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OxyElite Pro Lawsuit


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OxyElite Pro Lawsuit

OxyElite Pro is a fat-burning supplement sold by USPLabs. Until early 2013, OxyElite Pro contained DMAA, an illegal stimulant drug linked to cardiac arrest and death. After it was reformulated with more unapproved ingredients, it was linked to a deadly outbreak of liver damage. In February 2015, FDA lab tests detected the antidepressant Prozac (fluoxetine) in OxyElite Pro.

What You Can Do & How an OxyElite Pro Lawsuit Can Help

The Schmidt Firm, PLLC is currently accepting OxyElite Pro induced injury cases in all 50 states. If you or somebody you know has been diagnosed with liver damage or serious side effects, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Dietary Supplement Litigation Group or call us toll-free 24 hours a day at (866) 920-0753.

UPDATE: FDA Finds Prozac in OxyElite Pro Super Thermogenic

March 2, 2015 — The FDA is warning consumers not to buy or use OxyElite Pro Super Thermogenic because it contains fluoxetine, the active ingredient in the antidepressant Prozac. Click here to read more.

January 16, 2015 — The FDA’s criminal division is conducting a criminal mail fraud investigation of USPlabs over misleading statements about its sports supplements. Click here to read more.

December 15, 2014 – For the second time this year, a panel of federal judges have denied a request to centralize lawsuits involving OxyElite Pro under one judge in one federal court. Click here to read more.

November 13, 2014 — USPlabs, LLC has agreed to pay $2 million to settle another false-advertising class action lawsuit in Florida, Velasquez v. USPlabs, LLC, and offer reimbursements to people who bought OxyElite Pro, Jack3D, and Versa-1. Click here to read more.

September 24, 2014 — Law360.com reports that USPLabs and GNC have agreed to pay $2 million to settle a class action lawsuit in Florida involving OxyElite Pro and Jack3D. Click here to read more.

September 17, 2014 — Hawaii News Now reports that dozens of lawsuits have been filed by people who took OxyElite Pro and developed liver damage in the last couple months. Of the 17 lawsuits involving 46 plaintiffs, at least 38 plaintiffs are from Hawaii. Click here to read more.

September 16, 2014 — USPLabs, LLC has filed a second motion (PDF) to centralize dozens of lawsuits involving OxyElite Pro and Jack3D supplements in a MDL. They were hit with another 12 lawsuits involving 40 new plaintiffs in the last few months. Click here to read more.

April 8, 2014 — Federal judges have decided against centralizing lawsuits and class actions involving OxyElite Pro and Jack3D into a Multi-District Litigation (MDL). Click here to read more.

April 7, 2014 – Experts are calling on the FDA to improve the safety of dietary supplements. According to CDC data, OxyElite Pro has been linked to 97 cases of non-viral hepatitis (non-contagious liver inflammation) in at 16 states, resulting in 47 hospitalizations, three liver transplantations, and one death. Click here to read more.

February 26, 2014 – 40 OxyElite Pro lawsuits have been filed in federal court, and new victims continue to come forward to report liver damage. Click here to read more.

February 19, 2014 – A putative OxyElite Pro class action lawsuit has been filed in New Jersey. The plaintiff was not injured but alleges that he never would have purchased OxyElite Pro if he had known about the risks. Click here to read more.

January 22, 2014 – USPLabs requests the centralization of OxyElite Pro lawsuits in a federal Multi-District Litigation (MDL), consolidating 9 lawsuits and 3 class actions involving 30 plaintiffs. Click here to read more.

November 22, 2013 – Two more lawsuits have been filed by Hawaiians who developed severe liver injuries after taking OxyElite Pro. Click here to read more.

November 19, 2013 – OxyElite Pro recall expanded to include Raspberry Lemonade OxyELITE Pro Super Thermo Powder.

November 18, 2013 – In a Consumer Update, the FDA announced that they will oversee the destruction of $22 million worth of OxyElite Pro. Click here to read more.

November 18, 2013 – 56 cases of liver damage from OxyElite Pro have been reported in 13 states, including California, Ohio, and Hawaii. Click here to read more.

November 10, 2013 – USPLabs LLC has recalled OxyElite Pro. Click here to read more.

Products included in the OxyElite Pro Recall:

  • OxyElite Pro Super Thermo Powder
  • OxyElite Pro Super Thermo Capsules
  • OxyElite Pro Ultra-Intense Thermo Capsules

November 8, 2013 – The CDC has confirmed 56 cases of liver damage from OxyElite Pro. Most cases have been reported in Hawaii, but other cases have been confirmed on the mainland U.S. Click here to read more.

November 8, 2013 – USPLabs has agreed to re-fomulate OxyElite Pro to remove aegeline, an unapproved ingredient that the FDA has warned is illegal. Click here to read more.

October 18, 2013 – One case of liver damage in Hong Kong has been linked to OxyElite Pro. Yohimbine, a prescription drug, was also found in OxyElite Pro purchased over the internet by Singapore health authorities. Click here to read more.

October 14, 2013 – U.S. Marine Corps leads the way in banning OxyElite Pro on military bases. Click here to read more.

October 14, 2013 – FDA issues warning letter for aegeline, unapproved ingredient in OxyElite Pro and VERSA-1 that may be linked to liver injuries in Hawaii. Click here to read more.

October 11, 2013 – Central Texas health experts weigh in on OxyElite Pro removal request. An emergency room physician in Texas warns, “buyer beware” when it comes to using dietary supplements like OxyElite Pro for weight loss. Click here to read more.

October 10, 2013 – Counterfeit OxyElite Pro may be to blame for liver injuries in Hawaii. The FDA is investigating. User reports of fake OxyElite Pro and “bad batches” go back to at least 2010. Click here to read more.

October 9, 2013 – USPLabs has issued a statement on the liver injury epidemic linked to OxyElite Pro, calling it a “complete mystery” and cautioning that counterfeit products may be responsible. Click here to read more.

October 8, 2013 – OxyElite Pro will be removed from store shelves nationwide. USPLabs has agreed to stop selling the product until the CDC completes their investigation. Click here to read more.

October 8, 2013 – The FDA has issued a Drug Safety Communication to warn about the outbreak of non-viral hepatitis — 24 out of 29 people report using OxyElite Pro. Click here to read more.

October 4, 2013 – A “bad batch” of OxyElite Pro may be responsible for the epidemic of liver injuries in Hawaii. Although OxyElite Pro is used throughout the United States, liver injuries have only been reported in Hawaii, fueling speculation that the state received a contaminated shipment. The manufacturer, USPLabs, recently re-formulated OxyElite Pro, and liver injuries might be a reaction to new ingredients. Click here to read more.

October 3, 2013 – The Hawaii Department of Health has reported a cluster of at least 32 liver injuries have been associated with OxyElite Pro, including cases of acute hepatitis and liver failure. At least one person has had a liver transplant, and many more are on a waiting list or are being evaluated for a transplant. Click here to read more.

Hawaii News Now Exclusive Reports

Hawaii News Now has been reporting on the sudden outbreak of liver failure cases linked to the use of OxyElite Pro in Hawaii. Below are links to the video library:

Additional Resources:

UPDATE: $8 Million Worth of OxyElite, Jack3D Destroyed

July 16, 2013 -- Prosecutors from the Justice Department, on behalf of the FDA, have requested permission to seize 3,200 cases of DMAA products (Jack3D and OxyElite Pro) from warehouses owned by GNC in Pennsylvania and South Carolina. Click here to read more.

July 2, 2013 – The FDA has announced that USPLabs has voluntarily destroyed about $8 million worth Jack3D and OxyElite Pro stored at a facility in Dallas, Texas. Click here to read more.

April 16, 2013 – New FDA warning for DMAA. Click here to read more.

January 23, 2013 – USPLabs has agreed to settle a DMAA class action lawsuit for $2 million. Click here to read more.

April 27, 2012 –USP Labs, LLC, the company that manufactures and distributes OxyElite Pro, has just received a Warning Letter from the U.S. Food and Drug Administration (FDA). The FDA has concluded that “synthetically-produced DMAA is not a ‘dietary ingredient’ and, therefore, is not eligible to be used as an active ingredient in a dietary supplement.” The company is being specifically cited for failing to provide the FDA with a New Dietary Ingredient (NDI) notification. By law, all supplements that contain ingredients introduced after 1994 must provide the FDA with an NDI with evidence of the safety of the ingredient. Because manufacturers have never provided the FDA with this information, supplements containing DMAA are adulterated. Furthermore, the FDA warns that DMAA is known to cause blood vessel constriction, which can elevate blood pressure and increase the risk of deadly heart attacks.

August 2006 – The Washington Post reports that DMAA was first marketed as a supplement by Patrick Arnold, a chemist who served federal prison time for his role in the BALCO / Barry Bonds sports-doping scandal. Click here to read more.

OxyElite Pro Overview

OxyElite Pro is a dietary supplement that is mostly used for weight-loss and pre-workout performance enhancement. It is sold for $30-40 online and in dietary supplement stores such as GNC. OxyElite Pro contains DMAA, a stimulant drug with effects similar to amphetamines and ephedrine. DMAA is listed on the ingredient label of OxyElite Pro as “1,3-Dimethylamylamine (Geranium [stem]).” It is important to note that there is no credible evidence linking DMAA to the geranium plant, or any natural source.

OxyElite Pro is advertised as a “super thermogenic fat burner.” In the bodybuilding world, the term “thermogenic” refers to drugs that increase a person’s metabolic rate, causing the body to produce more heart, burn more calories, and burn fat (caffeine and ephedrine are two examples).

DMAA is often listed on product labels under the following names:

  • 1,3-DMAA
  • 1,3-Dimethylamylamine
  • 1,3-Dimethylpentylamine
  • 2-Amino-4-methylhexane
  • 2-Hexanamine
  • 4-Methyl-2-hexanamine
  • 4-Methyl-2-hexylamine
  • 4-methyl- (9CI)
  • Dimethylamylamine
  • Geranamine
  • Methylhexanamine
  • Methylhexanenamine

 

Products containing DMAA include:

  • USPlabs Jack3d (Tropical Fruit and Lemon Lime)
  • USPlabs Oxy Elite Pro
  • Nutrex Lipo 6 Black Caps (his and hers)
  • Nutrex Lipo 6 Black Ultra Concentrated (his and hers)
  • Nutrex Hemo Rage Black Powder (Punch and Berry)
  • Isatori PWR
  • Muscletech Neurocore
  • Muscletech Hydroxyslim
  • Fahrenheit Nutrition Lean EFX
  • Muscle Warfare Napalm
  • All American Efx K-Otic
  • SNI Nitric Blast
  • BIORhythm SSIN Juice
  • Muscle Meds Code Red
  • SEI MethylHex (4 and 2)
  • Grenade (universal) Grenade
  • M.A.P. (iovate) Arson
  • Gaspari Nutrition Spirodex

Military Bans DMAA & OxyElite Pro after Soldier Deaths

The U.S. Department of Defense banned the sale of DMAA on military bases after two soldiers suffered fatal heart attacks on the same base in the American Southwest. One soldier who died was a 22 year-old, who collapsed during a training run. The other soldier was a 32 year-old, who collapsed during a physical fitness test. Both soldiers had DMAA in their bloodstream.

In 2011, the military decided to pull DMAA products (including OxyElite Pro) off the shelves on military bases pending further review of the safety of the products. They cited concern that the products could cause deadly cardiovascular events, higher blood pressure, liver and kidney failure, lethal exhaustion, and more. In August 2013, the DOD concluded that there were risks in DMAA supplement use, but no link to soldier deaths.

Another death linked to DMAA was a New Zealand man who took DMAA-laced party pills and later died. Though his death may have been caused by factors other than DMAA, the fact that he had DMAA in his bloodstream is a cause for concern. Following this death, the government of New Zealand banned the sale and use of DMAA.

OxyElite Pro and the Geranium Plant

On the ingredient label for OxyElite Pro, DMAA is listed a “geranium stem.” A spokeswoman for USPlabs told the New York Times that DMAA is a natural substance derived from an Asian geranium, no more dangerous than caffeine, and has been used as food for more than a century.

The link between DMAA and the geranium plant is a point of contention, with most experts now agreeing that there is no credible evidence linking DMAA to any natural source. The government of Canada and New Zealand have banned DMAA because they believe is a synthetic drug. The American Herbal Products Association (AHPA), an herbal supplement trade group, has also banned its members from advertising DMAA as any part of the geranium plant.

The only report linking DMAA to the geranium was published in a Chinese technical journal in 1996. The report was not peer-reviewed. The authors of the report took dried botanical samples from a species of Asian geranium, and then ran the samples through a gas-spectrometer machine. The analysis included an automated system that identified 40 different compounds in the plant, including DMAA. Since that report was published, no one has been able to reproduce the results. The manufacturers of DMAA have never provided an independent chemist with the cut and dried botanical samples from which they purportedly derive the drug.

Though the evidence linking DMAA to a natural source is very weak, the evidence linking DMAA to a synthetic source is relatively strong. Synthetic DMAA was first mass-produced by the pharmaceutical drug company Eli Lilly in the 1940s. The company developed the drug as a nasal decongestant spray called Forthane, which was not a success. In the 1950s, safety studies of DMAA in animals found that it was more potent than ephedrine. Ephedrine was once a popular dietary supplement in the U.S., but it has since been linked to life-threatening cardiovascular events.

Soon after ephedrine was banned, DMAA was re-introduced to the market in the mid-2000s by a chemist named Patrick Arnold, who specialized in manufacturing performance-enhancing drugs that could not be detected in drug tests, according to an investigation published in 2006 by the Washington Post. Arnold trademarked methylhexanamine as “Geranamine,” claimed it was derived from the geranium plant, and began selling it in a workout supplement called Ergopharm Ergolean AMP. In 2006, Arnold served 3 months in federal prison for his role in the BALCO / Barry Bonds sports doping scandal. Arnold may have sparked the craze for DMAA in the bodybuilding community — by 2012, over 200 products contained DMAA.

OxyElite Pro Side Effects

The safety studies on USPlabs website claim that OxyElite Pro and other DMAA-containing dietary supplements are safe to use. The studies they cite were conducted on very small sample sizes (seven studies, involving 98 people, many of whom were taking a placebo). Most of the studies were “published” in an online journal that has a volunteer system for peer-review, and claims that it will publish studies in as little as three weeks. Furthermore, most of the studies were conducted over short periods of time (hours or weeks).

The reality is, no one knows how safe or effective DMAA is to use. Because these products are sold as dietary supplements, they have never been approved by the FDA. The manufacturers have never provided safety data to a government agency.

Advocates for DMAA products say that if a user “cycles” on and off the drug, they can avoid safety risks. You should know that many drugs actually become far more dangerous when a user is going on and off them, and there is no safety data backing up this method.

Other advocates say that a user should use “common sense” and take “reasonable” amounts of the drug. Because there is very little scientific literature regarding the side effects of DMAA, there is no way to know what is a “reasonable” amount or whether the drug is safe to use.

Liver injuries associated with OxyElite Pro (non-DMAA):

  • Liver inflammation
  • Acute non-viral hepatitis
  • Elevated liver enzymes in blood
  • Jaundice
  • Liver damage (hepatotoxicity)
  • Liver failure
  • Hospitalization and surgery for liver transplant
  • Brain damage (hepatic encephalopathy)

Side effects linked to OxyElite Pro with DMAA:

  • Headaches
  • Tremors
  • Light-headedness
  • Depression
  • Dehydration
  • Cold sweats
  • Kidney problems
  • High blood pressure
  • Respiratory distress
  • Lethal heat exhaustion
  • Abnormal heart rhythm
  • Heart attack
  • Stroke
  • Cardiac arrest
  • Nervous system disorders
  • Psychiatric disorders
  • Death

Do I have an OxyElite Pro Lawsuit?

The Schmidt Firm, PLLC is currently accepting OxyElite Pro induced injury cases in all 50 states. If you or somebody you know has been diagnosed with liver damage or serious side effects, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Dietary Supplement Litigation Group or call us toll-free 24 hours a day at (866) 920-0753.

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