Lawsuit: Faulty Theranos Test Results Contributed to Heart Attack

 (Photo by Steve Jurvetson/Flickr)

A lawsuit filed in Arizona federal court Friday claims that faulty Theranos blood test results contributed to a patient's heart attack.

The suit, which seeks class-action status, accuses the blood-testing company and/or its partner, Walgreens Boots Alliance, of consumer fraud, negligence, breach of contract and civil conspiracy, among other causes of action.

According to the suit, the plaintiff, identified only by the initials R.C., had blood drawn at a "Theranos Wellness Center" in a Walgreens pharmacy in Sun City West, Arizona, in February 2015. The patient had been sent there for a routine test of cholesterol and blood sugar, to "monitor R.C.'s annual heart health."

"Based on the normal blood test results, R.C.'s doctor recommended R.C. maintain his current medication regime and to return in one year for repeat testing," the suit asserts. Less than a month later, according to the suit, the plaintiff suffered a heart attack, requiring two stents.

The suit then suggests that the normal test results were incorrect,  alleviating any concern the doctor may have had, so that the doctor failed to intervene when it might have been necessary:

R.C. and his cardiologist were concerned that R.C. had even suffered an attack given that his blood panels came back clear less than a month prior. Additional blood work performed during his hospitalization strongly suggested that the near-contemporaneous Theranos blood test was inaccurate and that R.C. and his cardiologist’s reliance on the Theranos’ test results was potentially inaccurate or even harmful.

The plaintiff alleges that Theranos later voided the blood test, a nullification that would have been one of tens of thousands of changes to test results the company made as part of a failed attempt to assuage the ire of the Centers for Medicare & Medicaid Services. The federal regulator was threatening Theranos with unprecedented sanctions for running tests at its California lab that failed quality control assessments, among other deficiencies. CMS imposed those sanctions earlier this month.

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The voiding of his  test "strengthened [R.C's] concern that the Theranos test results were in fact inaccurate," the suit says.

In response to the lawsuit, a Theranos spokesperson sent this statement:

“Patient safety and clinical quality are our top priorities. This matter involves ongoing litigation which will resolve itself in due course. In the meantime, we remain committed to the highest standards across all our labs and look forward to continuing to bring access to high-integrity, affordable health information to every person.”

Walgreens said it doesn't normally comment on litigation and would not do so in this case. In June, the pharmacy chain shuttered every one of the dozens of Theranos centers in its stores.

The Wall Street Journal last week reported that at least eight consumer lawsuits seeking class-action status have been filed against Theranos.

But this latest filing could represent the most serious accusation of harm to come out of the Theranos debacle, which has seen the company go from a $9 billion Silicon Valley phenom to, basically, a pariah in the biomed tech world. On July 8, in a lengthy response to the CMS ruling on imposing sanctions, Theranos wrote a sort of FAQ about the case that included its answer to the question, "Was anyone injured because of the issues found at the Newark, Calif. lab?"

"As of now, we have not been made aware -- by CMS, physicians or patients -- of any harm to patient health resulting from our tests," Theranos wrote.

Meanwhile, Dr. William H. Foege, a member of the company's scientific and medical advisory board and its board of directors, wrote in an op-ed in The Hill today that Theranos is preparing "for the publication of its data in peer-reviewed scientific journals and presentations at public meetings."

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"Theranos has a strong and exciting future ahead," he wrote.

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