Theranos Class Action Says Lab Botched Blood Tests

Theranos is facing a consumer class action lawsuit alleging its Edison blood testing machines fail to provide accurate test results.

The plaintiff, identified in this Theranos class action lawsuit by the initials M.P.B., alleges that the Edison blood testing device offered by Palo Alto-based Theranos Inc. provided grossly inaccurate test results due to faulty processing at Theranos’s offsite laboratories.

According to the class action lawsuit, Edison is a hand-held machine designed to conduct blood tests outside of a lab. As an alternative to a more involved venous blood draw that would use a larger needle and tubing, Edison takes blood samples using a small pinprick in the user’s fingertip.

The blood sample goes into a nanocartridge to be placed in a proprietary Edison device that transmits test results to a database maintained by Theranos. The company promoted the system as offering “less invasive and more affordable clinician-directed lab-testing” using blood samples only 1/1000 the size of a traditional blood draw.

Theranos offered blood testing using Edison devices at Wellness Centers set up at Walgreens pharmacies throughout Arizona and California, M.P.B. says. Walgreens allegedly invested $50 million in the project. The partnership agreement between Theranos and Walgreens was originally intended to make testing available at Theranos Wellness Centers in over 8,200 Walgreens stores across the country.

A few days before the Theranos class action lawsuit was filed, Theranos announced it had voided all test results from its Edison machines. M.P.B. says that as a result of the errant test results, thousands of patients may have received unnecessary and possibly harmful medical treatment or may have been denied the opportunity to seek effective treatment.

M.P.B. alleges Theranos began using the Edison devices before they had been properly approved by the FDA. The plaintiff claims that by the time the Wellness Centers opened and started offering testing with the Edison devices, they had only gotten proper FDA approval to conduct a single test for herpes simplex type 1.

The plaintiff argues Theranos’s actions violate California’s Unfair Advertising Law, False Advertising Law, Consumer Legal Remedies Act, and other statutory and common law consumer protections.

M.P.B. proposes to represent a nationwide Class consisting of “[a]ll purchasers of Theranos lab panels and blood testing services.” The plaintiff also proposes a subclass of such Theranos customers from Arizona.

The Theranos class action lawsuit seeks an award of compensatory damages, punitive damages, disgorgement of all profits, and reimbursement of the purchase price of all Theranos tests.

The plaintiff is represented by Richard D. McCune, David C. Wright, Elaine S. Kusel, Joseph G. Sauder, Matthew D. Schelkopf, and Joseph B. Kenney, all of McCune Wright LLP.

The Theranos Faulty Blood Test Class Action Lawsuit is M.P.B. v. Theranos Inc., Case No. 3:16-cv-02810, in the U.S. District Court for the Northern District of California.