More Bad Legal News for Athena Diagnostics: Don’t Mess with Mayo

We have been reporting for more than a year about the case of Williams v. Quest Diagnostics (the parent company of Athena Diagnostics), in which the plaintiff has sued Athena and Quest for causing the death of her son by misclassifying a genetic variant when testing the boy’s DNA. That case is now on  hold in a South Carolina federal court until the state’s Supreme Court resolves the question of whether a genetic testing lab is a licensed healthcare provider under South Carolina law. If it is, then the case will be governed by the state’s malpractice statute of limitations and will probably be dismissed as having been filed too late. If it’s not, then the ordinary negligence statute of limitations will apply and the case will probably be allowed to proceed.

But now Athena faces an adverse ruling from another court—a Massachusetts federal district court—in a patent infringement suit that Athena and two co-plaintiffs brought against Mayo Collaborative Services and the Mayo Clinic: Athena Diagnostics, Inc. v. Mayo Collaborative Services, LLC. In an August 4, 2017 decision, Judge Indira Talwani invalidated Athena’s patent on a method for diagnosing myasthenia gravis (MG), an autoimmune disease that depletes muscle strength. Previous tests detected what are called AChR autoantibodies (antibodies that attack antigens originating in the patient’s own body as if they were foreign substances) to diagnose MG.

But 20% of MG patients don’t have AChR autoantibodies, so the earlier tests yield false negatives. The inventors of the Athena patent discovered that the 20% do have another kind of autoantibody that attacks a neuromuscular protein receptor called MuSK. The patented method calls for making a version of MuSK with a radioactive label (125I-MuSK) and then introducing the 125I-MuSK to a bodily fluid (blood) sample from the patient. If MuSK autoantibodies are detected, the patient is diagnosed with MG.


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Filed under Genomics & Medicine, Patent Litigation, Pending Litigation

A Constitutional Challenge to Alaska’s Genetic Privacy Statute

As part of its defense of a class action lawsuit that began in 2014, a genetic genealogy company (or DNA ancestry company as they are sometimes called) is challenging the constitutionality of the Alaska Genetic Privacy Act, arguing that the statute’s provisions are unconstitutionally vague. The State of Alaska is intervening in the lawsuit to defend the statute.

The Alaska Genetic Privacy Act (AK ST §18.13.010 et seq.) was passed into law in 2004. The state statute imposes a consent requirement that effectively prohibits surreptitious genetic testing and declares that a DNA sample and the results of any genomic analysis are the “exclusive property of the person sampled or analyzed.” More specifically, it requires prior written informed consent for the collection, analysis, retention, or disclosure of DNA samples and test results. The statute makes exceptions to the consent requirement for DNA identification registries like CODIS, law enforcement purposes, paternity testing, newborn screening, and emergency medical services. There are both civil and criminal enforcement mechanisms in the statute. Affected individuals can bring private civil court actions against violators of the statute (AK ST §18.13.020), while another provision criminalizes violations as Class A Misdemeanors (AK ST §18.13.030). The statute (AK ST §18.13.020) provides that a victim is entitled to compensation from the violator in the amount of $5,000 or, in instances in which the violation “resulted in profit or monetary gain to the violator,” $100,000.
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Filed under Genetic Testing/Screening, Genomics & Society, Informed Consent, Pending Litigation, Privacy

LabMD Update

Last September, I reported on the Federal Trade Commission’s decision upholding its enforcement action against the now-defunct clinical laboratory LabMD, Inc. In 2013, the FTC brought an administrative complaint against LabMD, alleging that its lax cybersecurity practices resulted in the exposure of patient data. As I wrote last year, exposure was the key word, as the FTC did not allege any actual data theft or other tangible harm to patients.
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Filed under Legal & Regulatory, Privacy

Comment on ACB v. Thompson Medical

In a recent conversation with John Conley about his April 25 post on the ACB v. Thompson Medical ruling by the Court of Appeal of Singapore, I made a couple of points, and he asked me to write them up to briefly comment on the topic for the Genomics Law Report.

First, the real damage caused by loss of genetic affinity is that the couple’s baby will never share any of the inherited (genetic) traits of the husband. For the mother who brought the case, this is significant because those traits (presumably) are an important part of the couple’s initial attraction and, ultimately, the mother’s implicit desire to have a child with a man with those specific traits. For the husband, of course–who is not the named plaintiff–the fact that the child is not biologically related to him is an even more definitive loss.

Second, it is curious that the husband was not the plaintiff (or at least a plaintiff) in the case. Given that his total genetic exclusion was not by his choosing, it could be argued that the husband was even more injured than the mother. After all, it is the husband who had the total “fracture of biological parenthood,” not the mother, as she has provided 50% of the child’s genetic makeup.

Jennifer Hutchens is a Robinson, Bradshaw lawyer who focuses on health care and life sciences.

Filed under General Interest, Genomics & Society, International News

Keeping an Eye on “Perceived Disability” Litigation in California: Chadam v. Palo Alto Unified School District

We mentioned in January that the Ninth Circuit Court of Appeals reversed the District Court’s earlier decision to grant a motion to dismiss and is instead allowing the case of Chadam v. Palo Alto Unified School District to move forward. At that time, we explained that this case should remain high on the watch list for genetic rights advocates, as it involves whether a genotype (such as carrier status for an autosomal recessive condition like cystic fibrosis) is a “perceived disability” under the Americans with Disabilities Act (42 U.S.C.A. §§12131 et seq.) and Section 504 of the Rehabilitation Act of 1973 (29 U.S.C.A. § 794).
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Filed under Genomic Policymaking, Genomics & Medicine, Genomics & Society, Pending Litigation, Privacy

Singapore Court Awards Damages for Loss of “Genetic Affinity”

In its March 22, 2017 decision in ACB v. Thomson Medical, the Court of Appeal of Singapore (the city-state’s supreme court) approved an award of damages for loss of “genetic affinity” against a fertility clinic that negligently fertilized a mother’s egg with sperm from an anonymous donor rather than her husband. The plaintiff and her husband had sought help from the four defendants, a group of related medical entities and practitioners, to conceive a child in vitro. The wife is an ethnically Chinese Singaporean and the husband is a Caucasian of German descent. After multiple attempts at fertilization, the wife gave birth to a baby girl (referred to in the opinion as “Baby P”). The family noticed that Baby P’s skin tone did not match that of either parent, nor that of their older child. They also learned that Baby P had a blood type that could not be reconciled with the parents’ types. Further medical investigation revealed that the wife’s egg had been fertilized not with the husband’s sperm, as the couple had intended, but with the sperm of an anonymous donor of Indian ethnicity.
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Filed under General Interest, Genomics & Society, International News

Disputes Continue over Foundational Patents for Gene Editing

CRISPR-Cas9 editing of the genome

As we noted early last year, a major dispute over patent rights to CRISPR-Cas systems broke out in January 2016 between Feng Zhang, the Broad Institute, and MIT on one side and Jennifer Doudna and the University of California-Berkeley as well as Emmanuelle Charpentier, Krzysztof Chylinski, and the University of Vienna on the other. CRISPR-Cas systems are powerful tools for genome editing that allow researchers to activate or deactivate target genes. As a reminder of this patent dispute, at issue is whether Zhang was first to invent the application of CRISPR-Cas9 in mammalian and human cells or whether Doudna’s invention of CRISPR-Cas9 was broad enough to encompass application in both prokaryotic and eukaryotic cells (including mammalian and human cells).

A few noteworthy events have occurred since our last coverage in February 2016. The two sides are engaged in what is called an interference proceeding. The U.S. Patent and Trademark Office (USPTO) determined preliminarily that the two sides were claiming patent rights to the same technology and initiated the interference to let them fight over who had priority. Under the pre-2013 version of the Patent Act that applies here, the key question would be who invented first.
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Filed under General Interest, Genomics & Society, Legal & Regulatory, Patent Litigation, Patents & IP

Some Thoughts on the New Common Rule for Human Subjects Research

On January 18, 2017, in one of its last official acts, the outgoing Obama administration issued a final revised version of the Common Rule—the regulation that governs the treatment of human subjects in all federally funded research. This was the culmination of a process that began in 2011 when the Department of Health and Human Services (HHS) issued an Advance Notice of Proposed Rulemaking, or ANPRM, that envisioned major changes to the original 1991 Common Rule. Then, on September 8, 2015, HHS and 15 other federal departments and agencies released a Notice of Proposed Rule Making (NPRM) that proposed specific changes to the Common Rule and opened a 90-day public comment period.
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Filed under Genomics & Medicine, Informed Consent, Patents & IP

Williams v. Athena Motion to Dismiss Hearing—SC Supreme Court May Be Asked to Decide Whether a Diagnostic Laboratory Qualifies as a Healthcare Provider

Foreword by John Conley 

Back on May 31, 2016, Contributing Editor Jennifer Wagner wrote a lengthy report on the newly filed case of Williams v. Quest Diagnostics, et al. As Jen recounted, plaintiff Amy Williams sued Athena Diagnostics and its corporate parent, Quest Diagnostics, alleging that Athena negligently misclassified a genetic variant it identified in testing the DNA of her late son. Ms. Williams claims that the misclassification caused the boy’s doctors to prescribe a potentially dangerous course of treatment that ultimately led to his death. The case was originally filed in a South Carolina state court and was then removed to federal court by the defendants, which they were able to do because the parties are citizens of different states.
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Filed under General Interest, Genetic Testing/Screening, Genomics & Medicine, Legal & Regulatory, Pending Litigation

Update on Chadam v. Palo Alto Unified School District

About a year ago we reported on a case involving allegations of genetic discrimination by a school district in California. According to the allegations, in fall 2012 the Palo Alto Unified School District used genetic information regarding cystic fibrosis in deciding to transfer a student away from his neighborhood school to another school.

Genetic nondiscrimination laws are stronger in California than anywhere else in the United States. CalGINA (S.B. 559), which took effect five years ago, extended genetic nondiscrimination rights beyond the narrow scope of the federal statute known as GINA, the Genetic Information Nondiscrimination Act of 2008, which prohibits genetic discrimination in employment and health insurance contexts. However, this case was interesting to Genomics Law Report largely because the plaintiffs did not rely on CalGINA in their complaint against PAUSD but instead focused on protections against “perceived disability” provided under the Americans with Disabilities Act or ADA (42 U.S.C.A. §§12131 et seq.) and Section 504 of the Rehabilitation Act of 1973 (29 U.S.C.A. § 794). The school district had convinced a federal district court to dismiss the complaint, but the plaintiffs filed an appeal in January 2016.
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Filed under Genomic Policymaking, Genomics & Medicine, Genomics & Society, Pending Litigation, Privacy