Synvisc-One Knee Injections are a type of pharmaceutical drug intended to supplement joint fluid in the knee in order to relieve pain brought on by osteoarthritis. In the fall of 2017, a lot of Synvisc-One injections vials were contaminated at some point during the manufacturing process, putting patients who had injections administered by the contaminated vials at risk for certain types of infection. Those who received contaminated injections reported a range of adverse effects.
Below are some frequently asked questions that patients who have come in contact with these injections may have.
What Are Synvisc-One Knee Injections?
Synvisc-One is an injection that supplements the natural fluid in the knee to help lubricate and cushion the joint. According to the manufacturer, it is intended for use in people with knee osteoarthritis who have not received enough pain relief from diet, exercise, and over-the-counter pain medication.
Synvisc-One is a single-dose treatment that is injected directly into a patient's knee by a doctor. This is most often performed by a specialist trained in treating knee osteoarthritis, such as an orthopedic surgeon or rheumatologist. These injections are manufactured by Sanofi Genzyme, an American biotechnology company headquartered in Cambridge, Massachusetts.
What Are the Side Effects of Synvisc-One Knee Injections?
According to Sanofi Genzyme, the side effects of Synvisc-One injections can include: pain, swelling, heat, redness and/or fluid build-up around the knee. Sanofi reports that in one medical study less than 6% of patients experienced these side effects, which were generally mild and did not last long.
Why Were Synvisc-One Knee Injections Recalled?
On December 11, 2017, Sanofi Genzyme recalled over 12,000 vials of Synvisc-One due to contamination. The company issued URGENT VOLUNTARY DEVICE RECALL notices and reply cards to their customers via courier service. In a letter sent to providers, it stated that the company was voluntarily recalling one lot of Synvisc-One injections distributed between October 25, 2017, and November 7, 2017. The company stated "This is a voluntary product recall due to an ongoing investigation in which subsequent investigational testing revealed the presence of microbial contamination. Use of this recalled lot may result in a risk of infection."
Sanofi then instructed providers to immediately discontinue use of the affected lot and to be aware of the potential of a Gram-negative infection. It also provided instructions for returning unused vials back to the company. Gram-negative infections can be especially troubling as these are developing partial to total resistance to treatment with antibiotics.
The company issued a follow-up communication on December 19, 2017, informing customers that the isolated bacterial organism involved in the contamination was Methylbacterium thiocyanatum. Another recall update was issued by the company on December 22, 2017, which included antibiotic sensitivity analysis guidance for the isolated organism.
The US Food and Drug Administration (FDA) has issued a Class 2 Recall for Synvisc-One vials related to the lots identified as contaminated by the manufacturer. A Class 2 recall is issued when the FDA has identified a product that might cause serious injury or temporary illness.
The contaminated vials were those in Lot Number: 7RSL021 and have the Expiration Date: 05-31-2020.
Were My Symptoms Caused by Contaminated Knee Injections?
Patients who were injected with the contaminated vials of Synvisc-One have reported various injuries. In one case, a physician-administered a contaminated vial and the patient presented to an emergency department approximately 10 hours later, complaining of stabbing pain and swelling in the injected knee. Emergency room doctors had to drain fluid from the knee in order to relieve the symptoms.
These symptoms are similar with what the manufacturer stated might occur from injections with contaminated vials (knee pain, swelling of the joint, issues with mobility and fluid build-up near the injection site). As of the time of this writing, no deaths have been associated with contaminated vials of Synvisc-One injections.
However, the full extent of adverse reactions related to contaminated injections would vary based on the individual characteristics of the patient, including age, health status, use of other medications, and other factors.
Who is Liable for Pharmaceutical Contamination?
In the United States, a manufacturer can be liable for delivering a defective product (including pharmaceutical drugs) to a consumer if that defective product causes injuries to the consumer when used in the matter it was intended to be used. The defect can occur at any point in the process, including a product suffering from an initial design defect, or one that is designed soundly but is somehow adulterated during manufacturing or transportation. Therefore, in a case such as this, where a pharmaceutical company has admitted that a drug was contaminated during the manufacturing process, they are likely liable for any damages that patients suffer as a result of this contamination.
Could I Bring a Lawsuit for Synvisc-One Related Injuries?
If you were treated with a contaminated vial of Synvisc-One, you may be entitled to compensation for injuries that you suffered as a result. If you were injected during the time period around the contamination (October-December 2017), there is a chance that you may have been injected with a contaminated vial. To determine if you are eligible, you should consult an experienced personal injury attorney who can analyze your medical history and advise you as to your potential eligibility.
The team at Gilman & Bedigian have decades of legal experience and extensive resources necessary to investigate these types of claims. Contact our team for a free consultation to discuss the specifics of your case.