An Update from Colorado. An ongoing prosecution, United States v. Fricosu,² became the most recent constitutional challenge to DNA fingerprinting upon arrest. The defendant, Ramona Fricosu, had her DNA sampled as part of her arrest pursuant to the DNA Fingerprinting Act of 2005, 42 U.S.C. §14135(a). She filed a motion challenging the constitutionality of the practice, requesting that the court order her DNA sample and CODIS profile be destroyed. Fricosu challenged the constitutionality of the practice on Fourth Amendment grounds. On February 22, 2012, Colorado District Judge Blackburn denied the motion (pdf).

Specifically, Judge Blackburn noted that only two federal appellate courts have considered the constitutionality of the DNA Fingerprinting Act as it applies to arrestees: the Ninth Circuit ruling of United States v. Pool³ and the Third Circuit ruling of United States v. Mitchell.⁴ As we noted previously, the Ninth Circuit opinion in United States v. Pool has no precedential value, the opinion having been vacated. Judge Blackburn followed the road map set out by the Third Circuit without any notable deviations. Like the Third Circuit, Judge Blackburn applied a totality-of-the-circumstances analysis and considered two separate searches: the DNA sampling and the subsequent creation of the CODIS profile. Quickly dismissing the first search as minimally invasive, Judge Blackburn’s opinion focused on the nature of the second search.

As has become commonplace in these opinions on DNA fingerprinting, the Judge focused on “junk DNA” and what “junk DNA” can tell us about “physical and medical characteristics.” Judge Blackburn, agreeing with the Third Circuit, reasoned that there is a significant difference in the “amounts of private information” included in a DNA sample and a CODIS profile, the latter of “which at present reveals only identity.” Judge Blackburn was not persuaded by the “potentially nefarious uses to which this information might be put,” citing a lack of evidence that “such hypothetical abuses are either likely or imminent.” Balancing the privacy interests against the government’s legitimate interests in the information, Judge Blackburn found there are sufficient safeguards in the statutes that limit law enforcement uses of the DNA sample to identification purposes and that deter and penalize abuse of law enforcement discretion or misuse of the DNA profiles.

Mitchell Not Moving on Up. On March 19, 2012, the U.S. Supreme Court denied (pdf) the petition of certiorari in United States v. Mitchell, the Third Circuit opinion upon which the Colorado District Court relied in Fricosu the previous month. Justice Kagan did not take part in the consideration or decision. It seems likely that the Justices are content to let the constitutionality of DNA fingerprinting upon arrest percolate a while longer at the lower court level and will not grant certiorari unless a clear divide among the federal circuits becomes apparent.
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¹Haskell v. Harris, — F.3d — (9th Cir. (Cal) 2012)
² United States v. Fricosu, — F.Supp.2d – (2012), 2012 WL 592322
³United States v. Pool, 2009 WL 2152029 (E.D. Cal, 2009), affirmed by 621 F.3d 1213 (9th Cir. (Cal.) 2010), rehearing en banc granted by 646 F.3d 659 (9th Cir. 2011), opinion vacated as moot by 659 F.3d 761 (9th Cir. 2011)
⁴United States v. Mitchell, 652 F.3d 387 (3rd Cir. 2011) (en banc), pet. for cert. filed (Nov. 22, 2011)(No. 11-7603, 11A384), cert. denied – S.Ct. – (Mar. 19, 2012).

Big news, right? Not really.

What this means is that the Court Granted cert in Myriad, but for the limited purpose of Vacating the Federal Circuit’s July 2011 decision and Remanding the case to that court for reconsideration in light of the Supreme Court’s decision last week in Prometheus.

As we wrote last week, there is nothing in Prometheus to suggest that the Federal Circuit should or will change its mind about the method claims it invalidated once before (relating to comparing BRCA gene sequences in cancer patients to sequences in healthy patients to identify deleterious mutations). Its decision upholding Myriad’s claims to methods of evaluating cancer therapies is a closer call, but nothing in Prometheus clearly compels the Federal Circuit to change its mind.

Finally, Prometheus said nothing at all about product patents, so there’s no good reason to think that the Federal Circuit panel will revisit—let alone reverse—its split (2-1) decision upholding those claims. While some commentators have suggested that there are implications for Myriad’s products of nature issue in Prometheus’s discussion of the laws of nature question that was central to that case, it’s hard to imagine that the Federal Circuit would discern from Prometheus any command to change its mind on the product claims in Myriad.

If the Supreme Court were ultimately to accept a second certiorari petition in Myriad—after the Federal Circuit’s remand decision—which is by no means certain, and is likely to be at least a year in the future, we’ll have plenty of time then to revisit the tea-leaf value of the Court’s laws of nature rhetoric. For now, though, Myriad heads back to the Federal Circuit and the status quo with respect to Myriad’s patents remains unchanged from yesterday.

History of the Case. Mayo originally bought and used Prometheus test kits that employed the patented method, but it then decided to sell and market its own test, which was similar, but not identical.  Prometheus sued for patent infringement.  The district court found that Mayo’s test would infringe the Prometheus patents, but it then held the patents invalid as essentially claiming unpatentable laws of nature–in this case, the relationship between the levels of the specified metabolite and the efficacy or toxicity of the relevant drugs.

The Federal Circuit reversed this decision in 2009, finding that the claims satisfied its then-controlling machine-or-transformation test.  Both the administering and determining stages, the court held, brought about a transformation of the patient’s body.  In the summer of 2010, while a Prometheus cert. petition (a request for Supreme Court review) was pending, the Supreme Court decided Bilski v. Kappos, a case involving a patent on a method of commodities hedging.  In a set of murky opinions, the Court held that the machine-or-transformation test was not the exclusive test of subject matter eligibility for method claims, but that it could be helpful in appropriate cases.  Immediately thereafter, the Court ordered the Federal Circuit to reconsider its Prometheus opinion in light of Bilski.  In an opinion that might be described as perfunctory, the Federal Circuit held once more that the Prometheus patents comprised statutory subject matter, and the Supreme Court granted cert.

The Supreme Court’s Reasoning. The Court’s opinion (pdf) focuses on the difference between claims to laws of nature themselves and claims to specific applications of such laws: the former fail the section 101 subject matter test, while the latter pass.  The laws of nature involved here are the “relationships between concentrations of certain metabolites in the blood and the likelihood that a dosage of a   thiopurine drug will prove ineffective or cause harm.”  The legal question then becomes, “do the patent claims add enough to their statements of the correlations to allow the processes they describe to qualify as patent-eligible processes that apply natural laws?” For all nine members of the Court, the answer was a clear no.

The Court’s analysis of the claims went through four steps.  First, it observed, the administering step just defines “the relevant audience”—doctors who treat patients with thiouprine drugs.  Second, “the ‘wherein’ clauses simply tell a doctor about the relevant natural laws.”  Third, the determining step does not specify any particular process, but merely invites doctors “to engage in well understood, routine, conventional activity.’  And fourth, “to consider the three steps as an ordered combination adds nothing to the laws of nature that is not already present when the steps are considered separately.”  In sum, “the three steps simply tell doctors to gather data from which they may draw an inference in light of the correlation.”  They “are not sufficient to transform unpatentable natural correlations into patentable applications of those regularities.”  To allow such a patent could “inhibit further discovery by improperly tying up the future use of laws of nature.”

What Do We Learn? The first point is that section 101 is alive and well as the first test of patentability.  Some recent Federal Circuit opinions have suggested that section 101 can and should be avoided in most cases, leaving the work of evaluating patents to sections 102 (novelty), 103 (nonobviousness), and 112 (written description).  The Court explicitly rejects that approach, refusing to let section 101, with its law of nature prohibition, become “a dead letter.”  So the Patent Office and the courts will continue to have to make an initial determination of whether an invention comprises statutory subject matter, independent of whether it satisfies the other criteria of patentability.  Nonetheless, the language quoted above about “well understood, routine, conventional activity” suggests that novelty and obviousness have some relevance to subject matter eligibility, despite loud protests that this conflates section 101 with issues presumably assigned to 102 and 103.

Second, although this opinion is light years ahead of Bilski in terms of clarity, it is still hard to be absolutely certain of what the subject matter test for method patents is.  We know—from the last paragraph of the opinion—that patents that “effectively claim the underlying laws of nature themselves” are invalid.  Another version of this is that a survivable claim must “differ significantly from a claim that just said ‘apply the algorithm.’” But just how to identify such a claim is a more difficult issue.  We know that a claim structured just like Prometheus’s is invalid: that is, a claim that involves nothing more than gathering data that may provoke an inference based on a law of nature (for example, maybe, the claims upheld by the Federal Circuit on August 31, 2011 in Classen Immunotherapies, Inc. v. Biogen IDEC?).  Some additional application of the law of nature is required—but how much?

The Court rejects “simply appending conventional steps, specified at high level of generality, to laws of nature.”  It expresses particular concern about claims so broad as to “seek pre-empt the use” of the law of nature.  But it gives little affirmative guidance about how specific the application of the law must be, declining to speculate on precisely what additional limitations might have saved the Prometheus claims before it.

Impact on Myriad? There have already been a lot of questions raised about the impact of Prometheus on the Myriad litigation, in which a cert petition is still pending in the Supreme Court.  Does this new decision make it more or less likely that the Court will take Myriad? Does it suggest a likely outcome if the Court does take it?

Before speculating about these questions, it is important to remember that the Federal Circuit decision in Myriad addressed three separate sets of patent claims: (1) the court upheld (with a partial dissent) Myriad’s product claims on cDNA and isolated DNA; (2) the court also upheld Myriad’s claims to methods of screening potential cancer therapeutics by analyzing growth rates of cells with altered BRCA genes in the presence or absence of the treatments; but (3) the court rejected Myriad’s claims to methods of analyzing BRCA gene sequences and comparing those with cancer-predisposing mutations to normal sequences. The cert petitions filed by both sides do not address the methods claims (only the product claims and the highly technical standing issue), but the Supreme Court could order briefing and argument on any aspect of the case.

The Prometheus decision says nothing about gene product claims, so is irrelevant to issue (1) in Myriad. But it says a lot, obviously, about method claims that bear at least some structural similarity to those in Prometheus.  So does Prometheus indicate that the Court is more or less likely to review those method claims? (Warning: anyone who claims to have inside information about pending Supreme Court decisions is lying—Court security makes the old KGB look like a sieve.) Our guess (and it’s little more than that) is that the issuance of Prometheus makes it less likely that the Court would review the Myriad method claims.  It has just issued a unanimous and—by the standards of Supreme Court patent cases—relatively clear opinion on generally similar medical methods.  History suggests that is unlikely to want to revisit that topic the very next year.  Prometheus itself is an obvious exception, of course, coming right after Bilski. But the Court may have realized how unhelpful its fractured Bilski opinion was, and all of the justices apparently believed that the Federal Circuit had either failed to understand it or chosen to ignore it.  And the history of Prometheus suggests a possible pathway for Myriad: that the Supreme Court would grant cert, but (with respect to the method claims) for the limited purpose of vacating the Federal Circuit’s opinion and ordering reconsideration in light of Prometheus.

But if the Court does decide to review Myriad (or if the Federal Circuit is ordered to do it over), does Prometheus help us to predict the outcome?  The method claims that the Federal Circuit rejected ((3) above) are hard to distinguish from those in Prometheus: doctors gather information and make a straightforward comparison, using basic genetic knowledge.  Those claims are likely to be rejected once again.  The drug-screening claims that were upheld ((2) above) are a closer call.  If the “algorithm” is the protocol for comparing the effects of treating or not treating cell lines, then “do the patent claims add enough to their statements of the correlations [or algorithm] to allow the processes they describe to qualify as patent-eligible processes that apply natural laws?”  There is a good bit of practical application going on here: cell lines must be grown and drugs applied (or not) before a judgment is made.  It looks more like a real-world pharmaceutical process than a broad statement of an algorithm.  For that reason, it seems more likely than not that this category of method claims would be upheld once again under section 101.

Conclusion. We now know considerably more about the Supreme Court’s views on methods than we did after the worse-than-useless Bilski opinion.  It is refreshing to these observers that the Court dove right back into method patents in an apparent effort to rectify the damage it did in Bilski (and there’s also some entertainment value in the revival of the Supreme Court-Federal Circuit tension that seemed to have abated a bit). But it also seems unlikely that the Court would go back to the method issue immediately, so we doubt that it will take that part of Myriad, except for the limited purpose of remanding to the Federal Circuit for reconsideration.

In terms of impact on the marketplace, there is, of course, serious impact if your business model depends on patents just like these (e.g., if you are Dr. Classen).  But for others, both in biotechnology and IT, the effect should be minimal.  Admittedly, the mere changing of the test from one that was formerly more inclusive to one that narrows eligibility is potentially destabilizing–under the former machine-or-transformation test, “administering” and “determining” steps were generally transformative and therefore corresponded with patent eligibility.  But the key word is potentially, since the Prometheus patents already reflected an extreme stretching of section 101’s limits, and were also—as the Federal Circuit pointed out in its 2009 opinion—highly suspect under sections 102 and 103.

The bill’s brevity should not, however, be mistaken for a narrowness of purpose. In under 200 words, the South Dakota bill, if passed, would (1) grant property rights to individuals in their DNA samples and genetic information, (2) prohibit surreptitious testing, (3) call into question many forensic and law enforcement uses of DNA, (4) eliminate newborn blood spot screening without explicit consent and (5) impose broadly worded informed consent requirements on all collections and uses of individual genetic data. So much for inefficient government.

Of course, what the South Dakota bill offers in brevity and breadth, it lacks in clarity. No details are provided to explain exactly what sort of property rights in DNA would be bestowed upon individuals, whether there would be statutory carve-outs to consent requirements for routine governmental and other uses (such as collection and forensic analysis of crime scene DNA) or what penalties might be imposed for violations of the new statute, should it be enacted.

And then there are the broadly drafted informed consent requirements. While the importance of securing informed consent for the full range of uses of personal genetic data is unarguable, as we have written previously, state-level attempts to define the informed consent process may be disruptive to research and public health efforts, particularly those spanning multiple states, as potential vertical and horizontal conflicts put investigators (academic researchers and those in the personal genomics industry) in a bind.

As just one example, the South Dakota’s bill requirement that no genetic data or DNA be “sold or given to any federal or state agency, any data bank for storage, or be used for research unless the person gives written informed consent after the test and use of the results is specifically explained” could easily call into question the use of broad consenting approaches that are crucial to large-scale and longitudinal genetic and genomic research. (SD H.B. 1260, Lines 13-15)

Parsing Proposals to Create Property Rights in DNA. Whatever its ultimate fate, South Dakota’s proposal shares at its core a theme that we have highlighted across numerous posts here at the Genomics Law Report, including similar proposals from Vermont, Massachusetts, and Alabama: the desire to confer greater individual rights in and control over genetic data. With that in mind, we offer a line-by-line comparison of how several proposed state statutes would purport to confer ownership rights to individuals over their genetic material and information.

On to the states (emphasis is ours unless otherwise noted):

1. South Dakota (SD H.B. 1260)

“All DNA, genetic information, or results of any genetic test…are the sole property of the person from whom it was derived…” (SD H.B. 1260, Lines 9-11)

2. Alabama (AL H. 78)

“GENETIC INFORMATION…is also the personal property of whom it is taken.” (Page 2, Lines 22-27; Page 3, Lines 1-4)

3. Massachusetts (MA S.B. 1080)

“…it shall be a goal of the Commonwealth to declare genetic information the excusive property of the individual from whom the information is obtained. (MA S.B.1080, Lines 5-6)

“Genetic material shall be considered real property subject to one’s individual control and dominion in accord with generally held precepts of property law in the Commonwealth.” (MA S.B.1080, Lines 64-65)

4. Vermont (VT H. 368)

“…it is the intent of the general assembly to declare genetic information the exclusive property of the individual from whom the information is obtained.” (VT H.368, Lines 15-17).

“…genetic material shall be considered real property subject to one’s individual control and dominion in accordance with generally held precepts of property law in Vermont…” (VT H.368, Lines 8-11)

When reviewing the state proposals, it is important to keep an eye on both clauses, the type of property (indicated by single underlines) and upon whom the property rights are conferred (indicated by italics).

Many of these phrases are legal terms of art, with distinct legal meanings that are often not in line with common usage. Take note of the following Black’s Law Dictionary (9th Ed) definitions:

• Real Property: “Land and anything growing on, attached to, or erected on it, excluding anything that may be severed without injury to the land.”

• Personal Property: “Any movable or intangible thing that is subject to ownership and not classified as real property.”

• Private Property: “Property – protected from public appropriation – over which the owner has exclusive and absolute rights”

• Tangible Property: “Property that has physical form and characteristics.”

• Corporeal Property: “1. The right of ownership in material things. 2. Property that can be perceived, as opposed to incorporeal property.”

• Qualified Property: “A temporary or special interest in a thing (such as a right to possess it), subject to being totally extinguished by the occurrence of a specified contingency over which the qualified owner has no control.”

Lawyers love their fine distinctions, which means here that the specific terms that legislators use in crafting genetics rights bills can carry important distinctions. For instance, bills purporting to grant “real property” rights (Massachusetts and Vermont) to genetic material and information, should they pass, would potentially create an awkward blurring of the lines between real property and personal property, which carry many differences, including how such rights may be enforced or transferred to others. It may be that legislators are attempting to confer the same ownership and possessory rights to DNA samples that are afforded to land because casting genetic rights as “real property” would subject any transfers (e.g. sales, bequests, licenses) of DNA samples to the same requirements as land (e.g. transfers of land are unenforceable unless supported by a writing sufficient to satisfy the Statute of Frauds).

Much more importantly, recognition of property rights of any manner in biospecimens and genetic information could vastly change the legal landscape and potentially abrogate the ruling in Moore v. Regents of the University of California, 793 P.2d 479 (Cal. 1990), the landmark California Supreme Court case that rejected John Moore’s claim of property rights in his blood, cells and other biospecimens. In Moore, the court ruled that an individual had no property rights in his cells or other unique products of his body, and thus could not share in the commercial profits generated as the result of research performed on using Moore’s biospecimens. An important rationale underpinning the California Supreme Court’s conclusion was the potentially chilling effect imbuing biospecimens with property rights might have on medical and scientific research. State statutes explicitly creating property rights in individuals’ DNA could put the result in Moore back under the microscope which, while potentially a welcome development for many individuals, could also create significant uncertainty for scientific and medical researchers, particularly those involved in ongoing research.

Similarly, it is unclear whether acknowledging property rights in genetic material and information would potentially renew or bolster legal arguments challenging the constitutionality of DNA fingerprinting upon arrest (as opposed to following conviction), as recognition of property rights could, by extension, create an argument that DNA Fingerprinting upon arrest constitutes an unlawful taking in violation of the Due Process clauses found in the 5th and 14th Amendments.

Similarly, as to the person or persons upon whom property rights (i.e., ownership and possession rights) are conferred by these proposed legislations, it is important to recognize narrow distinctions in phraseology. The clauses, “from whom the information is obtained” and “from whom the information has been derived,” are not likely to be construed similarly. The former is potentially much broader than the latter, particularly in a personal genomics and participatory research age. “From whom the information is obtained” could permit property rights to be extended to third parties not limited to relatives who share genetic information by virtue of shared ancestry. For example, if Annette shares her genomic information from 23andMe with her buddy Svend, and then Svend sells Annette’s genomic information along with his own to his friend Natalie, it follows that Natalie “obtained” Annette’s information from Svend, therefore Svend may be statutorily recognized (purposefully or perhaps unwittingly) as having property rights in Annette’s genomic information such that he could lawfully transfer or license the information to Natalie at his unlimited discretion. Conversely, “from whom the information has been derived” seems to be less generous, conferring property rights only on the individual who submits a DNA sample for analysis. In the previous example this would imply that Svend would have property rights sufficient to sell his own information to Natalie but not Annette’s information.

Of course, none of the discussion above should be taken to suggest that conferring property rights in individuals is a bad thing. However, as this discussion should make painfully obvious, it is certainly not a simple thing. While legislators should be applauded for drafting two-page statutes, they should also be mindful of the complexity and the potential implications of their proposals. With all due respect to the South Dakotan legislature – a body with 70 members and only 35 working days this year – the importance of defining a new set of legal rights for a new era of personal genomics, and the challenges inherent in doing so, is yet another reminder of the importance of securing clear federal and international leadership.

Jennifer K. Wagner, J.D., Ph.D., is a solo-practicing attorney in State College, PA and a research associate at the University of Pennsylvania’s Center for the Integration of Genetic Healthcare Technologies.

In December 2009 the Northern District of California upheld the constitutionality of California’s Prop 69, which authorizes DNA fingerprinting as part of the routine booking process of individuals charged with felonies. There, in Haskell v. Brown, the defendants challenged California’s Prop 69 by arguing it violated both the 4th and 14th Amendments since, respectively, DNA fingerprinting upon felony arrest was, according to defendants, an unreasonable search and a violation of informational privacy.

In its 2009 opinion, the district court went to great lengths to review three landmark 9th Circuit cases regarding DNA sampling: Kincade,¹ Kriesel,² and Friedman.³ Ultimately the court held that the defendants failed to articulate adequately why DNA fingerprinting differs “in a legally significant way” from other forms of identification (e.g. mug shot photographs, dermatoglyphic fingerprinting). The court explained:

Understandably, much of what drives Plaintiffs’ focus on DNA and its ability to “reveal a host of private information about a person” is the “potential for misuse”—a threat that does not apply to fingerprints. (at 1198)

Applying the totality of the circumstances test (as opposed to the “special needs test”), the district court upheld Prop 69, finding it did not constitute an unreasonable search after balancing the privacy interests of arrestees with the governmental interests in the identification information.

Last week, in a split decision (2-1), the 9th Circuit Court of Appeals affirmed the district court’s 2009 ruling in Haskell.⁴ The court’s opinion (pdf) affirmed the district court’s determination that the totality of the circumstances test was the appropriate analytical framework. The privacy interests of the arrestees were weighed against the numerous governmental interests (notably, the government’s interests in “identifying arrestees, solving past crimes, preventing future crimes, and exonerating the innocent,” at 12). The court concluded that the governmental interests were compelling and strongly outweighed the interests of the arrestees.

The 9th Circuit’s ruling concludes with an important caveat that should comfort those uneasy with the decision:

We emphasize that our decision deals solely with DNA extraction, processing, and analysis as it presently exists, and is enforced. We acknowledge that future developments in the law could alter the constitutionality of the DNA Act, as amended. (at 15)

This should serve as a reminder that any constitutional question involving reasonableness is open for subsequent analysis to accommodate contextual changes. What is reasonable now may not have been a hundred years ago and may not be a hundred years from now. In theory this leaves the door open for constitutional challenges to DNA acts if the profiles involve the analysis of additional loci (e.g. the CODIS panel has been recommended to expand from 13 to 24 loci);⁵ however, because the recommended loci for the expanded panel also were chosen for identification purposes, a renewed challenge on this basis alone would likely result in the same outcome.

While many have waited anxiously for the Haskell case to be resolved, last week’s decision may not be the last word, even in California. Given the significant precedential value of this case, an en banc review by the 9th Circuit may be inevitable.

Additional coverage of DNA fingerprinting and related issues can be found here, here, here, and here.

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¹ U.S. v. Kincade, 379 F.3d 813(9th Cir, 2004)

² U.S. v. Kriesel, 508 F.3d 941 (9th Cir, 2009)

³ Friedman v. Boucher, 580 F.3d 847 (9th Cir, 2009)

⁴ Haskell v. Harris, — F.3d — (9th Cir, 2012)

⁵ Hares DR. Expanding the CODIS core loci in the United States. Forensic Sci. Int. Genet. 2011. Dsi:10.1016/j.fsigen.2011.04.012

Jennifer K. Wagner, J.D., Ph.D., is a solo-practicing attorney in State College, PA and a research associate at the University of Pennsylvania’s Center for the Integration of Genetic Healthcare Technologies.

There is an increasingly apparent absence of national consensus on whether the practice of collecting a DNA sample and creating a CODIS profile as part of the routine arrest booking procedures (i.e., “DNA fingerprinting”) conforms to the constitutional proscription of unreasonable searches and seizures articulated as the 4th Amendment. We mentioned this topic at the Genomics Law Report previously here, here, and here.

In July 2011, the 3rd Circuit upheld the federal DNA Fingerprinting Act of 2005¹ in United States v. Mitchell.² Perhaps perceiving this ruling as a judicial green light, Pennsylvania’s General Assembly, as we recently noted, seems motivated to authorize the practice of DNA fingerprinting upon felony arrest. While the Pennsylvania Senate passed S.B. 775 and referred the matter to the House Judiciary Committee in December 2011, no apparent action has been taken on the measure since then.

Across the country, however, the practice of DNA fingerprinting upon arrest is anything but settled. The Eastern District of California was ready to acknowledge the constitutionality of the federal law in United States v. Pool, but that opinion has since been vacated as moot.³ The Supreme Court of California is presently considering an appeal of People v. Buza,⁴ wherein the California Court of Appeal struck down California’s DNA Fingerprint, Unsolved Crime and Innocence Protection Act (a ballot initiative known commonly as Prop 69, which passed in 2004) as unconstitutional. The 9th Circuit has yet to issue ruling in Haskell v. Brown,⁵ contributing to the uncertainty (see previous coverage).

Minnesota is the latest to weigh in on the matter. In January the Supreme Court of Minnesota, deciding In re Welfare of M.L.M.⁶ and State v. Johnson,⁷ determined that its state statute authorizing DNA fingerprinting during arrest booking procedures, Minn. Stat. §609.117, did not run afoul of either the United States or Minnesota Constitutions. The defendants had challenged the statute on both 4th Amendment and Equal Protection grounds.

At issue in In re Welfare of M.L.M. was whether the DNA fingerprinting of a juvenile petitioned for a felony but adjudicated for a misdemeanor arising from the same fact pattern (as required by Minn. Stat. §609.117 subd. 1(2)) was either an unreasonable search and seizure or a violation of Equal Protection clauses. At issue in State v. Johnson was whether the DNA fingerprinting of an individual arrested for a felony but subsequently only convicted of a misdemeanor arising from the same fact pattern (as required by Minn. Stat. §609.117, subd. 1(1)) was an unreasonable search and seizure. In both cases, the Minnesota Supreme Court applied a totality of the circumstances test, balancing the governmental interests with the reduced privacy interests of the individual convicted or adjudicated of the misdemeanor, and found in each case that the DNA fingerprinting did not constitute an unreasonable search and seizure. In both cases, the Minnesota Supreme Court rejected the defendants’ arguments that individuals who have been adjudicated/convicted of a misdemeanor but not charged with a felony are similarly situated with those individuals who have been adjudicated/convicted of a misdemeanor after having had a felony charge arising from the same facts and circumstances dismissed. Accordingly, the court ruled both subdivisions of the Minnesota state statute were constitutional.

While appropriately reserved for a separate discussion, it is noteworthy that courts – when applying a totality of the circumstances analysis to determine the reasonableness of the search/seizure occurring in DNA fingerprinting – are frequently resting their decisions on their varying perspectives regarding the aptness of the “fingerprint analogy,” i.e., the scope and nature of the information inferable from CODIS profiles and dermatoglyphic profiles. Legal arguments are also placing substantial weight on the definition and conceptualization of “identification purposes,” as opponents of DNA fingerprinting claim its use is not for identification per se but actually for broader investigative purposes. The recent recommended expansion of the CODIS profile from 13 to 24 STR loci is not expected to have a significant influence on the constitutional questions.

Given the varying perspectives among the circuit courts, it seems only a matter of time before the Supreme Court is called upon to resolve the question of whether DNA fingerprinting upon arrest passes constitutional muster.
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¹ DNA Fingerprinting Act of 2005, Pub. L. 109-162

² United States v. Mitchell, 652 F.3d 387 (3rd Cir. (Pa), 2011)

³ United States v. Pool, 621 F.3d 1213, rehearing en banc granted, 646 F.3d 659 (9th Cir., 2010), vacating as moot 659 F.3d 761 (9th Cir. 2011)

⁴ People v. Buza, 197 Cal. App. 4th 1424, 129 Cal. Rptr.3d 753 (Ct. App., 1st Dist., Div. 2, Ca 2011), petition for review granted, 262 P.3d 854, appeal pending Supreme Court of California No. S196200

⁵ Haskell v. Brown, 677 F.Supp.2d 1187 (N.D. Cal. 2009), appeal pending, 9th Cir. No. 10-15152

⁶ In re Welfare of M.L.M. – N.W.2d – (Minn., 2012), 2012 WL 204524

⁷ State v. Johnson, – N.W.2d – (Minn., 2012), 2012 WL 204520

Jennifer K. Wagner, J.D., Ph.D., is a solo-practicing attorney in State College, PA and a research associate at the University of Pennsylvania’s Center for the Integration of Genetic Healthcare Technologies

Thanks to technological innovation and a corresponding decline in cost, an increasing number of individuals are finding themselves with the task – or at least the opportunity – of accessing and interpreting their own genetic information. Over the past year, several state legislatures have taken notice.

Following on the heels of legislation passed or proposed in California, Vermont and Massachusetts, the Alabama House of Representatives is considering a bill by Representative Henry (pre-filed on January 23, 2012 and scheduled for first read on February 7, 2012) titled the “Genetic Information Privacy Act” (2012 AL H.B. 78). While the bill is relatively brief, its effects as written may reach far beyond those intended.

A New Bar for Informed Consent. First, the bill in its current form would require signature on separate informed consent documents to obtain, retain, or disclose genetic information. As drafted the bill would provide an exception for the insurance industry, permitting a single, integrated informed consent document if the genetic information is being obtained, retained, or disclosed “for the purpose of obtaining insurance” (Page 4, Line 25).

Given the federal Genetic Information Nondiscrimination Act of 2008 (GINA) prohibits acquisition and use of genetic information in health insurance contexts, it is likely the bill in its current form would be preempted except to other forms of insurance (e.g. disability and life insurance). In other words, because GINA sets a floor of protections for individuals nationwide, if the Alabama proposed statute is an attempt to permit health insurers to acquire genetic information inconsistent with GINA’s prohibition on such activity, the direct vertical conflict will be resolved in favor of GINA and against the Alabama proposed statute.

There are currently six exceptions to the informed consent requirements contained in the bill, though these exceptions are phrased with potentially controversial or confusing language. The bill states (Page 6, Lines 1-15) that the informed consent requirements

…shall not apply to genetic information obtained:

(1) By a state, county, municipal, or federal law enforcement agency for the purposes of establishing the identity of a person in the course of a criminal investigation or prosecution.

(2) To determine paternity.

(3) To determine the identity of deceased individuals.

(4) For anonymous research where the identity of the subject will not be released.

(5) Pursuant to newborn screening requirements established by state or federal law.

(6) As authorized by federal law for the identification of persons.

As written, it is unclear whether there are any actor constraints on exceptions (2) or (3) (for example, there is no limiting language such as that found in exception (1)). Additionally, the language of exception (4) may create vertical conflicts of law with existing federal human subjects research protections (e.g. such as those imposed by the Department of Health and Human Services, such as regulations pursuant to 45 CFR 46 also known as the “Common Rule”) that govern the acts of scientific investigators at the major research universities and institutions in the state of Alabama. And, of course, the ability to conduct anonymous research using an individual’s genetic information remains open for debate.

Additionally, in its current state, the bill might implicate the personal genomics industry, as it requires verbal interactions prior to DNA collection and, though the language of the bill is unclear, possibly signatures on written informed consent documents prior to DNA collection. (See Page 6, Line 16 to Page 7, Line 21). While it’s possible that some personal genomics companies currently satisfy one or both of these requirements with respect to their customers, it is safe to say that neither practice is currently widespread in an industry that is conducted largely online and through the mail.

Alabama’s proposed bill goes on to stipulate specific prerequisites for valid verbal and written informed consent (Page 8, Lines 4-26): among the disclosures required is an identification of the facilities that will collect and perform the analysis and “a description of all authorized uses of the DNA sample” (emphasis added). This suggests blanket consents, particularly consents intended to cover as-yet-unknown future uses, may not be sufficient in Alabama if this bill is signed into law.

Beyond Informed Consent. The proposed Alabama bill also takes direct aim at surreptitious testing. Section 3 would make it unlawful for any individual to “…collect or cause to be collected an individually identifiable DNA sample for genetic analysis without the written authorization of the sample source…” (Page 5, Lines 23-26).

Ultimately, Alabama’s proposed legislation would make violations of the law Class A Misdemeanors (Page 11, Lines 9-10) and would impose financial penalties to those found in violation. Noncompliance with the restrictions imposed on retention of genetic information would result in a minimum $1000/ maximum $10,000 fine (Page 10, Lines 13-17); noncompliance with restrictions on collection or disclosure of genetic information would result in a minimum $5000/maximum $50,000 fine (Page 10, Lines 18-21); and noncompliance with the disclosure restrictions also would subject the violator to liability for all actual damages proximately related to the disclosure (Page 10, Lines 22-26).

Finally – and significantly – the bill as drafted would make all DNA samples and any genetic information obtained through the analysis thereof “the exclusive property of the person sampled or analyzed.” (Page 11, Lines11-13).

Looking Past the State Houses. Alabama’s proposal resembles in many ways those that appeared in early 2011, particularly in Massachusetts and Vermont, but have not yet been codified into law. Consistent themes include a focus on informed consent and privacy, the creation of (typically ill-defined) property rights in DNA and an attempt to provide protection for individuals in areas where federal law is arguably not adequate (e.g., genetic nondiscrimination) or non-existent (e.g., surreptitious testing).

As we’ve written before (see, e.g., here and here), however, current legal and regulatory oversight in the field of personalized medicine – particularly when it comes to the access and use of personal genomic information – is a messy, patchwork affair. The industry would benefit from clearer guidance that transcends state lines. Despite a flurry of federal activity and publicly accessible discussions emanating from Washington D.C. in the first half of 2010, meaningful guidance for the future of personalized medicine and genomics has yet to take shape. A variety of factors – including political elections and budget shortfalls whose implications reach far beyond personal genomics – may explain why serious (public) talks have faded to near silence.

There is clear value in permitting the personal genomics industry to have period with which to “work out the kinks” and to establish industry customs (under the careful eyes of so many interested regulators-in-waiting). However, a prolonged waiting period – as well as the real possibility that states like Alabama will step into the void with new laws that may be inconsistent with each other and with federal law, thereby ultimately increasing legal and regulatory uncertainty – may carry with it significant costs that could hamper personal genomics’ growth and innovation.

One solution would be for key governmental regulatory and funding bodies, particularly the NIH and the FDA, to play a much more active role in setting personal genomics policy. While these administrative agencies may lack the present authority to implement a new and coherent system of oversight without Congressional action (pdf), they can nonetheless play a critical role in shaping the debate and pressing national and international decision-makers, including Congress, to develop clear, forward-looking policies and laws that will allow the field of personal genomics to continue to advance. Recently, however, leaders in Washington seem content to rely on bioethics commissions and similar groups lacking any regulatory or financial authority to drive the debate, a strategy which – particularly after so many prior recommendations have been left to wilt on the vine – seems highly unlikely to serve as the catalyst for meaningful change.

The need for leadership extends beyond agencies like the FDA and NIH to the world stage, where international policy leadership is an increasingly urgent need, particularly in light of far-reaching privacy regulations being considered by Europe that could reshape what personal genomics means for Europeans as well as American companies seeking to do business in Europe. Personal genomics is and should be a global undertaking and, in that context, consistent federal-level oversight that conflicts with what is happening in Europe and elsewhere is ultimately little better than the ambiguous and inconsistent state-level laws under consideration in Alabama and elsewhere. The need to improve the system of oversight for personal genomics is clear, as is the need for international leadership in doing so. Unfortunately, with the continued absence of such leadership, personal genomics’ companies and consumers may find that proposals like Alabama’s represent the only option on offer.

Jennifer K. Wagner, J.D., Ph.D., is a solo-practicing attorney in State College, PA and a research associate at the University of Pennsylvania’s Center for the Integration of Genetic Healthcare Technologies

Almost a year ago, North Carolina Governor Bev Purdue set up a Task Force charged with determining how the state should compensate victims of its eugenics program. The Final Report (pdf) by that Task Force was submitted to the Governor on January 27, 2012. If the state legislature takes action to implement the Task Force’s recommendations, North Carolina will become the first state (of the 32 states that had eugenics programs) to compensate the victims of its involuntary sterilization program.

Background of NC’s Eugenics Program. Charmaine S. Fuller Cooper, Executive Director of NC Justice for Sterilization Victims Foundation presented (pdf) the Task Force in April 2011 with the history of NC’s eugenics program, explaining that North Carolina adopted its first sterilization law in 1919, its second in 1929, and its third in 1933. North Carolina did not abolish its eugenics board until 1977. The involuntary sterilization law, however, was not repealed until 2003. Don Akin, State Center for Health Statistics, presented (pdf) the Task Force with estimates of how many of the >7,500 individuals sterilized through the program were expected to still be alive, calculating roughly 40% of the victims (~2,900 victims) would have survived to the year 2010, but placing a “realistic” estimate at 1,500-2,000 surviving victims.¹ Former North Carolina Governor Mike Easley issued formal apology for the program in 2002.

NC’s Task Force Recommendations. Preliminary recommendations (pdf) reported in August 2011 included lump sum financial payments that were to be exempt from state taxes; provision of mental health services; funding for a traveling eugenics exhibit; and continuation of funding for the NC Justice for Sterilization Victims Foundation. Since that time, the Task Force has been considering, among other details, what amount would be appropriate compensation.

The Final Recommendations (pdf) indicate that each victim should be compensated with a lump sum payment of $50,000 and requires the living victims to come forward within three years to be eligible for compensation. The Task Force considered, but ultimately decided against, allowing the estates of non-surviving victims to be compensated as well. The final report recommends mental health services like counseling and outpatient care. Additionally the final report emphasizes the importance of public education as a means to prevent these abuses from occurring again and, accordingly, recommends a permanent memorial to the victims of the Eugenics Board and a traveling exhibit. The Task Force’s final report concludes with an optimistic call on the NC legislature to pass the recommendations this year.

Looking Beyond North Carolina. An estimated 60,000 individuals nationwide were involuntarily sterilized as part of the eugenics programs.² As scholars such as Michael Silver have previously explained, Buck v. Bell – the infamous 1927 Supreme Court case that upheld Virginia’s compulsory sterilization law – has never been directly overturned (although the Virginia law upheld in Buck v. Bell was itself repealed in 1974), and its precedent as well as other obstacles (e.g. long expired statutes of limitation) have prevented victims from obtaining redress through the courts. At least two legal scholars noted that even in 2002 (on the 75th anniversary of Buck v. Bell), eight states still had involuntary sterilization statutes on the books (Arkansas, Delaware, Georgia, Idaho, Mississippi, North Carolina, Vermont, and Virginia).³ The anniversary did, however, help prompt governors of California, North Carolina, Oregon, South Carolina, and Virginia to offer officially apologies,⁴ and, as previously mentioned, motivated North Carolina to repeal its own sterilization law in 2003.

In California, where more than a third of the nation’s sterilizations occurred, a Senate Resolution was issued in 2003 apologizing for the program. California, however, has not yet made any attempts to provide compensation or to identify victims.⁵ In Oregon, where the last compulsory sterilization was conducted in 1981, it has been reported by the Eugene Register-Guard on July 31, 2002 that the state destroyed or misplaced records of the ~2,600 sterilizations it performed. Without such records, the state may face difficulties identifying victims and calculating the financial, mental health, and educational resources needed, should Oregon choose to follow the NC Task Force’s lead. We will all need to stay tuned to see whether the NC legislature takes action on the Task Force’s recommendations and whether other states follow suit.

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¹It is notable that while popular press describes most victims as having been poor, black women deemed unfit parents, the program was more nuanced. Don Akin’s source data included in his presentation to the Task Force (see Slides 8 and 9) contained data showing that (a) of the 7528 victims, 6418 were women and (b) through June 1968, 4315 of the victims were White. It is only upon viewing the figures by decade that one sees a racial disparity – as the only period when “Nonwhite” victims outnumbered “White” victims was the 1960-1968 period. The Preliminary Report (pdf) submitted by the Task Force in August 2011 noted similarly that 85% of the victims were female and roughly 40% of the victims were “Non-whites” (see page 8). The disproportionate victimization of black women is reported to have occurred in the late 1960s. See, e.g. Michael Silver, Eugenics and Compulsory Sterilization Laws: Providing Redress for the Victims of a Shameful Era in United States History, 72 Geo. Wash. L. Rev. 862, 887 (2004)

²See, e.g., Michael Silver, Eugenics and Compulsory Sterilization Laws: Providing Redress for the Victims of a Shameful Era in United States History, 72 Geo. Wash. L. Rev. 862 (2004).

³ Michael Silver, Eugenics and Compulsory Sterilization Laws: Providing Redress for the Victims of a Shameful Era in United States History, 72 Geo. Wash. L. Rev. 862 (2004) (at FN13) and Jana Leslie-Miller, From Bell to Bell: Responsible Reproduction in the Twentieth Century, 8 Md. J. Contemp. Legal Issues 123, 136-37 (1997) (at FN82) citing “Ark. Code Ann. § 20-49-101 et seq. (Michie 1987); Del. Code Ann. tit. 16 § 5702-5716 (1974); Ga. Code Ann. § 31-20-1 to 31-20-6 (Michie 1996); Idaho Code § 39-3902 to 39-3910 (1947); Miss. Code Ann. § 41-45-1 (1947); N.C. § 7-35-36 (1943); Vt. Stat. Ann. § 8705 (1959); Va. Code Ann. § 54.1-2974 to 54.1-2980 (1950).” But note the Vermont statute had been deemed inapplicable when the procedures were proposed for eugenic purposes by In Re Marcia R., 136 Vt. 47, 383 A.2d 630 (1978); portions of the Arkansas statute were repealed in 2009; portions of the Delaware statute were stricken in 2006; portions of the Idaho statute were rewritten in 2003; the North Carolina statute was repealed in 2003; the Mississippi statute was repealed in 2008; and Virginia permits sterilization of adults incapable of providing informed consent pursuant to Va. Code Ann. §54.1-2976. There is proposed legislation in Georgia.

⁴ See, e.g., Michael Silver, Eugenics and Compulsory Sterilization Laws: Providing Redress for the Victims of a Shameful Era in United States History, 72 Geo. Wash. L. Rev. 862, 886 (2004).

⁵See, e.g., Kris Pickrell, The Life Penalty – Sterilizing California, CBS 13, November 10, 2011, available at http://sacramento.cbslocal.com/2011/11/10/the-life-penalty-sterilizing-california/ last accessed 1/28/2012

While it will likely be a year or more before a final regulation takes effect, and there will almost certainly be amendments along the way, American companies – including those involved in the field of personalized medicine, where personal data is paramount by definition – should start paying attention now, since they may have to change the way that they do business in Europe.

We will provide a more detailed analysis of the Draft Regulation at a later date. In the meantime, here are some of the key issues we are examining:

• It is significant that the Commission is acting by Regulation rather than Directive (as was the case with the current privacy law, enacted by Directive in 1995). A regulation is top-down, imposed uniformly throughout the EU, whereas a directive is adopted country-by-country, which gives individual nations the chance to make adjustments.
• The EU is taking a very aggressive approach to jurisdiction, or its authority to regulate—and impose penalties on—U.S. and other foreign companies that do business in Europe. The Draft Regulation would cover all data processing activities (very broadly defined) by non-EU companies that involve offering goods or services to EU data subjects or monitoring their behavior.
• Data subjects (also broadly defined) will have significantly more rights than under current EU law. For example, the company will have the burden of proving that every subject has given consent for the processing of their data for specified purposes. Consent is defined as “any freely given specific, informed and explicit [emphasis added] indication of will,” and can be withdrawn at any time. The subject will also have a controversial “right to be forgotten and to erasure.” This means that when the subject withdraws consent or “the data are no longer necessary” for the purposes for which they were collected, the company must render the data inaccessible, including on the Internet.
• Along with data pertaining to race or ethnic origin, political opinions, religion or beliefs and trade-union membership, the Draft Regulation identifies “genetic data” as category of personal data designated for special protection. (The Draft Regulation defines “genetic data” broadly to include “all data, of whatever type, concerning the characteristics of an individual that are inherited or acquired during early prenatal development,” thus presumptively sweeping in all genetic information as well as family medical histories and other related health information.) Special protections include impact assessment and prior authorization of data processing operations, and activities lacking sufficient identification or mitigation of risks to individuals may be prohibited.

These are just a few of the more important features of the 96-page, 91-Article Regulation.

Elsewhere, the Draft Regulation would create other new rights and responsibilities and reaffirm and/or strengthen many provisions of existing law, including the current restrictions on transferring data outside of the EU. Ironically, the Draft Regulation notes that the “practical challenges to enforcing data protection legislation” across boundaries and the “risk of different levels of protection…creat[ing] restrictions on cross-border flows of personal data” between jurisdictions. While the Draft Regulation may ease some of these concerns within the EU, global companies seeking to move personal data in and out of the EU face a different calculus.

The draft must now be reviewed by several Directorates of the EU Commission before being submitted for review and approval by the Parliament and Council. But while full implementation will take some time—more than a year in most estimates—the proposed changes are so dramatic and far-reaching that U.S. companies doing business in Europe will require at least that much lead time to plan their compliance.

On December 22, 2011, the Pennsylvania General Assembly adopted two bills (H.B. 332 and H.B. 333) to amend the commonwealth’s Medical Practice Act of 1985 (P.L. 457, No. 112) and the Osteopathic Medical Practice Act of 1978 (P.L. 1109, No. 261) to include provisions that regulate genetic counselors. Pennsylvania Governor Corbett approved the bills and signed them into law the same day.

PA’s GC Law in Context. According to the National Conference of State Legislatures’ survey of state requirements for genetic counselors, in 2008 only six states required licenses to practice genetic counseling (California, Illinois, Massachusetts, Oklahoma, Tennessee, and Utah). Pennsylvania is the latest to join a number of states (including Delaware, Hawaii, Indiana, New Jersey, New Mexico, South Dakota and Washington) that have enacted GC licensing laws since 2008. The National Society of Genetic Counselors reports that additional states (e.g. Florida, Michigan, Minnesota, New York, Rhode Island, Texas, and Wisconsin) are considering similar legislation. While the state licensing requirements are similar, state-by-state variation and nuances in the statutes may exist. The following information pertains to Pennsylvania’s new licensing law only.

Defining the GC Field.  Specifically, the two laws define genetic counseling as “[t]he provision of services to individuals, couples, families and organizations by one or more appropriately trained individuals to address the physical and psychological issues associated with the occurrence or risk of occurrence of a genetic disorder, birth defect or genetically influenced condition or disease in an individual or a family.” They define genetic counselor as “[a]n individual who is licensed to practice genetic counseling by the State Board of Medicine or the State Board of Osteopathic Medicine.” (63 P.S. §422.2 and 63 P.S. §271.2)

The laws prohibit individuals from holding themselves out as genetic counselors unless they are licensed. There are a few notable exemptions to this licensure mandate. One exemption permits individuals licensed to practice medicine (though not licensed as genetic counselors) to provide services that constitute genetic counseling so long as two requirements are met: (1) they are acting within the scope of their licenses and training when they provide those services, and (2) they do not hold themselves out as genetic counselors.  Another exemption permits students to perform genetic counseling, so long as (1) the students are enrolled in a genetic counseling education program that is accredited by either the ABGC (i.e. the American Board of Genetic Counseling) or ABMG (i.e. the American Board of Medical Genetics), (2) the counseling is an “integral part of the student’s course of study,” and (3) the counseling “is performed under the direct supervision of a genetic counselor, licensed physician, certified registered nurse practitioner with a specialty or subspecialty in genetics or clinical nurse specialist with a specialty or subspecialty in genetics.” (63 P.S. §422.13.4(d) and §271.10.3(d))

The laws also stipulate what is required for licensure as a genetic counselor (63 P.S. §422.13.4(e) and §271.10.3(e)): the individual must (1) be at least 21 years of age, (2) be “of good moral character,” (3) have a master’s or doctoral degree in human genetics or genetic counseling from an ABGC- or ABMG-accredited program or otherwise meet the ABGC or ABMG certification requirements, (4) pass the certification exam by the ABGC or ABMG, and (5) complete the application and pay the appropriate fees.

There is a transition phase of three years that permits noncertified individuals to become licensed.

While initial licenses appear to have no continuing education requirements for the initial two years, license renewal will require no less than 30 hours of continuing education within the two years immediately preceding the renewal. (63 P.S. §422.13.4(j) and §271.10.3(j)).

Additionally, genetic counselors are required by these laws to carry professional liability insurance coverage (i.e. malpractice insurance) in the minimum amount of $1,000,000 per occurrence or claims made. (63 P.S. §422.13.4(k) and §271.10.3(k)).

Expanding or Limiting a GC’s Duties?  A provision worth noting for ELSI scholars (particularly those contemplating duties to report, ongoing duties to patients) may be 63 P.S. §422.13.4 (c)(2) and §271.10.3(c)(2)). These sections state:

“When in the course of providing genetic counseling services to a client, if a genetic counselor finds any indication of a disease or condition that requires diagnosis and treatment outside the scope of practice defined in this section, the genetic counselor shall refer the client to a licensed physician or appropriate health care practitioner.”

While it remains to be seen how this provision will be enforced, as written the statute seems to impose a number of duties on genetic counselors. Notice the language is not restricted to “patients” but, rather, imposes a duty to “clients.” It is possible that this word choice was simply in recognition of the fact that those individuals seeking genetic counseling services may not be symptomatic or otherwise fitting of the term “patients.” However, this word choice potentially conveys a much broader class of statutorily protected individuals and will likely permit a fair degree of play if legal disputes ever arise (e.g. who exactly is the client – the individuals tested, the individuals in the room during the counseling, the individual’s family members (all? only first-degree relatives? only first degree genetic relatives?), the person paying for the counseling, etc – and to whom did the genetic counselor owe duties of care).

The provisions’ introductory clause may limit these duties if the clause is interpreted as imposing a temporal restriction to the time of the counseling session (as opposed to ongoing duties if, for example, variants of unknown significance become better understood subsequently) or as suggesting a narrow definition of “client” that would release the genetic counselor from any duties to family members and extended relatives who are outside the clinic’s office door.

The provisions of Pennsylvania’s GC licensing law are scheduled to take effect 60 days after the law was signed, which would be on or about February 20, 2012.