More States See Legislation That Conditions Abortion Rights on the Genetic Status of the Fetus

The ongoing legal battles over the scope of reproductive rights protected by the 14th Amendment  – with claims of constitutionally protected values of liberty and privacy invoked – continue, going back to the signature case of Roe v. Wade in 1973 and furthered tailored by Planned Parenthood v. Casey (1992), among other cases. Other arguments for the protection of reproductive autonomy are grounded in gender equality. Fast forwarding to the rapidly developing technological landscape of genetic testing, reproductive medicine has steadily refined the options available for prenatal testing to provide prospective parents with ever more accurate – and earlier obtained – medical information. The most dramatic development has been the availability of non-invasive prenatal diagnosis (NIPD) that relies on obtaining fetal DNA (cell-free detal DNA, cffDNA) from maternal blood as early as 4 weeks into gestation and to test for a number of genetic/chromosomal disorders, including Down syndrome (attributed to the presence of an extra chromosome 21, leading to a trisomy). NIPD has reduced the need for invasive procedures, such as chorionic villi sampling and/or amniocentesis. As prenatal testing becomes more sophisticated, an ongoing political battle rages over whether abortion rights should be restricted based on the intent or rationale of the mother for seeking the procedure. This has led to both state and federal efforts to restrict abortion when it is sought on the basis of gender, race or genetic anomaly (e.g., Down syndrome). Currently, a bill, HB 135, is pending in Ohio that would ban any abortion that is sought sought because prenatal testing reveals Down syndrome. North Dakota enacted a similar bill in 2013 (that same bill would have prohibited abortions about as early as 6 weeks; that portion was struck down by the Eighth Circuit in July of this year). To date, there are no reports of enforcement of these selective bans on abortion. Yet they raise not only the most obvious legal issue of whether such laws impinge on the constitutional right enshrined by Roe (or present the “undue burden” prohibited in Casey). They raise a novel issue of whether the legal rights accorded to the mother can vary according to genetic status of a fetus. Beyond that, express litigation over the constitutional concerns of the fetus itself would lead into the legal personhood legal battles that have been fought already (and overwhelmingly seen the defeat of attempted personhood ballot initiatives and legislation) (see earlier posts here and here). Thus, an indirect genetically-determined legal climate of maternal rights emerges if these laws work as intended – with the twist that the relevant genetic information is derived from the fetus. While is appears that these laws are unworkable as a practical matter, these bills can formally require the provider to question the mother about her motives and can impose felony charges on a physician violating the ban. The Ohio bill is likely to pass, and join the North Dakota bill alone in targeting maternal rights on the basis of a fetal genetic anomaly. Proponents of these bills have argued that, for example, the current climate of genetic testing only encourages the elimination of offspring with detectable genetic abnormalities, with the result that Down syndrome births become increasingly uncommon, and they invoke a kind of disability discrimination argument in support of these measures (however, that leads back to the fetal personhood debate). Opponents argue that the Roe-based constitutional right to seek an abortion – while certainly cabined by many modern legislative limitations – is not conditioned on maternal motive or the genetic status of the fetus, but is simply motivated by a desire to limit women's reproductive choices.

EEOC Files GINA Lawsuit Against Employer for Unlawful Collection of Genetic Information

The Equal Employment Opportunity Commission (EEOC) has filed a federal complaint against a Virginia employer, Bedford Weaving, Inc., alleging that the company illegally sought medical information from a job applicant, and used that information to deny her a job. The lawsuit relies on the Americans with Disabilities Act (ADA) and the Genetic Information Nondiscrimination Act (GINA), both of which are enforced by the EEOC. The ADA, enacted in 1992, prohibits an employer from taking any adverse position against an applicant or an employee based on a real or perceived disability. GINA, enacted in 2008, prohibits inquiries regarding family or personal medical history; such inquiries might reveal genetic disorders or susceptibilities that an employer might use in hiring, retaining or promoting employees. Title II of GINA prevents employers from requesting genetic information or making employment decisions based on genetic information: 

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. 

More background from the EEOC: 

Bedford Weaving operates a weaving manufacturing facility in Bedford, Va.  According to the complaint, Bedford Weaving's employment application asked applicants questions about their family medical history, solicited disability-related information, and contained questions about applicants' personal medical history.

Pamela Hedrick applied for work at the facility in August 2013 and filled out an application at that time. Hedrick suffers from chronic obstructive pulmonary disease and asthma, which she disclosed on her application in response to Bedford Weaving's illegal medical questions.  EEOC's complaint stated that Bedford Weaving told Hedrick it had no vacant positions, while in fact it had at least two vacant positions for which Hedrick was qualified. EEOC charged that Bedford Weaving failed to hire Hedrick because of her disability, which Bedford Weaving became aware of because Hedrick disclosed disability-related information on her application. 

The questions asked on the employment application and the alleged failure to hire due to the information disclosed, violate the Americans with Disabilities Act which prohibits employers from making disability-related inquiries of an applicant before a job offer, and from refusing to hire an individual due to a real or perceived disability. The questions also violate the Genetic Information Nondiscrimination Act (GINA), the federal law that prohibits employers from requesting genetic information, including family medical history, or using that information in the hiring process.  

The EEOC seeks back pay, compensatory damages and punitive damages as well as injunctive relief.

In 2014, the EEOC settled a class action enforcement action against an employer that violated GINA by making prohibited pre-employment medical inquiries (see here). As illustrated by the new EEOC filing, while GINA is centrally concerned with prohibiting discriminatory practices in the workforce that are based on the genetic status of applicants or employees, it includes strong prohibitions against employer acquisition of such genetic information, whether directly (genetic testing) or indirectly (family history). An academic study published earlier this year found that the general public is largely unaware of GINA or the legal protections against genetic discrimination. That conclusion is noteworthy, as a major impetus for GINA's passage was to alleviate fears by employees that genetic test results sought in medical care might lead to adverse action by an employer. However, most employees in the U.S. are not aware of these legal protections; nonetheless, the use of genetic testing in medical care today continues to increase.

Federal Court Establishes Broad Scope of Genetic Privacy Under Genetic Information Nondiscrimination Act (GINA)

In a first of its kind case involving the scope of genetic privacy afforded by federal law, a federal court has ruled that an employer violated the Genetic Information Nondiscrimination Act (GINA) when it requested DNA samples from two employees for an internal investigation. In Lowe v. Atlas Logistics Group Retail Services (N.D. Ga) a grocery distributor in Atlanta, Georgia (Atlas) was confronted with several instances where it appeared that an employee had defecated on a grocery warehouse floor. In order to determine the culprit, Atlas requested DNA samples from two employees suspected of committing these acts. The employees provided saliva for the DNA testing, but were excluded as suspects. However, the employees went on to sue the company for violating GINA, the federal law which prohibits employers from using genetic information they may acquire to discriminate in hiring, promotion or firing decisions. Employers are also barred from requesting genetic information of employees except in very limited circumstances. Until this case, there was almost no contemplation of scenarios where an employer might request genetic information for a forensic purpose in the context of actual employment (most allegations of GINA violations concern employer access to medical genetic information). However, the plaintiffs alleged that the Atlas request, albeit for non-medical purpose, violated a general GINA prohibition on employer access to genetic information. Atlas contended that the requested genetic information was not covered by GINA, and that the statute was intended to apply only to the gathering of disease-related medical information. The federal judge disagreed and sided with the plaintiffs, finding that Atlas had indeed violated GINA:

If all the Court considers is the language of GINA, the undisputed evidence in the record establishes that the DNA analysis at issue here clearly falls within the definition of “genetic test.”

Now, a federal jury has awarded $500,000 in compensatory damages and $1.75 million in punitive damages to the two plaintiffs. This case is likely to remain somewhat idiosyncratic in its facts, but it signals a broad interpretation for the protection afforded to employees by GINA, which should insulate them from any attempt by employers to use genetic information for general retainment purposes, even when the DNA information is non-medical in nature. Of course, the plaintiffs alleged that the acquisition of their genetic information for arguably limited purposes still allowed an employer the possibility of testing that DNA sample for other medically-related information, or to keep the sample for such purposes later; one could imagine scenarios where an employer might try to obscure the purpose for testing by hiding behind a forensic pretext. This case makes that less likely. Thus, the case is notable as the first GINA case in federal court to interpret the scope of subject matter encompassed by the statute; its conclusion that GINA is to be read broadly sets a genetic privacy baseline. To date, GINA has been largely been invoked not in private litigation, but in complaints submitted to the Equal Employment Opportunity Commission (EEOC) (see here).

EEOC Settles Its First Class Action Lawsuit on Genetic Discrimination

The Equal Employment Opportunity Commission (EEOC) has ramped up its vigilance over instances of genetic discrimination in the workplace. Last year, it filed its first class action lawsuit alleging violations of the Genetic Information Nondiscrimination Act (GINA), and this case has now settled. In the complaint, the EEOC charged that Founders Pavilion, a New York rehabilitation center, requested that job applicants provide a family medical history as part of its post-offer, pre-employment medical exams of applicants, in violation of GINA (ADA and Title VII claims were also advanced). Title II of GINA, passed by Congress in 2008 and enforced by the EEOC, prevents employers from requesting genetic information or making employment decisions based on genetic information: 

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. The EEOC enforces Title II of GINA (dealing with genetic discrimination in employment). The Departments of Labor, Health and Human Services and the Treasury have responsibility for issuing regulations for Title I of GINA, which addresses the use of genetic information in health insurance. 

The definition of genetic information in the statute is broad: 

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. 

Details of the settlement: 

As part of a five-year consent decree resolving the suit, Founders Pavilion will provide a fund of $110,400 for distribution to the 138 individuals who were asked for their genetic information. Founders Pavilion will also pay $259,600 to the five individuals who the EEOC alleged were fired or denied hire in violation of the ADA or Title VII. 

The EEOC enforcement portfolio for GINA is relatively new. The EEOC filed and then settled its first GINA case last year, and it subsequently filed another case in September. 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, and this is likely to continue. An emerging issue in the post-Affordable Care Act climate is a possible intersection of GINA data collection prohibitions with employer-provided wellness programs, which might involve making a health risk assessment (HRA) that impermissibly strays into the acquisition of genetic information in a manner that GINA prohibits. GINA’s relative invisibility in the civil rights toolkit of the EEOC will likely diminish over time.

More GINA Enforcement: EEOC Files Genetic Discrimination Class Action

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).

GINA Enforced: EEOC Settles Its First Genetic Discrimination Lawsuit

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.

Medical Professionals Weigh in on Genetic Policy Issues

The American Heart Association (AHA), a leading professional organization focused on cardiovascular (disease) medicine (CVD) has published an interesting and comprehensive overview of many relevant issues at the intersection of genetics, law and medicine that is worth looking at (published in the AHA journal, Circulation). The professional medical organizations (e.g., American Medical Association and others) have lent their expertise and engaged in advocacy on genetic legal issues over the last decade. They have been visible in the gene patent litigation, Association for Molecular Pathology v. U.S. Patent and Trademark Office (AMP v. USPTO) (headed back to court this summer), where they have largely opposed the granting of gene patents and filed amicus briefs in this ongoing litigation. Now, the AHA has provided its professional analysis and policy recommendations on the central legal/political debates in genetic medicine: gene patents (oppose the granting of gene patents); the possible use of genetic information to discriminate in employment and health care (supports the federal Genetic Information Nondiscrimination Act (GINA), and recommends its expansion to life and long-term insurance policies); the very critical issue of regulatory oversight of genetic tests in the marketplace (recommends that the FDA exercise its enforcement discretion to review and advise on the clinical validity of the laboratory-derived tests in genetic testing); further attention to the establishment of solid pharmacogenetic correlations before genetic information is used to guide drug prescribing and to solid research before genetic risk classifications become routine; further work on a consensus patient consent mechanism that would allow study participants to clearly understand the limits and benefits to participation in large-scale genetic studies; some standardization for insurance payment schemes for genetic tests, and, lastly, the AHA calls attention to the need for deeper practitioner training in genetics. Here are links to some earlier stories here on these issues: FDA regulation; pharmacogenomics, genetic discrimination. Some of the issues discussed in the AHA article require legal resolution (gene patents? FDA oversight?) while others are challenges and overtures to the professional field itself (the AHA calls for increasing development of the specialization of CVD and genetics). In sum, this article is a useful cataloging of the issues confronting all practitioners who increasingly make genetically-informed medical decisions (e.g. oncologists, neurologists, etc.) and provides a template and scorecard to monitor these issues.

Genetic Discrimination in Employment: EEOC and GINA

The federal Genetic Information Nondiscrimination Act (GINA) was enacted in 2008, after years of lobbying to get Congress to respond to the emergence of genetic discrimination in employment and access to health insurance. Title I of the law addresses the use of genetic information in health insurance, while Title II prohibits genetic discrimination in the workplace against job applicants and/or employees (and applies to all employers with 15 or more employees). The federal Equal Employment Opportunity Commission (EEOC) is charged with enforcement of Title II of GINA, and also enforces, inter alia, the prohibition of discrimination on the basis of race, color, religion, national origin or sex under Title VII of the 1964 Civil Rights Act, and the protection for disabled individuals under the 1992 American with Disabilities Act (ADA). Prior to GINA, the resolution of claims of genetic discrimination found support in existing constitutional doctrines. In Norman-Bloodsaw v. Lawrence Berkeley Laboratory (9th Circuit, 1998), a case that predated GINA, where employees were subject to surreptitious genetic testing for and subsequent use of genetic information in a racially discriminatory manner, the court sustained claims of 4th Amendment violations as well as violations of the right to privacy under the 14th Amendment and Title VII violations. From the court opinion: "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." In 2002, and also pre-GINA, the EEOC settled the case of genetic discrimination against the Burlington Northern and Santa Fe Railway Company under the ADA. A new EEOC GINA regulation took effect this month that further solidifies the inclusion of GINA into the repertoire of civil rights laws in the workplace, including Title VII and the ADA. Employers subject to GINA must now comply with record-retention requirements as rigorous as those that apply to the enforcement of Title VII and the ADA. These include standard retention periods for all records as well as specific preservation of records that pertain to a charge of discrimination filed under GINA. Recent statistics from the EEOC report that in 2011, of the 211 charges investigated by the EEOC, a quick comparison of outcomes that reflect factual determinations shows approximately 67% found no reasonable cause, while approximately 5% did find reasonable cause. We can expect that the further development of genetic susceptibility data will intersect with the workplace in complicated determinations of causation for claims of workplace-induced injury or disease; GINA will now provide some measure of legal protection where genetic information is either used to screen out job applicants or terminate employees based on genetic status. 

Breast Cancer Awareness Month: New Technologies, Legal Dimensions

October is Breast Cancer Awareness Month, and it’s useful to note that several breast cancer-related advances from molecular biology have become central modalities in the fight against the disease. But it’s also interesting to note that there are accompanying legal/regulatory issues that attend to the intersection of genetics and cancer diagnosis/treatment, not all of which are resolved. For example, the breakthrough treatment of Herceptin, an antibody that targets a protein on the surface of cancer cells, has been around for about 10 years or so, with several collateral dimensions: the cost of a biotech drug (high so far as a singular, uncompeted advance), the possibility of generic alternatives (the pending regulation of biosimilars onto market); the use of accompanying genetic testing to identify the patients who will benefit from the drug (a prototypical pharmacogenomics approach).  A quick look at the use of BRCA1/2 testing to identify high-risk individuals raises the very prominent issue of patent rights in genes (Myriad litigation still in the courts; see here for a paper tracing patent conflicts and breast cancer) and the possible misuse of genetic information, whether workplace or insurance (beginning to be addressed with the Genetic Information Nondiscrimination Act/GINA).  Lastly, the evolving regulatory environment for novel biotech drugs was acutely illustrated this year with the FDA’s decision to withdraw its approval for Avastin as a treatment for late stage breast cancer, with the concomitant loss of insurance coverage for patients seeking use of this high-priced drug.  So this particular field is paradigmatic of many collateral legal and/or regulatory aspects of new cancer-related technologies.

Genetic Predisposition and Workplace Exposure to Carcinogens: Discrimination?

The intersection of genetics and the workplace is evolving; the most obvious pressure point is that possibility that employer-provided health insurance will be used to procure genetic testing, raising potential for privacy violations as well as workplace decisions that are based on the knowledge of an employee’s genetic makeup. Most often cited is the prototypical example of an employee who learns that she tests positive for the mutation in the Huntingon’s disease gene and faces the certainly that this degenerative and life-shortening disease will develop. There are other concerns for the use of genetic information  by employers. The well-known case of the Burlington Northern Santa Fe Railway Co. engaging in surreptitious genetic testing of employees who claimed compensation benefits for work-derived carpal tunnel led to the filing of an employment/genetic discrimination suit and settlement mediated by the Equal Employment Opportunity Commission (EEOC) in 2001, which relied on enforcement through the Americans with Disabilities Act. The railroad was intent on contesting the workmen’s compensation claims by asserting that the employees had a genetic predisposition to carpal tunnel syndrome. The evolving field of molecular toxicology aims to link new techniques of genetic definition with classic toxicology testing, to develop a more precise profile for how chemical affect (human or other) life. Now comes a scientific report that a genetic mutation has been linked to the development of mesothelioma, a deadly cancer of the lining of the lungs, often seen in workers exposed to asbestos. There have been many claims for compensation for workers exposed to asbestos who later developed mesothelioma; this fact is often cited in the decline of many asbestos companies (e.g., Johns-Manville) who could not survive the onslaught of litigation brought by employees and filed for bankruptcy. For the law, the recent report on mesothelioma raises the specter of possible employer-contesting of workplace claims, as well as future studies to define a risk spectrum for those who will encounter asbestos.