Testing for Diacetyl and Acetyl Propionyl, How its done, What is meaningful testing? Flavor Vendors

[tombaker]

@tombakerI think there's a lot of important conversation going on in here, and I don't think this is part of it. Would you two consider taking this to another thread?

Sure thing, no problem going forward, I replied to the last posts first and just saw this.
Legal stuff from my side, will be on a different thread...going forward.
cheers

 

[HeadInClouds]

Questions: Is Dr. F saying that 5ppm is safe for ALL vapers (i.e. it's physically impossible to inhale a dangerous amount of D at this concentration)? Or is this based on average vaping habits? If it's the former, then I don't see an issue with labeling a liquid with this concentration as D free. If it's the latter, then I think the limit to be considered D free should be lower, how much lower, I have no idea.

Dr Farsalinos (and NIOSH/OSHA) has never - and will never - use the word "safe" to describe ANY level of exposure to a toxin.
The only "safe" level of exposure to diacetyl is fully-acknowledged (by Dr Farsalinos, NIOSH/OSHA, and the rest of science) to be zero.

Dr Farsalinos used the word "reasonable" to describe his 5 ppm suggestion. Even he might be surprised to learn his suggestion is being represented/understood to be part of his latest published research. It's not! In science, until a statement is formally documented, peer-reviewed, and finally published -- it's just something some guy said. There are formal channels to take, (as he did with his study of diacetyl content of e-liquids). The burden of proof is always on the scientist making the claim; Dr Farsalinos hasn't even suggested he might begin that process.

NIOSH/OSHA writes in statistics. Their stated goal is to limit bronchiolitis obliterans cases to 1 in 1000 exposed workers. They graph the mathematical functions, finding just how high the exposure can be to keep the disease at 1-in-1000 workers. They arrive at 5ppb average over 8 hours, not to surpass 25ppb in any 15 minute period. NIOSH never says any amount is "safe" or "reasonable" - but they do use the term "acceptable" to describe 1 in 1000.[/QUOTE]

..but where I get lost is where you propose a 5ppb limit to deem a liquid D free.

Oh - I didn't say that! Instead of "diacetyl free," labels like these would be more correct: "diacetyl 0 ppb" or "diacetyl 0 ppm" or "diacetyl 0%" All of those are accurate, standard, scientifically-accepted ways to show both the measured amount as well as the level of precision used to in testing.

Content in the air : content in liquid is an apples : oranges comparison.

Not true - that would violate the basic laws of physics -- and it's not what Dr. Farsalinos says at all.
If you have liquid with 5ppm diacetyl, and you vaporize it, it is now a gas with 5ppm diacetyl. Dr Farsalinos does not claim otherwise.

How Dr F moves from ppb to ppm: he assumes that the air with diacetyl (vaporized eliquid) will be diluted with additional fresh air. THIS is where his assumptions come into play. If you accept all of his assumptions, it follows that every 1 part of vaporized eliquid will be diluted with 1,000 parts of fresh air. And that factor of 1000 changes the NIOSH ppb limit to Dr Farsalinos' ppm figure.

If you re-read that last paragraph, it begs the question: Are the assumptions appropriate? No other experts have yet weighed in with their thoughts or calculations (or objections or acceptance), because this has not been submitted for peer-review. It's not science yet, and those assumptions are highly arguable.

 

[InMyImage]

Sorry, posting error.

 

[InMyImage]

I don't have a problem continuing the legal discussion if necessary in another thread if Tom wants to start a new after the follow post.
This post is long, as it is an extract of the key points of the judges opinion brief regarding the motion to exclude testimony. If you are not interested in the details that clearly refute all of Tom's arguments to date then please skip to the next post.

Tom, the following extract source is noted below. This is a summary of the findings related to the admissability of the prosecutions key witnesses. I include the source so that you can wade through the full details if you so desire after reading the summary that I present below.
You will notice that I provide an unbiased summary and include the one point that the judge did dismiss. You are free to look for any that I may have missed, although I can state with a 99.9% certainty that I did not, in the event that you find the 0.1% please accept my apology for an honest mistake, it was a long, highly detail opinion and any omission on my part was not intentional.
I do hope that this summary finally lays to rest the discussion regarding the admissibility of the ALL of the expert witnesses called by the prosecution with regards to the source of Mr Watson's diacytel exposure and resulting condition.
Note that the summary is only related to the findings regarding Mr. Watson's health. There were other motions to dismiss with this case related to Kroger's and the manufactures knowledge of defect and attempts to deceive. If you would like I can discuss those in detail as well.
As mentioned previously, I would be more than willing to discuss the issue further if you decide that the information below is not satisfactory. Feel free to start a new thread if that is your desire and simply let me know where to find it.

Bill

Apparently this will take more than one post due to post size restrictions...

 

[InMyImage]

***** Continuation of Legal Rebuttal - Move on if not interested *****

http://co.findacase.com/research/wfrmDocViewer.aspx/xq/fac.20110622_0003940.DCO.htm/qx
The opinion of the court was delivered by: Senior Judge Walker D. Mille
ORDER ON MOTION FOR SUMMARY JUDGMENT AND MOTIONS TO EXCLUDE TESTIMONY
This matter is before me on the Joint Motion for Summary Judgment (ECF No. 572) filed by Defendants Dillon Companies, Inc., d/b/a King Soopers, Inter-American Products, Inc., and The Kroger Company (collectively, the "Kroger Defendants"), Gilster-Mary Lee Corporation ("Gilster-Mary Lee") and Birds Eye Foods, Inc., ("Birds Eye"). These Defendants have also filed motions to exclude portions of testimony of Plaintiffs' expert witnesses (ECF Nos. 567, 568, 569, and 570).
Statement of Facts, ECF No. 600-6, at 165. Studies at popcorn plants revealed a strong association between exposure to vapors from flavorings, including diacetyl, and decreased lung function. Kreiss, supra, ECF No. 600-1, at 333 ("The prevalence of airway obstruction increased with increasing cumulative exposure to diacetyl"); NIOSH ALERT, supra, ECF No. 600-4, at 1; INTERIM REPORT (Aug. 22, 2001), supra, ECF No. 600-5, at 18 ("The exposure-response relationship between diacetyl cumulative exposure and pulmonary function was unequivocal");
Harber, supra, ECF No. 600-7, at 262 (results of surveys at popcorn plants "pointed to a clear association between a particular chemical agent (diacetyl) and bronchiolitis obliterans"). Studies of emissions from microwave popcorn preparation have shown that the highest levels of release occur when opening the bag after popping.
Jacky A. Rosati, et al., Emissions from Cooking Microwave Popcorn, CRIT. REV. IN FOOD SCI. & NUTRITION, 47, 701 (2007), Exh. 47 to Pls.' Statement of Facts, ECF No. 602-7, at 709. It has been established that chemicals emitted during normal popping of microwave popcorn are similar to those found by NIOSH in popcorn manufacturing plants, with the exception of one chemical not at issue here.
Although the relationship between exposure to butter flavorings and respiratory problems has been established, there remain numerous unanswered questions about what level of exposure triggers health effects and whether such effects are caused by peak or by cumulative exposures.
Researchers from at least one study have concluded that the risk to QC workers, as with mixers, may result from brief, intense exposures to the flavoring chemicals even when low average exposures are maintained. Kanwal, supra, ECF No. 560-14, at 156. This study also noted that the risk to QC workers is of a different nature than other workers because they work with the product at much higher temperatures, which increases the volatility of the flavoring chemicals.
…
I now turn to the evidence relating to Mr. Watson's health history and his diagnosis of bronchiolitis obliterans. Bronchiolitis obliterans is a rare lung disease involving inflammation of the small airways. INTERIM REPORT (Aug. 22, 2001), supra, ECF No. 600-5, at 15.
Mr. Watson owned a carpet cleaning company from approximately 1998 or 1999 to 2001. He was exposed to carpet cleaning chemicals in the course of that work and did not regularly use respiratory safety equipment, although he testified that he used fans for ventilation and kept windows and doors open while working. As noted above, his heavy consumption of Defendants' microwave popcorn products occurred from around 2000 to 2007.
Mr. Watson's history of respiratory problems goes back some time. He was diagnosed with asthma and pneumonia in 1998, although no pneumonia was revealed on his chest x-ray at that time. He also had reflux disease. Mr. Watson was diagnosed with pneumonia again in 2000, but the chest x-ray again was not conclusive. His medical records showed additional breathing problems and coughing in 2002 and 2003. In 2005, he began noticing that while singing he could not sustain his notes and that he was short of breath. His records show more evidence of breathing difficulty and coughing in 2006. He consulted a physician at National Jewish Medical and Research Center in May 2006, where he was evaluated for sleep apnea; his decreased pulmonary function was also noted. A lung biopsy was taken, which showed various abnormalities.
In 2006, his physician noted that even though Mr. Watson's exposure to carpet cleaning chemicals had ceased in 1999, his shortness of breath had progressed.
Mr. Watson was examined by Dr. Cecile Rose at National Jewish in February 2007. She noted that he consumed large amounts of microwave popcorn on a daily basis and recommended that he stop. He did and began feeling better; his symptoms have apparently stabilized since then. Dr. Rose has worked as a consultant to the flavoring industry with respect to occupational exposure to flavoring ingredients and was already quite familiar with the research concerning respiratory problems among popcorn factory workers. It appears that Dr. Rose diagnosed Mr. Watson with bronchiolitis obliterans and opines that his disease was caused by his exposure to microwave popcorn flavorings.
On February 22, 2007, John Martyny, Ph.D., an industrial hygienist, performed an assessment of diacetyl levels in the Watson home before and during the process of preparing two bags of microwave popcorn. Martyny Dep., Exh. 53 to Pls.' Statement of Facts, ECF No. 602-13, at 27.
Using the gas monitor, a peak diacetyl concentration was measured at 3.045 ppm, which occurred upon opening the microwave door immediately following completion of popping the first bag of popcorn. Id. Upon opening the bag, a peak concentration of 1.143 ppm was measured. Id. This was similar to background levels measured before popping, see hearing Exhibit 209, which could signify unreliability in the measurement, as Defendants' witnesses suggest, or the presence of residual diacetyl in the Watson home, as Plaintiffs' witnesses suggest.
On July 18, 2007, Dr. Rose wrote a letter to the Food and Drug Administration and other regulatory agencies identifying Mr. Watson as perhaps the first case of a consumer developing lung disease from butter flavorings. Exh. 52 to Pls.' Statement of Facts, ECF No. 602-1… She recognizes the difficulty of making a causal connection from one case study but states she is providing the information to the federal agencies because of the possible public health implications. Id.
At the June 14-15, 2011 hearing, testimony was provided by Dr. David Egilman, Dr. Allen J. Parmet, Dr. E. Neil Schachter, Dr. Colin Soskolne, and Dr. Kenneth Kulig. Several exhibits were referenced and the parties have stipulated to their admission into evidence.*fn5At the June 14-15, 2011 hearing, testimony was provided by Dr. David Egilman, Dr. Allen J. Parmet, Dr. E. Neil Schachter, Dr. Colin Soskolne, and Dr. Kenneth Kulig. Several exhibits were referenced and the parties have stipulated to their admission into evidence.*fn5
…
Plaintiffs have proffered three experts who have opined that Mr. Watson has bronchiolitis obliterans caused by exposure to microwave popcorn flavoring. This is clearly relevant to the issues to be decided; the dispute here concerns only the reliability of those opinions. I will summarize the proposed testimony and opinions of each expert and Defendants' objections. Defendants do not appear to contend that these witnesses are not qualified to serve as experts but rather take issue with the substance of their proposed testimony.
…

 

[InMyImage]

***** Continuation of Legal Rebuttal - Move on if not interested *****

1. David Egilman, M.D. (expert report attached as Exh. 17 to Pls' Statement of Facts, ECF No. 600-17)
Dr. Egilman reviews Mr. Watson's medical records and other evidence pertaining to his medical history. Dr. Egilman also reviews Mr. Watson's work history, including his time working as a carpet cleaner. He notes that Mr. Watson is a lifelong non-smoker…. Mr. Watson has not been exposed to the chemicals known to cause this condition.
Dr. Egilman then discusses the research on health hazards associated with diacetyl, particularly in the microwave popcorn factory setting. He reviews two other cases involving consumers claiming to have suffered lung disease as a result of exposure to butter flavoring ingredients.
Dr. Egilman opines on general causation using a model for determining causality developed by Sir Austin Bradford Hill. This model requires examination of temporality, biologic gradient (dose-response), consistency, biologic plausibility, strength of association, analogy, experimental evidence, coherence and specificity, concepts which are explained in detail. Egilman Report, ECF No. 600-17, at 20-25. Applying the framework, Dr. Egilman relies on much of the research cited above to show a strength of association between bronchiolitis obliterans (or other respiratory symptoms) and exposure to diacetyl and butter flavoring. This research has generally shown that workers in higher exposure areas have significantly higher rates of symptoms that those who work in areas with lower exposures. He focuses in particular on the studies at the Gilster-Mary Lee plant in Jasper. Id. at 25 (citing Kreiss, supra, ECF No. 600-1). He also relies on an article examining data from six separate studies conducted at microwave popcorn plants, which concluded that microwave popcorn workers at many plants are at risk for flavoring related lung disease. Id. at 26 (citing Kanwal, supra, ECF No. 560-14).
Turning to temporality, Dr. Egilman notes that diacetyl exposure preceded the occurrence of bronchiolitis obliterans in all studies. He then addresses the question of dose-response, and opines that "diacetyl's effect on the lung follows a dose-response relationship." Id. at 26. As grounds, Dr. Egilman relies on an animal study showing that diacetyl was shown to cause increased necrosis in the airway epithelia of rates exposed to a higher dose of diacetyl than a lower dose. Id. at 26 (citing Hubbs, supra, ECF No. 600-3). He also relies on the studies of plant workers that showed that the rates of respiratory symptoms were lower in areas with less exposure to diacetyl; similarly, workers who reported being mixers for longer periods of time had more symptoms than those with less time. Id. at 26-27 (citing Kreiss, supra, ECF No. 600-1; Kanwal, supra, ECF No. 560-14)
He then discusses the consistency of the findings, observing that associations have been found between diacetyl exposure from butter flavoring in at least six popcorn manufacturing plants. He also notes that animal studies have consistently shown a relationship between diacetyl exposure and necrosis of the airway epithelial tissue. He observes that several researchers, including those with NIOSH, have relied on these animal studies to conclude that diacetyl is the mechanism causing damage. Id. at 28 (citing NIOSH reports for various popcorn factories). He also cites studies showing that cases of lung disease have been reported in association with diacetyl exposure across a number of food manufacturing industries, including raw material workers, butter flavoring manufacturing, popcorn production, and other flavoring workers. Id.
As to specificity, Dr. Egilman states that the adverse effects have been limited to lung and other mucus membranes where the chemicals have direct contact with human or animal cells. Id. at 29. He notes that bronchiolitis obliterans is a very rare disease (other than for organ transplant patients) but has been diagnosed in a number of workers exposed to diacetyl. He addresses biologic plausibility, and cites research from the 2002 Kreiss, et al., study as well as a 2009 study in which the researchers reported that artificial butter flavoring was the causative agent in the cases of brochiolitis obliterans at the Jasper plant. Id. (citing Sahakian & Kreiss, supra, ECF No. 600-11). He further notes that diacetyl is an alpha-dicarbonyl compound, which inhibits protection from oxidative stress. Id. (citing Kreiss, supra, ECF No. 600-1). He argues that this explanation is coherent and has been supported by the animal studies discussed above. Id. at 30-33 (citing research on rats, guinea pigs showing direct toxic effect on respiratory linings, as well as other studies showing respiratory health effects on mice). He cites literature noting that although mouse and rat biology is different from humans, the studies "suggest significant amounts of inspired diacetyl penetrate to the bronchioles of the human, with greater penetration occurring during exercise than rest." Id. at 32 (citing Morris, JB, Toxicology Program, University of Conn., Storrs, CT, Abstract: A PBPK Model for Inspired Vapor Intake in the Human and its Application to Diacetyl Diosmetry, Society of Toxicology, 2010 Annual Meeting). Finally, he addresses the analogy component of the model, and notes that other substances have proved toxic when inhaled, including substances that cause changes in the respiratory epithelium, and that exposures to these chemicals are accepted causes of bronchiolitis obliterans. Id. at 33.
Dr. Egilman then opines that microwave popcorn emits diacetyl vapors when bags are opened and that diacetyl remains in the air after popping. Id. at 33. He relies on a 2007 EPA study which specifically tested chemical emissions in seventeen types of microwave popcorn from eight different brads; all contained diacetyl but in different amounts. Id. (citing Rosati, supra, ECF No. 602-7). As noted above, the Rosati study determined that the highest rate of emission occurred at the stage when the bags were opened, and the second occurred during popping; diacetyl remained in the air for up to 40 minutes after popping.
Dr. Egilman also opines on specific causation. He relies on the levels of diacetyl found by Dr. Martyny and compares the peak levels measured in the Watson home, approximately 3 ppm, to levels at the Gilster-Mary Lee plant. Id. at 40. He contends that peak levels in the Jasper plant upon opening a bag and in a QC worker's breathing zone (approximately 4 ppm, 7 ppm, and 13 ppm) are comparable to the peak levels to which Mr. Watson was exposed in his consumption of the Kroger label popcorn. Id. He then calculates a daily average exposure for Mr. Watson of 0.0015 to 0.003 ppm for weekdays and 0.0015 ppm to 0.0045 ppm on weekends, and an average cumulative exposure level. Id. at 41. He argues that these levels are similar to those found in QC areas of microwave popcorn plants, relying primarily on data from the Jasper plant. He also notes the conclusion of some researchers that "intermittent peak exposure" may increase risk of disease even if average exposures are lower. Id. at 41 (citing Kanwal, supra, ECF No. 560-14). Dr. Egilman also relies on Dr. Rose's letter to the FDA and her conclusion that it was plausible that Mr. Watson's exposure to butter flavoring vapors caused his lung disease. Id. at 42.

 

[InMyImage]

***** Continuation of Legal Rebuttal - Move on if not interested *****
I now address Defendants' objections to these opinions…
I agree with Plaintiffs that the "substance at issue" here is vapor from butter flavoring containing diacetyl. The "slurry" in the factory setting is the same combination of ingredients put in the packages of popcorn and so I fail to see a meaningful distinction between the two, particularly since the product consumed by Mr. Watson is the same as that produced in the Gilster-Mary Lee plant in Jasper. Indeed, studies of emissions from cooking microwave popcorn have established that the chemicals emitted are essentially the same as those sampled in the air at microwave popcorn factories. Rosati, supra, ECF No. 602-7, at 706. Moreover, the published literature on this issue indicates that the exposure risk from popping may be greater, because the higher temperature involved means greater volatility and release of the chemicals in the flavoring ingredients.*fn7 Kanwal, supra, ECF No. 560-14, at 156. Defendants' arguments essentially seek to make a distinction based on quantity or level of exposure, which is clearly greater in the factory setting. That issue, however, is a matter relevant to specific causation, not to the general causation question of whether the chemicals emitted in vaporizing butter flavoring ingredients can cause harm to the human respiratory system.
I agree with Defendants that there appear to be few if any epidemiological studies examining the effect of exposure from popping microwave popcorn at the levels that Mr. Watson prepared popcorn. Again, however, I conclude that the level of exposure is an issue going to specific causation, not general causation, and that there is adequate evidence for Dr. Egilman to opine that vapors from butter flavorings can be harmful.
Dr. Egilman and Dr. Rose have both discussed why they believe that other known causes of bronchiolitis obliterans have been eliminated, leaving Mr. Watson's exposure to butter flavoring vapors as the most plausible explanation. Accordingly, I conclude that the lack of epidemiological studies on consumers does not mean that Dr. Egilman's general causation opinion is unreliable or irrelevant. I will discuss the issues regarding the applicability of studies of QC workers to Mr. Watson's condition with respect to specific causation, below.
Given the significant evidence of the toxicity of diacetyl and the epidemiological studies showing health effects from inhalation of butter flavoring ingredients containing diacetyl, I conclude that Dr. Egilman should be permitted to opine regarding general causation.
I agree with Defendants that there is little to no reliable evidence establishing a threshold dose and that Dr. Egilman's opinion in this regard is not based on a reliable foundation…. Dr. Egilman's opinions regarding a specific dose-response or minimum threshold
exposure level should be excluded.
Defendants also argue that Dr. Egilman relies on the peak level of 3.045 ppm measured by the second method (using the Innova monitor) but fails to adjust for background levels of diacetyl which were present before any popcorn was popped and the evaluation was in general not a controlled scientific study. I conclude that these are issues for cross examination but do not render all of Dr. Egilman's conclusions inadmissible. Dr. Martyny's measurements are sufficient to demonstrate that Mr. Watson was exposed to some level of diacetyl, although the precise amount is disputed, and Dr. Egilman's opinions are admissible to the extent that they are based on the fact of that exposure.
Defendants further contend that Dr. Egilman cannot rely solely on a temporal relationship between Mr. Watson's exposure to microwave popcorn flavoring vapors and his illness. Were this the only basis for Dr. Egilman's conclusions I would agree. However, this is but one factor that Dr. Egilman considered in his analysis and I see no reason to exclude his entire causation opinion testimony on this basis, when temporality appears to be a factor taken into account in considering causation.
Finally, Defendants object to Dr. Egilman's differential diagnosis to rule out other causes of Mr. Watson's bronchiolitis obliterans. "Differential diagnosis refers to the process by which a physician 'rules in' all scientifically plausible causes of the plaintiff's injury. The physician then 'rules out' the least plausible causes of injury until the most likely cause remains." Sandoz, 289 F.3d at 1209 (citations and internal punctuation omitted). The Tenth Circuit has implicitly approved of the use of differential diagnosis as a method for determining causation in appropriate circumstances. Id. at 1211-12.
Defendants argue that Dr. Egilman did not properly "rule out" Mr. Watson's history of pneumonia and his exposure to carpet cleaning chemicals as possible alternative causes of his illness. I again conclude that these are issues that go to the weight of the evidence, not its admissibility, and can be addressed on cross-examination.Dr. Egilman does explain why he has ruled out these possible explanations for Mr. Watson's illness. As to pneumonia, Dr. Egilman opines that the diagnosis of pneumonia was not definite and, even if had this been the cause, there would have been signs of bronchiolitis obliterans soon after the illness in 2000. Dr. Rose also explains why she believes that pneumonia was not the cause of Mr. Watson's illness, specifically that his condition would have continued to deteriorate instead of stabilizing after ceasing to consume microwave popcorn. Similarly, Dr. Egilman explains, albeit briefly, why he does not consider that the chemical exposure from carpet cleaning is the cause: Mr. Watson was not exposed to chemicals known to cause bronchiolitis obliterans. Defendants present evidence that Mr. Watson may have used a product called polymethyl methacrylate, which can in some cases cause hypersensitivity pneumonitis and that there may be some kind of relationship between hypersensitivity pneumonitis and bronchiolitis obliterans. Mr. Watson has also been diagnosed with hypersensitivity pneumonitis. While this relationship may be something to explore on cross-examination, Defendants have not demonstrated that Mr. Watson was exposed to a chemical known to cause bronchiolitis obliterans in quantities sufficient to cause the condition such that Dr. Egilman's opinion regarding alternative causes is entirely unreliable and inadmissible.
Additional evidence regarding the reliability of Dr. Egilman's methodology in arriving at an opinion regarding general and specific causation was provided at the hearing. Dr. Soskolne was proffered as an expert in epidemiology and testified that he had reviewed Dr. Egilman's report for the purpose of evaluating the reliability of the methods used. He testified that it is entirely appropriate to extrapolate disease causation from the occupational setting to other contexts, as Dr. Egilman did here. Dr. Soskolne also testified that Dr. Egilman's methods for arriving at his opinion, including his use of the Hill factors and a differential diagnosis, were accepted in the field and were applied validly. He noted that Dr. Egilman's source data was provided and that the methods were reproducible, which are the standards that Dr. Soskolne would apply in reviewing an article for publication.
Dr. Schachter was offered by Plaintiffs as an expert in pulmonary medicine. He also had reviewed Dr. Egilman's report and was prepared to testify regarding the reliability of the methodology used by Dr. Egilman. Dr. Schachter also opined that it is an appropriate scientific practice to extend theories of causation from occupational disease to the same disease occurring other settings. He also explained why it is considered acceptable in medical field to make a causal inference even without knowledge of an exact dose or dose threshold of a particular disease-causing agent. Dr. Schachter testified that Dr. Egilman applied the Hill criteria appropriately and properly performed a differential diagnosis in determining the cause of Mr. Watson's disease.
In rebuttal, Defendants presented Dr. Kulig, an expert in medical toxicology. Dr. Kulig did not question the validity of the use of the Hill factors or of the use of a differential diagnosis in determining causation; indeed, on cross-examination, he admitted that these are commonly used tools in the field. Rather, he critiqued the validity of using Dr. Rose's letter as a "case study" to prove causation, arguing that a true case study involves extensive case history and detail and publication in a peer-reviewed journal so that other practitioners may evaluate the legitimacy of the claimed causal relationship. He argued that key details were omitted from Dr. Rose's letter and that Dr. Martyny's data was unreliable and not a good determinant of Mr. Watson's exposure or of the dose relationship. Dr. Kulig's criticisms again go to the weight of the evidence but do not demonstrate that the basic methodology employed by Dr. Egilman was unreliable or that the data upon which he based his opinion, other than the measurements of diacetyl in Mr. Watson's home, were insufficient.
Given the evidence and authority discussed above, I conclude that Dr. Egilman's opinions regarding both general and specific causation, with one exception, employ reliable methods and are based on sufficient, reliable data. The exception concerns the portions of Dr. Egilman's testimony that purport to establish a minimum threshold amount of diacetyl sufficient to cause respiratory illness, including bronchiolitis obliterans. These opinions will not be permitted at trial. Otherwise, Defendants' motions to strike Dr. Egilman's opinions are denied.
…

 

[InMyImage]

***** Continuation of Legal Rebuttal - Move on if not interested *****
2. Alan J. Parmet, M.D., MPH (expert report attached as Exh. 36 to Pls.' Statement of Facts, ECF No. 601-17)
Dr. Parmet is another medical doctor who opines on specific causation. Dr. Parmet has significant experience with popcorn flavoring related illness and was the physician who first observed the cluster of cases at the Jasper plant and has remained involved in the study of these conditions.
His diagnosis is "Flavoring-induced bronchiolitis obliterans/bronchiolitis obliterans syndrome/popcorn worker's lung." Parmet Report, ECF No. 601-17, at 12. As grounds, he observes that Mr. Watson's consumption exceeds average consumer intake of microwave popcorn. He notes that Mr. Watson's cough and other respiratory problems from the 1990s were resolved with treatment for reflux. However, he concludes that Mr. Watson's condition has progressed to severe pulmonary abnormalities and that his lung biopsy is consistent with flavoring-induced bronchiolitis obliterans. Other factors include Mr. Watson's lack of smoking history. Dr. Parmet contends that Mr. Watson's exposure to solvents and cleansers as a carpet cleaner was "minor" and "could not possibly [ac]count for the severity of [Mr. Watson's] current lung disease." Id. Dr. Parmet concludes there is no other reasonable cause that is demonstrated, particularly since Mr. Watson has responded to all other treatments of his health conditions.
ill give it whatever weight it deems appropriate. The same applies to the records allegedly omitted from the review; given Dr. Parmet's examination of Mr. Watson and experience with the condition, Defendants have not established that Dr. Parmet's omission in this regard renders the opinions unreliable.
…
3. Cecile Rose, M.D. (opinions contained in deposition excerpts, Exh. 14 to Pls.' Statement of Facts, ECF No. 600-14)
As noted above, Dr. Rose is one of Mr. Watson's physicians and has treated him since 2007.
In her deposition, she explains that she was asked to consult on Mr. Watson's case after his lung biopsy was found to have characteristics of hypersensitivity pneumonitis and Mr. Watson's lung function was continuing to deteriorate. Id. at 23. The biopsy also showed signs of bronchiolitis obliterans. Id. at 25. She believes that both conditions were caused by his exposure to the butter flavorings. Id. at 96. The basis for her opinion on causation is the following: (1) that Mr. Watson's lung disease stabilized when he ceased using the product; (2) there was no other causal explanation;
(3) the clinical findings in his lung disease were similar to those that occurred in workers exposed to butter flavorings. Id. at 80. She acknowledges that Mr. Watson's exposures to the flavoring ingredients were likely lower than those experienced by workers in production processes. Id. at 81. She explains that she rules out pneumonia as a cause because his lung function would have continued to decline; she explains that progressive bronchiolitis obliterans after an infection is difficult to interrupt, but Mr. Watson's condition stabilized after he stopped consuming microwave popcorn. Id. at 107. She also acknowledges his exposure to carpet cleaning chemicals. Rose Dep., Exh. A-15 to Def.'s Statement of Facts, ECF No. 560-37, at 53. She states, however, that she is unaware of any of the chemicals to which he was exposed being potential causes of bronchiolitis obliterans. Id. at 54-55.
In challenging Dr. Rose's testimony, Defendants rely on several of the same arguments that I have rejected above. Defendants also argue that Dr. Rose is somewhat equivocal as to the cause of Mr. Watson's disease, claiming that she has stated she is not "sure" of the cause of his disease and arguing that she has not adequately ruled out other causes. Again, I see no basis to exclude Dr. Rose's testimony. There is no requirement that a medical expert be one hundred percent certain as to a diagnosis or cause and Dr. Rose has stated her opinion to a reasonable degree of medical probability. She has also provided an explanation for why other causes are not probable, which Defendants may challenge on cross-examination at trial. The motion will be denied.

 

[InMyImage]

***** Final continuation of Legal Rebuttal - Move on if not interest ***** And rejoice that they are done
**** Precedents Cited *****
Defendants seek to exclude much of the opinion testimony of Plaintiffs' expert witnesses based on Rule 702 of the Federal Rules of Evidence and the reliability standards set forth by Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993) and its progeny.
Summary judgment is appropriate when there is no genuine issue as to any material fact and the moving party is entitled to judgment as a matter of law. Fed. R. Civ. P. 56. A factual issue is genuine if "the evidence is such that a reasonable jury could return a verdict for the nonmoving party." Anderson v. Liberty Lobby, 477 U.S. 242, 248 (1986).
Where "the moving party does not bear the ultimate burden of persuasion at trial, it may satisfy its burden at the summary judgment stage by identifying 'a lack of evidence for the non-movant on an essential element of the non-movant's claim.'" Bausman v. Interstate Brands Corp., 252 F.3d 1111, 1115 (10th Cir. 2001) (quoting Adler v. Wal-Mart Stores, Inc., 144 F.3d 664, 671 (10th Cir. 1998)). Then, "[t]o avoid summary judgment, the non-movant must establish, at a minimum, an inference of the presence of each element essential to the case." Id.
This "gatekeeping" function applies to all expert testimony proffered under Fed. R. Evid. 702. Kumho Tire Co., Ltd. v. Carmichael, 516 U.S. 137, 149 (1999) (extending Daubert's holding on scientific expert testimony to all expert testimony).
Plaintiffs have the burden of proving that popcorn flavoring ingredients caused Mr. Watson's injury. This requires a two-fold showing: (1) that the substance at issue is capable of causing a particular injury or condition (general causation); and (2) whether that substance caused the plaintiff's particular injury. Norris v. Baxter Healthcare Corp., 397 F.3d 878, 881 (10th Cir. 2005).
Elements that may assist in establishing specific causation include the following: (1) the toxic substance at issue has been demonstrated to cause in humans the disease or illness suffered by the plaintiff; (2) the individual has been exposed to a sufficient amount of the substance in question to elicit the health effect at issue; (3) the chronological relationship between exposure and effect is biologically plausible; and (4) the likelihood that the chemical caused the disease or illness is considered in the context of other known causes. Henricksen v. ConocoPhillips Co., 605 F. Supp. 2d 1142, 1156 (E. D. Wash. 2009) (citation omitted).
the Tenth Circuit has recognized that a medical expert does not always have to cite to published studies on general causation in order to establish causation and, under the right circumstances, a differential diagnosis (i.e., ruling out other possible causes of the condition) may reliably form the basis of an opinion that a particular item caused an injury. Hollander v. Sandoz Pharm. Corp., 289 F.3d 1193, 1211-12 (10th Cir. 2002) (quoting Turner v. Iowa Fire Equip. Co., 229 F.3d 1202, 1209 (8th Cir. 2000))

 

[HeadInClouds]

@InMyImage - will you save me from looking it up myself and tell me if the retailers (Kroger, King Soopers...) were penalized ? I didn't know they were even named in the suit. (shows how little I've read about it...)

 

[InMyImage]

@HeadInClouds $7.2 million was awarded to the Watson's as a result of the case.

They later settled with Kroger, et. al. for 5.8 million in order to avoid a lengthy appeal process.

 

[HeadInClouds]

@HeadInClouds $7.2 million was awarded to the Watson's as a result of the case.
They later settled with Kroger, et. al. for 5.8 million in order to avoid a lengthy appeal process.

So the retailers were deemed at least partially responsible.

Does that imply that if a reseller buys ready-to-vape e-liquid and resells it (without even opening it) they could be theoretically held liable for damages?
How about if it's labeled "diacetyl free" but is later found to contain it anyway?

 

[bluraff3]

Dr Farsalinos (and NIOSH/OSHA) has never - and will never - use the word "safe" to describe ANY level of exposure to a toxin.
The only "safe" level of exposure to diacetyl is fully-acknowledged (by Dr Farsalinos, NIOSH/OSHA, and the rest of science) to be zero.

Dr Farsalinos used the word "reasonable" to describe his 5 ppm suggestion. Even he might be surprised to learn his suggestion is being represented/understood to be part of his latest published research. It's not! In science, until a statement is formally documented, peer-reviewed, and finally published -- it's just something some guy said. There are formal channels to take, (as he did with his study of diacetyl content of e-liquids). The burden of proof is always on the scientist making the claim; Dr Farsalinos hasn't even suggested he might begin that process.

NIOSH/OSHA writes in statistics. Their stated goal is to limit bronchiolitis obliterans cases to 1 in 1000 exposed workers. They graph the mathematical functions, finding just how high the exposure can be to keep the disease at 1-in-1000 workers. They arrive at 5ppb average over 8 hours, not to surpass 25ppb in any 15 minute period. NIOSH never says any amount is "safe" or "reasonable" - but they do use the term "acceptable" to describe 1 in 1000.



Oh - I didn't say that! Instead of "diacetyl free," labels like these would be more correct: "diacetyl 0 ppb" or "diacetyl 0 ppm" or "diacetyl 0%" All of those are accurate, standard, scientifically-accepted ways to show both the measured amount as well as the level of precision used to in testing.



Not true - that would violate the basic laws of physics -- and it's not what Dr. Farsalinos says at all.
If you have liquid with 5ppm diacetyl, and you vaporize it, it is now a gas with 5ppm diacetyl. Dr Farsalinos does not claim otherwise.

How Dr F moves from ppb to ppm: he assumes that the air with diacetyl (vaporized eliquid) will be diluted with additional fresh air. THIS is where his assumptions come into play. If you accept all of his assumptions, it follows that every 1 part of vaporized eliquid will be diluted with 1,000 parts of fresh air. And that factor of 1000 changes the NIOSH ppb limit to Dr Farsalinos' ppm figure.

If you re-read that last paragraph, it begs the question: Are the assumptions appropriate? No other experts have yet weighed in with their thoughts or calculations (or objections or acceptance), because this has not been submitted for peer-review. It's not science yet, and those assumptions are highly arguable.

Reasonable. That is a much better word to use than safe. The fact that 1 in 1000 is considered reasonable is pretty unsettling...

My apologies for saying you would call liquid that measures 5ppb diacetyl free. Never meant to put words in your mouth.

On the apples to oranges analogy:
Yes, the literal mass of a substance is the same in liquid and gas form. However, the amount that one inhales through 8 hours of working in an environment with 5ppb in the air will almost certainly not equal the amount someone inhales by vaping a liquid at 5ppb all day (it could be less or more). Maybe I'm missing something, but I don't see how the OSHA 5ppb level of reasonability has any relevance to the ppb in a liquid until it is "translated" as Dr. F did (or according to whatever the scientific community ultimately agrees on).

 

[HeadInClouds]

The fact that 1 in 1000 is considered reasonable is pretty unsettling...

5ppb in the air will almost certainly not equal the amount someone inhales by vaping a liquid at 5ppb all day (it could be less or more).

That red part, bluraff - there is no standard for any such conversion. One guy suggested one value on a radio show. For that to be accepted as science at all, Dr F needs to write it up, submit it for peer review, get written reviews by other scientists (perhaps a chemist among them, as this is a chemistry issue and Dr F is a cardiac expert), and get it published. Until then, that red part will just remain a big question mark to me.

Here's another way to look at it. You said, "The fact that 1 in 1000 is considered reasonable is pretty unsettling."
If you accept Dr Farsalinos methods, you can apply them here for yourself. Like this:
Dr. F said 5 parts-per-million max in eliquid yields the same exposure as NIOSH's 5 parts per billion in vapor.
That exposure amount is computed to produce bronchiolitis obliterans in 1 out of 1,000 people.
Following Dr. F's method, you can reduce that to 1 out of 1,000,000 people (1/1000th the risk) if you lower your limit by a factor of 1000.
Which gives you a limit now of 5 parts per billion in eliquid.
This uses Dr Farsalinos' own mathematical method to show a good reason for 5ppb testing for eliquid.

 

[InMyImage]

So the retailers were deemed at least partially responsible.

Does that imply that if a reseller buys ready-to-vape e-liquid and resells it (without even opening it) they could be theoretically held liable for damages?
How about if it's labeled "diacetyl free" but is later found to contain it anyway?

In this case they were. This particular issue gets complicated because the laws applied are defined by the consumer protection laws the state where the case is filed. If you are in California you are screwed... This one was tried in Colorado and laws and precedents in Colorado deemed Kroger Cos liable as both a knowledgable seller as well as a de facto manufacturer even though they had no control over the manufacturing of the product and no direct knowledge or control over the ingredients used in the product until the Watson's lawsuit was filed.

At this time, given the common knowledge that Diacetyl and Acetyl Propionyl, has negative health risks as set by NIOSH in this precedent setting case, any manufacturer of e-liquid who includes ingredients using Diacetyl and Acetyl Propionyl, would most likely be found liable, especially if it is known and not disclosed.

Bill

 

[InMyImage]

It is also important to understand that the case of Wayne Watson and Mary Watson v. Dillon Companies is now "Case Law". This includes the findings of David Egilman, M.D. regarding acceptable levels of Diacetyl.

As defined in Black's Law Dictionary, Case Law is defined as "A professional name for the aggregate of reported cases as forming a body of jurisprudence; or for the law of a particular subject as evidenced or formed by the adjudged cases; in distinction to statutes and other sources of law.… "

Black's Law is the Webster's of the legal world.

 

[InMyImage]

Sorry, my brain is kinda of burnt out now, but one of the key points here is that even if Dr. Farsalinos, the defense would need to prove that his research is better than Dr. Egilman's and NIOSH's findings. Actually prove is a strong word... they would need to convice a jury that it is true.

This may be difficult in front of a jury based on the fact that NIOSH is a division of the CDC, and Dr. Egilman's findings are based on clinical lab trials in rodents.

Bill

 

[HeadInClouds]

It is also important to understand that the case of Wayne Watson and Mary Watson v. Dillon Companies is now "Case Law". This includes the findings of David Egilman, M.D. regarding acceptable levels of Diacetyl.

Thank you for your patience with my questions. Just one more? Do you know if that (red part) was that the 0.02ppm diacetyl that I find when I do a quick Google search? If you already posted that, I missed it.

 

[InMyImage]

Thank you for your patience with my questions. Just one more? Do you know if that (red part) was that the 0.02ppm diacetyl that I find when I do a quick Google search? If you already posted that, I missed it.

It is important to understand that in Case Law, safe limits are not necessarily defined as hard limits. The accepted and prevailing evidence tends to be specific to the case unless citing a defined regulation. In this case, there are simply to many NIOSH bulletins and Statements of Fact included in the case for me to spend the time digging through to find out what might be in them.
In this case, the important factors that were clearly specified were the levels present in the home as well as the peak levels at the time of opening the microwave and opening of the bag as compared to the QC and manufacturing area of the plants tested by NIOSH.

A lawyer who decides to leverage this evidence would most likely take those numbers and extrapolate from them as a foundation for their case. The relevant testimony that survived the motion to dismiss is:

Dr. Egilman also opines on specific causation. He relies on the levels of diacetyl found by Dr. Martyny and compares the peak levels measured in the Watson home, approximately 3 ppm, to levels at the Gilster-Mary Lee plant. Id. at 40. He contends that peak levels in the Jasper plant upon opening a bag and in a QC worker's breathing zone (approximately 4 ppm, 7 ppm, and 13 ppm) are comparable to the peak levels to which Mr. Watson was exposed in his consumption of the Kroger label popcorn. Id. He then calculates a daily average exposure for Mr. Watson of 0.0015 to 0.003 ppm for weekdays and 0.0015 ppm to 0.0045 ppm on weekends, and an average cumulative exposure level. Id. at 41. He argues that these levels are similar to those found in QC areas of microwave popcorn plants, relying primarily on data from the Jasper plant. He also notes the conclusion of some researchers that "intermittent peak exposure" may increase risk of disease even if average exposures are lower. Id. at 41 (citing Kanwal, supra, ECF No. 560-14). Dr. Egilman also relies on Dr. Rose's letter to the FDA and her conclusion that it was plausible that Mr. Watson's exposure to butter flavoring vapors caused his lung disease. Id. at 42.

 

[InMyImage]

Thank you for your patience with my questions. Just one more? Do you know if that (red part) was that the 0.02ppm diacetyl that I find when I do a quick Google search? If you already posted that, I missed it.

Just a quick note to reinforce what I said previously that the issue of minimum values to cause disease was not set by this case was the sole testimony exclude by the judge, the rest of his numbers, including the ones I quoted above were admissable:

The exception concerns the portions of Dr. Egilman's testimony that purport to establish a minimum threshold amount of diacetyl sufficient to cause respiratory illness, including bronchiolitis obliterans. These opinions will not be permitted at trial.

 

[InMyImage]

After reading another thread about this same topic, I did a search and there are already several threads regarding the general Diacetyl issue. @bluraff3 @tombaker @HeadInClouds this thread has a lot of the legal doctrine discussed that is important and useful and I don't think separating it out into it's own thread would be good because it would lose the history of the discussion so far.
So... in case a new thread on the topic does get created, I'll probably just grab the contents of the first message as a quote and bring it back over here for a response.
Hope you understand the reasoning behind this @bluraff3
Bill

 

[tombaker]

It is also important to understand that the case of Wayne Watson and Mary Watson v. Dillon Companies is now "Case Law". This includes the findings of David Egilman, M.D. regarding acceptable levels of Diacetyl.

As defined in Black's Law Dictionary, Case Law is defined as "A professional name for the aggregate of reported cases as forming a body of jurisprudence; or for the law of a particular subject as evidenced or formed by the adjudged cases; in distinction to statutes and other sources of law.… "

Black's Law is the Webster's of the legal world.

And now you don't even know what the term Case Law is. Very sad.
Case law is not the evidence present at trial, its not the finding by Egilman. Case law is what judges interpret.

Bil, please read this
"case law n. reported decisions of appeals courts and other courts which make new interpretations of the law and, therefore, can be cited as precedents.."

Go ask a lawyer Bill, get straight with the facts

 

[tombaker]

[QUOTE="InMyImage, post: 121987, member: 8369/QUOTE] Its a pre-Trial motion...no precedent at all.

 

[InMyImage]

And now you don't even know what the term Case Law is. Very sad.
Case law is not the evidence present at trial, its not the finding by Egilman. Case law is what judges interpret.

Bil, please read this
"case law n. reported decisions of appeals courts and other courts which make new interpretations of the law and, therefore, can be cited as precedents.."

Go ask a lawyer Bill, get straight with the facts

Sorry, but as far as the law is concerned, Black's Law is THE dictionary. Go ask a lawyer. Additionally, any evidence presented during a case is subject to being used in a future case to refute or establish arguments in another case, even a failed case... although it would be professional suicide to do so in most instances...

Like most parts of law, things are always more complicated than they appear which does cause me to use some generalized layman's presentation of the facts and vernacular, particularly since it has been a long time since I have dealt with this particular area of expertise.

[QUOTE="InMyImage, post: 121987, member: 8369/QUOTE] Its a pre-Trial motion...no precedent at all.

First, your incessant arguments so far have been that the testimony of the expert witnesses and facts they testified to in this case are irrelevant and that do to the Daubert "test" they were dismissed and inadmissable, which is not true as I have shown you in detail because I didn't feel like anything less would satisfy you.

Second, case research is the primary reason that I did not complete my pursuit of a law degree. I realized that a significant portion of my interest in law was debating at trial and wasn't interested in the 100's of hours required every month doing basic research to build the foundation of cases that would primarily be settled out of court. Basically when entering college I was naive and during college I came to my senses and went into consulting instead. My particular interest was corporate law, so this discussion has been extremely interesting and satisfying for me.

The facts I presented previously were all admissible except for the single point I identified which was minor in terms of the case. These facts have been reviewed by appeal beyond the motion by appeals court judges and established as admissible confirming the presiding judges decisions. The context of the decisions that I have researched thus far confirm the facts as stated in the judges decision regarding the motion to dismiss.

I am sorry that your bubble has been burst and that you had to resort to trying to argue the significance of case law at this point as way to make your last stand, but unless you can make a cogent argument, I'm simply not going to put in the hours of additional research required to satisfy you because I know that it will simply invite you try to pull this down the rabbit hole as far as you can in order to find some point of saving face, ESPECIALLY given your PUBLIC presentation thus far.

Sir, accept that you were wrong and move on. In common vernacular, "take a chill pill" and learn how to discuss things calmly and clearly. You have brought up good points and ideas worthy of discussion that I'm sure are helpful to others even if they don't quite realize it...

Respectfully,

Bill

 

[cherrycakes]

PENIS

 

[InMyImage]

PENIS

Hey, I have one, but hoping that you weren't referring to mine, unless in an alternate universe

 

[bluraff3]

That red part, bluraff - there is no standard for any such conversion. One guy suggested one value on a radio show. For that to be accepted as science at all, Dr F needs to write it up, submit it for peer review, get written reviews by other scientists (perhaps a chemist among them, as this is a chemistry issue and Dr F is a cardiac expert), and get it published. Until then, that red part will just remain a big question mark to me.

Here's another way to look at it. You said, "The fact that 1 in 1000 is considered reasonable is pretty unsettling."
If you accept Dr Farsalinos methods, you can apply them here for yourself. Like this:
Dr. F said 5 parts-per-million max in eliquid yields the same exposure as NIOSH's 5 parts per billion in vapor.
That exposure amount is computed to produce bronchiolitis obliterans in 1 out of 1,000 people.
Following Dr. F's method, you can reduce that to 1 out of 1,000,000 people (1/1000th the risk) if you lower your limit by a factor of 1000.
Which gives you a limit now of 5 parts per billion in eliquid.
This uses Dr Farsalinos' own mathematical method to show a good reason for 5ppb testing for eliquid.

That all makes sense to me. I have never taken bio-chem, so I have no real ground to speculate, but I wouldn't think that reduction from 5ppm to 5ppb would translate linearly from 1 out of 1,000 to 1 out of 1,000,000, if anything I would guess it's an exponential reduction, which would be even better. In any case, 1 out of 1,000,000 is a much more palatable rate. Personally, I would prefer my risk was even lower.

 

[InMyImage]

I would prefer my risk was even lower.

Agree, hopefully more flavor vendors will not only come forward with data and statements about "vapable" flavors, but also complete more rigorous testing that what appears to be done today. I can't imagine that it's any more effort on the part of the lab, but may very well be an issue of how many labs have sensitive enough equipment.

 

[HeadInClouds]

For those that DIY We offer 24 certified flavors

http://www.nicvape.com/DIY-Juice-Flavors/E-Flavors

These test results are probably the most thorough I've ever seen, and the numbers are impressive!

For anyone unsure, those numbers translate directly to ppm: <0.340 ppm diacetyl and <0.405 ppm acetyl propionyl
And those are raw flavorings that would be further diluted before vaping.
Mixed at 10%, you would have <0.034 ppm diacetyl and <0.041 ppm acetyl propionyl (34 and 41 parts per billion)
Impressive! Perhaps they'd be mixed at even lower percents; Niquid says they are strong.

(The only question I personally would ask before vaping them is whether their tests would also detect acetoin.)

 

[tombaker]

Bill, when you say thinks like "accept that you were wrong and move on". Its why you would not be a good lawyer. You can not just jump up and down, make assumptions and other comments, and copy and paste pretrial ruling, and because you shovel all that out, think you are right about every thing you say. But that is what you do.

Case Law, is the foundation of how appeals court have ruled, on how the lower courts should interpret the laws on the books. Pointing to a dictionary, ignoring other legal resources, how about you just get it right.

Additionally, any evidence presented during a case is subject to being used in a future case to refute or establish arguments in another case, even a failed case... although it would be professional suicide to do so in most instances...

Oh by golly, so you are saying that any evidence, that is accepted by the court as evidence, can be the evidence that is presented to the jury of any court matter, because evidence is evidence. Gosh wow.
Then you say it only counts if they won in an earlier case? Evidence is unchanged by the trial outcome. If it is presented is the choice of the attorneys, but it does not come packaged as "this evidence was used in a winning case" Most of the Watson evidence can not be presented to any other court, because its a one off case, without any study. Dr. Rose says she can not be sure if Diacetyl was the cause of injury. So that is not the evidence that would be of much use in subsequent cases.

Like most parts of law, things are always more complicated than they appear which does cause me to use some generalized layman's presentation of the facts and vernacular, particularly since it has been a long time since I have dealt with this particular area of expertise.

Long way of saying your are a layman and making it up as you go. Check the dictionary for Layman too.

First, your incessant arguments so far have been that the testimony of the expert witnesses and facts they testified to in this case are irrelevant and that do to the Daubert "test" they were dismissed and inadmissable, which is not true as I have shown you in detail because I didn't feel like anything less would satisfy you.

1. You got it wrong in your reciting of the my arguments 2. the jury is the fact finder, evidence is considered to make that judgemet 3. There are 3 cases being spoken about, Eigman was a problem witness in all. 4. You have not show anything except pasting a pre-trial ruling over 5 long posts, where you could have simple posted a link. Page after page, and you still missed the point.

The problem is the case will not be a good precedent for others, that is the entire thing. Its not case law, there are no Prosecutors involved as you claim, it a case that allowed into trial, non-credible scientific evidence only because the Expert Witness was the treating doctor of the patient. Its a one off case. The MD involved Dr. Rose changed the diagnosis, of an existing ailment, and made it popcorn lung.

Second, case research is the primary reason that I did not complete my pursuit of a law degree.

what a shocker, say it is not so

The facts I presented previously were all admissible except for the single point I identified which was minor in terms of the case. These facts have been reviewed by appeal beyond the motion by appeals court judges and established as admissible confirming the presiding judges decisions. The context of the decisions that I have researched thus far confirm the facts as stated in the judges decision regarding the motion to dismiss

Bill read the sentences you wrote above. Its gibberish. Really pure Gibberish. I mean you could use it..... Maaaaybe if you were on a beauty pageant, and wanted to show up as a joke on Youtube the next day. Otherwise its garble.

So with that, the facts I presented previously were all admissible except for the single point I identified which was minor in terms of the case. These facts have been reviewed by appeal beyond the motion by appeals court judges and established as admissible confirming the presiding judges decisions. The context of the decisions that I have researched thus far confirm the facts as stated in the judges decision regarding the motion to dismiss.

 

[bluraff3]

After reading another thread about this same topic, I did a search and there are already several threads regarding the general Diacetyl issue. @bluraff3 @tombaker @HeadInClouds this thread has a lot of the legal doctrine discussed that is important and useful and I don't think separating it out into it's own thread would be good because it would lose the history of the discussion so far.
So... in case a new thread on the topic does get created, I'll probably just grab the contents of the first message as a quote and bring it back over here for a response.
Hope you understand the reasoning behind this @bluraff3
Bill

Makes sense to me. Do your thing man.

 

[InMyImage]

Wow Tom, this merry-go-round has gone around so many times that you can't even follow your own arguments.

Reread your own posts.

As far as the spread out posts with the case information that shows the admissability of the case, I put them here simply because I was pretty certain that you would not follow a link to read the case documentation yourself, and this was the only way for anyone else interested in the subject to see that your arguments that the expert witness testimony was thrown is in fact wrong.

@bluraff3 Thanks for understanding. Have a good one.

Bill

 

[Cloudy Peak Vapes]

Thanks for the nicvape link, @Artemis ! I wish the prices weren't so high, however, I suppose safety is worth it. I just can't afford to spend that much, but again, money vs. my health, seems stupid to vape cheap so I can vape more. I hope more vendors follow suit.

I spent the majority of my run this morning thinking about all this diacetyl AP and diketone stuff. I live such a healthy life, yet I'm vaping diketones undoubtedly. It seems a bit ironic that I am so obsessively picky about the food I consume, and my exercise regimen, yet I continue to inhale diketones. I spend the majority of my income on food, since I cook my own meals, and will only consume quality food, but I vape cheap? It's so expensive to eat healthy, and I have to eat a ton to maintain weight, so it Seems a bit stupid that I buy inexpensive, but tasty juice.

 

[tombaker]

Wow Tom, this merry-go-round has gone around so many times that you can't even follow your own arguments.
As far as the spread out posts with the case information that shows the admissability of the case, I put them here simply because I was pretty certain that you would not follow a link to read the case documentation yourself, and this was the only way for anyone else interested in the subject to see that your arguments that the expert witness testimony was thrown is in fact wrong.

Bill, You lie.
You also characterize what I have said, and when you are corrected you ignore the correction. You choose to be a liar in making assertion about what I have said, and I regard it as a pathetic attempt.

Because you dropped out of law because you hated research is your own deal, but saying I don't research and I have not read items, as you continue to do is just another one of your lies. You say it like a fact. Whatever amount of moot court you think you are winning here, its a failing grade. So good choice then.

I know what my position is, and I made a simple remark, the Watson case won't be a good case for setting precedent to any future one.
The same expert witness doctors were involved in all the cases. 2 of the 3 cases failed. One kicked out by the court. The other failed by the jury, and failed in an appeal for new trial. The third Watson named case, Won. Egilman was laughed out of the court room in the first case, he took the bizzare move of filing a motion against the judge for defaming him. The other judges, spit it back as lack of standing. Egilman in the next case, was refused to take the stand as rebuttle, he already was on the stand, and that case lost.

I read the pretrial hearing stuff. The stuff that excluded small portion of Egilman again. And the court clearly saying the treating doctor can not be removed. So they got the quackery on.

This is a long way of saying, I read it, I understand it, I have said my position, I don't need to address this any more on this thread, as was already agreed to before you started shoveling shit. One link would have been fine. You have lied enough about what I have said, so its done. If that is a WIN for you, your clowning got your erroneous thrill.

Perhaps you said it best, so I will leave you with your own quote, which I 100% agree you said.
So with that, the facts I presented previously were all admissible except for the single point I identified which was minor in terms of the case. These facts have been reviewed by appeal beyond the motion by appeals court judges and established as admissible confirming the presiding judges decisions. The context of the decisions that I have researched thus far confirm the facts as stated in the judges decision regarding the motion to dismiss.

Did you read that Bill, your words, remember the jury is the fact finder, there is good evidence, there is bad evidence, and then there is your gibberish.
Whatever else you write to me, assume FO

 

[HeadInClouds]

Good God, Tom. Increase your nicotine or something!

 

[InMyImage]

Wow... just wow...

If you are not already getting help, I think you need some...

 

[tombaker]

Wow... just wow...

If you are not already getting help, I think you need some...

That is the kind of thing to expect from a hypocritical liar. I post a full response to you assumptions and your ignorant conjecture on the law.
You come back with that, are you proud of that, think it profound. Explain thy self.

You would think that some sort of bliffernoob, who has all your banners of preaching you do, would not resort to the same sort of tactics you profess to be against.

And to your banners, you may not have the guts to hear the other perspective, instead focusing on a single words.
A word is not the problem, conduct is, and yes I don't like your conduct.

 

[InMyImage]

That is the kind of thing to expect from a hypocritical liar.

The only way I could be made to look like a liar on this thread to anyone reading it is if you went back and edited just about every single post you made on this topic to change them in their entirety. The ability to go back and edit a post long after it was made is one of the few things I don't like about this forum.

I post a full response to you assumptions and your ignorant conjecture on the law.
You come back with that, are you proud of that, think it profound. Explain thy self.

Your constant statements that the evidence presented by the expert witnesses in the Watson case were thrown out when in fact only a single minor point was is enough explanation, if you need further elaboration go back and read the thorough in depth posts that I have made in this thread.

You would think that some sort of bliffernoob, who has all your banners of preaching you do, would not resort to the same sort of tactics you profess to be against.

Seriously? Given that I have conducted my without resort to childish name calling while you have in just about every single post you have addressed to me is the only response necessary.

And to your banners, you may not have the guts to hear the other perspective, instead focusing on a single words.
A word is not the problem, conduct is, and yes I don't like your conduct.

Again... seriously?

I think that this thread has run well beyond it's course. If anyone had any doubts remaining as to your character I don't think that there is anything that can be said or done at this point to solidify the fact that you have no class, grace or credibility in any way beyond the words that you have written in this single post.

I'm going to exit stage left now, and let you call me a coward for leaving you behind to wallow in your anger and frustration like a spoiled child. It will be interesting to see what topic you decide to throw a tantrum about in the future. It's actually the only reason I don't put you on ignore.

Respectfully,

Bill

 

[tombaker]

Bill, I will try to explain your conduct one more time. When you sign "respectfully" you are anything but.
1. You take your insults to a base level making assumptions and accusation to who a person is. I find that deplorable. Especially with your Preaching Service Announcements included in your signature.

2. If you look back at what I said, it about what your are doing. Your demonstrative conduct.

3. I have not gone about editing down my posts, and you should see that what I am talking about is clearly what you are doing, not who you are. When you said you did not like legal research and you dropped the pursuit of being a lawyer, that you talking about what you did. I can address that after you bring it up, but I won't go with your style of below the belt attacks of a person nature and character. I have no idea who you are, what your history is, nor should I care. I can deal simply with what you DO.

4. When I say you are a hypocrite, its because you preach about R-Words and insults, yet you use vile and deplorable characterizations of individuals, without a recognition of what you are doing.

5. When I say you lie, its because you are saying things about me, what I do, what I have done, that are false. You do it so often, its more than meer error, they are lies. I know them to be lies, because you are represent me to others in a purely false way. I know this. You don't know what I will do, or have done, you should only deal with what I have said, and not lie as if you have some sort of other information.

6. When this thread was moving back to only talking about testing and E-liquids, after we all agreed, you started spaming the thread with a wall of legal filings, instead of just posting a simple link. You said that was because you KNEW, I would not read it, if you just posted a link. Its a lie, and its presumptuous on top of that.

7. When you injected that the Watson legal case was the tip of the iceberg of lawsuits, and would be a good precedent for future cases. I simply said, it would not be a good precedent. This is what seems to have spawned your ire.

8. The legal side in a nutshell. There were 3 cases, the first tossed out, the 2nd lost, the Third was a Win against Popcorn makers. The doctors were the same in all. The doctors all used Watson as their model case, even though Watson was the last tried. The Watson Doctor changed the diagnosis of the patent, and sent multiple letters to the FDA saying she found the first case. That Dr. Rose, had changed an establish diagnosis of Watson to be Popcorn lung. Other Doctors dispute if that change was correct. Expert testimony was excluded from all three trials to differing degrees, but the set of Experts were the same. The last trial, Watson, would have had Dr. Rose excluded for not having solid science if it were not for that she was the TREATING PHYSICIAN to Watson. The Judge said he must be allowed in. That last case, was won. But it won't be good precedent because, the other experts don't have any solid science to back up there claims. The testimony of Dr. Rose is only good for Watson case ONLY. If Dr. Rose would try to come into another case, she would be excluded under a challenge. And lastly Dr. Rose said she was not sure if Diacetyl caused the disease, and she did not have to be sure. And that is only because a treating doctor must treat, regardless of cause. Dr. Rose's testimony is not available to other cases, in any form, as Precedent. I know you dislike legal research and don't understand much of the rules of evidence, but that is the entire crux of why Watson is not a good precedent.

9. I have read plenty, and the document you posted in 5 or 6 posts I had read days and days earlier.

10. I have have had co-workers with high functioning Aspergers, I have had friend and co-workers wither cerbal palsy, and I still have sporadic contact with a class-mate who was mainstreamed with mental retardation. (it was called that back then) My high-school friend works at a Pizza shop, he has a particular form which was profiled on 60 minutes years back which makes him highly social and outgoing. He remembers everyone's names, and is concerned about their welfare. The other two are people who could easily be online with us right now. You preaching focuses on words, but your writting is disparaging and nasty without care for the other individual. But more, you attempt to shame, and that shame can stop others from speaking up.
11. I made up a word, completely nothing, but you pound your shoe on the table as it being an outrage. Meanwhile you post the following. Which is far more vile, harmful, and full of hate, than the word retarded. You attack a person's character, I focus on what you are saying, doing, and your conduct. Unlike you I don't assert I know anything about you. If I has crossed the line, I am confident I would be told. But Bozo, is the most well known and beloved clown in American History. Clowning around not negative. And so for Bozo, or questioning failed legal logic you

Bill, say all of this:

If anyone had any doubts remaining as to your character I don't think that there is anything that can be said or done at this point to solidify the fact that you have no class, grace or credibility in any way beyond the words that you have written in this single post.

Now, I am going to belittle you a bit just because I think you deserve it... I saw that you caught up on the meat of this thread at least by 1pm EST today, but it took you quite a while to come back and post your response. I'll be here tomorrow so you can take enough time to read the thread again and let me know what I missed or don't understand.

I'm going to exit stage left now, and let you call me a coward for leaving you behind to wallow in your anger and frustration like a spoiled child. It will be interesting to see what topic you decide to throw a tantrum about in the future. It's actually the only reason I don't put you on ignore.

If you are not already getting help, I think you need some...

I know that it will simply invite you try to pull this down the rabbit hole as far as you can in order to find some point of saving face, ESPECIALLY given your PUBLIC presentation thus far.

Sorry, you are confused. I didn't call you a know nothing... I merely said that you don't seem to know much about the law. I did it maturely and succinctly, and I am pretty confident, accurately.

I understand that some people seem to have their debate skills perpetually stuck in the fifth grade, but you make such good, interesting points. Why completely obliterate them by opening up with such immaturity? I'd like to engage you in an adult discussion, but you just make it so hard...

If you can formulate an introductory paragraph using mature, well thought out sentences I might even read it beyond the first one.​

​

Bill, none of that is respectful, and they are your words. You focus on the word, and not the conduct. The word is nothing. Actions and conduct are the significant. Insults like yours reveal something from the messenger I don't care to know or explore. I would rather be called a stupid asshole frankly, and then I can tell you to fuck off, and we can both gone on with our day as if nothing happened.

Your banners don't reflect understanding.

 

[Vangrl]

https://docs.google.com/file/d/0B0JrO25MOsG5VjBBd0d4SlVNOXM/edit

interesting read

 

[Vangrl]

also, Flavor West posted this today

https://www.dropbox.com/sh/dgcbcda45ghrkad/AACOwhaFQUX41lau0gt2FCO2a/FW Ingredient List.pdf?dl=0

Did they reformulate? 3 of those tested VERY high for Diacetyl, one last year and two around 4 months ago

 

[Cloudy Peak Vapes]

https://docs.google.com/file/d/0B0JrO25MOsG5VjBBd0d4SlVNOXM/edit

interesting read

Sounds fun... Thanks for the link.

 

[Vangrl]

I wonder where the lab reports are?

Also,

just realized, those are listed in %, and last I heard Flavor West said that as long as it was under 1% that they could claim "Diacetyl Free".

I think the ug/ml is a better indication

 

[Vangrl]

but the acetoin is listed at less than 1% so they must be detecting for lower than that?

 

[Scuba-Matt]

 

[Jonathan Tittle]

I'm chiming in because @HeadInClouds cited on of the posts I made about Capella and their v2 Vanilla Custard. I've read the first 2 pages and skimmed the 4th, so don't jump on me if I've missed something - it's been a long day and I'm going on zero sleep for 72 hours .

I've spoke to Linda at TFA, Tom at Capella, dozens of members here, dozens on ECF and nearly 100 people on about 20-30 Facebook groups about flavoring and the presence of Diacetyl, Aetoin, Acetyl Propionyl and Butyric Acid. That doesn't represent the majority by far, but it is a considerable amount of people to talk to in a short amount of time. Some were knowledgeable of the issue, others were not, some did not care.

When it comes to flavoring, there's 4 chemicals that produce a buttery / creamy flavor: Diacetyl (normally on it's own), a combination of Acetoin and Acetyl Propionyl or Butyric Acid. It's basically dissected in to 3 groups. Some flavors only have Acetoin or only Acetyl Propionyl, some have both, so you could dissect that down in to 4 groups (some of TFA's flavors fall in to this 4-group dissection).

To keep the creamy / buttery flavor intact, one or more of those chemicals is going to be present. To keep the same intended flavor profile, those chemicals need to be present. If you remove them, you remove a part of the flavor. It's like removing the sauce portion of an Italian dish, it's no longer going to taste the same. Capella v2 Vanilla Custard is a prime example. Tom didn't confirm or deny the presence of Butyric Acid, though from speaking with Linda, another vendor (which was not named during our phone conversation) did test it and it was found.

To me, and many others, v2 is weaker, less flavorful, and doesn't taste the same. The same applies to many flavors which use Butyric Acid in place of the primary chemicals of concern (although BA is a concern, IMO, in and of itself). If you are bent on having one chemical removed, you need to be careful as it's replacement, and it will be replaced, may be equally as bad, or worse. Look up the information on Butyric Acid and see what you find. We are pushing flavor manufacturers to remove Diacetyl, Acetoin and Acetyl Propionyl, and they are, but it is being replaced by something that has yet to even become a hot topic in our industry: Butyric Acid. So are we now going to jump on that and push for it to be removed as well? Sure, we can, but there's a slim chance that a flavor manufacturer is going to go down the route of saying "This flavor is now 100% safe for inhalation" or "Now reformulated and tastes the exact same" - they're not and it won't.

That said, it's my opinion that the FDA will regulate e-liquid to a point, though unless they intend on regulating the same chemicals nation-wide, and and forcing all companies to limit exposure to said chemicals, I don't foresee them pushing too far to get them removed.

 

[Jonathan Tittle]

Essentially, we need to be cautious, but we also need to be careful of what we're asking for. You may get what you ask for short-term, but in a less then desirable way.

Keep in mind, flavoring is designed for food use. It always has and always will be. NicVape seems great, but are they testing for every single chemical compound in their e-liquids, beyond Diacetyl, Acetoin, Acetyl Propionyl and Butyric Acid? Most likely not. The fact of the matter is simple, we don't know what chemicals go in to flavoring. We don't know if there's something far worse than the above mentioned 4 because none of it has truly been tested for direct inhalation. Flavor Companies keep their flavor recipes a closely guarded secret, and that's the nature of the industry.

So let's say we remove Diacetyl, Acetoin, Acetyl Propionyl, and Butyric Acid. Have we successfully eliminated any sort of risk? No. Far from it. We don't know what else is being used to make up said flavor. I'll use an example by citing a breakdown of what's in a random Artificial Strawberry flavor.

http://www.feingold.org/strawberry.html

Now....are we going to individually test each of those chemicals to see which ones are safe for inhalation and break each of them down to a specific PPM/PPB exposure level? Are we going to see what each of these chemicals does to our lungs, blood, brain etc? That probably won't happen in my lifetime and I'm turning 30 this year.

I'm not saying we shouldn't worry about the currently trending chemicals of choice, but if we push and push, eventually, unflavored is what you're going to be left with because you're going to eliminate all options to ensure "potential" safety.


Edit: Just in case the link above doesn't work, here's a quick list of chemicals in a random strawberry flavoring:

Amyl acetate, amyl butyrate, amyl valerate, anethol, anisyl formate, benzyl acetate, benzyl isobutyrate, butyric acid, cinnamyl isobutyrate, cinnamyl valerate, cognac essential oil, diacetyl, dipropyl ketone, ethyl acetate, ethyl amyl ketone, ethyl butyrate, ethyl cinnamate, ethyl heptanoate, ethyl heptylate, ethyl lactate, ethyl methylphenylglycidate, ethyl nitrate, ethyl propionate, ethyl valerate, heliotropin, hydroxyphenyl-2-butanone (10 percent solution in alcohol), a-ionone, isobutyl anthranilate, isobutyl butyrate, lemon essential oil, maltol, 4-methylacetophenone, methyl anthranilate, methyl benzoate, methyl cinnamate, methyl heptine carbonate, methyl naphthyl ketone, methyl salicylate, mint essential oil, neroli essential oil, nerolin, neryl isobutyrate, orris butter, phenethyl alcohol, rose, rum ether, g-undecalactone, vanillin, and solvent.

 

[InMyImage]

https://docs.google.com/file/d/0B0JrO25MOsG5VjBBd0d4SlVNOXM/edit

interesting read

Nice find. The ppb info cited is what @HeadInClouds has been looking for

 

[Scuba-Matt]

This e-liquid vendor (The Vapor Bar) has the right approach.

 

[HeadInClouds]

https://docs.google.com/file/d/0B0JrO25MOsG5VjBBd0d4SlVNOXM/edit

interesting read

Wow - that certainly blows a hole through Dr Farsalinos' latest statements and assumptions (post-publication), doesn't it? Very informative - thank you for finding and posting it.