Genomics & Society
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.
What’s happened since the appeal was filed in January 2016?
The U.S. Court of Appeals for the Ninth Circuit heard arguments on October 19, 2016, and issued a decision on November 15, 2016. The court’s ruling overturned the district court’s dismissal of the ADA and Section 504 claims and remanded the case to the district court for further proceedings. While the court issued an unpublished judgment, which “is not precedent except as provided by Ninth Circuit Rule 36-3,” the plaintiffs’ attorney, Stephen R. Jaffe, publicly announced on LinkedIn that it was “a great victory for personal privacy.” The Ninth Circuit Court of Appeals is allowing the ADA and Section 504 genetic discrimination claims to move forward, all based on the student’s genetic information being a “perceived disability.”
The court made its decision by determining that the district court erred in two ways. The first error was the district court’s finding that there was a “direct threat” defense available under the facts presented in the complaint. The school district had argued that it made its decision out of concern for the health or safety of other students at the school who do have cystic fibrosis and that it had made a reasonable judgment that the student posed a “direct threat” to those other students. According to the Ninth Circuit, the error in allowing a direct threat defense was twofold: (1) such a defense requires an individual assessment of the threat but, as per the facts in the complaint (which must be taken as true in evaluating a motion to dismiss), no such individual assessment was made; and (2) the school district’s decision that the student posed a direct threat was contrary to “reasonable judgment” with “best available objective evidence.” The district court’s second error was finding that the plaintiff had not shown the requisite intent to establish a claim for discrimination. Establishing a claim for discrimination, the Court of Appeals noted in its decision, does not require the plaintiff to show “bad motive, will, or animosity” or even an intent to cause harm. Rather, the action or decision to exclude someone categorically (e.g., because of protected class status) is “facial discrimination” and sufficient, even if no harm or injury was intended.
The case moves forward
The Ninth Circuit’s rejection of the motion to dismiss means that the case is back on track toward eventual trial. There are no apparent signs that the school district will settle the case. On December 21, 2016, the school district’s attorneys filed an answer to the amended complaint and raised a litany of affirmative defenses, including:
• failure to state a claim,
• lack of jurisdiction,
• lack of intent,
• defendant acted in conformity with law,
• equity (e.g., unclean hands and equitable estoppel),
• res judicata,
• statute of limitations,
• lack of standing,
• remedies not supported by claims, and
• no damages attributable to the defendant.
The defendant did not provide any details about these affirmative defenses to explain how or why they might be applicable. Because some affirmative defenses can be waived if not asserted, it is reasonable to treat these defenses for the moment as mere boilerplate—that is, inserted as a matter of lawyerly self-protection.
The court has ordered mediation to resume before March 14, 2017 and has since appointed a mediator to the case.
Keep this case on your watch list
Courts have never directly acknowledged a person’s genotype or carrier status as sufficient to pursue a “perceived disability” claim under the ADA or Section 504 protections against discrimination. A plaintiff’s victory would clarify (at least for people who live in the Ninth Circuit—CA, WA, OR, ID, MT, NV, AZ, AK, and HI) that those who are victims of genetic discrimination in areas of society other than employment or health insurance (the areas covered by GINA) are not left unprotected by federal law and are able to seek remedies under the Americans with Disabilities Act and Section 504.
The case is an important reminder that even if the PAUSD’s actions were permissible under federal law, state law (CalGINA) applicable at the time and applicable today prohibits school districts in California from using genetic information to make decisions about its students. The PAUSD’s decision to continue defending this case signals one or both of two things. The first is that defense attorneys believe that they can successfully slam the door on a broad ADA precedent that would allow “perceived disability” claims against those who discriminate based on genetic information. That seems somewhat unlikely, given the willingness of the Ninth Circuit to allow the case to proceed and the strength of the facts alleged by the plaintiff’s attorneys. The second is that the school district is focused solely on the money—either trying to minimize the size of any settlement or court award or trying to make sure an insurer is responsible for covering the payment of that settlement or award. Perhaps the PAUSD is showing its willingness to roll the dice if a reasonable court award is perceived as having a good chance of being substantially lower than any settlement amounts under consideration.
There has been very little public discussion of the case since initial interest when the appeal was filed last year. The plaintiff’s case has now survived a motion to dismiss, but the case has yet to be decided on the merits. For genetic rights advocates, this case should remain high on the watch list in 2017 with the Ninth Circuit Court of Appeals poised to strengthen genetic nondiscrimination rights through ADA and Section 504 case law.
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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The Cleveland Clinic’s Roger Klein responds to my previous GLR post:
The 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.
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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
Just 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.
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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.
This case unequivocally does not involve GINA, a federal nondiscrimination statute that has very limited scope and does not protect individuals from discrimination in education. While the facts alleged could have supported a clear claim for violation of California’s genetic nondiscrimination statute, CalGINA, which affords broader protections than the federal statute, the attorney for the Chadams did not raise that claim. Instead, this case alleges violations of two federal antidiscrimination statutes, the Americans with Disabilities Act (ADA) and Section 504 of the Rehabilitation Act. Title II of the ADA requires public education to be free from discrimination, and Section 504 requires all federally funded programs and activities to be free from discrimination. Under both provisions, individuals cannot be excluded from participating in or enjoying the benefits of education because of disability. The statutes protect three basic classes of individuals: (1) those who have a disability (i.e., those who have a physical or mental condition that substantially limits a major life activity); (2) those with a history or record of having a disability; and (3) those with a perceived disability (i.e., those “regarded as” having a disability). (For more information, see A Guide to Disability Rights Laws published by the Civil Rights Division of the US Department of Justice)
The plaintiffs in Chadam have appealed the trial court’s decision to grant the school district’s motion to dismiss the case (a Rule 12(b)(6) motion). In granting the school district’s motion, the court basically decided that even if it assumed all of the facts alleged by the plaintiffs to be true and drew all reasonable inferences in favor of the plaintiffs, there would not be a valid claim upon which relief could be granted. On appeal, the United States Court of Appeals for the Ninth Circuit, which covers California, will focus on whether the district court erred in reaching that decision. The court of appeals will consider the motion de novo—that is, will give no deference to the trial court’s decision—and determine whether the facts alleged in the pleadings, when read in the light most favorable to the plantiffs, state a claim for relief that is plausible. The amicus brief filed by the United States (Department of Justice and Department of Education) urges the Ninth Circuit to reverse the district court’s decision and remand the case, stating that the plaintiffs have alleged sufficient facts to support a claim of intentional discrimination under Title II of the ADA and Section 504.
Is there judicial precedent for ADA protection of genetic information?
About 15 years ago, long before Congress passed the Genetic Information Nondiscrimination Act, there was a case in which individuals sought ADA protection from genetic discrimination. That case involved the Burlington Northern Santa Fe Railroad (BNSF), which allegedly had been using employees’ genetic information in connection with work-related carpal tunnel syndrome claims. The case was never decided by a court, however. In 2001 the Equal Employment Opportunity Commission (EEOC) and BNSF settled the EEOC’s request for injunctive relief to stop the company’s genetic testing, and in 2002 the EEOC and BNSF settled the request for damages with an agreement to compensate individuals with up to $2.2 million. While the settlement agreement was subject to approval by the Eastern District of Wisconsin (see 2002 WL 32155386), this case did not set judicial precedent that the ADA protects individuals from decisions based on genetic information.
Does the relevant legislative history suggest that individuals are protected from genetic discrimination because of “perceived disability”?
To answer this question, it is useful to start with legal scholar Mark Rothstein’s thorough 1992 analysis of the law regarding genetic discrimination and possible protection under the ADA as it existed at that time. See Mark A. Rothstein, Genetic Discrimination in Employment and the Americans with Disabilities Act, 29 Hous. L. Rev. 23 (1992).
In the early 1990s, in a letter to a Congressional committee chair, the EEOC actually rejected the idea that the ADA prohibits genetic discrimination against asymptomatic individuals, instead taking the position that the ADA would only protect an individual once the condition existed and symptoms were present. The EEOC’s technical assistance manual in 1992 also noted that genetic predisposition and family history are not “impairments” protected by the ADA. Nearly 10 years later, following the issuance of the Executive Order 13145 in 2000 that protects federal employees from genetic discrimination, the EEOC provided guidance indicating that instances of disparate treatment on the basis of genetic test results or family medical history would support a claim that an individual was “regarded as” having a disability and thus protected under the ADA and Rehabilitation Act.
As a matter of history, Congress and advocates alike did not believe that the ADA or Section 504 were sufficient to protect individuals from genetic nondiscrimination. In the statutory text of GINA, Congress found, “Federal law addressing genetic discrimination…is incomplete in both the scope and depth of its protections.” (PL 110-233, Finding 5).
To date, there are no direct cases on point deciding that genetic information is a “perceived disability” under the ADA and Section 504 or, conversely, ruling out that possibility.
What are the implications of this case?
Ultimately, a broad ruling in Chadam that genetic information alone is a sufficient basis to bring an action for “perceived disability” could dramatically expand individual genetic nondiscrimination protection—at least in the Ninth Circuit. Courts in other federal circuits would not be bound by a Ninth Circuit decision and could choose whether or not to follow it. That reality, combined with the strong public reactions to this case, suggests that Congress has important work to do to strengthen genetic nondiscrimination protections in education and other sectors of society currently not addressed directly by federal statutes.
The Patent Dispute Over Gene Editing Technologies: The Broad Institute, Inc. vs. The Regents of the University of California
The 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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As 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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Robert Cook-Deegan, MD
On September 5, the Federal Court of Australia (the appeals court) upheld a claim on isolated DNA from the BRCA1 gene. It dismissed Yvonne D’Arcy’s appeal of a case that has attracted international attention. Australian patent 686,004 has never been enforced, so the court decision has little real-world concrete impact. As Richard Gold and Julia Carbone explained in their classic case study, “Myriad Genetics: In the Eye of the Policy Storm,” the patent rights on BRCA1 and BRCA2 were exclusively licensed for use in Australia and New Zealand to Genetic Technologies, Ltd. (GTG), which in turn made them a “gift to the people of Australia.” When the CEO of GTG proposed taking back that gift in the summer of 2008, he provoked a firestorm and the company backed down in October, restating that it would not enforce its patent rights against laboratories offering BRCA testing. The Australian Senate held a series of hearings, and a bill proscribing DNA sequence patents was proposed, but the new government opposed it, and it lapsed. Instead, Australia enacted patent reforms in 2012 that raised the bar for utility and clarified the Australian law’s exemption from infringement liability for research and regulatory approval. Most of the provisions of that law took effect on April 15, 2013, the very day Association for Molecular Pathology v Myriad Genetics (AMP v Myriad) was argued before the U.S. Supreme Court.
On July 31, 2014, the FDA gave Congress notice that in the next 60 days it would be announcing draft guidelines on the regulation of laboratory developed tests (LDTs). This topic has been discussed on the Genomics Law Report frequently for years. [You can access the previous coverage here].
The “Anticipated Details of the Draft Guidance for Industry, Food and Drug Administration Staff, and Clinical Laboratories: Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs)” mark a large expansion of FDA regulatory activity into industry practices that have been–depending on your perspective on the scope of the agency’s regulatory power—enjoying the FDA’s discretionary forbearance from regulation or taking place just outside of FDA’s regulatory reach. Indeed, aside from a few “it has come to our attention” letters in Summer 2010 and the second, more forceful warning letter issued to 23andMe in Fall 2013, the FDA has not taken action against companies providing individuals with direct-to-consumer (DTC) access to their personal genetic/genomic information.
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