Comment-button-on-keyboard

Recently, the National Commission on Forensic Science (NCFS) released a series of draft regulations through regulations.gov:

He is entitled to his opinion. I think it is wrong. I submitted my own comment. It is Comment Tracking Number: 1jz-8ih2-877a:

It is impossible to draft a provision that covers such a broad field as pre-trial discovery in all forensic cases. These 4 principles are a good start.

I agree with others in their comments for allowing/requiring the disclosure of what in the clinical and the broader testing industry would be referred to as Quality Management System such as those based on ISO 15189 and CLSI GP26-A3 (e.g., policies, procedures, and instruction, calibration records, traceability of reference materials, personnel qualifications/testing/competency, longitudinal instrument stability records, quality assurance practices, root cause analysis).

I wholeheartedly disagree with the proposition that data (I am assuming something such as electronic instrumental data is what is meant by the comment) should not be available unless an expert is retained on the other side. Besides obvious issues from a legal Due Process point of view, we call such action editing or censoring data. Data is data. It is essential that the electronic instrumental data be wholly and readily available to anyone and everyone. The solution to stem fatal forensic Fukushima like events such as Annie Dookhan is not through hiding data, but exposing data. If you are doing good quality work, you should have no problem in releasing all of your data. There is a growing number of us in the legal community who have sufficient knowledge to issue spot matters and/or have a pre-existing technical scientific background to issue spot and/or effectively question interpretation of data. Where there is a call for interpretation, the release of data that the interpretation is based upon isn’t just a good idea, it is mandatory to allow for confidence and weight in the interpretation. The idea of “trust us” is anti-scientific.

My main comment to this document is that in forensic science there is a grand conversation that is going on with respect to basic issues of the validation of techniques. It is essential that the bedrock foundation of the validity of the technique and instructions be readily available: validation studies. It would be wonderful if validation studies were posted on line for all to see and examine. Does that level of specificity in terms of disclosure needed in a policy statement? Probably not. But what is the sense of being granted materials for a given testing event if you are denied access to the validation records and validation studies that would prove suitability? It would expose whether or not at the very minimum that the USP method validation technique was used (i.e., Accuracy (Bias), Precision, Specificity, Limit of detection, Limit of quantitation, Linearity and range, Ruggedness, and Robustness). Or if the more complicated GLP method of method validation that Dr. Ludwig Huber advocates (i.e., Selectivity of standards (optimizing separation and detection of standard mixtures if selectivity is insufficient), Linearity, limit of quantitation, limit of detection, and range, Repeatability (short-term precision) of retention times and peak areas, Intermediate precision, Selectivity with real samples, Trueness/accuracy at different concentrations, and Ruggedness (interlaboratory studies)) Or is the SWGTOX method validation recommendations followed? Or is there no method validation at all? Is it just intermediate precision testing?

Further and related to the bedrock question, access to Equipment Qualification Plan (EQP) must be allowed. In the industry, we know that instruments cannot be used like a plug and play device such as an X-box. In forensic science, I find a lack of adherence to important matters such as documentation and awareness of Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), scheduled repeat OQ, Performance Qualification (PQ), and Re-Qualification after Repair (RQ) when it comes to equipment.

As I wrote, it is impossible to cover at a macro level a document that will allow for all things related to pre-trial discovery, I fear that the way that this is written, this document will be used to artificially restrict and “hide” possible bedrock errors such as a lack of method validation and a failure to prove an EQP. It would be nice to read some sort of declarative statement that nothing in this document should be read to limit or restrict inquiry.

At the end of the day, if you fear inquiry of your method or the testing event, you are not a scientist, you are an advocate.

Thank you for considering my comments.

I would urge everyone to speak up and to participate in the system. Just like voting, if you don’t participate, then don’t bitch later.
 

USADA presents at the ACS National Meeting about Doping in Sports

 

On March 23, 2015, Attorneys Justin J. McShane of The McShane Firm, LLC and Josh D. Lee of Ward, Lee and Coats moderated a symposium at the national American Chemical Society meeting in Denver, Colorado. The symposium concerned the chemistry and the law involved in Doping in Sports. Officials from the United States Anti-Doping Administration were present. The presentation was made within the Chemistry and the Law Division of the American Chemical Society.

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Attorney Josh D. Lee introduces the speakers at the USADA Anti-Doping Symposium at the ACS National meeting

 

Biographical Sketches of the Presenters

  • Rich Young is the Managing Partner of the Bryan Cave LLP office in Colorado Springs, Colorado. Over the last 20 years, he has participated as a prosecutor, defense counsel, arbitrator or adviser in hundreds of sport doping cases involving most of the Olympic sports. Mr. Young served as the principal draftsman of the World Anti-Doping Code and Code amendments, and has presented the Code at numerous international conferences on doping in sport. He has also assisted in drafting anti-doping rules for numerous International Federations, National Federations, National Olympic Committees and National Anti-Doping Organizations. Mr. Young serves as a legal advisor to the United States Anti-Doping Agency, the Australian Sports AntiDoping Authority, the PGA Tour, lronman, the NBA and other professional sports, as well as several International Federations. Mr. Young is a member of the ad hoc World Anti-Doping Agency Legal Committee and the Pan American Sports Organization Medical Commission. He has also been an arbitrator for the International Court of Arbitration for Sport, and served on its ad hoc panels for the Sydney and Nagano Olympic Games.
  • Dr. Larry Bowers is the Chief Science Officer of the U.S. Anti-Doping Agency. From 1992- 2000, Dr. Bowers was the Laboratory Director of the International Olympic Committee-accredited laboratory at Indiana University. Prior to his tenure at IU, he was a Professor of Laboratory Medicine and Pathology and an Adjunct Professor of Chemistry at the University of Minnesota for 17 years. He has published over 100 scientific articles and chapters on chromatography, mass spectrometry, steroid and peptide analysis, and anti-doping policy. He has received a number of awards, including the American Association for Clinical Chemistry Young Investigator award and the Franklin and Marshall College Distinguished Career award. In 2000, he joined the US Anti-Doping Agency as its third employee and has been responsible for developing most of its scientific policies and procedures over the last 15 years. Dr. Bowers has had the opportunity over the past decade to participate in many of the major milestones in anti-doping. He was the principal author of the WADA International Standard for Laboratories and many of its attendant Technical Documents in 2002. He participated in the BALCO legal action and has served as an expert witness in numerous legal cases over the last 20 years including the Barry Bonds trial. He also serves as the Chair of the Scientific Advisory Board of the Partnership for Clean Competition (PCC), a research-funding consortium of major U.S. sports organizations.
  • Bill Bock became General Counsel for USADA in September, 2007. Prior to becoming General Counsel Bill had served USADA as outside counsel for seven years. As USADA’s General Counsel, Bill has principal responsibility for the prosecution of U.S. athletes and coaches charged with doping offenses, investigations and other legal matters pertaining to USADA. In 2010 Bill became deeply involved in USADA’s investigation into doping in cycling and in the proceedings involving Lance Armstrong and team officials and doctors from the United States Postal Service (USPS) cycling team. Bill was named as a lawyer of the year in 2012 by Colorado Law Week and in 2013 was designated as a Distinguished Barrister by the Indiana Lawyer. He was selected as a 2014 honoree for the NASBA Center for Public Trust’s Being a Difference Award and was named a 2015 Super Lawyer in the State of Indiana.

 

Presentation Overviews

Dr. Bowers presented first. He presented a short historical overview of doping and anti-doping evolution over the period from 1900 to 2000 that lead to the formation of the World AntiDoping Agency (WADA) and the US Anti-Doping Agency (USADA). He briefly summarized the governance of international Olympic sport.

Mr. Young discussed the evolution of doping practices by athletes and the anti-doping rules and methods that have been put in place to detect and sanction dopers. This discussion included the World Anti-Doping Code and its supporting International Standards developed by the World Anti-Doping Agency. He also discussed the shift to out-of-competition testing and specialized laboratory analytical techniques designed to catch up to or hopefully stay ahead of the evolving practices of dopers trying to beat the system.

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Attorney Rich Young gives examples of successful USADA prosecutions including information and evidence form the BALCO scandal.

 

Dr. Bowers again presented. Deterrence is the primary goal of anti-doping. The decision to follow the rules is primarily determined by an individual’s moral inhibitions. When moral inhibitions are weak, the certainty of being caught is the most important factor in compliance with the rules. The ability of testing to detect prohibited substances and methods plays a major role in the certainty of being caught. Several examples of advances in detection of anabolic steroids were presented, including the chemistry underlying the discovery of long-lived metabolites and the detection of designer steroids.

Bill Bock presented on his role as general counsel for USADA and the investigations that he has been part of. The U.S. Anti-Doping Agency (USADA) is the congressionally authorized, independent anti-doping agency for Olympic and Paralympic Movement Sport in the United States and conducts drug testing and drug investigations for America’s elite and Olympic athletes. With particular focus on the USADA investigation into doping by Lance Armstrong and his teammates on the U.S. Postal Service Cycling team as well as the Bay Area Laboratory Cooperative (BALCO) investigation, which involved unlawful conduct by athletes including Marion Jones, Barry Bonds, and Tim Montgomery, USADA’s General Counsel, Bill Bock, discussed how USADA conducts investigations regarding the use of performance enhancing drugs in sport, promoting a level playing field in sport in the United States.

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Attorney Bill Bock explains a key piece of the evidence in the BALCO scandal that showed the doping schedule and the “Rosetta Stone” to decode the drug use by all. This comes from Olympic sprinter Kelli White whose various victories on the international stage were changed into disqualifications based upon doping

 

Dr. Eichner was called away on official WADA duties. So Dr. Bowers presented his slides and information. The World Anti-Doping Agency has the primary responsibility to harmonize anti-doping practice in international sport. The World Anti-Doping Code and the attendant International Standards, Technical Documents, and Guidelines form the framework of that harmonization. The List of Prohibited Substances and Methods and the International Standard for Laboratories are critical to harmonization. WADA recognizes laboratories to conduct doping control analysis for Olympic sports under agreements with national/SO accrediting organizations to assess under ISO 17025. Testing strategies and practice have evolved over the years. WADA-accredited laboratories have moved from reactionary, to be more proactive in the fight against doping. Anticipating potential doping agents progressing through clinical trials and scientific research are paramount in staying ahead of doping athletes. Focusing on “indirect” methods of detection offer the laboratories a way to detect endogenous hormones and other performance-enhancing practices that are not possible to detect directly. There are also numerous rogue companies that exploit the FDA’s “research use only” classification of drugs to target athletes.

At the end of the session, there was a lively Q&A where the audience got to directly ask about Lance Armstrong, Carl Lewis and others. The issue about the anti-doping culture (or lack thereof) in other countries was discussed in terms of policy. The panelists were frank and forthright with their comments. It was a great event.

Attorney Justin J. McShane moderates the panel discussion

Attorney Justin J. McShane moderates the panel discussion

 

In a dramatic turn of events as covered here in Federal Judge resigns from National Commission on Forensic Science and The Jed Rakoff and Matt Redle, co-chairs, Subcommittee on Reporting and Testimony Memo, US Senior District Judge Jed Rakoff resigned in protest from the National Commission on Forensic Science over the DOJ veto wielded by James Cole (DAG) to promptly end all discussion on the broken discovery system in America when it comes to criminal law and in forensic science.

DAG James Cole

Today, after the DOJ re-evaluated its position and announced that it would no longer veto talks on discovery in the National Commission on Forensic Science, Judge Rakoff has rejoined the commission. It is sad to see the tremendous amount of power that the DOJ has over this discussion. Even though DOJ ultimately withdrew its objection, it makes many wonder about how truly transparent, open and balanced any discussions are. If it takes the resignation of a federal judge to have DOJ listen what hope does another commissioner have?

Judge Rakoff returns to forensic panel after Justice Department backs off decision

January 30 at 11:58 AM

A federal judge Friday returned to a presidential commission on forensic science after the U.S. Justice Department reversed a decision to bar the panel from discussing changes that would give criminal defendants more information about forensic evidence before their trials, a federal official said.

U.S. District Judge Jed S. Rakoff of the Southern District of New York had resigned in protest Wednesday from the Obama administration panel, accusing the department of placing “strategic advantage [for prosecutors] over a search for the truth.”

However, Acting U.S. Deputy Attorney General Sally Q. Yates invited Rakoff to return, saying she had not been aware the commission had worked openly on its plans for nearly a year.

Yates told the National Commission on Forensic Science that “it seemed only fair” that it “make its determination as to what information should be provided to the Attorney General.”

“This is obviously a critically important issue to the Department,” Yates said. “We take very seriously our obligation to ensure that defendants receive a fair trial.”

A Justice Department official said the initial decision that pretrial evidence discovery rules were beyond the commission’s scope was made by Yates’s predecessor, James Cole, before his departure Jan. 8. The official, who spoke anonymously because he was not authorized to discuss the issue publicly, added that Yates may not agree with the panel’s suggestions.

Rakoff, the commission’s only federal judge, thanked Yates and said he looks forward to a discussion “on the merits.”

Prosecutors routinely share evidence with defense lawyers, but Rakoff and other commissioners propose that criminal defendants be allowed the same access before trial to government forensic evidence as defendants in federal civil court cases.

In an e-mail to colleagues, Rakoff wrote that it is only through disclosure of scientific results and methods “that forensic science can be meaningfully scrutinized in any specific case” and that “trial by ambush” can be avoided.

The panel began work last year in response to growing criticism by scientists and many legal experts about the quality of forensic evidence used in criminal cases. Citing lab scandals and exonerations, critics have said that police and prosecutors exercise too much control over crime labs, which suffer from weak standards over research, testimony and examinations.

The commission is preparing recommendations for Attorney General Eric H. Holder Jr. or his nominated successor, Loretta Lynch.

 

Policy_Recommendation

Breaking news

I just received a copy of the joint memorandum that was co-authored by the Honorable Jed S. Rakoff and Matt Redle, co-chairs, Subcommittee on Reporting and Testimony that was forwarded to Brette Steele, ‎Senior Advisor on Forensic Science and Senior Counsel to the Deputy Attorney General.

What strikes me on my first reading is who the authors are. Far from the Ivory Tower types, the authors are people that should be listened to and their perspective strongly considered.

U.S. District Judge Jed S. Rakoff

U.S. District Judge Jed S. Rakoff

Honorable Jed S. Rakoff is a sitting senior status Judge for the Southern District of New York.  According to Wikipedia page that features his background, the Judge spent seven years as a federal prosecutor with the United States Attorney for the Southern District of New York. For the last two of those years, he was Chief of the Business and Securities Fraud Prosecutions Unit. He then returned to private practice where he was a partner first with Mudge, Rose, Guthrie, Alexander & Ferdon, and then with Fried, Frank, Harris, Shriver & Jacobson. He headed both firms’ criminal defense and civil Racketeer Influenced and Corrupt Organizations Act (RICO) sections. So, in this author we have experience and a perspective that should be listen to by all.

DA Matt Redle

Matt Redle is the elected County and Prosecuting Attorney for Sheridan County since 1987 is District Attorney in Sheridan, Wyoming. Prior to his election he was a Deputy County and Prosecuting Attorney for 6 years in that office. He is a member of the Wyoming Supreme Court, Permanent Rules Advisory Committee, Criminal Division. He was the Vice President of the National District Attorneys’ Association, having been a member of the board since 2000. He has been a member of the National District Attorneys Association DNA Legal Assistance Advisory Group since 1995. Mr. Redle was the National District Attorneys Association liaison to the ABA Criminal Justice Standards Committee. He was co-chair of the ABA Criminal Justice Section’s Legislative and Policy Committee. He is a past president of the Wyoming County and Prosecuting Attorneys Association. Certainly, this is someone who has front-line experience in state court.

You should read the memorandum: You can download and read it here: November 6, 2014 memorandum to Brette Steele, DAG; from Jed Rakoff and Matt Redle, co-chairs, Subcommittee on Reporting and Testimony

Key quotes from the joint memorandum:

  • At the October meeting of the National Commission on Forensic Science, the Subcommittee on Reporting and Testimony presented a draft report on discovery that, reduced to essentials, recommends that the Attorney General direct his prosecutors to require that forensic science experts testifying on behalf of the Government make considerably fuller disclosure of their data, methodology, experience, and results than is presently disclosed.
  • Indeed, from the standpoint of improving forensic science and making its application to criminal prosecutions more accurate (which were key reasons for the very creation of the Commission), discovery is probably the most important area of intersection between forensic science and the courtroom, because it is only through adequate discovery that forensic science can be meaningfully scrutinized in any specific case.

And just what is so offensive in the idea that trial by ambush does not promote justice? What is in the National Commission on Forensic Science, the Subcommittee on Reporting and Testimony Pretrial Discovery in Forensic Evidence Cases-Policy Recommendations that is too radical for DOJ to handle? Looking at the members of the subcommittee and the work product at the end of the process is instructive.

members1

members2

From the work product:

1. Pretrial disclosure of forensic evidence should be comprehensive and reciprocal — subject to the U.S. Constitution and the law of privilege. The prosecution’s disclosure obligation should apply whether or not the information will be used at trial. The defense obligation should apply to evidence that is intended for use at trial, including the opinions of testifying experts who have not performed any testing.
2. The results of all forensic examinations and all expert opinions should be recorded; oral reports should be reduced to writing. The results of examinations and expert opinions should be recorded at the time the examination is conducted or an opinion is formed — or promptly thereafter.
3. The results of all forensic examinations, expert opinions, and related case documents (e.g., bench notes, graphs, electropherograms, calibration reports, etc.) should be subject to disclosure.
4. An expert witness’s qualifications should be subject to disclosure, including a list of publications authored and a list of recent cases in which the witness testified as an expert at trial.
5. Disclosure should be timely, although all items need not be disclosed at the same time:
a. Disclosure of initial laboratory reports should occur as soon as practicable after completion of the examination so that counsel has sufficient time to consult with an expert — which may require applying for funds to retain an expert — and to permit retesting.
b. Disclosure of all other items should occur as requested and no later than 90 days before the scheduled trial date.
6. There should be a continuing duty to disclose throughout the trial until sentencing. For exculpatory evidence, the duty to disclose should apply after sentencing.4
7. Information, such as laboratory testing protocols, quality assurance procedures, accreditation and audit reports, proficiency testing results, and internal validation studies, should be readily accessible — preferably by posting on the internet or electronically upon request.
8.Forensic evidence should be preserved both before and after trial — until appeals are exhausted and sentences served. Jurisdictions should promulgate procedures concerning the preservation and retention of evidence. Evidence should not be unnecessarily consumed during testing, and consumptive testing should not be done without notice to the defense if a defendant has been charged.
9. The defense has the right to inspect and retest forensic evidence that is under the custody or control of the prosecution. The prosecution has the right to inspect and retest forensic evidence that is under the custody or control of the defense and that the defense intends to use at trial.

Who in their right mind can object to any of this?