Monday, May 14, 2018

NECC Owner Denied Separate Trial


By Walter F. Roche Jr.

A bid to have a separate trial by a former part owner of a defunct drug compounding company has been denied in a brief order from a federal judge.
In the order U.S. District Judge Richard G. Stearns wrote that Gregory Conigliaro, one time vice president and part owner of the New England Compounding Center, will be tried along with nine other defendants beginning in early October.
That trial will come on the sixth anniversary of the deadly fungal meningitis outbreak caused by fungus riddled steroids shipped from NECC's Framingham, Mass. offices. Seventy six patients from 20 states died after being injected with NECC's drugs.
Conigliaro's lawyer had argued that Conigliaro, who faces a single conspiracy charge, would be unduly prejudiced by the evidence against co-dfendants facing multiple charges.
Stearns, however, concluded that instructions to jurors could avert any prejudice.
He also noted that he already has ruled that evidence of deaths and illnesses from the 2012 fungal meningitis outbreak cannot be used at the upcoming trial.
Stearns said he was confident his ruling would enable the jury to focus its attention "on the actual allegations that remain against the defendants."
He also cited the "cardinal principle" that the law favors the joint trial of defendants who are indicted together to "prevent inconsistent verdicts and to conserve judicial and prosecutorial resources."
Conigliaro was one of 14 indicted following a two year federal probe of the deadly outbreak. Two. of those defendants, Barry Cadden and Glenn Chin, are already serving lengthy prison sentences following their conviction on racketeering and conspiracy charges.
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Monday, May 7, 2018

Judge Bars Testimony on Outbreak Deaths


By Walter F. Roche Jr.

In a major setback to prosecutors, a federal judge has ruled that testimony and evidence of deaths caused in a nationwide fungal meningitis outbreak can not be used in the upcoming trial of 10 defendants linked to the company blamed for the outbreak.
In a 17-page ruling issued today in Boston, Mass., U.S. District Judge Richard G. Stearns ruled that the evidence and testimony of deaths would be highly prejudicial to the ten defendants who have not been charged with causing any of the deaths or involvement in the production of the contaminated drug that killed 76 people.
As Stearns noted prosecutors already had agreed not to present autopsy reports or elicit testimony from the next of kin of deceased victims.
Instead they said testimony would be limited to a CDC official, Dr. Benjamin Park, who played a key role in the prior trials of Barry J. Cadden and Glenn Chin. Cadden was president and part owner of the New England Compounding Center while Chin was a supervising pharmacist for the company. Both are now serving lengthy prison terms.
But Stearns ruled that even within those limitations agreed to by prosecutors, the effect would be highly prejudicial.
"I am convinced that the proposed evidence of patients' deaths and injuries entails a substantial risk that jurors will decide the case 'on an improper basis rather than on the evidence presented," Stearns wrote.
In the decision Stearns struck down one by one the series of arguments put forward by Assistant U.S. Attorneys Amanda Strachan and George Varghese.
He faulted prosecutors for failing to distinguish between two separate racketeering enterprises alleged in the original 2014 indictment. One, he wrote, involved murder and grievous injury, while the other did not. In addition he noted that both Cadden and Chin were cleared by separate juries of the murder/racketeering charges.
Stearns also rejected the argument by prosecutors that evidence of the deaths was necessary as a scene-setting device.
"The need for this information is slight and the liklihood of misuse is great," Stearns wrote.
Calling one argument of prosecutors "unfathomable," Stearns noted that Park's testimony in the Cadden and Chin trials was particularly detailed.
Park, he wrote "is a convincing witness and by all accounts one of the true heroes that emerges in the tragic story of the
response to the fungal meningitis outbreak."
While acknowledging that some of Park's testimony would be relevant to the charges against the remaining defendants, Stearns said, "the evidentiary shards are impossible to isolate from his more dramatic description of mass-scale injury and death related to the the tainted methylpredniolone acetate."
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Monday, April 30, 2018

Judge Defers Action on Patient Harm Evidence


A federal judge has taken under advisement arguments over whether prosecutors can present evidence of patient harm in the upcoming trial of the nine remaining defendants indicted following a federal probe of a deadly fungal meningitis outbreak.
U.S. District Judge Richard G. Stearns heard arguments Monday in his Boston, Mass. courtroom from lawyers for the defendants and federal prosecutors.
Prosecutors have stated that evidence of patient harm is essential to prove their case against defendants, including Gregory Conigliaro, who was Vice President and part owner of the New England Compounding Center, the company blamed for the outbreak that took the lives of at least 76 patients across the country. NECC shipped thousands of vials of fungus tainted methylprednisolone acetate to health care providers across the country.
Lawyers for Conigliaro and the eight other defendants have argued that they had nothing to do with the production of the methylprednisolone acetate and evidence related to illnesses and deaths caused by the steroid would be highly prejudicial.
Prosecutors, Assistant U.S. Attorneys Amanda Strachan and George Varghese, have stated that they do not intend to seek testimony from relatives of the deceased victims or to present autopsy reports on outbreak victims.
That victim testimony was key in the recent trials of NECC President Barry Cadden and supervising pharmacist Glenn Chin. Both were found guilty of racketeering, conspiracy and mail fraud. Both are serving lengthy prison terms in federal prisons in Pennsylvania.
All of the defendants were employed by NECC or a sales affiliate.
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Tuesday, April 24, 2018

Judge Sets Hearing on Patient Harm


By Walter F. Roche Jr.

A federal judge has set a hearing for next week on a key issue in the upcoming trial of the nine remaining defendants indicted in the federal probe of a deadly fungal meningitis outbreak.
U.S. District Judge Richard G. Stearns has agreed to hold a hearing Tuesday in his Boston, Mass. courtroom on the issue of whether or not prosecutors can present evidence of harm caused to patients as a result of the 2012 outbreak caused by fungus riddled drugs produced by the now defunct New England Compounding Center.
Lawyers for the defendants have argued that presenting evidence of patient harm would be highly prejudicial.
They also have stated that their clients had nothing to do with the production of contaminated methylprednisolone acetate causing the deaths of some 76 patients around the country. Those victims were among nearly 800 sickened by contaminated NECC drugs.
In their motion the attorneys stated that their clients did not "have any responsibility whatsoever for any methylprednisolone related act or omission that caused harm to patients."
Assistant U.S. Attorneys Amanda Strachan and George Varghese have asked Stearns to reject the request to bar evidence of patient harm.
They argued that the evidence was "direct and intrinsic" and necessary to show the existence of a conspiracy. They also noted that they already have agreed not to call victims as witnesses or to present autopsy reports on the victims who died.
Also pending before Stearns are motions from three of the defendants seeking separate trials. Currently all nine are slated to go on trial on Oct. 2.
The nine defendants were among 14 indicted by a federal grand jury in late 2014. Two, Barry Cadden and Glenn Chin, are already serving lengthy prison sentences.
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Friday, April 20, 2018

FDA Gets Injunction vs. Compounder

Federal judge enters consent decree against
Cantrell Drug Company
U.S. District Judge Kristine G. Baker for the Eastern District of Arkansas entered a consent decree of permanent injunction between the U.S. and Cantrell Drug Company of Little Rock, Arkansas, and the company’s Chief Executive Officer and co-owner, James L. McCarley, Jr.

The consent decree prohibits Cantrell and McCarley from manufacturing, processing, packing, holding, or distributing drugs until they comply with the Federal Food, Drug, and Cosmetic Act (FD&C Act) and FDA regulations, in addition to other requirements.

“As a public health agency, the FDA is committed to fully implementing the Drug Quality and Security Act for compounded drugs set forth by Congress that helps ensure compounded drugs are made under appropriate production standards,” said FDA Commissioner Scott Gottlieb, M.D. “We’ll continue to take action against compounders who produce drugs under substandard conditions and put the health of patients at risk."

The complaint filed with the consent decree alleges that Cantrell manufactured and distributed purportedly sterile drug products, such as injectable opioids and antibiotics, that were adulterated under the FD&C Act because the drugs were made under insanitary conditions and in violation of current good manufacturing practice (CGMP) requirements. Drugs that are prepared, packed or held under insanitary conditions whereby they may have become contaminated with filth or rendered injurious to health are adulterated under the FD&C Act.

The consent decree requires Cantrell to cease operations until it completes corrective actions, including hiring a qualified independent expert to inspect its facility to ensure the company is complying with the FD&C Act and CGMP requirements. Under the consent decree, Cantrell cannot resume operations until it receives authorization from the FDA.

Cantrell is registered as an outsourcing facility under section 503B of the FD&C Act. The Drug Quality and Security Act, signed into law on Nov. 27, 2013, added a new section -- 503B – to the FD&C Act. Under section 503B, a compounder can elect to register as an outsourcing facility. Outsourcing facilities must comply with CGMP requirements, are inspected by the FDA according to a risk-based schedule and must meet certain other conditions, such as reporting adverse events and providing the FDA with certain information about the products they compound.

The complaint was filed by the U.S. Department of Justice on behalf of the FDA.

For more information, please visit: Cantrell Drug Company Consent Decree.

Thursday, April 19, 2018

Chin to Appeal, Seeks New Lawyer


By Walter F. Roche Jr.

A former pharmacist convicted of racketeering and mail fraud charges has filed notice of appeal and wants the government to pay for a new lawyer to represent him in that effort.
Glenn Chin, 49, filed the notices today in U.S. District Court in Boston, Mass. He is already serving an eight year sentence at a federal prison in Pennsylvania.
In a related development federal prosecutors filed an 11-page brief opposing the move by a codefendant to have his trial severed from eight other codefendants.
Chin and 13 others were indicted in late 2014 following a two year probe of the 2012 fungal meningitis outbreak which took the lives of at least 76 patients in 20 states. All 14 defendants were affiliated were affiliated with the now defunct New England Compounding Center and and a relate sales company. NECC caused the outbreak by distributing fungus riddled drugs to health providers.
Chin's notice states that he plans to appeal his guilty verdict, the sentence imposed and a forfeiture order imposed by U.S. District Judge Richard G. Stearns.
Chin, who has been represented by Stephen Weymouth, also said he is seeking a new government-paid lawyer to represent him.
The government motion filed today opposes a motion by former NECC Vice President Gregory Conigliaro to have his upcoming trial separated from the other eight remaining defendants. Conigliaro is charged with conspiring to defraud the U.S. Food and Drug Administration by falsely claiming that NECC was operating as a state regulated pharmacy and not a drug manufacturer under FDA jurisdiction.
Federal prosecutors George Varghese and Amanda Strachan wrote that severance was not warranted. While Conigliaro is not charged in as many counts as the others he is "not less culpable than his codefendants," the filing states.
They also denied that any so-called "prejudicial spillover" would occur because of evidence applying to the other defendants (but not Conigliario) could easily be avoided by instructions to jurors by the presiding judge.
Conigliaro's conduct "is inextricably intertwined with NECC's fraudulent drug production," the filing states.
They argued that jurors could discern the differences between the charges against Conigliaro versus the other defendants.
"This is what jurors do in this courthouse every day," they wrote.
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Monday, April 16, 2018

Two NECC Defendants Seek Separate Trial


By Walter F. Roche Jr.

Two of the nine remaining defendants in a criminal case stemming from a deadly fungal meningitis outbreak are asking the presiding judge to either exclude major pieces of evidence or grant them a trial separate from the remaining defendants who are facing more serious charges.
In a nine-page filing today lawyers for Kathy Chin and Michelle Thomas, said the evidence prosecutors plan to present against the seven other defendants would be highly prejudicial.
The evidence in question relates to the deaths and injuries caused by fungus riddled steroid drugs produced by the New England Compounding Center, the now defunct company that employed Chin and Thomas.
The two were among 14 persons connected to NECC who were indicted in late 2014 following a two year probe of the 2012 fungal meningitis outbreak. Some 76 patients died among nearly 800 who were sickened after being injected with fungus laden methylprednisolone acetate shipped from NECC's facility in Framingham, Mass.
In their filing today, attorneys Michael Bourbeau and Joan Griffin, wrote that the evidence in question "has no relevance whatsoever" to the charges against" their respective clients.
Thomas and Chin, the filing states, had nothing to do with the clean room where the tainted drugs were produced.
The two face charges of misbranding drugs, while the others face racketeering and conspiracy among other charges.
"It will be difficult if not impossible for the jury to make a reliable judgment," the motion states, citing the prospect of confusion among the jurors.
Chin is the wife of Glenn Chin who was a supervising pharmacist at NECC. Chin was convicted on racketeering and conspiracy charges and is currently serving an eight sentence at a federal prison in Pennsylvania. He was in charge of the clean room where the tainted drugs were manufactured.
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