The undecided issue that remains alive in the litigation is whether Bayer’s so-called structure/function claims related to heart health and immunity are false.

Josh Long, Associate editorial director, Natural Products Insider

August 25, 2015

4 Min Read
Bayer Unsuccessful in Bid to Dismiss One A Day Multivitamin Lawsuit

A federal judge in San Francisco denied a request to throw out a proposed class-action lawsuit filed against Bayer AG.

The ruling keeps in play allegations that Bayer misrepresented the benefits of its One A Day multivitamin/multimineral supplements. Supplementation with Bayer’s 11 minerals and vitamins found in the products “does not affect the heart health, immunity, or energy levels of the majority of Americans to whom Bayer markets its supplements," according to the March 30, 2015 lawsuit.

The health care giant did receive some good news at the same time. Although Bayer’s motion to dismiss the case was denied, the judge rejected plaintiffs’ arguments that Bayer’s products profess to cure, mitigate, prevent or treat diseases. He made the same finding in a previous ruling.

“Once again, plaintiffs ‘have pointed to no specific language on the packaging, websites, or advertisements’ that illustrates how ‘supports heart health’ or ‘supports immunity’ have been linked to the treatment or prevention of cardiovascular disease," U.S. District Judge William Orrick wrote in a 14-page order dated Aug. 18.

The remaining question is whether Bayer’s so-called structure/function claims relating to heart health, immunity and physical energy are false and misleading. While the Federal Food, Drug & Cosmetic Act (FD&C) prohibits dietary supplements from making claims to treat diseases, such products are allowed to describe a nutrient’s or dietary ingredient’s role in affecting the structure or function in the human body, such as “calcium builds strong bones."

“As a recognized leader in dietary supplements, Bayer’s One A Day vitamins provide the benefits as advertised," said Christopher Loder, a Bayer spokesman, in an emailed statement to Natural Products INSIDER.

“We look forward to defending our structure/function claims, which are ubiquitous in the industry," Loder continued. “The plaintiffs’ remaining challenge to these claims is simply a broad-based attack on the efficacy of the most commonly consumed and studied vitamins, including vitamins A, B, C, and E, which are found in almost all multivitamins and have been recommended by doctors for decades."

The named plaintiffs—Californian Colleen Gallagher and four other women from California, Florida and New York—are seeking to represent a nationwide class of consumers. Plaintiffs, who are represented by Kaplan Fox, Stanley Law Group and the Center for Science in the Public Interest (CSPI), have alleged Bayer’s heart health, immunity and physical energy claims are false and misleading.

The judge previously denied Bayer’s request to dismiss the “supports physical energy" claim from the case.

“As a result of this ruling, the entire case is moving forward," said Lauren Dubick, a senior associate in New York with the law firm Kaplan Fox, plaintiffs’ co-counsel, in a brief phone interview. “It’s still early in the case and while it doesn’t dictate the ultimate ruling, the plaintiffs are pleased with the decision."

Dubick said discovery has commenced and plaintiffs intend to move for class certification.

Ruling

In Bayer’s motion to dismiss the second amended class-action lawsuit, the judge was required under the federal civil rules of procedure to accept as true the plaintiffs’ allegations and draw all inferences in their favor.

Orrick refuted Bayer’s arguments that scientific studies referenced by the plaintiffs were not relevant in determining whether Bayer’s vitamins support heart health and immunity. Regarding cardiovascular disease, the lawsuit cited facts sheets on vitamins B6, C and E from the National Institute of Health (NIH), Office of Dietary Supplements.

“There is undoubtedly a correlation between health and the absence of disease," Orrick wrote in the order. “Many of the barometers of ‘heart health,’ such as homocysteine levels, are also associated with the presence or absence of heart disease.

“Moreover, the studies provide some direct evidence of the falsity of the ‘supports heart health’ claim," the judge continued. “They state that the various supplements have no effect on ‘cardiovascular events,’ and provide evidence of vitamins’ negative effect on certain indicia of ‘heart health.’ Importantly, they include some indications that vitamin supplements actually harm heart health, which is inconsistent with Bayer’s claim that its products support heart health."

Plaintiffs also referenced evidence—including NIH fact sheets, published articles and randomized controlled trials—to refute the veracity of Bayer’s immunity claims.

“The studies cited in support of plaintiffs’ ‘supports immunity’ structure/function claim present both direct and circumstantial evidence of the claim’s falsity," Orrick stated in the order. “Plaintiffs have pleaded a plausible claim that the ‘supports immunity’ claim is a false structure/function claim."

About the Author(s)

Josh Long

Associate editorial director, Natural Products Insider, Informa Markets Health and Nutrition

Josh Long directs the online news, feature and op-ed coverage at Natural Products Insider, which targets the health and wellness industry. He has been reporting on developments in the dietary supplement industry for over a decade, with a focus on regulatory issues, including at the Food and Drug Administration.

He has moderated and/or presented at industry trade shows, including SupplySide East, SupplySide West, Natural Products Expo West, NBJ Summit and the annual Dietary Supplement Regulatory Summit.

Connect with Josh on LinkedIn and ping him with story ideas at [email protected]

Education and previous experience

Josh majored in journalism and graduated from Arizona State University the same year "Jake the Snake" Plummer led the Sun Devils to the Rose Bowl against the Ohio State Buckeyes. He also holds a J.D. from the University of Wyoming College of Law, was admitted in 2008 to practice law in the state of Colorado and spent a year clerking for a state district court judge.

Over more than a quarter century, he’s written on various topics for newspapers and business-to-business publications – from the Yavapai in Arizona and a controversial plan for a nuclear-waste incinerator in Idaho to nuanced issues, including FDA enforcement of the Dietary Supplement Health and Education Act of 1994 (DSHEA).

Since the late 1990s, his articles have been published in a variety of media, including but not limited to, the Cape Cod Times (in Massachusetts), Sedona Red Rock News (in Arizona), Denver Post (in Colorado), Casper Star-Tribune (in Wyoming), now-defunct Jackson Hole Guide (in Wyoming), Colorado Lawyer (published by the Colorado Bar Association) and Nutrition Business Journal.

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