The lawsuit is one of several filed against Bayer over claims it made about prostate cancer and selenium-containing multi-vitamin supplements.
Plaintiffs David Johns and Marc Bordman allege shoppers were duped into paying over the odds for Bayer’s One-A-Day Men's Health Formula and Men's 50+ Advantage vitamins, which claimed to ‘support prostate health’.
Granting the plaintiffs’ motion for class certification last Friday (Feb 3) in the US district court in the southern district of California, judge Anthony J. Battaglia said: “The court agrees with plaintiffs that common questions predominate over individual questions.”
Credible and reliable scientific support
The plaintiffs allege that throughout the class period, Bayer did not have “credible and reliable scientific support for the promise”.
They also allege that recent clinical studies have shown that for some men, increased selenium consumption may increase prostate cancer risk, although Bayer said the claims at issue “must be evaluated in the context of scientific evidence available at the time”.
The class refers to all persons who purchased Bayer’s Bayer's One-A-Day Men's Health Formula and Men's 50+ Advantage vitamins in California from the date they started making prostate health claims up to May 31, 2010.
2003 qualified health claims for selenium
The claim that selenium 'supports prostate health' is a structure/function claim, whereas claims about selenium and cancer risk reduction are qualified health claims.
In April 2003, the Food and Drug Administration (FDA) authorized the use of the following qualified health claims:
"Selenium may reduce the risk of certain cancers. Some scientific evidence suggests that consumption of selenium may reduce the risk of certain forms of cancer. However, FDA has determined that this evidence is limited and not conclusive."
"Selenium may produce anticarcinogenic effects in the body. Some scientific evidence suggests that consumption of selenium may produce anticarcinogenic effects in the body. However, FDA has determined that this evidence is limited and not conclusive."
2009 qualified health claim: 'It is highly unlikely that selenium supplements reduce the risk of prostate cancer'
In June 2009, however, the FDA said the evidence specifically on selenium and prostate cancer risk justified the following - highly qualified - health claim:
“Two weak studies suggest that selenium intake may reduce the risk of prostate cancer. However, four stronger studies and three weak studies showed no reduction in risk. Based on these studies, FDA concludes that it is highly unlikely that selenium supplements reduce the risk of prostate cancer."
Bayer then agreed to amend packaging and promotional materials to exclude reference to the qualified health claim regarding the relationship between selenium intake to the reduced risk of certain cancers.
Multi-state $3.3m settlement
However, in October 2009, health-advocacy group the Center for Science in the Public Interest sued Bayer in the Superior Court of California in San Francisco for allegedly failing to recall packages bearing its earlier claims, and for allegedly failing to amend claims it said were still misleading.
That lawsuit was later “dismissed on procedural grounds”, claims the CSPI, which says it was “preparing to refile when the attorneys general of Oregon, California, and Illinois announced a broad settlement with Bayer on the same issues. This settlement achieved results similar to the relief CSPI sought, so CSPI advised Bayer that it would not proceed with a second, unnecessary lawsuit.”
Announcing a $3.3m settlement with Bayer and the above three states in October 2010, California’s attorney general Edmund G. Brown Jr. said: "By virtue of this settlement, Bayer has stopped making totally unsubstantiated claims that its One-A-Day multivitamins can reduce men's risk of developing prostate cancer."
The three states had alleged that Bayer made misleading claims about selenium and continued to do so after results of a clinical trial funded by the National Institute of Health concluding that selenium did not reduce the risk of prostate cancer were published in October 2008.
Bayer was unavailable for comment as this article went to press.