Medical Organizations Can’t Shape the Rules for Admitting Expert Testimony

96-well plateA little more than a year ago I wrote a post about the then-new Recommendations for Reporting of Incidental Findings in Clinical Exome and Genome Sequencing from the American College of Medical Genetics and Genomics (ACMG). Those Recommendations (since modified somewhat) proposed that whenever a patient undergoes whole-genome or whole-exome sequencing (WES) for any purpose, the laboratory doing the testing should always sequence and report to the ordering physician the results for 57 (now 56) genes on the ACMG’s list. Among the questions I addressed in that post was this one: “Do those Recommendations become by definition the standard of care for the specialty, immediately or in the near future?” I wondered specifically about a future case in which a doctor ordered WES, the lab analyzed only the genes the doctor was interested in, leaving out some of the ACMG’s 56, and the patient subsequently suffered a bad medical outcome linked to an omitted gene. Would failure to follow the ACMG Recommendation be evidence—maybe even conclusive evidence—of malpractice?
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Filed under Genetic Testing/Screening, Genomics & Medicine

New Article on Myriad Litigation and the Company’s Evolving Strategy

MyriadGLR editor John Conley has just co-authored a new article in the North Carolina Journal of law & Technology about Myriad Genetics’ response to last summer’s Supreme Court case that invalidated its broadest gene patents. The article focuses on Myriad’s business decision to rely less on patents and more on its vast proprietary database, especially in its growing European operations. The co-authors are Robert Cook-Deegan, M.D., a research professor of public policy and medicine at Duke, and Gabriel Lazaro-Munoz, J.D., Ph.D., a post-doctoral fellow at UNC’s Center for Genomics and Society (where John is also an investigator). The article was included in NC JOLT’s 2014 Symposium, “Gene Patents After Myriad.” The Symposium also includes articles by Sandra Park of the ACLU, who was involved in the Supreme Court case, and law professors Lori Andrews and Christopher Holman. The Symposium can be accessed at http://ncjolt.org/. Here are links to the full Conley, Cook-Deegan and Lazaro-Munoz article the abstract (NC JOLT is Open Access):
http://ncjolt.org/myriad-after-myriad-the-proprietary-data-dilemma/
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Filed under Uncategorized

ACMG Backs Down a Bit

57 sauceA year ago, the American College of Medical Genetics and Genomics (ACMG) released its Recommendations for Reporting of Incidental Findings in Clinical Exome and Genome Sequencing. As I reported in a July 2013 post, the core recommendation was this: “The ACMG recommends that for any evaluation of clinical sequencing results, all of the genes and types of variants in the Table should be examined and the results reported to the ordering physician.” Specifically, the ACMG recommended that whenever a lab does whole genome or whole exome sequencing on a patient, it should examine all 57 [now 56] genes on the list included in the Recommendations and report any clinically significant findings to the ordering physician. It would then be the duty of that physician “to provide comprehensive pre- and post-test counseling to the patient.” Most controversially, the ACMG recommended that the test findings “be reported without seeking preferences from the patient and family and without limitation due to the patient’s age.” As I characterized it in the July post, “patients should be given the 57-gene screening whether they want it or not and told the results even if they say they don’t want them.”
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Filed under Genetic Testing/Screening, Genomic Policymaking, Genomic Sequencing, Genomics & Medicine, Informed Consent

District Court Denies Myriad’s Preliminary Injunction Against Ambry

MyriadIn a 106-page opinion issued on March 10, 2014, Judge Robert Shelby of the federal district court in Salt Lake City denied Myriad Genetics’ Motion for Preliminary Injunction in its lawsuit against Ambry Genetics Corporation. For reasons I’ll try to explain, this is a significant development from a practical standpoint, but not earth-shaking from a legal point of view. Above all, it is not surprising. Reluctant as I am to say “I told you so,” well, I told you so.

As we previously reported, after the Supreme Court decided AMP v. Myriad Genetics, a number of competitors, including Ambry, jumped into the BRCA testing market. Myriad started suing them in the Utah federal district court, beginning with Ambry (filed July 9, 2013) and Gene by Gene (July 10). The cases were soon consolidated, to be handled together by Judge Shelby. In both cases, Myriad alleged that the defendant’s testing would infringe patent claims that had not been struck down by the Supreme Court’s AMP decision, which had held that DNA that had merely been isolated from the body was not patentable subject matter. In both cases, Myriad sought a preliminary injunction: a pre-trial order that the defendant must cease its testing activity for the duration of the case. If Myriad then prevailed at trial, the injunction would become permanent. The defendants denied Myriad’s allegations, opposed the preliminary injunction, and filed massive antitrust counterclaims alleging that Myriad has used its patents in unlawful ways to monopolize the BRCA testing market.
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Filed under Genetic Testing/Screening, Genomics & Medicine, Genomics & Society, Myriad Gene Patent Litigation, Patent Litigation, Patents & IP, Pending Litigation, Pending Regulation

The Revolt of the Cs: Class Action Filed Against 23and Me

The “Cs” in DTC have revolted, in the form of a consumer class action filed November 27, 2013, in a California federal court (Case 3:13-cv-02847-H-JMA). The suit, called Casey v. 23andMe, alleges that 23andMe falsely and misleadingly advertises its Personal Genome Service (PGS) test kit. The suit charges that these advertising practices violated numerous California statutes as well as other laws pertaining to misrepresention, breach of warranty, and unjust enrichment.

A class action is a suit brought by a limited number of “named plaintiffs” or “class representatives” (here just one, 23andMe customer, Linda Casey) on behalf of a large number of other, similarly situated people (the class members) who don’t actually participate in the litigation but would share in any recovery. The class here consists of all of 23andMe’s customers. The case seeks unspecified monetary damages, including at a minimum a refund of whatever the class members paid for the PGS, as well as an order (an injunction) prohibiting 23and Me from engaging in false advertising in the future. If there have been, as estimated, almost half a million PGS purchasers who paid the list price of $99, then the damages are potentially big. The complaint in this case also asks that 23andMe be ordered to pay the fees of the class lawyers. Attorneys’ fees can be huge in class actions, sometimes—and very controversially—running into the millions of dollars.

The complaint makes extensive reference to the November 22, 2013, FDA warning letter as evidence of 23andMe’s false advertising, so it is reasonable to ask whether that letter prompted this suit. That is, did the lawyers see an opportunity to free-ride on the FDA’s work and the negative publicity attendant on the letter? Hard to say: On the one hand, the complaint is long, detailed, and carefully prepared, evidence that’s in been in preparation for a while. On the other, the timing coincidence and the symbiosis of the allegations are suggestive. Across the legal spectrum, class action filings have a tendency to follow bad news for the defendant.

What can we say about the likelihood of success, or at least a valuable settlement, for the plaintiff class and their lawyers? It’s too early to do much more than speculate. Nonetheless, there are a few factors to keep in mind. First, the proposed class has to be initially approved, or “certified,” by the court before the case can continue as a class action. That’s a long (often a year or much more) and complex process involving difficult legal standards. As classes go, this one seems pretty coherent, so at first glance it would seem to have decent prospects for certification. As far as an ultimate winner and loser, the FDA has significantly helped the plaintiff class by setting out in its warning letter several specific advertising claims that it says are unsubstantiated. The class would have to prove at trial that the FDA’s charges are true, but those charges give the class a considerable head start. It is certainly a case with significant potential.

Filed under Direct-to-Consumer Services, Genetic Testing/Screening, Genomic Policymaking, Genomics & Society, Uncategorized

Reader Response . . .

James P. Evans, Bryson Distinguished Professor of Genetics & Medicine and Editor-in-Chief of Genetics in Medicine, responds to my post on the FDC “warning letter” to 23andMe:

I liked your piece – with one exception. You say you are “libertarian” in the medical realm. This could make sense if you paid for all of your medical care. But you don’t – and I warrant even Bill Gates doesn’t. We’re all in some kind of insurance scheme, be it private or public. Thus, the libertarian argument (“It’s my body, I want this test/treatment/etc”.) doesn’t fly in my mind.

When medical tests are misused, we all pay – even if you pay for the initial test itself – because of downstream costs. If I give someone antibiotics inappropriately because they make the libertarian argument and even offer to pay for the prescription out of pocket, the problem is that the complications of antibiotic resistance may well cause downstream complications for them that their insurance (and thus I) have to pay for.

By the same token, if people use that argument to get inappropriate complex testing (e.g. a 23andMe profile or a whole-body MRI), we all end up paying for the (inevitable) downstream costs. Simply put, we all have a stake in seeing that complex medical tests are used appropriately. Thus, the FDA’s action was entirely reasonable and appropriate.

So, since your hand is in my pocket when it comes to medical care, I just don’t see the libertarian argument working, even putting aside my concerns about harm to people (which we all, I think, want to avoid) and my (admittedly paternalistic) view that we have to protect people from slick advertisements and themselves.

Filed under FDA LDT Regulation, General Interest, Genomic Policymaking, Genomics & Medicine, Genomics & Society, Legal & Regulatory

If 23andMe Falls in the Forest, and There’s No One There . . .

FDA v LDTGenomics Law Report has paid close attention to the FDA’s potential regulation of laboratory developed tests (or LDTs) over the years. We have decided to address the most recent development – a cease and desist letter sent by the FDA to 23andMe – in two posts — by Jennifer Wagner and by John Conley.

On November 22, 2103, the Food and Drug Administration issued a “warning letter” to Google-backed 23andMe demanding that the company “immediately discontinue marketing” its Saliva Collection Kit and Personal Genome Service (PGS), a direct-to-consumer (DTC) genomic testing service. The letter states that 23andMe markets the PGS as a source of “health reports on 254 diseases and conditions,” and “specifically as a ‘first step in prevention’ that enables users to take ‘steps toward mitigating serious diseases’ such as diabetes, coronary heart disease, and breast cancer.” Consequently, the FDA concludes, the PGS is a medical device subject to FDA regulation, as opposed to a mere source of information, as 23andMe has long contended. Because 23andMe has not obtained required approvals, the FDA claims the authority to order its removal from the market.

The letter has already generated tremendous interest in the media and among investors. Jen Wagner and I have been deluged with questions from both groups. Here are my thoughts on some of the most frequently asked questions. As you’ll see, my overall reaction is: calm down, take a deep breath, it’s not that big a deal. Jen has posted her views here.
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Filed under Badges, FDA LDT Regulation, General Interest, Genomic Policymaking, Genomics & Medicine, Genomics & Society, Legal & Regulatory

Myriad Back in Court Again — This Time as a Defendant

MyriadMyriad Genetics is once again embroiled in litigation over its BRCA-related patents. But this time Myriad is the defendant. Counsyl, Inc., a San Francisco-based company that focuses on genetic carrier testing, sued Myriad in U.S. District Court for the Northern District of California on September 20, 2013. As we noted in an earlier post, Myriad — as a plaintiffhas recently sued two small companies, Ambry and Gene By Gene, that have entered the BRCA testing market in response to the Supreme Court decision invalidating Myriad’s gDNA patent. Myriad presumably filed those suits — against vulnerable defendants — to send a message that it would maintain its testing monopoly by enforcing patent claims that had survived the earlier litigation. But it took the risk that the defendants might succeed in invalidating those surviving claims. Now, with the Counsyl suit, the BRCA controversy has entered a new stage, with a prospective competitor launching a preemptive strike against Myriad and its patents.


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Filed under Genetic Testing/Screening, Genomics & Medicine, Myriad Gene Patent Litigation, Patent Litigation, Patents & IP, Pending Litigation, Pending Regulation

Readers Respond to ACMG Recommendations Post

57 sauceThe GLR received some interesting comments on my recent post about the American College of Medical Genetics Gene Screening Recommendations. Here are two of the comments. As we are still in the early stages of what is likely to be a continuing and controversial story, we welcome others.

From an anonymous GLR reader:

Just read and am very intrigued by the new GLR piece. I think the potential for recommendations like those to be implicated in setting the standard of care in certain medmal cases is there, although I can’t imagine that these recommendations could seriously be argued (well, I’m sure they could be argued – but I don’t think the argument is at all a winner) as the standard of care now, since I don’t really expect that their adoption has yet been widespread. But it sure will be interesting to see somebody try at some point down the road. I just think, if and when that happens, it would have to be in a case where whole genome or whole exome sequencing was performed for a specific clinical purpose.

That brings me to the second thing I found interesting about your piece:
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Filed under Genomic Sequencing, Genomics & Medicine, Genomics & Society

The ACMG Gene Screening Recommendations

57 sauceIn March, the American College of Medical Genetics and Genomics (ACMG) released its much-anticipated Recommendations for Reporting of Incidental Findings in Clinical Exome and Genome Sequencing. The ACMG describes itself as “an organization composed of biochemical, clinical, cytogenetic, medical and molecular geneticists, genetic counselors and other health care professionals committed to the practice of medical genetics.” Its brief mission statement includes a commitment to “Define and promote excellence in the practice of medical genetics and genomics in the integration of translational research into practice.” It publishes the journal Genetics in Medicine, and has previously issued “standards and guidelines” for clinical genetics laboratories and cystic fibrosis carrier screening.

The core recommendation is straightforward: “The ACMG recommends that for any evaluation of clinical sequencing results, all of the genes and types of variants in the Table should be examined and the results reported to the ordering physician.” Reading this in light of the definitions section and the rest of the report, it seems to mean this: Whenever a lab is requested to do any “clinical sequencing” (more below on what this means), it should examine the 57 genes listed on the Table and report any significant mutations it finds. It is the responsibility of the clinician who ordered the initial sequencing “to provide comprehensive pre- and post-test counseling to the patient.” In what has become the most controversial aspect of the Recommendations, the ACMG recommends the test findings “be reported without seeking preferences from the patient and family and without limitation due to the patient’s age.” In other words, patients should be given the 57-gene screening whether they want it or not and told the results even if they say they don’t want them—in effect, if you consent to any clinical sequencing, you automatically consent to this further screening and to hearing the results. The same holds true for the parents of minor patients.
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Filed under Direct-to-Consumer Services, Genetic Testing/Screening, Genomic Sequencing, Genomics & Medicine