DoD Contractor Valisure Accused Of Incompetence And Shaking Down Pharmaceutical Manufacturers

A Connecticut testing company called Valisure has been accused of shoddy testing methodologies and extortionary practices.  You might remember the Zantac recall, which was a result of a Valisure testing method which drew widespread criticism.  The United States' Department of Defense contracts with Valisure for the testing of pharmaceuticals bought by DoD and the Department of Veterans Affairs:

https://defenseopinion.com/the-department-of-defenses-bitter-pill-to-swallow/792/

The Department of Defense’s Bitter Pill to Swallow
By Phil Goldberg - December 9, 2024

U.S. servicemembers deserve the best America has to offer, particularly when it comes to their health and safety. In setting last year’s budget, Congress instructed the Department of Defense to assess the risks to its pharmaceutical supply chain and create assurances that the medicines sold to the military and the Department of Veterans Affairs met proper standards.

The program makes sense. But the department’s choice of vendors to carry out this mission —Valisure Laboratories— has raised eyebrows in the legal and public health communities.

Valisure may not be known to most people, but it is to the Food & Drug Administration (FDA) and federal courts—both of which have raised concerns with Valisure’s testing methods.

Questionable testing methodologies

Over the past few years, Valisure has made headlines for testing medications and other household products and claiming some of them cause harm. However, in assessing Valisure’s claims, the FDA found Valisure used testing methodologies that were not “appropriately validated” or “suitable”—they failed to establish their “accuracy, sensitivity, specificity, and reproducibility.” A federal judge echoed these findings, stating Valisure’s methods were “unreliable” and lacked “substantiation” and “objective science-based standards.”

These specific comments came in response to Valisure’s allegations against the heartburn medication Zantac (ranitidine). Valisure filed a citizen’s petition in 2019 based on a study alleging that Zantac breaks down in the body in a way that can create large amounts of the cancer-causing chemical NDMA. It turns out, though, this appeared to be a false alarm.

The federal judge explained that in doing the testing, Valisure heated Zantac to 266 degrees—nearly three times the human body temperature—and added enormous amounts of salt, a process the court said created the NDMA. The federal judge dismissed the lawsuits in federal court, but tens of thousands remain in the states.

The Wall Street Journal revealed another Valisure incident. Last year, in its editorial “A Legal Shakedown Exposed,” the paper reported: “Valisure tried to cash in on its dubious claims about cancer.” Valisure claimed 70% of the dry shampoo it tested contained benzene in excess of the safe daily limit.

As with Zantac, companies pulled the products from the market out of caution, and lawsuits followed. Before that, the newspaper reported that Valisure approached one company and offered to not make the study public about that company’s product if it paid Valisure $1.25 million and $250,000 per month as part of a side arrangement. The company declined.

The newspaper then detailed Valisure’s “coziness” with law firms. It reported that Valisure’s CEO has a brother-in-law at the law firm that filed the Zantac cases, which it did the same day Valisure made its findings public in its citizen petition to FDA. It also found emails showing coordination with the law firm, as well as discussions with a litigation investor. Earlier this year, Legal Newsline reported another firm gave Valisure $833,000 on a $3.1 million settlement over dry shampoo and $1 million on a $3 million hand sanitizer case—both over benzene allegations.

The unfortunate reality of mass tort litigation today is that many companies find it more cost effective to settle cases even when meritless, rather than spend years waging expensive litigation. Indeed, Valisure was in the news this fall because a company chose this settlement route in state Zantac cases. When the state judges did not follow the federal courts and toss the cases, companies were looking at having to try 80,000 cases. That is insurmountable, regardless of whether the federal courts discredited the underlying scientific theories.

Report needed on the Valisure pact

Now that the election is over, Congress is expected to take up a new National Defense Authorization Act, the annual legislation that authorizes appropriations for the U.S. military. When it does, it should ask the Department of Defense to report on the Valisure arrangement, including why it chose Valisure, whether it sought input from the FDA, any results so far and what the department has done based on these findings.

In 2015, the U.S. Chamber of Commerce issued a report titled, “The Trial Lawyer Underground,” which detailed how the trial bar embedded their allies in federal agencies—often to facilitate litigation. Hopefully, that is old news and not what is at play here.

In the meantime, what should servicemembers and veterans believe if questions are raised about medications they are taking?

That’s what really matters when it comes to safeguarding the health of the troops. Based on the history discussed above, any allegations Valisure makes about the medicines it tests for the Department of Defense are no doubt likely to raise more questions than answers.