The company responsible for both alarms, Valisure, is a private Connecticut laboratory. In 2019 Valisure filed a Citizen’s Petition on their finding of Zantac. While Valisure’s Zantac “findings” were not submitted in the MDL (multi-district class action litigation), in rejecting that Zantac suit (involving at least 50,000 plaintiffs), Judge Rosenberg began with a review of the Valisure “data” submitted in the initial citizen suit.
Valisure defended their methodologies - in The Wall Street Journal no less, although in other documents they admitted they often serve as expert witnesses for plaintiffs in the citizen suits they instigate. The Judge wasn’t convinced by their methodology and made it so known, along with being appalled by the lack of scientific integrity in all 13 studies submitted by the MDL plaintiffs, before she tossed the case. The FDA was also non-plussed, sending Valisure an eight-page letter criticizing its methodology.
The Valisure defense was viciously rejected on the Journal’s editorial page, and the Journal editors didn’t mince words:
“The Valisure methods and plaintiff attorney suits look like a litigation scam, and congratulations to Judge Rosenberg for exposing it.”
Alas, Valisure has more to say on citizen exposures - now complaining in a new citizen suit, filed in October 2022, that dry shampoos, like Suave and Dove, have potentially elevated levels of benzene, an acknowledged carcinogen. Of course, the exposure dose and route (inhalation, ingestion, or dermal) determine whether disease will ensue. And, while exposure through the skin (dermal exposure) is a delivery route of a carcinogen, as someone who has used dry shampoo, I’ve never massaged it into my scalp. Theoretically, if someone did, and significant doses of benzene from the dry shampoo penetrated the scalp, it might be a concern. Except, many of these products don’t have any benzene in them at all. It’s the propellant that’s possibly spreading trace amounts of the stuff that is the issue.
Indeed, the FDA raised concerns that Valisure had not complied with federal regulations, including good manufacturing requirements, based on “methodological deficiencies [and] analytical discrepancies in its testing methods.” Not satisfied with finger-pointing at dry shampoos, Valisure also took on aerosol sunscreens and deodorants, again, not because these products contain benzene, which in most cases they don’t, but because the propellant might cause unexpected “trace” levels of exposure. This, in turn, led to several voluntary recalls.
Benzene is ubiquitous in the environment, and humans have daily exposure to it from multiple sources. Per the FDA, such exposures are not expected to cause cancers, even to the recalled products, according to independent health assessments using established modeling guidelines.
While ties to the plaintiffs’ bar are being established, and Valisure’s methodology is being questioned, Valisure’s activities have significantly impacted consumer usage. Here’s a headline touting high levels of benzene found in several dry-hair products, although the amount “high” is never specified.
“Popular Dry Shampoos Found to Have Cancer-Causing Chemical”
Valisure has been prolific and productive, bringing “numerous citizen petitions … [and generating] countless class actions, most alleging consumers were unaware the products they purchased contained cancer-causing elements, leading to settlements worth millions of dollars.”
Bodily harm, though, isn’t the driving factor.
“The vast majority of the cases, however, don’t allege that anyone got sick. Instead, they are class actions brought on behalf of consumers seeking refunds or other economic damages.”
This trend in class actions is gaining momentum. Hundreds of class actions against dried oregano, thyme, and an array of other spices, have been filed recently, joining consumer lawsuits claiming dangerous levels of toxic metals, such as arsenic, lead, cadmium, and mercury, found in baby foods. The suits all cite scientific research from non-profit organizations (whose “experts” also often serve as paid experts in the cases), which, using hyper-specialized techniques, have found trace amounts of various carcinogens. These cases are still in their early stages, “but the class action bar is enthusiastic about the success of the lawsuits.”
They also claim that the manufacturers deceived the consumers by not divulging these chemicals' (infinitesimal) presence. How much is enough to warrant disclosure to avoid these frivolous lawsuits and recalls? One lawyer described it as levels not being material to the consumer, defining it this way:
“Often, the allegation is that these substances appear in the product in insanely minute amounts – 10 parts per billion, the equivalent of half a drop of water in an Olympic-sized swimming pool.” (Frankly, homeopathic doctors should be claiming that these minute amounts are actually healthful and helpful).
So, should disclosures of trace amounts be required to avoid these lawsuits?
As technology improves, we can detect smaller and smaller amounts of all sorts of toxins. Their mere presence is not determinative of the risk of disease. But instead, the route of exposure, duration, frequency, the likelihood of reaching the target organ, and, most critically, dose are the determinative factors. And as readers of ACSH know, as Paracelsus said, and Susan Goldhaber echoes, “it’s the dose that makes the poison.”
Fear of lawsuits has prompted pharmaceutical companies to disclose any and all risks that might be associated with or arise in temporal proximity to exposure, proven or not. These disclosures themselves have harmful effects, dissuading drug usage or even creating what’s called a nocebo effect – where a strong belief of a poor outcome or adverse effect can increase the likelihood that it will occur, the opposite of the placebo effect, where a belief in a positive outcome increases the likelihood of a positive effect.
Another casualty of over-disclosure was illustrated by California’s Proposition 65. When every disclosure possible is mandated, people disregard all of them.
What can be done?
One possibility is instituting a loser-pays policy for these types of lawsuits, which does exist in some places, e.g., Alaska, Oregon, and Oklahoma. A second might be sanctions on attorneys for bringing patently improper suits
Of course, there is a tried and true method: wracking up wins for the defense. That approach takes lawyers who really know the science and can communicate it. In other words, lawyers who don’t just rely on their experts; they learn the hard stuff themselves. That can and does happen. Plaintiffs' lawyers may get reimbursed expenses if they lose, but they only get a payday when they win. A series of losses will soon discourage the institution of frivolous lawsuits. Finally, we can enact legislation requiring disclosing likely exposures to only significant amounts.
As I and others have said, it’s time the law caught up with the science.
