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

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

Litigating the Accountability of Clinical Genomics Laboratories

Seeking Accountability from Clinical Genomics Laboratories

A wrongful death case pending in a federal court in Columbia, SC—Williams v. Quest Diagnostics, Inc., et al.—demonstrates the very high stakes involved with clinical genomics testing. The case also underscores the ongoing struggle to (1) establish accountability when mistakes happen and (2) establish a reasonable and effective level of governmental oversight for the laboratories performing such tests. The case could have dramatic implications for the future practice of genomic medicine, and regardless of how this specific case ultimately plays out in the courtroom, the allegations should serve as a serious wake up call to those involved in genomics for clinical purposes in any way.
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Filed under General Interest, Genetic Testing/Screening, Genomics & Medicine, Legal & Regulatory, Pending Litigation

New Diagnostic Guidelines and DTC Testing for Alzheimer’s Disease

Last month, the National Institute on Aging and the Alzheimer’s Association issued new diagnostic guidelines that divide Alzheimer’s disease into three distinct stages, reflecting recent evidence that the disease begins to affect the brain years before symptoms become evident. The expanded definition of Alzheimer’s includes two new phases of the disease:

(1) presymptomatic and (2) mildly symptomatic but pre-dementia, along with (3) dementia caused by Alzheimer’s. This reflects current thinking that Alzheimer’s begins creating distinct and measurable changes in the brains of affected people years, perhaps decades, before memory and thinking symptoms are noticeable.

At least for the moment, the new guidelines are intended to be used only with patients enrolled in clinical trials, making them more of a work in progress and not a standardized method of determining disease onset in Alzheimer’s patients.

Federal Alzheimer’s Activity. The revisions to the diagnostic guidelines – the first in nearly three decades – indicate how far scientists have come in understanding the disease and are reflected in new legislation introduced in both the Senate (S.738) and the House (H.R.1386) that would expand Medicare coverage of Alzheimer’s to cover “comprehensive Alzheimer’s disease diagnosis and services,” including for individuals who fall under stage (1) or (2) of the new guidelines.

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Filed under Direct-to-Consumer Services, General Interest, Genetic Testing/Screening, Genomic Policymaking, Genomics & Medicine, Genomics & Society, Industry News, Legal & Regulatory, Patents & IP, Pending Regulation