Defendants Seek Ban on Patient Harm Testimony

By Walter F. Roche Jr.

Citing the risk of unfair prejudice, nine remaining defendants in the deadly fungal meningitis criminal case are asking a federal judge to bar the use of any evidence of harm caused to victims of the 2012 outbreak which sickened nearly 800 patients, killing 76 of them.
In a joint motion filed today in U.S. District Court in Boston, Mass., lawyers for the defendants said their clients have not been charged with playing any role in the production of the fungus laden steroids that caused the deadly outbreak. Therefore such evidence is irrelevant and would be a waste of the jury's time, the motion states.
In a separate motion, Gregory Conigliaro, who was a vice president and part owner of the company that produced the tainted steroids, asked U.S. District Judge Richard G. Stearns to allow his lawyers to file a secret motion to sever his trial from the other remaining defendants.
"Mr. Conigliaro submits that it is not appropriate for the other defendants, nor the general public, to have access to Mr. Conigliaro's description of those antagonistic defenses," his motion states.
Conigliaro and the other eight are scheduled for trial in September. They were among 14 indicted following a two year probe of the outbreak caused by fungus ridden methylprednisolone acetate produced at the now defunct New England Compounding Center in Framingham, Mass.,
Two of those defendants, Barry J. Cadden and Glenn A. Chin, are now serving lengthy prison sentences following their conviction on racketeering, mail fraud and other related charges.
The motion to exclude evidence cites the fact that in the Cadden and Chin trials Stearns limited the testimony and evidence of patient harm. That was so even though they were both charged with second degree murder in the deaths of some outbreak victims. Both were ultimately cleared of the murder charges.
The remaining defendants were not alleged to "have any responsibility whatsoever for any methylprednisolone related act or omission that caused harm to patients," the motion states, adding, "They are not charged with killing or injuring anyone."
"Such evidence would be even more prejudicial here," the motion states, citing the "risk of seriously confusing the issues."
"This trial will be lengthy and complex as it is and there is no need to prolong or taint it through the introducton of unfairly prejudicial evidence which is irrelevant to the facts at hand," the motion concludes.
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Judge Sets Strict Limit on Outbreak Restitution

By Walter F. Roche Jr.

Stating that federal law leaves him no choice, a federal judge has set strict limits on the amount of restitution a convicted former pharmacist can be forced to pay.
In a nine-page ruling issued today U.S. District Court Judge Richard G. Stearns sitting in Boston, Mass. rejected a request by federal prosecutors to order Glenn Chin to pay some $82 million which could have gone to hundreds of  patients who were sickened by drugs produced under Chin's supervision at the New England Compounding Center..
Though he put off setting an exact amount of restitution, Stearns wrote that "reality casts a cold light" on the government's $82 million request.
Chin was convicted on racketeering and mail fraud charges for his role in the 2012 fungal meningitis outbreak which took the lives of 76 patients in addition to the more than 700 who were sickened.
In his decision Stearns said the federal law sets a strict definition on those that can be considered victims under federal law.
"Under the law, as I must apply it, the direct victims of the mail fraud crimes were the medical facilities who purchased drugs from NECC," Stearns wrote.
Adding that he did not in any way suggest that the patients injected with NECC's tainted drugs were not victims of the terrible tragedy spawned by NECC, Stearns wrote that NECC "made no representations to end users and patients."
The judge also expressed concern for Chin stating that he and his family were destitute and the one time supervising pharmacist already has been hit with a $175,000 forfeiture order.
In a footnote to his decision, Stearns said that while it was not a factor in his decision, the patients/victims had a more realistic chance of obtaining compensation from the settlement of NECC's bankruptcy and  civil suits against health providers.
Stearns stated that setting the final amount of restitution cannot be computed until the remaining NECC defendants go to trial, now set for Oct. 2.
In the ruling Stearns said his decision on Chin would not be binding on co-defendant Barry Cadden, but he agreed with prosecutors that some legal issues should be decided now.
Chin is serving an eight-year sentence at a minimum security federal prison in central Pennsylvania while Cadden is serving a nine-year sentence in western Pennsylvania.
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Chin To Serve Sentence in PA.

By Walter F. Roche Jr.

Glen Chin, the former pharmacist convicted of racketeering and mail fraud, will be serving his eight year jail sentence at a federal prison in Pennsylvania.
Chin, 49, is due to report today to the federal prison in Allenwood, in the central part of the state,  about 130 miles away from the prison where co-defendant Barry J. Cadden is serving his nine year sentence.
Both were charged by a grand jury in Massachusetts following a two year federal probe of the deadly fungal meningitis outbreak which took the lives of 76 patients. The two were also charged with 25 counts of second degree murder, but two separate juries cleared them of those charges.
Chin had originally requested to serve his sentence at a federal prison in Massachusetts but later asked for placement in Danbury, Conn. He lives in Canton, Mass., in the Boston suburbs.
Despite getting U.S. District Judge Richard G. Stearns to recommend the Connecticut placement, the federal Bureau of Prisons assigned Chin to the Allenwood facility. Cadden is  serving his sentence at Lorettto, PA.
Nine other defendants, including Chin's wife Kathy,  are scheduled to go on trial in September.

Lawyers Seek 8 Per Cent in Fees

By Walter F. Roche Jr.

Three law firms are asking a federal judge to award them fees totaling eight percent of the amount a Tennessee clinic has agreed to pay to settle law suits filed by victims of the 2012 fungal meningitis outbreak.
In a 17-page motion filed in U.S. District Court in Boston, Mass. the law firms said the fee was reasonable and justified. The motion, however, keeps secret both the amount of the settlement fund and the amount sought by the three law firms.
According to the filing the largest share of the legal fees would go to the Nashville, Tenn. firm of Branstetter, Stranch and Jennings which would be paid for 1,251 hours of work while the Lief, Cabraser, Herman and Bernstein firm would be paid for 438 hours.
The third firm, Kinnard, Clayton and Beveridge, also based in Nashville, would be paid for 26.5 hours.
The fee award is being sought for so called common benefit work the three firms did in behalf of some 14 outbreak victims who were injected with fungus laden steroids at the Specialty Surgery Center in Crossville, Tenn.
An additional 11 victims sued the center but had their claims dismissed.
"Plaintiffs counsel expended significant time and expense in litigating the Specialty Surgery Center cases," the motion states.
The motion notes that the eight  per cent fee matches the amount awarded to lawyers who performed similar work in other fungal meningitis cases.
In addition to the legal fees the motion seeks approval of expenses incurred by the law firms, but those amounts were not disclosed.
"No lawyer will get his or her common benefit time reimbursed dollar for dollar," the motion states, noting that the three firms performed some 13 separate tasks in pursuing the claims.
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Chin Gets $175,000 Forfeiture Order

By Walter F. Roche Jr.

A federal judge has formally approved a $175,000 forfeiture order against a former pharmacist convicted of playing a major role in the deadly 2012 fungal meningitis outbreak.
U.S. District Judge Richard G. Stearns sitting in Boston, Mass. approved the order this week against Glenn A. Chin, who is scheduled to begin serving an eight year prison term in less than a week.
Federal prosecutors had urged Stearns to approve an order forcing Chin to pay $611,774, but Stearns ruled that amount was excessive. Prosecutors subsequently submitted the formal order for a $175,000 forfeiture which Stearns approved.
Chin's lawyer had argued for the forfeiture of only $5,775.
Chin was convicted of racketeering, mail fraud and violations of the federal Food Drug and Cosmetic Act and is set to begin serving an eight year sentence on March 14. Stearns has recommended that he serve the sentence in the the federal prison in Danbury, Conn. as requested by Chin's lawyer, Stephen Weymouth.
Chin was a supervising pharmacist at the now defunct New England Compounding Center, the company blamed for the outbreak that took the lives of 76 patients. Nearly 700 others were also sickened.
Chin was in charge of NECC's clean room where thousands of vials of contaminated steroids were produced and shipped to be injected in unsuspecting patients. The fungus laden methylprednisolone acetate caused fungal meningitis, strokes and other illnesses.
Codefendant Barry Cadden already is serving a nine year sentence following his conviction on similar charges. Cadden was a part owner of NECC.
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FDA Discloses Another Recall

		Sagent Pharmaceuticals Issues Voluntary Nationwide Recall of Methylprednisolone Sodium Succinate for Injection, USP, 40mg, 125mg, and 1g Due to High Out of Specification Impurity Results
		Sagent Pharmaceuticals, Inc. today announced the voluntary nationwide recall of ten lots of Methylprednisolone Sodium Succinate for Injection, USP, 40mg, 125mg, and 1g. A detailed listing of products and lots is listed below. These products were manufactured by Gland Pharma Ltd. and distributed by Sagent Pharmaceuticals. Sagent has initiated this voluntary recall of Methylprednisolone Sodium Succinate for Injection, USP to the user level due to the discovery of high out of specification impurity results detected during routine quality testing of stability samples for two lots.  This impurity has not yet been identified.  An elevated impurity has the potential to decrease effectiveness of the product in patients. To date, Sagent is not aware of any adverse patient events resulting from the use of the subject product lots.

Deadline Extended for Victims' Fund

By Walter F. Roche Jr.

The Massachusetts Attorney General has once again extended the deadline for victims of the 2012 fungal meningitis outbreak to apply for a grant from a $40 million fund.
Attorney General Maura Healey announced that victims now have until June 30 to apply for grants. The old deadline was March 1.
According to the announcement only a small fraction of the total, $6.35 million, has been awarded thus far and only about 200 victims have had applications approved.
The funding came from a U.S. Justice Department allotment after U.S. Rep. Mike Bishop, a Michigan Republican and other members of Congress called on the federal agency to make the money available from a national fund for crime victims.
In announcing the extension Healey's office urged victims who have not yet applied to fill out the application form. Some 2,000 victims may be eligible, based on the number of victims approved for compensation in unrelated litigation.

                                                                NOTICE

Eligible claimants for these funds are those included in the USAO’s Victim Notification System. If victims haven’t already been identified by the USAO, they may still submit an application and will be given an opportunity to present medical records showing they meet all the criteria for eligibility. Applications may be submitted online, or hard-copy applications may be requested by calling 617-573-5375.

FDA Cites Major Compounder

	FDA alerts health care professionals and patients not to use compounded drugs from Cantrell Drug Company; agency seeks action to stop production and distribution
	The U.S. Food and Drug Administration is alerting health care professionals and patients not to use drug products produced by Cantrell Drug Company of Little Rock, Arkansas, including opioid products and other drugs intended for sterile injection, that were produced by the company and distributed nationwide. The agency is concerned about serious deficiencies in Cantrell’s compounding operations, including its processes to ensure quality and sterility assurance that put patient safety at risk. Administration of contaminated or otherwise poor quality drug products can result in serious and life-threatening injury or death. “A key aspect of the FDA’s mission to protect public health is creating a regulatory framework that helps ensure that compounded drugs are made under appropriate quality standards to reduce their risk of patient harm — and to take action when those important standards are forsaken,” said FDA Commissioner Scott Gottlieb, M.D. “Despite the FDA’s concerns about egregious conditions observed at Cantrell’s facility, during several inspections, with the most recent in 2017, the company continued to compound and distribute drugs without adequately addressing their potentially dangerous conditions. This reckless activity threatens patient safety and will not be tolerated.” The FDA has also sought legal action to prevent the company from further producing and distributing drugs. In a preliminary injunction filed today in the U.S. District Court in the Eastern District of Arkansas, the Department of Justice, in conjunction with the FDA, asked the court to order Cantrell to stop manufacturing, processing, packing, labeling, holding and/or distributing any drugs until the company complies with the Federal Food, Drug, and Cosmetic Act (FD&C Act) and its implementing regulations. The proposed order also will require Cantrell to recall all non-expired drug products on the market. Products from the company can be identified by looking at the drug labels — which should include the company name, “Cantrell Drug Co.” Health care professionals should immediately check their medical supplies, quarantine any drug products from Cantrell Drug Company and not administer them to patients. Examples of some of the drugs that Cantrell has compounded include opioids and common antibiotics. The FDA urges health care professionals who obtained products from Cantrell to make alternative arrangements to obtain medications they administer or dispense to patients from sources that adhere to proper quality standards. Patients who have received any drug product produced by Cantrell and have concerns should contact their health care professional. FDA investigators most recently inspected Cantrell’s facility in June 2017, and observed poor compounding drug operations. Of particular concern, the FDA investigators observed insanitary conditions and violations of current Good Manufacturing Practice (CGMP) that could cause Cantrell’s drugs to become contaminated or made injurious to health. Because Cantrell produces drugs that are intended for sterile injection, the conditions identified — which can expose such products to contamination and render them unsterile — raise significant public health concerns. In response to the FDA’s recommendation, in July 2017, Cantrell recalled all drug products marketed as sterile and ceased sterile compounding. However, against FDA advice, the company resumed production and distribution without demonstrating that it had adequately addressed the problems identified. The FDA is not yet aware of reports of illness associated with the use of Cantrell’s products. The FDA asks health care professionals and consumers to report adverse events or quality problems associated with Cantrell Drug Company’s products to FDA’s MedWatch Adverse Event Reporting program by: Completing and submitting the report online at MedWatch Online Voluntary Reporting Form Downloading and completing the form, then submitting it via fax at 1-800-FDA-0178 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. For more information, please visit: Cantrell Drug Company.