News Alert

Janelle N. Winters, Randolph Portugal

The Johnson & Johnson Talc Multidistrict Litigation (MDL), consolidated under 28 U.S.C. §1407, continues to undergo significant expert-admissibility developments following Special Master Freda L. Wolfson’s issuance of a 119-page Report and Recommendation addressing the reliability of Dr. William Longo’s chrysotile-detection methodology.

Dr. Longo, the Chief Executive Officer of Materials Analytical Services, introduced a revised protocol for testing talc for the presence of chrysotile combining elements of criteria for heavy liquid separation (HLS), polarized light microscopy (PLM), dispersion straining, and modified refractive-index (RI).

HLS is a sample-preparation technique originally developed in a 1973 report by the Colorado School of Mines (CSM), designed to concentrate mineral impurities based on differences in specific gravity. PLM is an optical microscopy technique that uses polarized visible light to identify minerals based on optical properties. Dispersion straining is an optical method used to determine refractive indices by comparing how light travels through a mineral relative to an immersion liquid.

Dr. Longo asserted that his combined approach allowed his laboratory to detect chrysotile asbestos in nearly every talc sample tested, regardless of mine source or decade of manufacture.

Plaintiffs argued that this revised methodology was more sensitive and addressed prior concerns about PLM’s limitations.

Defendants, however, challenged this methodology as scientifically unreliable, inconsistent, and unsupported by peer-reviewed research of industry standard.

The Special Master agreed with defendants and recommended exclusion of Dr. Longo’s chrysotile opinions under Federal Rule of Evidence 702 (FRE 702).

Legal Analysis Under FRE 702

The Special Master’s Analysis focused on whether Dr. Longo’s methodology satisfied the reliability requirements of FRE 702 and the framework established in Daubert v. Merrell Dow Pharmaceuticals, Inc. She emphasized that expert testimony must be grounded in reliable principles and methods and must be applied reliably to the facts of the case. In evaluating Dr. Longo’s methodology, she concluded that his technique lacked the necessary scientific validation, transparency, and consistency required under FRE 702.

The Special Master determined that there was an absence of a clear, consistently applied protocol. Dr. Longo’s Fourth Supplemental report did not contain a complete methodology used for samples given, forcing the Special Master to reconstruct the process from state-court reports and deposition testimony. This omission was problematic because Materials Analytical Services (MAS) modified the CSM HLS procedure without demonstrating that the alterations were scientifically validated or reproducible. The Special Master further noted that the original CSM procedure has never been adopted by the talc and cosmetic industries and has not been recognized by the Environmental Protection Agency (EPA) or the Occupational Safety and Health Administration (OSHA) for detecting chrysotile in cosmetic talc.

The Special Master also determined that MAS’s PLM analysis departed from the International Organization for Standardization (ISO) 22262-1 standard in critical respects. Although Dr. Longo testified that ISO 22262-1 provided the framework for his analysis, he acknowledged that his laboratory did not follow the standard RI criteria for chrysotile identification. Instead, the laboratory substituted his own RI ranges and relied on subjective structural assessments. The Special Master concluded that these deviations were not supported by peer-reviewed research and introduced unacceptable levels of subjectivity into the analysis. She emphasized that adherence to established standards is essential when testing for trace levels of asbestos, particularly in litigation where methodological rigor is of principal importance.

The Special Master further found that MAS did not demonstrate that its dispersion-straining procedures were performed with the necessary controls, calibration, or documentation. In fact, the record lacked evidence of error rates, proficiency testing, or inter-laboratory validation. Without these safeguards, the Special Master determined that the RI measurements could not be considered reliable under FRE 702. She also noted that this methodology lacked general acceptance in the scientific community and had not been subject to peer review. No published studies supported the use of HLS combined with PLM for detecting chrysotile in cosmetic talc, and no regulatory agency has endorsed the technique. Moreover, the absence of non-judicial use also suggested that this methodology was developed mainly for litigation purposes as opposed to scientific inquiry.

Although Dr. Longo is qualified in materials science and asbestos testing, the Special Master emphasized that qualifications alone cannot cure methodological defects. She reiterated that expert testimony must be grounded in reliable principles and methods, not merely in the expert’s experience or credentials.

Daubert Factors Analyzed

In conducting her doctrinal analysis under Daubert, the Special Master evaluated the traditional reliability factors that guide courts in determining whether a scientific method is sufficiently established to be presented to a jury.

The first factor – general acceptance – strongly weighed against admissibility. The Special Master explained that neither the scientific community nor any regulatory body has adopted HLS combined with PLM as a recognized method for detecting chrysotile in cosmetic talc. Dr. Longo’s application of the CSM procedure has never been incorporated in industry standards and has not been used by laboratories outside litigation.

The second factor – peer review and publication – also weighed against admissibility. The Special Master found no peer-reviewed literature supporting the HLS combined with the PLM for chrysotile detection, nor any publications endorsing the modifications MAS made to the original CSM procedure. She noted that scientific methods gain reliability through scrutiny, replication, and debate within the scientific community, none of which occurred here.

The third factor – non-judicial use – further undermined the methodology’s reliability. The Special Master observed that the combined HLS-PLM approach has not been used outside litigation and has not been adopted by laboratories engaged in regulatory compliance, academic research, or commercial testing. Methods developed exclusively for litigation raise concerns because they lack safeguards inherent in scientific practices.

The fourth factor – standards controlling the technique’s operation – also weighed against admissibility. The Special Master found that MAS did not adhere to ISO-22262-1, which governs PLM analysis of asbestos in bulk materials. Dr. Longo substituted its own RI criteria and did not follow ISO-prescribed parameters. Without adherence to established standards, Dr. Longo’s technique lacked the objective benchmarks necessary to ensure consistent and reproducible results.

The fifth factor – the known or potential rate of error – was also problematic. The Special Master explained that MAS did not document error rates, conduct proficiency testing, or perform inter-laboratory comparisons. Because Dr. Longo did not quantify the accuracy or precision of his measurements, the methodology lacked the empirical foundation necessary to satisfy Daubert.

The final factor – testability and reproducibility – also weighed against admissibility. The Special Master found that the methodology did not consist of a testable hypothesis because MAS did not demonstrate that its results could be replicated by other laboratories. Reproducibility is a cornerstone of scientific reliability, and methods incapable of replication cannot be considered reliable under Daubert.

Dr. Sanchez Rebuttal Opinions

In addition to evaluating Dr. Longo’s Methodology, the Special Master addressed plaintiffs’ motion to exclude the rebuttal opinion of Dr. Matthew Sanchez among other defense experts. She declined to exclude Dr. Sanchez’s testimony, finding that his critiques were grounded in established mineralogical and microscopy principles. Dr. Sanchez offered an analysis of PLM limitations for detecting trace chrysotile, the importance of adhering to ISO standards, and the need for validated RI criteria. He also addressed the scientific shortcomings of MAS’s HLS modifications and explained why that technique lacked reproducibility and general acceptance. The Special Master concluded that Dr. Sanchez’s opinions were reliable and admissible under FRE 702.

Conclusion

The Special Master’s Report and Recommendation represents a significant tightening of expert-admissibility standards in asbestos-in-talc litigation. By rejecting Dr. Longo’s combined HLS-PLM methodology, the ruling narrows the evidentiary foundation for plaintiffs’ asbestos contamination theories and reinforces the principle that novel scientific techniques must meet FRE 702 admissibility standards before they can be used in complex litigation. This report and recommendation underscore the importance of consistent documentation, transparent methodology, and strict adherence to established standards when presenting scientific evidence in court.