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 While subsequent testing did rule out CTS and Jones provided that information to Fabricut, Fabricut allegedly rescinded the job offer on the basis of the pre-employment medical examination and its view that she had CTS.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.
On April 15, the Supreme Court heard oral arguments in Association for Molecular Pathology v. Myriad Genetics. This was another significant step—probably the penultimate one—in the long-running Myriad drama. It began with a group of plaintiffs (including researchers, doctors, and breast cancer patients) joining an American Civil Liberties Union-organized lawsuit to invalidate Myriad’s patents on two breast cancer susceptibility genes (BRCA1 and 2) as well as patents on methods of interpreting genetic test results and testing anti-cancer drug efficacy. In a shocking decision, the federal district court in New York threw out all of Myriad’s patents. The Federal Circuit then reversed the district court’s rulings on the gene patents, with the three-judge panel holding unanimously that cDNA is patentable subject matter and holding 2-1 that isolated genomic DNA is patentable as well. The Federal Circuit affirmed the district court’s ruling that Myriad’s methods of interpreting mutations are not patentable, but reversed it in reinstating Myriad’s claims to methods of testing drug efficacy.
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Three days of hearings by a House of Representatives committee concluded yesterday with a pledge from an FDA official to finalize long-awaited guidance on the regulation of mobile medical applications “in coming weeks“; at the latest by the end of the FDA’s fiscal year (i.e., September 30th).
The hearings, convened jointly by several subcommittees of the House Energy and Commerce Committee, were announced last week following a pointed letter to the FDA (pdf) from seven committee members on March 1st. In the letter, the Congressmen pressed the FDA for information on the agency’s mHealth regulatory timeline and the implications for innovation and industry of the proposed regulations.
A Preview of Guidance to Come. As covered previously here at the Genomics Law Report, in July 2011 the FDA released draft guidance (pdf) outlining its intent to regulate a limited subset of mobile medical applications based on their perceived risk to patients and consumers.
Last week, the FDA published on its website a warning letter to AMARC Enterprises, Inc., a marketer of a dietary supplement known as Poly-MVA. (Here is the company’s description of the supplement.) While the letter is not addressed to a high-profile company or product, given that the FDA’s action will likely have broader significance beyond just AMARC and its Poly-MVA supplement, all currently or potentially FDA-regulated entities, including consumer genomics companies, should take note.
The AMARC letter, issued by a regional compliance office and dating to this past December, is unremarkable in most respects. The majority of the letter focuses on website copy, printed information packets, customer testimonials and other materials that appear, at least to the FDA, to represent claims made by AMARC that the Poly-MVA supplement is “intended for use in the cure, mitigation, treatment, or prevention of disease,” thus making it a drug subject to FDA regulatory approval.
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 Supreme Court building and waited amidst biting winter temperatures in excess of four hours before being allowed inside. [I thought to myself, “if I can brave the cold for football, I can brave the cold to see our nation’s highest court in action.”] The second of two cases scheduled for the morning of February 26, 2013, oral arguments for Maryland v. King were already underway when the fortunate final spectators were ushered inside. Katherine Winfree and Michael Dreeben argued for the Petitioners (the State of Maryland) and Kannon Shanmugam argued on behalf of the Respondent (Alonzo King).
The Genomics Law Report has covered the brewing constitutional controversy of DNA fingerprinting upon arrest previously, as U.S. v. Mitchell tentatively settled the matter in the 3rd Circuit, as the 9th Circuit continued to wrestle with Haskell v. Harris, and as various state courts, including Minnesota and Colorado [pdf], faced similar questions.
Background on Maryland v. King. Alonzo Jay King, Jr. was arrested in 2009 and charged with first- and second-degree assault. As part of his initial arrest, King submitted to DNA fingerprinting collected by law enforcement under the Maryland DNA Collection Act. More than half the states [pdf] have statutes similar to Maryland’s, and there is also a similar federal statute (the DNA Fingerprint Act of 2005 [pdf]). King admitted to his involvement and was ultimately convicted of second-degree assault, a misdemeanor and an offense not qualifying on its own for DNA collection upon arrest under Maryland’s law.
A day after Amgen purchased deCODE Genetics for a whopping $415M, in part for access to its unique data (as described in yesterday’s post), 23andMe announced today it had raised $50M in new financing as part of a concerted effort to grow its genetic database to one million customers.
Both events underscore the increasing importance of data to the business of personalized medicine. In addition, today’s news suggests that 23andMe’s efforts to refocus the company to maximize its most valuable asset – “an engaged, enthusiastic and growing community of customers-qua-research-participants” who supply the raw genetic, phenotypic and other material for 23andMe’s expanding database – continue apace.
Either way, in securing another massive round of financing and lowering its price to $99, the last company standing of the direct-to-consumer (DTC) genetic testing pioneers appears unlikely to be joining deCODE, Navigenics and others in abandoning its consumer-facing approach any time soon.
The big biotech news of the day is the $415 million sale of deCODE Genetics to Amgen. Coverage of the deal is everywhere, including a typically excellent overview from Matthew Herper of Forbes.
We’ve written extensively about deCODE here at the Genomics Law Report over the years, including the company’s well-publicized bankruptcy and privatization two years ago. That transaction left plenty of deCODE shareholders out in the cold, and those shareholders aren’t likely to be feeling any better about things this winter.
Two years ago, questions were raised regarding how the newly private deCODE would utilize one of its most noteworthy assets: it’s database of genetic and other personal health information about Icelandic citizens. Those questions are likely to resurface now, as Amgen seeks to extract $415 million worth of a company that it bought – at least according to one of deCODE’s owners – in large part for access to deCODE’s data. Expect the usual assurances, but remember that those assurances are only as strong as the paper – and legal framework – upon which they are premised.
For years, and with increasing frequency, health care and information technology companies have touted the potential of mobile medical and health applications and technologies to improve the quality and delivery of health care through the use of technology. While the future of mobile health (frequently referred to as “mHealth”) is undoubtedly filled with promise, the legal and regulatory landscape in which mHealth technologies reside is only now beginning to take shape.
As mHealth developers, funders and even users consider investing in the field, or including in particular mHealth technologies, they should keep in mind the emergent and fluid nature of the mHealth regulatory landscape. Here, we outline the likely key players and discuss several recent and projected initiatives with respect to the oversight of mHealth technologies:
The Supreme Court today granted a writ of certiorari (meaning they agreed to hear the appeal) in Assoc. for Molecular Pathology v. Myriad Genetics, Inc., et al., the famous case centered on patents covering two human genes: BRCA1 and BRCA2.
Of note is that the Court limited its grant of the appeal to the first of the three questions posed by the petitioners/plaintiffs: “Are human genes patentable?”
This morning, Gene By Gene, Ltd. – better known as the parent company of the popular genetic genealogy provider Family Tree DNA – formally announced a corporate reorganization that includes the debut of a new division, DNA DTC. (Apparently the news was also announced earlier this month at the Family Tree DNA Conference, although the company waited until today to launch press releases.)
The announcement from Gene By Gene is newsworthy for several reasons, including:
1. The Return of True DTC Whole Genome and Whole Exome Sequencing. According to DNA DTC, the company offers a range of products “utilizing next generation sequencing including the entire exome (at 80x coverage) and the whole genome.” The company’s website, while fairly spartan, appears to bear this out. Whole exomes ($695 at 80x coverage) and genomes ($5,495 at 30x coverage) are both listed as available products.
Now, Gene By Gene is not, as its Wikipedia page claims (as of this writing), “the first commercial company to offer whole genome sequencing tests.” Knome earned that honor more than four years ago, when it started selling whole genome sequences for $350,000; an astounding price, either low (given the cost of the first human genome was $3 billion) or high (given that, well, it was $350,000) depending on your perspective. Gene By Gene probably does represent, however, the only commercial company currently offering a whole genome sequence in a truly direct-to-consumer (DTC) manner.