Saturday, December 1, 2012

California Bill Would Require Reporting of Prescription Drug Related Deaths to State's Medical Board


November 28, 2012 02:19 PM

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A bill that would require coroners in California to report all prescription drug related deaths to the Medical Board of California was introduced to the state Senate by Senator Curren D. Price, Jr (D-Los Angeles). The bill aims to help authorities identify physicians whose “prescribing practices may be harming patients,” reports the Los Angeles Times. A Los Angeles Times investigative report indicated that in four California counties 3,733 accidental deaths were related to prescription drugs, and that in almost half of those cases the individual had a prescription for at least one drug that caused the death. California law already requires that prescription drug related deaths suspected to be caused by “gross negligence” by a physician must be reported to the Medical Board. After considering the findings of investigative report, the Medical Board agreed that “all deaths related to prescription drug overdoses should be reported to the board for further investigation,” according to the Los Angeles Times.

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U.S. Attorney for S.D.N.Y. Files Complaint Against K-V Pharmaceutical Corporation Seeking Determination That Debts Are Not Dischargeable in Bankruptcy and Copy of Complaint


The United States Attorney for the Southern District of New York, Preet Bharara, filed an adversary complaint on behalf of the U.S. Government against K-V Pharmaceutical Corporation on Monday in the Southern District of New York Bankruptcy Court. The complaint seeks a judgement of the bankruptcy court (which is presiding over K-V Pharmaceutical Corporation’s chapter 11 case) that certain obligations owing to the government are not dischargeable in K-V Pharmaceutical’s bankruptcy pursuant to sections 523(a)(2), 523(a)(7) and 1141(d)(6) of the Bankruptcy Code.

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K-V Pharmaceutical Owes United States $67.1M In Fines, Settlement, Lawsuit Says


by Tara Arick on November 30, 2012 · 0 comments

A U.S. attorney on Nov. 26 sued K-V Pharmaceutical Co., telling a New York federal court that the bankrupt company’s $ 67.1 million debt of criminal fines and civil settlements are nondischargeable (In Re: K-V Discovery Solutions, Inc., et al., No. 12-13346, S.D. N.Y. Bkcy., United States of America v. K-V Pharmaceutical Company, No. 12-13346, S.D. N.Y.).
Parent company K-V Discovery Solutions Inc. in October filed a Chapter 11 bankruptcy petition in the U.S. Bankruptcy Court for the Southern District of New York. At the heart of the company’s financial troubles is its inability to make scheduled payments to Hologic Inc. for the rights to the Makena preterm labor drug due to alleged market price resistance.
In its complaint filed in the U.S. District Court for the Southern District of New York, the U.S. attorney for the Southern District of New York says that in March 2010, K-V subsidiary Ethex Corp. pleaded guilty to two felony charges for failing to issue field alerts about oversized drug tablets. As part of the judgment, Ethex was ordered to pay a criminal fine of $ 23.4 million in four installments.
Installment Plan
Ethex was subsequently shut down by K-V.
The government says that K-V paid the first installment of $ 2.3 million, after which the parties modified the payment schedule with the next payment due Dec. 15. The government says that the total unpaid balance of the criminal fine is $ 16.1 million.
In addition to the criminal action, the government says that Ethex violated the False Claims Act by misrepresenting the regulatory status of certain drugs that were paid for by Medicare and Medicaid. It says that K-V and Ethex settled the whistle-blower lawsuit for payments totaling about $ 17 million.
Obligations Not Dischargeable
The government says both the criminal plea and settlement agreement provided that neither the fine nor the settlement would be dischargeable in the event Ethex or K-V filed for bankruptcy. It says that in the civil settlement, K-V agreed not to contest that the United States has a valid claim against K-V for $ 51 million.
The government says its position is that it does not have to file an adversary proceeding to obtain a determination of nondischargeability of K-V’s debts to the government. It says it filed the adversary proceeding to preserve its rights in the event the court determines such a filing is necessary to obtain an exemption from discharge.
Source found here

More Questions On Who Should Be Liable in the NECC case

Does anyone think the Pharmaceutical Representatives or Marketing Reps/Directors in the New England Compounding Center case should be civilly or criminal liable and if so under what theory 

USP 2010–2015 Compounding Expert Committee


Focus Areas

  • Human Drug Compounding (Sterile and Nonsterile)
  • Veterinary Drug Compounding
  • Radiopharmaceuticals Compounding
  • Compounding Flavorings

Expert Committee Members

  • Gigi S. Davidson, R.Ph., DICVP, Chair
  • Lisa D. Ashworth, B.S.Pharm., R.Ph., Vice Chair
  • Loyd V. Allen, Ph.D.
  • Gus S. Bassani, Pharm.D.
  • Edmund J. Elder, Jr., Ph.D.
  • Maria do Carmo M. Garcez, B.S.Pharm.
  • Deborah R. Houston, Pharm.D.
  • Ken Hughes, R.Ph.
  • Eric S. Kastango, B.S.Pharm., M.B.A.
  • Patricia C. Kienle, M.P.A.
  • Keisha D. Lovoi, B.S.Pharm.
  • Linda F. McElhiney, Pharm.D.
  • William A. Mixon, M.S.
  • David W. Newton, Ph.D.
  • Alan F. Parr, Pharm.D., Ph.D.
  • Regina F. Peacock, Ph.D.
  • Robert P. Shrewsbury, Ph.D.
  • Keith St. John, M.S.

Government Liaisons

  • Ian F. Deveau, Ph.D.
  • Edisa Gozun
  • Martine Hartogenesis, DVM
  • John W. Metcalfe, Ph.D.
  • Terrance W. Ocheltree, Ph.D., R.Ph.
  • Judith McMeekin, Pharm.D.
  • Yichun Sun, Ph.D.

USP Documentary Standards Staff

  • Shawn Becker, M.S., R.N.
  • Anthony DeStefano, Ph.D.
  • Donna Goldberg, M.Ph.
  • Rick Schnatz, Pharm.D.
  • Ivonne Zuniga

Primary Points of Contact

Who is liable for the meningitis outbreak from tainted steroids? - FindLaw

Who is liable for the meningitis outbreak from tainted steroids? - FindLaw

$10 million meningitis suit filed by Moneta woman


A Moneta woman with fungal meningitis filed a lawsuit this week in Roanoke Circuit Court, as the number of local legal cases continues to mount in the deadly national outbreak blamed on tainted steroid injections.
Michelle Powell was sickened in the outbreak after being treated at Insight Imaging in Roanoke with one or more doses of the steroid injections made by New England Compounding Center, according to the complaint filed Monday. The suit, which names both the compounding center and Insight, seeks $10 million.
Powell's suit marks the 12th filed locally since the outbreak was discovered in October. All of the cases have named New England Compounding, the Massachusetts pharmacy that produced the steroid shots. And most have also sought to place blame on Insight, the Roanoke outpatient clinic that administered the shots. Spokespeople for both companies have declined to comment on the legal proceedings.
As of Monday, the outbreak has sickened 510 people in 19 states and is blamed in 36 deaths, according to the latest count by Centers for Disease Control and Prevention in Atlanta. In Virginia, 51 cases and two deaths have been recorded
Source found here

Sen. Richard Moore to Join Compounding Pharmacy Panel


Meningitis outbreak: Cases moved from state to federal court

4:46 PM, Nov 30, 2012

Lawyers for the drug compounding firm blamed for a deadly nationwide outbreak of fungal meningitis are moving forward with a strategy to get the growing number of lawsuits consolidated in federal court and want a Boston-based judge to preside over all of them.
Federal court records show that a total of 37 cases originally filed in state and county courts have been transferred to federal courts across the country at the request of lawyers representing the New England Compounding Center. The lawyer for the company, headquartered in suburban Framingham, says it wants the cases eventually to be consolidated in Massachusetts.
That would include six suits originally filed in circuit court in Nashville and subsequently transferred to U.S. District Court here.
Forty other cases against the company were filed in federal courts to begin with, pushing the total number of pending federal suits over 70. Dozens of additional suits still remain in local courts, including seven in Davidson Circuit Court. Lawyers for the compounding firm have predicted that the final total will top 400.
In several of the transferred cases, New England Compounding’s lawyers have stated that their ultimate goal is to have all of the cases consolidated in Boston before U.S. District Judge F. Dennis Saylor IV, who currently has a dozen cases assigned to him.
“Judge Saylor has the judicial experience needed to steer this anticipated massive litigation on a prudent course to an expeditious conclusion,” New England’s attorney wrote in a recently filed brief.
“That’s what their plan is,” said Nashville attorney Randy Kinnard, who represents Colette Rybinski of Smyrna, the widow of Thomas W. Rybinski , who was the first patient to be diagnosed with fungal meningitis. He also represents nine other victims.

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In wake of meningitis outbreak, Dana-Farber Cancer Institute explains compounding

11/28/2012 3:01

By Carolyn Y. Johnson, Globe Staff


Hundreds of fungal infections linked to injectable drugs made by a Framingham specialty pharmacy have sparked questions among regulators, hospitals, and patients about the role such drugmakers play in providing crucial drugs.
In an effort to educate patients about its drug compounding efforts, Dana-Farber Cancer Institute has produced a video that goes into its pharmacy, showing how drugs are prepared and what steps the hospital takes to ensure that drugs are safe and sterile. Compounding is a little-known corner of pharmacy that involves preparing individualized doses for patients, but the company at the center of a major public health crisis, New England Compounding Center, was apparently acting more like a drug manufacturer, providing large batches of drugs and shipping them nationally.
Dana-Farber’s compounding pharmacy prepares 950 sterile products a day, including chemotherapy, anti-nausea medication, and intravenous

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