Drug Induced Meningitis (DIAM)  Steroids  Drug deaths

14 Arrested In Deadly Meningitis Outbreak Linked To Framingham Pharmacy

December 17, 2014 1:42 PM

http://boston.cbslocal.com/2014/12/17/necc-owner-employees-arrested-in-deadly-meningitis-outbreak/

BOSTON (CBS/AP) – Fourteen people were arrested and charged Wednesday for their alleged roles at the Framingham pharmacy blamed for a deadly national meningitis outbreak.

Read: The NECC Indictment (.pdf)

The two co-founders of the New England Compounding Center, Barry Cadden and Greg Conigliaro, and 12 other former employees were arrested at their homes around the state early this morning.

Tainted steroids manufactured by the pharmacy were blamed for a 2012 outbreak that killed 64 people. About 750 people in 20 states developed meningitis or other infections after receiving the contaminated steroids. Michigan, Tennessee and Indiana were the hardest-hit states.

Cadden and Glenn Adam Chin, a pharmacist who was in charge of NECC’s sterile room, are charged with racketeering for allegedly causing the deaths of patients who received tainted steroids manufactured by the company.

Both are accused in a federal indictment of “acting in wanton and willful disregard of the likelihood ” that their actions would cause death or great bodily harm, officials said.

Chin’s lawyer, Stephen Weymouth, said he was stunned that prosecutors charged his client with second-degree murder under the federal racketeering law and that they allege that he and Cadden caused the death of patients.

“He feels hugely remorseful for everything that’s happened — for the injuries and the deaths — but he never intended to cause harm to anybody,” Weymouth said. “It seems to be a bit of an overreach.”

The others face charges ranging from mail fraud to the introduction of adulterated and misbranded drugs into interstate commerce.

Prosecutors say NECC’s primary business was “high-risk compounding” and Cadden allegedly instructed his sales team to “falsely represent to customers that NECC was providing the highest-quality compounded medications.

“The physicians and patients were not notified of the potential risk of using the untested drugs,” prosecutors wrote in the indictment, adding that NECC’s conduct was reasonably “certain to cause death and unlawfully killed the individuals.”

The indictment cites several examples of fake names listed on prescriptions, such as “Big Baby Jesus,” “Wonder Woman,” “Jennifer Lopez,” “Michael Jackson,” “Diana Ross,” and many more.

Several law enforcement vehicles were seen leaving Cadden’s Wrentham estate before sunrise.

Conigliaro was taken into custody at his home in Southborough, according to WBZ-TV’s Lauren Leamanczyk.  He was booked at the Southborough police station.

All those arrested were expected to make an initial court appearance later Wednesday.

“Every patient receiving medical treatment deserves the peace of mind and knowledge that the medicine they’re receiving is safe. When people in companies break that trust and break the law through conduct as alleged in the indictment we are announcing today, the consequences to patients and their families can be catastrophic,” said acting Assistant Attorney General Stuart Delery during a Wednesday press conference.

U.S. Attorney Carmen Ortiz called the case an “unprecedented national tragedy.”

Ortiz said production and profit were prioritized over safety. According to the U.S. Attorney, “clean rooms” where the drugs were manufactured failed to comply with the “most basic health standard.”

Logs that were intended to show when the room was cleaned and disinfected were falsified, Ortiz said.

Officials, including U.S. Attorney Carmen Ortiz at center, address the NECC indictments. (WBZ-TV)

“Senior NECC pharmacists knew that, despite the filthy conditions at NECC, the drugs they made were not properly tested for sterility. They knew that the drugs that eventually killed 64 people and injured hundreds more could not be and should not have been injected into patients,” Ortiz said.

“And yet they continued to make and sell those drugs, label them as injectable, which meant that they were sterile, and dispense them throughout the country.”

Assistant Attorney General for the Civil Division Joyce Branda said the NECC is unprecedented.

“The indictment is only a step. It’s the next step in a process that began two years ago when dedicated public health officials across the country identified and stopped a deadly outbreak unlike anyone had ever seen. Those heroes saved countless lives,” said Branda.

“Now it’s our turn. Our turn to enforce the law, to hold accountable those charged with recklessly causing the loss of life, as well as those who put others at risk, and to do our part to make sure that this never happens again.”

The press conference was paused for several minutes after a woman appeared to faint near the podium while Ortiz was speaking. The woman was taken out of the room and the press conference continued.

Fungus inside a test tube that was grown from the spinal fluid of a patient. (Image credit: 60 Minutes)

NECC is being investigated as the manufacturer of steroid shots contaminated with black mold that were distributed to medical facilities in at least 23 states exposing thousands of patients to fungal meningitis in the fall of 2012.

The pharmacy ceased operations and surrendered its license to the Massachusetts Board of Registration in Pharmacy on October 3, 2012.

NECC was founded in 1998 by brothers-in-law Cadden and Conigliaro.

It filed for bankruptcy protection after it was flooded with hundreds of lawsuits filed by victims and their families.

Cadden was called before Congress in November 2012 and refused to testify, exercising his Fifth Amendment rights.