, but, but, “complete, clarify or contradict” were your own words, said Ms. Roberts. Mr. Riordan replied that they were obvious responses because they were matters of correspondence. Finally Mr. Bouchard discussed Tab 21 that concerned packaging legislation.

A judgement on exhibits

Justice Riordan declared a break, with time for him to digest the arguments. He came back within a half hour with his judgement. Of the eight exhibits at issue, two had been withdrawn, leaving six at issue. Two of these were accepted (RL9277 and RL 9284) and four documents refused because they have no connection to the ones already in exhibits. They could be accepted later in some other way.

So, that was a day with two judicial decisions. The half-day session was nearly over and it was starting to feel a lot like Friday, for a Thursday. 


Then the calendar was discussed, Justice Riordan trying hard to get more work done and avoid empty weeks. Next week is definitely a break, although various financial statements and a list of plaintiff’s reply witnesses have to be prepared.

The next court date is April 8. Financial documents will be filed at 9:30 a.m. and then the court will be suspended until 1 p.m., which is 10 a.m. in Victoria, B.C. Ms. Roberts and Ms. Gagné will examine and cross-examine Mr. James Sinclair in Victoria, with a live video link to the courtroom.

Wednesday, 26 March 2014

March 26: The theatre is dark today

Because there was no sitting today, I'm offering our readers a novice blogger’s view of Courtroom 1709. As someone who just stepped into this 2-year long trial, I bring a somewhat different perspective from your regular blogger who is at a conference in Europe this week.

Courts are a lot like the theatre: there are sets, costumes, roles, entrances and exits, dialogue and monologue, an audience, and, if you are lucky, some interesting drama. There is no admission fee, however, and audience participation is not permitted, despite the improv nature of the “script”.

The play is about to begin: the players gather in separate clumps in the hallway. (The parties are civil but not sociable with each other. And they never take the same elevator.) The players and the tiny audience move quickly inside once the doors have been unlocked.

This stage has been set for more than two years. In all that time, this has been the only trial in Courtroom 1709 of the Palais de Justice. File boxes of evidence are stacked around the lawyers’ desks, making half-walls in some areas. Thick binders line bookshelves and are spread out on tables as well. Filing cabinets line the back wall. Microphones hang from the ceiling at regular intervals. Large screens are set up to the left and right of the bench, and smaller ones are suspended so everyone can see. The clerks occupy a table immediately in front of the bench, with lots of books, papers, computers and other gear at their fingertips. The bailiff sits in a corner, ready for the judge’s arrival.

The players get into costume. Lawyers have entered carrying garment bags or with black robes draped over their arms, and now they begin the robing process. The men wear white shirts and some wear a quaint black waistcoat or vest. The women dress the same. Then the black robes go on; some are elegant and pressed, while others look a little neglected. The final flourish is the white tab tie that goes outside the robe. Fortunately, the wigs of English courts have been left behind.

People take their places, strictly according to the stage directions. Lawyers are within the barred area, their non-legal assistants, some witnesses and lawyers without robes are in the next area back. Those people are all fortunate enough to have desks on which to rest their computers. And everyone has a computer. (The props department has done its work, I suppose.)

The occasional curious visitors, friends of witnesses and lawyers, and the bloggers—for other representatives of the press seldom turn up—spread sparsely through the farthest rows of seats, and work with laptops on their laps. At least electrical current is provided. This is more of a workshop production than a fully staged play.

The stage is set, the actors and audience in place. The bailiff hears his cue and announces, “Veuillez fermer vos telephones cellulaires. Please close your cell phones” followed by “All rise”. Then he goes to open the door for the judge, who enters stage right. With some electronic bings, and the screens coming to blank, blue life, the sitting has begun.

Our judge could have come from central casting; he really looks the part. His robes are deep black, with red shoulders and inserts, and an interesting red medallion on the upper back. He is nice looking and clearly very intelligent, pays attention to everything that goes on, slides effortlessly between English and French, and asks the best questions.

A witness stands at the clerks’ table, facing the judge, with his back to the spectators. Luckily he wears a microphone and his voice comes at us through speakers.

Unlike a play, there is no playbill, no program, no Dramatis Personae. Unless you hear each player addressed by name, or someone more knowledgeable whispers in your ear, you can see which side the characters are on, but you wonder who's who .

The day proceeds like all courtroom dramas; a witness is introduced and sworn; the lawyers who have called the witness begin the questioning; then comes cross-examination and redirect. The judge asks a few questions, responds to objections, and asks his most probing questions just before the curtain comes down.

At the end of the drama, the judge exits, and with no applause, the lawyers disrobe, the clerks shut off the screens, everyone turns on their cell phones, and the bloggers pack up their laptops, to go home and write their reviews of the show.

Tuesday, 25 March 2014

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.

Monday, 24 March 2014

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.

Thursday, 20 March 2014

Day 219: The foggy road ahead

It was an odd amalgam of formal legal arguments, informal negotiations, logistical discussions and name-calling during the half-day session of the Montreal Tobacco Trials.

As the "defence proof" winds to a close (only 3 more expert witnesses to go!), there is a lot of interest in seeing the next stage take shape. When will the plaintiffs present their counter proof? What structure will be imposed on the final arguments? Will there be class members?

All these were up for discussion -- but for someone, like me, who has little or none of the paper work, there was more mystery than discovery. Nonetheless, I am reasonably confident that little has yet been decided. If anyone knows for sure what will be happening in May, they aren't sharing.

The calendar and remaining defence witnesses

There seems to be little incentive for the defence to get to the end of this trial, and those few witnesses who remain seem to be steadily pushed later in the schedule. Illness. Jewish Holidays. Personal issues. Scheduling conflicts.

Today another empty week appeared. There will be no hearings for the first two weeks of April.

The court was informed -- in the mildest of tones, as though it were never ever much of an issue -- that Simon Potter and Lyndon Barnes would not, after all, be called as witnesses for Imperial Tobacco. An interesting cross-examination never to be heard!

The plaintiffs' counter-proof

As far as I know, the plaintiffs still intend to call three experts to respond to things that have been said in recent months: Mr. Paul Slovic will reply to Kip Viscusi's views on warnings, Mr. Siemiatycki will respond to the comments of the past two weeks and perhaps Mr. Proctor will also return.

But when? Not yet settled.

Quebec smokers as witnesses

One reason for the uncertainty about the counter-proof is the ongoing dance about the scheduling of class members. Will they testify after the defence counter-proof? Or will they be heard first, as would be the normal course of events?

Imperial Tobacco is the only company with plans to call these Quebecers. I heard today that it has identified some of the individuals they wish to call, but have not yet shared their entire list with the plaintiffs. Suzanne Côté, who is managing this aspect of the case for Imperial, was told to provide the list of witnesses by next week.

Before scheduling her witnesses, Ms. Côté wants to know how the Appeal Court will rule on her request that it allow access to the medical records of these people. She said today that she would not schedule witnesses in advance of this, as she did not want to have to recall them for a second appearance.

If the Appeal Court upholds Justice Riordan's ruling to keep these records out of bounds, witnesses will likely be scheduled soon after. If, on the other hand, it says that the records must be produced, then all bets seem to be off the table.

I heard today that it can take a considerable time for a complete version of those records to be obtained - and that's before the argy-bargy about expert opinion on them!

Capacity to pay: show us the money

One of the last parts of the trial will be evidence on how much money the companies have. It has yet to be scheduled, but today's brief discussion makes it sound like it might be a lively one.

Financial capacity to pay is a factor in determining amounts of punitive damages, as set out in Quebec's Civil Code, article 1621:  Where the awarding of punitive damages is provided for by law, the amount of such damages may not exceed what is sufficient to fulfill their preventive purpose.

Punitive damages are assessed in the light of all the appropriate circumstances, in particular the gravity of the debtor's fault, his patrimonial situation, the extent of the reparation for which he is already liable to the creditor and, where such is the case, the fact that the payment of the damages is wholly or partly assumed by a third person. 
(There are lots of unusual expressions in Quebec courts. "Patrimonial situation" seems a very peculiar way to describe assets.)

Today, Justice Riordan instructed Imperial Tobacco and Rothmans, Benson and Hedges to provide updated financial statements to the plaintiffs. (The versions made public will be redacted).

The plaintiffs know all too well the situation of JTI-Macdonald. Last week the Court of Appeal rejected their request for a review of the ruling of Justice Mongeon to not impose a hold-back on the revenue from that company before it is sent back to Tokyo in the form of a loan-payment.

Their "transactions" to reorganize themselves into a debtor subsidiary instead of a profitable branch plant as a tax-minimizing strategy remain intact. Where, you might ask, is Revenue Canada ????

The amended proceedings

It would appear that there have been several versions of the plaintiffs' motion to amend their claim, a subject that has been discussed at least twice before. It sounded like the areas of concern had been considerably narrowed, and Justice Riordan indicated he would rule soon. (Another connected motion was not revisited today).

The final arguments

Justice Riordan has circulated an outline for the final arguments - not, he emphasized, to limit what they say or what topics are covered, but to create a parallel structure to each submission for ease of review.  The parties have responded to this, and it was discussed today. Much more than that, I can't tell you!

The trial resumes on Monday with testimony by Stephen Young. 

Wednesday, 19 March 2014

Day 218: Still no bridge to Tadoussac

The Montreal trial adjourned at noon today, after an intensive three-man six-day assault on the plaintiffs' epidemiological expert, Jack Siemiatycki.

There have been lots of dramatic and phoney-dramatic moments in this trial, but there has been nothing to compare to the past two weeks in terms of intensity or importance of discussion. (At least not yet!)

It may be a long time before the winner of this particular battle in this long legal war is declared. However Justice Riordan decides the issue, there is always the likelihood that the Appeal Court and Supreme Court will want to weigh in on how population-level harm is assessed or population-level blame assigned.

Introducing Mr. Price

Mr. Bertram Price was the third and last of the experts hired by the defendant tobacco companies to challenge Mr. Siemiatycki's estimates of the number of Quebecers made ill (with the diseases covered by the Blais suit) as a result of smoking. He was engaged by Imperial Tobacco and has also been retained by its parent company, British American Tobacco.

Mr. Price began to present his expert report (Exhibit 21315) mid afternoon yesterday, and continued this morning. He was on the stand for less than a day.

Mr. Price is an old hand at the numbers game - and not only because he is one of the more chronologically advanced of the expert witnesses (he is 74 years old).

For almost three decades he has managed his own consulting firm, Price Associates, which specializes in using statistics to assess risk in occupational and public health. By his resumé (Exhibit 21315.1), much of his work has been focused on asbestos. This is the first time he has appeared as an expert at a tobacco trial.

At the request of Imperial Tobacco's counsel (Allan Coleman), and over the objections of the plaintiffs, Mr. Price was qualified as an "expert in applied statistics, risk assessment, the statistical analysis of health risks, the use and interpretation of epidemiological methods and data to measure statistical associations and to draw causal inferences." 

Mr. Price is not exactly a new face in this court room: he had attended the testimony of Mr. Siemiatycki last year and was sitting a few seats from me earlier this week as Mr. Marais and Mr. Mundt gave their views on the model used by the plaintiffs' expert. It's hard not to notice when Mr. Price is in the room -- he is several inches taller than 6 feet in height. (Tall enough to have played in the NBA - for the Detroit Pistons.)

Mr. Price may even have had as much court-time as Mr. Allan Coleman, the Toronto-based lawyer assigned to work with him. Mr. Coleman's sole assignment in this case seems to be to work on the epidemiological issues. His pleasant manner and level pace made it an easy-to-follow exercise.

Third on the match 

Mr. Price spoke on the heels of two other long and detailed critiques, but nonetheless had something new to offer.

He suggested another level of analysis that could and should be done: to remove from the body count those people who might have become sick because of smoking, but not because of any misconduct on the part of the companies.

To illustrate this concept, Mr. Price was asked to reflect on the circumstances of a few hypothetical smokers, like that of a man who smoked a pack a day from 1962 until he was diagnosed with cancer in 2000.

If the court ruled "that any smoking after 1963 is not attributable to the defendants' misconduct," Mr Price felt that he would have "only smoked for 2 pack-years in the misconduct period" and therefore not be eligible for a screening which required 5 pack years. (1964 is the year of the Surgeon General's report, which the defendants maintain is the point at which "everyone knew")

And what if the court ruled there was misconduct only until 1972? In such circumstances, Mr. Price looked at the difference in relative risk for having smoked 12 years (in the misconduct period) and having smoked 28 years (in the non-misconduct period). He noted that it did not double, although he did not say what values he was using.

Therefore, he suggested, this smoker should also not be considered eligible under the Siemiatcyki approach.

An encouraging moment for the plaintiffs

This suggestion prompted one of the strongest comments from the bench to date - and one of the few that suggests so clearly that Justice Riordan has an opinion formed on the topic of addiction. The judge asked Mr. Coleman to confirm that in his hypothetical example "this fellow ... was smoking because of the misconduct of the company," before stating a question that he will be in a position to decide:

So isn't his smoking, morally and logically and medically attributable to the whole period of his smoking? How does it stop all of a sudden in 1972 after he's addicted to cigarettes?  

As if that weren't enough to make the plaintiff's leave the courtroom happy (the clock was running out on the day), the Judge also hinted at his views on misconduct. He responded to Mr. Coleman's suggestion that some people may have started smoking before any misconduct, i.e. in the 1940s, by saying "In the 1940s it's probably an easier argument to say there was no misconduct on the companies' part than later."


Overnight, Mr. Coleman must have decided to pursue the idea of "misconduct" no further. Without this element, there was little in Mr. Price's report that had not already been discussed at length by the previous men.

Like those before him, Mr. Price had criticized Mr. Siemiatycki's approach for not having included more information. He felt that in addition to individual smoking histories it was important to know which brands people smoked, what other risks they were exposed to, and whether or not the smoker believed what the companies said about smoking. None of this information was in the analysis and therefore, he concluded, "the Siemiatycki report is not adequate for this purpose." 

Mr. Coleman invited his witness to consider whether there were better methods already established and available to be applied to this problem. (The first two industry experts had been more than reluctant to suggest that the task could be accomplished without considerable additional effort).

Mr. Price gave the impression that there were models available that were better suited for the purpose than the "too simple" dependence on pack years, or the limitations imposed by meta-analysis. Cox Models. Logistic regression models.Survival models. He noted that other scientists had been able to include other variables, such as smoking intensity (Exhibit 20222), or the effects of quitting (Exhibit 20223),

Mr. Trudel was on his feet more than once over the morning, pointing out that Mr. Price should be limited to testifying what was included in his report, and could not introduce new topics. (There are rules, you know!)

Mr. Coleman seemed stuck between the rock of the scope of his witnesses' report and the hard place of Justice Riordan's clear hints that more was needed.

Navigating these constraints, Mr. Coleman nonetheless gave Mr. Price the opportunity to sketch out the approach that he thought could be taken. He identified several steps - the development of a model, the establishment of ways to measure of exposure, the selection of parameters for analysis, the search for existing data and the generation of new data, the application to individuals or groups of individuals.

His option was more detailed than that offered by Mr. Mundt (who had recommended an expert committee) or Mr. Marais (who said a new survey of many thousands of people would be required), but it was not necessarily one that was more readily accomplishable.

Justice Riordan again made clear that he needed something more concrete to work with, drawing on a local metaphor."Everyone says you can build a bridge over the river at Tadoussac, but no one has been able to do it."  

The Toronto-based Mr. Coleman and the Maine resident Mr. Price looked confused by the reference. Justice Riordan explained to the come-from-aways that the highway ends at Tadoussac, and ongoing traffic must use a ferry to cross the Saguenay river.

"I understand Maitre Trudel's comment. It's nice to say you can have it, but nobody does it. They don’t show anything in the literature that says it has been done. So what am I supposed to take from that?"
Minutes later - only an hour after the morning start - Mr. Coleman ended his question.

The cross-examination

The plaintiffs took the same approach with Mr. Price as they had with Mr. Mundt  -- using his own publication record to show that he had at one time supported the analytical approach or principles he was now criticizing.

Given that Mr. Price had watched the trial over the past week, he might have been better prepared for these questions. As it was, he seemed bewildered by his former research, as he was by the questions about it. Confused too, perhaps, by questions expressed in a French accent and using a syntax more common in Montreal than in Maine. "I don't understand the question"  was the frequent reply.

His halting and occasionally conflicting replies may not have affected Justice Riordan's view of his testimony, but it really slowed things down!

One of the first sets of questions put to him by Mr. Trudel regarded mesothelioma and its relationship to asbestos (a subject much studied by Mr. Price). In his own study on how to apportion risk in this area (Exhibit 1715), Mr. Price had not factored in the effect of a potentially confounding risk.

Despite repeated questions by Mr. Trudel (and reminders that he was at the court as an "expert in the inference of causation), Mr. Price steadfastly refused to state a threshold value at which he would infer causation. "There is no bright line cut-off," he said. "No magic number. No normal number." But in his own work on asbestos and lung cancer (Exhibit 1716), he used the same threshold value as the one identified by Mr. Siemiatycki -- 50%.

Mr. Lespérance used the opportunity of cross-examining Mr. Price to sweep away some red herrings. The industry experts had suggested that Quebec smokers' exposure to radon, asbestos and other harmful toxins might be responsible for a large proportion of cancers.

He asked Mr. Price to compare the risks from smoking with those from asbestos -- showing him a recent paper with updated estimates.(Exhibit 1718). Mr. Price confirmed that in this study the relative risks for lung cancer among current smokers (26) and former smokers (6) were all above the threshold value of 2.

How did they compare with risks for asbestos or radon? "The risk with asbestos for lung cancer is smaller than those numbers," Mr. Price said grudgingly, and that for radon "would not be greater."

By not acknowledging the huge gap in risks, or sharing his knowledge about asbestos, Mr. Price opened the door for Mr. Lespérance to rub his nose in them. Only after 20 years of "substantial exposure" to asbestos did the risk exceed 2. (Exhibit 1719). And the number of Quebec homes where radon exposure exceeded the threshold risk level was only around 3,300. (Exhibit 1720).

Soon it was finished, and Mr. Price was thanked for his time and invited to step down.

The defence strategy of offering no positive evidence on epidemiology may prove to be a good one in the long run. But in the short-run of this week, it certainly drew some fire!

Tomorrow, back to some important legal wrangling.

This post was back-timed for consistency in indexing

Tuesday, 18 March 2014

Day 217: The variable views of Kenneth Mundt

There are some edge-of-the-seat moments at the Blais-Létourneau trial this week. It is really beginning to feel like play-off season - with every play, every call, every bench switch getting super-charged attention.

Justice Riordan has also upped the intensity, with a much more assertive refereeing than at any previous point in the trial. (Today he actually told Simon Potter to stop interrupting!)

Today was the second-last lap in the defendant's tag-team wrestling match against the conclusions of the plaintiff's expert epidemiologist (Jack Siemiatycki). This morning was the end of (epidemiologist) Kenneth Mundt's turn, and this afternoon statistician Bertram Price began to present his views.

Both these men are in the same line of business -- they are consultants to industries described by Mr. Mundt as having a "dark" past.  Asbestos. Roofing. Chromium. Tobacco. (Mr. Mundt works with Environ, and Mr. Price with his own eponymous consultancy).

Both are experienced expert defence witnesses, based in the United States and initially recruited by U.S. law-firms. Both were given the job of finding fault with Mr. Siemiatycki's estimates of how much one had to smoke before a subsequent illness in the Blais category (emphysema, or cancers of the lung, larynx or pharynx) could be attributed to smoking. (Mr. Mundt's expert report is Exhibit 30217, and Mr. Price's is Exhibit 21315).

Let's pick up where we left off yesterday -- with the cross-examination of Mr. Mundt by plaintiff lawyer André Lespérance.

Not your regular hatchet job?

Mr. Lespérance had seemingly rattled Mr. Mundt last night by showing him that he had once adopted or approved similar methods to those he is now criticizing.

Among those was a citation from an expert opinion written in early 2010 by Mr. Mundt, when he was engaged to help fend off a U.S. lawsuit involving light cigarettes. At that point, he expressed support for the use of pack-years as a measure of how much harmful exposure to which a smoker might have been exposed. But a few months later, in late 2010, when he filed his report in his case (Blais), he said that results based on pack-years were not up to the job.

This morning, Mr. Mundt looked and sounded more confident. He gave a nice-sounding explanation for these differing views in the same year.

He said his own thinking during that period had evolved as he became more "intimately" involved in the topic of exposure to cigarette smoke -- and underlined that the old way of thinking was inadequate. Thsi court would also "benefit from embracing the more recent" perspective.

He quite smoothly worked to keep on his main message track - and to reflect questions about his own choices back to the flaws he saw in the plaintiffs' measurements. "There are simple methods that are attractive because of their simplicity, but sometimes you need a more precise tool. A hatchet works for some jobs, a scalpel is required for others."

Some concessions

But while Mr. Lespérance was mostly unsuccessful at getting Mr. Mundt to agree with his interpretation of published results, he did succeed in having this epidemiologist say some useful things:

* Mr. Mundt said that a relative risk of over 1 would still suggest an association with exposure, even if it did not pass the "magic number" of RR=2 used in this trial. (Mr. Marais had made a great deal about not using any figures whose confidence intervals fell below 2)

* He validated the use of the cancer registry as an appropriate source for information.

* He described the growth of lung cancer as an "epidemic" largely due to smoking.

But no number - no matter how pressed for one

Mid morning, Mr. Lespérance asked the questions that have clearly been on Justice Riordan's mind. "What would be your critical amount. At what point would you be confident that on a population basis the number [indicating causality] is reasonable?"

Mr. Mundt steadfastly refused to give a number. He gave a long methodological rationale for his decision,
citing his desire not to "hamstring" the court, or to make assumptions or inputs that would make the conclusions speculative. "I cannot and I will not give a number."

Justice Riordan stepped up his pressure on the defence witnesses to produce a number. (Each of them has watched the testimony of the others -- so they know what is happening).

He told Mr. Mundt that in his role in this trial he should be prepared to do more than just criticize the numbers of another witness. "An expert witness in Canada comes to assist the Court in the job it has to do. I am looking to you for help, as I looked to Dr. Marais to help. Basically, I am getting 'you can't do it.' I am not getting help."

Mr. Mundt's response to the judge was a differently worded version of that given by Mr. Marais: an estimate or range of estimates can be produced, but only in a long and costly way. He repeated that the Siemiatycki method could not be made to work, and then offered the possibility of setting up a panel of experts to review the matter.

He bristled at the suggestion that he should have anticipated this need. "Had they (the plaintiffs) asked me, I would have done it. But it is hardly my role for this purpose."

There are none so naive as those who will not see?

With an agreement to end this witness by noon, the plaintiffs were racing the clock -- rushing their questions and growing impatient with Mr. Mundt when his answers grew long. (A marked - strategic? - difference from his laconic replies to Mr. Potter yesterday.)

Mr. Johnson had the second round of questions. As he often does, he raised issues that cast a poor light on Mr. Mundt's credibility. And, as he often does, he used analyses from U.S. scholars to connect this witness' testimony to documented industry tactics south of the border.

Almost an hour was spent detailing the role that Mr. Mundt had played in an effort to develop "good epidemiology."

Ong and Glantz
Mr. Johnston gave Mr. Mundt reason to question whether he might have been a willing or unwilling dupe of industry lawyers, showing an analysis of this exercise that linked the effort to a sophisticated tobacco industry strategy to try to avoid restrictions on public smoking.

Mr. Mundt showed neither surprise nor concern. To the contrary, he maintained that furthering good science - no matter at whose behest or on what side in court - was a worthy objective. "All clients have dark past," he said "including governments – we can't let that blind us."

Mr. Johnston gave him several opportunities to consider his work in light of concerns within his profession about the role of the tobacco industry. To each of these Mr. Mundt made it clear that he thought he was part of a respectable -- maybe even laudable -- attempt to improve scientific methods for decision makers.

A flexible witness

The morning had opened with Mr. Mundt being challenged to explain his differing statements to courts on the value of pack years as a measure of smoking. It closed with his being asked to explain a dramatic discrepancy between this week, and his views at a deposition in 2000. (The Falise case).

Fourteen years ago Mr. Mundt did not willingly agree that smoking and lung cancer were causally linked. Instead, he said that causality could not be inferred from observational data. He did not use the term causal without qualifying it: "At best we can make guesses about causality. So we temper it by saying potentially causal."

Although he remained poised and kept his voice on the level, Mr. Mundt seemed stressed by the questions. His face reddened, and his replies became obtruse and a little rambling.

He said that over the years he had changed the way he described things to better communicate in courts, but that the uncertainty he referred to then was nonetheless still part of to epidemiology. He appealed to "the philosophy of science."

Despite good intentions, Mr. Mundt was not freed to go until shortly after the noon recess. Two down, one remain.

A report on Mr. Price's testimony (which began this afternoon) will appear here tomorrow.

A juicy story about Mr. Mundt -- but not from this trial!

Sadly one of the other enlightening stories about Mr. Mundt never made it to this court record. 

Only last year, Mr. Mundt's work was the focus of an enforcement action by the EPA

Mr. Mundt had looked into the relationship between occupational exposure to hexavalent chromium and lung cancer among workers, and had found a dose-response in a study of four sites.  But the study had been repressed by Mr. Mundt's client, Elementis Chromium - and the EPA ultimately imposed a fine of more than $2 million on this company for hiding its results.

Mr. Mundt did not publish the study in its original form. Instead, he split his report into two separate studies -- neither of which had the "statistical power" to demonstrate the strong relationships evident in the four-site study.   They were individually published -- one for Germany, one for the United States. The weaker conclusions of the disaggregated studies were more favourable to the interests of his sponsors,

More on this story can be found in David Michael's book, Doubt is their Product or the Defending Science web-site.

Monday, 17 March 2014

Day 216: The one-question questionnaire

There will be early starts and maybe late closings this week at the Montreal Tobacco Trials.

The days have been extended as part of an agreement to take only three more days to finish the industry's critique of the plaintiffs' expert epidemiologist, Jack Siemiatycki.

That leaves one and a half (long) days each for the second (Mr. Kenneth Mundt) and third (Mr. Bertram Price) of the three men hired to kill off the idea that it is reasonable to conclude that if someone has smoked for 5 pack-years and has one of the diseases covered by the Blais class action, then their illness is more likely due to smoking than not.

It's not just the compression of time - nor the fast pace of the questions and answers - that gave today an unusual intensity and concentrated focus.

Ever since Mr. Siemiatycki testified, it's been clear that his numbers and the principles behind them are key to the Blais case, and therefore key to the companies' defence. With that defence winding to a close, this is a make-or-break moment for both sides.

The first of Mr. Siemiatycki's three critics testified last week. Mr. Laurentius Marais testified on behalf of JTI-Macdonald, with erudition and mannered precision, took a fine-tooth comb to the methods used by Mr. Siemiatycki. He pounded especially hard on the idea the way in which confidence intervals were treated by Mr. Siemiatycki's meta-analysis, saying that the result was statistically unreliable and that the results could not be trustedt.  Justice Riordan may have been convinced of the methodological sincerity, but he did not sound satisfied that this criticism helped him address his challenge of finding something reasonably reasonable to apply to this case.

All that to say that it didn't look (to me at least) that Mr. Marais had scored a home run.

The second man up to bat

American epidemiologist, Mr. Kenneth Mundt, was hired by Philip Morris/Rothmans, Benson and Hedges (PMI/RBH), and given essentially the same mandate as Mr. Marais -- i.e. to critique Mr. Siemiatcyki's methods and conclusions.

He is a man with long experience in studying the link between toxins and diseases on behalf of industries that produce toxins and don't want them linked to disease. Now only 54 years old, he has spent about half of  his professional life as a consultant to industries in need of "Applied Epidemiology", and is now a principal at Environ, a one-stop shop for industries in search of expert witnesses and regulatory friends.

Although Mr. Mundt has been hired as an expert in about a dozen tobacco trials, and has testified at "ten or eleven" other trials, this is only his second appearance as a witness in a tobacco suit.

The voir-dire process was no longer than it had to be (the plaintiffs asked few questions and did not oppose his role). Within an hour, Justice Riordan qualified Mr. Mundt as an expert in "epidemiology, epidemiological methods and principles, cancer epidemiology, etiology and environmental and lifestyle risk factors, and disease causation in populations." 

Much of a sameness

Although it is shorter (a mere 27 pages!) and less dense than the report discussed last week, Mr. Mundt covers much of the same ground, and takes a similarly harsh view. He concludes that the numbers produced by Mr. Siemiatycki are "unreliable for their intended purpose, and cannot be scientifically or convincingly substantiated."

And, like the previous witness, Mr. Mundt produced no estimates of his own, nor gave any advice on where more reliable numbers could be found.

But a different line of attack 

Although the message was the same, the messengers and the delivery (of both lawyers and witness) were vastly different today. Different also was the angle of attack on Mr. Siemiatycki.

Mr. Pratte had used open-ended questions to invite Mr. Marais to give bookish answers about profound methodological concerns. Today, Mr. Simon Potter (counsel to PMI/RBH) used very pointed questions to invite Mr. Mundt to say "yes" or "no" to questions that gradually painted Mr. Siemiatycki's report as one which was flawed and misleading.

The goal seemed to be to demonstrate to Justice Riordan that using Mr. Siemiatycki's numbers would not only be unreasonable from a statistical point of view, but would also be unjust. Such a broad-brush approach would cover too many people who should not be considered harmed by cigarettes.

And such different style!

Each of the lawyers in this case has their own distinct style, but that of Mr. Potter is perhaps more overwhelmingly distinct than others'. (If you can remember what over-acting looked like in the years when people still said "thespian", then you might have a flavour of the day).

From an audience perspective, it worked for him today. His points were made memorably - and there was a narrative arch to his message.

He had distilled his points and was careful to not walk over them. If Law and Order were about toxic torts, this could have been television.

One question is never enough

The thread that was used to weave Mr. Mundt's views together was the denouncement of a "one question questionnaire," and the elaboration of the many ways in which such an approach would be a bad route to follow.

The "one question" refers to Jack Siemiatycki's estimate that if someone with the four Blais diseases had smoked a "critical amount" of cigarettes before becoming ill, then their disease could be considered, on a balance of probabilities, to have resulted of smoking. The critical amount -- 5 pack-years, or a lifetime smoking of 36,500 cigarettes or more -- is now part of the definition of the Blais class.

(The "one question" isn't quite accurate! In addition to answering a question about whether or not they had smoked 36,600 cigarettes, a potential class member would also have to say "yes" to whether or not they had a fatal disease.)

In a volley of short questions, and one word answers, Mr. Mundt confirmed the many ways in which this "one question questionnaire" was inadequate to the task.

It would not take into account how many cigarettes per day (intensity) or how many years (duration) or how long ago one quit. Nor did it reflect the age at which one started smoking, the types of cigarettes one smoked or the amount of tar they produced. It provided no information on whether one knew about the risks of smoking, or were exposed to tobacco advertising or tobacco industry positions on harm. Etc.etc. etc.

Yes. Yes. Certainly. Yes. Yes. Then, a change of pace to No. No. Absolutely Not. No.

For much of the morning, Mr. Potter did the heavy lifting. Mr. Mundt had little to do but nod along. (Perhaps he too was lulled by the steady rhythm of the questions - at least once he said "yes" too quickly to an improperly phrased question, which later required Mr. Potter to back-track.)

Special attention was paid to:

*  the benefits of quitting. Mr. Mundt agreed that it came close to that of a never-smoker after a few decades, and with the studies and Health Canada statements to that effect. (Exhibit 30219)

* the shape of the dose-response curve. Mr Siemiatiycki had used a straight line to represent the increase in risk from increased smoking. Mr. Mundt felt it should be "s" shaped. (words for the day: Sigmoidal and Spline)

* the need for "other metrics".  Pack-years were deficient, as they did not take into account the variables in ways people smoked that might affect disease outcomes.

* heterogeneity. Lumping people together, combining study results, lumping cancers together, or averaging risk continued to come under heavy fire.

Past studies 

A non-linear dose
response curve (Exhibit 30223)
A second device used by Mr. Potter to good effect was to contrast the methods used by Mr. Siemiatycki in his expert report with those that he used in previous studies.  The clear inference in the questions, if not in the answers, was that the methods used for court purposes had been chosen to exaggerate the plaintiffs' case.

Among Mr. Siemiatycki's long publication record, Mr. Potter introduced papers where more heterogeneity had been used, more concern for confounding were expressed, non-linear dose response curves had been considered, and smokers who quit a long time ago were considered to be at low risk. (Exhibits 30221, 20023, 30221).

These were all missing from Mr. Siemiatycki's "overly simplistic" expert report, said Mr. Mundt.

It was only when Mr. Mundt was asked to conclude that he spoke at length without additional prompting from Mr. Potter. He delivered a well-constructed and very polished-sounding summary of his concerns. He directly addressed Justice Riordan:

 "I find it (the report) too simplistic and too blunt to be of the use that I think I understand you will put it." 

"I wish to raise before you that this is not indicative of the strongest science. The other papers from Dr. Siemiatycki are a testimony of what he is capable of producing, but has not produced for your purposes in this matter." 

He elaborated his concerns for several minutes, concluding with advice that echoed that given last week by Mr. Marais': "Collectively, these [faults] make it an unreliable summary for your purposes."

Questions from the other side

It was a much tougher André Lespérance who stood to cross-examine Mr. Mundt following a brief mid-afternoon break. The body language was tough, the tone of voice unusually firm and there was no sugar-coating of questions.

Nor was there any of the usual softening-up exchanges. Mr. Lespérance went quickly to a paper that Mr. Mundt had co-authored -- one in which he had employed essentially the same analytic approach that he now criticized in Mr. Siemiatycki. (Exhibit 1705)

Mr. Mundt's recent harsh words when contrasting Mr. Siemiatycki's earlier works heightened the drama of this moment. As did the change in tone by Mr. Mundt, who looked genuinely non-plussed. He looked at the paper as if he had never seen it before. (As third author, is it possible he had not?). He said he had trouble recalling it or the methods used in it.

The paper studied the cause of lung cancer among roofers. Although published in a scientific journal, it had been underwritten by trade organizations representing roofing companies. They were, I presume, pleased at the conclusion that it was roofers' smoking that was the cause of their disease, not their occupational exposure to asphalt.

Mr. Lespérance pointed out that in coming to that conclusion, Mr. Mundt and his co-authors used an even more crude categorization of smoking history than pack-years. Nor did they distinguish between types of cancer or make other adjustments for heterogeneity in their "random effects model."

"Is it good epidemiology?" Mr. Lespérance asked Would it pass muster with Mr. Marais?

"It serves its purposes," said Mr. Mundt opaquely, before conceding that his paper also would also have been vulnerable to criticism by Mr. Marais.

Mr. Lespérance challenged him to address the issues as if he were in a judge's position. "You have somebody working as a roofer, who has smoked and has quit smoking. ...  How are you going to determine whether smoking was the cause of disease? ...."In a smoker you will never know because we can't see - we need to work with probabilities.

Mr. Mundt took refuge in his message box. "You are asking me to speculate on any one individual. I wouldn’t speculate on the specific causes of his disease on those circumstances..." But he also defended his profession and the use of epidemiology in such an instance. "Individual causation may not be knowable" but "epidemiology is the right place to go."  

Mr. Mundt said that science had marched on since that paper was published  in 2007. His views on multiplicativity and pack years had changed because there were now newer techniques and better methods of collecting data. (Mr. Siemiatycki's expert report was written only 2 years later).

Mr. Lespérance showed him the opinion of other prominent epidemiologists who recently reconfirmed support for the use of pack-years. (Exhibit 1707). Over the objections of Mr. Potter, he asked Mr. Mundt to respond to the views of an unidentified proponent of pack-years: "More accurate estimations [of tar dose] can be approximated through the combination of measures such as duration and intensity of smoking like pack years." 

Mr. Mundt's looked quite uncomfortable, and reasonably so as Mr. Lespérance revealed that man behind those words was none other than Mr. Mundt -- and that he had said his as recently as 2010.

It was already past 5:00, and the court soon adjourned. Saved by the bell -- at least temporarily.

The cross-examination of Mr. Mundt will continue Tuesday morning.

This post was back-timed to make indexing consistent