A Constitutional Challenge to Alaska’s Genetic Privacy Statute

As part of its defense of a class action lawsuit that began in 2014, a genetic genealogy company (or DNA ancestry company as they are sometimes called) is challenging the constitutionality of the Alaska Genetic Privacy Act, arguing that the statute’s provisions are unconstitutionally vague. The State of Alaska is intervening in the lawsuit to defend the statute.

The Alaska Genetic Privacy Act (AK ST §18.13.010 et seq.) was passed into law in 2004. The state statute imposes a consent requirement that effectively prohibits surreptitious genetic testing and declares that a DNA sample and the results of any genomic analysis are the “exclusive property of the person sampled or analyzed.” More specifically, it requires prior written informed consent for the collection, analysis, retention, or disclosure of DNA samples and test results. The statute makes exceptions to the consent requirement for DNA identification registries like CODIS, law enforcement purposes, paternity testing, newborn screening, and emergency medical services. There are both civil and criminal enforcement mechanisms in the statute. Affected individuals can bring private civil court actions against violators of the statute (AK ST §18.13.020), while another provision criminalizes violations as Class A Misdemeanors (AK ST §18.13.030). The statute (AK ST §18.13.020) provides that a victim is entitled to compensation from the violator in the amount of $5,000 or, in instances in which the violation “resulted in profit or monetary gain to the violator,” $100,000.
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Filed under Genetic Testing/Screening, Genomics & Society, Informed Consent, Pending Litigation, Privacy

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).
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Filed under Genomic Policymaking, Genomics & Medicine, Genomics & Society, Pending Litigation, Privacy

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.
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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.
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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.
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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

The EEOC’s Final Rule on GINA and Employer-Sponsored Wellness Programs to Take Effect This Month

Gina name tagOn May 17, 2016, the Equal Employment Opportunity Commission (EEOC), which is the agency charged with enforcing Title II of the Genetic Information Nondiscrimination Act (GINA), issued a final rule changing how employers can set up incentives for the wellness programs they sponsor for their employees.

As previously reported on Genomics Law Report, on October 30, 2015 the EEOC had issued a proposed rule to amend the GINA regulations in an attempt to harmonize them with the Affordable Care Act’s promotion of employer wellness programs to lower health care costs. The EEOC indicated it had received more than 3000 public comments before the close of the comment period on January 28, 2016.

In short, the final rule allows employers to offer financial and in-kind incentives for an employee’s spouse to provide information about the spouse’s current or former health status as part of a health risk assessment in connection with a voluntary employer-sponsored wellness program so long as certain requirements are met.
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Filed under Genomic Policymaking, Genomics & Medicine, GINA, Legal & Regulatory, Privacy, Privacy, Privacy

Litigating the Accountability of Clinical Genomics Laboratories

Seeking Accountability from Clinical Genomics Laboratories

A wrongful death case pending in a federal court in Columbia, SC—Williams v. Quest Diagnostics, Inc., et al.—demonstrates the very high stakes involved with clinical genomics testing. The case also underscores the ongoing struggle to (1) establish accountability when mistakes happen and (2) establish a reasonable and effective level of governmental oversight for the laboratories performing such tests. The case could have dramatic implications for the future practice of genomic medicine, and regardless of how this specific case ultimately plays out in the courtroom, the allegations should serve as a serious wake up call to those involved in genomics for clinical purposes in any way.
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Filed under General Interest, Genetic Testing/Screening, Genomics & Medicine, Legal & Regulatory, 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.
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Filed under Genetic Testing/Screening, Genomic Policymaking, Genomics & Society, GINA, Pending Litigation

The Patent Dispute Over Gene Editing Technologies: The Broad Institute, Inc. vs. The Regents of the University of California

CRISPR-Cas9 editing of the genomeThe patent dispute already called “the biggest in biotech history” is only getting started. On January 11, 2016, Administrative Law Judge (ALJ) Deborah Katz officially declared an interference over patents for the CRISPR-Cas gene editing technologies. An interference is a U.S. Patent and Trademark Office (USPTO) administrative proceeding conducted to determine which of multiple claimants to a particular invention has priority rights. Since the patents in question were filed before the March 2013 effective date of the America Invents Act, priority will be awarded to the claimant who was the first to invent the technology in question. This dispute pits Feng Zhang, the Broad Institute, and MIT against Jennifer Doudna and the University of California-Berkeley as well as Emmanuelle Charpentier, Krzysztof Chylinski, and the University of Vienna. Law professor Jacob S. Sherkow has followed the case closely and has provided useful background information on Stanford’s Law and Biosciences Blog.
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Filed under Genomics & Society, Legal & Regulatory, Patent Litigation, Patents & IP, Pending Litigation

Genetic Discrimination Case Against School District is Appealed to Ninth Circuit

classroom-1534186As Stephanie M. Lee reported for Buzzfeed in a well-written account (which contains links to the relevant court documents), an appeal was filed in January with the Ninth Circuit Court of Appeals in the case of Chadam v. Palo Alto Unified School District (4:13-CV-04129-CW). At issue in the case is whether the school district violated a boy’s rights when it decided to force him to transfer schools. The student’s parents allege the transfer decision was because he is a carrier of a genetic variant associated with Cystic Fibrosis or CF (although he has not exhibited symptoms of the disease), and the appeal argues the trial court erred in dismissing the complaint that the school district’s decision to transfer violated his rights under Title II of the American’s with Disabilities Act or ADA (42 U.S.C.A. §12131 et seq.), Section 504 of the Rehabilitation Act of 1973 (29 U.S.C.A. § 794), and the First Amendment of the U.S. Constitution. At the trial court level, the school district successfully defended its decision to transfer the boy by arguing it relied on medical advice and made the decision in an attempt to protect other children at the school who have CF.
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Filed under Badges, Genomics & Medicine, Genomics & Society, GINA, Privacy