Wednesday, March 14, 2018

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.

Saturday, March 10, 2018

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.

Friday, March 9, 2018

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.

Tuesday, March 6, 2018

FDA Discloses Another Recall

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.

Saturday, March 3, 2018

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.

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.

Thursday, March 1, 2018

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:
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.

Monday, February 26, 2018

Chin Facing Inquiry Over Hidden Assets

By Walter F. Roche Jr.

With just weeks to go before he begins serving an eight year prison sentence, the former pharmacist for the company blamed for a deadly outbreak,  is facing an inquiry into whether he misrepresented his assets to qualify for free legal representation.
The inquiry of Glenn A. Chin by a magistrate judge was disclosed in an 18-page ruling by the same judge who ruled that he must serve an eight year sentence following his conviction on racketeering and mail fraud charges.
U.S. District Judge Richard G. Stearns sitting in Boston, Mass. said the magistrate judge was examining whether Chin "may have misrepresented his net worth to avoid contributing to the payment for the services of the lawyers appointed by the court to represent him."
Stearns said the concerns arose following the disclosure that Chin and his wife Kathy, a codefendant in the case spent nearly $700,000 over the past 16 months for items including the purchase of a new car, paying off a mortgage and investing in new businesses.
In seeking a forfeiture of more than $600,000 federal prosecutors had charged that Chin failed to disclose some $700,000 held in a retirement account.
The references to the spending came in a ruling in which Stearns imposed a $175,000 forfeiture order against Chin, who was a supervising pharmacist at the now defunct New England Compounding Center, the company blamed for the 2012 fungal meningitis outbreak. Some 778 patients were sickened and 76 died from fungus laden steroids shipped from NECC.
In the same ruling Stearns acknowledged that the victims of the outbreak were unlikely to feel any sympathy for Chin.
"It is unlikely that many, if any of these victims will have any sympathy for Mr. Chin's circumstances," Stearns wrote.
Nonetheless the judge acknowledged his concern that Chin had lost his pharmacist's license and that his two children would still be minors when he is released from prison. He said that was a factor in limiting the forfeiture order to $175,000.
Chin is due to report to the federal Bureau of Prisons on March 14.