A Theranos blood testing lawsuit is expected after federal regulators discovered several alleged violations of clinical standards at a laboratory run by medical lab company Theranos. The inspection, conducted in 2015, reported inadequate quality control issues within the laboratory that may have led to inaccurate blood test results for patients, putting the health and safety of many people at risk. Theranos is currently under a federal criminal investigation following these findings. Patients who may have been affected by inaccurate blood test results from a Theranos facility may be eligible to seek compensation for any damage or injuries that they suffered with the assistance of a defective medical device attorney.
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Officials: Situation at Theranos Lab Posed “Immediate Jeopardy to Patient Health”
According to nytimes.com, privately-held Theranos claims that it can perform numerous medical tests using only a finger prick of blood. However,the health-technology startup however has caught the attention of federal officials who have begun a criminal investigation into the company regarding its new technology. The probe comes after federal regulators released an inspection of the company in March 2016, reportedly citing unqualified or inadequately trained staff and blood samples in freezers that were not at the correct temperature. While criminal charges would be separate from any allegations made in a Theranos blood testing lawsuit, evidence from any criminal investigation could be relevant in a civil action.
The inspection report also suggested that Theranos failed to ensure that the quality control for a blood-clotting test was acceptable before reporting their results to patients. The test at issue is for the clotting ability of blood, a measurement used to help determine the correct dose of the blood-thinning drug warfarin. Too much warfarin can cause internal bleeding, while too little can leave a patient at risk of a stroke. The inspectors found this particular deficiency in quality control extremely serious, stating that the situation posed “immediate jeopardy to patient health and safety.”
An article published in The Wall Street Journal has also called into question whether the company’s technology works, and Theranos has come under the scrutiny of its two main regulators, the U.S. Food and Drug Administration and the Centers for Medicare and Medical Services. Theranos was created in 2003 and drew the media’s attention by claiming that it can bring laboratory testing to the masses, including allowing patients to order tests without going through a doctor. But it was always unclear exactly how and whether Theranos’s technology worked, the New York Times reported.
Theranos denies any substantial wrongdoing in its labs and has asserted that it will take all necessary steps to meet the requirements of regulators.
Two Years of Blood Test Results Voided
On May 18, 2016, The Wall Street Journal reported that the company “told federal health regulators that the company voided two years of results from its Edison blood-testing devices.” A laboratory medicine professor quoted in the report described the Theranos blood testing recall as “massive” and “unprecedented.”
In the article, one doctor is noted as have received a corrected report
for a patient she sent to the emergency room after receiving abnormally elevated test results from Theranos in late 2014.
The corrected report from Theranos now shows normal values for those tests, according to the doctor.
According to the article, other physicians confirmed receiving corrected test reports. The voided test results could be another basis on which a Theranos blood testing lawsuit is filed.
How a Theranos Blood Testing Lawsuit Can Help
The allegations made against the company may become the basis for a Theranos blood testing lawsuit, arising either out of consumer protection laws (in cases where tests did not perform as advertised) or product liability (if harm resulted to a patient due to an inaccurate test).
When a company engages in false or misleading advertising of its products or services, or otherwise commits deceptive trade practices, that company could be liable for any damage that result. If the allegations of misrepresentation of services against the Theranos are proven, patients may be able to recover the costs they paid for the blood tests, along with compensation for the costs of any additional medical treatment they received as a result of inaccurate tests, as well as injuries that occurred as a result of inaccurate blood test results.
Moreover, medical device makers have a duty to provide safe products. If there are risks of harm associated with their devices, they also must provide adequate warnings. If a device maker fails to fulfill this duty, it could be held liable in lawsuits for injuries that may result.
Patients who are injured as a result of a Theranos blood test may be entitled to compensation for damages, including:
- Medical expenses
- The permanency of the injury
- Pain, suffering, and mental anguish
- Loss of income or ability to work
If a patient dies from complications related to a defective Theranos blood test, family members may be entitled to compensation for the wrongful death of their loved one, including:
- Conscious pain and suffering of a loved one prior to death
- Pain, suffering, and mental anguish from the loss of a loved one
- Funeral expenses
Affected patients are encouraged to seek the advice of an experienced consumer fraud or defective medical device attorney to learn more about their rights and remedies in pursuing a possible Theranos blood testing lawsuit.
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