A Synvisc-One lawsuit may be an option for people who experienced serious complications associated with the arthritis treatment, including knee pain and infection. Synvisc-One is a type of medication injected into the knee joint to reduce the pain associated with osteoarthritis.
In addition to the voluntary recalled issued by the product’s manufacturer, researchers have indicated that the knee pain treatment may have an increased risk of adverse health events, in some cases, outweighing the benefits. 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 Synvisc-One Lawsuit Commercial?
You may have seen a Synvisc-One 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 lawsuits and other litigation involving dangerous drugs so that you have a better understanding of your options.
Osteoarthritis (OA) is one of the most common chronic conditions affecting the joints, often occurring in the knees, hips, lower back and neck, and joints located in the fingers and toes. According to the Arthritis Foundation, OA (sometimes called degenerative joint disease or degenerative arthritis) affects approximately 27 million Americans and most commonly affects people aged 65 or older. Common risk factors for OA include increasing age, obesity, previous joint injury, overuse of the joint, weak thigh muscles, and genes.
Symptoms of the condition may vary, but people with OA most commonly experience pain and stiffness, swollen joints, limited range of motion, and clicking or cracking near joints. Pain and other symptoms associated with OA may make simple tasks and activities difficult to perform. When finger and hand joints are affected, people may have a hard time grasping or holding objects. When lower body joints are affected, activities such as walking, climbing stairs and lifting objects may become difficult.
Osteoarthritis is a long-term, chronic disease. Although there is not a cure for OA, treatments can be used to manage symptoms, including:
- Physical activity
- Weight management
- Physical and occupational therapy
- Assistive devices
- Natural and alternative therapies
In addition to physical activity and other types of treatment, patients may use pain and anti-inflammatory medications available either over-the-counter or by prescription. Medicines used to treat OA may be taken orally, applied topically (such as a cream or lotion), or injected directly into the affected joint.
What is Synvisc-One?
Synvisc-One is a type of injection used to treat people who are affected by OA in the knee when diet, physical exercise and over-the-counter pain medication do not provide enough relief.
Synvisc-One contains a gel-like substance made from chicken combs called hyaluronan, a natural substance already present in the joints. Hyaluronan acts as a lubricant and shock absorber, potentially easing the pain associated with OA. Synvisc-One can provide up to six months of OA pain relief.
Synvisc-One was approved by the U.S. Food and Drug Administration (FDA) in 2009 as the only single-injection viscosupplement available in the U.S. for patients with knee pain associated with OA. Synvisc-One belongs to a class of drugs known as hyaluronic acid derivatives (HADs) and is typically given by a specialist trained in treating knee osteoarthritis, such as an orthopedic surgeon or rheumatologist. Although HADs are occasionally used to treat patients with OA of the knee, some researchers claim that the use of knee injections is “associated with a small and clinically irrelevant benefit and an increased risk for serious adverse events.”
Synvisc-One Side Effects
Side effects related to Synvisc-One may include pain, swelling, redness, heat, and/or fluid build-up in or around the knee.
According to the injection’s prescribing information, other side effects may include:
- Muscle pain/cramps
- Flushing and/or swelling of the face
- Fast heart beat
- Difficulty breathing
- Swelling in the arms and/or legs
In rare cases, patients experienced a low number of platelets in the blood, a type of blood cell that are needed to help the blood clot.
Lauren A. on May 16, 2016
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Other Synvisc-One Complications
The most commonly reported adverse events associated with Synvisc-One may include arthralgia (pain or inflammation), arthritis, arthropathy, injection site pain, and joint effusion.
Other adverse events that may occur in relation to intra-articular injections, including Synvisc-One may include joint stiffness, joint effusion, joint swelling, joint warmth, and gait disturbance.
Before using Synvisc-One, patients are advised to notify their doctor of any allergic reaction, such as swelling of the face, tongue or throat, respiratory difficulty, rash, itching or hives to Synvisc-One or any other hyaluronan-based product.
Allergic reactions, some which can be potentially severe, have been reported during the use of Synvisc-One.
Has There Been a Synvisc-One Knee Injection Recall?
On December 11, 2017, Sanofi Genzyme, an American biotechnical company and subsidiary of Sanofi S.A., initiated a voluntary product recall for a single lot of Synvisc-One (lot 7RSL021) due to an ongoing investigation which revealed the presence of microbial contamination. The microbe is a common airborne organism and is a rare cause of human infections in both immunocompromised and immunocompetent patients.
There is a potentially increased risk of infection associated with the recalled lot. This lot was distributed October 25, 2017 through November 7, 2017 in the United States. The most frequently reported adverse events in association with this lot are consistent with documented adverse events in the product label. Adverse side effects can be painful and could require hospitalization for treatment, which can possibly leave patients with long recovery periods that limit their ability to work and reduce their quality of life.
Drug recalls are usually conducted by the drug manufacturer, by FDA request, or by FDA order. Potential litigation could possibly claim that the drug makers failed to disclose known side effects of the drug and that patients suffered damages as a result. 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.
Is There a Synvisc-One Class Action Lawsuit?
At the time of this article’s publication, a Synvisc-One class action lawsuit action has not been filed on behalf of patients who suffered serious complications. Synvisc-One lawsuit attorneys are doubtful that a class action will be certified for patients who are adversely affected by the device.
Instead, if multiple lawsuits are filed against the manufacturers, alleging injuries and other damages caused by adjustable valves, shunts and similar medical devices, it is anticipated that these potential lawsuits will be consolidated for discovery and other pretrial proceedings.
When cases are consolidated in this way in federal court it is called 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 defective medical devices.
In most cases that proceed in an MDL or state court consolidated proceedings, after a certain period of time initial trials, also known as bellwether trials, take place. The purpose of these trials is for the parties to get an idea of the types of evidence and arguments that will made, as well as to see how juries will respond to the evidence and arguments.
After a certain number of cases have been tried, the parties are in a better position to determine whether a case can be settled.
Have There Been Any Synvisc-One Lawsuit Settlements?
Some dangerous drug lawsuits may settle early in the claims process. However, it is not expected that there will be any Synvisc-One lawsuit settlements at this time. Instead, it is expected that Synvisc-One lawsuits will be consolidated in federal court through an MDL. Synvisc-One lawsuit attorneys note that the outcome of any case is never guaranteed, and past results are not necessarily predictive of future outcomes.
Synvisc-One Lawsuit News
- December 2017Sanofi Genzyme initiated a voluntary product recall for a single lot of Synvisc-One knee injection due to an ongoing investigation which revealed the presence of microbial contamination.
- February 2009 According to the manufacturer’s press release, the FDA grants marketing approval for Synvisc-One (hylan G-F 20), making it the only single-injection viscosupplement approved for the treatment of pain associated with osteoarthritis (OA) of the knee in the United States.
- August 1997 FDA approves Synvisc for the treatment of OA knee pain as a three-injection regimen for patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics such as acetaminophen.
How a Synvisc-One 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 Synvisc-One, or other potentially contaminated knee injections, may be eligible to recover money for:
- Medical Expenses
- Lost Wages
- 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.