A Limbrel lawsuit may be an option for people who have experienced serious complications associated with the unapproved drug, including drug-induced liver injury and hypersensitivity pneumonitis. Limbrel is a medical food product used to “manage the metabolic processes associated with osteoarthritis.” Affected patients and their families may be able to pursue a claim and recover compensation with the help of a dangerous drug attorney.
If you or a loved one have been adversely affected by a potentially dangerous drug, contact Attorney Group to learn about your options. We offer free, no obligation consultations. We can help answer your questions, and if you choose to pursue a claim we can connect you with an affiliated attorney who can assist you throughout the legal process.
Have You Seen a Limbrel Lawsuit Commercial?
You may have seen a Limbrel lawsuit commercial on television and wondered whether you or a loved one have been affected by it and similar drugs and, if so, whether you are eligible to pursue a claim against the drug manufacturer or distributor. The purpose of this article is to provide you with additional information about Limbrel, a medical food product designed to address the metabolic processes related to osteoarthritis.
Osteoarthritis is the most common chronic condition of the joints and is often referred to as degenerative joint disease or degenerative arthritis. According to the Arthritis Foundation, osteoarthritis affects approximately 27 million Americans. Osteoarthritis can occur in any joint but most often affects the joints in the knees, hips, lower back and neck, and fingers and toes.
Common symptoms of osteoarthritis include pain, stiffness and swelling of the affected joints, potentially making it difficult to perform ordinary tasks or engage in physical activity.
Factors that may contribute to the development of osteoarthritis may include:
- genetic traits, such as a rare defect in the body’s production of collagen or slight defects in the way bones fit together;
- obesity, which could put additional pressure on the hips and knees; and
- repetitive movements or injuries (such as fractures, surgery or ligament tears).
According to the Arthritis Foundation, other factors may contribute to osteoarthritis, including “bone and joint disorders like rheumatoid arthritis, certain metabolic disorders such as hemochromatosis, which causes the body to absorb too much iron, or acromegaly, which causes the body to make too much growth hormone.”
Although there is no cure for osteoarthritis, there are treatment options available to manage symptoms associated with the condition. Those treatment options may include:
- Physical activity
- Weight management
- Pain and anti-inflammatory medications
- Physical and occupational therapy
- Assistive devices or tools
People affected by osteoarthritis may also choose to utilize natural or alternative therapies, including acupuncture or acupressure, massage therapy, relaxation techniques and hydrotherapy, and nutritional supplements.
What is Limbrel?
Limbrel is a medical food product, consisting primarily of flavonoid (polyphenol) ingredients, in capsule form marketed to “manage the metabolic processes associated with osteoarthritis.” Flavonoids belong to a class of plant and fungus compounds found in almost all fruits and vegetables.
According to the FDA, a medical food, as defined in section 5(b) of the Orphan Drug Act, is “a food which is formulated to be consumed or administered internally under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation.”
Limbrel is a proprietary blend of two flavonoids (baicalin and catechins) and is developed and marketed by Primus Pharmaceuticals, a manufacturer of medical nutrition prescription products based in Scottsdale, Arizona.
Unlike dietary supplements, medical foods differ in that they are not designed to be consumed by healthy individuals. Instead, medical foods are used as a treatment for a specific medical condition. Medical foods are not drugs and, therefore, are not subject to any regulatory requirements that specifically apply to drugs.
Limbrel Side Effects
The most common side effects related to the use of Limbrel include nausea, diarrhea and gas.
Other potential side effects associated with Limbrel and other bioflavonoids may include:
- Blurred vision
- Dull ache or feeling of pressure or heaviness in legs
- Fluid accumulation in the knee
- Itching skin near damaged veins
- Pounding in the ears
- Red, scaling, or cursed skin
- Slow or fast heartbeat
- Swollen feet and ankles
Also, serious allergic reactions may occur, including hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Drug-Induced Liver Injury
Drug-induced liver injury is a rare liver disease affecting approximately 10 to 25 people per 100,000 people per year worldwide and is the most common cause of liver failure in the United States.
The liver plays a crucial role in metabolism and is linked to the functions of the gastrointestinal tract. As a result, the liver can potentially be injured by drugs and other substances, including dietary supplements and products labeled as medical foods.
Symptoms of drug-induced liver injury can vary and may include jaundice, nausea, fatigue, and gastrointestinal discomfort.
According to the American Lung Association, hypersensitivity pneumonitis is a disease of the lungs in which your lungs most commonly become inflamed as an allergic reaction to inhaled dust, fungus, molds or chemicals. In some cases, the disease may be associated with pharmacological agents, including the plant and fungus compounds known as flavonoids.
Symptoms of hypersensitivity pneumonitis can vary and may include fever, chills, headache, cough, chronic bronchitis, shortness of breath or trouble breathing, weight loss, and fatigue. According to the National Heart, Lung and Blood Institute, if hypersensitivity pneumonitis is not diagnosed or treated properly, the condition may lead to potentially fatal complications, including irreversible lung damage, permanently reduced lung function, pulmonary hypertension and heart failure.
The FDA began investigating a rise in reports of serious adverse events in early September 2017. According to the agency, serious adverse events associated with the use of Limbrel may include drug-induced liver injury and hypersensitivity pneumonitis. According to the FDA, Limbrel products are unapproved new drugs and represent a serious health hazard.
In total, the FDA has received 200 adverse event reports regarding Limbrel; 30 of these reportedly contained sufficient information to use the Council for International Organizations of Medical Sciences (CIOMS) causality assessment method to determine the likelihood that an association between the consumption of Limbrel and the adverse events reported exists.
The FDA is advising consumers not to use any Limbrel products because of the risks associated with the medical food. Consumers using the product have been asked by the FDA to discontinue use immediately and contact their health care provider. Likewise, health care providers who are aware that their patients are taking Limbrel have reportedly been told to advise their patients to stop using it.
Has There Been a Limbrel Recall?
On December 18, 2017, the FDA sent a letter to Primus Pharmaceuticals formally requesting a recall of all non-expired lots of Limbrel products, due to the possible risk of liver injury and other serious adverse events associated with the products. According to the letter, the FDA received 194 adverse event reports related to the use of Limbrel products from January 1, 2007, and November 9, 2017.
On December 21, 2017, in response to the FDA’s request, Primus Pharmaceuticals voluntarily suspended promotion and sale of Limbrel, according to the product’s website. The drug manufacturer claims that Limbrel is an important (and in many cases the only) medical option for people suffering from osteoarthritis.
In their request, the FDA stated that it “anticipates classifying this recall as a Class I recall, and believes that pursuing this recall request is necessary at this time to address the ongoing public health risk.” A Class I recall represents a serious health hazard, and in some cases, may be life-threatening.
Failure to warn of side effects of a drug can be a basis of drug company liability, regardless of whether the drug has been recalled.
Lauren A. on May 16, 2016
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Is There a Limbrel Class Action Lawsuit?
At the time of publication, no Limbrel class action lawsuit has been filed on behalf of patients who experienced serious complications associated with the drug. Likewise, Limbrel lawsuit attorneys are doubtful that a class action will be certified for patients who are adversely affected by the drug. Instead, if multiple lawsuits are filed against the drug makers alleging injuries and other damages caused by Limbrel and similar drugs, it is anticipated that these lawsuits will be consolidated for discovery and other pretrial proceedings.
When cases are consolidated in this way in federal court it is called a multidistrict litigation (MDL), and on a state level it is known as a state court consolidated proceeding. MDLs are distinct from class actions, and it is generally agreed that consolidating cases instead of proceeding in a class action is a more efficient and effective way of handling claims arising from injuries caused by pharmaceutical products.
Have There Been Any Limbrel Lawsuit Settlements?
Some dangerous drug lawsuits may settle early in the claims process. However, it is not expected that there will be any Limbrel lawsuit settlements at this time. Instead, it is expected that opioid lawsuits will be consolidated in federal court through an MDL. Limbrel lawsuit attorneys note that the outcome of any case is never guaranteed and past results are not necessarily predictive of future outcomes.
Limbrel Lawsuit News
- December 2017After recommending that Primus Pharmaceuticals voluntarily recall Limbrel, the FDA formally requests, via letter, that the drug maker recall all non-expired lots of Limbrel products, because of the risk of liver injury and other serious adverse events associated with the products.
- November 2017According to an FDA safety alert, the agency recommends a voluntary recall, but the company declined to take the product off the market.
- November 2017The FDA reportedly first contacts Primus Pharmaceuticals regarding the adverse events and requested information about the formula for Limbrel. The formula is being reviewed by the FDA.
- September 2017The FDA begins investigating a rise in reports of serious adverse events associated with Limbrel.
How a Limbrel Lawsuit Attorney Can Help
Drug makers have a duty to provide safe products. If there are risks of harm associated with their products, they also must provide adequate warnings. If a drug maker fails to fulfill this duty, it could be held liable in lawsuits for injuries that may result.
People injured by Limbrel or similar medical food products may be eligible to recover money for:
Pain and Suffering
The families of those who have died may be eligible to recover money for funeral expenses and the pain that comes with losing a loved one.