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fungal meningitis outbreak. 50 articles

FDA ensures stronger oversight of compounding pharmacies

On the same day the co-owner of the Massachusetts compounding pharmacy blamed for the 2012 fungal meningitis outbreak that killed 76 people and sickened hundreds of others was sentenced to nine years in prison for conspiracy and fraud, the Food and Drug Administration (FDA) released a statement stressing the importance for more robust oversight of compounding pharmacies and the efforts the agency has taken to reduce the risk of a similar outbreak happening in the future. The outbreak was linked to contaminated steroid shots manufactured by the pharmacy, New England Compounding Center (NECC), and distributed to medical facilities across the ... Read More

Trial dates set for first two bellwether cases in fungal meningitis outbreak

Trial dates for the first two bellwether cases in the multidistrict litigation in to the 2012 multistate fungal meningitis outbreak linked to a compounding pharmacy have been set by U.S. District Judge Rya Zobel, the Massachusetts federal judge overseeing the case. The first trial is sechduled for Oct. 30 and involves the case of a patient who survived the outbreak. The next trial will begin after the first ends, and is brought on behalf of a patient who died from injuries caused by the infection. The outbreak is blamed on contaminated steroid shots manufactured by New England Compounding Center (NECC) ... Read More

NECC principal tied to fungal meningitis outbreak bragged about lax oversight in employee videos

Barry Cadden, one of two former principals in the now-shuttered Massachusetts-based New England Compounding Center (NECC) blamed for the 2012 fungal meningitis outbreak, bragged on employee training videos that the state’s pharmacy board had no clue about the pharmacy’s business, gave lax inspections of the lab where drugs were manufactured, and trusted him so much that they would blow off customer concerns when they arose. The videos were entered into evidence during Cadden’s murder trial as part of a series of legal actions against former employees and owners of NECC due to the fungal meningitis outbreak. Tens of thousands of ... Read More

Widow recalls husband’s painful death following tainted steroid injection

When Colette Rybinski spoke in the courtroom, her voice was barely audible. She talked about her husband Tom, who at 55, died after receiving a steroid injection to relieve lower back pain at a medical clinic near his home in Tennessee. Shortly afterward, at a time when the pain should have been easing from his back, his head began to ache so badly that Colette had no choice but to seek medical attention. His meningitis diagnosis was confounding. How could he have contracted the deadly brain inflammation? For weeks, Colette watched as Tom’s health went from better to worse in ... Read More

Opening arguments begin in wrongful death trial related to fungal meningitis outbreak

Opening arguments are scheduled to begin this week in the trial of Barry Cadden, one of two former principals at the now shuttered New England Compounding Center (NECC) blamed for the 2012 fungal meningitis outbreak that sickened more than 700 people and killed 64 across 20 states. Cadden is being charged with second-degree murder and other crimes in the deaths of 25 patients who received tainted steroid shots manufactured at NECC. An inspection at the compounding pharmacy following the outbreak revealed a wide range of potential sources of contamination including standing water, mold, and bacteria in the air and on ... Read More

Pharmacy owner’s trial begins this week over fungal meningitis outbreak

The owner of a Massachusetts compounding pharmacy blamed for the 2012 fungal meningitis outbreak that killed 64 people and sickened at least 750 across nine states is scheduled to stand trial this week on federal racketeering, murder and other charges. Barry Cadden, owner and lead pharmacist of the now-shuttered New England Compounding Center (NECC), will be tried in U.S. District Court in Boston over charges that NECC manufactured tainted steroid shots and distributed them to medical facilities across the country. Charges also include using expired ingredients to create sterile drugs, inadequately sterilizing instruments, failing to properly test drugs for sterility, ... Read More

Victims of tainted steroid shots ask judge to consolidate cases against surgical center

Four people who claim to have developed fungal infections from tainted steroid shots, and family members of four patients who died from infections after receiving the shots, asked a federal judge to consolidate their cases against a Maryland surgery center where they received the contaminated injections. The plaintiffs are suing Box Hill Surgery Center LLC, claiming their lawsuits are “nearly identical” and should be consolidated to save time, money and other resources. The plaintiffs received the steroid injections at Box Hill during a multistage outbreak of fungal meningitis that was traced to steroid shots produced and distributed by New England Compounding Center (NECC). ... Read More

Judge asked to reinstate charges against former NECC employees involved in fungal meningitis outbreak

The 2012 fungal meningitis outbreak tied to a Massachusetts compounding pharmacy continues to stir up controversy as those involved in the crime continue to face legal woes. This week, the government asked a Massachusetts federal judge to reinstate criminal charges against three former employees of the New England Compounding Center (NECC) saying that the decision to toss out the charges against them was based on incorrect assumptions. The fungal meningitis outbreak, which sickened more than 750 and killed at least 64 people across 20 states, was caused by contaminated steroid shots that were manufactured and distributed by NECC. NECC employees Kathy ... Read More

TN medical center tries to toss some lawsuits by victims of fungal meningitis outbreak

A motion by Tennessee-based Specialty Surgery Center PLLC to toss 15 lawsuits in a multidistrict litigation (MDL) related to the 2012 fungal meningitis outbreak, based on a technicality, should be rejected, the plaintiff’s steering committee (PSC) told a federal court. The medical group argued that under the state’s health care liability law, the claims needed to be accompanied by an avowal of good faith in relation to expert testimony. Fifteen of the 24 original complaints lack this information. The medical group argued this was grounds for dismissal. Plaintiffs said that the delay was because of an initial uncertainty about whether ... Read More

Compounding pharmacy warned over insanitary conditions

A July 2015 site inspection at Essential Wellness Pharmacy in Peoria, Ill., turned up serious deficiencies in the production of sterile products posing a risk to patients, including the presence of spore-forming bacteria in multiple locations in the facility, the Food and Drug Administration (FDA) stated in a warning letter. “Our investigators noted that your firm did not use a sporicidal agent … and used non-sterile disinfectants as part of your disinfection program for the aseptic processing area,” the warning letter stated. “In addition, your firm conducted environmental monitoring of surfaces, which could potentially bias the results.” The agency also ... Read More