Robinson Bradshaw

Author: Jennifer K. Wagner

The Sky is Falling for Personal Genomics! Oh, nevermind. It’s just a cease & desist letter from the FDA to 23andMe.

Genomics Law Report has paid close attention to the FDA’s potential regulation of laboratory developed tests (or LDTs) over the years. We have decided to address the most recent development – a cease and desist letter sent by the FDA to 23andMe – in two posts — by Jennifer Wagner and by John Conley. A […]

Revisions to the Ethical Standards for Research

The World Medical Association published revisions to the Declaration of Helsinki (DoH) in JAMA on October 19, 2013. As noted previously on the Genomics Law Report, the DoH was adopted in 1964 and is considered a foundational guiding document for ethical medical research. The DoH has been revised six times previously, and these are the […]

Genomic Research Ethics: Special Rules for HeLa Cells

In her 2010 book The Immortal Life of Henrietta Lacks, Rebecca Skloot told the story of Henrietta Lacks and the cell lines derived from her cervical tumor biospecimen (cell lines known to scientists simply as “HeLa cells”). To make a long story short, in 1951 physicians at Johns Hopkins Hospital took a biopsy from a […]

Ninth Circuit Orders Rehearing of Haskell v. Harris

When the Supreme Court issued the Maryland v. King opinion on June 3, 2013 upholding Maryland’s DNA Collection Act, numerous cases were pending in which similar DNA fingerprinting upon arrest statutes in other jurisdictions were being challenged. The dissenting justices encouraged cases to press forward and give the Court an opportunity to change its current […]

Approved North Carolina State Budget Includes Funds to Compensate Sterilization Victims

Jennifer K. Wagner, J.D., Ph.D., is a solo-practicing attorney in State College, PA and a research associate at the University of Pennsylvania’s Center for the Integration of Genetic Healthcare Technologies. Nearly a year and a half ago, the GLR reported that North Carolina was one step closer to compensating the victims of its sterilization program. […]

Looking Back at Myriad: A User’s Guide

The Genomics Law Report has provided ample coverage throughout the litigation over Myriad Genetics’ BRCA1/2 patents. The saga had a rather lengthy procedural history, so a timeline of key landmarks with hyperlinks to GLR coverage as appropriate (in the “where” column) may be useful. When Where Action Citation 1997 USPTO US Patent 5693473 issued to Myriad […]

DNA Fingerprinting as Routine Arrest Booking Procedure Upheld as Anticipated

Jennifer K. Wagner, J.D., Ph.D., is a solo-practicing attorney in State College, PA and a research associate at the University of Pennsylvania’s Center for the Integration of Genetic Healthcare Technologies. Oral arguments in Maryland v. King were held on February 26, 2013, as reported previously here on GLR. Following oral arguments, I stated, “If forced […]

EEOC Files and Settles Its First GINA-based Employment Discrimination Lawsuit on May 7, 2013

 Jennifer K. Wagner, J.D., Ph.D., is a solo-practicing attorney in State College, PA and a research associate at the University of Pennsylvania’s Center for the Integration of Genetic Healthcare Technologies. The Equal Employment Opportunity Commission (EEOC) issued a statement that it had filed a lawsuit against Fabricut, Inc. on May 7, 2013 in the U.S. […]

All Eyes on Maryland v. King: Recapping the Supreme Court Oral Argument

Seating was in short supply to hear oral arguments before the Supreme Court in what J. Alito referred to as “the most important criminal procedural case that this court has heard in decades,” Maryland v. King. Eager spectators –including this contributor for the Genomics Law Report – lined up along the marble steps of the […]

ENCODE, CODIS, and the Urgent Need to Focus on what is Scientifically and Legally Relevant to the DNA Fingerprinting Debate

Sara Huston Katsanis, MS is an Associate in Research at the Institute for Genome Sciences & Policy at Duke University. On September 5, 2012, a coordinated release of 30 articles in Nature, Cell, Science, Genome Research, Genome Biology and other journals published the long-awaited findings of The Encylopedia of DNA Elements (ENCODE) Consortium. The press coverage […]