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Synvisc-One Knee Injection Lawsuits

Patients who suffered complications after receiving contaminated Synvisc-One knee injections are filing lawsuits against Sanofi Genzyme and Genzyme Biosurgery. Complaints say patients suffered infections that required medical treatment and/or resulted in death.

People who required medical attention within a week after receiving a contaminated Synvisc-One knee injection may have a strong case against the manufacturer, Sanofi Genzyme.

Contaminated syringes belonged to lot 7RSL021 and were initially distributed to 36 states on Oct. 25, 2017. Sanofi Genzyme recalled the syringes on Dec. 11, 2017.

People in any of the affected states can file lawsuits in the states’ courts. They may also file lawsuits in federal courts.

Synvisc-One Recall

In early December 2017, reports of complications from the arthritis treatment spiked. Sanofi Genzyme investigated and discovered gram-negative bacteria in one lot of syringes. Gram-negative bacteria include E. coli, Salmonella and several other hard to treat bacteria.

The company did not specify exactly what type of bacteria its investigation discovered.

On Dec. 11, 2017, the company issued a voluntary recall for 18,000 syringes. But by that time, more than 12,000 syringes in the lot had been in distribution for up to seven weeks.

Recalled Synvisc-One Syringes
  • Lot Number: 7RSL021
  • Distributed: Oct. 25, 2017 through Nov. 7, 2017
  • Recall Issued: Dec. 11, 2017
  • Recall Expires: May 31, 2020

Sanofi Genzyme sent out a recall letter to doctors about its investigation into contaminated syringes. It warned doctors to be “aware of the potential of a gram-negative [bacteria] infection.”

People seeking to file a lawsuit may have to prove they received a Synvisc-One injection from the recalled lot between Oct. 25, 2017, and Dec. 11, 2017.

Injuries from Contaminated Synvisc-One

Synvisc-One injuries are generally related to infections caused by the bacterial contamination.

You may be eligible for compensation for physical injuries and the cost of medical treatment, including:
  • Infection
  • Outpatient procedures (injection, aspiration)
  • Emergency room visit
  • Hospitalization
  • Death

Injured patients may have received an outpatient injection or aspiration with the contaminated product. Others may have received an injection in the emergency room or hospital. Lawyers are also accepting cases on behalf of people whose loved ones died after a Synvisc-One injection.

Settlements and Verdicts for Similar Injuries

People are just beginning to file lawsuits over contaminated Synvisc-One syringes, so there have been no large settlements or large verdicts.

But there have been other cases involving contaminated syringes in recent years:
  • May 2014
    New England Compounding Center paid $100 million to settle 751 lawsuits after syringes became contaminated with fungal meningitis. The outbreak linked to the syringes was described as the worst of its kind in U.S. history. Among the plaintiffs were the families of 64 patients who died after receiving tainted steroid shots for back pain.
  • May 2016
    B. Braun Medical paid $7.8 million to the federal government in penalties and forfeiture and to resolve criminal liability. Pre-filled saline syringes infected patients in four states with Serratia marcescens, a gram-negative bacterium that can cause urinary or respiratory tract infections.

According to the U.S. Department of Justice, B. Braun was aware of problems at the manufacturing plant even before it began purchasing syringes from it. B. Braun approved of changes to the sterilization process even after it received reports of the syringes changing colors. Under the terms of an agreement with the Justice Department, B. Braun said it would increase oversight of its product suppliers by conducting on-site audits of companies that design and make finished products that bear the B. Braun name on the label or logo and testing such products for sterility, identity and purity, as appropriate, on a periodic basis.

AmerisourceBergen Corp. (ABC), one of the nation’s largest wholesale drug companies, agreed to pay $625 million in combined civil and criminal penalties to resolve allegations that it illegally repackaged injectable drugs for cancer patients, according to an announcement from the Justice Department on Oct. 1, 2018. The company was accused of improperly repackaging cancer drugs into prefilled syringes and distributing those syringes to doctors who treated vulnerable cancer patients.

Prosecutors said the company sought to profit from the “overfill” in the original FDA-approved vials by creating a pre-filled syringe program through a repackaging subsidiary that it claimed was a pharmacy. ABC purchased original vials from manufacturers, broke their sterility, combined the contents, and repackaged the drugs under conditions that were not sterile.

Suffering from complications related to Synvisc-One knee injections? Review Your Legal Options

FDA Warns Genzyme About Earlier Version of Synvisc-One

In 2001, the FDA warned Genzyme about problems at its Ridgefield, New Jersey, plant. The company made an earlier version of Synvisc at the time.

In its warning, the FDA told the company to fix the problems, including obtaining approval for certain medical products and investigating product complaints, or face severe consequences.

Reports of Complications

The first report of problems with Synvisc-One injections came in less than a month after the contaminated lot shipped.

In November 2017, a medical professional sent a report to the U.S. Food and Drug Administration. It said a patient had developed excess fluid on the knee.

Nurse draining fluid from knee
Excess fluid in the knee is a reported side effect of contaminated Synvisc-One knee injections.

The health care provider had to drain the knee twice. A test of the fluid did not find gram-negative bacteria. But it did find an elevated white blood cell count, an indication that the body is making more white blood cells to fight an infection.

Three weeks later, a woman reported she stumbled trying to stand up after getting an injection. She said her knee could not support her weight.

Please seek the advice of a medical professional before making health care decisions.

Related Pages
Terry Turner
Written By Terry Turner Writer

Terry Turner has been writing articles and producing news broadcasts for more than 25 years. He covers FDA policy, proton pump inhibitors, and medical devices such as hernia mesh, IVC filters, and hip and knee implants. An Emmy-winning journalist, he has reported on health and medical policy issues before Congress, the FDA and other federal agencies. Some of his qualifications include:

  • American Medical Writers Association (AMWA) and The Alliance of Professional Health Advocates member
  • Centers for Disease Control and Prevention Health Literacy certificates
  • Original works published or cited in Washington Examiner, MedPage Today and The New York Times
  • Appeared as an expert panelist on hernia mesh lawsuits on the BBC
Medically Reviewed By
Dr. Aimee V. Hachigian-Gould
Dr. Aimee V. Hachigian-Gould Orthopedic Surgeon

6 Cited Research Articles

  1. NBC News. (2014, May 6). Fungal Meningitis Victims to Get $100 Million Settlement. Retrieved from https://www.nbcnews.com/health/health-news/fungal-meningitis-victims-get-100-million-settlement-n98576
  2. Saltzman, J. (2017, December 8). Sanofi Genzyme puts hold on arthritis medicine following surge in side effects. Retrieved from https://www.bostonglobe.com/business/2017/12/08/sanofi-genzyme-recalls-arthritis-medicine-following-surge-side-effects/JDKQI2zMEHobUXna7qoyUN/story.html
  3. U.S. Department of Justice. (2018, October 1). AmerisourceBergen Corporation Agrees to Pay $625 Million to Resolve Allegations That it Illegally Repackaged Cancer–Supportive Injectable Drugs to Profit From Overfill. Retrieved from https://www.justice.gov/opa/pr/amerisourcebergen-corporation-agrees-pay-625-million-resolve-allegations-it-illegally
  4. U.S. Department of Justice. (2016, May 18). B. Braun Medical Inc. Agrees to Resolve Criminal Liability Relating to its Sale of Contaminated Syringes. Retrieved from https://www.justice.gov/opa/pr/b-braun-medical-inc-agrees-resolve-criminal-liability-relating-its-sale-contaminated-syringes
  5. U.S. Food and Drug Administration. (2018, January 31). MAUDE Adverse Event Report: Genzyme Synvisc-One Retrieved from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7209040&pc=MOZ
  6. U.S. Food and Drug Administration. (2018, January 31). MAUDE Adverse Event Report: Sanofi Genzyme Synvisc-One 48 Mg/6 Ml Intra-Articular Syringe Acid, Hyaluronic Intraarticular. Retrieved from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7142071&pc=MOZ
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