SAN FRANCISCO (CN) - A federal judge refused to dismiss class claims that Bayer makes false representations about the health benefits of its One A Day multivitamins.
Lead plaintiff Colleen Gallagher challenged three statements Bayer made about each of 20 vitamin and mineral supplements at issue: "That the supplements promote or support (i) 'heart health;' (ii) 'immunity;' and (iii) 'physical energy,'" U.S. District Judge William Orrick previously wrote in a 16-page ruling in March.
Orrick found that the claims on heart health and immunity are pre-empted as "structure/function claims" which are expressly approved by the U.S. Food and Drug Administration, unless the class can plausibly allege the statements are false or misleading - and back up their allegations with scientific evidence.
He then granted Bayer's motion to dismiss those claims, with leave to amend, but denied the rest of its motion and gave the class 20 days to alter their first two claims.
But in a 14-page order filed Tuesday Orrick found the amended complaint met the pleading burden by "citing National Institute of Health fact sheets and other reports that cast sufficient doubt that Bayer's dietary supplement products have the benefits it claims." denied Bayer's motion to dismiss the causes of action regarding the "supports heart health" and "supports immunity" claims.
"While I agree with Bayer that structure/function claims cannot be proved false by pointing only to evidence of a product's ability to treat or prevent disease, in this case the studies are not as narrow as Bayer suggests," Orrick wrote.
"The amended complaint cites to the National Institute of Health, Office of Dietary Supplements' fact sheets for vitamins B6, C, and E. Each of these fact sheets includes a section entitled 'Vitamin [B6, C, or E] and Health.' These sections discuss the health claims typically made about each vitamin and focus on diseases or disorders in which the vitamin might play a role. All include a section focused on cardiovascular or coronary heart disease. All also include a section that discusses health risks from excessive intake of such vitamins."
The class' amended complaint cites studies where NIH found that vitamin B6 does not reduce the risk of cardiovascular disease, and that vitamin C actually "'increased cardiovascular disease mortality'" in one study's participants, Orrick wrote.
"Another that showed 'supplements of 500 mg vitamin C plus 400 IU vitamin E twice per day not only provided no cardiovascular benefit, but significantly increased all-cause mortality compared with placebo,'" the ruling stated, again citing the plaintiffs' amended claims. "Although the fact sheet focuses on the effect of vitamin C on cardiovascular disease, it includes information that has some relevance to overall heart health."
Meanwhile the NIH reported studies finding that vitamin E might help prevent blood clots but provided no significant protection against heart attacks, strokes and other cardiovascular diseases after seven years of treatment, according to the ruling.
Similarly, the class reports that NIH found no scientific support for Bayer's immunity claims - instead finding in its compilation of reports that unless an individual suffers from rare vitamin or mineral deficiencies, Bayer's supplements will provide no immunity support at all.
"The studies cited in support of plaintiffs' 'supports immunity' structure/function claim present both direct and circumstantial evidence of the claim's falsity. Plaintiffs have pleaded a plausible claim that the 'supports immunity' claim is a false structure/function claim," Orrick wrote.
He also granted a request by the class to appoint interim class counsel.
Neither Bayer's representation Jonathan Cohn nor Gallagher's attorney Lauren Dubick could immediately be reached for comment.
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