A man by the name of Sandeep Barot has filed a proposed consumer protection class-action lawsuit against the manufacturer and distributor of dietary supplements that allegedly cause liver damage. See Barot v. USPLabs LLC et al., No. 1:14-cv-00562, complaint filed (D.N.J. Feb. 3, 2014).

The defendant companies are USPLabs, LLC (“USPLabs”) and General Nutrition Center Holdings Inc. (“GNC”). USPLabs sells a variety of energy and weight loss dietary supplements under the brand name of OxyElite Pro through GNC.

The complaint was filed in the U.S. District Court for the District of New Jersey. In it, Plaintiff Barot says he bought and used OxyElite Pro supplements while living in New Jersey between March 2010 and October 2011. He says he bought the product at a GNC store. Barot says OxyElite Pro was sold in New Jersey between January 2008 and November 2013.

In April 2012, the Food and Drug Administration warned USPLabs about the use of a dangerous stimulant called dimethylamylamine (“DMMA”) in its products. A class-action complaint followed and was resolved by a settlement agreement. Hogan v. USPLabs LLC, No. BC486925 (Cal. Super. Ct., L.A. County).

However, during and subsequent to Hogan v. USPLabs, LLC, Defendant USPLabs contained and or included another dangerous ingredient in OxyElite Pro called, Aegeline. Public health officials are currently investigating severe illnesses allegedly connected to Aegeline, including liver disease and hepatitis.

Plaintiff Barot points to medical records submitted to the FDA by the Hawaii Department of Health in which patients who used OxyElite Pro became severely ill. The complaint states that the use of the product was the only common factor among the patients and many became well again after stopping its use. Therefore, the complaint argues, the likelihood that OxyElite Pro caused the illnesses is strong.

While some consumers were lucky enough to get well after they ceased ingesting the dietary supplement, for others, the damage had already been done. Several patients sustained liver injuries that required transplantation. Tragically, one patient died before a transplant could be performed. As of February, OxyElite Pro has been linked to 97 cases of hepatitis.

On Oct. 11, 2013, the FDA issued a warning to USPLabs to stop distribution of all products containing aegeline. The company conducted a voluntary recall about one month later, but Barot says it failed to provide any notice to consumers.

The complaint alleges violations of the New Jersey Consumer Fraud Act, N.J. Stat. Ann. § 56:8-1; breach of implied warranty; unjust enrichment; and violation of the Magnuson-Moss Warranty Act, 15 U.S.C. § 2301.

Specifically, Barot says he and other potential class members suffered economic damage in buying USPLabs’ products, which they would not have taken had they known of aegeline’s potential adverse effects. He also alleges that inadequate labeling on the product constituted an unfair trade practice because the ingredients were unfit for safe use and that the defendant companies were unjustly enriched at the expense of consumers’ health.

Though the diet supplement OxyElite Pro was recalled last year due to a connection with liver damage and acute liver failure, more people continue to get sick, according to a recent report by Scientific American.

Currently, at least 97 people have suffered severe hepatitis in connection with OxyElite Pro, and one person has died.  The first reports of liver damage linked to OxyElite Pro came to light in May 2013, but the FDA was not aware of this until September of that year.  Several months later, the manufacturer of OxyElite, USPLabs, issued a voluntary recall.

Scientists now believe that the questionable OxyElite ingredient, aegeline, is responsible for these cases of hepatitis, and the FDA has ordered USPLabs to discontinue its use.

Dr. Pieter Cohen of Harvard University published an article in The New England Journal of Medicine on this topic topic and explains that the hepatitis cases linked to OxyElite Pro are merely emblematic of a larger problem: the safety and efficacy of dietary supplements are not regulated by the FDA before products hit the shelves.

Cohen writes “The FDA’s delayed response — with its life-threatening consequences — is attributable to our woefully inadequate system for monitoring supplement safety. Americans spend more than $32 billion a year on more than 85,000 different combinations of vitamins, minerals, botanicals, amino acids, probiotics, and other supplement ingredients. Unlike prescription medications, supplements do not require premarketing approval before they reach store shelves. Under the Dietary Supplement Health and Education Act of 1994, anything labeled as a dietary supplement is assumed to be safe until proven otherwise. The FDA is charged with the unenviable task of identifying and removing dangerous supplements only after they have caused harm.”

He explains that in 2013 alone, his colleagues and FDA researchers identified two novel analogues of methamphetamine present in products currently available to consumers. One analogue was present in a sports drink, and the other analogue was present in nine dietary supplements.  By law, none of these products were to be reviewed ad hoc by the FDA, a loophole in effect making lab animals out of consumers.

Though a US Senate bill sponsored by Dick Durbin (D-IL) and Richard Blumenthal (D-CT) is currently under review by committee that would ensure proper labeling of “vitamins, minerals, botanicals, probiotics, and other supplement ingredients,” Dr. Cohen states that this “would not improve the FDA’s ability to detect and remove dangerous supplements from store shelves.”

What is required is a more broadened reform of the approval processes for dietary supplements and other such products.  It seems clear and obvious that anything consumed in our country should undergo rigorous testing before it becomes available on the market, particularly if a product advertises health benefits.  While this could lengthen the time it takes before products may be sold and increase costs, any financial burden or wait time would be well worth the benefit of a more protected America.

Seizures are potentially dangerous episodes resulting from abnormal neuronal activity in the brain.  Several medications have been created to prevent these episodes from occurring.  One such Anti-seizure medication is called Onfi, which is a schedule IV (CIV) oral antiepileptic.  Onfi has also been linked to some very harmful side effects, which has prompted the FDA to warn the public of these reactions.

According to a recent article by Medscape.com, the primary side effects that have caused these warnings are rare but serious skin reactions, which can result in permanent damage and even death.  The two documented skin reactions, Stevens-Johnson syndrome (SJS) and Toxic Epidermal Necrolysis (TEN), are most likely to occur during the first 8 weeks or when treatment is discontinued and restarted, although they may occur at any time while taking the medication.

Both skin conditions are very dangerous – all cases of SJS and TEN have resulted in hospitalization, one case resulted in blindness and another resulted in death.  While there may have been additional factors increasing the risk of these side effects, the available evidence suggests that Onfi was the likely cause of the reactions.

Patients taking Onfi to treat epilepsy should be closely monitored for signs or symptoms of SJS and TEN, especially during the first 8 weeks or when re-introducing the medication.  Onfi should be discontinued when signs of a rash are observed, unless the rash may be due to another cause.

On October 11th, the US Centers for Disease Control and Prevention reported that 317 people have become sick across the country in a recent outbreak of salmonella “tied to a California poultry producer.”  As reported by the American Association for Justice, “nearly half of the cases required hospitalization” and about three-quarters of the cases have been in California.

According to Mayo Clinic, “Salmonella infection is a common bacterial disease that affects the intestinal tract. Salmonella bacteria typically live in animal and human intestines and are shed through feces. Humans become infected most frequently through contaminated water or food sources.”  In this case, products sold by this California chicken company were likely contaminated with animal feces.

Mayo Clinic continues, “Typically, people with salmonella infection develop diarrhea, fever and abdominal cramps within eight to 72 hours. Most healthy people recover within a few days without specific treatment. [ ] In some cases, the diarrhea associated with salmonella infection can be so dehydrating as to require prompt medical attention. Life-threatening complications also may develop if the infection spreads beyond your intestines”.

This poultry farm (Foster Farms) operates a number of chicken plants in the California, and this recent salmonella outbreak is tied to three particular facilities operated by the company in central CA. According to an interview that Christopher Braden of the CDC food-borne diseases division gave the American Association for Jusice, “the outbreak involves seven different strains of salmonella Heidelberg”.  A few of the strains “are resistant to at least one antibiotic and one is resistant to five [antibiotics]”. (emphasis added)

Sadly, the New York Times has reported that “[this] is not the first time the government has linked Foster Farms poultry to salmonella poisoning”, citing that “[in] July, the Centers for Disease Control and Prevention reported tying 134 cases of it dating back to June 2012, including 33 that required hospitalization, to Foster Farms products.”

As when the NY Times questioned Foster Farms about the recent salmonella contamination and the company “referred calls to Tom Super, the spokesman for the National Chicken Council,” we learn that “‘This isn’t a recall, because they haven’t been able to link it to a specific product,’ … ‘The service listed the codes of the plants where these products originated, but it doesn’t indicate that every product or even most products made in those plants are unsafe.’”

If you or a loved one got sick from eating chicken from Foster Farms, call your doctor right away.  Salmonella poisoning is very serious.  When you are better, it may be worthwhile to call our team of salmonella poisoning lawyers at the information provided below for a free, no-obligation case consultation.  You may be entitled to significant financial compensation for the potentially life-threatening health risks you endured due to negligence at a modern food processing plant.

At your convenience, you may contact our offices either by phone at (855) 452-5529 or e-mail at justinian@dangerousdrugs.us.  We have the experience, resources, and skills required to win the justice you deserve.  Call today and see how we can help!

On October 11th, the US Centers for Disease Control and Prevention reported that 317 people have become sick across the country in a recent outbreak of salmonella “tied to a California poultry producer.”  As reported by the American Association for Justice, “nearly half of the cases required hospitalization” and about three-quarters of the cases have been in California.

According to Mayo Clinic, “Salmonella infection is a common bacterial disease that affects the intestinal tract. Salmonella bacteria typically live in animal and human intestines and are shed through feces. Humans become infected most frequently through contaminated water or food sources.”  In this case, products sold by this California chicken company were likely contaminated with animal feces.

Mayo Clinic continues, “Typically, people with salmonella infection develop diarrhea, fever and abdominal cramps within eight to 72 hours. Most healthy people recover within a few days without specific treatment. [ ] In some cases, the diarrhea associated with salmonella infection can be so dehydrating as to require prompt medical attention. Life-threatening complications also may develop if the infection spreads beyond your intestines”.

This poultry farm (Foster Farms) operates a number of chicken plants in the California, and this recent salmonella outbreak is tied to three particular facilities operated by the company in central CA. According to an interview that Christopher Braden of the CDC food-borne diseases division gave the American Association for Jusice, “the outbreak involves seven different strains of salmonella Heidelberg”.  A few of the strains “are resistant to at least one antibiotic and one is resistant to five [antibiotics]”. (emphasis added)

Sadly, the New York Times has reported that “[this] is not the first time the government has linked Foster Farms poultry to salmonella poisoning”, citing that “[in] July, the Centers for Disease Control and Prevention reported tying 134 cases of it dating back to June 2012, including 33 that required hospitalization, to Foster Farms products.”

As when the NY Times questioned Foster Farms about the recent salmonella contamination and the company “referred calls to Tom Super, the spokesman for the National Chicken Council,” we learn that “‘This isn’t a recall, because they haven’t been able to link it to a specific product,’ … ‘The service listed the codes of the plants where these products originated, but it doesn’t indicate that every product or even most products made in those plants are unsafe.’”

If you or a loved one got sick from eating chicken from Foster Farms, call your doctor right away.  Salmonella poisoning is very serious.  When you are better, it may be worthwhile to call our team of salmonella poisoning lawyers for a free, no-obligation case consultation – you may be entitled to significant financial compensation for the potentially life-threatening health risks you endured due to negligence at a modern food processing plant.

At your convenience, you may contact our offices either by phone at (855) 452-5529 or e-mail at justinian@dangerousdrugs.us.  We have the experience, resources, and skills required to win the justice you deserve.  Call today and see how we can help!

On August 21st, the US Food and Drug Administration issued a Class-1 recall for Siemens MicroScan Synergies plus® and MicroScan® rapID/S plus Negative Panels, affecting “78,020 panels distributed in the US between 07/11/2011 and 08/02/2013.” (FDA)

These panels come as part of kits used by medical professionals to test a patient’s saliva or tissue for microbial infection, and according to another FDA safety alert for Siemens MicroScan panels published September 4th, “using the MicroScan WalkAway System” may lead to a “false susceptible” reading or “false intermediate results for imipenem and meropenem antimicrobial susceptibility”. (emphasis added)

“This defect may lead to treatment with an inappropriate antibiotic or a delay in initiating appropriate therapy.”

These panels use new, innovative technology and are generally considered effective for determining a patient’s susceptibility to infection by some bacteria, but not others.  In 2002, medical researchers Caroline M. O’Hara and J. Michael Miller of the Centers for Disease Control and Prevention (Epidemiology and Laboratory Branch, Division of Healthcare Quality Promotion, Centers for Disease Control and Prevention, Atlanta, Georgia) published a paper titled  “Ability of the MicroScan Rapid Gram-Negative ID Type 3 Panel To Identify Nonenteric Glucose-Fermenting and Nonfermenting Gram-Negative Bacilli” in which they write, “With an accuracy approaching 75%, this product may be used for the identification of the commonly isolated non-Enterobacteriaceae bacteria but may present problems in identification of other non-glucose-fermenting gram-negative bacilli.”

If you were recently tested for a microbial infection by one of these bacteria, consider asking your doctor if he or she used a Siemens MicroScan Synergies plus® or MicroScan® rapID/S plus Negative Panels kit.  Using antibiotics when you don’t need them can compromise your immune system, which could be just as dangerous as a false negative reading or the use of the wrong antibiotic drug.

Cipro (ciprofloxacin), an antibiotic that has recently been linked to retinal detachment and other nerve disorders, came under fire last week as the US Food and Drug Administration rules that new warnings and usage guidelines be included on its packaging “to better describe the serious side effect of peripheral neuropathy”[1] or, nerve damage.

MedlinePlus, an online medical encyclopedia curated by the National Institutes of Health and the US National Library of Medicine explains peripheral neuropathy in this way:

“Peripheral nerves carry information to and from the brain. They also carry signals to and from the spinal cord to the rest of the body.

Peripheral neuropathy means these nerves don’t work properly. Peripheral neuropathy may be damage to a single nerve. It may be damage to a nerve group. It may also affect nerves in the whole body.”[2]

This warning label update applies to all oral fluoroquinolones, including “levofloxacin (Levaquin), ciprofloxacin (Cipro), moxifloxacin (Avelox), norfloxacin (Noroxin), ofloxacin (Floxin), and gemifloxacin (Factive),”[3] and the FDA warns that “This serious nerve damage potentially caused by fluoroquinolones may occur soon after these drugs are taken and may be permanent.”[4] (emphasis added)

Many peer reviewed studies have previously shown associations between Cipro and rare, but serious side-effects affecting the central nervous system; it is about time that the labels were properly updated.

However, due to allegations that the manufacturer of Cipro (Bayer Healthcare Pharmaceuticals, Inc.) knew the risks associated with its product but failed to act, a number of Cipro retinal detachment lawsuits and Cipro nerve damage lawsuits are currently being filed.

If you or a loved one used Cipro and experienced retinal detachment or another Cipro side-effect, you may be entitled to significant financial compensation.  For more information, or for a free, no-obligation Cipro lawsuit consultation, please do not hesitate to contact our team of Cipro lawyers at the information provided below.

We have the experience, resources, and skills required to bring you the justice you deserve.  Call today and see how we can help!

(855) 452-5529

justinian@dangerousdrugs.us

On August 1st, the FDA issued a safety alert for acetaminophen, the main ingredient in Tylenol and other painkillers, based on new data that has shown exposure to the drug can trigger several rare but dangerous skin reactions.

An excerpt from the FDA report:

“These skin reactions [associated with acetaminophen], known as Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), and acute generalized exanthematous pustulosis (AGEP), can be fatal. These reactions can occur with first-time use of acetaminophen or at any time while it is being taken.”[1] (emphasis added)

In May, 2012, a team of medical researchers from The Aga Khan University Hospital in Pakistan presented the case of a woman who suffered SJS and TEN concurrently while using acetaminophen.  Discussing their research, this woman’s doctors stated that “This case addresses the fact, that severe hypersensitivity reactions can occur with acetaminophen which can be potentially life threatening.”[2]  Sadly, these findings did not prompt FDA action.

The FDA believes that “It is difficult to determine how frequently serious skin reactions occur with acetaminophen, due to the widespread use of the drug, differences in usage among individuals (e.g., occasional vs. long-term use), and the long period of time that the drug has been on the market; however it is likely that these events (i.e., SJS, TEN, and AGEP) occur rarely.”[3] (emphasis added)

Because other similar drugs “also carry the risk of causing serious skin reactions, which is already described in the warnings section of their drug labels,” the FDA will now “require that a warning be added to the labels of prescription drug products containing acetaminophen to address the risk of serious skin reactions.”[4]

WARNING: FDA TO INVESTIGATE VICTOZA-CANCER LINK

Recently, the FDA has moved to evaluate whether or not Victoza (liraglutide), a drug used in GLP-1 therapy for the treatment of type II diabetes is associated with an increased rate for cancer.

Victoza and other GLP-1 therapy drugs have been previously linked to asymptomatic pancreatitis, and it is well-known that pancreatitis is associated with an increased risk for pancreatic cancer, but research showing a specific association between liraglutide and cancer has as yet been inconclusive.  This current FDA announcement is regarding a possible connection between Victoza and thyroid cancer.

Though Mayo Clinic states that “Clinical studies have also shown that liraglutide may cause pancreatitis,” some doctors believe the risks associated with Victoza outweigh the risks associated with Victoza use, but this may change if evidence that Victoza causes cancer is documented in peer-reviewed scholarly print.

Here is the original FDA announcement regarding cancer and Victoza:

Victoza (liraglutide [rDNA origin]) Injection: REMS – Risk of Thyroid C-cell Tumors, Acute Pancreatitis

[Posted 06/13/2011]

AUDIENCE: Endocrinology, Family Practice

ISSUE: Novo Nordisk reminded healthcare professionals of important safety information about Victoza (liraglutide [rDNA origin]) injection required in a Risk Evaluation and Mitigation Strategy (REMS). The letter is being sent because a recent assessment of healthcare providers showed that some primary care providers are not fully aware of the serious risks associated with the use of Victoza.

Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice. It is unknown whether Victoza causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as human relevance could not be ruled out by clinical or nonclinical studies. Additionally, in clinical trials studying Victoza, there were more cases of pancreatitis in patients treated with Victoza than in patients treated with comparators.

BACKGROUND: FDA may require a REMS for newly or already approved prescription drug product when FDA determines that a REMS is necessary to ensure the benefits of a drug outweigh the risks of the drug. Victoza is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

RECOMMENDATION: Patients with thyroid nodules noted on physical examination or neck imaging obtained for other reasons should be referred to an endocrinologist for further evaluation. Although routine monitoring of serum calcitonin is of uncertain value in patients treated with Victoza, if serum calcitonin is measured and found to be elevated, the patient should be referred to an endocrinologist for further evaluation.

After initiation of Victoza, and after dose increases, observe patients carefully for signs and symptoms of pancreatitis (including persistent severe abdominal pain, sometimes radiating to the back, and which may or may not be accompanied by vomiting).

Healthcare professionals and patients are encouraged to report adverse events, side effects, or product quality problems related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm

  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[June 2011 – Dear Healthcare Professional Letter – Novo Nordisk]

[May 2011 – Prescribing Information – Novo Nordisk]

I got an email from the FDA alerting me to new warnings about the usage of Avandia.  Apparently, the FDA has not decided to withdraw Avandia, but is severely restricting who may use it:

FDA will require that GSK develop a restricted access program for Avandia under a risk evaluation and mitigation strategy, or REMS. Under the REMS, Avandia will be available to new patients only if they are unable to achieve glucose control on other medications and are unable to take Actos (pioglitazone), the only other drug in this class. Current users of Avandia who are benefiting from the drug will be able to continue using the medication if they choose to do so.

Doctors will have to attest to and document their patients’ eligibility; patients will have to review statements describing the cardiovascular safety concerns associated with this drug and acknowledge they understand the risks. The agency anticipates that the REMS will limit use of Avandia significantly.

Source: Avandia (rosiglitazone): REMS – Risk of Cardiovascular Events

This will hurt GlaxoSmithKline (GSK) in two ways.  First, the obvious pain will come in the form of reduced sales.  Avandia can no longer be used as a first-line treatment for patients with diabetes.    New prescriptions are going to drop like a rock.

Second, this announcement will probably spur a second wave of Avandia lawsuits.  That’s because an entirely new batch of people will see this news announcement and decide to contact an Avandia lawyer.  I know that GSK has already settled quite a few Avandia lawsuits, but their defense attorneys should probably gear up for another round.