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

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

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

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

FTC Muscles in on Health Privacy

600px-US-FederalTradeCommission-Seal.svgIn its July 29, 2016 decision in LabMD, Inc., the Federal Trade Commission clearly signaled its intent to get more involved in the regulation of health privacy. Specifically, the case indicates that the agency intends to go well beyond its traditional role of protecting consumers against deception and to begin scrutinizing the nuts and bolts of companies’ health data security practices.
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Filed under Legal & Regulatory, Pending Regulation, Privacy, Privacy

New Federal Trade Secret Act and Its Impact on Life Sciences

918333_u_s__capitol_buildingOn May 11, 2016, a new federal trade secrets law called the Defend Trade Secrets Act (DTSA) took effect. Its primary impact is to allow the victims of trade secret misappropriation to sue in federal court. It also provides some new civil remedies that exceed what is usually available under state law. The DTSA will be slotted into the U.S. Criminal Code (chapter 90 of Title 18), which already makes industrial espionage and trade secret theft a federal crime. In terms of what companies have to do to comply, the answer is almost nothing—the sole exception being a change in future employee contracts that is discussed below. In this post I’ll describe and analyze the new law and offer some thoughts about its potential impact on the life sciences industry.

Until now, civil trade secret protection has been entirely a matter of state law. The law is very consistent from state to state, as 47 states have enacted the Uniform Trade Secrets Act (UTSA). The exceptions are New York, Massachusetts, and North Carolina, though the North Carolina statute is generally similar to UTSA. Enforcement actions must usually be brought in state court, though federal courts can take jurisdiction if the plaintiff and defendant are citizens of different states. Even then, however, the federal court must apply state law in deciding the case.
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Filed under Direct-to-Consumer Services, Genetic Testing/Screening, Patent Litigation, Patents & IP

EU Adopts New Privacy Shield for Data Transfers to U.S.

Back in April, we reported on some new developments in European Union law that have implications for the life sciences industry. One of these developments was in the privacy area—the final approval of the EU’s new General Data Protection Regulation (GDPR). The GDPR will have enormous significance for medical research and practice, since it will govern the collection and use of health data related to EU citizens. This month has brought a complementary and equally significant development, this time dealing with the transfer of personal data—including health data—from the EU to the U.S.

On July 12, 2016, the European Union announced that it had formally adopted the long-awaited EU-U.S. Privacy Shield to permit the transfer of personal data from EU countries to the United States.
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Filed under International Developments, Privacy, Privacy, Privacy

NIH Refuses to March In—Again—And National Academies Challenge Human Subjects Regulation

The last few days have seen two significant news items from Washington. First, the National Institutes of Health have refused—yet again—to exercise their “march-in” rights to grant third-party licenses to a patented drug developed with federal funding. The drug in question is enzalutamide, a prostate cancer treatment marketed under the brand name Xtandi by Japanese pharmaceutical company Astellas Pharma. Xtandi was derived from federally supported research at UCLA. Under such circumstances, NIH has the statutory authority to grant a license to a third party if the grantee or its assignee “has not taken, or is not expected to take within a reasonable time effective steps to achieve practical application of the subject invention.” “Practical application” means that that the invention must be “available to the public on reasonable terms.”
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Filed under Legal & Regulatory, Patents & IP, Uncategorized

Cleveland Clinic Pathologist Urges Contract Solution for Return of Genomic Data

The Cleveland Clinic’s Roger Klein responds to my previous GLR post:

Roger-Klein-MD-JDThe Office of Civil Rights’ interpretation of the requirements of 45 CFR § 164 could pose problems for clinical laboratories and the professionals who practice within them. Although the issue of providing benign variants for a single gene, at least prospectively, would be straightforward, a broad definition of the designated medical record set could result in considerable complexity when one considers large-scale sequencing. Some excluded data can be of variable reliability, may be prospectively filtered by software, or may otherwise be omitted from the patient report because of professional interpretation and judgment. One can legitimately argue that this interpretation and judgment, as reflected in the patient report, should serve as the gateway to the official medical record.
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Filed under Genetic Testing/Screening, Genomic Sequencing, Genomics & Medicine, Genomics & Society