Lawsuit Claims CVS Statement in Supplement Eye Product Blind to Truth

Plaintiffs contend CVS’ formula in its Advanced Eye Health “is in no way comparable" to a formula that was used by the National Institutes of Health (NIH) in a five-year study.

Josh Long, Associate editorial director, Natural Products Insider

January 15, 2015

5 Min Read
Lawsuit Claims CVS Statement in Supplement Eye Product Blind to Truth

Two Californians who are suffering from an eye disease known as age-related macular degeneration (AMD) have filed a putative class-action lawsuit against CVS Health, Inc.

Larry Meredith and David Gumner claim the retailer misrepresented that its supplement product, Advanced Eye Health, was similar to a formula that was contained in a major government study and found to slow the progression to advanced AMD. The lawsuit described AMD as the No. 1 cause of blindness in the developed world, comprising more than half of all blindness in the United States and predominantly affecting individuals over the age of 60.

CVS’ formula “is in no way comparable" to one that was used by the National Institutes of Health (NIH), Meredith and Gumner declared in the 17-page complaint.

Meredith and Gumner have filed causes of action under California’s Unfair Competition Law (UCL), False Advertising Law (FAL) and Consumers Legal Remedies Act (CLRA). The suit also alleged Unjust Enrichment and Breach of Implied Warranty of Merchantability.

CVS’ formula “only contains ingredients that the NIH found ineffective at slowing the progression of AMD (omega-3 fatty acids), and two carotenoids that NIH said could be used as an alternative to the originally studied carotenoid beta-carotene," the complaint, filed Wednesday in California Superior Court in Marin County, stated. “NIH’s study did not find that these two carotenoids have any independent effect on AMD."

CVS’ Advanced Eye Health stated on a label that it was “comparable to ongoing study formula in AREDS2," according to the Center for Science in the Public Interest (CSPI), whose litigator Amanda Howell is one of the plaintiffs’ lawyers on the case.

The AREDS2 comparison is what landed CVS in court. AREDS stands for Age-Related Eye Disease Study, and AREDS2 was the second of two major NIH studies that examined a supplement formula on eye health.

“The Advanced Eye Health supplement does not contain any vitamin C, vitamin E, zinc, or copper—all a part of the specific formula that NIH found to be effective at reducing the risk of developing advanced AMD," the suit declared.

CVS shelved its product next to a Bausch + Lomb PreserVision supplement, which contains ingredients in the AREDS2 formula that NIH found curtailed the risk of developing advanced AMD, plaintiffs alleged. CVS’ placement of the two different supplements mislead consumers into believing the products contained the same ingredients, according to the suit.

“CVS is blatantly cheating older consumers who may fear developing age-related macular degeneration," said David Schardt, senior nutritionist with CSPI, the Washington-based consumer advocacy group, in a statement. “It’s a fraudulent bait-and-switch, since there’s no evidence that the formula used in the CVS formula will provide any benefit whatsoever regarding AMD."

AREDS Studies

A government study that concluded in 2001 “established that daily high doses of vitamins C and E, beta-carotene, and the minerals zinc and copper—called the AREDS formulation—can help slow the progression to advanced AMD," according to NIH, an agency within the U.S. Department of Health & Human Services.

Starting in 2006, the National Eye Institute within NIH launched a five-year study known as AREDS2 to test whether the original AREDS formula could be improved by adding omega-3 fatty acids, adding the antioxidants lutein and zeaxanthin, removing beta-carotene, or reducing zinc.

Michael DeAngelis, a spokesman for Woonsocket, Rhode Island-based CVS, declined to comment on the lawsuit. But he said CVS introduced Advanced Eye Health in July 2012 while the AREDS2 study was ongoing. According to a CVS label displayed in a CSPI press release, the formula contained 1000 mg of omega-3, 10 mg of lutein and 2 mg of zeaxanthin.

“CVS/pharmacy Advanced Eye Health dietary supplement was formulated with the same nutrients that were the primary focus of the study. CVS/pharmacy removed this statement from the product once the results of the AREDS2 study were released," DeAngelis said in an emailed statement.

DeAngelis said the statement at issue was removed last year. He didn’t specify the month.

NIH announced the AREDS2 results in 2013. In a May 5, 2013 press release, NIH revealed that adding omega-3 fatty acids didn’t improve the supplements formula for treating AMD. Lutein and zeaxanthin also had no impact, according to NIH.

Reliance on AREDS2

I don’t think CVS’ decision to remove the statement last year is much help to its defense. First, it appears the retailer didn’t remove the statement until at least several months after the AREDS2 results were announced. As noted above, the company said it removed the statement in 2014–after the results were published in May 2013.

More importantly, the participants in the AREDS2 trials consumed the very substances that were found to be effective 14 years ago in slowing the progression to advanced AMD. As the plaintiffs point out, those ingredients—including vitamins C and E, copper and zinc—weren’t present in CVS’ formula. The retailer would have known that AREDS2 participants were consuming the latter substances.

So why did CVS declare on a label that its product was “comparable to ongoing study formula in AREDS2"? I suppose CVS will try to give “comparable" a very broad meaning, arguing that the purpose of the AREDS2 trial was to test the ingredients that were contained in its product.

On its face, the plaintiffs’ complaint is far from frivolous. If we accept as true many of the allegations in it, I agree that the retailer’s statement was misleading for the simple reason that CVS’ formula only included some (emphasis added) of the ingredients in AREDS2.

The more interesting question is whether Meredith and Gumner actually relied on the AREDS2 comparison in purchasing Advanced Eye Health. As the law firm Baker Botts noted a few years ago, plaintiffs in class-action lawsuits who assert claims under California’s UCL, FAL and CLRA must establish that they relied on the representation. Plaintiffs could face hurdles in this area. But that’s a story for another day.

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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