A federal judge rejected an argument that FDA’s regulation of homeopathic drugs pre-empts a state consumer protection law.

The decision in a false advertising class action lawsuit against homeopathic firm Boiron shows homeopathics, despite their separate status among FDA-regulated products, are just as vulnerable to consumer suits as pharmaceuticals, foods and dietary supplements.

In a July 25 order in U.S. District Court for the Central District of California, Judge Josephine Tucker denied Boiron’s motion for judgment on the pleadings, allowing the case to proceed. The firm had argued that OTC homeopathic drugs in compliance with FDA regulations inherently cannot be in violation of the California Consumers Legal Remedies Act.

Plaintiff Gina Delarosa originally brought her complaint under the state law, arguing she found Boiron’s Children’s Coldcalm pellets to be ineffective for relief of cold symptoms.

Tucker noted the federal Food, Drug and Cosmetic Act says homeopathic products need not prove efficacy to FDA and must only conform to the non-governmental Homeopathic Pharmacopoeia of the United States.

But in Delarosa v. Boiron, she has taken a stance against federal pre-emption of consumer protection laws.

“The court concludes that the FDA has largely abdicated any role it might have had in creating standards for homeopathic OTC drugs,” the judge wrote.

Further, Tucker pointed to apparent logical discrepancies in FDA’s regulation of homeopathics. She posited that a homeopathic drug product could be ineffective for its indicated use but still comply with FDCA, though if it lacked an indication it would be illegal.

“The court concludes that the FDA has largely abdicated any role it might have had in creating standards for homeopathic OTC drugs.” – Judge Josephine Tucker

The judge does not believe finding for the plaintiff under the state law would pre-empt or come into conflict with the requirements of FDCA.

“Plaintiff’s claims, if proven to be true, would simply require defendant to truthfully state its efficacy or not sell its products,” the order said.

FDA Acts Against Violative Homeopathics

Homeopathics have long been a magnet for controversy, but products from firms such as Boiron and Hyland’s Inc. recently have broadened their appeal among consumers looking for OTC therapies outside of traditional pharmaceuticals (Also see "Homeopathy Gains From J&J Recalls As Consumers, Retailers Seek Alternatives" - Pink Sheet, 4 April, 2011.).

Homeopathy is founded on the “law of similars,” which contends that diluted quantities of a substance can treat a condition that it would otherwise cause in a healthy individual. FDA does not require proof of a homeopathic drug’s claims; efficacy instead is based on “provings” indicated in the HPUS.

Though Tucker does not see much in the way of robust federal oversight of homeopathic drugs, FDA’s relative lack of enforcement may be due more to prioritization of other product areas than a lack of statutory authority regarding homeopathics.

According to a compliance policy guide the agency published in 1988 and revised in 1995, the main regulatory characteristic of a homeopathic drug is that it must meet the standards for strength, quality and purity established by HPUS. Traditional pharmaceuticals must meet standards set by U.S. Pharmacopeia.

“A product’s compliance with requirements of the HPUS, USP or [National Formulary] does not establish that it has been shown by appropriate means to be safe, effective and not misbranded for its intended use,” the compliance guide says.

Though the active ingredients in homeopathics typically are diluted to a point at which safety is not a concern, FDA has in recent years taken action against homeopathic marketers for prescription drug claims.

In April, FDA warned Pacific Naturals of Burbank, Calif., that its Herpeset, which claimed “natural homeopathic relief from the painful symptoms of herpes,” was misbranded since it was not intended for self-limiting disease conditions (Also see "FDA Expects STD Claims Enforcement To Deter Future Violations" - Pink Sheet, 9 May, 2011.).

Matrixx Initiatives’ Zicam Cold Remedy RapidMelts with Vitamin C & Echinacea elicited an FDA warning in June because its combination of HPUS active ingredients – zincum aceticum, zincum gluconicum and echinacea – with the non-homeopathic ingredient vitamin C caused the cold remedy to be an unapproved new drug (Also see "FDA Warns Matrixx On Combination Supplement/Drug Products" - Pink Sheet, 20 June, 2011.).

FDA’s 2009 consumer warning and requested market withdrawal of Matrixx’s Zicam intranasal cold products, due to consumer reports of associated anosmia, marks the agency’s highest-profile action against a homeopathic product due to safety concerns in recent years.

California Case In Line With Legal Trends

The Boiron suit follows a general trend toward more consumer class action complaints alleging false advertising against marketers of drugs, foods and dietary supplements, says Kelley, Drye & Warren attorney Sarah Roller.

“While the case may be a bitter pill for homeopathic drug companies, neither the plaintiff’s false advertising allegations nor the court’s decision in Delarosa v. Boiron should come as a surprise,” said Roller, chair of the food and drug law practice in the firm’s Washington office, in an email.

Homeopathic marketers, like other companies selling consumer health products, must ensure their labeling and advertising conform to the requirements of FDA and the Federal Trade Commission and state laws such as California’s Proposition 65, Roller added.

Judge Tucker’s decision in the Boiron case also follows a judicial trend against federal pre-emption. The Supreme Court’s 2009 ruling in Wyeth v. Levine said FDA-approved drug labeling does not preclude individuals from pursuing personal injury claims under state law (Also see "High Court’s Wyeth v. Levine Ruling Returns Pre-Emption Status Quo" - Pink Sheet, 9 March, 2009.).

In the OTC sector, a California state appeals court this year rejected Johnson & Johnson's motion to dismiss a claim the firm was negligent for not providing specific warnings about Stevens-Johnson Syndrome on Motrin labels after J&J attorneys argued that FDA policies precluded adding an SJS warning (Also see "Judge Returns Motrin Suit To Trial Court, Reject's J&J's Motion To Dismiss" - Pink Sheet, 21 February, 2011.).

Boiron Intends To Fight Lawsuit

A ruling on class action certification is the next step in Delarosa v. Boiron.

Delarosa filed her suit in August 2010 in the Superior Court of California, Orange County, claiming the class comprises all consumers in the state who had purchased Children’s Coldcalm – which she calls “nothing more than a sugar tablet” – in the preceding four years.

The active HPUS ingredients in Children’s Coldcalm are allium cepa, apis mellifica, belladonna, eupatorium perfoliatum, gelsemium sempervirens, kali bichromicum, nux vomica, phytolacca decandra and pulsatilla.

Delarosa’s complaint was moved to federal district court in October, in part because the total damages, assuming a class of 25,000 plaintiffs, could reach as high as $50 million, counsel for Boiron said in a filing.

Boiron’s attorney Christina Guerola Sarchio of Patton Boggs said the firm is disappointed with Tucker’s decision on the motion for judgment on the pleadings.

However, “it doesn’t put us in any different position than where we were before the ruling,” she said in an interview.

“Before then, homeopathic drug manufacturers were subject to lawsuits, and this ruling simply means that homeopathic drug companies may continue to be subject to these lawsuits and they will need to continue to defend themselves,” Sarchio said.

Should Delarosa’s class action certification succeed, Boiron intends to file for summary judgment. Sarchio declined to comment on whether the French firm, with a U.S. office in Newtown Square, Pa., is interested in settling with the plaintiff.

“The company has a number of very loyal consumers,” she said. “It did not do anything wrong. It certainly did not make false statements on its label, and so it looks forward to defending itself in court.”

By Dan Schiff

FDA Regulation Of Homeopathics Does Not Pre-empt Damages Claims – Court

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