Big trouble ahead for companies selling homeopathic remedies in California (revised)
Last month, the California Court of Appeals came out with a decision which should scare the bejesus out of companies selling homeopathic remedies in California. The case is Rosendez vs. Green Pharmaceuticals. Here is the decision:
First horrible thing: It was a class action
You want to get a company’s attention: file a class action. It’s more time consuming and expensive for plaintiff’s counsel to obtain “class certification” as opposed to filing a case for just one or two plaintiffs, but obviously a class action ups the stakes for the defendant. In my view, many class actions are about the lawyers making money, since except in wrongful death or serious injury cases, each class member gets a small amount of money and/or the damage or injury is relatively insignificant. All the real money goes to the attorneys.
This was surely the case here. The plaintiffs’ firm, Newport Trial Group, files a lot of class actions, especially labeling claims against product manufacturers. These guys get a lot of bad press for many reasons, but the legal system allows for these semi extortionistic lawsuits, so these lawyers are just taking advantage of an imperfect system. I’d like to see the class action system changed to make it much more difficult to obtain class certification, but so long as the plaintiffs’ bar continues with its generous and public spirited support of legislators, change is not coming.
So what were the terrible wrongs that this big bad class action lawsuit tried to rectify?
Green Pharmaceuticals makes a homeopathic remedy called “SnoreStop” which claims to eliminate or reduces snoring. It’s a homeopathic product meaning that there are very, very small amounts of the active ingredients or no chemical traces of the active ingredients, (which makes it more potent under the homeopathic principle of infinitesimals/dilution). The company cited one scientific study as support for its claim.
The plaintiffs’ allegation was that the product is just a sugar pill which has no proven benefit, thus making the company’s efficacy claims a violation of California’s false advertising and unfair business practices laws. California like most states, has a false advertising and unfair business practices causes of action. Until recently, these types of statutes were not used a whole lot against CAM health products.
The trial court rules for the defendant, but sometimes winning isn’t enough
The case was tried to a judge. Because of the way the case unfolded, the judge’s decision granting judgment to the defendant was perplexing.
The plaintiffs had a well credentialed expert pharmacologist who testified that 1. None of the ingredients listed on the label have any proven effect on snoring, 2. The homeopathic law of infinitesimals/dilution as well as the other tenant of homeopathy – the law of similars – are unsupported and contradicted by legitimate science, 3. The study supposedly supporting the claims is worthless because of fatal methodological flaws, 4. Whatever benefit the study might have found was due to the placebo effect, or at least the study wasn’t properly placebo controlled.
After the plaintiff rested, the defendant moved for judgment on the grounds that the plaintiff hadn’t made its case (in legal parlance, failure to make a prima facia showing). The judge denied the motion, finding that the plaintiffs expert’s testimony, established a prima facia case for both the false advertising and unfair business practices claims.
By denying the motion for judgment at the end of the plaintiffs’ case, the judge was saying that you Mr. Defendant have to produce evidence to rebut the plaintiffs’ case and if you don’t, you lose.
So the defendant put on its case primarily in the person of Dana Ullman, a very knowledgeable and well-regarded homeopathic practitioner and author. Dana however has no mainstream recognized scientific or health care credentials. Knowledgeable as Dana might be, bringing only a “Mr.” to rebut a “Dr.” on a technical scientific matter is like bringing a knife to a tank battle. Don’t get me wrong, a knife could come in handy in a tank battle, but what you really need is a tank.
The trial court was turned off by the fact that Dana believes in or made some positive comments about radionics, which for those who don’t know, involves healing through mental energy and can use pictures of a person to direct the energy or test the potency of a proposed remedy. Even in the integrative medical community, radionics is way, way out there.
The plaintiffs moved to disqualify Dana as an expert witness. The trial judge granted the motion, finding him biased and unqualified. That should have been a death blow to the defense, but strangely it wasn’t. Despite rejecting the defendant’s expert and plaintiffs’ expert’s withering attack on the one study supporting the snore relief claims, the judge granted judgement for the defense, ruling that the plaintiffs failed to meet their burden of proof. The judge made some noises about the plaintiffs’ expert not having tested the product. But still, the defense had no rebuttal evidence to the Plaintiffs’ case that there was no valid scientific support for the product or its ingredients and the expert’s testimony that the principles of homeopathy were scientific nonsense was unrebutted.
You don’t have to be a legal scholar to realize that the judge’s final decision for the defendant was technically and legally inconsistent with his previous decision requiring the defendant to put on a case to rebut the plaintiffs’ case. Moreover, while judges have some latitude in rejecting expert testimony, in this case, the plaintiffs’ expert testimony was at least allowed into evidence by the judge which meant it met the basic evidentiary test of reliability (the Daubert standard). Because the plaintiffs had some evidence and the defense had no evidence in rebuttal, it’s hard to see what was going through the judge’s mind.
The plaintiffs appealed. Not surprisingly, the appellate court reversed. The decision pointed out the inconsistency of the lower court’s decision, and stated that the plaintiffs produced evidence showing that the product was worthless and hence the claims of benefit or cure were false, and the defendant produced no evidence since its expert testimony was rejected by the lower court and the one study supporting the product was eviscerated by the plaintiffs’ expert.
The appellate court ordered the lower court to enter judgment for the plaintiffs and figure out how much money the company should pay the class members (and their lawyers). Very bad for the defendant obviously.
I hear Green is looking to raise money for a cert petition to the California Supreme Court (There’s no automatic right to appeal to the California Supreme Court).
What the case means, Part 1
Of course the appellate court decision is bad for the company but also bad for all homeopathic manufacturers who sell in California. All homeopathic remedies have some claims that they help some medical or lifestyle problem, and none of these claims are supported by the level of scientific evidence required for drug or even health claims approval. So if it is false advertising and unfair business practices to make a claim which doesn’t have a drug level of proof, then any company that makes such claims could be as liable as the company in this case, and that’s obviously a bad thing.
And of course, Dana Ullman one of the luminaries in the field has taken a professional hit, which hurts the homeopathic community.
The case and its legal context is actually more complicated than it appears, and raises some conundrums and Hobson’s choices for manufacturers of homeopathic remedies, but that requires getting into the weeds of FDA statutes, prior legal cases and some heavy legal analysis, which I’ll save for Part 2.
Rick Jaffe, Esq.
5 thoughts on “Big trouble ahead for companies selling homeopathic remedies in California (revised)”
I wonder if the homeopathy company could have used Prof Gerald Pollack as an expert witness? He is an expert in structured water, and could have described that science wrt homeopathy. Very smart, extremely well-credentialed.
Prof. Gerald Pollack would have provided solid evidence for how and why water stores information. However, my testimony clearly showed that high-quality research was published in LANGMUIR, a highly respected scientific journal published by the American Chemistry Society. This study proved that three different types of spectroscopy were able to find nanoparticles of six different homeopathic medicines tested even when they were diluted 1:100 six times, 30 times, or even 200 times. Despite this and other strong evidence for homeopathy published in the Lancet, the British Medical Journal, Pediatrics, Chest, Rheumatology, Cancer, Pediatrics Infection Disease Journal, and others, the Judge chose to ignore all of this evidence. Instead, he was upset that I once “tweeted” a critique of conventional medicine as a type of “witchcraft” because its practices change every couple of decades with only a small percentage of drugs persisting beyond 50 years. The bottomline is that some Judges are excellent on legal issues but are ill-informed and uninformed about all medical issues. This is to be expected, but one would hope that some judges can learn. In this case, this judge showed a real misunderstanding of evaluating clinical research.
People who wish to read my testimony at this Green Pharmaceuticals vs. Rosendez can find it here: https://www.dropbox.com/s/fmus23mkhfubzi9/2014GreenTestimonyOfDanaUllman%2BContents9-25-2014.pdf?dl=0
My Declarations made prior to the trial are here:
It is important to note that the appellate court chose not to publish its decision, which means that the case cannot be cited in any other case in California, which strictly limits its impact. In the opinion of the Association, the appellate court’s ruling is a fairly narrow decision involving a matter of civil procedure, not a decision which puts homeopathy at risk.