AMERICAN ASSOCIATION FOR AFFIRMATIVE ACTION <br />In partnership with New Jersey Affirmative Action Officers’ Council (NJA...
Presentation by Ronald W. Brown, Esq.<br />Recent Legal Developments: A Presentation on the Genetic Information Non-Discri...
AN OVERVIEW OF THE GENETIC INFORMATION NONDISCRIMINATION ACT<br />Presentation by Ronald W. Brown, Esq.<br />
G.I.N.A. IN THE WORKPLACE: CASE SCENARIO<br />While on break at a work water cooler, Carol tells her coworker Bob about th...
G.I.N.A. IN THE WORKPLACE:  CASE SCENARIO continued <br />Carol’s supervisor, Ted, walks by and overhears the conversation...
G.I.N.A. IN THE WORKPLACE:  CASE SCENARIO continued <br />Presentation by Ronald W. Brown, Esq.<br />Carol starts using “s...
G.I.N.A. IN THE WORKPLACE:  CASE SCENARIO #1 continued <br />Furious, Carol leaves the performance review, goes back to he...
G.I.N.A. IN THE WORKPLACE:  CASE SCENARIO #1 continued <br />Carol also starts coming to work wearing Jeans for Genes  wit...
Four Answers to the Question: What Do You Do?<br />1. If you need it, ask for help from functional “superheroes” with SME,...
G.I.N.A. IN THE WORKPLACE: CASE SCENARIO <br />Q1. Can Carol be fired or denied a promotion due to her risk of Huntington’...
G.I.N.A.<br />Title I<br />Title II<br />Prohibits discrimination in health coverage based on genetic information.<br />Pr...
WHO ENFORCES G.I.N.A?<br />The Department of Labor, the Department of the Treasury, and the Department of Health and Human...
The Use and Misuse of Genes and Genetic Information Have Popped Up In A Variety of Older Sci-Fi and Film Contexts <br />Pr...
Genetic Testing Issues Have Popped Up In A More Recent Film  Context<br />“Officially they are called ‘In-valids’…They are...
Genetic Testing Issues Have Popped Up In A Variety of Contexts: Major League Baseball <br />In July, 2009, Major League Ba...
G.I.N.A. <br />In A Nutshell<br />The law forbids discrimination on the basis of genetic information when it comes to any ...
G.I.N.A In A Nutshell<br />Title II of G.I.N.A. prohibits use of genetic information in the employment context, restricts ...
G.I.N.A. IN A  Nutshell—What Is and What Is Not A Genetic Test?<br />“Genetic test” refers to “analysis of human DNA, RNA,...
G.I.N.A. IN A NUTSHELL<br />Information about race and ethnicity that is not derived from a genetic test is not “genetic i...
Gene Testing and State Intervention<br />Overall, 24 states prohibit or limit so-called direct access testing without a do...
Gene Testing and State Intervention<br />“New York State’s Department of Health sent letters raising the specter of fines ...
Gene Testing and State Intervention<br />“California’s  Department of Public Health sent cease-and-desist letters to 13 co...
Genetic Testing Legislation : There Are A Number of State Proposals<br /> G.I.N.A. sets a floor, not a ceiling. <br /> Sta...
The Legislative Landscape:Proposed Laws--Massachusetts<br /> The Massachusetts Genetic Bill of Rights, (“MAGBR”)introduced...
The Legislative Landscape: Proposed Laws--California<br />SB 559 seeks to “expand the bases upon which discrimination is p...
The Growth of Genetic Testing and the Direct To Consumer Market<br />In 1995, only about 300genetic tests were available.<...
Genetic Testing and the Direct To Consumer Market Today<br />Direct-to-consumer (DTC) genetic tests are available from ret...
Presentation by Ronald W. Brown, Esq.<br />
The Food and Drug Administration<br />In March 2011, the FDA’s Molecular and Clinical Genetics Advisory Panel recommended ...
Three Upshots from the Growth in Genetic Testing in the DTC Market<br />#1.	 A lot more information is going to be availab...
Upshot from the Growth in Genetic Testing in the DTC Market<br />#2.	The meaning of DTC genetic test results may be misint...
Upshot from the Growth in Genetic Testing in the DTC Market<br />#3. Users of the test may tell someone their test results...
G.I.N.A. IN THE WORKPLACE: CASE SCENARIO <br />Q1. Can Carol be fired or denied a promotion due to her risk of Huntington’...
Answers To The Case Study<br />No, Carol can not be fired or denied a promotion due to her risk of Huntington’s disease.<b...
Answers To The Case Study<br />“GINA indicates when an employer can legally have genetic information about an employee. Tw...
FINAL REGULATIONS UNDER G.I.N.A.—THE WATER COOLER EXCEPTION<br />The `water cooler problem' arises when an employer unwitt...
THE SAFE HARBOR PROVISION<br />  “The Equal Employment Opportunity Commission  included a safe harbor for information acci...
THE SAFE HARBOR PROVISION<br /> However,  “in order for the safe harbor to apply, requests for information from healthcare...
SAMPLE LANGUAGE A COVERED ENTITY MIGHT USE TO PROVIDE THE NOTICE THAT WOULD BRING IT WITHIN THE SAFE HARBOR<br />‘‘The Gen...
EEOC  FINAL REGULATIONS UNDER G.I.N.A. EFFECTIVE JANUARY 10, 2011—”REQUESTING”  INFOMATION<br />An employer who does the f...
SIX THINGS EVERY EMPLOYER MUST DO<br />#1.  Understand what G.I.N.A. requires you to do and not  to do.<br />#2.  Map out ...
SIX THINGS EVERY EMPLOYER MUST DO<br />#3. Update your non-discrimination policies  and procedures to include  G.I.N.A.<br...
SIX THINGS EVERY EMPLOYER MUST DO<br />#4. Incorporate the safe harbor language into the forms you utilize for requesting ...
SIX THINGS EVERY EMPLOYER MUST DO<br />#5. Do not discriminate or retaliate against a person on the basis of protected gen...
SIX THINGS EVERY EMPLOYER MUST DO<br />#6. Do not request, require, or purchase genetic information about an individual or...
G.I.N.A. AND Corporate Wellness and Disease Management Programs<br />Presentation by Ronald W. Brown, Esq.<br />
G.I.N.A. AND Corporate Wellness and Disease Management Programs<br />This is a potential minefield.<br />However, an emplo...
The E.E.O.C.<br /> Most of the GINA complaints received by the Equal Employment Opportunity Commission  involve situations...
The Pre-G.I.N.A. Legal Landscape<br />EEOC  v, Burlington Northern Santa Fe (2002 Settlement) (Alleged violation of ADA) <...
The Current G.I.N.A  Landscape: CHARGES WITH THE E.E.O.C.  IN 2010<br />Presentation by Ronald W. Brown, Esq.<br />
Fink v MXEnergy Company<br />The first case alleging termination because of genetic information <br />Fink's attorney, Gar...
Fink v MXEnergy Company<br />The first lawsuitunder the Genetic Information Nondiscrimination Act (GINA) has been filed. (...
Fink v MXEnergy Company<br /><ul><li>In 2004, Fink and her two sisters had genetic tests  done at the Yale Cancer Center.
The tests showed all three carried the BRCA2 gene.
That gene predisposed them to developing breast cancer.</li></ul>Presentation by Ronald W. Brown, Esq.<br />
Fink v MXEnergy Company<br />Both of Fink’s sisters developed breast cancer, but survived with treatment. After several bi...
Fink v MXEnergy Company<br /><ul><li>Fink took four weeks off, during which a consultant took over her duties. In the mont...
Fink says she started to receive negative performance reviews, which hadn’t been the case in her previous four years with ...
Fink v MXEnergy Company<br /><ul><li>Fink then sued, saying her termination was illegal because it was brought on by her m...
GINA, bars discrimination against an employee based on the person’s genetic information and medical history. “Genetic info...
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Overview of the Genetic Information Nondiscrimination Act

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Overview of the Genetic Information Non-Discrimination Act

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  • My overview is going to start with a scenario that you could be faced with. The scenario ends with a question. My presentation will enable you to answer the question when we come back to the scenario a bit later.
  • If you are a Star Trek fan, then you know about Ricardo Montalbán portraying Khan Noonien Singh. According to Wikipedia, Khan was a “genetically enhanced superhuman who used his strength and intellect to briefly rule much of Earth in the 1990s. Again, as summarized in Wikipedia, the plot of the Wrath of Khan “ features James T. Kirk (William Shatner) and the crew of the starship USS Enterprise facing off against the genetically-engineered tyrant Khan Noonien Singh (Ricardo Montalbán), a character who first appeared in the 1967 Star Trek television series episode &quot;Space Seed“. “Montalbán said that he believed all good villains do villainous things, but think that they are acting for the &quot;right&quot; reasons; in this way, Khan uses his anger at the death of his wife to justify his pursuit of Kirk.[6] Contrary to speculation that Montalbán used a prosthetic chest, no artificial devices were added to Montalbán&apos;s muscular physique.[5] Montalbán enjoyed making the film, so much so that he played the role for much less than was offered him, and counted the role as a career highlight.”
  • These italicized words reflect a vision of a genetic discriminating future that would give anyone pause, and which G.I.N.A. type laws are intended to guard against. There is a risk that what is science fiction today can become science fact tomorrow.The name Gattaca was derived from the four basic chemical building blocks or nucleotides of DNA: Guanine (G), Adenine (A), Thymine (T), and Cytosine (C).Here is a plot summary of the film: “Vincent is one of the last &quot;natural&quot; babies born into a sterile, genetically-enhanced world, where life expectancy and disease likelihood are ascertained at birth. Myopic and due to die at 30, he has no chance of a career in a society that now discriminates against your genes, instead of your gender, race or religion. Going underground, he assumes the identity of Jerome, crippled in an accident, and achieves prominence in the Gattaca Corporation, where he is selected for his lifelong desire: a manned mission to Saturn&apos;s 14th moon (titan). Constantly passing gene tests by diligently using samples of Jerome&apos;s hair, skin, blood and urine, his now-perfect world is thrown into increasing desperation, his dream within reach, when the mission director is killed - and he carelessly loses an eyelash at the scene! Certain that they know the murderer&apos;s ID, but unable to track down the former Vincent, the police start to close in, with extra searches, and new gene tests. With the once-in-a-lifetime launch only days away, Vincent must avoid arousing suspicion, while passing the tests, evading the police, and not knowing whom he can trust... Written by Cynan Rees &lt;cynanrees@hotmail.com&gt; “
  • “DTC testing encompasses two separate but related issues: claims made about the tests to induce purchase (e.g., through advertising); and the sale of genetic testing services and provision of test results directly to consumers. In regards to the former, critics argue that consumers are vulnerable to being misled by advertisements and lack the knowledge to make appropriate decisions about whether to get tested or how to interpret the results. Consumers with little knowledge of genetics might have difficulty distinguishing between tests widely used and accepted by medical professionals (such as those for mutations causing cystic fibrosis), and those whose validity is unproven in the scientific literature (such as those purporting to predict risk of depression or an appropriate skin care regimen). Advertisements may also underemphasize the uncertainty of genetic testing results, or exaggerate the risk and severity of a condition for which testing is available, thus increasing consumer anxiety and promoting unnecessary testing. Some companies that advertise tests directly to consumers require that they see their doctors in order to have the tests performed, while others allow individuals to send samples directly to the laboratory and receive the results at home. In the first case health care providers have the opportunity to guide patients away from unneeded tests and to clarify the results when they arrive, although surveys have shown that many health care providers lack adequate knowledge and training to provide quality genetic counseling. Taking tests without a provider’s supervision increases the likelihood of harmful outcomes to consumers, ranging from wasted money to loss of genetic privacy to basing major decisions — such as whether to have a child or take a certain medication — on faulty information. Whether health care provider authorization is required to obtain a genetic test, or any laboratory test, is the province of state law. Some states explicitly authorize laboratories to accept samples from and deliver test results for specific tests (such as cholesterol or pregnancy tests) directly to patients without authorization from a health care provider. Other states categorically prohibit all DTC testing. And still other states are silent on the issue, which leaves it up to individual laboratories to decide whether to offer DTC testing. Currently, 25 states and the District of Columbia permit DTC laboratory testing without restriction, whereas 13 categorically prohibit it. DTC testing for certain specified categories of tests is permitted in 12 states; these laws would likely not extend to genetic tests. It should be noted that even when a health care provider&apos;s order is required, the provider may have a conflict of interest if he or she is employed by the laboratory offering the testing. “ The Food and Drug Administration (FDA) has authority to regulate claims made by products under its jurisdiction. However, currently, FDA regulates only those genetic tests that are sold as “test kits” and used by laboratories to perform testing. FDA considers test kits to be medical devices and requires that they undergo premarketreview before they can be made commercially available. Since the vast majority of genetic tests are instead developed by the laboratory, neither tests nor claims made about them is subject to FDA oversight.”John Hopkins, Genetics and Public Policy Center.
  • The EEOC filed suite against BNSF “for secretly testing its employees for a rare genetic condition that causes carpal tunnel syndrome as one of its symptoms.” BNSF claimed the testing was a way of determining whether the high incidence of repetitive-stress injuries was work related. “Besides testing for this rare problem, company-paid doctors were also instructed to screen for several other medical conditions such as diabetes and alcoholism.” Employees were not told they were being genetically tested and one employee who refused testing was threatened with possible termination. EEOC argued the tests were unlawful under the ADA because they were not job related and any condition of employment based on such tests would be cause for illegal discrimination based on disability.” Thirty six Burlington employees received a total of $2.2 million.The Bloodsaw case raised the question whether a clerical or administrative worker who undergoes a general employee health examination may, without his or her knowledge, be tested for highly private and sensitive medical and genetic information such as syphilis, sickle cell trait, and pregnancy. Lawrence Berkeley Laboratory is a research institution jointly operated by state and federal agencies. Plaintiffs- appellants, present and former employees of Lawrence, allege that in the course of their mandatory employment entrance examinations and on subsequent occasions, Lawrence, without their knowledge or consent, tested their blood and urine for intimate medical conditions -- namely, syphilis, sickle cell trait, and pregnancy. Their complaint asserts that this testing violated Title VII of the Civil Rights Act of 1964, the Americans with Disabilities Act (ADA), and their right to privacy as guaranteed by both the United States and State of California Constitutions. The district court granted the defendants-appellees&apos; motions for dismissal, judgment on the pleadings, and summary judgment on all of plaintiffs- appellants&apos; claims. The U.S. Court of Appeals, Ninth Circuit, affirmed as to the ADA claims, but reversed as to the Title VII and state and federal privacy claims.
  • Overview of the Genetic Information Nondiscrimination Act

    1. 1. AMERICAN ASSOCIATION FOR AFFIRMATIVE ACTION <br />In partnership with New Jersey Affirmative Action Officers’ Council (NJAAOC) <br />Access, Equity and Diversity Summit <br />The Atlantic City Convention Center <br />A PRESENTATION BY <br />RONALD W. BROWN, ESQ.<br />
    2. 2. Presentation by Ronald W. Brown, Esq.<br />Recent Legal Developments: A Presentation on the Genetic Information Non-Discrimination Act<br />
    3. 3. AN OVERVIEW OF THE GENETIC INFORMATION NONDISCRIMINATION ACT<br />Presentation by Ronald W. Brown, Esq.<br />
    4. 4. G.I.N.A. IN THE WORKPLACE: CASE SCENARIO<br />While on break at a work water cooler, Carol tells her coworker Bob about the battle her mom is having with Huntington’s disease. Carol tells Bob that “Huntington’s disease is a progressive, degenerative disease” that causes certain nerve cells in the brain to waste away. As a result,” a person may experience uncontrolled movements, emotional disturbances and mental deterioration.” <br />Carol tells Bob that she fears she is at risk for this genetic disease and that she periodically uses in the rest room at work, a Direct To Consumer testing kit she purchased over the Internet.<br />Presentation by Ronald W. Brown, Esq.<br />
    5. 5. G.I.N.A. IN THE WORKPLACE: CASE SCENARIO continued <br />Carol’s supervisor, Ted, walks by and overhears the conversation. Carol becomes concerned that she may be treated differently by Ted or fired due to her risk for developing HD. Carol starts reading about the disease during her lunch time at work.<br />Presentation by Ronald W. Brown, Esq.<br />
    6. 6. G.I.N.A. IN THE WORKPLACE: CASE SCENARIO continued <br />Presentation by Ronald W. Brown, Esq.<br />Carol starts using “sick days” in order to take her mom to the doctor. At her annual performance review, Ted gives Carol numbers that are so low they will preclude her qualifying for the promotion she wanted and would otherwise get. <br />Carol had always had stellar reviews in the past. When Carol asks Ted about the numbers, Ted tells her “Carol, you are no longer a team player. Whenever I really need you here working you are out sick.”<br />He also says, “Carol, you are not as mentally sharp as you used to be. You seem to be emotionally disturbed and deteriorating mentally. What’s wrong with you?”<br />
    7. 7. G.I.N.A. IN THE WORKPLACE: CASE SCENARIO #1 continued <br />Furious, Carol leaves the performance review, goes back to her cubicle. Saying “He does not know who he is messing with!”, she proceeds to put up two posters. One reads” Power to the People”. Every time she passes it she starts chanting: “United, the people, can never be defeated!”<br />The other is A Genetic Bill of Rights poster that reads “All People Have The Right To Be Free From Genetic Discrimination.” <br />Presentation by Ronald W. Brown, Esq.<br />
    8. 8. G.I.N.A. IN THE WORKPLACE: CASE SCENARIO #1 continued <br />Carol also starts coming to work wearing Jeans for Genes with a button that reads “How my jeans fit or my genes behave is none of this company’s business!”<br />Presentation by Ronald W. Brown, Esq.<br />Carol comes to you as EEO-AA officer to file a G.I.N.A. claim. What do you do?<br />
    9. 9. Four Answers to the Question: What Do You Do?<br />1. If you need it, ask for help from functional “superheroes” with SME, e.g. legal, medical, etc.<br />. 2. Familiarize yourself with what G.I.N.A. is, what it covers, and what it does not cover.<br />3. Determine if you need to adapt your normal investigative procedures to fit G.I.N.A.<br />Presentation by Ronald W. Brown, Esq.<br />4. Focus on answering at least the following two important questions.<br />
    10. 10. G.I.N.A. IN THE WORKPLACE: CASE SCENARIO <br />Q1. Can Carol be fired or denied a promotion due to her risk of Huntington’s disease?<br />Q2. If Carol needs to take a leave under FMLA to care for her mom, can the employer use the information on the forms to discriminate against Carol?”<br />Presentation by Ronald W. Brown, Esq.<br />
    11. 11. G.I.N.A.<br />Title I<br />Title II<br />Prohibits discrimination in health coverage based on genetic information.<br />Prohibits discrimination in employment based on genetic information.<br />Presentation by Ronald W. Brown, Esq.<br />
    12. 12. WHO ENFORCES G.I.N.A?<br />The Department of Labor, the Department of the Treasury, and the Department of Health and Human Services have specific responsibilities for enforcing the health insurance provisions.<br />Presentation by Ronald W. Brown, Esq.<br /><ul><li>The E.E.O.C is responsible for enforcing the employment provisions.</li></li></ul><li>What is Genetic Discrimination?<br />“Genetic discrimination occurs if people are treated unfairly because of differences in their DNA that increase their chances of getting a certain disease.”<br />Presentation by Ronald W. Brown, Esq.<br />
    13. 13. The Use and Misuse of Genes and Genetic Information Have Popped Up In A Variety of Older Sci-Fi and Film Contexts <br />Presentation by Ronald W. Brown, Esq.<br />
    14. 14. Genetic Testing Issues Have Popped Up In A More Recent Film Context<br />“Officially they are called ‘In-valids’…They are the ‘healthy ill’. They don’t actually have anything yet—they may never have. But since few of the pre-conditions can be cured or reversed, it is easier to treat them as if they were already sick.”<br />Pre-G.I.N.A.?<br />Presentation by Ronald W. Brown, Esq.<br />
    15. 15. Genetic Testing Issues Have Popped Up In A Variety of Contexts: Major League Baseball <br />In July, 2009, Major League Baseball used DNA testing to determine if Miguel Sano, a prospect from the Dominican Republic, was really 16 years old. MLB said that testing in the Dominican Republic is used“ in very rare instances and only on a consensual basis to deal with the identity fraud problem that the league faces in that country.” The statement added that the results of the tests were not used for any other purpose.<br />Presentation by Ronald W. Brown, Esq.<br />Also in July 2009, the New York Yankees voided the signing of an amateur from the Dominican Republic after a DNA test conducted by Major League Baseball’s department of investigations showed that the player had misrepresented his identity.<br />
    16. 16. G.I.N.A. <br />In A Nutshell<br />The law forbids discrimination on the basis of genetic information when it comes to any aspect of employment, including hiring, firing, pay, job assignments, promotions, layoffs, training, fringe benefits, or any other term or condition of employment. <br />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 any disease, disorder, or condition of an individual’s family members (i.e. an individual’s family medical history). <br />“An employer may never use genetic information to make an employment decision because genetic information doesn’t tell the employer anything about someone’s current ability to work.”<br />Presentation by Ronald W. Brown, Esq.<br />
    17. 17. G.I.N.A In A Nutshell<br />Title II of G.I.N.A. prohibits use of genetic information in the employment context, restricts employers and other entities covered by Title II from requesting, requiring, or purchasing genetic information, and strictly limits such entities from disclosing genetic information. <br />Presentation by Ronald W. Brown, Esq.<br />
    18. 18. G.I.N.A. IN A Nutshell—What Is and What Is Not A Genetic Test?<br />“Genetic test” refers to “analysis of human DNA, RNA, chromosomes, proteins, or metabolites that detects genotypes, mutations, or chromosomal changes.”<br />“Tests to determine whether an individual carries the genetic variant evidencing a predisposition to breast cancer, colorectal cancer are genetic tests.”<br />“Tests for infectious and communicable diseases that may be transmitted through food handling, complete blood counts, cholesterol tests, and liver-function tests are not genetic tests.”<br />Presentation by Ronald W. Brown, Esq.<br />
    19. 19. G.I.N.A. IN A NUTSHELL<br />Information about race and ethnicity that is not derived from a genetic test is not “genetic information” for purposes of GINA.<br />Presentation by Ronald W. Brown, Esq.<br />
    20. 20. Gene Testing and State Intervention<br />Overall, 24 states prohibit or limit so-called direct access testing without a doctor or other medical professional’s involvement”—Forbes<br />Presentation by Ronald W. Brown, Esq.<br />
    21. 21. Gene Testing and State Intervention<br />“New York State’s Department of Health sent letters raising the specter of fines and jail time to six online gene-testing firms that offer consumers the ability to pear into their genome to assess the risk of getting disease. Often, it turns out, the services offering these DNA deep-dives are doing so without the involvement of a doctor. That puts them on the wrong side of the law.”--Forbes<br />Presentation by Ronald W. Brown, Esq.<br />
    22. 22. Gene Testing and State Intervention<br />“California’s Department of Public Health sent cease-and-desist letters to 13 companies that offer gene testing to consumers via the Web. California law requires that a licensed physician order any lab tests, including genetic tests, All lab tests must also be validated for accuracy and medical utility. These businesses are apparently operating without a clinical laboratory license in California. And they are scaring a lot of people to death.”--Forbes<br />Presentation by Ronald W. Brown, Esq.<br />
    23. 23. Genetic Testing Legislation : There Are A Number of State Proposals<br /> G.I.N.A. sets a floor, not a ceiling. <br /> States can go beyond G.I.N.A ., and some states are proposing legislation doing just that.<br />Presentation by Ronald W. Brown, Esq.<br />
    24. 24. The Legislative Landscape:Proposed Laws--Massachusetts<br /> The Massachusetts Genetic Bill of Rights, (“MAGBR”)introduced on 1/21/11 seeks “to place genetic information on a par with medical records” <br /> MAGBR declares GI “to be the exclusive property of the individual from whom the information was obtained” and prohibits use of GI for marketing or determining creditworthiness.”<br />Presentation by Ronald W. Brown, Esq.<br />
    25. 25. The Legislative Landscape: Proposed Laws--California<br />SB 559 seeks to “expand the bases upon which discrimination is prohibited” under California law to include genetic information.<br /> Provides that California has a “compelling public interest in” both “realizing the medical promise of genetics” and “relieving the fear of discrimination and in prohibiting its actual practice.”<br />Would prohibit discrimination based on genetic information “in the areas of housing, employment, education, public accommodations, health insurance coverage, life insurance coverage, mortgage lending and elections,”<br />
    26. 26. The Growth of Genetic Testing and the Direct To Consumer Market<br />In 1995, only about 300genetic tests were available.<br />Presentation by Ronald W. Brown, Esq.<br /><ul><li>Most of those tests were for rare diseases and were usually performed in research settings. </li></li></ul><li>Genetic Testing and the Direct To Consumer Market Today<br />More than 2,000 genetic tests are available to health care consumers and providers, and in a variety of settings, including churches and direct mail. <br />Presentation by Ronald W. Brown, Esq.<br />
    27. 27. Genetic Testing and the Direct To Consumer Market Today<br />Direct-to-consumer (DTC) genetic tests are available from retailers and the Internet.<br /> DTC is rapidly expanding market. There are now some 1,300 things you can be genetically tested for – including a genetic susceptibility to cystic fibrosis, muscular dystrophy, hemophilia, Huntington's chorea, sickle cell disease, multiple sclerosis, Cohn's disease, breast cancer, diabetes, heart disease and Alzheimer's.<br />Presentation by Ronald W. Brown, Esq.<br />
    28. 28. Presentation by Ronald W. Brown, Esq.<br />
    29. 29. The Food and Drug Administration<br />In March 2011, the FDA’s Molecular and Clinical Genetics Advisory Panel recommended that “Certain types of genetic tests that are available for at-home use without a prescription should not be used without the involvement of a physician or genetic specialist . The panel wasn’t clear on whether that would mean a physician would have to order the test, or if a physician would have to interpret the test, or both. That will ultimately be up to the FDA to decide.” http://abcnews.go.com March 12, 2011.<br />Presentation by Ronald W. Brown, Esq.<br />
    30. 30. Three Upshots from the Growth in Genetic Testing in the DTC Market<br />#1. A lot more information is going to be available to users of the tests.<br />Presentation by Ronald W. Brown, Esq.<br />
    31. 31. Upshot from the Growth in Genetic Testing in the DTC Market<br />#2. The meaning of DTC genetic test results may be misinterpreted. (False Negatives and False Positives) <br />Presentation by Ronald W. Brown, Esq.<br />
    32. 32. Upshot from the Growth in Genetic Testing in the DTC Market<br />#3. Users of the test may tell someone their test results at work. That information could be overheard, and misused.<br />Presentation by Ronald W. Brown, Esq.<br />
    33. 33. G.I.N.A. IN THE WORKPLACE: CASE SCENARIO <br />Q1. Can Carol be fired or denied a promotion due to her risk of Huntington’s disease?<br />Q2. If Carol needs to take a leave under FMLA to care for her mom, can the employer use the information on the forms to discriminate against Carol?”<br />Presentation by Ronald W. Brown, Esq.<br />
    34. 34. Answers To The Case Study<br />No, Carol can not be fired or denied a promotion due to her risk of Huntington’s disease.<br />No, the employer can not use information on a FMLA form to discrimination against Carol.<br />Case and answers from the Genetics and Public Policy Center website<br />Presentation by Ronald W. Brown, Esq.<br />
    35. 35. Answers To The Case Study<br />“GINA indicates when an employer can legally have genetic information about an employee. Two examples: (1) An employer accidentally becomes aware (overhearing a conversation); (2) When an employee provides information for family and medical leave.”<br />“When an employer has genetic information, the employer can not use it to discriminate against an employee, and the information must be kept in a separate and confidential file.”<br />Case and answers from the Genetics and Public Policy Center website<br />Presentation by Ronald W. Brown, Esq.<br />
    36. 36. FINAL REGULATIONS UNDER G.I.N.A.—THE WATER COOLER EXCEPTION<br />The `water cooler problem' arises when an employer unwittingly receives otherwise prohibited genetic information in the form of family medical history through casual conversations with an employee” or by overhearing conversations among co-workers. Congress did not want casual conversation among co-workers regarding health to trigger federal litigation whenever someone mentioned something that might constitute protected family medical history. <br />Presentation by Ronald W. Brown, Esq.<br />The Commission's proposed regulation therefore noted that a covered entity “inadvertently acquires family medical history” where a manager or supervisor overhears a conversation among co-workers that includes information about family medical history (e.g., a conversation in which one employee tells another that her father has Alzheimer's disease or her mother has Huntington’s disease).<br />
    37. 37. THE SAFE HARBOR PROVISION<br /> “The Equal Employment Opportunity Commission included a safe harbor for information accidently received as part of a request for documentation to support requests for reasonable accommodation or FMLA requests.”<br />Presentation by Ronald W. Brown, Esq.<br />
    38. 38. THE SAFE HARBOR PROVISION<br /> However, “in order for the safe harbor to apply, requests for information from healthcare providers must clearly warn the healthcare provider that requests for health information should notinclude genetic information. “ <br />Presentation by Ronald W. Brown, Esq.<br />
    39. 39. SAMPLE LANGUAGE A COVERED ENTITY MIGHT USE TO PROVIDE THE NOTICE THAT WOULD BRING IT WITHIN THE SAFE HARBOR<br />‘‘The Genetic Information Nondiscrimination Act of 2008 (GINA) prohibits employers and other entities covered by GINA Title II from requesting or requiring genetic information of employees or their family members. In order to comply with this law, we are asking that you not provide any genetic information when responding to this request for medical information. ‘Genetic information,’ as defined by GINA, includes an individual’s family medical history, the results of an individual’s or family member’s genetic tests, the fact that an individual or an individual’s family member sought or received genetic services, and genetic information of a fetus carried by an individual or an individual’s family member or an embryo lawfully held by an individual or family member receiving assistive reproductive services.’’<br />Presentation by Ronald W. Brown, Esq.<br />
    40. 40. EEOC FINAL REGULATIONS UNDER G.I.N.A. EFFECTIVE JANUARY 10, 2011—”REQUESTING” INFOMATION<br />An employer who does the following would be in violation of GINA: “conducting an Internet search on an individual in a way that is likely to result in a covered entity obtaining genetic information; actively listening to third-party conversations or searching an individual’s personal effects for the purpose of obtaining genetic information; and making requests for information about an individual’s current health status in a way that is likely to result in a covered entity obtaining genetic information.”<br />Presentation by Ronald W. Brown, Esq.<br />
    41. 41. SIX THINGS EVERY EMPLOYER MUST DO<br />#1. Understand what G.I.N.A. requires you to do and not to do.<br />#2. Map out a compliance strategy engaging key individuals with leadership skills to serve on a cross-functional compliance team: Management, Legal, Human Resources, and EEO-AA. If you have a corporate Medical Department, engage a leader from that group as well.<br />Presentation by Ronald W. Brown, Esq.<br />
    42. 42. SIX THINGS EVERY EMPLOYER MUST DO<br />#3. Update your non-discrimination policies and procedures to include G.I.N.A.<br />Presentation by Ronald W. Brown, Esq.<br />
    43. 43. SIX THINGS EVERY EMPLOYER MUST DO<br />#4. Incorporate the safe harbor language into the forms you utilize for requesting business related health information (including ADA accommodation, FMLA or state equivalent).<br />Presentation by Ronald W. Brown, Esq.<br />
    44. 44. SIX THINGS EVERY EMPLOYER MUST DO<br />#5. Do not discriminate or retaliate against a person on the basis of protected genetic information in any employment context.<br />Presentation by Ronald W. Brown, Esq.<br />
    45. 45. SIX THINGS EVERY EMPLOYER MUST DO<br />#6. Do not request, require, or purchase genetic information about an individual or their family members, for example, a wellness program with a premium discount or waiver if the participant takes a health risk assessment.<br />Presentation by Ronald W. Brown, Esq.<br />
    46. 46. G.I.N.A. AND Corporate Wellness and Disease Management Programs<br />Presentation by Ronald W. Brown, Esq.<br />
    47. 47. G.I.N.A. AND Corporate Wellness and Disease Management Programs<br />This is a potential minefield.<br />However, an employer is allowed to collect genetic information for corporate wellness and disease management programs with three provisos.<br />#1: That employees give “prior, knowing, voluntary, and written consent”.<br />#2: That the employer only receives the genetic information in aggregate form.<br />#3: That the employee does not have to fill out a health risk assessment form in order to get a reward.<br />Presentation by Ronald W. Brown, Esq.<br />
    48. 48. The E.E.O.C.<br /> Most of the GINA complaints received by the Equal Employment Opportunity Commission involve situations in which an employer had improperly acquired or had disclosed genetic information. <br />Presentation by Ronald W. Brown, Esq.<br />
    49. 49. The Pre-G.I.N.A. Legal Landscape<br />EEOC v, Burlington Northern Santa Fe (2002 Settlement) (Alleged violation of ADA) <br />Norman-Bloodsaw v. Lawrence Berkeley Laboratory, 135 F.3d 1260 (9th Cir. 1998<br />
    50. 50. The Current G.I.N.A Landscape: CHARGES WITH THE E.E.O.C. IN 2010<br />Presentation by Ronald W. Brown, Esq.<br />
    51. 51. Fink v MXEnergy Company<br />The first case alleging termination because of genetic information <br />Fink's attorney, Gary Phelan, of the Stamford- and New York-based law firm Outten & Golden, said Fink is the first person in Connecticut to file a complaint under the new law, known as GINA. Fink filed complaints with both state employment officials and the Equal Employment Opportunity Commission (EEOC).<br />Presentation by Ronald W. Brown, Esq.<br />
    52. 52. Fink v MXEnergy Company<br />The first lawsuitunder the Genetic Information Nondiscrimination Act (GINA) has been filed. (June ,2010)<br />Fink was the public relations director for MXenergy from 2006 until her dismissal in March.<br />Presentation by Ronald W. Brown, Esq.<br />
    53. 53. Fink v MXEnergy Company<br /><ul><li>In 2004, Fink and her two sisters had genetic tests done at the Yale Cancer Center.
    54. 54. The tests showed all three carried the BRCA2 gene.
    55. 55. That gene predisposed them to developing breast cancer.</li></ul>Presentation by Ronald W. Brown, Esq.<br />
    56. 56. Fink v MXEnergy Company<br />Both of Fink’s sisters developed breast cancer, but survived with treatment. After several biopsies and frightening false alarms, Fink opted for a preventative double mastectomy last year.<br />Feeling comfortable in what she described as a supportive work environment, on her own initiative, she told her bosses at MXenergy about her genetic tests and the surgery.<br />"I'd had great reviews, I had merit increases, I had bonuses. I really felt it was a place where I could be comfortable and confident and be honest with them, and that was a mistake,“ Fink said.<br />Presentation by Ronald W. Brown, Esq.<br />
    57. 57. Fink v MXEnergy Company<br /><ul><li>Fink took four weeks off, during which a consultant took over her duties. In the months following her return to work, the consultant became her permanent supervisor.
    58. 58. Fink says she started to receive negative performance reviews, which hadn’t been the case in her previous four years with the company. Finally, after she had taken an additional ten days off for a second procedure, she was fired.</li></ul>Fink said "I was a great employee and I did really great work.” "The only thing that changed from the time that I had a great review to when I didn't was my two surgeries." <br />Presentation by Ronald W. Brown, Esq.<br />
    59. 59. Fink v MXEnergy Company<br /><ul><li>Fink then sued, saying her termination was illegal because it was brought on by her medical condition — not her on-the-job performance. She claims that her bosses gave her glowing evaluations for years — until her test results were revealed.
    60. 60. GINA, bars discrimination against an employee based on the person’s genetic information and medical history. “Genetic information” is defined under federal law as “information about an individual’s genetic tests, the genetic tests of that individual’s family members, and the manifestation of a disease or disorder in family members of the individual.”</li></ul>Company spokesman Todd Miller said MXenergy “emphatically and categorically” denies the allegations, but has a policy not to discuss personnel matters and will not comment further.<br />Presentation by Ronald W. Brown, Esq.<br />
    61. 61. THREE VIEWS FROM THREE LAWYERS AND A FINAL WORD FROM MRS. FINK<br />1. “The purpose of GINA is to offer protections from companies trying to purge their workforce of people who drive up health insurance costs, or those who could drive up costs based on test results that show they’re susceptible to certain diseases.”<br />2. “I can see [litigation] happening with more and more people as genetic testing becomes less costly and more available”.<br />3. The chairwoman of the board of the national Women’s Law Project says: “Unfortunately, I think in today’s day and age people have started sharing a lot more personal information about themselves, whether it’s in social media or in the workplace. I think it may behoove people to keep some of that information closer to the vest” .<br />Presentation by Ronald W. Brown, Esq.<br />
    62. 62. Fink v MXEnergy Company<br />Presentation by Ronald W. Brown, Esq.<br />

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