Browsed by
Tag: false advertising

Breaking News: Manhattan Doc in NY AG Case Files Answer Targeting the FDA and Says New Yorkers have a Privacy Right to the Treatment and a First Amendment Right to Info About it

Breaking News: Manhattan Doc in NY AG Case Files Answer Targeting the FDA and Says New Yorkers have a Privacy Right to the Treatment and a First Amendment Right to Info About it

Earlier this month, the New York Attorney General’s Office filed a false advertising case against a Manhattan Stem Cell clinic owned by Joel Singer, M.D. The clinic offers autologous stem cell transplant procedures for a wide variety of medical conditions. The clinic used to be affilated with the California Cell Surgical Network run by Mark Berman and Elliot Lander, who as you know, are defendants in one of the two FDA’s civil injunction lawsuits.

Here is the Washington Post article about the case.

https://www.washingtonpost.com/national/health-science/fda-sends-letters-to-20-companies-in-attempt-to-rein-in-stem-cell-industry/2019/04/03/7e01556e-564e-11e9-8ef3-fbd41a2ce4d5_story.html?utm_term=.e6c968d5d4c1

It was also reported in the New York Times

https://www.nytimes.com/2019/04/04/health/stem-cells-lawsuit-new-york.html

and the New York Post.

The articles reported that they couldn’t reach the clinic or its attorneys for comment.

The clinic’s attorney just filed the answer to the complaint. It’s not half bad, but you can judge for yourself.

Here it is.
singerfiledanswer

STAY TUNED!

Rick Jaffe, Esq.
rickjaffeesquire@gmail.com

The Feds Send Some Love Letters to CBD Companies

The Feds Send Some Love Letters to CBD Companies

CBD is the new gold rush in complementary and integrative health. It’s everywhere. But while CBD based products may be legal federally, they are obviously not approved drugs, and are at best regarded as dietary supplements. As such, no medical claims can be made. But legal technicalities have not stopped the CBD companies from marketing their products as miracle cures for all things pain related and more.

And therein lies the problem according to the feds.

Two days ago there was a joint FDA and FTC announcement of warning letters being issued to four CBD manufacturers who made disease or cure claims. Here is the press release.
https://www.ftc.gov/news-events/press-releases/2019/04/ftc-joins-fda-sending-warning-letters-companies-advertising

One of the companies was selling a CBD based product for dogs. Lucky them.

Here is the warning letter to that company which lays out the standard FDA/FTC litany of violations for false and unsubstantiated advertising and the unapproved new drug mantra.
https://www.ftc.gov/system/files/attachments/press-releases/ftc-joins-fda-sending-warning-letters-companies-advertising-selling-products-containing-cannabidiol/advancedspine_relievus_wl.pdf

The warning letter is instructive for companies to see what’s not allowed to be claimed (and not much is allowed).

CBD is now on the fed’s radar screen for medical and disease claims, so CBD manufacturers should be careful.

Rick Jaffe, Esq.
rickjaffeesquire@gmail.com

Brief Memo on Advertising to Private Stem Cell Clinics (Especially the “Affiliates” of the two Defendant Organizations)

Brief Memo on Advertising to Private Stem Cell Clinics (Especially the “Affiliates” of the two Defendant Organizations)

The free pass given by the federal and state authorities on private stem cell clinic’s publicly professed exuberance (aka web site advertising) is coming to an end.

By early 2019, I expect both federal and some state regulators to bring lawsuits and/or announce settlements with more than a few private stem cell clinics, many of which are affiliates of the two stem cell networks which are currently defendants in the FDA injunction lawsuits in California and Florida.

Having looked over a web site or two, it might be time for you folks to rethink your marketing strategy. The authorities have a different and quite technical view of what constitutes false advertising and what constitutes substantiation of actual and implied claims. And don’t even get me started on their view on implied claims. It’s not to be believed.

It’s the end of the year and now would be a good time to implement a correction plan for advertising which is likely to be viewed by the authorities as deceptive trade practices, for a couple reasons. First, of course it’s always to better to comply with what the authorities think is the law, which is better than having to duke-it-out with the authorities in an injunction action brought by the FDA/FTC or the state’s attorney general office, because it’s not really a fair fight. There might be arguments to be made in defense of some commonly made stem cell claims. However, per the above, the best choice is not to have to make them.

Second, there could be medical board implications for physicians who consent to or have a judicial finding of false advertising. That opens-up a whole other front, and who needs that!

In short, now is a good time.

Rick Jaffe, Esq.
www.rickjaffeesquire.com
rickjaffeesquire@gmail.com

Update on the Green Pharmaceuticals Homeopathy Case/You Do What You Can

Update on the Green Pharmaceuticals Homeopathy Case/You Do What You Can

To recap and expand on my prior post on the case:

(http://rickjaffeesq.com/2017/11/05/big-trouble-ahead-companies-selling-homeopathic-remedies-california-revised/)

Green Pharmaceuticals which makes SnoreStop was sued by a bottom feeding (IMO) plaintiffs class action law firm for false advertising and unfair business practices in California. The theory of the case was that homeopathy is unscientific nonsense and none of the product’s ingredients have any possible effect on snoring.

What made the case harder for the plaintiffs’ lawyers was that unlike most homeopathic products, the claims supporting SnoreStop were based on a gold standard clinical trial, i.e., a double blind, placebo controlled clinical trial, the results of which were published in a reputable international scientific journal. At the bench trial, the plaintiffs’ expert, a retired pharmacologist, disputed the validity of the study.

The defense called a well-regarded homeopath, but he had no conventional medical or scientific credentials. The judge rejected his testimony in toto as unhelpful and biased. (I’ve talked to both the homeopath and the trial attorney about the reasons for disqualification. It’s complicated and, not having access to the trial transcript, I can’t evaluate the disqualification).

Apparently a company employee (maybe the wife of the owner) also testified and discussed the study. It’s unclear to me (and to the Green Pharma people as well) whether the study was offered and admitted into evidence. I think it should have been if it wasn’t because the study is the scientific justification for the claims, and it was a bench trial so there was no issue of jury confusion.

The trial judge gave judgement to Green, finding that the plaintiffs didn’t prove their case on either count. The decision on its face was odd because after the plaintiffs rested, the defendant moved for judgement arguing that the plaintiffs hadn’t made their case (made a prima facie showing in legalese), but the judge denied the motion, finding that the plaintiffs put on enough evidence such that they could win unless Green rebutted the plaintiffs’ case. But since the judge rejected the defendant’s expert testimony, and he didn’t say he thought that the clinical study rebutted the plaintiffs’ expert testimony, his judgement for the Green was a real head-scratcher in that it seemed inconsistent with his earlier finding.

The plaintiffs took the case up on appeal. The appellate court also had a problem with what the judge did, and not only reversed, but ordered the trial court to enter judgment for the plaintiff class members and figure out how much each should get back from Green. This was an absolutely stunning and shocking result. The appellate court did this by disregarding some pretty important and hard-fought legal precedent protecting homeopathy. The appellate court also, in effect, rewrote the false advertising statute to make it easier to sue any manufacturer. Rewriting statutes is not something the courts are supposed to do.

My friends at the National Heath Freedom Coalition asked me to look at the case and give my opinion. The more I looked at it, the more pissed-off I got. I called some of the people involved to see if I could figure out how this all happened. I haven’t figured it all out yet, but I know enough to know that the appellate court’s decision is dead wrong, sort of outrageous and the result, ordering judgement for the plaintiffs rather than sending the case back for retrial or reconsideration, is either incompressible under clear existing law or idiotic (or both). I also know that the decision will hurt the CAM field and consumers who use products like this.

Green’s lawyers timely filed a petition for review with the California Supreme Court. They did a good job, especially on the technical points about why the appellate court was wrong. Interestingly, the plaintiffs didn’t file any opposition papers. There is no automatic appeal to the Supreme Court in California; it’s discretionary, and it’s very hard to get the Supreme Court to take a case. So the plaintiffs played the odds and didn’t file a response.

I hate legal bullying and I really hate opportunistic class action lawsuits which only benefit lawyers. This case had both. Despite Green’s good papers, I was concerned that more, more concise and focused, and something broader was needed to show the Supreme Court the bad things that would result from this horrible decision.

Well if not me, who?

Here is my amicus letter to California Supreme Court. For some reason, the published clinical study which supported Green’s claim wasn’t made part of the record that the Supreme Court was going to review, so I decided to remedy that problem as well and attached it to my letter.

greenamicusletter1

Hope it helps. Stay tuned!

Rick Jaffe, Esq.
rickjaffeesquire@gmail.com
www.rickjaffe.com