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OxyElite Pro Lawsuit

OxyElite Pro, a pre-workout dietary supplement made by USPlabs, has been linked to serious side effects including heart attack, heat stroke, seizure, liver failure and death.

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What’s the problem with OxyElite Pro?

For better or worse, being thin and fit has long been an obsession in American culture. For most people, though, losing weight is an excruciatingly slow and difficult process. At times it can seem practically impossible to drop that pesky extra 10, 20, or 30 pounds you’ve been trying to get rid of. These common difficulties people face when trying to lose weight have spawned a massive dietary supplement industry. Unfortunately, some companies that manufacture and market such products make claims that are unfounded or even completely fabricated.

Enter USPlabs’ OxyElite Pro. According to the manufacturer, OEP increases the user’s metabolic function, enabling you to burn calories even while you are at rest. Additionally, USPlabs claims that OxyElite Pro is designed to suppress your appetite, increase your energy, and even improve your mood.

Can all these claims be true, and what about the risk of side effects associated with OxyElite Pro? According to the package label, OxyElite Pro contains the following ingredients:

What is DMAA?

DMAA was the main active ingredient in OxyElite Pro, and is designed to give the user increased workout intensity, focus, and other desired effects associated with elevated adrenaline levels. However, DMAA has recently come under scrutiny by the U.S. Food & Drug Administration (FDA) due to its potential for serious side effects and life-threatening complications.

First synthesized and patented by Eli Lilly in 1944, the pharmaceutical giant went on to trademark the compound as a nasal decongestant known as Forthane in 1971.

According to one Chinese study published in the Journal of Guizhou Institute of Technology (1996, Vol. 25, pp. 82-85), DMAA is derived from geranium oil, but no other research to date has been able to detect its presence. The American Herbal Products Association (AHPA) enacted a trade requirement that went into effect in January 2012 which bars its members from labeling DMAA as a geranium-based constituent.

Due to the fact that DMAA is classified as a food additive, it does not require approval by the FDA to be sold on the U.S. market. However, a number of highly-respected sports organizations such as Major League Baseball and the World Anti-Doping Authority (WADA) have reclassified DMAA as a banned stimulant.

OxyElite Pro Side Effects

The most serious side effects reported in OxyElite Pro users include:

  • Hepatitis
  • Liver damage
  • liver failure
  • Kidney damage
  • Kidney failure
  • Hyperthermia
  • Irregular heartbeat
  • Seizures
  • Heart attack
  • Stroke
  • Psychiatric side effects
  • Elevated blood pressure
  • Sudden cardiac death
  • And more

Other, less severe side effects associated with OxyElite Pro include:

  • Skin reactions
  • Irritability
  • Nervousness
  • Dizziness
  • Trembling
  • Headache
  • Insomnia
  • Profuse perspiration
  • Dehydration
  • Itchy scalp and skin

Deaths Linked to OxyElite Pro

In February 2012, the United States Department of Defense banned sales on dietary supplements containing DMAA in military facilities following the sudden deaths of two soldiers. In the summer of 2011, a 22-year-old soldier collapsed and died while running at a Southwestern US military base. No more than three months later, a 32-year-old soldier collapsed while exercising and subsequently died after a month of intensive care in the hospital. Both soldiers were later found to have DMAA in their systems.

Hawaiian Who Had Liver Transplant After Taking OxyElite Pro Dies

September 1, 2017 – A man from the Big Island of Hawaii who needed a liver transplant after taking OxyElite Pro has died, according to Hawaii News Now. Kenneth Waikiki was just 22-years-old when he had the liver transplant surgery in 2013, and had been taking OxyElite Pro for just about a month before he got sick. After several medical procedures, Waikiki died earlier this month at The Queen’s Medical Center.

GNC to Pay $2.25 Million in OxyElite Pro Settlement

December 8, 2016 – GNC Holdings Inc. has agreed to pay $2.25 million and take steps to ensure potentially unlawful ingredients are not included in its supplements, according to the U.S. Justice Department. The announcement follows a federal investigation into how a misbranded version of OxyElite Pro reached the company’s shelves in 2013.

The investigation found that “GNC’s practices related to ensuring the legality of products on its shelves were lacking” when it sold OxyElite Pro Advanced Formula, according to Reuters.

The supplement was manufactured by USPlabs, which was indicted in November 2015 on charges of conspiring to import ingredients from China using false labeling and documentation. GNC suspended sales of all products made by the company shortly following news of the indictment.

According to the Justice Department, USPlabs told some of its retailers and wholesalers that it used natural plant extracts in its products when it was actually using synthetic stimulants that were manufactured in China.

Investigators concluded that GNC had “relied on the representations and written guarantees of USP Lab” that OxyElite Pro was lawfully represented and did not perform additional testing to confirm the company’s representations.

Benjamin C. Mizer, head of the Justice Department’s civil division, called the agreement a “significant step forward in reforming an industry rife with alarming practices,” adding that “companies like GNC need to do more to ensure that they are not selling products containing questionable and untested ingredients.”

USPlabs Offers Experts to Demonstrate ‘Safety’ of OxyElite Pro

July 8, 2016 – In its defense of a felony prosecution alleging fraud and consumer harm, USPlabs LLC is attempting to introduce experts to testify that its workout supplement OxyElite Pro was safe.

An 11-count indictment brought last November claimed that USPlabs profited millions of dollars through a criminal conspiracy which included the production of fraudulent documents to hide the source of synthetic chemicals in its dietary supplements, including use of DMAA and an outbreak of liver injuries linked to OxyElite Pro in 2013.

Criminal charges have been filed against USPlabs, its contract manufacturer S.K. Laboratories, and executives for both companies. A Nebraska-based consultant who worked with USPlabs also was named as a defendant in the indictment, according to Natural Products Insider.

Defense lawyers want the judge to conduct a hearing to decide whether experts will be allowed to testify on the safety of OxyElite Pro. Such expert testimony should be addressed with a hearing before the case moves to trial, the filing said.

The defense team intends to call numerous experts to support their belief that OxyElite Pro was safe to use as directed, including clinicians who can review medical records, treatment and history of patients who were allegedly injured by the supplement. Prosecutors also intend to call their own experts, including a specialist who can discuss the efficacy of dietary supplements in general, as well as the results of studies regarding the safety of OxyElite Pro and its link to a hepatitis outbreak, according to court filing issued last month.

In a wrongful death lawsuit filed against USPlabs that was dismissed earlier this year, the judge struck the testimony of 3 plaintiffs’ experts who were attempting to illustrate the risks of DMAA in USPlabs’ supplement Jack3d, and that it was likely a contributing factor in a soldier’s death.

Regulators have described DMAA as an amphetamine-like substance that is unfit for use in dietary supplements, though products containing the chemical are still widely available.

Last month, U.S. Magistrate Judge Paul Stickney granted the defendants permission to communicate with each other in order to prepare their defense. The case is pending in the U.S. District Court for the Northern District of Texas, Dallas Division.

Criminal Charges Filed Against OxyElite Pro Manufacturer

November 17, 2015 – USPlabs LLC, maker of the best-selling workout supplements Jack3D and OxyElite Pro, faces criminal charges for the unlawful sale of nutritional supplements, the U.S. Justice Department has announced.

The indictment says that USPlabs used a Chinese-made synthetic stimulant to manufacture Jack3d and OxyElite Pro, but told retailers that the ingredients were made from plant extracts, according to Reuters.

“From California to Maine, consumers ingest pills, powders and liquids every day, not knowing whether they are wasting money or whether they may end up harming, rather than helping themselves,” said Benjamin Mizer, Principal Deputy Assistant Attorney General for the Civil Division. “Unfortunately, many of these products are not what they purport to be or cannot do what the distributors claim they can do.”

A total of 6 executives with USPlabs and S.K. Laboratories — the company that actually manufactured the supplements — have been indicted. Four were arrested today and the other 2 are expected to surrender, according to the Justice Department.

The indictment also noted an outbreak of hepatitis and liver damage linked to OxyElite Pro in late 2013, and that several patients required liver transplants as a result of their injuries.

GNC Agrees to $2 Million OxyElite Settlement

On September 23, 2014, GNC and USPLab agreed to a $2 million settlement in a class action lawsuit against them for injuries allegedly sustained by OxyElite Pro and Jack3d. Plaintiffs alleged that the companies:

  • Violated the Florida Drug and Cosmetic Act
  • Violated the Florida Deceptive and Unfair Trade Practices Act
  • Breached its express warranty and implied warranty
  • Made false statements regarding the safety of DMAA supplements, and that OxyELITE Pro and Jack3d do not work

OxyElite Pro Class Action

USP Labs and GNC are offering rebates of up to $300 per customer under the terms of a settlement in an OxyElite Pro Class Action Lawsuit. The complaint accused the companies of false and misleading claims relating to OxyElite Pro, Jack3d and VERSA-1. USP Labs and GNC have denied any wrongdoing but agreed to the settlement in order to avoid more costly litigation.

Judicial Panel Denies OxyElite Pro, Jack3d Lawsuit Consolidation

April 16, 2014 – Earlier this month, a panel of federal judges denied a motion by the makers of OxyElite Pro and Jack3d to transfer and consolidate a number of products liability lawsuits to federal court in Philadelphia. The complaints consist of both individual personal injury claims and false advertising class actions that were originally filed in various courthouses around the country. The litigation contends that OxyElite Pro and Jack3d contained altered ingredients that were unsafe and unapproved by the FDA, leading to a nationwide hepatitis outbreak.

On April 2, the U.S. Judicial Panel on Multidistrict Litigation (JPML) denied a motion by USPlabs to consolidate the OxyElite Pro and Jack3d lawsuits, which at the time consisted of 9 federal complaints pending in Pennsylvania, Florida, California, Texas and Hawaii. USPlabs sought to form the claims into a multidistrict litigation (MDL), and transfer the cases to the Eastern District of Pennsylvania. GNC Holdings Inc., which is USPLabs’ retail partner, is located in Pittsburgh.

According to court documents, 10 of the co-defendants and 1 plaintiff supported the MDL, while the plaintiffs in 6 other actions and 4 potential tag-along actions opposed consolidating 9 actions, but supported some combination of separate consolidated litigation. However, the plaintiffs in 2 other lawsuits and defendant Natural Alternatives International opposed any form of centralization.

The defendants argued that consolidation of all of the lawsuits was warranted, regardless of the differences in the supplements’ active ingredients and the claims presented by the tort and false advertising suits, due to the fact that all of the cases allege the products are dangerous and rely on the same series of FDA actions to support their claims. Additionally, the defendants argued that discovery and pretrial motions would be likely to overlap.

In response to the defendants’ claims, the plaintiffs argued that the DMAA and aegeline in the supplements are so dissimilar that they might as well be different drugs. According to the pending lawsuits, both OxyElite Pro and Jack3d contained ingredients that were unsafe and “adulterated,” thus making them illegal to sell as dietary supplements.

In January, USPlabs’ defense attorneys requested that the JPML have any potential consolidated litigation overseen by “experienced MDL jurist” Judge Eduardo C. Robreno. In its denial of this request, the judicial panel stated it was not persuaded that the MDL was necessary, either to assure the convenience of the parties involved or for the “just and efficient conduct of this litigation.”

“On the present record, it appears that the different formulations of the products will not give rise to substantially overlapping discovery, particularly in light of the differences in the health risks alleged and the distinct regulatory responses to the DMAA and aegeline products,” the JPML wrote. “Additionally, the three consumer class actions raise a unique threshold issue with respect to the alleged impact of a state court class settlement agreement reached in 2012.”

OxyElite Pro Super Thermogenic Contains Prozac: FDA Warning

February 28, 2014 – A laboratory analysis has confirmed that the weight-loss supplement OxyElite Pro Super Thermogenic contains fluoxetine, the active ingredient in Prozac. Fluoxetine is an antidepressant medication that has been linked to serious side effects in users, as well as birth defects in babies born to mothers who take the drug during pregnancy.

The U.S. Food & Drug Administration (FDA) issued a warning advising consumers not to purchase or use OxyElite Pro Super Thermogenic, a weight-loss supplement manufactured by USPlabs LLC. An analysis of international mail shipments has confirmed that OxyElite Pro Super Thermogenic (Lot# 216732, Exp. 04/17) contains fluoxetine, a selective serotonin re-uptake inhibitor (SSRI) used to treat major depressive disorders, obsessive-compulsive disorder (OCD), bulimia nervosa and premenstrual dysphoric disorder (PMDD).

Side effects of Prozac may include:

  • Suicidal thoughts / ideation
  • Bleeding
  • Seizures / convulsions
  • Anxiety
  • Excessive or irregular heartbeat
  • Breathing problems
  • Muscle pain
  • Hives, itching or skin rash
  • And more

OxyElite Pro Class Action Lawsuit Filed Against Texas Drugmaker Over False Advertising

November 27, 2013 – In the wake of this month’s nationwide OxyElite Pro recall, the supplement’s manufacturer now faces a class action lawsuit over a false and misleading advertising campaign. The complaint was filed against USPlabs LLC and GNC Corporation in the U.S. District Court for the Northern District of Florida on November 13. In addition to the new OxyElite Pro class action lawsuit, USPlabs faces numerous individual lawsuits filed in courthouses around the country on behalf of individuals who suffered serious liver injuries after taking the controversial pre-workout dietary supplement.

A group of four plaintiffs seek to bring an OxyElite Pro class action lawsuit on behalf of all consumers who purchased the product, focusing on the use of DMAA, which is a “long forgotten, ineffective, extremely dangerous and potentially lethal ingredient,” according to the complaint.

OxyElite Pro and Jack3d also also contain caffeine, which is known to intensify the effects of sympathomimetics. DMAA has been outlawed in a number of countries, and was placed on Major League Baseball’s banned substances list.

According to allegations raised in the new class action lawsuit, USPLabs and GNC used deceptive marketing claims to market OxyElite Pro and Jack3d, including statements which described the supplements as “university studied,” “scientifically reviewed”, supported by “clinical studies” and “proven to be safe and effective.” The plaintiffs contend that these statements are false and lack any tangible substantiation.

In response to the controversy surrounding DMAA, FDA banned the ingredient nationwide in April 2012. A year later, after determining that at least 60 illnesses and deaths had been caused by DMAA-containing products, the agency issued a warning indicating that the substance is too dangerous to be used in dietary supplements.

More recently, a new ingredient contained in OxyElite Pro, aegeline, has been linked to serious health concerns. A growing number of reports have surfaced, first in Hawaii and then all around the country, of OxyElite Pro users who were diagnosed with acute hepatitis and liver failure after taking the supplement.

To date, nearly 60 cases of OxyElite Pro liver damage have been identified by state and federal health authorities, leading to a removal of the product from the market and indications from the manufacturer that it will further reformulate the supplement before re-introducing it.

FDA had the authority to force the OxyElite Pro recall because it was found to contain aegeline, an unapproved ingredient that made the product adulterated. While the administration does not approve dietary supplements before they reach the market, if a new ingredient is included, it is the manufacturer’s responsibility to provide information concerning the safety before it can be sold. FDA was able to ban OxyElite Pro because aegeline was used without proper notification and approval. USPLabs has also promised to destroy all its remaining inventory of aegeline-containing products.

OxyElite Pro Recall Expanded to Include Raspberry Lemonade Super Thermo Powder

November 19, 2013 – USPlabs, LLC is expanding its nationwide recall of OxyElite Pro dietary supplements to include Raspberry Lemonade Super Thermo Powder. These products contain aegeline, an ingredient the FDA has determined to be illegal to use in dietary supplements. USPlabs initiated the OxyElite Pro recall earlier this month after the supplement was linked to a nationwide outbreak of hepatitis and liver failure.

Epidemiological evidence has shown that OxyElite Pro can cause users to develop liver damage, liver failure, acute hepatitis, and other serious side effects. Dallas, TX-based USPlabs agrees with the FDA that a national recall is appropriate to limit adverse events associated with these products. OxyElite Pro was distributed nationwide through retail stores, mail orders and direct delivery.

The following products are subject to the nationwide OxyElite Pro recall:

OxyElite Pro Super Thermo capsules

  • 2 count capsules UPC #094922417275
  • 10 count capsules UPC #094922417251
  • 10 count capsules UPC #094922417268
  • 21 count capsules UPC #094922426604
  • 90 count capsules UPC #094922395573
  • 90 count capsules “Pink label” UPC #094922447906
  • 180 count capsules UPC #094922447852

OxyElite Pro Ultra-Intense Thermo capsules

  • 3 count capsules UPC #094922447883
  • 3 count capsules UPC #094922447876
  • 90 count capsules UPC #094922395627
  • 180 count capsules UPC #094922447869

OxyElite Pro Super Thermo Powder

  • Fruit Punch 0.15 oz UPC #094922417237
  • Fruit Punch 0.15 oz UPC #094922447517
  • Fruit Punch 4.6 oz UPC #094922426369
  • Fruit Punch 5 oz. UPC #094922447487
  • Blue Raspberry 4.6 oz UPC #094922426376
  • Grape Bubblegum 4.6 oz UPC #094922447500
  • Green Apple 4.6 oz. UPC #094922426499
  • Raspberry Lemonade 4.6 oz. UPC #094922447494

USPlabs Agrees to Recall, Destroy Remaining OxyElite Pro Inventory

November 18, 2013 – USPlabs has agreed to recall all remaining stocks of OxyElite Pro after the supplement was linked to dozens of cases of acute liver failure and hepatitis, including two liver transplants and one death. Additionally, the company has assured the FDA that it will destroy warehouse stocks of the supplement, worth an estimated retail value of approximately $22 million.

Cleveland Woman Hospitalized With Liver Damage After Taking OxyElite Pro

November 15, 2013 – A 33-year-old Cleveland woman is in an area hospital recovering from liver damage after taking OxyElite Pro. Phetsamone Senevoravong started using OxyElite Pro several months back in an attempt to lose weight to impress a man, but instead became increasingly ill, suffering from fatigue, nausea, and jaundice. After weeks of the unexplained symptoms, Senevoravong finally went to the hospital, where she was diagnosed with liver damage. Her doctors identified OxyElite Pro as the likely cause of her injuries.

Senevoravong, who is known to her friends as Samone, is recovering at University Hospitals Case Medical Center in Cleveland, awaiting the results of a liver biopsy that will determine whether she will require further treatment. She’s nervous, but is steadfastly optimistic about how she’ll fare: Samone believes in the power of positive thinking.

“Right now it’s a waiting game to see if my liver can recover,” she said. “It’s going to recover.”

At first, it wasn’t clear to Senevoravong that OxyElite Pro had anything to do with her failing health. She started using OxyElite Pro in June, after a workout partner gave her a pill to sample. When she went to buy her own at GNC, an employee mentioned some trouble with the pills, and that the formula her partner had shared wasn’t on the market anymore. There was a new version available, though.

The problem the GNC employee referred to was the U.S. military’s ban of DMAA-containing dietary supplements like OxyElite Pro after two soldiers died of heart attacks during routine exercises.

“They were misusing it, and they took a whole bunch of it under like 100-degree weather,” Senevoravong said. She assumed it was safe to try the new OxyElite Pro, since the product no longer contained DMAA.

As part of her new workout routine, which also included jogging and a healthy diet, Senevoravong took between four and 10 OxyElite Pro pills per week. It was at the end of September, during a trip to Maryland that she began experiencing unexplained symptoms. After a night out on the town, she woke up lethargic and with a headache. To wake herself up, she popped some OxyElite Pro.

“They had a caffeine-like effect on me,” Senevoravong said. “I never took it to help me lift weights or to help me keep muscles. I’d use it in the morning to get me going.”

Despite her increasingly severe symptoms, it took another few months for Senevoravong to finally make it to the hospital. During the weeks leading up to her hospitalization, she became increasingly fatigued and nauseated, and started noticing her eyes yellowing. She thought maybe it was because she was tired.

“I tried to make excuses for myself all the time,” she said. “I thought it was the weather, or depression.”

A friend finally drove from Akron and dragged Senevoravong to the emergency room. She was transferred to Parma Community General Hospital and then to UH Case. Three days later, her doctors believed they had pinpointed the probable cause of her illness. She’d answered countless questions about the medications she was taking, but hadn’t mentioned OxyElite Pro.

Senevoravong was scheduled to have her gallbladder removed when a liver specialist asked her again about her medication history. This time, she admitted to taking OxyElite Pro.

“Something told me to tell him I was taking it,” she said. The specialist told her OxyElite Pro had been recalled because of liver illnesses.

The next day, Senevoravong’s doctor made a call to health officials in Hawaii to talk about the outbreak of liver failure cases there. He said dietary supplement complications like these are very uncommon, so pinning symptoms or illnesses to their use is very difficult. A cluster of cases is usually what draws the attention of the FDA or the Centers for Disease Control (CDC), he said.

“The FDA does not restrict food additives, and all of these things are considered food additives,” said Dr. Stanley Cohen, Senevoravong’s doctor and medical director of hepatology at UH Case. “It doesn’t mean that they don’t work, it just means that we don’t have the science behind them to know, and that’s our biggest concern about these things.”

Cohen said there’s a real chance of the need for a liver transplant in cases like Senevoravong’s, where there the patient has jaundice and certain liver abnormalities. Between 10 and 30% of these patients will need a transplant or could die.

Senevoravong refuses to even entertain those thoughts.

“I’m trying to keep a positive spirit,” she said. “If I start to cry and feel bad for myself, my body’s going to take a turn. As long as I keep the good, positive energy and spirit, it’s going to go well.”

USPlabs Announces OxyElite Pro Recall

November 9, 2013 – USPlabs announced a nationwide recall for all lots and sizes of OxyElite Pro. These products contain aegeline, an adulterated substance that has not proven to be safe.

According to an FDA press release, USPlabs issued the OxyElite Pro recall after learning that it had been linked to a cluster of hepatitis cases in Hawaii, and that the product may be adulterated with an illegal ingredient. The press release also notified the company that if it did not initiate a voluntary recall, the FDA could enforce a recall by law. The action marks only the second time the administration has exercised its recall authority under the Food Safety Modernization Act.

Products affected by the recall include:
OxyElite Pro Super Thermo capsules

  • 2 count capsules UPC #094922417275
  • 10 count capsules UPC #094922417251
  • 10 count capsules UPC #094922417268
  • 21 count capsules UPC #094922426604
  • 90 count capsules UPC #094922395573
  • 90 count capsules “Pink label” UPC #094922447906
  • 180 count capsules UPC #094922447852

OxyElite Pro Ultra-Intense Thermo capsules

  • 3 count capsules UPC #094922447883
  • 3 count capsules UPC #094922447876
  • 90 count capsules UPC #094922395627
  • 180 count capsules UPC #094922447869

OxyElite Pro Super Thermo Powder

  • Fruit Punch 0.15 oz UPC #094922417237
  • Fruit Punch 0.15 oz UPC #094922447517
  • Fruit Punch 4.6 oz UPC #094922426369
  • Fruit Punch 5 oz UPC #094922447487
  • Blue Raspberry 4.6 oz UPC #094922426376
  • Grape Bubblegum 4.6 oz UPC #094922447500
  • Green Apple 4.6 oz UPC #094922426499

Hawaii Man Diagnosed With Liver Failure After Taking OxyElite Pro

October 14, 2013 Lance Taniguchi is the latest Hawaiian to be diagnosed with liver failure after taking OxyElite Pro. Tests have indicated that the 24-year-old has 40 to 50% liver failure, and could require a liver transplant if it doesn’t heal itself soon.

Lance Taniguchi had been an OxyElite Pro user for 2 years, but it wasn’t until a few weeks ago that he noticed any negative side effects. He started vomiting, and thought it was a case of food poisoning. When his skin turned yellow he realized it was something far more serious, and went to an emergency room.

“I’m really scared and disappointed,” said Taniguchi in an exclusive interview with Hawaii News Now. “I’d rather have a few extra pounds than be six feet under.”

Taniguchi, who says he only took one OxyElite Pro pill a day, had no pre-existing medical conditions or allergies. He works as an electronic engineer for the Navy, and was sent to Virginia when got sick. He’s now worried about his health and future career with the Navy.

“My lab signs are not showing progression and recovery and regeneration of my liver right now,” Taniguchi said. “If it doesn’t show signs of recovery I could be do for a major operation.

Hawaii Department of Health Makes OxyElite Pro Illegal to Sell

October 11, 2013 – The Hawaii Department of Health has issued a request that OxyElite Pro be voluntarily removed from store shelves statewide. The request came after at least 29 cases of acute hepatitis and liver failure – including one death – had been linked to the supplement on the islands. The DOH is now implementing an embargo on OxyElite Pro, temporarily deeming sales of the product illegal in Hawaii.

When the Hawaii DOH imposed a statewide ban on OxyElite Pro, it was greeted with near universal acceptance from stores across the state. Just one distributor, GNC, refused to pull the supplement off their shelves.

“GNC uniformly informed us they were not going to remove it,” said Hawaii Deputy Director of Environmental Health Gary Gill. While all other retailers unanimously agreed to remove OxyElite Pro, every local GNC manager visited by the DOH said they had no plans to stop selling it.

According to an FDA press release, at least 29 cases of acute non-viral hepatitis have been reported in Hawaii. Eleven of these patients required emergency hospitalization, two received liver transplants, and a 48-year-old mother of seven died as a result of her injuries. The Centers for Disease Control and Prevention (CDC) is looking at other cases of liver injury around the country that may be attributed to OxyElite Pro.

Bowing to pressure, on Wednesday GNC agreed to pull OxyElite Pro off shelves of their Hawaii stores, a claim that has been confirmed by the DOH. A statewide embargo has been placed on OxyElite Pro, temporarily deeming sale of the product illegal on the Hawaiian Islands. DOH inspectors will visit every distributor throughout the state to take inventory and issue notice that OxyElite Pro is not to be sold or moved.

Should the investigation reveal that OxyElite Pro is indeed a serious health risk, the DOH will seize and destroy all remaining stocks of the product. A fitness trainer who took OxyElite Pro for years told Hawaii News Now that she believed she had purchased a counterfeit batch, citing differences in packaging, taste and effects.

USPLabs said it would voluntarily cease the nationwide manufacture and distribution of the product until the investigation into the problem can be concluded. But this does not mean that OxyElite Pro will be pulled off retailers’ shelves nationwide. Once retailers purchase OxyElite Pro from USPLabs, it is up to them whether or not to remove it.

OxyElite Pro Found to be Adulterated

On October 11, 2013, the FDA sent a Warning Letter to USPlabs stating that OxyElite Pro and another supplement made by the company, VERSA-1, contain an ingredient called aegeline which has no history in the food supply and has not been properly tested for safety. According to the FDA:

“In the absence of a history of use or other evidence of safety establishing that aegeline, when used under the conditions recommended or suggested in the labeling of your products, will reasonably be expected to be safe, OxyElite Pro and VERSA-1 are adulterated under 21 U.S.C. 342(f)(1)(B) and 350b(a) because they contain a new dietary ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury. Introduction of such a product into interstate commerce is prohibited under 21 U.S.C. 331(a) and (v). FDA is aware of no history of use or other evidence of safety establishing that aegeline will reasonably be expected to be safe when used under the conditions recommended or suggested in the labeling of OxyElite Pro and Versa-1.”

OxyElite Pro Linked to 32 Cases of Liver Failure in Hawaii

October 1, 2013 – The Hawaii State Department of Health has confirmed that at least 32 new cases of liver failure have been linked to OxyElite Pro. As a result of these events, the Department of Health sent out an alert to medical professionals around the country requesting that doctors and dietitians report any patients suffering from liver conditions who were taking OxyElite Pro or other similar dietary supplements.

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:

If You’ve Been Harmed By OxyElite Pro

If you suffered a serious injury after taking OxyElite Pro, you should:

  • Seek immediate medical attention.
  • Save all evidence. This step is crucial if you plan on filing a lawsuit. This includes all packaging and receipts.
  • Document all the expenses you incur that are related to OxyElite Pro, especially medical expenses.
  • Contact a knowledgeable and experienced OxyElite Pro lawyer who can advise you about how to proceed with your claim.

What OxyElite Pro Lawsuits Need To Prove

Victims of OxyElite Pro may be entitled to damages through the filing of a lawsuit. If you or someone you love has been injured by OxyElite Pro, you may be entitled to recoverable damages for your losses, including:

  • Lost wages
  • Wrongful death
  • Pain and suffering
  • Legal fees
  • Reimbursement for medical expenses

With this type of lawsuit, an injured plaintiff may qualify for compensation if the following conditions are met:

  • OxyElite Pro has been proven to be unreasonably dangerous. There must be a defect in the product that caused the plaintiff’s injury.
  • The product was used in an “ordinary” way, as it was intended to be used per the instructions on the product’s labeling.
  • OxyElite Pro was not significantly altered from the condition it was in at the time it was purchased. For example, if a third party had tampered with the packaging of OxyElite Pro after the products had been purchased, it would likely affect the plaintiffs’ claims.

Do You Have an OxyElite Pro Lawsuit?

The Product Liability & Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in OxyElite Pro lawsuits. We are handling individual litigation nationwide and currently accepting new injury and death cases in all 50 states.

Free Confidential Case Evaluation: If you or a loved one has been injured by OxyElite Pro, you should contact our law firm immediately. You may be entitled to compensation by filing an suit and our lawyers can help.

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