GINA
The Genetic Information Nondiscrimination Act (GINA) was signed into law in May 2008 after 13 years of debate. Title I of GINA prohibits health insurers from using genetic information to deny coverage or to set premiums or payment rates. Title II prohibits employers from requesting genetic information or using genetic information in hiring, firing and other employment-related decisions. This page aggregates all of the Genomics Law Report’s GINA coverage, including the Act’s implementation by regulatory agencies, courts and businesses.
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. District Court for the Northern District of Oklahoma, making it the first lawsuit brought by the agency to enforce genetic nondiscrimination rights afforded by Title II of the Genetic Information Nondiscrimination Act of 2008 (GINA). A consent decree was filed concurrently, thereby settling the lawsuit on the same day.
Facts of the Case and Details of the Settlement (as reported by the EEOC statement). Rhonda Jones had been working as a temporary memo clerk for Fabricut, Inc. When her temporary employment was nearing an end, she applied for a permanent position with the company. Fabricut, Inc. initially offered her the position but then ran afoul of GINA Title II when, as part of its pre-employment medical examination, it allegedly requested family history on a variety of specific conditions. As previous GLR coverage has discussed, GINA defines “genetic information” broadly to include family medical history. On the basis of the information provided during the pre-employment medical examination, Fabricut allegedly required Jones to obtain additional testing to rule out carpal tunnel syndrome (CTS). While subsequent testing did rule out CTS and Jones provided that information to Fabricut, Fabricut allegedly rescinded the job offer on the basis of the pre-employment medical examination and its view that she had CTS.
As part of the consent decree settling the case, Fabricut agreed to pay $50,000 in damages. The company also agreed to undertake corrective actions that include posting a non-discrimination notice to employees. GINA requires that employers post a non-discrimination notice, and “Equal Employment Opportunity is the Law” posters are readily available on the EEOC website. Fabricut also agreed to have its employees responsible for hiring decisions undergo non-discrimination training and further agreed to distribute non-discrimination policies to its employees.
Significance of the Case. Although individuals have brought complaints against employers alleging GINA violations, this is the first lawsuit initiated by the EEOC to enforce GINA. The EEOC, charged with enforcement of the employment protections of Title II of GINA, provides a summary of the intake and resolution of GINA complaints brought to the agency’s attention. (Similar data have been provided online by the Department of Health and Human Services’ Office of Civil Rights (OCR), the agency charged with enforcement of the health insurance protections of GINA Title I; however, no enforcement data have yet been posted for fiscal year 2012, with the limited exception of press releases to highlight resolution agreements for selected cases.) For previous GLR coverage of GINA Title II, see here and here.
The Fabricut case is a reminder of cases that led to GINA’s eventual passage, including EEOC v. Burlington Northern and Sante Fe Railway Company, 2002 WL 32155386, which also involved employer interest in carpal tunnel syndrome information from employees. Together, these cases highlight the close connection between conduct prohibited under GINA and conduct prohibited under the Americans with Disabilities Act of 1990 as amended (42 U.S.C. §12101 et seq., Pub. L. 101-336). GINA Title II prohibits both the acquisition and the use of genetic information in employment contexts. The ADA prohibits employment discrimination on the basis of disability, but defines disability broadly to include “(a) a physical or mental impairment that substantially limits one or more of the major life activities of such individual; (b) a record of such an impairment; or (c) being regarded as having such an impairment.” (42 U.S.C. §12102(2)). This third definition (an inherently subjective determination), when combined with widely-held views of genetic determinism, widespread genetic illiteracy, and the breadth of GINA’s statutory definition of “genetic information”, ensures that GINA Title II and ADA claims will be brought concurrently when individuals believe themselves to be the victims of genetic discrimination in employment contexts.
Importantly, GINA Title II regulations provide “Safe Harbor” language (see 29 CFR 1635.8(b)(1)(i)(B)) that can help employers to avoid the trap of an unlawful acquisition of genetic information during the hiring process. Use of the “Safe Harbor” language means that any genetic information (e.g., family medical history) disclosed to the employer will be deemed an “inadvertent” discovery rather than an unlawful request for and acquisition of genetic information. However, the safe harbor language provides no defense for the employer that subsequently tries to use any genetic information in its employment decisions. As a reminder, GINA regulations do not provide employers with a bona fide occupational qualification (BFOQ) defense for use of genetic information (again, including family medical history) in reaching an employment decision.
Data are currently unavailable regarding the level of GINA awareness specifically among employers and those medical practitioners engaged in pre-employment (sometimes called “fitness for duty”) examinations. Available empirical data of GINA awareness among physicians (Laedtke et al. 2012) and consumers (Allain, Friedman, and Senter, 2012), as well as public knowledge and awareness of genetics (e.g., Haga et al. 2013) collectively suggest that substantial educational efforts (e.g., from public service announcements to formal education initiatives) may be needed before GINA, a largely symbolic law, is to have any meaningful impact. The Fabricut case suggests that the EEOC may have decided that filing this lawsuit – even when filing the settlement concurrently – may be a useful approach to spread the word.
The Burden of Enforcing GINA: EEOC v. Nestle Illustrates One Challenge in Pursuing Genetic Discrimination Claims
The Genetic Information Nondiscrimination Act of 2008 (GINA) is a federal law making it illegal for insurers and employers to acquire and to use genetic information in certain contexts. Specifically, Title II of GINA prohibits employers with more than 15 employees, employment agencies, labor organizations, and joint labor-management training and apprenticeship program committees from using genetic information when making employment decisions (e.g. hiring, firing, promotions, placement, compensation, privileges, seniority, etc).
The employment discrimination provisions took effect on November 21, 2009, with an air of uncertainty, as the Final Rules implementing Title II of GINA were not issued by the Equal Employment Opportunity Commission (EEOC) until a year later (See 75 Fed Reg 68912-68939 [pdf], issued November 9, 2010) and did not take effect until January 10, 2011. (See previous GLR coverage of GINA Title II here and of GINA generally here).
Alabama’s “Genetic Information Privacy Act” & the Ongoing Need for Personal Genomics Leadership
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.
Thanks to technological innovation and a corresponding decline in cost, an increasing number of individuals are finding themselves with the task – or at least the opportunity – of accessing and interpreting their own genetic information. Over the past year, several state legislatures have taken notice.
Following on the heels of legislation passed or proposed in California, Vermont and Massachusetts, the Alabama House of Representatives is considering a bill by Representative Henry (pre-filed on January 23, 2012 and scheduled for first read on February 7, 2012) titled the “Genetic Information Privacy Act” (2012 AL H.B. 78). While the bill is relatively brief, its effects as written may reach far beyond those intended.
A New Bar for Informed Consent. First, the bill in its current form would require signature on separate informed consent documents to obtain, retain, or disclose genetic information. As drafted the bill would provide an exception for the insurance industry, permitting a single, integrated informed consent document if the genetic information is being obtained, retained, or disclosed “for the purpose of obtaining insurance” (Page 4, Line 25).
A New Law to Raise GINA’s Floor in California
Jennifer K. Wagner, J.D., Ph.D., is a solo-practicing attorney in State College, PA and a post-doctoral researcher at the University of Pennsylvania’s Center for the Integration of Genetic Healthcare Technologies.
Earlier this fall, California Governor Jerry Brown signed SB559 (pdf), the bill referred to as “CalGINA” (i.e., the California Genetic Information Nondiscrimination Act). The bill was double-jointed with AB887 (pdf), the Gender Nondiscrimination Act, which ultimately meant that CalGINA would only take effect if Governor Brown also signed AB887 into law. He did so on October 9, 2011, so both laws are scheduled to take effect on January 1, 2012.
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Weekly Roundup: UK Insurance Genetics Moratorium Renewed & Breast Cancer Patents, Research in the News
With so many developments at the intersection of genomics and the law, there is often a variety of interesting stories that, for one reason or another, don’t find their way into a full-length posting on the Genomics Law Report. In this post we recap several recent key developments and, at bottom, round up all of the recent tweets from @genomicslawyer.
UK Insurers Continue Moratorium on Predictive Genetic Tests. In 2008 the United States passed the Genetic Information Nondiscrimination Act (GINA). Title I of GINA prohibits health insurers from using genetic information to deny coverage or to set premiums or payment rates. Title II of GINA addresses the use and misuse of genetic information by employers. In the United Kingdom, which provides universal health coverage through the government-funded National Health Service (NHS), discussion of genetic nondiscrimination has largely focused on the employment context (see, e.g., the 2009 report on Genomic Medicine from the House of Lords). To date, however, the United Kingdom has not enacted a formal prohibition on the use of genetic information by either employers or insurers.
Considering the Impact of Yet Another Proposal for Genetic Legislation
Last month we examined Massachusetts’ proposed Genetic Bill of Rights. Last week, we looked at a similar proposal to expand individuals’ property and privacy rights in genetic information proposed in the Vermont legislature. Today, we head west to California to examine another piece of recently introduced genetic legislation.
A New Padilla Proposal. The California proposal comes from state Senator Alex Padilla. If Padilla’s name sounds familiar, it is likely because he is the same Senator Padilla who introduced a widely discussed “bioinformatics bill” to the California legislature two years ago. That bill (S.B. 482) was drafted with the close participation of direct-to-consumer (DTC) genetic testing company 23andMe, and 23andMe and Senator Padilla later co-sponsored a policy forum in San Francisco on “genomics and the consumer” (at which I presented).
Unlike Padilla’s earlier effort, which would have significantly altered the regulatory environment for so-called “post-CLIA bioinformatics services” (basically, genetic interpretation performed after the generation of genetic genotype or sequence data in a CLIA environment), 2011’s effort (S.B. 559 (pdf)) will almost certainly be viewed as a much less controversial proposal.
Is the Genetic Rights Movement Picking Up Steam?
The movement to confer greater legal protection to individuals’ genetic information has added another participant. Last month, we examined newly introduced legislation in Massachusetts which, if passed, would create a “Genetic Bill of Rights,” significantly expanding Massachusetts residents’ personal property and privacy rights in their genetic information. Since then, in what the Council for Responsible Genetics has termed a “groundswell for genetic privacy building in states,” state legislators in both California and Vermont have introduced new legislation that would confer greater protection upon individuals’ genetic information.
What should we make of this three state “groundswell?” Although not identical in scope or substance to the Massachusetts Genetic Bill of Rights (“MA GBR”), both the Vermont and California proposals appear to reflect a concern (shared by the MA GBR) that, at least when it comes to the use and misuse of genetic information, the current system of federal oversight is inadequate. Then again, as the legislative findings section of the California proposal (pdf) puts it, perhaps “the current explosion in the science of genetics” simply “compels legislative action in this area.”
Genetic Bill of Rights Proposed in Massachusetts
On January 21, 2011, the Massachusetts Genetic Bill of Rights (MA GBR) (pdf) was introduced before the Massachusetts state legislature. At its core, the proposed legislation establishes property and privacy rights for genetic information and genetic material, while providing protections designed to shield individuals from genetic profiling and other misuses of genetic information.
Taken as a whole, the legislation, if enacted, would confer upon Massachusetts residents a significantly expanded set of genetic rights than exist under current federal law. Below we examine several of the bill’s most noteworthy proposals.
The MA GBR addresses perceived gaps and limitations in the coverage provided by major federal statutes, including the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and the Genetic Information Nondiscrimination Act of 2008 (GINA), and the Constitution of the Commonwealth of Massachusetts, by seeking to place genetic information on a par with medical records.
The MA GBR’s provisions set basic limitations on the use, including the commercial use, of personal genetic information that would go above and beyond the user agreements and privacy policies employed by some commercial services. For example, the MA GBR prohibits the use of genetic information for marketing or determining credit worthiness. With the proliferation of genetic information, particularly in consumer or commercial contexts, such basic limitations would help address concerns about the lack of mandatory restrictions regarding the sale, transfer or other use of personal genetic data.
The Personal Property Theory of Personal Genomes. But the MA GBR goes much further than mere consumer protection reforms. Section 1 of the proposed legislation explicitly declares genetic information to be “the exclusive property of the individual from whom the information is obtained.” (emphasis added)
2011 Personal Genomics Preview: It’s Déjà Vu…
Last January we kicked off the new year by posing “Five Questions for Personal Genomics in 2010.” Here were the five questions we asked:
1. Will the $1,000 genome live up to the hype?
2. Will personal genomics stay DTC?
3. How will the ongoing gene patent debate affect the progress of personalized medicine?
4. When and where will the next regulatory shoe fall?
5. Who will control the data?
A year later the question that comes first to mind is, has anything really changed?
The short answer is no, not fundamentally, although that is not meant to imply that nothing of note happened in 2010. Far from it, as significant legal, regulatory, policy and technological developments continued to reshape the personal genomics landscape.
With that in mind, we welcome 2011 with a look back at the year that was, and a look ahead at what to expect from 2011 and beyond.
MLB Takes Another Swing at Complying with GINA
In 2008 Congress passed the Genetic Information Nondiscrimination Act (GINA). Although GINA is arguably “the first civil rights bill of the 21st century,” we have consistently reminded Genomics Law Report readers that passing GINA into law was only the first step.
As is the case with any piece of new legislation, even after a law is passed, considerable work remains to implement that law in practice. GINA is no different. Congress provided a basic framework designed to eliminate genetic discrimination, but many of the details of the law were left to regulatory agencies.
Two and a half years after GINA’s passage, the first part of that process is still underway. Last month the EEOC issued final rules and regulations implementing Title II of Gina, which applies to employers. (Final regulations for Title I of GINA, which applies to health insurers, have yet to be issued.) With the long-awaited arrival of the EEOC’s final regulations, the next step is to begin to apply those regulations.
MLB’s Genetic Testing Program. In July of 2009 The New York Times reported that Major League Baseball (MLB) had begun using genetic testing to verify the age and identity of Latin American baseball prospects. We analyzed MLB’s genetic testing program and the potential legal concerns raised by GINA in a pair of posts: “MLB Meets GINA” and “MLB’s Genetic Testing Program at the Plate Again.”
