The Equal Employment Opportunity Commission (EEOC) has filed its first class action lawsuit, EEOC v. Founders Pavilion, alleging violations of the Genetic Information Nondiscrimination Act (GINA), which took effect in 2009. GINA applies to two separate spheres, health insurance (Title I) and employment (Title II). Under Title II of GINA, it is illegal to discriminate against employees or applicants because of genetic information. In this legal action, the EEOC has sued Founders, Inc., a Corning, N.Y., nursing and rehabilitation center. In the complaint filed last week, the EEOC alleges that Founders:
(1) requires a class of applicants and employees to provide genetic information in response to questions about family medical history, in violation of GINA, (2) terminated two individuals it regarded as disabled, and terminated one disabled individual after failing to provide her a reasonable accommodation during her probationary period, all in violation of the ADA, and (3) refused to hire one woman, withdrew an offer of employment to a second woman, and terminated a third woman because they were pregnant, in violation of Title VII.
This lawsuit originates from the violation of three separate statutes enforced by the EEOC: GINA, American with Disabilities Act (ADA), and Title VII of the Civil Rights Act of 1964. This is the second GINA enforcement action announced by the EEOC this month (see here). This newly filed case has overtones of an earlier pre-GINA lawsuit from 1998, Norman Bloodsaw v. Lawrence Berkeley Laboratory, alleging multiple civil rights claims based on the employment practices of a federal research laboratory. The 9th Circuit upheld findings that the laboratory had conducted unlawful surreptitious medical testing of and discriminated against employees in violation of the ADA, Title VII, and both the federal and state (California) constitutional rights to privacy. With respect to genetic testing, the courts found that the laboratory had conducted unauthorized testing for sickle cell trait, a genetically based condition, and the 9th Circuit found that practice unconstitutional under the general privacy protections afforded by the 4th Amendment:
One can think of few subject areas more personal and more likely to implicate privacy interests than that of one's health or genetic make-up.
Norman-Bloodsaw reached unauthorized genetic testing through constitutional privacy claims in a pre-GINA era; surreptitious genetic testing in the workplace has also been captured using ADA violations. This month’s actions from the EEOC signal its seriousness about utilizing GINA to limit excessive probing of genetic medical information from applicants or employees, an aspect of the statute that, until now, was likely less appreciated (or observed) than the more prominent prohibition of adverse workplace treatment of employees based on their genetic status (discrimination in the form of failure to hire, differential treatment or termination).
The regulation of genetic tests is uneven, with the FDA exercising enforcement discretion of this field within its general authority to regulate medical devices. To date, the FDA requires approval of genetic testing kits, considered to be in vitro diagnostics (IVD). The FDA has paid specific attention to one subset of genetic test kits, known as companion diagnostics. The FDA describes companion diagnostics:
A companion diagnostic device can be in vitro diagnostic device or an imaging tool that provides information that is essential for the safe and effective use of a corresponding therapeutic product. The use of an IVD companion diagnostic device with a particular therapeutic product is stipulated in the instructions for use in the labeling of both the diagnostic device and the corresponding therapeutic product, as well as in the labeling of any generic equivalents and biosimilar equivalents of the therapeutic product.
Companion diagnostics illustrate the use of pharmacogenetics to refine pharmaceutical treatment of cancers or other illnesses. The FDA has just approved a new companion diagnostic test for use in the treatment of non small cell lung cancer, the cobas EGFR Mutation Test that refines the optimal use for Tarceva, a biotech drug approved by the FDA in 2004 (a monoclonal antibody). This approval scenario illustrates how the optimal treatment profile for an already approved drug is being refined by subsequent genetic research, where new understandings of the relationship between particular genes and the specific cancers is allowing for more refinement in treatment decisions. The FDA published a guidance document for the approval of companion diagnostics in 2011:
An IVD companion diagnostic device could be essential for the safe and effective use of a corresponding therapeutic product to identify patients who are most likely to benefit from a particular therapeutic product; identify patients likely to be at increased risk for serious adverse reactions as a result of treatment with a particular therapeutic product; or monitor response to treatment for the purpose of adjusting treatment (e.g., schedule, dose, discontinuation) to achieve improved safety or effectiveness.
The FDA also recognizes a scenario of co-development between a drug manufacturer and a test developer, such that both products are approved simultaneously, as illustrated by the FDA's co-approval of Xalkori and the Vysis ALK Break Apart FISH Probe Kit in 2011. The list of approved companion diagnostics continues to grow. As a general matter, the FDA regulates genetic tests sold as kits to laboratories or consumers. In the general genetic testing market, however, most genetic tests are offered as laboratory-derived tests (LDTs), available as services, rather than products. The FDA does not regulate LDTs, although it has stated that some LDTs are considered medical devices, subject to its oversight. However, despite issuing a statement of intention for possible oversight in 2010, the FDA to date has not taken on LDTs in general, or even the genetic LDTs. Laboratories providing LDTs are regulated under the Clinical Laboratory Improvement Amendments (CLIA), administered by the Centers for Medicare and Medicaid Services (CMS), which requires that laboratories meet specified standards, and that individual tests are scientifically accurate, but which does not evaluate the clinical validity or clinical utility of LDTs. Calls for the FDA to increase its involvement in the regulation of LDTs have come from many sources, including the Secretary's Advisory Committee for Genetics, Health and Society in 2008. More recently, the American College of Medical Genetics published a risk-classification framework for the regulation of LDT genetic tests, calling for FDA pre-market approval of high-risk LDTs, where "the consequence of an incorrect result or interpretation could lead to serious mortality or morbidity."
Yesterday, the Supreme Court issued its opinion in Bowman v. Monsanto, a patent infringement case that tested how the doctrine of patent exhaustion applies to self-replicating patented inventions such as genetically engineered (GE) seeds. The patented invention is the Monsanto Roundup Ready soybean, which contain a gene that encodes EPSPS, a glyphosate-tolerant enzyme. The genetically modified plants express the enzyme and thus exhibit resistance to the herbicide glyphosate– specifically, to the application of the Monsanto glyphosate product, sold as Roundup. A license restriction accompanies the sale of the Roundup Ready seeds, and it prohibits the use of second-generation seeds in later plantings. Farmer Vernon Bowman was accused of patent infringement by buying GE commodity seed from a grain elevator (not directly from Monsanto) which he then used for replanting (replication); Monsanto characterized his activities as an unauthorized use of a patented invention because it involved the “making” of a patented article. The doctrine of patent exhaustion operates to limit the control that an inventor holds over the life of a lawfully sold patented article – the first sale of a patented invention is authorized, and that act exhausts the control that the patent holder retains over subsequent uses of the article (absent some valid conditional sale agreement that accompanies the sale). Did that doctrine extend to a claim that a later sale of originally-patented GE seed to Bowman and his use in planting became an act of patent infringement because the seed replicates and he “made” an infringing article? In 2011, the Federal Circuit ruled that Bowman’s planting of the GE seed he purchased became an act of patent infringement, rejecting an interpretation of the exhaustion doctrine that would recognize the special attributes of seeds, which embody the property of replication and “manufacture” of an originally-patented invention (see earlier post). Did the company’s patent rights extend to this later series of events, or did they exhaust upon the first sale of the patented seed? Although one can freely “use” a product after patent exhaustion, does that authorize a use that results in the creation of a new copy of the patented article, which is generally viewed as an act of patent infringement? In the unanimous opinion authored by Justice Kagan, the Supreme Court said no:
Reproducing a patented article no doubt “uses” it after a fashion. But as already explained, we have always drawn the boundaries of the exhaustion doctrine to exclude that activity, so that the patentee retains an undiminished right to prohibit others from making the thing his patent protects.
What does not exhaust is the ability of patent holder to enforce one of the rights of exclusion, that is, the ability to prevent unauthorized replication of a patented invention. No exception applied here to GE seeds in this scenario, despite Bowman's invocation of self-replication by the product itself. Justice Kagan did note, however, that the decision was limited to this set of facts:
Our holding today is limited—addressing the situation before us, rather than every one involving a self-replicating product. We recognize that such inventions are becoming ever more prevalent, complex, and diverse. In another case, the article’s self-replication might occur outside the purchaser’s control. Or it might be a necessary but incidental step in using the item for another purpose.
This restraint from the Court at least references analogous scenarios in computer software, where use of a lawfully obtained program often requires the making of a copy on a host computer; Congress has address this with an amendment to copyright law (17 U.S.C. 117) that immunizes users from copyright infringement in such circumstances. There is some pushback in Congress with respect to patented seeds and the restrictions that accompany their sale; H.R.19, the Seed Availability and Competition Act of 2013 was introduced this year and it authorizes second generation plantings of patented seeds, effectively establishing a compulsory license, but setting a royalty mechanism for payments to the patent holder. This is unlikely to garner significant support in Congress, but it indicates that there are legislative approaches that can theoretically modulate patent rights for certain technologies, if the political will exists to do so.
The U.S. Department of Agriculture's Animal and Plant Health Inspection Service (APHIS) has announced this week that it will heighten its regulatory review for the possible introduction of the next wave of herbicide-resistant genetically engineered (GE) crops. Using its authority under the Plant Protection Act, APHIS regulates genetically engineered crops because it has determined that they may pose a risk as plant pests. Companies seeking to introduce a new crop to market file an application for deregulated status with APHIS. In this case, the applications seeking APHIS deregulation are for Dow Chemical’s corn and soybeans genetically engineered for resistance to the herbicide 2,4-D and Monsanto’s cotton and soybeans genetically engineered for resistance to dicamba. In addition to compliance with the Plant Protection Act, APHIS must also comply with the National Environmental Policy Act (NEPA).
Under the National Environmental Policy Act, APHIS is required to evaluate the potential environmental impacts from a "major Federal Action" - that can include the deregulation of new GE plants by the Agency. If APHIS finds that its potential regulatory decision may significantly affect the quality of the human environment, the Agency must prepare an EIS (environmental impact statement) before making a decision on the proposed Federal action.
APHIS had prepared a draft environmental assessment for the crops in the Dow petition. Petitions for deregulation of these crops (which would allow commercial release) had been submitted to APHIS and published for public comments; APHIS noted that significant numbers of comments had been received. APHIS has thus concluded:
With regard to these new herbicide-resistant plants, through its analysis of information submitted by the developers, as well as public comments, APHIS has determined that its regulatory decisions may significantly affect the quality of the human environment. APHIS therefore believes it necessary under NEPA to prepare these two EIS's to further assist the Agency in evaluating any potential environmental impacts before we make a final determination regarding the products' regulatory status.
Several points are worth noting about the APHIS decision and the larger debate over the use of genetically engineered crops (which are largely engineered for agronomic, not dietary purposes). In
contrast to several other proposed deregulations over the last several
years (alfalfa, sugar beets), where APHIS did not conduct an EIS, and
was sued for noncompliance with NEPA, here APHIS is triggering an EIS of
its own accord. The use of genetically engineered glyphosate-resistant crops (most famously, Monsanto Roundup Ready corn, soybeans) since the 1990’s led to extensive litigation over how APHIS managed its NEPA requirements; ultimately, judicial action compelled APHIS to prepare an EIS, and it then deregulated the crops. In the decade or more since the Roundup approach to weed management, glyphosate-resistant weeds have emerged, thus undermining the viability of this strategy for weed containment. Debate continues over whether successive waves of genetic engineering related to designated herbicides will adequately provide effective weed management (one research group describes an “accelerated transgene facilitated herbicide treadmill”). Criticism is also directed at the environmental consequences from the use of the herbicides; litigation against the Environmental Protection Agency attempted to rescind its approval of 2,4-D. However, it is notable that APHIS specifically cabins the focus of the EIS:
While the EIS’s will look more broadly at potential impacts to the environment as a whole, APHIS’ regulatory authority is based on The Plant Protection Act and the Agency’s oversight is specific to evaluating the potential for the GE plants to pose a plant pest risk to crops or other plants.
While technically true, APHIS is also charged by NEPA with an evaluation that considers how a “potential regulatory decision may significantly affect the quality of the human environment.” The decision by APHIS suggests that the agency might have anticipated immediate litigation if it had not prepared an EIS, and due to the delays that previous cases have imposed, may have decided that direct preparation of an EIS was more efficient. That, of course, does not predict the outcome of the EIS. However, it will take place against the backdrop of some of the limitations to genetically engineered weed management that have been revealed by earlier containment strategies.
The Equal Employment Opportunity Commission (EEOC) has announced a settlement in what it describes as the first lawsuit it has filed alleging genetic discrimination in violation of the Genetic Information Nondiscrimination Act (GINA), enacted in 2008. GINA applies to two separate spheres, health insurance (Title I) and employment (Title II) (see here). From the EEOC:
Under Title II of GINA, it is illegal to discriminate against employees or applicants because of genetic information. Title II of GINA prohibits the use of genetic information in making employment decisions, restricts employers and other entities covered by Title II (employment agencies, labor organizations and joint labor-management training and apprenticeship programs - referred to as "covered entities") from requesting, requiring or purchasing genetic information, and strictly limits the disclosure of genetic information.
In this case, the EEOC charged that Fabricut, Inc., an Oklahoma wholesale distributor of home furnishing items, violated GINA’s general prohibition on obtaining genetic information from an applicant or employee; it then denied employment based on the results. GINA defines genetic information broadly:
Genetic information includes information about an individual’s genetic tests and the genetic tests of an individual’s family members, as well as information about the manifestation of a disease or disorder in an individual’s family members (i.e. family medical history). Family medical history is included in the definition of genetic information because it is often used to determine whether someone has an increased risk of getting a disease, disorder, or condition in the future. Genetic information also includes an individual's request for, or receipt of, genetic services, or the participation in clinical research that includes genetic services by the individual or a family member of the individual, and the genetic information of a fetus carried by an individual or by a pregnant woman who is a family member of the individual and the genetic information of any embryo legally held by the individual or family member using an assisted reproductive technology.
Here, an individual who was offered a position with Fabricut was required to take a pre-employment (post-offer) medical exam, during which her family medical history was compiled, in violation of GINA. Based on this history and testing performed by its contract medical examiner, the company told the newly hired employee that she needed to be evaluated for carpal tunnel syndrome (CTS), a type of neuropathy that can result in muscle weakness and a marked inability to perform repetitive tasks (and which can have a genetic component). The employee’s own doctor concluded she did not have CTS, but the company nonetheless rescinded her job offer. In the consent decree, Fabricut will pay $50,000, in addition to undertaking “the posting of an anti-discrimination notice to employees, dissemination of anti-discrimination policies to employees and providing anti-discrimination training to employees with hiring responsibilities.” The lawsuit had also alleged a violation of the American with Disabilities Act (ADA) in that its failure to hire the employee was based on the fact that she was “regarded as” having a disability, in violation of the statute (the ADA also has guidelines on when medical exams can be required in the workplace in general). In 2001, the EEOC reached a settlement with Burlington Northern Santa Fe Railway over the misuse of genetic information under the ADA, where the company attempted to deny disability payments by surreptitious genetic testing of its employees for susceptibility to CTS. At the time, GINA did not exist, and the ADA was used to capture what resembled genetic discrimination in the absence of a more directed statute. Now, GINA exists, and the EEOC can charge genetic discrimination directly. The statistics on genetic discrimination complaints filed with the EEOC for 2012 reveal that of the 280 GINA charges investigated by the EEOC, approximately 59% found no reasonable cause, while approximately 13% did find reasonable cause. The trendline shows an increase in GINA complaints every year. Although many employers are aware of GINA and the general prohibition against genetic discrimination, the Fabricut case will further emphasize how employers must steer clear of collecting genetic information in the course of otherwise legitimate employment-related medical exams, and how GINA builds on the ADA protections for employees or applicants against extraneous medical inquiries by employers.