Theranos Labs, a company specializing in blood testing services, has recently faced scrutiny from U.S. heath inspectors. Inspections of the company's labs conducted by the Centers for Medicare and Medicaid Services revealed the issues. While the final results of the inspections will be revealed to the public at a future date, the company has been put on notice to curtail much of its testing activities until its problems are addressed.
One issue with which Theranos Labs must contend relates to its use of its proprietary vial, commonly called a "nanotainer." Last year, the Food and Drug Administration declared the company's nanotainer as being an "uncleared medical device." However, the FDA did approve one of the company's proprietary devices for use in testing for the herpes virus.
When a company offers a product or service to the general public, it must be safe and should be approved for use. Sometimes products may function well in a laboratory setting, only for problems to arise when it reaches the marketplace. In some cases, consumers or patients may be harmed if the product does not function properly.
Cases such as the one featured in this post present a complicated mixture of interests. The parties involved can include government agencies, hospitals, doctors and, of course, the company that offered its services to the public. This means that if someone is injured by a product or service, a liability case can become very complicated when trying to determine fault.
If you believe that you or someone you love has been harmed by a defective or ineffective medical product or service, you may have grounds for a liability claim. As such, you may want to speak to a civil litigation attorney to review your rights. Medical science is a high-stakes industry and that is why there are so many checks on new technologies, to ensure that they work before patients put their lives on the line.
Source: Wall Street Journal, "Deficiencies Found at Theranos Lab," John Carreyrou, Christopher Weaver, Jan. 24, 2016