Tuesday, July 21, 2009

Direct-To-Consumer Baby Gender Mentor Test in a Three Year Stalemate

In 2005, news headlines excitedly shared the latest development in direct-to-consumer testing: the Baby Gender Mentor early prenatal gender detection test. Acu-Gen Biolab, Inc., a company based in Lowell, Massachusetts, claimed that as early as five weeks, pregnant women could use a simple finger-prick test to obtain a blood sample and send it to Acu-Gen who would use “established qPCR technology analysis” to determine their baby’s sex. Originally claiming their $275 test was “infallible” and 99.9% accurate with a 200% money back guarantee, many expectant women relying on Acu-Gen’s claims eagerly purchased the test.

Months later, numerous accusations surfaced relating to the accuracy of the test, Acu-Gen’s failure to honor the warranty policy, and more disturbingly, allegations that C.N. Wang, PhD, President of Acu-Gen, advised several women that the results of their gender detection test conflicted with their ultrasound results because their baby had chromosomal abnormalities or a fetal “defect.” As a result of this alleged medical advice, many women sought further testing and procedures to determine whether their baby did indeed have a chromosomal abnormality. In addition to enduring the tremendous anxiety caused by Wang’s statements, these women underwent additional procedures such as extra ultrasounds, amniocentesis, and chromosomal testing, accumulating costly and unnecessary expenses.

Why is this seemingly dated piece of news still an issue? Because it has yet to be resolved. Although thepregnancystore.com, a prior vendor of the test no longer carries the product, The Baby Gender Mentor website still sells the potentially dangerously misleading early prenatal gender detection test.

In early 2006, New Jersey law firm Gainey & McKenna filed a class action law suit, Blumer, et. al. v. Acu-Gen Biolabs, Inc., et. al. on behalf of over 100 women who purchased the Baby Gender Mentor test, claiming among other things, that Wang and Acu-Gen’s deceptive advertising, misrepresentation of the test’s accuracy, and illusory guarantee induced them to purchase an inaccurate test and caused them corresponding harm, amounting to eight counts of legal violations.

In the complaint, Blumer et. al. requested:

(1) profit disgorgement and restitution, which would recognize Acu-Gen’s unfair business practices and require them to pay Blumer and the women back, thus honoring their money back guarantee;

(2) compensatory damages, to compensate women for any other undue expenses such as the hundreds or thousands of dollars spent on additional medical testing to clarify whether their baby suffered from a chromosomal abnormality;

(3) punitive damages, to penalize the defendant’s wrongdoing and serve as a deterrent to similar companies; and

(4) injunctive relief to prevent Acu-Gen and Wang from further marketing, selling, and profiting from the test.

Acu-Gen maintains their product works, and Wang has referred to the allegations as “totally bogus.”

Although Gainey & McKenna negotiated on behalf of Blumer and arrived at a settlement agreement with Acu-Gen and Wang, according to Barry Gainey, lead counsel for the plaintiffs, both defendants reneged on their settlement agreement. The District Court of Massachusetts denied Blumer’s motion to enforce the settlement, leaving these women and all other similarly situated individuals at square one- susceptible to cutting edge and supposedly infallible technological advancements that leave them aggrieved without effective or timely recourse.

Barry Gainey confirmed that the case is still active and plaintiffs filed a motion to amend the complaint. To clarify this timetable: over three years have passed since filing serious accusations of legal violations, yet there has still not been a hearing on the case’s merits or enforceable settlement. This progression illustrates the inefficiency of the judicial system to address gaps in federal regulation and the potentially grave impact of direct-to-consumer tests.

Like many other direct-to -consumer tests available online, gender prediction tests have been treated as outside the scope of federal regulation. Despite the FDA’s mandate to regulate medical devices used in the diagnosis of disease or other conditions (such as pregnancy), the FDA has thus far declined to regulate the “home-brew” variety to direct-to-consumer tests where a laboratory such as Acu-Gen uses its own reagents and protocols. Thus, the FDA does not regulate the clinical or analytical validity of these tests. The FTC has similarly followed suit in declining to regulate the industry, despite its authority to prohibit false or misleading advertising.

Private remedy through the judicial system is ineffective in addressing the regulatory shortcomings in direct-to-consumer tests. Over three years later, and the women wronged by the Baby Gender Mentor test have yet to receive their day in court. Meanwhile, Acu-Gen continues to market, sell, and profit from a test that at best, is of uncertain validity, and more troubling, may reflect the allegations in the Blumer complaint. How many more aggrieved individuals and how many more years must the public wait until the FDA and the FTC step in?

-Katherine Drabiak-Syed

Wednesday, July 1, 2009

Will Stronger Privacy Protections Result in Better Health Data? The Health Privacy Project Recommendations

The Health Privacy Project of the Center for Democracy & Technology (CDT) recently released a paper arguing for changes in how the HIPAA Privacy Rule protects "de-identified" health information. The recommendations grow from a one-day, CDT workshop held in September 2008. The Health Privacy Project makes the following eight recommendations:

1. Re-examine the Privacy Rule de-identification provisions (in particular, the safe harbor method for de-identification);
2. Strengthen accountability by requiring data use agreements;
3. Expand data anonymization options under the Privacy Rule;
4. Provide incentives to use less than fully identifiable data for certain purposes;
5. Provide support through “Centers of Excellence” in de-identification;
6. Require or encourage the use of limited access datasets and other technical solutions;
7. Require education and training of staff de-identifying data; and
8. Consider increasing public transparency regarding uses of de-identified data.

The Project argues that the HHS needs to re-examine the Privacy Rule "to ensure that the de-identification standard remains robust as re-identification becomes easier."

For readers struggling with the "Babel" of data privacy vocabulary (for example, what's the difference between "anonymous" and "anonymized"?), these recommendations may open the door to additional confusion, especially if #3 (above) means that additional categories of protected data are created. The Privacy Rule currently offers two categories data which are exempt from regulation: "de-identified" (presumed to be beyond the risk of re-identification and therefore not regulated) and not fully identifiable, "limited data sets" (incomplete data which includes some identifiers, for example: birth dates). While the Rule's current categories may seem simple, The Health Privacy Project notes that a "one-size-fits-all de-identification approach" does not, one the one hand, meet the diverse data needs of researchers and health providers, nor does it, on the other hand, provide sufficient protections in era of evolving data technologies.


The Health Privacy Project, Center for Democracy & Technology. Encouraging the use of, and rethinking protections for de-identified (and “anonymized”) health data. Center for Democracy & Technology, June 2009. http://www.cdt.org/healthprivacy/20090625_deidentify.pdf


Knoppers BM, Saginur M. The Babel of genetic data terminology. Nat Biotechnol. 2005 Aug;23(8):925-7. PubMed PMID: 16082354.

Sharyl J. Nass, Laura A. Levit, and Lawrence O. Gostin, Editors; Committee on Health Research and the Privacy of Health Information: The HIPAA Privacy Rule; Institute of Medicine. Beyond the HIPAA Privacy Rule: Enhancing Privacy, Improving Health Through Research. Washington, D.C.: Institute of Medicine, The National Academies Press, 2009. http://www.nap.edu/catalog.php?record_id=12458

Other Stories in the News

Your Genes Aren’t Covered for That: One Year Later, Gaps in Genetic Discrimination Legislation Reveal the Challenges Ahead. Susannah Baruch, Science Progress. June 29, 2009.

FDA’s Current Ability to Regulate Genetic Testing Is Problematic, FDLI-AAAS Colloquium Attendees Say. Food and Drug Law Institute (FDLI) and the American Association for the Advancement of Science (AAAS) [Press Release]. June 22, 2009. http://www.fdli.org/press/pressrelease/062209.pdf

New Comparative Effectiveness Bill Enhances Dx, Genomics Focus. Matt Jones, GenomeWeb. June 18, 2009.

The GINA Law: Consumer Protection in a New Era of Genetic Testing Research Report. N. Lee Rucker, M.S.P.H., AARP Public Policy Institute, May 2009. http://www.aarp.org/research/health/prevention/fs156_gina.html

-- J.O.