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Friday, March 29, 2024

Class action alleges blood work device lacked FDA approval

Medical malpractice 04

SAN FRANCISCO (Legal Newsline) – A California consumer is suing a medical device manufacturer, alleging it defrauded the public by knowingly marketing a blood testing unit that delivered incorrect results.

R.G., using initials to protect his privacy, on behalf of himself and all others similarly situated, filed a class action lawsuit May 30 in U.S. District Court for the Northern District of California against Theranos Inc., Walgreens Boots Alliance and 10 unnamed defendants, alleging unfair business practices, false advertising and fraud.


According to the complaint, Theranos sold the Edison device to Walgreens in-store clinics, alleging it was able to draw a small amount of blood from a patient’s finger to test for various conditions. However, the suit says, the Food and Drug Administration found the unit failed quality control standards and rendered inaccurate results.

The plaintiffs seek a jury trial, reimbursement for tests using the Edison device, disgorgement of profits from the sale of the device, a ban on further advertising of the unit and additional damages under consumer fraud laws. They are represented by attorneys Richard D. McCune, David C. Wright, Elaine S. Kusel, Joseph Sauder, Matthew Schelkopf and Joseph Kinney of McCuneWright LLP in Redlands, California, and Berwyn, Pennsylvania.

U.S. District Court for the Northern District of California Case number 5:16-cv-02891

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