Pharmaceutical Litigation

By: admin Feb 10

In December 2017, an urgent Synvisc-One recall was issued that affects nearly 13,000 syringes used to treat osteoarthritis, due to a lot that tested positive for microbial contamination. Syringe contents must be sterile.

Manufactured by Sanofi Genzyme and FDA approved in 2009, Synvisc-One (Hylan G-F 20) is a hyaluronic acid injection used for the treatment of pain from knee osteoarthritis. However, doctors sometimes use these injections in other joints. These injections are for patients seeking stronger treatment over nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen.

About Synvisc-One

Synvisc-One injections use hylan A fluid and hylan B gel, made from a substance called hyaluronan, along with salt water. The syringe uses this gel-like mixture to relieve pain mainly associated with knee osteoarthritis or other joint pain. Hyaluronan, also known as sodium hyaluronate, is naturally present in healthy joints. The substance acts as a shock absorber and lubricant, allowing joints to move smoothly over each other. However, the substance appears to break down in people with osteoarthritis. Injecting it into a joint may lessen pain and inflammation. If non-sterile microbes contaminate the injections, then, patients experience harmful and dangerous side effects.

Synvisc-One Recall

In December 2017, Sanofi Genzyme voluntarily recalled Synvisc-One, as a result of microbial contamination of lot number 7RSL021 sold in 36 U.S. states from October 25, 2017, through November 7, 2017. This recalled lot equates to 12,380 syringes. Investigators pinpointed that the microbe is a common airborne organism, which causes serious infections.

However, Sanofi Genzyme did not express which side effects prompted the recall. A representative of the pharmaceutical company stated the infected syringes increased the presence of side effects found on the label. The warnings listed on the package insert include pain, swelling, heat, redness, and fluid build-up in and around the knee.

Synvisc-One Bacteria

On February 14, 2018, nearly two months after the manufacturer initiated the recall, the recall was updated. The company revealed that the bacterial contaminant in the syringes was Methylbacterium thiocyanatum. The company allegedly distributed a second notice on December 19, 2017, with this information, yet it didn’t reach all individuals who were adversely affected by the contaminated lot. This bacteria usually originates from environmental sources, such as water, soil, and sewage, however, studies have seen Methylobacterium species in healthcare-associated infections. The most troubling characteristics of this bacterium are that it is a gram-negative bacillus, which studies show it to be opportunistic pathogens in immunocompromised patients. Additionally, the Methylobacterium species can form a biofilm, which allows it to stick to many surfaces. Also, it is resistant to the majority of sanitation practices. Therefore, a traditional attempt at keeping a sterilized environment, such as using chlorine as a disinfecting agent would fail. Plus, this bacteria is slow growing. Therefore, it could have been present and infecting syringes for weeks or months before detection.

Microbial Contamination Symptoms

Patients suffering from contaminated syringes may experience any of the following symptoms:

Knee pain
Swelling
Trouble walking
Heat or redness
Fluid build-up in or around knee

Several patients needed cortisone injections or joint aspirations to rectify the harm from these contaminated injections. However, many others experienced these painful side effects but also required hospitalization. This also means that many have mounting hospital bills all from one seemingly safe injection to help curb their pain. A legal claim could help defray these costs.

Synvisc-One Bacteria Contamination Theories

Without knowing Sanofi Genzyme’s manufacturing process, we cannot say for sure how the contamination occurred. However, it is possible that the bacteria came from a water source, possibly during the manufacturing process, and infected the syringes. This bacterium is chlorine-resistant. Therefore, even if the plant attempted to clean using traditional cleaning agents, it would not have worked. The bacteria would have remained.

Also, this bacterium isn’t one that people internally come in contact with. Therefore, it can send a horrific chain of reactions throughout one’s body after a medical professional injects it. One of these side effects is a pain so intense that the victim cannot walk. Some have reported to swelling so severe that doctors had to drain numerous vials of off-colored fluid from the knee.

Additionally, this Synvisc-One bacteria is very resistant to traditional antibiotic measures. Doctors have attempted to use dangerous fluoroquinolone antibiotics like Cipro. These antibiotics carry a black box warning for disabling and potentially permanent damage to tendons, muscles, and even the central nervous system. Additionally, studies link fluoroquinolones to causing aortic aneurysms and death. In fact, the FDA only recommends fluoroquinolones for extreme circumstances.

Your Rights

When manufacturers produce unsafe products that create pain and suffering, you deserve compensation. Although no amount of money will change the fact that you have suffered a serious injury because of manufacturer irresponsibility, compensation will help offset your current and future medical costs, as well as provide for the pain and suffering you have experienced. By filing, you may also help protect other women and their families from needless distress.

This isn’t the first time a microbe contaminated injections, and the result was catastrophic. Several years ago, plaintiffs secured a $100 million settlement after fungal meningitis contaminated steroid injections. The tainted injections ultimately killed 64 people and injured over 750 in 20 states. It was one of the worst American outbreaks of fungal meningitis.

We Want to Help Victims

Furthermore, it is your right for manufacturers to inform you about the long-term risks associated with medications, and it is the responsibility of manufacturers to provide this information. If you or a loved one has suffered any side effects from Synvisc-One, you should demand accountability from Sanofi Genzyme. Why did no one tell you?

Of course, we want to help send a message that this is not acceptable. We are advocates for consumers who have been harmed by dangerous products, and likewise, we have the experience necessary to successfully litigate these cases.

Contact the Michael Brady Lynch Firm today for a free consultation to learn more about seeking justice. Compensation may be available for any medical expenses associated with this ordeal, as well as for your physical and emotional suffering. There is no obligation.

How We Can Help

When you experience side effects from a dangerous drug, it can have devastating effects on your entire life. You also may be entitled to compensation for their injuries and damages. The types of losses we can help you recover include:

Past and future medical expenses
Lost wages
Loss of an ability to work; and Pain and suffering

If a person dies from complications from a drug, family members may also be able to recover damages for the wrongful death of their loved one, including:

Funeral expenses
Medical expenses prior to death
Loss of economic support; and
Loss of companionship

Therefore, if a jury finds the conduct of a company to be highly reckless, they may award punitive damages to punish the company and deter similar conduct in the future. If you received a Synvisc-One injection from the contaminated lot distributed between October and November 2017 and experienced a painful side effect, please speak to us to learn more about your rights.

The Michael Brady Lynch Firm is currently accepting cases in all 50 states. Please use the form on this page or call the Synvisc recall number at 1-877-513-9517.