Shakedown Lawsuits, Not Safety, Explain Drug Shortages – RedState

On October 31, 2023, U.S. Sen. Richard Blumenthal (D-CT) sent a letter to U.S. Food and Drug Administration (FDA) Commissioner Robert Califf, M.D. urging him to take “appropriate actions to investigate and recall products with unacceptable levels of benzene.”

Blumenthal wrote an “independent quality assurance company,” a fancy phrase for a lab, found “unacceptable” high levels of benzene in popular over-the-counter acne treatment products in a study in March 2023.  Benzene, Blumenthal pointed out, is a “known hormone disruptor and carcinogen.”

Blumenthal left out three key facts. The FDA itself found “methodological deficiencies” in at least four areas of Valisure’s laboratory work. Second, in litigation, a federal judge chastised Valisure for subjecting the heartburn drug Zantac to unrealistic temperatures to prove the product contained a carcinogen. And last, but not least, Valisure is in Blumenthal’s home state; more on that in a moment.

If Blumenthal gets his way, a recall of acne treatment products will do more than just anger a bunch of teenagers. Product recalls can lead to drug shortages, higher prices, and a hard stop on research and development. Who would want to put a new product on a shelf, a product that meets FDA safety standards, when recall threats and lawsuits can be so easy?

The Fear Factor

Many consumers have no idea what benzene is, let alone its safety risks. If given the choice, consumers would probably opt not to have any dangerous-sounding chemical in a health and beauty product. 

The fact is without chemicals, products would be ineffective. People have been using acne products for decades, and while cancer rates persist, it is impossible to pinpoint a specific cause. The human body is a complicated machine, and humans are constantly exposed to risk. Carcinogens abound, but not everyone gets cancer.

But let’s look at the specific case of acne medications. Valisure is what many might call a “hired gun.” These are the “experts” we see in lawsuits hired by plaintiff attorneys to indict deep-pocketed defendants.

The acne medication industry is a $5 billion cash cow. Like it did with Zantac, evidence suggests Valisure heated acne products to 158 degrees to produce said carcinogen. Naturally, the pigs are lining up at the trough. Google “acne lawsuits,” and you will find no shortage of law firms willing to help consumers with a “claim,” which will require the consumer to fill out all kinds of paperwork and, if the attack lawyers prevail, could garner the consumer with something like a $12.50 check.

The lawyers will typically collect one-third of an award, sometimes hundreds of millions of dollars, depending on where the jury pool lives.

A Holy Grail of Lawsuits

If the shakedown lawsuits aren’t enough, consider the latest development. With the political help of Blumenthal and another Connecticut politician, Rep. Rosa DeLauro (D-CT), Valisure has secured a contract with the Department of Defense (DoD) to “generate objective drug quality data through independent chemical testing of certain drugs,” states a Valisure news release.

Laughably, the release goes on to say, “Drug quality issues are the reason for the majority of drug shortages currently plaguing the nation.”

Thank you, Valisure, for contributing to the cause! The DoD will be a bonanza of potential lawsuits, given that the DoD maintains the massive Defense Medical Epidemiology Database, a huge get for lawyers mining for potential lawsuits.

All Suppliers Under Scrutiny

Under the “Cooperative Research and Development Agreement,” DoD will establish a “working group” to “assess risks to the Department’s pharmaceutical supply chain” to “complement FDA efforts by conducting independent testing of medicines and generating meaningful and actionable transparency to drug quality.’’

As at least one lawsuit has shown, and as the FDA’s own report against Valisure suggests, “independence” comes with strings attached. In fact, Valisure doesn’t have to indict any one company specifically. The lab could use the opportunity to sell “certification” programs to keep companies out of the clutches of plaintiff attorneys.

The contract will keep Valisure in business for years to come. DeLauro and Blumenthal gain bragging points in the next tight election in their home state, not to mention a deep stream of campaign contributions.

Unfortunately, the losers will be the rest of us. Consumers will find fewer products on store shelves due to unnecessary recalls, higher prices due to shortages, and no exciting new products on the horizon.

AnneMarie Schieber ([email protected]) is the managing editor of Health Care News at The Heartland Institute.