Drug Company Owners arrested for outbreak of meningitis that killed 64

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From the 'who needs regulations' files............






Two owners and 12 former employees of a US pharmacy have been arrested in connection with a 2012 outbreak of meningitis that killed 64 people across the country, prosecutors said.


Barry Cadden and Gregory Conigliaro owned the New England Compounding Centre (NECC), which lost its licence in 2012 after inspectors found it guilty of multiple sanitary violations.


The pharmacy, in the city of Framingham, Massachusetts in the US northeast, voluntarily shut down and recalled all products following the unprecedented outbreak of fungal meningitis.


The US Centres for Disease Control and Prevention says the outbreak was caused by contaminated vials of preservative-free methylprednisolone acetate manufactured by NECC.The CDC says 751 patients in 20 states were diagnosed with a fungal infection, of whom 64 patients in nine states died.


A detailed, 73-page grand jury indictment unsealed in Boston levelled 131 charges against the defendants, including racketeering, mail fraud, conspiracy and second degree murder.


The most serious charges were levelled against Cadden and supervisory pharmacist Glenn Chin, who face up to life in prison if convicted on all counts.


They were charged on Wednesday with 25 acts of second degree murder.The indictment alleges that from 2008 to 2012, the pharmacy used expired ingredients to make drugs, falsely labelled drugs, failed to properly sterilise drugs, failed to properly clean and disinfect working areas and shipped out untested medications.


It also alleges drugs were made by an unlicensed technician and names of celebrities were used to create fraudulent prescriptions, such for a Michael Jackson and a Diana Ross in Nebraska.




The fungus that contaminated the steroids was so prevalent it could be seen with the naked eye in some vials.

Critics say drug manufacturers have found a way to sidestep costly and strict oversight by classifying themselves as pharmacies, which are given freer rein to mix drug compounds for patients.



14 arrested over meningitis drugs

 

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Lab chief faces sentencing in Michigan 12 years after fatal U.S. meningitis outbreak
Author of the article:Associated Press
Associated Press
Ed White
Published Apr 17, 2024 • 3 minute read

Streptococcus bacteria
Streptococcus species are responsible for pharyngitis, meningitis, bacterial pneumonia, endocarditis and necrotizing fasciitis.
HOWELL, Mich. — Days after a routine injection to ease back pain, Donna Kruzich and a friend drove across the border to Canada in 2012 to see end-of-summer theater in Stratford, Ontario.


The 78-year-old Michigan woman suddenly became ill and returned home. By early October, she was dead.

“Most of the time she could not communicate with us. She was basically in a coma,” son Michael Kruzich recalled. “We knew she had meningitis — but we didn’t know how she got it.”

Evidence soon emerged: Donna Kruzich was one of at least 64 people in the U.S. who died because of tainted steroids made by a specialty pharmacy in Massachusetts. Nearly 12 years later, the operator of New England Compounding Center is returning to a Michigan court Thursday for his sentence for involuntary manslaughter.

Barry Cadden already is serving a 14 1/2-year sentence for federal crimes related to the extraordinary outbreak of fungal infections, which was traced to dirty conditions inside the lab and caused meningitis and other debilitating illnesses. More than 700 people in 20 states were sickened, according to the U.S. Centers for Disease Control and Prevention.


Michigan is the only state that charged Cadden and a key employee, pharmacist Glenn Chin, in any deaths.

Cadden, 57, recently pleaded no contest to 11 counts of involuntary manslaughter in a deal that took second-degree murder charges off the table. Prosecutors also agreed to a minimum prison term of 10 years, which will run at the same time as the federal sentence.

That means he is unlikely to face additional time in custody, an outcome that disappoints Michael Kruzich.

“My mother is gone, and Cadden and Chin are responsible. My family would like to see Cadden go to trial. It feels like they’ve run out the clock and they just want it to be done,” he said, referring to state prosecutors.

Attorney General Dana Nessel said most of the 11 families supported the plea agreement.


“We’ve ensured that this plea fits their desire for closure and justice,” she said in a written statement on March 5.

Cadden’s attorney, Gerald Gleeson II, declined to comment ahead of the sentencing. In federal court in Boston in 2017, Cadden said he was sorry for the “whole range of suffering” that occurred.

Chin has not reached a similar plea deal, court filings show, and his trial on 11 second-degree murder charges is pending in the same Livingston County court, 60 miles (96.5 kilometers) northwest of Detroit. Separately, he is serving a 10 1/2-year federal sentence.

New England Compounding Center in Framingham, Massachusetts, operated in a little-known but vital corner of the U.S. health care system. Compounding pharmacies make versions of medications that often aren’t available through larger drugmakers.


Children, for example, might need a customized dose that is different than what’s common for adults.

“They’re very important,” said Eric Kastango, a pharmacist and industry expert who testified for prosecutors in Cadden’s federal trial. “I don’t think the general public is necessarily aware what pharmacists do. They know they go into a hospital and they might need an IV. They might not know who made it or how they made it.”

In 2012, New England Compounding was shipping pain-relieving steroids to doctors across the U.S., including a clinic in Brighton, Michigan, where Donna Kruzich and others received treatment. But the lab was a mess, leading to the growth of mold in the manufacturing process.

“The environment quickly spiraled out of control,” Michigan prosecutors said in a court filing last June.


Investigators “uncovered a company placing profits over human lives. Barry Cadden was the ‘big boss’ at NECC who made many of the company’s important decisions,” the state said. “He cut corners on safety.”

Crime victims can speak in court in Michigan. Michael Kruzich, 70, said he doesn’t plan to attend Thursday, although he submitted a poem on his family’s behalf.

He told The Associated Press that his mother was a “healthy, happy woman” who loved to travel and was treasurer of her golf league in the Ann Arbor area.

“I was told 12 years ago, that you cannot harm someone more than killing them,” Kruzich said in his poem. “I’ve come to disagree _ you can harm them more, when justice fails them.”

Lab chief faces sentencing in Michigan 12 years after fatal U.S. meningitis outbreak

Donna Kruzich was one of at least 64 people in the U.S. who died because of tainted steroids made by a specialty pharmacy in Massachusetts

torontosun.com