Genomics & Society

Comment on ACB v. Thompson Medical

In a recent conversation with John Conley about his April 25 post on the ACB v. Thompson Medical ruling by the Court of Appeal of Singapore, I made a couple of points, and he asked me to write them up to briefly comment on the topic for the Genomics Law Report.

First, the real damage caused by loss of genetic affinity is that the couple’s baby will never share any of the inherited (genetic) traits of the husband. For the mother who brought the case, this is significant because those traits (presumably) are an important part of the couple’s initial attraction and, ultimately, the mother’s implicit desire to have a child with a man with those specific traits. For the husband, of course–who is not the named plaintiff–the fact that the child is not biologically related to him is an even more definitive loss.

Second, it is curious that the husband was not the plaintiff (or at least a plaintiff) in the case. Given that his total genetic exclusion was not by his choosing, it could be argued that the husband was even more injured than the mother. After all, it is the husband who had the total “fracture of biological parenthood,” not the mother, as she has provided 50% of the child’s genetic makeup.

Jennifer Hutchens is a Robinson, Bradshaw lawyer who focuses on health care and life sciences.

Comments Off on Comment on ACB v. Thompson Medical
Filed under General Interest, Genomics & Society, International News

Keeping an Eye on “Perceived Disability” Litigation in California: Chadam v. Palo Alto Unified School District

We mentioned in January that the Ninth Circuit Court of Appeals reversed the District Court’s earlier decision to grant a motion to dismiss and is instead allowing the case of Chadam v. Palo Alto Unified School District to move forward. At that time, we explained that this case should remain high on the watch list for genetic rights advocates, as it involves whether a genotype (such as carrier status for an autosomal recessive condition like cystic fibrosis) is a “perceived disability” under the Americans with Disabilities Act (42 U.S.C.A. §§12131 et seq.) and Section 504 of the Rehabilitation Act of 1973 (29 U.S.C.A. § 794).
Read the rest of this entry »

Comments Off on Keeping an Eye on “Perceived Disability” Litigation in California: Chadam v. Palo Alto Unified School District
Filed under Genomic Policymaking, Genomics & Medicine, Genomics & Society, Pending Litigation, Privacy

Singapore Court Awards Damages for Loss of “Genetic Affinity”

In its March 22, 2017 decision in ACB v. Thomson Medical, the Court of Appeal of Singapore (the city-state’s supreme court) approved an award of damages for loss of “genetic affinity” against a fertility clinic that negligently fertilized a mother’s egg with sperm from an anonymous donor rather than her husband. The plaintiff and her husband had sought help from the four defendants, a group of related medical entities and practitioners, to conceive a child in vitro. The wife is an ethnically Chinese Singaporean and the husband is a Caucasian of German descent. After multiple attempts at fertilization, the wife gave birth to a baby girl (referred to in the opinion as “Baby P”). The family noticed that Baby P’s skin tone did not match that of either parent, nor that of their older child. They also learned that Baby P had a blood type that could not be reconciled with the parents’ types. Further medical investigation revealed that the wife’s egg had been fertilized not with the husband’s sperm, as the couple had intended, but with the sperm of an anonymous donor of Indian ethnicity.
Read the rest of this entry »

Comments Off on Singapore Court Awards Damages for Loss of “Genetic Affinity”
Filed under General Interest, Genomics & Society, International News

Disputes Continue over Foundational Patents for Gene Editing

CRISPR-Cas9 editing of the genome

As we noted early last year, a major dispute over patent rights to CRISPR-Cas systems broke out in January 2016 between Feng Zhang, the Broad Institute, and MIT on one side and Jennifer Doudna and the University of California-Berkeley as well as Emmanuelle Charpentier, Krzysztof Chylinski, and the University of Vienna on the other. CRISPR-Cas systems are powerful tools for genome editing that allow researchers to activate or deactivate target genes. As a reminder of this patent dispute, at issue is whether Zhang was first to invent the application of CRISPR-Cas9 in mammalian and human cells or whether Doudna’s invention of CRISPR-Cas9 was broad enough to encompass application in both prokaryotic and eukaryotic cells (including mammalian and human cells).

A few noteworthy events have occurred since our last coverage in February 2016. The two sides are engaged in what is called an interference proceeding. The U.S. Patent and Trademark Office (USPTO) determined preliminarily that the two sides were claiming patent rights to the same technology and initiated the interference to let them fight over who had priority. Under the pre-2013 version of the Patent Act that applies here, the key question would be who invented first.
Read the rest of this entry »

Comments Off on Disputes Continue over Foundational Patents for Gene Editing
Filed under General Interest, Genomics & Society, Legal & Regulatory, Patent Litigation, Patents & IP

Update on Chadam v. Palo Alto Unified School District

About a year ago we reported on a case involving allegations of genetic discrimination by a school district in California. According to the allegations, in fall 2012 the Palo Alto Unified School District used genetic information regarding cystic fibrosis in deciding to transfer a student away from his neighborhood school to another school.

Genetic nondiscrimination laws are stronger in California than anywhere else in the United States. CalGINA (S.B. 559), which took effect five years ago, extended genetic nondiscrimination rights beyond the narrow scope of the federal statute known as GINA, the Genetic Information Nondiscrimination Act of 2008, which prohibits genetic discrimination in employment and health insurance contexts. However, this case was interesting to Genomics Law Report largely because the plaintiffs did not rely on CalGINA in their complaint against PAUSD but instead focused on protections against “perceived disability” provided under the Americans with Disabilities Act or ADA (42 U.S.C.A. §§12131 et seq.) and Section 504 of the Rehabilitation Act of 1973 (29 U.S.C.A. § 794). The school district had convinced a federal district court to dismiss the complaint, but the plaintiffs filed an appeal in January 2016.
Read the rest of this entry »

Comments Off on Update on Chadam v. Palo Alto Unified School District
Filed under Genomic Policymaking, Genomics & Medicine, Genomics & Society, Pending Litigation, Privacy

FDA Issues Guidance for Next Generation Sequencing

On July 8, 2016, the FDA issued draft guidance on the subject of next generation sequencing (NGS) activities: (1) “Uses of Standards in FDA Regulatory Oversight of Next Generation Sequencing (NGS)-Based In Vitro Diagnostics (IVDs) Used for Diagnosing Germline Diseases” and (2) “Use of Public Human Genetic Variant Databases to Support Clinical Validity for Next Generation Sequencing (NGS)-Based In Vitro Diagnostics.” The first focuses on the FDA’s proposed use of standards to help establish the safety and efficacy of NGS-based tests. The second focuses on the importance of high quality and publicly accessible databases to provide robust scientific evidence for understanding genomic variation, to inform decision-making, and to assess the clinical validity of NGS-based tests. Guidance is not a formal regulation, but rather an agency’s statement about how it will interpret or apply a regulation in the future. Draft guidance is a proposed policy that means the agency is formulating a position, whereas a final guidance is a document that represents what the agency has settled on as its interpretive policy. In theory, guidance is intended to serve as additional instructions for complying with rules and not intended to serve as the rules themselves.

The premise underlying the draft guidance is the controversial and—as yet—legally untested assertion that genomic analyses of all kinds are “medical devices” that Congress has, by statute, authorized the FDA to regulate. If they are, then the FDA would have the power to bring them under its current risk-based classification scheme for medical devices or to create a new scheme for them. If they are not medical devices, then the effort to regulate them might exceed the FDA’s statutory authority and conceivably amount to an unconstitutional regulatory overreach. Both draft guidance documents avoid any mention of the overarching debate, a subject covered extensively on Genomics Law Report, surrounding FDA oversight of all laboratory developed tests (LDTs) and in vitro diagnostic multivariate index assays (IVDMIAs). As others have noted, it is impossible to consider these new pieces of draft guidance outside of that context. Nonetheless, even the FDA asserts (via Twitter and elsewhere) that the two new drafts are intended to facilitate the Precision Medicine Initiative (PMI) and are distinct from the agency’s expressed intention to regulate LDTs. These pieces of draft guidance also give a policy-based reason for pause, as they could be another example of governance by guidance, a highly problematic approach as highlighted recently by John Conley with regard to the HIPAA right to access lab data and results.
Read the rest of this entry »

Comments Off on FDA Issues Guidance for Next Generation Sequencing
Filed under Badges, Direct-to-Consumer Services, FDA LDT Regulation, General Interest, Genetic Testing/Screening, Genomic Sequencing, Genomics & Medicine, Genomics & Society, Legal & Regulatory, Pending Regulation

Cleveland Clinic Pathologist Urges Contract Solution for Return of Genomic Data

The Cleveland Clinic’s Roger Klein responds to my previous GLR post:

Roger-Klein-MD-JDThe Office of Civil Rights’ interpretation of the requirements of 45 CFR § 164 could pose problems for clinical laboratories and the professionals who practice within them. Although the issue of providing benign variants for a single gene, at least prospectively, would be straightforward, a broad definition of the designated medical record set could result in considerable complexity when one considers large-scale sequencing. Some excluded data can be of variable reliability, may be prospectively filtered by software, or may otherwise be omitted from the patient report because of professional interpretation and judgment. One can legitimately argue that this interpretation and judgment, as reflected in the patient report, should serve as the gateway to the official medical record.
Read the rest of this entry »

Comments Off on Cleveland Clinic Pathologist Urges Contract Solution for Return of Genomic Data
Filed under Genetic Testing/Screening, Genomic Sequencing, Genomics & Medicine, Genomics & Society

UNC Geneticist Comments on Testing Laboratories’ Duty to Return Genomic Data to Patients

UNC’s Karen Weck responds to my previous GLR post:

I agree in principle that patients have the right to access their genomic data; however, in practice it is much more complicated (as things often are). Giving a patient his/her raw sequencing data would be meaningless – it is the interpretation of the clinical significance of sequence data that is important when reporting results. This latter requires the expertise of molecular genetic laboratorians and clinical geneticists. We do not return all genomic sequence variants to individuals in exome sequencing, for example when we determine that they are unlikely to be contributory to their disease or medical health. It is important to those of us doing this that we retain the ability to use our professional judgement to determine what should be reported to patients as medically relevant, primarily so as not to dilute important medical information with irrelevant information.

Karen E. Weck, MD
Professor of Pathology & Laboratory Medicine and Genetics
Director, Molecular Genetics
University of North Carolina at Chapel Hill

Comments Off on UNC Geneticist Comments on Testing Laboratories’ Duty to Return Genomic Data to Patients
Filed under Genetic Testing/Screening, Genomic Sequencing, Genomics & Society

ACLU v. Myriad Genetics, Round 2: The Problem of Governance-by-Guidance

MyriadJust about everyone interested enough in genomics and the law to read this post will know that the American Civil Liberties Union waged a long and ultimately successful legal campaign to invalidate Myriad Genetics’ patent claims to isolated BRCA genes, mutations of which are linked to breast and ovarian cancer. Now the ACLU has launched a second front, this time attacking Myriad’s post-patent business model of maintaining its vast and unique database of genotype-phenotype associations as a trade secret. GLR reported on that evolving strategy two years ago.

The new ACLU attack has, thus far, received modest attention in the scientific press, and some of what has been reported is inaccurate. In this post I will briefly review what has actually happened and then try to sort out fact from fiction in the reportage. The bottom line is that the federal government has not created new stealth regulations dealing with the disclosure of genomic data to patients. It has, however, used the practice of governance-by-guidance to make significant new policy, which is problematic enough in its own right.
Read the rest of this entry »

Comments Off on ACLU v. Myriad Genetics, Round 2: The Problem of Governance-by-Guidance
Filed under Genomic Policymaking, Genomics & Society, Myriad Gene Patent Litigation, Patent Litigation, Patents & IP, Pending Litigation

Genetic information as “perceived disability”: Chadam v. PAUSD

Chadam v. PAUSD, as previously covered on Genomics Law Report, is a case in which parents of a school boy are alleging that a school district violated their son’s rights when it made the decision that it would transfer the boy to another school because of his genetic information. Specifically, the allegation is that when the boy moved to the area and registered for school, (1) the school district learned of the boy’s genetic information related to cystic fibrosis, (2)  the boy was regarded as disabled by the school district, and (3) on the basis of this perceived disability, the school district decided to transfer the boy to another school to protect two other students at the school who have cystic fibrosis. The school district’s decision was apparently based on the idea that the boy, because of his genetic markers, posed a cross-infection risk to the students with cystic fibrosis. Individuals with cystic fibrosis, because their respiratory symptoms create host environments favorable to microbiological pathogens, are often separated from one another to minimize risk of spreading germs to one another. Mere carriers of the genetic markers associated with cystic fibrosis do not pose such cross-infection risks.
Read the rest of this entry »

Comments Off on Genetic information as “perceived disability”: Chadam v. PAUSD
Filed under Genetic Testing/Screening, Genomic Policymaking, Genomics & Society, GINA, Pending Litigation