BOSTON — Two senior executives of a Massachusetts compounding pharmacy were charged Wednesday with racketeering and murder in the production of tainted drugs that killed 64 people and sickened hundreds of others across the country with fungal
meningitis in the fall of 2012.
The United States attorney’s office here charged Barry J. Cadden, an owner of New England Compounding Center Inc. and the head pharmacist, and Glenn A. Chin, a supervisory pharmacist, with 25 acts of second-degree murder in seven states — Florida, Indiana, Maryland, Michigan, North Carolina, Tennessee and Virginia.
“Senior N.E.C.C. pharmacists knew that, despite the filthy conditions at N.E.C.C., the drugs that they made were not property tested for sterility,” said Carmen Ortiz, the United States attorney for Massachusetts.
In all, 14 people were charged in a 131-count indictment, many of them pharmacists at the company, which is now closed. The charges include mail fraud, conspiracy and violation of the Food, Drug and Cosmetic Act. Most were taken into custody at their homes early Wednesday, officials said.
Barry Cadden, an owner of the New England Compounding Center, in 2012. Credit Susan Walsh/Associated Press
Among those accused were members of the Conigliaro family of Massachusetts — Gregory, Douglas and Carla. The family founded the company in 1998 as part of a broader business organization that included a recycling firm.
Carla and Douglas Conigliaro, a husband and wife, were accused of transferring $33 million in assets to eight different bank accounts after the pharmacy went into bankruptcy and a court ordered all assets frozen. The couple pleaded not guilty.
David Meier, a lawyer for the couple, said his clients had done nothing wrong. “To the extent that there were transfers, they were all legal,” he said.
Only Mr. Cadden and Mr. Chin were charged with murder. Homicides are normally a matter of state jurisdiction, but the federal government can bring murder charges as part of a racketeering case. Both men appeared in federal court on Wednesday. Each could face a maximum sentence of life in prison.
The charges opened a new chapter in the case against the pharmacy, whose contaminated medicine caused a national uproar in 2012 and prompted new legislation governing compounding pharmacies, which make specialized formulations of drugs for patients with particular needs. Over the years, such companies had grown into mass manufacturers distributing medicine all over the country, virtually unregulated by the federal government.
Legal experts said the charges were sweeping, and showed an effort on the part of prosecutors to portray executives’ actions as a broader pattern of criminal fraud that went beyond routine regulatory violations.
“These are very serious charges,” said Daniel C. Richman, a law professor at Columbia University.
“It certainly is a dramatic move to label what was happening as fraud and tie that to murder, instead of casting it as regulatory violations. That frames the misconduct in stark criminal terms.”
The federal prosecutor’s office said in a statement that the murder charges do not require them to prove that Mr. Cadden and Mr. Chin “had specific intent to kill,” just that they had “acted with extreme indifference to human life.”
Photo Glenn Adam Chin, the former head pharmacist at the New England Compounding Center, in September. Mr. Chin and Mr. Cadden are both accused of racketeering and second-degree murder in seven states. Credit Steven Senne/Associated Press
Mr. Cadden and Mr. Chin “were aware that doctors would inject M.P.A. into their patients’ bodies, and that if the M.P.A. was not in fact sterile, it could kill them.” M.P.A. is an abbreviation for methylprednisolone acetate, the statement said.
Stephen Weymouth, the lawyer for Mr. Chin, said, “I think this is overreach on the part of the government.” He said his client “feels so remorseful for what’s happened, all the deaths that resulted and all the people that were injured.”
He added: “I know for a fact that he didn’t do anything intentional to harm anyone.”
In an email, Bruce Singal, a lawyer for Mr. Cadden, said the deaths resulting from the tainted drugs were tragic, but suggested they were not the result of criminal activity.
“To this day, we do not know how the particular vials of drugs that triggered this tragedy got contaminated,” Mr. Singal said, adding: “We do not know why they got contaminated. And we do not know who caused their contamination. Not every accident, and not every tragedy, are caused by criminal conduct.”
The racketeering counts describe a pattern of reckless and unsafe manufacturing practices, casting them as a criminal enterprise that led to dozens of deaths. Prosecutors said the company devised a scheme “to obtain money and property by means of materially false and fraudulent pretenses, representations and promises.” Essentially, the government contends that company executives and staff produced medicine — an injectable
steroid — in unsanitary conditions and knowingly sold it even though it posed a risk to patients.
According to the indictment, employees and managers mislabeled batches of the medication even though it had expired or had never been tested, and then shipped it to customers.
The company consistently failed cleanliness tests, the indictment says. In 2012, sampling results of bacteria and mold were found in the air and on surfaces, including on employees’ hands, but nothing was done. It said “action-level” samples were found in 37 out of 38 weeks of testing in 2012.
The indictment said Mr. Chin instructed his technicians to “prioritize production over cleaning and inspecting” and that he instructed them to “fraudulently complete cleaning logs.”
http://www.nytimes.com/2014/12/18/us/new-england-compounding-center-steroid-meningitis-arrests.html?_r=0
Prosecutors must show pattern and intent, analysts say
Jim Davis/Globe Staff
Gregory Conigliaro, an owner of the New England Compounding Center, was among 14 employees of the company who were arrested Wednesday.
Pharmacist was on way to Hong Kong; charged with count of federal mail fraud
By Evan Allen , Milton J. Valencia and Liz Kowalczyk Globe Staff September 04, 2014
A pharmacist from the Massachusetts company linked to tainted drugs that killed 64 people was arrested Thursday as he prepared to leave the country, becoming the first person to be criminally charged in an ongoing federal investigation.
Glenn Adam Chin, 46, who prosecutors allege supervised the preparation of fatally contaminated medicine at now-bankrupt New England Compounding Center, was taken into custody at Logan Airport, where he had a ticket to Hong Kong.
It was the latest turn in a medical scandal that left hundreds of patients sickened, made headlines nationwide, and sparked hundreds of civil lawsuits.
“I am so mad about this, because this could have been prevented,” said Anna Adair, 51, who developed an infection in her spine caused by black mold after receiving contaminated injections at Michigan Pain Specialists. Adair said she was upset about the possibility that Chin was trying to flee the country to avoid responsibility for any role he had in the outbreak.
“If this guy only knew all the people who died and the pain we went through, he wouldn’t leave the country. He would stand up and say, ‘I am sorry about it,’ and not try to run and hide.”
Chin, who lives in Canton, pleaded not guilty to a single count of mail fraud Thursday, was released on $50,000 unsecured bond, and is under house arrest. He agreed to surrender his passport and must wear an electronic monitoring bracelet.
His attorney, Paul Shaw, scoffed at the implication that his client was fleeing, saying Chin was headed to a family wedding with his 66-year-old mother, his wife, and his young children. He called Chin’s airport arrest a ploy by prosecutors for media attention.
“It was orchestrated by the government to have all this,” he said during the hearing.
Shaw said Chin had round-trip tickets purchased ahead of time, which the government knew about. Chin was never told he was under investigation, said Shaw, nor was he interviewed.
Prosecutors said if convicted, Chin faces up to 20 years in prison and a $250,000 fine.
Assistant US Attorney George Varghese said his office could not take the risk that Chin would leave the country and not return.
The US attorney’s office and the Justice Department’s consumer protection branch have been investigating New England Compounding since a nationwide fungal meningitis outbreak began in fall 2012. Prosecutors said 751 patients fell ill after receiving contaminated medicine, and 64 of them died.
“These people have suffered tremendously,” said Kim Dougherty, managing attorney in the
Boston office of Janet, Jenner & Suggs LLC, who represents about 100 victims.
Several clients, she said, have lost relatives, and others have lost livelihoods. People once physically active now use wheelchairs; store owners were forced to sell their businesses.
The first criminal charge in the investigation reassured her clients the government is taking the case seriously, she said.
“It was a bit of a relief, a sign that things are moving forward and the government is still doing this investigation, and in all likelihood, will be indicting the people who are responsible for all the deaths and the illnesses,” Dougherty said.
A US attorney’s office spokeswoman declined to say whether more charges were expected, saying only that the criminal investigation is ongoing.
Attorneys associated with the Framingham pharmacy did not respond to requests for comment
Thursday.
According to the criminal complaint filed by Benedict Celso, a special agent for the Food and Drug Administration, Chin supervised four pharmacists and 10 pharmacy technicians in so-called clean rooms, and was personally responsible for compounding steroid stock solutions.
“During the course of this investigation, I have learned of numerous unsafe practices employed by Chin at NECC while producing supposedly sterile medication,’’ Celso wrote. “These unsafe practices included improper sterilization and improper testing of supposedly sterile medication. Moreover, to conceal these unsafe practices, Chin instructed pharmacy technicians to mislabel medication to indicate it was properly sterilized and tested.’’
Chin was in charge on June 29, 2012, when one batch of methylprednisolone acetate was made. Chin, the federal complaint alleges, “directed that filled vials be sent out of the clean room for shipment to NECC customers.’’
On Aug. 7, 2012, Michigan Pain Specialists in Brighton, Mich., ordered 400 vials of the material, the complaint alleged. New England Compounding sent the requested vials, each of which included the abbreviation for “injectable’’ on the label, indicating the medicine “was sterile and fit for human use,” the complaint said.
Over the next two months, doctors at the Michigan clinic injected 625 patients with the compound, the complaint alleges. After receiving the injections, 217 patients contracted fungal infections; fifteen of them died, according to the complaint.
After the hearing, Chin’s attorney called the allegations in the complaint “absolute nonsense.”
He said he did not dispute that the contaminated medication was compounded on Chin’s watch, but said officials have never determined the cause of the contamination.
“Until the government can tell you what the cause of the contamination was, it was hard to say it was under Mr. Chin,” Shaw said. “Once the vials left that clean room, and then were shipped, it was no longer under his responsibility.”
Adair received injections of the compound that were shipped to Michigan in summer and fall 2012.
By October, she was in too much pain to walk. She spent 41 days in the hospital receiving antifungal treatment, and while she feels better almost two years later, she has lingering symptoms.
Lower-back pain radiating down her legs makes it difficult to walk or bend down to tend her beloved flower and vegetable gardens.
“I don’t do what I want to do anymore,” she said.
http://www.bostonglobe.com/metro/2014/09/04/feds-make-arrest-logan-compounding-pharmacy-case/rajkImPf9WVZxS73XYBw2H/story.html
No comments:
Post a Comment