By now, the allegations against Alere over its INRatio and INRatio 2PT/INR Monitor System and INRatio Test Strips are well known to the legal community and patients who have used these devices. Those patients are ones treated with the anti-coagulant drug warfarin or Coumadin. The device first came to the market in 2008, and was used for monitoring blood levels of clotting agents. It allowed patients to adjust their medication levels so as to minimize the risks of fatal hemorrhaging.

It goes without saying that a patient’s life depends on accurate measurements. And that was what the Alere products failed to provide. After nearly 19,000 reports of “adverse events” over a one-year period – which included three deaths – Alere issued a “voluntary recall” in May of 2014. However, it wasn’t until seven months later that the recall was made involuntary by the FDA, when it was upgraded to Class I status (having the potential to cause death or permanent injury).

Today, plaintiffs allege that Alere is guilty of a “failure to warn” – in other words, the company was fully aware of the problem and took no steps to inform the public.

Yet, does Alere bear the entire burden of liability? Legally, yes – but there is more to the story. How was it that a defective product was allowed to come to market in the first place, assuming the company was aware of potential problems? The answer is one that comes up again and again in liability cases involving a host of prescription medicines and medical devices. It is known as “Substantial Equivalence.”

According to attorney Chris Paulos, who is handling Alere INRatio lawsuits, the gaping loophole in FDA regulations is found in Section 510(k) of the Federal Food, Drug, and Cosmetic Act. In basic terms, it allows “fast tracking” for approval of a medical device or medication if the manufacturer can demonstrate that the product is “substantially equivalent” to one that has already been approved and currently on the market. The manufacturer can thus bypass the usual rigorous testing and clinical trials that are usually required.

According to the FDA website, a device is considered “substantially equivalent” if it has the “same intended use” as its predecessor as well as the “same technological characteristics.” If that technology is different in some way, the device may still be approved if it “does not raise new questions of safety and effectiveness” and is demonstrated to be “at least as safe and effective” as its predecessor.

According to Alere’s 510(k) application, the only major difference between the INRatio®2PT/NR Monitoring System was the test strip employed. Like diabetic blood meters, the INRatio uses a special medium upon which the patient places a drop of blood. It is then inserted into the meter, which analyzes the blood sample. The new test strips had a shorter shelf-life – 11 months vs. 15 months for the older ones.

It is not known if that had anything to do with the inaccurate readings these meters provided; as of May 2014, the FDA has stated that the “root cause is not known.” What is apparent is that Alere’s “new and improved” device was poorly tested, as was the case with artificial hips and numerous other health care products. According to a study published in 2011 in the Archives of Internal Medicine, physicians at the National Research Center for Women and Families and the Cleveland Clinic found that a majority of medical devices subject to a Class I recall over the previous five-year period had been cleared through the 510(k) process.

So far, there is little indication that FDA procedures and oversight in this regard will be subject to any sort of review, since it is easier and less expensive for an industry that continues to have legislators and regulators in its pockets.

After all, when it comes to maximizing profits, what’s a few hundred million dollars in judgments and a few human lives?

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K.J. McElrath is a former history and social studies teacher who has long maintained a keen interest in legal and social issues.