CORONA, Calif. -- A new legal challenge will likely put energy-drink regulation back in front of legislators. On Monday, U.S. Food & Drug Administration (FDA) spokesperson Shelly Burgess said the agency had received reports of five deaths and one heart attack that may be associated with Monster Beverage Corp.'s Monster energy drink from 2009 through June this year, said Reuters.
The FDA said it investigates any report of injury or death that it receives. The notices to the FDA's adverse events database do not in themselves confirm a risk from a product. Spokesperson Judy Lin Sfetcu told The New York Times that the company is "unaware of any fatality anywhere that has been caused by its drinks."
The family of Anais Fournier sued Monster on Friday for failing to warn about the product's dangers. The lawsuit, filed in California Superior Court, said that after drinking two 24-ounce cans of Monster Energy on consecutive days Fournier went into cardiac arrest. She was placed in an induced coma and died six days later on Dec. 23, 2011.
The lawsuit said Fournier died from "cardiac arrhythmia due to caffeine toxicity" that complicated an existing heart valve condition related to a genetic disorder called Ehlers-Danlos syndrome.
The two drinks together contained 480 milligrams of caffeine, the equivalent of 14 12-ounce cans of Coca-Cola, according to the lawsuit.
"Monster is saddened by the untimely passing of Anais Fournier, and its sympathies go out to her family," Monster Beverage said in a statement. "Monster does not believe that its products are in any way responsible for the death of Ms. Fournier and intends to vigorously defend the lawsuit."
The Corona, Calif.-based company added:
"Tens of billions of energy drinks have been sold and safely consumed worldwide for approximately 25 years, including more than eight billion cans of Monster Energy that have been sold and safely consumed in the United States and around the world since 2002. The company monitors consumer communications it receives, is unaware of any fatality anywhere that has been caused by its products, and has never before been the subject of any lawsuit of this nature.
"Monster Energy drinks generally contain approximately 10 milligrams of caffeine from all sources per ounce. By comparison, the leading brands of coffee house brewed coffee contain on average more than 20 milligrams of caffeine per ounce. An entire 24-ounce can of Monster Energy contains about 240 milligrams of caffeine from all sources, which is around 30% less than the average caffeine contained in a medium-sized, 16-ounce cup of coffee house brewed coffee.
"Monster Energy drinks, including their ingredients and labeling, are in full compliance with all laws and regulations in each of the more than 70 countries in which they are sold.
"The U.S. Food & Drug Administration (FDA) has stated that adverse event reports about a product do not mean that the reported event is caused by the product. The FDA has made it clear that it has not established any causal link between Monster Energy drinks and the reports it has received.
"Neither the science nor the facts support the allegations that have been made. Monster reiterates that its products are and have always been safe."
The lawsuit and reports of other deaths that may be associated with energy drinks stem from safety concerns surrounding the highly caffeinated beverages that are popular with young people. They could also embolden the industry's critics, including federal and state legislators and law enforcement officials, the news agency said.
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"I don't think they are going to ban energy drinks," Morningstar analyst Thomas Mullarkey told Reuters. "The question arises whether or not it gives them more firepower for increased regulation."
That could mean more extensive labeling requirements or age restrictions, Mullarkey said. He added that the negative headlines also made Monster a less attractive takeover target.
"This really reduces the likelihood that Coke would want to acquire Monster," Mullarkey said. Sources told Reuters in April that the two companies had discussed a possible deal as recently as last year.
Monster Beverage is a marketer and distributor of energy drinks and alternative beverages, including Monster Energy brand energy drinks, Monster Energy Extra Strength Nitrous Technology brand energy drinks, Java Monster brand non-carbonated coffee + energy drinks, X-Presso Monster brand noncarbonated espresso energy drinks, M3 Monster Energy Super Concentrate energy drinks, Monster Rehab noncarbonated rehydration energy drinks, Ubermonster energy drinks, Worx Energy shots, and Peace Tea iced teas, as well as Hansen's natural sodas, apple juice and juice blends, multi-vitamin juices, Junior Juice beverages, Blue Sky beverages, Hubert's Lemonades, Vidration vitamin enhanced waters and PRE Probiotic drinks.
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