On the morning of January 29, 2016, Steckler LLP, the law firm of Bruce Steckler and Co-Counsel for USPLabs, contacted us with some breaking news:
The wrongful death case against USPLabs (Jack3d) and GNC has been dismissed by a federal judge.
This highly publicized case concerned the death of soldier Michael Sparling, who died during military training exercises at Ft. Bliss, TX in 2011. The plaintiffs (Michael’s parents) filed wrongful death charges against USPLabs and GNC, claiming that Jack3d caused his death.
USPLabs has repeatedly maintained that Jack3d is (was) safe, especially when used according to the label, and has now been vindicated one more time.
During this case, Steckler and USPLabs cited a report by the United States Department of Defense, which stated that the “evidence does not establish that DMAA containing products are causally associated with adverse events.” The courts agreed with the DOD’s findings when overruling the plaintiff’s objections to dismissal.
“We are extremely pleased at the outcome. This victory exonerates USPlabs and proves that these allegations were unfounded.” — Bruce W. Steckler, lead counsel for the defendants
Even more interesting, however, is this quote:
“The most important information to emerge through this lawsuit is that the court found no scientific evidence that the product is harmful or hazardous. Mr. Sparling’s tragic death was simply not caused by this product.”
— Bruce Deming, counsel for USPlabs in the civil case
Jared Wheat Speaks up with an important upcoming announcement
Before we share the PDFs, we have one quote very well worth reading, from Jared Wheat of Hi-Tech Pharmaceuticals, the company that continued the fight against the FDA for the right to use the ingredient:
“We are pleased that USP won the case and DMAA was exonerated. In our fights over the years with ambulance chasers and class action shakedown lawyers we have won on similar grounds. We expect in the lawsuit where we sued FDA to get a similar outcome.
We have sold over 200 million doses of DMAA with no serious AERs.
We will have our expert report from our toxicologist ready next week and will share with PricePlow. It shows DMAA has fewer AERs than Vitamin C per amount consumed, which backs up the safety of the compound and there is no evidence establishing that DMAA containing products are causally associated with adverse events.”
— Jared Wheat, Hi-Tech Pharmaceuticals (emphasis ours)
The DMAA toxicology report was later released and reported on this blog.
For those of you unaware, Hi-Tech Pharmaceuticals sells a Jack3d clone named Jack’d Up and has kindly disclosed the most important ingredients so that we know how to dose it effectively and safely.
The USPLabs Case Dismissal PDFs
Back to the case, here are links to the PDFs:
Court order dismissing with prejudice all claims against all defendants in Sparling vs. USPLabs (filed January 27, 2016):
“With Prejudice” means that this case can never be filed again. It is done and closed.
The court ruled that scientific evidence presented by plaintiffs was unreliable as a matter of law and disqualified the plaintiff’s experts from testifying:
This is the longest and most interesting one, and all supplement industry insiders should read it thoroughly. It’s summarized below for our readers.
The order overruling the plaintiff’s objections, where the DOD report was upheld by the courts:
Plaintiff Objection Overruling PDF
After objections were heard and overruled in January, the case was all but shut, leading to the case’s dismissal linked above.
The second PDF is long, but is also where things are very interesting.
Three major points, which led to the dismissal of three expert witness testimonies for the plaintiffs:
Outlier Data in the court of law?
One of the plaintiffs’ expert witness (Dr. Louis Cantilena) attempted to use case studies of other Jack3d-related injuries where the users used SEVEN scoops of Jack3d, or mixed it with alcohol and other supplements!
The courts threw Dr. Cantilena’s testimony out due to the reliance of such outlier data in his testimony, yet failure to provide methodology behind the calculations used (they were also untested and not peer reviewed).
In fact, Dr. Cantilena “readily acknowledged that the outliers only demonstrate safety signals rather than a causal relationship between DMAA and hyperthermia in the general population.”
Cause of death: Hyperthermia, or heat stroke?
Another major part of the case was that Sparling’s autopsy listed his cause of death as “hyperthermia”, a condition where body temperature far greater than normal.
The defendants (USPLabs and GNC) argued that decedent died due to heat stroke, rather than hyperthermia, and that DMAA does not cause hyperthermia.
We have sold over 200 million doses of DMAA with no serious AERs.
— Hi-Tech Pharma
The courts ultimately concluded that it cannot be reliably shown that DMAA causes hyperthermia, which seems to fall in line with anecdotal reviews of the ingredient. The only study measuring DMAA and body temperature was the Schilling study, and in that study, while there was a statistically significant rise in body temperature over baseline, they were still within normal body temperature limits.
Regarding this data, the courts excluded another expert witness, Dr. Edward Mills, whose “opinion is full of contradictions and equivocations that ultimately weaken the value of his opinion and make his methodology unreliable.”
DMAA should not be compared to MDMA!
A third expert witness, Dr. Daniel Rusyniak, an expert on causation, had his testimony thrown out as well. In order to make his case, Dr. Rusyniak relied heavily on scientific literature of other molecules, including MDMA (the ecstasy drug), amphetamine, and methamphetamine!
As most of our readers know, DMAA is nowhere near the same ballpark as drug like ecstasy.
The courts saw through this, and due to Dr. Rusyniak’s inexperience with DMAA and reliance on the other two less-credible witnesses above, they deemed his testimony unreliable as well, and rejected the entirety of his argument on causation.
Ultimately, with the three medical expert witnesses all having their testimonies thrown out and overruling the objections filed, the judge then dismissed the case in early 2016.
Obvious disclaimer with all stimulant supplements
Now, this is not to say that everyone should go and take stimulants. DMAA was ultimately banned from dietary supplement ingredients. Stimulant-based workout supplements are for experienced users who are perfectly healthy, train in controlled environments, and use conservative doses according to the label.
Although we have a long ways to go in terms of compliance and quality assurance in this industry, this case vindicates USPLabs in some ways, who has seen quite a bit of trouble due to this kind of media attention.
With respect and condolences
We’d like to take a moment and be real here.
Please understand, this post in no way is meant to disrespect the Sparling family. We are sincerely sorry for your loss, and for the military’s loss as well. Michael is said to have been an incredible young man. This post is in no way meant to be celebratory – it is a sad situation for all involved.
On this site, we consistently and repeatedly state that stimulants are supplementary tools, but potentially dangerous when improperly used. We continually stress that stimulant supplements should never be combined, should never be used without a doctor’s consent, and should never be mixed with alcohol — nor any other situations that promote dehydration — and they certainly should never be used in greater doses than the label dictates.
At PricePlow, we are quite liberal when it comes to a consumer’s choice to consume what they wish, so long as they have all sides of the research (which we do our best to provide) and understand their personal risk tolerance. However, we’re extremely conservative when it comes to the actual dosing and usage.
Further, we will continue to push companies to disclose their stimulant doses, as we have with Hi-Tech Pharma, which we feel leads to a better-informed and safer consumer.
If you have a son or daughter who is getting into supplements, have them contact us with any questions and we’ll give them the honest truth and conservative recommendations for beginners, with sources cited.
Our deepest condolences to the Sparling family.
Mike and the team at PricePlow
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