The goal of Monster Energy Drink plaintiff attorneys Goldberg and Alex Wheeler is to prove in the lawsuit that Anais Fournier’s consumption of Monster Energy Drink was the cause of her death, and that the energy drinks she consumed were dangerous, and that Monster’s marketing improperly targeted Anais. The lawyers also hope that this litigation will force energy drink companies to put a stronger warning label on their product, and stop targeting their marketing to teenagers.LawyersandSettlements (LAS): The FDA has known of adverse event reports that potentially link five deaths, one non-fatal heart attack and numerous hospitalizations to Monster energy drinks for a few years now. Why hasn’t it done anything, such as request that Monster add warnings to its labels?
Kevin Goldberg (KG): The FDA has done a terrible job of informing the public about the potential dangers of energy drinks. There is definitely a gray area where Energy Drink companies like Monster have attempted to avoid more stringent regulation and public disclosure of the amount of caffeine in their drinks. Energy drink companies do this by self-classifying their energy drinks as “dietary supplements,” as opposed to the product being regulated as a “food or beverage.” Rather than challenge these improper self-classifications, the FDA has allowed energy drink companies to do this.
LAS: What is the difference between a “dietary supplement” vs. beverage supplement categories?
KG: The problem is that the FDA allows energy drink companies to choose whether they will be regulated as a “dietary supplement” or as a food (food or beverage). To me it is crystal clear that Energy Drinks fall into the traditional beverage category, and should be regulated that way. As of late 2012, some energy drinks such as Red Bull and AMP self-classified as “food/beverage.” Others such as Rockstar and Monster self-classified as “dietary supplements.” In 2009, the FDA issued draft guidelines that would seem to require that energy drinks classify themselves as a food/beverage, that provide guidance to the beverage industry about how the industry was to make these determinations. Unfortunately, it seems that good lobbyists for the energy drink companies kept this draft guidance from becoming final. (More about FDA guidelines.)
The situation with Monster is a perfect example of the current problem. In the aftermath of the recent press coverage of the numerous adverse event reports related to energy drinks (including five adverse event reports of deaths after consuming Monster Energy Drink), Monster decided to reclassify itself as a traditional food/beverage. As such, they will no longer have to report all known adverse events to the FDA. This is not good for the public. I suppose the good news for consumers is that as a traditional food/beverage the public will finally find out exactly how much caffeine is in each can of Monster from all sources (including guarana). But in truth, just as the regulatory teeth of the Dietary Supplement Act were working and the public was becoming aware of the numerous adverse events potentially associated with Monster, the company has now reclassified itself, making it so that the company no longer has to report adverse events to the FDA.
LAS: Won’t the move to beverage supplements spell stricter regulations by the FDA and consequently be safer for the public? Isn’t Monster doing a good thing?
KG: In some ways yes, and in some ways no. Monster will now have to disclose the amount of the ingredients in its product on the label, but Monster no longer has to report adverse events to the FDA. I believe that Monster’s reclassification was done purely for its own economic gain, and they did not make the change to enhance public safety about energy drinks. It seems that the reclassification was done in the immediate aftermath of public scrutiny Monster Beverage Corporation received due to a high number of adverse event reports.
As I mentioned, under the Dietary Supplements Act, a company has to disclose all adverse events they know of. The Food and Beverage Act is classified under food, and it has stricter FDA regulations but you don’t have to report adverse events to the FDA. Further, by classifying themselves as a beverage, consumers can buy Monster with food stamps and possibly in some circumstances be exempt from sales tax. Red Bull has been classified as a beverage for a long time so I think that Monster is making this move in order to gain market share. Only Monster Beverage Corporation knows why the change was made. But as a result of the change, the FDA will not be made aware of all of the future adverse events that possibly associate Monster Energy Drinks with illnesses, heart attacks and deaths.
LAS: Once Monster Energy Drink is categorized as a beverage, won’t the company have to be more transparent with its labeling - particularly when it comes to disclosing how much caffeine a 24-oz drink contains?
KG: Yes. Monster has always included the fact that its drinks contain caffeine as part of its proprietary “energy blend.” The problem is that Monster has not always disclosed the amount of caffeine in its drinks. That has been a big mystery. Now that Monster is choosing to categorize itself as a “food” instead of as a “dietary supplement,” it will be required to disclose on its can the amount of caffeine from all sources (including guarana).
Last December Consumer Reports studied 27 popular brands of energy drinks. The investigators found that, out of those 27 drinks, 11 didn’t even include the amount of caffeine on the label. The remaining 16 products did specify the amount of caffeine, but five out of the 16 products contained about 20 percent more caffeine than listed on the label.
LAS: According to Consumer Reports, when Monster Beverage officials were asked to comment on why they don’t list the amount of caffeine on their product label, a Monster spokesperson said, “There is no legal or commercial business requirement to do so, and also because our products are completely safe, and the actual numbers are not meaningful to most consumers.”
KG: First of all, for Monster to say that its products are complete safe is very troubling, considering the mounting scientific evidence that such drinks are unsafe - especially for children and individuals with underlying heart conditions. This evidence includes the fact that The American Academy of Pediatrics has issued a clinical statement advising all pediatricians that children should not consume energy drinks. A recent report from The American Heart Association indicates that energy drinks can raise blood pressure and alter the heart’s rhythm. In March 2013, eighteen well-known medical doctors and scientists wrote a letter to the FDA urging the agency to take immediate steps to protect children and adolescents from the dangers of energy drinks. They have also suggested a link between energy drink consumption and increased blood pressure, and changes in the heart’s QT rhythm.
As I said, the Energy Drink World is like the Wild West, and this particular quote from Monster Beverage is indicative of the problem - The Rooster is guarding the Hen House. As I said, a company like Monster, Rockstar or Red Bull can choose to classify itself as a dietary supplement or as a traditional food/beverage. The energy drink companies can also change their classification when it thinks it will benefit its bottom line. Monster’s recent change from being a dietary supplement to a traditional “beverage” is a perfect example. Just as the regulatory environment for Monster as a “dietary supplement” was heating up, and their adverse event reports were receiving a lot of scrutiny, Monster decided that it would change its classification.
It seems that the decision to change was made shortly after the press became aware of the adverse event reports linked to Monster. Therefore, I think it is likely that Monster decided that it made more economic sense to change its classification, to go ahead and disclose the amount of caffeine (which had already previously been disclosed by the press), but avoid having to report adverse events by reclassifying itself to a traditional Beverage. I am sure that the Monster decision makers weighed the bottom line impact of classifying as a Dietary Supplement versus as a traditional Food/Beverage. The problem is that from a policy perspective, the company should not be choosing how they are categorized and how they will be regulated. That is the responsibility of our government, the FDA and ultimately our elected officials.
Energy Drinks can be dangerous and deadly to any individual with an underlying heart condition (even sub clinical undiagnosed conditions). Regardless of how Energy Drink companies choose to classify themselves, the bottom line is that right now they are being marketed to teenagers and young adults, and many of these individuals should not be drinking energy drinks because they are dangerous. Many of whom may have unknown cardiac conditions, and these vulnerable consumers are putting themselves at risk by consuming energy drinks.
LAS: Let’s get back to the wrongful death lawsuit that you and the R. Rex Parris Law Firm of Lancaster, California, filed on behalf of the Fournier Family. How did this claim first come about?
KG: Anais’s parent’s main goal is to make sure that no other children die as a result of consuming energy drinks. To this end, the family has done a tremendous amount of research on energy drink dangers and other deaths and injuries from energy drinks; and has spent a lot of time meeting with experts and legislators from various communities.
At some point, the Freedom of Information Act was used to obtain FDA adverse event reports potentially linking other deaths and injuries from the consumption of Monster, Red Bull, and other Energy Drinks. To be honest, we were shocked that there were as many adverse event reports as there were, and even more surprised that despite the accumulation of FDA Adverse Event Reports at the FDA, nobody at the agency was doing anything to inform the public about the potential dangers of energy drinks. We provided copies of the adverse event reports to the press, and soon after that, newspaper articles and media coverage about the dangers of energy drinks increased.
Senators Dick Durbin and Richard Blumenthal got involved. They have implored the FDA to improve the safety of energy drinks by taking stronger regulatory action and limiting the legal amount of caffeine. As well, health experts are concerned about the lack of warnings regarding caffeine consumption and that some products don’t even disclose the amount of caffeine on their labels.
LAS: So the public wouldn’t have known about the five deaths? The FDA Adverse Event reports would not have been made public otherwise?
KG: Dietary Supplement companies are required to report adverse events to the FDA but, as far as I can tell, these numerous adverse event reports were just sitting in the FDA’s database and nobody was doing anything about them or showing any concern about the public health dangers of energy drink consumption by our youth. The only reason that the media became aware of these reports was because Anais Fournier’s mother (and those attorneys representing the victims) requested information via the Freedom of Information Act, and worked closely with the American Association for Justice to disseminate the information to the public.
While FDA adverse event reports are not proof of a scientific link between the energy drink and the death, we felt that the public deserved to know about the number of possible associations between energy drink consumption and injuries. We were shocked that the FDA was not getting this information out to the public, so we took the bull by the horns and did what we could to get the word out.
Initially, the FDA just sent us a chart showing adverse events, including the reported deaths that may be linked to Monster drinks and all other energy drinks.
We then sent a much more detailed FOIA request to the FDA asking for complete adverse event report files - about six months ago. I received several hundred pages of documents, including redacted autopsy reports and medical records from the other deaths.
LAS: Based on the work you have done on Energy Drinks, do you think that the incidents actually reported to the FDA as adverse events are the only incidents of injuries from teens and young adults consuming energy drinks?
KG: Absolutely not. The problem is that energy drinks can be lethal for anyone with an underlying heart condition, and the energy drink cans do not provide people with an adequate warning. I believe that there are hundreds - if not thousands - of individuals who suffer injuries as a result of energy drink consumption but it is not officially reported. Many times when someone suffers a heart attack or cardiac arrest nobody bothers to ask the person if they consumed energy drinks within close proximity to the heart attack. Therefore, the problem of energy drink-related deaths is likely under-reported in my opinion. The FDA website even acknowledges that “Even with mandatory reporting of adverse events for dietary supplements, generally only a small fraction of adverse events associated with any product is reported.”
LAS: Have other lawsuits been filed against Monster Energy Drinks besides the claim by The San Francisco City Attorney regarding business practices violations, including promoting caffeinated beverages to youth? (People of the State of California v. Monster Beverage Corporation)
KG: Yes. And I have also spoken to the families of many individuals who believe that they were seriously injured as a result of energy drink consumption. Unfortunately, the Statute of Limitations ran out for one family that I spoke to who lost their child. It is very important that, if you believe that a loved one suffered an injury or death as a result of consuming an energy drink, you consult with a lawyer as soon as possible. The law imposes a strict deadline called the statute of limitations on bringing energy drink lawsuit claims. The statute of limitations can vary from state to state and from case to case depending on the facts of any particular case.
LAS: Another lawsuit that has been filed states: “Monster Energy Drinks, in fact, contain a dangerously high amount of caffeine that have never been subjected to any kind of pre-market review by any regulatory authority prior to them being put in the stream of commerce.”
KG: Well, there are other class-action lawsuits pending against Monster Beverage Corporation. One class-action lawsuit filed in California alleges that one particular ingredient in Monster Rehab Green Tea + Energy has “a toxic and potentially lethal ingredient” called “epicallocatechin-3-gallate” or ECGC, which has been associated with “dangerous hepatotoxic effects, including without limitation, death, acute liver failure, hepatitis and other liver injuries.”
Our law firm, Goldberg, Finnegan & Mester, LLC, also filed a Monster Energy lawsuit in Washington, D.C., under the District of Columbia Consumer Protection Act’s private attorney general law. This lawsuit alleges, on behalf of the citizens of the District of Columbia, that Monster Beverage Corporation targets teens and improperly implies that its beverages are completely safe. This lawsuit seeks restitution for Washington, D.C. consumers and other equitable relief that will hopefully change Monster’s marketing practices and also change the warning that Monster provides to consumers with regard to the safety of its product.
READ MORE MONSTER ENERGY DRINK INJURY LEGAL NEWS
KG: Anais Fournier’s family hopes that this lawsuit will send a message to energy drink companies that they should stop targeting their marketing to children and that they need to provide a much better warning - including a statement that anyone with an underlying heart condition should not consume energy drinks. We are hopeful that this lawsuit will also help push the FDA and Congress to take a closer look at energy drinks and take whatever measures are necessary to protect the public, and especially our children and teens.
Attorney Goldberg will be appearing pro hac vice in the case, along with Baltimore attorneys Michael Blumenfeld, Michael A. Brown, and Joseph W. Hovermill of Miles & Stockbridge, P.C.
READER COMMENTS
Admin
on
Maureen at ABA
on