Evidence That Consuming Vitamin E Can Lead To Death Insufficient for Action to Proceed

Friday, January 11, 2019

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Ninth Circuit:

Evidence That Consuming Vitamin E Can Lead To Death Insufficient for Action to Proceed

Assault on Validity of Claims on Labels, Under California Law, Is Preempted By Federal Food, Drug, and Cosmetic Act, Judge Graber Declares

By a MetNews Staff Writer

The Ninth U.S. Circuit Court of Appeals yesterday affirmed summary judgment in favor of the manufacturers of Nature’s Bounty’s line of vitamin E products.

The Ninth U.S. Circuit Court of Appeals yesterday affirmed summary judgment in favor of the makers of Nature’s Bounty line of vitamin E products, declaring that the evidence that the supplement increases the risk of “all-cause mortality” is too sparse to create a genuine issue of material fact

The opinion by Circuit Judge Susan P. Graber also affirms summary judgment for the defendants as to plaintiff Paul Dachauer’s state-law attack on the labeling of a popular brand’s vitamin E supplements, holding that his claim that the supplement does not promote “heart health” is preempted by the federal Food, Drug, and Cosmetic Act (“FDCA”).

While Graber said that the cardiovascular health and immune health claims are preempted by the FDCA, declared that the plaintiff’s claim that the defendants’ products increases the risk of death is not barred by preemption, but lacks substantiation. She found insufficient testimony by plaintiff’s expert witness, Edgar Raymond Miller III, a medical doctor and professor of medicine at John Hopkins University.

Miller headed a study the results of which were released in 2004 showing that daily vitamin E doses of 400 IU or more can increase the risk of death. Miller warned at the time that persons consuming multi-vitamins should make certain dose of vitamin E is low.

FDCA Regulations

Graber wrote:

“FDCA regulations state that a food label ‘shall be deemed to be misleading if it fails to reveal facts’ that are ‘[m]aterial with respect to consequences which may result from use of the article’ under normal conditions of use or the conditions of use that the label prescribes….In other words, if a supplement’s label recommends taking one capsule per day, and that dose actually causes an increased risk of death—a material fact ‘with respect to consequences which may result from use of the article’—the FDCA would deem it misleading not to reveal that fact on the label….

“Likewise, a label that omitted that fact would be misleading under California law.”

However, she continued:

“At best, the record reveals, in Dr. Miller’s words, a ‘small’ correlation between high-dose vitamin E supplements (which Defendants sell) and an increased risk of all-cause mortality.…And, as the term ‘all-cause mortality’ suggests, the record contains no evidence about the actual cause of death for any of those included in the studies. Those causes could include many things unrelated to vitamin E supplements or immune function, such as suicide or a car accident.”

Heart-Health Claims

Graber said summary judgment—granted by District Court Judge Vince Chhabria of the Northern District of California—was appropriate with respect to Dachauer’s contention in his putative class action that many of the labels’ claims for the vitamin E products are misleading. in violation of California’s Unfair Competition Law and Consumers Legal Remedies Act. Such claims included the representation that vitamin E “Promotes Immune Function & Healthy Heart.”

The state-law claims are preempted to the extent a state law purports to impose requirements for supplement labeling that differs from the federal scheme, Graber said.

She noted that under the Food, Drug, and Cosmetic Act (“FDCA”), “disease claims” and “structure/function claims” on dietary supplement labels are treated differently. Disease claims include claims that a product can diagnose, cure, or prevent a specific disease or group of diseases, and are prohibited for dietary supplements.

Must Be True

Structure/function claims, on the other hand, are expressly permitted, Graber said, explaining that these types of statements require a manufacturer to have substantiation that the claim is true and must include a disclaimer that the Food and Drug Administration has not evaluated the claim.

In contrast to the federal law’s requirement that a manufacturer have substantiation for a claim, under California law the burden is on the plaintiff to prove a statement is misleading, and consumers cannot demand substantiation from manufacturers, she pointed out.

Federal regulations promulgated by the FDA further define structure/function claims as permitting terms such as “strengthen,” “improve,” and “protect,” such as the example that a product “helps maintain cardiovascular function and a healthy circulatory system,” which would be permitted, Graber explained.

Expert’s Testimony

She noted that Miller had put forth “ample evidence that vitamin E supplements, taken in the doses that defendants sell, fail to prevent cardiovascular disease.” She continued:

“In essence, Dr. Miller rejects the discrete categories of claims that the FDCA establishes; by definition, structure/function claims do not and may not claim to treat or prevent disease.…Yet Plaintiff seeks to impose a requirement under California law that structure/function claims—at least those related to cardiovascular, circulatory, and heart health—made on a supplement’s label require proof that the supplement treats or prevents cardiovascular disease.”

She added:

“On appeal, Plaintiff argues that it does not matter whether he categorizes Defendants’ claims as structure/function claims or as disease claims, because he addressed the falsity of the labels’ text. To the contrary, it matters very much. Plaintiff’s argument would vitiate the FDCA’s distinction between disease claims and structure/function claims. The FDA allows manufacturers of supplements to make general claims—such as ‘promotes heart health’—and to substantiate them with evidence that a supplement has some structural or functional effect on a given part of the human body.”

The case is Dachauer v. NBTY, Inc., No. 17-16242.

Later Studies

Subsequent studies have intensified concerns over the vitamin, included one reported in the Journal of the American Medical Association in 2011 saying that “dietary supplementation with vitamin E significantly increased the risk of prostate cancer among healthy men.”

The U.S. government National Institutes of Health’s Office of Dietary Supplement says:

“In supplement form…, high doses of vitamin E might increase the risk of bleeding (by reducing the blood’s ability to form clots after a cut or injury) and of serious bleeding in the brain (known as hemorrhagic stroke). Because of this risk, the upper limit for adults is 1,500 IU/day for supplements made from the natural form of vitamin E and 1,100 IU/day for supplements made from synthetic vitamin E. The upper limits for children are lower than those for adults. Some research suggests that taking vitamin E supplements even below these upper limits might cause harm.”

A 2013 paper published online by the University of California at Berkeley—where vitamin E was discovered in 1922—concludes:

“There is little clinical research showing that vitamin E supplements are beneficial. Most clinical trials from the past few years have yielded negative or inconclusive results. In fact, the evidence is growing stronger that vitamin E supplements might actually be harmful in some circumstances.”