Scientific Studies
Admissibility of indoor air releases and expert testimony based upon them by Robert Lishman
On May 31, 2006, Grace filed a motion in limine to exclude evidence of or derived from indoor asbestos releases.[1] Under Federal Rule of Evidence 402, all relevant evidence is admissible. Under Rule 403, relevant evidence “may be excluded if its probative value is substantially outweighed by the danger of unfair prejudice, confusion of the issues, or misleading the jury, or by considerations of undue delay, waste of time, or needless presentation of cumulative evidence.”
The district court held that indoor sampling performed by EPA and testimony based on this sampling was inadmissible under Rule 402. Specifically, it is inadmissible to show Grace committed a release of asbestos in violation of the Clean Air Act. The Court also held that evidence derived from indoor testing and sampling was barred for most purposes under Rule 403 because of its potential to be “highly confusing and prejudicial.” This evidence was only admissible to show Grace’s knowledge of the danger posed by asbestos. The government appealed the exclusion of indoor air studies and expert testimony based upon them for the purpose of showing violations of the Clean Air Act.
The Ninth Circuit affirmed the district court’s decision, under Rule 403, to exclude the indoor air studies for the purpose of proving a release into the ambient air, concluding it was with the district court’s discretion to do so. The issue of whether the district court erred in excluding expert testimony based on documents and studies derived from indoor air releases was remanded because the district court failed to consider whether the data from the indoor air tests is of a type reasonably relied upon by experts in the field or whether the data is within the scope of Rule 702.
Under Rule 702, expert testimony should be admitted if it “will assist the trier of fact to understand the evidence or to determine a fact issue.” Under Rule 703, if the data is of the type reasonably relied upon by experts in the field, the facts or data need not be admissible in order for the opinion or inference to be admitted. In other words, if the indoor air studies are determined to be a type of data reasonably relied upon by experts in the field, an expert may base his opinion on the data even though the studies themselves are inadmissible.
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[1] A motion in limine is a motion made before trial seeking a ruling on whether certain evidence is admissible.Admissibility of W.R. Grace’s historic product testing by Robert Lishman
On May 31, 2006, Grace filed a motion in limine to exclude expert opinion testimony on Grace’s historical, non-ambient air product and commercial testimony.[1] Grace sought to exclude any testimony from expert government witnesses who might “attempt to draw unsupportable correlations between Grace’s historical product and commercial tests and expected ambient air exposures from disturbances of vermiculite materials found in the town of Libby.”[2]
The district court granted Grace’s motion with respect to any such testimony offered to prove a release in violation of the Clean Air Act, but denied the motion with respect to any such testimony offered for the purpose of showing Grace’s knowledge of the danger posed by asbestos. The government appealed the district court’s order.
The Ninth Circuit reversed the district court’s decision to exclude expert testimony based upon the historical product testing when used for the purposes to prove a release in violation of the Clean Air Act. The court concluded that “historic testing is admissible for purposes of expert opinion formation and testimony regarding the propensity of Libby vermiculite to release asbestos as relevant” to the Clean Air Act.[3]
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Ninth Circuit Opinion
Admissibility of medical screening study by Robert Lishman
In 2000-2001, the Agency for Toxic Substances and Disease Registry (ATSDR) conducted a medical screening study in Libby. The study showed that certain factors (e.g. being a former Grace employee) were associated with respiratory illness and abnormalities.
On May 31, 2006, Grace filed a motion in limine seeking “to exclude expert evidence relating to the ATSDR Medical Testing Program.”[4] The district court granted Grace’s motion and ruled that the ATSDR study and any expert testimony based upon it was inadmissible under Federal Rules 403 and 702 of evidence. The prosecution appealed the district court’s order.
The Ninth Circuit affirmed the district court’s decision to exclude the study under Rule 403, concluding the court acted within its discretion. However, the Ninth Circuit reversed the decision of the district court to exclude expert testimony and opinion formed from the study. According to the Ninth Circuit, the district court misapplied Rule 403 and should have applied Rule 703. While Rule 403 serves as a basis for excluding the study itself it is not relevant as to whether experts may be permitted to base their testimony and opinion on the study. The court concluded that because the study was published in a peer-review journal, it met the requirements of Rule 702.
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[1] A motion in limine is a motion made before trial seeking a ruling on whether certain evidence is admissible.[2] U.S. v. W.R. Grace, 504 F.3d 745, 761-762 (9th Cir. 2007).[3] Id. at 763
[4] A motion in limine is a motion made before trial seeking a ruling on whether certain evidence is admissible.
Whether the results of four studies, and failure to notify concerning the data of those tests pursuant to the Toxic Substances Control Act(TSCA) § 8(e), are inadmissible by Christopher Orman
A. Introduction
At issue in the defendant’s motion to exclude, pursuant to Counts I through IV, four studies conducted by Grace. Statutorily a manufacturer/distributor encounters data showing a substantial risk exists when exposed to a certain workplace product. Grace failed to disclose these test results to the EPA within 15 days from receiving the results. These tests were:
(1) The Hamster study: Performed by Dr. William Smith from 1976 to 1978. Dr. Smith injected asbestos into the pleural cavity (the membrane which surrounds the lungs) of hamsters. In his May 25, 1978, conclusion Smith found the length and width of the tremolite fibers dictated the carcinogenic effect of asbestos.
(2) The Enbionics review: In 1978, a Denver firm reviewed chest x-rays of 205 Libby employees and 70 South Carolina employees. The firm concluded that the difference between the findings and the larger number of asbestos related disease in the Libby employees was the result of the length and width of the asbestos fibers.
(3) The Monson study: In July 1982, Dr. Richard Monson published a three-page study from his review of 66 Libby death certificates. He counted the number of cancer victims, finding 11 of the workers had died from asbestos-related cancer. Monson, in his study, concluded the rate of cancer increases with increased exposure to asbestos and is fiber-size dependent.
(4) The Product tests: From 1976 to 1978, Grace conducted drop tests, chute tests, model tests, and other analysis to determine exposure levels for insulation products.
B. Discussion
Under § 8(e) of the TSCA, a manufacturer, processor or seller must report certain information about toxic substances if the company “obtains information which reasonably supports the conclusion that such substance or mixture represents a substantial risk of injury to health or the environment shall immediately inform the EPA administrator, unless such person has actual knowledge that the Administrator has been adequately informed of such information.”(emphasis added) 15 U.S.C. § 2607(e). To “immediately disclose,” a company has 15 days to disclose the information.
However, a company does not have a duty to disclose the information if an exception applies. Pursuant to Grace’s motion, two exceptions are applicable, “(c)[the data] has been published in the scientific literature and referenced by the following abstract services…, (d) [the data] is corroborative of well-established adverse effects already documented in the scientific literature and referenced as described in (c).” 43 Fed. Reg. 11,112 (1978).
1. Grace had actual knowledge that the EPA had been adequately informed pursuant to the results of the Hamster Study.
Grace contends it had no duty to disclose the Hamster study because the company had actual knowledge the EPA was informed of the scientific results of the study. In 1977, Dr. Smith had presented at a conference hosted by the Society for Occupational and Environmental Safety. EPA officials attended the conference. Robert Locke, an executive for Grace’s Construction Products Division was present, making note of the EPA’s presence in his notes on the presentation. During this presentation, Smith presented data and studies showing the carcinogenic qualities of various types of asbestos fibers.
After the presentation, and from 1977 to 1982, the EPA continued to receive data showing the effects of long fiber asbestos. An animal study of rats, performed in 1982, directly mirrored the results of the Hamster test. Therefore, Grace contends the Hamster study would have been unnecessary repetition of already known data.
2. An exception applies for the Enbionics Review and Monson Study.
Grace contends that both the Enbionics review and Monson study meet exception 43 Fed. Reg. 11,112(d). According to Grace, both studies reiterate what was common knowledge at the time; asbestos is carcinogenic and the longer, wider fibers are more deadly.
3. The product tests did not show a significant risk requiring reporting.
Lastly, Grace contends that the product tests did not show a significant risk. All of tests concerned levels of asbestos and the results therein. None of those tests displayed data Grace considered problematic. Most of the studies were “modeling” studies, looking at whether a certain type of ore should be used, and not really investigating the asbestos.
4. With no duty to disclose, Grace did not defraud the government.
Grace contends the Government must prove that the defendants “withheld information they were under a definite statutory or regulator obligation to disclose to a governmental agency.” The three elements of a conspiracy are: (1) an agreement to achieve an unlawful objective, (2) an overt act in furtherance, and (3) the requisite intent to defraud the U.S. “Where a conspiracy charge is based upon failure to volunteer information, there may be no conviction if: (1) the information was not required to be provided; or (2) if the information was in fact provided as required.”
Based on the above analysis, Grace claims the government cannot establish the tests had to be disclosed. All of the tests satisfy an exception or an exemption, pursuant to TSCA § 8(e). Grace maintains the information was common knowledge; widely known in scientific journals and conferences going back to 1956. Nothing in the tests conducted by Grace was new. Therefore, Grace did not defraud the government, because it did not have to disclose the information; thus the information should not be admitted at trial as it applies to Count I.
5. The knowing endangerment argument?
In the introduction of Grace’s brief, it mentions the government will use the failure to disclose to show “knowing endangerment” under Count II-IV(Clean Air Act violations). However, in the brief, which exceeded the 20 page limit by 2 pages, this issue was not addressed. Whether Grace wants a limiting instruction for the evidence, or planned another section of analysis which had to be removed due to length is uncertain.
6. The hearsay argument?
Also truncated was Grace’s hearsay argument. Oscar Hernandez, EPA official, made statements that the studies contained “substantial risk information.” Grace argues Hernandez’s statements are inadmissible. According to Grace, Hernandez was not listed as an expert witness, therefore his statements are to the truth of the matter asserted. To be admissible a hearsay exception must apply, but according to Grace there is not an applicable hearsay exception.
7. Government’s response: These are issues for the fact finder to determine.
The government responded with a three page brief. The basic rule the government applies is that Grace is presenting an argument for the fact finder to determine. Grace did not provide the information to the EPA of those tests until 1983. Meaning for six years Grace knew about the dangers of the Libby mine asbestos and did nothing. The government contends such evidence is extremely relevant pursuant to 401. The fact that Grace has a different way of interpreting the evidence does not mean the evidence is inadmissible.
As for the hearsay issue, the government notes that FRE 803(10) applies as does FRE 1006. Therefore the statements are admissible.
C. Conclusion
According to the court’s order, the majority of these issues must be determined at trial. As Judge Molloy states, “making any determinations before trial would be premature.” The court notes that there are no regulations on record for TSCA § 8(e), only the Federal Register citation.
Molloy ruled if the government does not provide any other conspiracy evidence, and Grace can show its acts were consistent with TSCA § 8(e), then Grace can make a motion for acquittal under Federal Rules of Criminal Procedure rule 29. In the event the government does have other evidence concerning Count I, then a limiting instruction, pursuant to FRE 105, can be used if Grace can show compliance with TSCA § 8(e).
Whether evidence of indoor testing from the 1970s and 1980s is admissible to prove ambient air levels of asbestos pursuant to “knowing endangerment” by release under 42 U.S.C. § 7413(c)(5) by Christopher Orman
A. Introduction
During the 1970s and 1980s, Grace conducted private tests of the exposure levels of asbestos in the occupational areas. Grace’s motion in limine was filed to prevent those tests from being used to draw conclusions about ambient air levels. If ambient air levels could be deduced from the indoor levels, then the government would have an easier time proving knowing endangerment under the Clean Air Act.
B. Grace contends the indoor testing has no correlation with ambient air testing.
A corporation can face criminal penalty if it “knowingly released into ambient air any hazardous pollutant listed.” 42 USC § 7413(c)(5)(A). Ambient air has been defined as “that portion of the atmosphere, external to buildings, to which the general public has access.” 40 CFR § 50.1(e). Case law has established that once air is indoors, it is no longer ambient air. US v. Pearson; US v. Ho.
1. Daubert Factors
Under FRE 702, scientific evidence is admissible if it will assist the trier of fact to understand the evidence or to determine…and..if (1) the testimony is based upon sufficient facts or data, (2) the testimony is the product of reliable principles and methods, and (3) the witness has applied the principles and methods reliably to the facts of the case.”
Daubert replaced the Frye test, which prevented new scientific evidence from being admitted such as DNA evidence. Under Daubert, the following factors must be considered when admitting scientific evidence: (1) the theory has been tested, (2) has been subjected to peer review, (3) the error rate is low, and (4) the theory/evidence has been generally accepted.
2. Failure to meet the Daubert Factors
Grace contends, the evidence of indoor testing from the 1970s and 1980s as it relates to “knowing endangerment” to ambient air does not satisfy the Daubert factors.
First, there is no direct correlation which can be made between indoor testing and ambient air concentrations, meaning no tested theory exists. Grace cites EPA and OSHA handbooks which do not recommend using indoor occupational exposures for measuring ambient air exposures. The theory has never been tested, and the organizations who would potentially use it have never made such a correlation.
Second, the testing of indoor, airborne asbestos during that period was extremely unreliable. Three main problems occurred during that period of testing: (1) distance issues, (2) time issues, (3) space issues. Scientific evidence provided by Grace shows that the breathing airs and exposure rates changed significantly within feet and from day to day. Over time, the results fluctuated as well. Therefore, the error rate is extremely high for testing results during that period.
Third, the scientific methods used to measure asbestos in the 1970s and 1980s were not sufficient to measure the amount of asbestos present. Phase Contrast Microscopy(PCM), was used to test occupational areas. However, PCM cannot single out asbestos for testing in a mixed fiber environment. Therefore, the error rate, again, is extremely high, confirmed by the fact that only 1.5% to 6% of all particles counted by a PCM are asbestos.
3. FRE 403 issue
Rule 403 provides that the probative value of the evidence must substantially outweigh the unfair prejudice which the evidence would cause.
Grace contends admitting the indoor test evidence as it relates to outdoor exposure levels would cause unfair prejudice The jury would confuse the issues, not differentiating between the CAA criminal prohibitions to ambient air and these indoor tests.
C. Government response
1. Expert testimony can establish that the friability and propensity to release fibers are consistent, whether indoor or ambient, therefore the evidence is relevant.
The government contends its experts can establish a direct link between the indoor tests and the result to the ambient air. The scientific knowledge of the experts can prove that issue. As a result, the evidence is relevant to showing in proving that Grace tested, knew the hazards of asbestos and “knowingly endangered” the public.
2. The Daubert factors were inconsistently applied by Grace, mischaracterizing opinion testimony as scientific.
The government next contends Grace has taken what is opinion testimony, by an expert who has reviewed data, and made it into a methodology.
The government cites the Daubert case, to establish that Daubert applies for when methodology, or how tests were performed, must be established. Here, testing is not at issue, but rather how facts are going to be construed. Daubert exists, according to the government, to protect the jury from evidence without scientific background, not deduced opinion.
D. Conclusion
In an order published on 2/10/09, Judge Molloy maintained the evidence of indoor testing could not be used to extrapolate approximations of ambient air concentrations for both the conspiracy and the standard CAA violations. Molloy echoed Grace’s argument that the dated evidence is unreliable, and does not satisfy the Daubert factors; specifically the issue of methodology used to extrapolate those indoor results to ambient air. Therefore, Rule 105 applies, limiting the use at trial and the jury will be informed accordingly.
MOTION TO EXCLUDE EXPERT TESTIMONY REGARDING THE ATSDR SCREENING STUDY. by Paul Nicol
WR Grace argued that the “screening study conducted by the ATSDR … does not show that non-occupational exposures to asbestos in Libby actually caused pleural abnormalities in the screened populations.” Specifically, the fact that the ATSDR Screening Study showed an “association” is not reason enough to admit the evidence. WR Grace contends that Rule 403 will still bar the evidence even if the District Court finds that the evidence is admissible under Rules 702 and 703.
Citing the Ninth Circuit’s opinion WR Grace asked the District Court to apply a “holistic” approach in determining the admissibility of the ATSDR Study. WR Grace contended that the Government has not shown that “post-1999 asbestos exposures in Libby caused anyone to become sick, let alone die or suffer serious bodily injury.”
Setting forth the standard that the Government must meet, WR Grace interpreted the elements of the “holistic” approach as follows; 1) the Government must prove “that experts in the field reasonably would rely upon the ATSDR Screening Study, 2) the Government must show that “the Screening Study—alone or in combination with other facts or data—provides a sufficient basis” for the opinions an expert hopes to offer, 3) the Government “must show that the expert applied a scientifically reliable methodology” connecting the ATSDR Study and his conclusions, 4) the Government must show the conclusions are relevant and 5) that then probative value outweighs the prejudicial effect.
Next WR Grace contended that on its own the ATSDR Study cannot “support any expert opinion on causation” because the study was not designed to show causation. Conceding that this evidence might be admissible if used in conjunction with other evidence, WR Grace argued that this is the only evidence the Government has that could support expert testimony regarding causation.
Finally WR Grace reiterated its contention that evidence predating November 3, 1999 should not be admitted. WR Grace argued studies conducted in the “1930’s, 40’s, 50’s, 60’s, and 70’s,” when “higher concentrations of asbestos were present” will prejudice the jury in deciding the danger in Libby after November 3, 1999. WR Grace contended that a jury instruction addressing the difference between association and causation would not be sufficient to prevent prejudice.