Legislatures Race to Define Rights and Obligations Relating to Genetic Information: Avoiding Another Bearder

California is the latest state to take steps toward defining permissible uses and restrictions relating to obtaining, retaining, and sharing individuals’ genetic information.  Senator Alex Padilla recently introduced Senate Bill 1267, the Genetic Information Privacy Act, designed to protect individuals against surreptitious testing of their genetic material without consent.  SB 1267 is a comprehensive piece of legislation which would require a specific authorization to obtain, analyze, or disclose genetic information unless otherwise exempted or allowed by law (exemptions include activities such as newborn screening, duties of the medical examiner, using some types of data for research, and law enforcement uses).  The legislation also contains a civil penalty structure for violations and provides a private right of action for aggrieved individuals who suffer economic, bodily, or emotional harm proximately caused by such violations. 

California’s legislation classifies genetic information within a privacy framework and seeks to increase individual control by requiring the individual to understand the purposes of how the information will be used and stored, as well as which entities have access to the information.  Other states such as Alabama, Massachusetts, South Dakota, and Vermont have introduced similar legislation that govern the collection, retention, and sharing of DNA, genetic information, and or genetic test results.  These states differ in their comprehensiveness and scope- from South Dakota’s paragraph long House Bill 1260 to Alabama’s extensive eleven page House 78.

Unlike California, these states seek to classify DNA, genetic information, and or genetic test results within a property law framework rather than under the umbrella of privacy, which carries distinct legal requirements for transfer, use, and retention.   As legislatures race to define individual rights within existing  legal concepts, they should be well aware of property law’s limitations at upholding individual autonomy while appropriately and efficiently defining permissible research uses depending on how the legislature crafts the language of the statute. 

As we witnessed in the progression of the Bearder v. Minnesota litigation (related to collecting, retaining, and disseminating newborn blood spots) even if a law is seemingly clear, individuals, clinicians, and investigators still may face confusion over relevant terminology and obligations relating to the meaning of key terms and the scope of consent exemptions.  (Blogs and article on that topic here.) Specifically, will these statutes govern the collection, use, and dissemination of genetic information after the analysis of a genetic test using a blood sample or will the language broadly address collecting blood samples, DNA, and genetic test information?  Public health officials, investigators, and individuals have vehemently disagreed over the meaning and scope of these terms and when consent is required.  Individuals have claimed immense injury to privacy and dignity when public health officials and investigators collect, retain, and disseminate their blood samples without consent, while public health officials and investigators decried setbacks to research efforts after they were legally ordered to destroy their improperly obtained blood samples. 

Last November, the Minnesota Supreme Court clarified its state Genetic Privacy Act, holding that an individual’s blood sample contains biological information and biological information falls within the definition of genetic information.   That is, any statutory references to genetic information also applies to blood samples.  It appears that the majority adopted the Plaintiffs' argument  that a blood sample contains DNA and the structure of DNA is genetic information, which means statutory requirements governing the collection, use, storage, and dissemination of genetic information necessarily include blood samples.   

Although this seminal holding is jurisdictionally limited, defining the meaning and scope of biological specimen, blood sample, DNA, and genetic information requires painstaking semantic precision.  Furthermore, the concurrence/dissent in Bearder demonstrates even keen legal minds apply varying logic to interpret terminology and arrive at starkly divergent conclusions.  Defining these terms becomes even more pressing should this or similar state legislation pass because it carries the compliance incentive of a penalty structure for violation.  Legislators should take note of litigation in this area and aim to meticulously and unambiguously define relevant terminology so individuals, public health officials, and investigators can understand their interrelated rights, obligations, and statutory exemptions.  

--Katherine Drabiak-Syed

Second Lawsuit Against Texas Department of State Health Services Over Alleged Misuse of Newborn Blood Spots

Last week parents in Texas filed a lawsuit against Texas Department of State Health Services (TDSHS) relating to the storage and distribution of their child’s newborn blood spots (NBS). Emerging approximately a year after a settlement over the NBS last December, this news headline looked like déjà vu. The new lawsuit focuses on the gaps of last December’s settlement agreement of the prior case against TDSHS and facts discovered after the settlement.

This separate class action lawsuit led by parent Jeffrey Higgins takes issue with how and for what purposes TDSHS shared the NBS. During the Beleno suit last year, the Beleno plaintiffs repeatedly asked TDSHS with whom they were sharing the NBS and for what purposes. During each of those discussions in the spring of 2009 and before a House Public Health Committee Hearing, TDSHS maintained it shared the NBS for the purpose of public health research but disclosed minimal additional information.

However, a large number of NBS were not used for public health research and this information did not become public until after the settlement. TDSHS numerous NBS to for-profit entities such as Perkin Elmer and bioMerieux in exchange for laboratory supplies. TDSHS only fully shared the extent of how many samples it shared, with what entities it shared the samples, and for what reasons on its website as part of the settlement agreement.

Perhaps most shocking, however, was that TDSHS sent 800 NBS to the Armed Forces Institute of Pathology (AFIP) to build a mitochondrial DNA (mtDNA) registry. AFIP designed this registry as a forensics tool to identify missing persons, solve old crimes, and eventually, share the samples internationally for law enforcement and anti-terrorism efforts. An investigative report that discovered this project surfaced in the media months after the settlement agreement in the Beleno case. [Read our commentary on the mtDNA registry here.]

The Higgins lawsuit focuses on TDSHS’s lack of transparency during the Beleno settlement discussions and alleges that TDSHS intentionally withheld pertinent information that would have substantially altered that case’s discussions and outcome. Similar to the Beleno complaint, Higgins argues that selling or trading the NBS to outside corporations and giving the NBS to the AFIP to build the mtDNA registry rises to Constitutional violations.

1. First, he maintains that taking his child’s NBS and sharing it with outside entities without consent constitutes a violation of his child’s right against seizure of deeply private genetic information.
2. Second, he asserts that sharing his child’s NBS without consent constitutes a violation of privacy.

The Higgins complaint emphasizes TDSHS’s alleged failure to disclose significant facts and communicates the plaintiffs’ concerns about misuse of the hundreds of thousands of NBS that were sent to outside entities. Importantly, the settlement agreement last December 2009 only provided that TDSHS was required to destroy the NBS in its possession. This meant the settlement had no legal effect on what other entities did with the NBS they received from TDSHS.

Accordingly, the complaint asks the court for injunctive relief to stop TDSHS from sharing the NBS with outside entities without consent in the future and for the court to order outside entities that previously received the NBS to destroy the blood samples and any associated data they may have. The first request is significant because it directly challenges the current law in Texas that requires parents to opt-out if they do not want TDSHS to use and share their child’s NBS for research and instead argues that TDSHS must actually obtain consent.

Carrie Williams, spokesperson for TDSHS, maintains that these issues have already been resolved and stated that the Texas Civil Rights Project representing the plaintiffs merely wants “to double dip back into this issue with baseless assertions.”

Despite Williams’ response, mounting evidence does show a startling lack of transparency on the part of TDSHS. Furthermore, if the case goes before the same judge that heard the Beleno case, the result may have a substantial impact. As with other highly unexpected court rulings recently relating to gene patents and embryonic stem cell funding, this case could potentially constitute a monumental turn for whether it is acceptable to collect blood to use and share for research by the opt-out method. In the last Beleno case, Judge Biery in the Western District of Texas denied TDSHS’s motion to dismiss, meaning the court planned to hear the merits of the those Constitutional issues. However, before the parties argued the merits they arrived at a settlement agreement, taking the question out of the courtroom.

The case is still in its infancy, and TDSHS has yet to file a response to Higgins’ complaint. As the case progresses and if Judge Biery eventually hears the merits, we may see another highly surprising court ruling impacting future collection of blood for research purposes.

--Katherine Drabiak-Syed

Timeline of Events

• March 2001- December 2010: TDSHS sends NBS to outside entities for various other projects.

• May 2003: TDSHS sends 200 NBS to the Armed Forces Institute of Pathology to build their mtDNA registry.

• December 2006- December 2007: TDSHS sends a total of 3600 NBS to bioMerieux in exchange for laboratory supplies.

• May 2007: TDSHS sends 600 NBS to the Armed Forces Institute of Pathology to build their mtDNA registry.

• March 2009: Parents led by Andrea Beleno (Beleno plaintiffs) file a complaint against TDSHS.

• March 2009: Beleno plaintiffs question where TDSHS has sent the NBS and for what purposes. TDSHS maintains they use and share the NBS for public health research.

• December 2009: Beleno plaintiffs and TDSHS settle the lawsuit out of court.

• March 2010: An investigative report reveals TDSHS sent a total of 800 NBS to the AFIP’s mtDNA registry. TDSHS spokesperson, Carrie Williams, still asserts that this project falls within the category of “public health research.”

• December 2010: Parents led by Jeffrey Higgins file a complaint against TDSHS.

Read past PredictER News coverage relating to newborn blood spots here:

Oklahoma Legislature Requires Express Consent to Retain Newborn Blood Spots

Transparency of Texas' NBS Transfer and Reassessing Evasive Statutory Interpretation

Newborn Blood Spot Banking in Canada

Minnesota Judge's Dismissal of Newborn Blood Spot Case Misses the Mark

Newborn Blood Spot Litigation Continues in Minnesota and Texas

Critiquing HHS's Summary Recommendations on Newborn Blood Spots: Opt-Out is Not Optimal

Newborn Screening: an Update on Minnesota

Minnesota and Genetic Privacy: Why the Rule of Law is Good for Research

See also:

Jere Odell. Newborn Blood Spots, Biobanks, and the Law: Research Ethics in the News. Indiana Bioethics. February 2010.

Katherine Drabiak-Syed. Newborn blood spot banking: approaches to consent. PredictER Law and Policy Update.Indiana University Center for Bioethics. March 12, 2010.

Oklahoma Legislature Requires Express Consent to Retain Newborn Blood Spots

During the past several months, states continue splitting on the issue of how to approach their state health department’s retention and research use of newborn blood spots (NBS).

On September 13, The Edmond Sun ran an article on Oklahoma’s enrolled Senate Bill 1250, a new law that prevents the state health department from storing and using NBS. The text of the law reads:

“A laboratory, medical facility, hospital, or birthing place is prohibited from the unathorized storage, transferring, use, or databasing of DNA from any newborn child without express parental consent.

It being immediately necessary for the preservation of the public peace, health and safety, an emergency is hereby declared to exist…”

Sen. Nichols explained he sponsored the bill as a deliberate pre-emptive measure in response to ethical and privacy concerns related to unauthorized “databasing” and use of NBS in other states. According to Sharon Vaz, the Oklahoma State Department of Health genetics coordinator, Oklahoma only retains the samples for 42 days and does not have plans for long term NBS retention or to use the NBS for research purposes.

Oklahoma’s law demonstrates that different jurisdictions are arriving at starkly divergent interpretations of seemingly simple definitions such as what is or is not encompassed in the meaning of DNA. SB 1250 refers to storing or using DNA, and Sen. Nichols unequivocally explains that he intends this to encompass the retention of NBS- a blood sample. This interpretation is significant because it means the law will use the term DNA to include biological materials from which DNA can be derived.

Unlike Sen. Nichols’ inclusive approach, in late August the Court of Appeals in Minnesota affirmed that NBS do not fall within the definition of “genetic information.” We previously wrote on the Bearder case here. Minnesota has determined that biological samples (such as NBS) that contain DNA and genetic information are not genetic information.

This distinction of separating the source of raw materials (the blood) used for research from the substance of the raw materials (the DNA) is also playing out in the stem cell legal battles- although here, the debate centers around using embryos to create embryonic stem cells v. research using embryonic stem cells. In both arenas, interpreting uncertainty or disagreement of how to apply a law to favor rsearch connects to the decision to splice parts of the process to circumvent barriers to using raw materials.

SB 1250 attempts to rectify several terms that have been disputed when determining the rules for retaining and using biological materials from newborns. Although Sen. Nichols references the law with regard to NBS, the language broadly refers to “DNA from any newborn child,” which would include NBS as well as other biological samples such as umbilical cord blood that contains DNA. This would mean that if an Oklahoma hospital or a partnering research entity wanted to retain and use other biological samples containing DNA from the newborn, the hospital would need to seek parental consent. Furthermore, this law clarifies that the hospital and state health department are not exempt from compliance with the law under a research exception.

Interestingly, the text refers to the law as necessary to preserve the “public peace, health and safety” in Oklahoma. The law is set to be codified in the Oklahoma statute in the same location as crimes consisting of public disturbances, safety hazards, and physical violations against one’s person- examples of tangible harm to indivduals and society at large. This classification itself nods a recognition to the Beleno case in Texas, where plaintiffs’ emphatically argued unauthorized retention of NBS constituted a serious privacy violation and an unlawful seizure of one’s deeply private medical and genetic information.

Whether other state legislatures and health departments agree with Oklahoma’s requirement for express parental consent or the current state of “emergency,” this law reminds us that each jurisdiction should adopt a prospective law or departmental policy to address these questions in a deliberate manner.

--Katherine Drabiak-Syed

Newborn Blood Spot Banking in Canada

A controversy that began in Minnesota and Texas has spread north of the Canadian border to British Columbia. The BC Civil Liberties Association (BCCLA) is opposing the potential research use, without parental consent, of 800,000 newborn blood spots stored in a facility operated by Iron Mountain of Burnaby, B.C. The BCCLA published a press release on May 12 explaining its opposition and its concerns regarding B.C. Legislative Assembly 2010, Bill 11. The BCCLA describes Bill 11 as: "a grab bag of miscellaneous legislative provisions, including sections 165-167 that give the Minister of Health power to collect, gather, use and share personal information without any notice to or consent from affected individuals."

In addition to opposing Bill 11, the BCCLA's David Eby and an unnamed parent are challenging the privacy practices of the B.C. Newborn Screening Program operated by the B.C. Women's Hospital. The hospital's president, Dr. Jan Christilaw, insists (in The Province), “No researcher is actually going to walk out of there with someone else’s blood.” However, at CBC News, the Screening Program's director confirms "some of the samples have ... been used by medical researchers to establish 'normal values and ranges'" to improve testing methods. Nonetheless, privacy advocates are not satisfied. The Globe and Mail (and others) quoted one worried parent, Rhian Walker:

“This was never, ever explained anywhere to me .... I think this would change a lot of parents’ perception of that test. You’re trying to do what’s best for your baby, so I’m a bit taken aback to learn that now that information is being stored and utilized in a way that I haven’t given consent for.”

Although, Eby wants samples stored without consent to be destroyed, Christilaw confirmed in The Vancouver Sun that "staff are finalizing an opt-out part of the program, so parents will be able to decide up front if they wish to participate in the screening."

While BCCLA's advocacy may or may not slow the progress of Bill 11, will it discourage the uptake of a valuable public health service?

Related:

Katherine Drabiak-Syed. Newborn blood spot banking: approaches to consent. PredictER Law and Policy Update. Indiana University Center for Bioethics. March 12, 2010.
Jere Odell. Newborn Blood Spots, Biobanks, and the Law: Research Ethics in the News. Indiana Bioethics. February 2010.
Link: National Newborn Screening and Genetics Resource Center

Other Predictive Health Ethics News

Dan Vorhaus. DNA Spit Kits Off Walgreens’ Shelves? Try Amazon.com. Genomics Law Report. May 13, 2010.
Michael Rugnetta. FDA Intervention Shelves Plan for Drugstore Genome Tests. Science Progress. May 13, 2010.
Andrew Pollack. Walgreens Delays Selling Personal Genetic Test Kit. The New York Times. May 12, 2010.
Courtney Hutchison. Over-the-Counter DNA Testing: Wave of the Future or Waste of Money? ABC News. May 11, 2010.
Philippa Brice. US genetic discrimination complaint. PHG Foundation News. May 7, 2010.
Sound Ethics. The Immortal Life of Henrietta Lacks. Sound Medicine. May 2, 2010.
Bridget M. Kuehn. NIH Launching Genetic Test Registry. JAMA. 2010;303(17):1685.
Keith Doyle. UK Biobank 'close to signing up 500,000 participants'. BBC News. April 24, 2010.
Nuffield Council on Bioethics. Human bodies in medicine and research: consultation. Nuffield Council on Bioethics. April 19, 2010.
Larry Greenemeier. Case Studies Reveal that Patents Can Hinder Genetic Research and Patient Care. Scientific American. April 16, 2010.

- J.O.

Transparency of Texas’ NBS Transfer and Reassessing Evasive Statutory Interpretation

A recent investigative report from the Texas Tribune revealed new information relating to the sharing of newborn blood spots (NBS) in Texas.

In November 2009, Texas Tribune reporters contacted the Texas Department of State Health Services (TDSHS) with a record request to review agency information and activities related to the NBS as permitted under the state’s Sunshine laws. TDSHS refused, maintaining that the NBS records were confidential. After parties filed the settlement with the court, Texas Tribune inquired again to obtain the records and found that TDSHS transferred hundreds of de-identified NBS to the Armed Forces Institute of Pathology to build a mitochondrial DNA (mtDNA) registry.

The Armed Forces Institute of Pathology designed the mtDNA registry as a forensics tool to identify missing persons, solve old crimes, and eventually, share the samples internationally for law enforcement and anti-terrorism efforts. Throughout the plaintiffs’ allegations and questions, TDSHS asserted it was storing and using the NBS for medical research, never mentioning any forensic use even through plaintiffs’ attorney James Harrington specifically inquired how TDSHS used the samples. TDSHS’ provision of information relating to the mtDNA registry would have been both directly pertinent and material to answering plaintiffs’ questions about the NBS disposition and how plaintiffs chose to proceed with the lawsuit.

In addition to the information on the mtDNA registry, the records request also uncovered email communications from the time when TDSHS began storing NBS at Texas A & M University. When the storage began, Texas A & M asked to issue a press release, but a TDSHS official stated that releasing this information made him “nervous” and would “only generate negative publicity.”

Although the decision revealed in the emails prevented public knowledge of storage for research use, it demonstrates a problematic mentality that transparency poses an unnecessary burden. Remaining in the dark about research using NBS is one issue, but failing to disclose (even when asked on several occasions) that the NBS are included in a registry for forensic and future law enforcement purposes creates a multitude of distinct issues. Both explicit knowledge and consent should be required to include one’s DNA in such a database.

Following terms of the settlement agreement, TDSHS’s website lists projects for which TDSHS uses the NBS. The mtDNA registry is now included on this list of projects, and TDSHS spokesperson Carrie Williams maintains that it falls within the category of “public health research.”

Sweeping forensic and law enforcement uses into the definition of public health research warrants close analysis. First, a plain reading of each definition would clearly show that the purpose of research into the causes of autism is not remotely connected to using DNA to identity a suspected criminal. Applying such a definition extends the limits of creative statutory interpretation too far. Second, states’ legislatures have attempted to impose limits on the use of NBS and other biological samples by creating exemptions or abbreviated pathways when the samples are used for public health research. Including forensic and law enforcement purposes ignores this precision and opens the possibility that samples would be shared for even more uses that would not disclosed to the public because the state health department could use this precedent to assume this use also would constitute “public health research.”

The potential for negative publicity alone should not serve as a barrier to transparency, but rather encourage public education for why TDSHS thought giving NBS to the mtDNA registry (with proper consent) would be beneficial. Dodging specific inquiries related to the uses of NBS, failing to disclose that they were given to this registry, and subsequently classifying the registry as a public health project have created even more of a publicity nightmare than TDSHS could have imagined. Other state health departments may be wise to assess whether their own policies encourage transparency, public engagement, and a sincere interpretation of what projects constitute public health research.


--Katherine Drabiak-Syed

Minnesota Judge’s Dismissal of Newborn Blood Spot Case Misses the Mark

On November 24, 2009, Judge Marilyn Rosenbaum signed an order dismissing plaintiffs’ complaint with prejudice in the Bearder et al. v. Minnesota et al. (MDH) lawsuit. This dismissal quickly disposed of plaintiffs’ claims that MDH’s practices of retention and research use of newborn blood spots (NBS) conflicted with specific protections outlined in the Minnesota Genetic Privacy Act (GPA) and constituted violations of their childrens’ property and privacy interests.

Judge Rosenbaum responded to plaintiffs’ claim that MDH failed to comply with the GPA by ruling that the GPA does not even apply to MDH’s actions because:

• NBS samples do not constitute genetic information; and
• The statute contains reference that it will not apply if an express provision in the law exists.

The GPA clearly defines genetic information as:

• “Information about an identifiable individual derived from the presence, absence, alternation, or mutation of a gene… which has been obtained from an analysis of the individual’s biological information or specimen” and
• “Medical and biological information about a particular genetic condition that is or might be used to provide medical care to that individual.”

Judge Rosenbaum’s finding that NBS are not classified as genetic information ignores the plain language of the statute. NBS are collected to analyze the presence, absence, or mutation of a disease during the newborn screening process and used to obtain medical and biological information about a particular genetic condition so parents of newborns can make medical decisions accordingly. Thus, logic compels classifying NBS as genetic information.

Defendants argued that the newborn screening statute which states that the NBS and results of the screening tests “may be retained by the [MDH]” amounts to an express provision authorizing exemption from the GPA. Judge Rosenbaum’s agreement disregards the meaning of “express provision” and the substantive fact that the collection and temporary retention for screening purposes is distinct from the collection, retention, and use for additional research reasons. Accounting for this important division, the statute would have explicitly and distinctly contained a section authorizing additional retention and research use beyond the collection and retention for detection, treatment, and follow up of heritable and congenital disorders if the legislature intended.

Additionally, this interpretation ignores the purpose of the GPA as a means to limit collection of genetic information by a government entity.

The finding that this section of the newborn screening statute (“may be retained by the [MDH]”) constitutes an express provision allowing retention and research beyond the initial screening poses two additional dilemmas. First, it problematically ratifies blurring screening with additional retention and research. Second, Judge Rosenbaum’s finding ignores that the retention and research is not limited to the MDH but extends to its research partners such as the University of Minnesota, the Mayo Clinic, and the CDC.

Randall Knutson, attorney for the plaintiffs, responded:

“It is our hope to bring some legal guidance and common sense to DNA issues, including the storage and dissemination of genetic information by our government agencies. As it now stands, the State of Minnesota appears free to use and sell our genetic information, without us having any say in the matter. That is simply unacceptable, and we intend to continue to fight on to change this situation.”

Knutson plans to appeal Judge Rosenbaum’s decision.

--Katherine Drabiak-Syed

Newborn Blood Spot Litigation Continues in Minnesota and Texas

The litigation occurring in Minnesota and Texas regarding the unauthorized retention and research use of newborn blood spots (NBS) continues, and has developed into respective battles seeking judicial recognition for a property and privacy interest in one’s genetic material from which governmental entities such as state health departments are not exempt.

In September 2009, the Minnesota district court heard the defendants’ motion to dismiss and motion for summary judgment in Bearder et al. v. Minnesota et al. (MDH). MDH argued that there are no genuine issues of material fact so the court could simply rule as a matter of law in its favor to exempt the application of the Minnesota Genetic Privacy statute to the state health department's activities as well as preclude any of the plaintiffs’ privacy claims. Following this interpretation, two active bills in the Minnesota House (HF 1341) and Senate (SF 1478) seek to alter Minnesota state law by creating a compliance exemption for the state health department.

According to Bearder et al.'s attorney Randall Knutson, the parties are waiting for the court’s ruling, which is scheduled for return before December 18, 2009. Plaintiffs contend that NBS are genetic information, individuals have a property and privacy interest in their DNA, both tort and Constitutional law protect these interests, and they seek to compel MDH’s compliance with the Minnesota Genetic Privacy Act.

Bearder et al.’s memorandum of law submitted to the court prior to the hearing developed concerns related to MDH’s continued noncompliance with the Minnesota Genetic Privacy Act. Mark McCann, Manager of Public Health Laboratory in the Newborn Screening Program testified before the Minnesota Senate that “the number of parents who have given consent to store…the residual dried blood spots with the Minnesota Department of Health is zero” and despite the Minnesota Genetic Privacy Law requiring that the MDH obtain parental consent for retention and research use, according to McCann, actually obtaining consent is not a current practice.

The memorandum also describes the intersection of problematic shortcomings related to parental requests for destruction, “de-identification,” and research sharing with outside entities such as MDH’s $6 million contract with the Mayo Clinic. According to plaintiffs’ affidavits, some parents were not even told that the specimens would be retained and used for genetic research purposes (undermining the ability to request their destruction) or their requests for destruction were not honored. MDH refers to its system of storing and sharing the NBS as “de-identified” but it provides linked and coded NBS to the Mayo Clinic, retains the key to re-link the specimens (meaning they are not in fact “de-identified,”) and admits there is no standardized procedure for this process.

In Texas, the companion case Beleno et al. v. Texas Department of State Health Services et al. (TDSHS) asserts that individuals have a fundamental privacy interest in their DNA, which exists even absent any statutory provision specifically recognizing genetic privacy. On September 22, 2009, the Texas district court judge denied TDSHS’s motion to dismiss, meaning the court would schedule a hearing for the merits of the case unless the parties arrived at an alternate settlement. The Texas Civil Rights Project which represents plaintiffs indicated that the parties are in settlement negotiations, but as of November 20, 2009, parties have yet to sign an agreement.

Even if parties reach a settlement, Beleno et al.’s arguments used in this case merit pause and further examination. In plaintiffs’ response to defendants’ motion to dismiss, Beleno et al. argue that the defendants committed unlawful and unreasonable seizure, because although parents may have consented to providing the NBS for screening tests, they did not consent to the retention and research use of NBS. Even if the NBS were de-identified, plaintiffs argue that TDSHS unlawfully seized the specimens if they did not obtain actual parental consent, highlighting that issues of consent and privacy are both distinct yet inextricably linked both in practice and legal analysis. Importantly, Beleno et al. also argue that passive storage even absent any additional research or sharing of NBS constitutes a per se violation of Constitutional and tort privacy principles given the fact that they contain deeply private medical and genetic information.

Independent of how these courts proceed, these two cases continue to ask:

• Do, or should, we have a property or privacy interest arising from tort or Constitutional principles in our genetic material (here, in the form of NBS) that requires consent to transfer this interest?
• Can we minimize the potential for future litigation simply by obtaining parental consent for retention and research use?
• Would creating codified exemptions for state health departments deter or encourage privacy advocates from litigation?
  

-Katherine Drabiak-Syed

Critiquing HHS's Summary Recommendations on Newborn Blood Spots: Opt-Out is Not Optimal

On August 21, 2009 the Department of Health and Human Services (HHS) issued “Considerations and Recommendations for a National Policy Regarding the Retention and Use of Dried Blood Spot Specimens after Newborn Screening” relating to storage and use of newborn blood spots (NBS). The agency recommendations discussed assurances of privacy and confidentiality for storage and advised that each state should disseminate policies that promote public trust, emphasize transparency, and encourage informed public participation. It promulgated seven recommendations, including: all states should have a policy in place to address NBS retention, use, and research access; states should provide educational materials to the public and expecting mothers on use and potential future uses; and states should adopt an opt-in or opt-out model if NBS are available for any process outside the screening process or internal screening test development.

However, parental attitudes and pending litigation in this area suggests that the agency’s goals to promote public trust and encourage public participation may not be achieved with these guidelines.

Tarini, et al.’s survey in Public Health Genomics examined parental willingness to permit NBS storage and research. If permission is obtained, 76.2% of parents were very or somewhat willing to permit use of NBS for research, but if permission was not obtained, only 28.2% of parents would be very or somewhat willing to permit use of NBS for research. These results show most parents will permit retention and use as long as they are asked, reiterating the importance of respecting a person’s autonomy and dignity to permit or refuse participation.

Two pending cases in Minnesota and Texas confirm the results of Tarini et al.’s study and demonstrate that collection, retention, and research use of NBS and associated PHI even if conducted or facilitated by the state department of health is biobanking research. Accordingly, it should be governed under the Common Rule and Privacy Rule, meaning actual consent is not only optimal but perhaps required.

In June 2009, Minnesota parents (Bearder, et al.) filed a civil complaint against the state of Minnesota and the Minnesota Department of Health (MDH, et al.) for failing to comply with the Minnesota Genetic Privacy Act and continuing to store and use NBS without consent. The complaint contains a litany of claims, including violation of the Minnesota Genetic Privacy Act, eight tort claims, fundamental right claims, and government taking. Plaintiffs’ claims for intrusion into seclusion, fraud and misrepresentation, and government taking summarize the essence of the alleged injury:

• A person has a privacy interest in his or her own blood (acting as guardian for the newborns’ blood) and the medical information that may be obtained from it;
• The MDH intentionally omitted that the NBS was not taken solely for screening but would be retained and used, knew that parents would provide them NBS for the purpose of screening, and parents relied on these representations but would not have consented to providing MDH the NBS had they known; and
• Blood and genetic information constitute a “valuable national resource” and a represent a “gold mine” for the state and affiliated researchers that the government cannot automatically appropriate even in the name of public health research.

In a prayer for relief, plaintiffs request damages as statutorily indicated, request an injunction, and a cease and desist order against MDH. Minnesota’s history confirms that NBS collection, retention, and research falls within its Genetic Privacy Act, meaning a separate consent is required for each activity; and importantly, that the research conducted or approved by the Minnesota Department of Health is not exempt from these requirements.

In Texas, parents (Beleno, et al.) filed a civil complaint in March 2009 against the Texas Department of State Health Services (TDSHS, et al.) claiming TDSHS has no legal authority to retain and use NBS without consent. Beleno et al. assert this practice violates the privacy principles as well as violates the prohibition against seizure. Plaintiffs request that the court order the destruction of all NBS stored without consent (around 4.2 million samples) since it began the practice in 2002 or obtain retroactive parental consent. Additionally, plaintiffs seek an order to compel TDSHS to disclose for what purposes the NBS have been used and financial transactions involving the NBS.

New legislation TX HB 1672 that implements a compromise by using an opt-out system was signed into law and will take effect September 2009. It remains to be seen whether all Texas parents will agree with this solution and how the court will address the issue of what to do with the 4.2 million NBS that were stored without consent.

If NBS constitute such a valuable resource, then it is incumbent on us to encourage transparency of state health departments’ intentions by educating parents on the importance of using NBS for research purposes, how the state plans to use them, and respect parents enough not to circumvent the law’s intent but actually obtain their consent. If not, parents could turn to the judicial system and potentially prevail, creating a costly and lengthy legal battle for the state health department as well as jeopardizing the current collection of NBS.

-Katherine Drabiak-Syed

Newborn Screening: An Update on Minnesota

A recent article in the Minneapolis-St. Paul Star Tribune indicates that the controversy between the Minnesota Department of Health (MDH) and the Citizen’s Council on Healthcare (CCH) regarding collection and retention of newborn blood samples remains a live issue. Reporter Chen May Yee invoked our pathos by using the “sick baby” card, framing the debate as one between a camp committed to genetic screening to save newborns and a gang of privacy advocates, outlandishly exaggerating the harms resulting from applying the Minnesota Genetic Privacy Act. Yee describes the newborn screening program as a small intrusion necessary to save lives while characterizing CCH’s concerns as fear of the unknown.

The article misrepresents CCH’s objections and presents a mutually exclusive approach to newborn screening: perform newborn screening or apply the Minnesota Genetic Privacy Act which requires parents to consent to the blood collection, genetic screening tests, and retention of the blood samples for future research use. As the administrative courts have ruled, the Minnesota Genetic Privacy Act does in fact apply to newborn screening practices. In theory, application of this law provides even more public benefit: parents consent to allow newborn screening, they can consent to the MDH’s retention of blood samples for more research to develop new screening tests, and the law ensures parents have an informed understanding of each process and its value.

MDH’s chief legal counsel David Orren stated that “data in the hands of public health is very different from the data in the hands of an identity theft or hacker.” Yet, as long as the MDH was not in compliance with the law and they do not have specific permission to retain this information, can their status as a government agency change the fact they should not have or retain these samples and information? -- Katherine Drabiak

Minnesota and Genetic Privacy: Why the Rule of Law is Good for Research

On March 23, 2007 Minnesota Administrative Law Judge Barbara Neilson ruled on the ongoing controversy regarding genetic privacy and blood specimens collected during newborn screening. The Citizen’s Council on Healthcare’s (CCH) claimed that the Minnesota Department of Health (MDH) was unlawfully retaining and using the specimens. In addition to prompting Minnesota privacy advocates like Craig Westover to ask: "Does the End Justify the Genes?", this dispute between the public health advocacy group and state raised the question: Is the government exempt from legal requirements relating to genetic specimens in the name of improving public health?

Parents Required to Opt-Out

MDH has been collecting and storing newborn blood specimens since 1997; however, in 2003 the legislature added a provision which required parents to sign a form to indicate they wanted the blood specimen destroyed after the screening tests. If parents do not sign this form, the MDH stores the specimen indefinitely and uses it, as well as disseminates it to other institutions, for genetic research to develop new screening tests.

CCH maintained that MDH’s assumption they could retain the blood specimens if parents did not specifically request their destruction was faulty and ran counter to other Minnesota laws. ALJ Neilson and Chief ALJ Raymond Krause ruled that the original law did not expressly authorize retention or research use and could not be justified based on an assumption. Over MDH’s vigorous objections, ALJ Neilson held that the collection, retention, and use of the blood specimens must be interpreted along with Minnesota’s Genetic Privacy Act (144.125, Minnesota Statutes 2006). This law explicitly requires that an individual’s genetic specimen:

May only be used for the purposes to which the individual has given informed consent;

May only be stored for a period of time to which the individual has given consent;

Requires affirmative consent to disseminate the specimen.

A Losing Strategy

The MDH, in this controversy, exemplifies the creative lengths to which parties will go to evade the laws which seemingly obstruct research progress. Although Minnesota's government sponsored projects and research to improve public health are worthy endeavors, they are not exempt from privacy protections. Here, MDH’s failure to comply with the law’s provisions requiring actual consent is a grave shortcoming. There is no question that newborn blood screening tests have been essential for early detection, diagnosis, and proper treatment of debilitating diseases. MDH estimates that Minnesota screens more than 73,000 newborns and diagnoses approximately 100 infants with disorders annually (Report of the Administrative Law Judge Barbara L. Neilson In the Matter of the Proposed Amendments to Rules Governing Newborn Screening, Minnesota Rules, Chapter 4615, January 23, 2007-- 11-0900-17586-1).

What's Next?

The MDH has recently announced they are working with legislators to create new screening policies that will comply with the law; in the interim, the department is retaining all specimens. As the policies are revised, let's hope that the MDH avoids the quiet paternalism of its recent practices. As the controversy demonstrates, such behavior sparks backlash and eventually leads to loss of public trust. Although the MDH may have realized some immediate gains in collecting blood samples for research, bypassing the community and the law is not a long-term strategy for success. If parents lose faith in state departments of health, they may refuse to donate newborn blood samples for research or, in the worst case, these parents may refuse newborn screening for their children. In such a scenario, the ultimate "ends" are lamentable and the "means" are unjustified; everyone loses: parents, children, researchers, communities, and industries. -- K.D.

[Katherine Drabiak is a 3rd year law student at the Indiana University School of Law-Indianapolis. She is interested in issues related to genetic privacy and conflicts between federal and state regulations which result in legal ambiguities in field of biomedical research.]

Newborn Screening News and Resources from the March of Dimes

Nearly 90% of Babies Receive Recommended Newborn Screening Tests: State Programs Expand, But Half a Million Babies Still Not Screened for Serious Genetic Disorders

WHITE PLAINS, N.Y., JULY 11, 2007 - Nearly 90 percent of all babies born in the United States - more than double the percentage in 2005 - live in states that require screening for at least 21 life-threatening disorders, according to the latest March of Dimes Newborn Screening Report Card. [Read more ]

Related Resources: In addition to last week’s press release (excerpt above) visit the March of Dimes PeriStats site for related statistics, “report cards”, and basic GIS maps. For additional maps, including a U.S. map linked to state genetic services plans, visit a PeriStats collaborator, the National Newborn Screening and Genetics Resource Center.