Judge Moves Meningitis Cases Forward

By Walter F. Roche Jr.

A federal judge helping oversee more than 200 lawsuits filed by victims of a 2012 nationwide fungal meningitis outbreak has issued a series or orders setting a schedule that could move the massive litigation to a quicker conclusion.
The orders issued by U.S. Magistrate Judge Jennifer C. Boal clear the way for victims' lawyers to begin collecting evidence and taking testimony from defendants in the case.
"We're very happy with this," said Nashville, Tenn. attorney Gerard Stranch. "This is what we've wanted for a long time."
Boal issued the orders Thursday in Boston, Mass. following a hearing on the cases which have been consolidated under U.S. District Judge Rya Zobel. Zobel had referred the scheduling issue to Boal.
Stranch said the order means that the defendants in the cases, including the Saint Thomas Outpatient Neurosurgical Center in Nashville, will have to respond to subpoenas for records. Clinic officials will also be required to answer questions under oath in a series of depositions.
Stranch said the plaintiffs in the case also will have to produce new information including profiles of the patients making the claims.
Those profiles will not be required, however, for victims whose cases are involved in a mediation process.
Chris Tardio, one of the lawyers representing the Saint Thomas outpatient center, said he too was pleased with the Boal order, which he added included many provisions they had requested.
 "We are looking forward to demonstrating that, in the setting of complete abandonment of oversight by the U.S. Food and Drug Administration and Massachusetts Board of Pharmacy, our clients had no reason to foresee the Massachusetts pharmacy would send us contaminated medication despite assuring us they followed proper safety procedures."

Another filing in the case by attorneys for the plaintiffs shows that of the 212 cases now before Zobel, 118 were filed in behalf of Tennessee patients. Ninety-one of the cases involve patients of the Saint Thomas outpatient center, while the remaining 27 were treated at two clinics.
Other cases include 39 from Virginia, seven from Ohio and four from California.  Two of those California claims were filed by patients of an Encino outpatient facility. Twenty-three claims have been filed in behalf of New Jersey patients, but 13 of that total are involved in mediation.
Only six suits before Zobel come from Michigan patients, but dozens of others remain in state courts.
Michigan had the most victims, according to data compiled by the U.S. Centers for Disease Control and Prevention.
According to the CDC, 751 patients were sickened in the outbreak, while 64 died. There were 264 victims in Michigan with 19 deaths, while Tennessee reported 153 sickened and 16 dead. Virginia had 54 sickened and five dead while New Jersey listed 51 sickened but no deaths.
Lawyers involved in the case predict that actual trials are not likely to take place until 2016, nearly four years after the outbreak was discovered.

Drug Compounding Probe "Active and Ongoing"

By Walter F. Roche Jr.

The chief federal prosecutor in a probe of a deadly fungal meningitis outbreak has written to victims across the country assuring them that the investigation is "very active and ongoing" and a recent arrest does not signal the end of the inquiry.

U.S. Attorney Carmen M. Ortiz signed the Sept. 8 two page letter sent to the victims, including Joan Peay, a Nashville resident who has suffered two bouts of fungal meningitis.

Peay received the Ortiz letter Thursday, the same day Glenn A. Chin, 46, was arraigned in U.S. District Court in Boston on a mail fraud charge. Chin, who entered a not guilty plea and was released on bond, was a supervising pharmacist for the now shuttered New England Compounding Center, the firm blamed for the 2012 outbreak that killed 64 patients and sickened 751.

In the letter, Ortiz wrote that Chin's arrest came because federal officials learned of his plans leave the country. The suburban Boston resident was arrested at Logan International Airport as he was preparing to board a flight to China.

"The federal criminal investigation of Mr. Chin and others remains very active ongoing," Ortiz stated in the letter, adding that the arrest "does not signify the end of the investigation."

In a five-page indictment filed earlier this week, a grand jury charged that Chin not only personally compounded tainted steroids, but supervised others who he instructed to certify that the drugs were sterile and fit for injection into patients.

State and federal officials eventually concluded thousands of vials of the NECC steroids were tainted with fungus due to unsanitary conditions at its Massachusetts facility, where Chin was in charge of sterility.

The letter also notified victims that they can  monitor the progress in the case on-line or by phone by utilizing a unique sign-on and password to a victims service center.

Peay said she was pleased to learn that the investigation is continuing and that she already had signed up to get continuing updates..

Peay was administered doses of the steroid, methylprednisolone acetate, at the Saint Thomas Outpatient Neurosurgical Center. She has been hospitalized on multiple occasions for the fungal meningitis she subsequently contracted.

Formal Indictment in Drug Compounding Case Gives New Details, Not Guilty Plea Entered

UPDATE: Glenn A. Chin entered a not guilty plea Thursday in a one count indictment charging him with mail fraud.

By Walter F. Roche Jr.
A formal one count indictment was issued today by a federal grand jury in Boston giving new details on the charges being leveled against a supervising pharmacist for the firm blamed for a nationwide fungal meningitis outbreak.
The five-page indictment spells out the charges against Glenn A. Chin, 46, who was in charge of maintaining sterility in special clean rooms at the New England Compounding Center, the now defunct firm blamed for the fatal outbreak.
The indictment states that Chin engaged in a scheme to defraud NECC's customers to enrich himself and NECC "by selling for a profit preservative free methylprednisolone acetate labeled as injectable."
Chin, the indictment states, failed to properly clean and maintain and oversee proper cleaning and maintenance of the NECC clean room.
He was charged with one count of mail fraud.
Chin was arrested last week as he was preparing to board a plane headed to China.  He had been scheduled to appear tomorrow at a show cause hearing on the original arrest warrant, but that session has now been canceled. Instead Chin will be formally arraigned on the grand jury charges in a 10 a.m. hearing.
According to the indictment, Chin was first employed as a pharmacist at NECC in 2004 and was promoted to a supervisory position in January of 2010.
In the new post, the court filing states, Chin was "overseeing all aspects of NECC's clean room."
The 2012 outbreak caused some 751 patients across the country to be sickened. Sixty-four died including 19 in Michigan, 16 in Tennessee  and 11 in Indiana.
The indictment states that in addition to personally compounding a lot of the fungus tainted drugs, Chin "instructed pharmacy technicians to fraudulently complete cleaning logs...purporting to show that the NECC clean room was properly cleaned and maintained."

Pharmacist Charged in Meningitis Outbreak Files Emergency Motion

By Walter F. Roche Jr.
Lawyers for the pharmacist charged in the 2012 fatal fungal meningitis outbreak have filed an emergency motion to force a federal agent to appear at a show cause hearing later this week.
The motion filed Monday in U.S. District Court in Boston seeks an order compelling Food and Drug Administration Special Agent Benedict Celso to appear at the hearing scheduled for Thursday.
It was Celso's affidavit that led to last week's arrest of Glenn A. Chin, 46, the supervising pharmacist for the now defunct New England Compounding Center.
The Framingham, Mass. firm has been blamed by state and federal officials for the fungal meningitis outbreak that sickened more than 750 patients and killed at least 64.
In the motion filed, Paul W. Shaw, one of Chin's lawyers said Celso was "a necessary and material witness" for the hearing.
He wrote that because of the short time frame, they were unable to comply with the usual requirements for issuing a subpoena to an FDA employee.
The motion states that Celso's presence is necessary because of the "various conclusionary assertions made in the affidavit."
In the affidavit made public last week, Celso charged that Chin was personally responsible for overseeing the production of a spinal steroid that was tainted with fungus and led to the deaths and illnesses recorded during the outbreak.
Chin was charged with a single count of mail fraud for his role in the shipping of the drugs and the certification that the drugs met federal purity and sterility standards.
Chin was arrested last week at Boston's Logan International Airport as he was preparing to board a plane for China.

First Arrest In Drug Compounding Probe

By Walter F. Roche Jr.

Federal authorities have made the first arrest in the probe of the Massachusetts drug compounding firm blamed for the deaths of at least 64 patients.
Arrested at Boston's Logan International Airport Thursday was Glenn A. Chin, 46, one of the pharmacists who worked at the New England Compounding Center, the now shuttered drug compounding firm blamed for the deaths and illnesses suffered by over 750 patients. The record breaking outbreak of fungal meningitis became public in September of 2012.
Chin a resident of Canton, a Boston suburb, was charged with one count of mail fraud. Federal officials said they made the arrest when they learned Chin was trying to flee the country.
An affidavit filed by a federal agent in the Chin case states that the number of victims is actually higher than the the official count issued nearly a year ago by the federal Centers for Disease Control and Prevention.
Noting that the CDC stopped revising its count in 2013, U.S. Food and Drug Administration Special Agent Benedict Celso wrote in a footnote that based on his personal knowledge, "the total number of patients (sickened) has continued to increase as have the total number of patients who have died."
The affidavit specifically cites multiple cases of victims in Michigan and Tennessee. Six Tennessee victims are mentioned while 217 patients at a Michigan clinic were stricken.
According to the complaint Chin caused contaminated vials of a spinal steroid, methylprednisolone acetate, to be issued and shipped in interstate commerce with the certification that it was injectable, when in fact, it was contaminated with a lethal fungus.
According to the complaint and a U.S. Justice Department press release, Chin was a supervising pharmacist for NECC.
The affidavit states that Chin supervised four other pharmacists who performed sterile drug compounding and that he was personally involved in preparing some of the vials of steroids later injected into unsuspecting patients.
He also supervised technicians and staffers and instructed them "to mislabel medication" and to "fraudulently complete cleaning logs."
The affidavit states that Chin was responsible for labels stating the steroids were injectable, "meaning that the medication was sterile and fit for human use."
The affidavit states that among the unsafe practices Chin oversaw were "improper sterilization and improper testing of supposedly sterile medication."
There have been recent indications that the lengthy federal probe was stepping up as FBI agents questioned some of the victims of the nationwide outbreak. Those victims included Joan Peay of Nashville who was sickened in the initial outbreak and suffered a lengthy relapse a year later.
Peay said she was glad to learn of Chin's arrest and added that she hoped federal authorities are also keeping a close eye on other NECC officials.
If convicted on the charge, Chin could face a jail term of up to 20 years and a fine of up to $250,000. He was arraigned Thursday in U.S. District Court in Boston and will remain under home confinement pending further court action.