Lawsuit alleges that Theranos lab tests misled consumers
- Lawsuit alleges Theranos marketed tests as highly accurate but later voided results
- The lawsuit seeks class-action status with both a national class and an Arizona subclass
A federal lawsuit filed Wednesday contends that Theranos misled consumers in Arizona and elsewhere about its finger-prick blood draws, which the company marketed as highly accurate but produced results the company later voided or corrected.
The lawsuit's plaintiff is an Arizona resident, identified as M.P.B., who bought a Theranos test last December at a Walgreens store in Tempe.
The Arizona resident would not have bought the test had he known that Theranos' Edison testing machine "did not work as described, and that the company did not conduct accurate testing," said the lawsuit filed in U.S. District Court for the Northern District of California by the McCune Wright law firm, which has locations in Berwyn, Pa., and Redlands, Calif.
Theranos spokeswoman Brooke Buchanan said the lawsuit is without merit and the company will "vigorously defend itself against these claims."
The lawsuit comes one week after reports emerged that Theranos told regulators it voided or corrected test results from its proprietary Edison devices and machines made by third-party vendors in 2014 and 2015. The company informed patients and doctors that it voided some results.
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The Wall Street Journal first reported about the voided or corrected test results, and the company later issued a statement that said it took "comprehensive corrective measures" to address issues raised by inspectors from the Centers for Medicare and Medicaid Services.
"As a result, tens of thousands of patients may have been given incorrect blood-test results, been subject to unnecessary or potentially harmful treatments, and/or been denied the opportunity to seek treatment for a treatable condition," the lawsuit stated.
Many of those tests likely were performed in metro Phoenix, which has been Theranos' largest market with testing centers in 40 area Walgreens stores.
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In addition to establishing testing centers at Phoenix-area Walgreens stores and at an Arizona State University health clinic in downtown Phoenix, Theranos lobbied for House Bill 2645, which allows consumers to access lab tests without a physician’s order.
Gov. Doug Ducey signed the bill in April 2015 at a Theranos location in Scottsdale, saying the legislation "expands freedoms for people across the state to get the lab tests they need." Other lab companies, including Sonora Quest, expanded direct-to-consumer testing after the legislation passed.
Theranos has faced scrutiny from media reports and CMS regulators who issued an "immediate jeopardy" warning after inspections found shortfalls at the company's lab in Newark, Calif. Arizona inspectors also cited issues at the company's Scottsdale lab, but those findings were corrected to the satisfaction of state lab inspectors.
A study that appeared in the Journal of Clinical Investigation found that Theranos' lab results were more likely to fall out of ranges when compared with two other laboratories.
The lawsuit seeks class-action status with both a national class and an Arizona subclass of consumers who purchased lab panels and blood-testing services in this state.
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