Law

It’s difficult to draw concrete conclusions in the world of homeopathic drugs.  It seems that we don’t know exactly what they are, why they work or whether they even do work.  We’re not exactly sure why we take them, but our friend at the yoga studio said they worked and so did Dr. Oz.  So we take them, hoping that they’re more fix than fairy dust.

In the preemption and FDA world, it’s even more difficult to draw concrete conclusions when homeopathic drugs are involved.  The FDA recognizes these drugs and has in fact devoted a section of its Compliance Policy Guide (“CPG”) to them.  CPG § 400.400, “Conditions Under WhichHomeopathic Drugs May be Marketed."  But after reading it, it’s not entirely clear how much the FDA is regulating these drugs.  For OTC homeopathic drugs, it’s even less clear.  For the most part, these drugs must comply with labeling requirements, meaning that their labels must include directions for use, ingredients, the dilution and the indication.  Id.; see also 21 C.F.R. §§ 201.5, 201.10, 201.61, 201.62.  Depending on certain particulars, homeopathic drugs must also be recognized by and comply with requirements of the Homeopathic Pharmacopeia of the United States, the United States Pharmacopeia, or the National Formulary.  But none of that means that the drugs will perform as indicated or are not misbranded.  CPG § 400.400.

Given this almost half-hearted regulation, it’s not all that surprising that certain courts see a way around preemption when it comes to state-law claims against homeopathic drugs.  In Forcellati v. Hyland’s, Inc., 2015 U.S. Dist. LEXIS 3867 (C.D. Cal Jan. 12, 2015), a putative class sued the manufacturer of homeopathic cold medicines, seeking financial damages under the usual trio of claims based on the California Legal Remedies Act, False Advertising Law and Unfair Competition Law, as well as warranty claims and a claim for violation of the Magnusson-Moss Act.  The FDCA has an express preemption clause for OTC homeopathic drugs that applies if the claims touch upon the same subject matter as FDA regulations and seek to impose a requirement that is “different from or in addition to, or that is otherwise not identical with” FDA regulations.  21 U.SC. §379r(d)(1).  It’s similar to the FDCA preemption clause that applies to medical devices.  While there is an exception to preemption for product liability claims, that preemption exception doesn’t apply to claims like these seeking only financial damages.

So in Forcellati, the plaintiffs’ claim was that the homeopathic drugs didn’t work and that plaintiffs could prove it through clinical trial results and other evidence.  Forcellati, 2015 U.S. Dist. LEXIS 3867 at *13-18.  Defendants argued that such a claim is expressly preempted because the FDA doesn’t require clinical trials for OTC homeopathic drugs.  And so, the defendants argued, plaintiffs’ claims would improperly impose a requirement different from and in addition to those imposed by the FDA.  Id. at *8.  At first blush, that certainly seems right.  The FDA doesn’t require clinical trials, yet plaintiffs are seeking financial damages for the failure of the drugs to successfully complete a clinical trial.  

But the court saw a way around that, explaining that the plaintiffs were not arguing that the manufacturer should have conducted a clinical trial and that its failure to do so constitutes the basis for their claim.  Rather, they were claiming that the manufacturer’s claim that the drugs were effective is disproved by clinical trial results: 

Defendants’ argument fails from the outset because Plaintiffs are not making a substantiation claim.  Plaintiffs are not arguing that Defendant’s use of the word “effective” is false or misleading because Defendants did not conduct tests to substantiate their claim before marketing their product.  Rather, Plaintiffs claim that using the word “effective” is false because Defendants’ products are not effective, period. 

Id.  

Okay.  The more we think about it, the more we get it.  The state law claim isn’t imposing a requirement that manufacturers of homeopathic drugs conduct clinical trials.  It simply asserts that, if the manufacturer make a claim that the drugs are effective, plaintiffs may try to prove that they aren’t effective (through clinical trials and other evidence) and collect financial damages if they do.  

Further supporting this notion is the FDA’s statement in its Compliance Policy Guide that, even if a homeopathic drug’s label satisfies labeling requirements, it can still be misbranded.  And so, we guess, these state law claims are more akin to parallel claims than preempted claims.  

Maybe.  We can't help but think, though, that this decision was somewhat influenced by the product involved and came with a bit of fairy dust sprinkled on top.  Okay.  We get it.