DOJ Seeks to Block NECC Depositions

By Walter F. Roche Jr.

Federal prosecutors are asking a federal judge to block an effort by a Rhode Island clinic to depose key figures from the now defunct company blamed for a deadly fungal meningitis outbreak.
In a six-page motion filed today in U.S. District Court in Boston, Mass., Assistant U.S. Attorney Amanda Strachan charged that Ocean State Pain Management was "forum shopping" and trying to bypass a previous ruling barring depositions of officials of the New England Compounding Center and a related sales company.
Lawyers for Ocean State have moved to depose Barry Cadden, the convicted former president of the New England Compounding Center, Joseph Connelly, a former NECC employee and NECC's one time sales chief Robert Ronzio. Also on the list is John Notarianni, another sales official employed by Medical Sales Management, an NECC affiliate.
"The court should not sanction the defendant's' forum shopping," the U.S. Attorney's motion states. "The Ocean State defendants are bound by that (prior) ruling."
Ocean State is one of dozens of health facilities that injected patients with  fungus laden steroids purchased from NECC in 2012.
Strachan noted that Ocean State joined in a similar motion filed by attorneys for a Tennessee clinic. That motion was denied.
"The court should not allow them to proceed," the government motion states.
The action comes as the second major defendant in the criminal case stemming from the outbreak is about to go to trial.
Opening arguments are scheduled for Tuesday in the case against Glenn Chin, who was a supervising pharmacist at NECC. He has been charged with racketeering and 25 counts of second degree murder.
Cadden, who is now serving a nine-year prison sentence was convicted of racketeering and mail fraud charges in a 10-week trial ending in March. He was cleared of second degree murder charges.
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Chin Trial To Begin With Time Limits

By Walter F. Roche Jr

Under a judge's streamlined schedule the trial of the second major defendant stemming from the criminal probe of a deadly 2012 fungal meningitis outbreak is set to begin later this month.
Jury selection in the trial of Glenn A. Chin is set for Sept. 15 with opening arguments scheduled to begin four days later. The trial in U.S. District Court in Boston, Mass. follows the March conviction of co-defendant Barry J. Cadden, who was convicted  following a marathon 10-week trial.
Cadden was president and part owner of the New England Center, the company that produced the contaminated steroids blamed for the outbreak that sickened 778 patients, killing at least 76 of them.
Chin was NECC's chief pharmacist and he faces many of the same charges as Cadden.
Chin's trial, however, won't be a repeat of the Cadden trial due to an order issued this summer by U.S. District Judge Richard G. Stearns.
In an initial July order Stearns limited prosecutors to 60 hours to present their case with Chin's lawyers capped at 20 hours. After an appeal by the U.S. Attorney, Stearns upped the prosecution limit to 75 hours while keeping Chin's lawyers to a 20-hour limit.
The revised limits would indicate the trial could last five weeks or about half the time consumed in the Cadden trial. Stearns order states that he will consider extensions on the limits only as the trial proceeds.
Like Cadden, Chin is charged with racketeering and 25 counts of second degree murder. But Cadden, who is now serving a nine-year prison sentence, was acquitted on all the murder charges. He was convicted on a total of nearly 60 counts of racketeering, conspiracy and mail fraud.
While Chin now faces the same charges as Cadden, there are key differences in the facts charged against the two defendants.
Cadden was the president and a stockholder of NECC. Evidence presented at his trial showed the millions of dollars he and his wife profited from NECC. Chin, a supervising pharmacist, was an employee with no ownership interest.
While Cadden was the chief pharmacist, prosecutors never charged that he had any hands-on role in the production of the steroids that triggered the outbreak. In contrast the indictment charges that Chin was directly involved in the production of fungus laden methylprednisolone acetate.
For instance the indictment states that Chin "attempted to sterilize" one of the deadly drug lots by placing the drugs in an autoclave for 15 minutes and five seconds, instead of the required 20 minutes.
In addition, it charges, he failed to verify the sterilization process and to follow the accepted industry standards for sterilized drugs.
Chin was not only directly involved in the production of the suspect drugs, he was the supervisor in the clean room where that production occurred, prosecutors have charged
Another key difference in the two cases is the contention by prosecutors that NECC produced the fungus laden steroids that caused the outbreak.
While Cadden conceded at the outset that NECC produced the deadly lots of methylprednisolone acetate, Chin has made no such concession. During the Cadden trial, government witnesses conceded that they never found the exact fungi found in victims in the lengthy and detailed examination of NECC's Framingham, Mass. factory.
While there are marked differences in the Cadden and Chin cases, prosecutors are likely to seek to replicate testimony from the Cadden trial in which a string of NECC employees  described a locker room atmosphere with frequent lapses in the proper preparation of sterile drugs destined for injection in the spines and joints of unsuspecting patients.
It is also likely that Chin will seek to blame Cadden for any problems at NECC, just as Cadden's lawyers repeatedly argued during his trial that it was Chin who cut corners and opened the door to tainted and deadly drugs being shipped to hundreds of unsuspecting health care providers.
Stearns cited the likely blame shifting when he reluctantly agreed not to put both defendants on trial at the same time, as originally planned.
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Maryland Clinic Moves For Dismissal

By Walter F. Roche Jr.

A Maryland clinic where dozens of victims of a deadly outbreak were injected with fungus laden steroids is moving to have the remaining cases against it dismissed.
In a five-page motion filed today in U.S. District Court in Boston, Mass. lawyers for the Box Hill Clinic in Abingdon sought approval from Senior U.S. District Judge Rya Zobel to file another motion for dismissal, citing evidence compiled thus far.
The clinic noted that it bought the tainted steroids from the same company that was selling its products to "some of the nation's most prestigious" health facilities. It was not "reasonably forseeable" that its products would cause illness and death, the motion states.
The suits are among hundreds filed in the wake of a deadly 2012 fungal meningitis outbreak caused by tainted steroids shipped from the now defunct New England Compounding Center.
"Box Hill defendants complied with the recognized standards of acceptable practice, the motion states.
The clinic lawyers also noted that even if patient specific prescriptions had been written for each of its patients, that would not have prevented the outbreak.
The motion applies to the handful of Box Hill cases that remain in federal court. Still more were filed in state courts in Maryland.
Overall the 2012 outbreak sickened 778 patients in more than 20 states. Seventy-six of them died. In Maryland 26 patients were sickened and three died.
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Hospira Initiates Another Recall

Hospira, Inc., a Pfizer company, is voluntarily recalling one lot of Hydromorphone HCI Injection, USP, CII (2 mg/mL) 1mg/mL Vial and four lots of Levophed® (Norepinephrine Bitartrate Injection, USP), 4 mg/4 mL (1 mg/mL) Vial due to a potential lack of sterility assurance resulting from use of a damaged sterilizing filter for nitrogen used in the manufacturing process. To date, Hospira, Inc., a Pfizer company has not received any reports of adverse events related to this recall.
In the event that impacted product is administered to a patient, adverse events ranging from fever, chills, and malaise, to severe adverse events such as septicemia, bacterial meningitides and wound infection could occur. The possibility of a breach in sterility assurance in distributed product, while not confirmed, cannot be eliminated.  No batches of product have been identified as containing microorganisms. To date, Hospira has not received reports of any adverse events associated with this issue for these lots. Hospira places the utmost emphasis on patient safety and product quality at every step in the manufacturing and supply chain process.
Hydromorphone Hydrochloride Injection, USP, CII is indicated for the relief of moderate to severe pain. Levophed® (Norepinephrine Bitartrate Injection, USP) is indicated in adults for blood pressure control in certain acute hypotensive states.
The following lots were distributed Nationwide in the U.S.A (including Puerto Rico), Singapore, and Taiwan to wholesalers and hospitals from May 2017 to July 2017. Hospira has initiated an investigation to determine the root cause and corrective and preventive actions.
Product/Lot Information (for US/Puerto Rico lots)

Product	NDC	Lot Number

18 Representatives Sign on to Compounders' Bill

By Walter F. Roche Jr.

Eighteen more U.S. House members have signed on as co-sponsors of a bill which would make significant changes in a 2013 law passed in the wake of a deadly outbreak caused by contaminated compounded drugs.
The 18, all but two Republicans, join Reps. H. Morgan Griffith, a Virginia Republican, and Henry Cuellar, a Texas Democrat, the original sponsors of the bill backed by the International Academy of Compounding Pharmacists.
The bill, H.R.2871, would eliminate a requirement that pharmacists have a patient specific prescription for each dose of a drug they compound.
Griffith and other backers of the measure contend it will make compounded drugs more readily available for patients who may need them on an emergency basis. They also charge that federal regulators are using the 2013 law to interfere in matters meant to be handled by state pharmacy boards.
Opponents, including Public Citizen, contend it would create a massive loophole that would lead to a repeat of the 2012 fungal meningitis outbreak caused by steroids laden with fungus and shipped to health facilities across the country.
The outbreak took the lives of 76 patients among 778 who were sickened. The former president and owner of the defunct Massachusetts compounding pharmacy blamed for the outbreak is serving a nine year federal prison sentence following his conviction on racketeering and mail fraud charges.
The new cosponsors include several from states that were hard hit in the outbreak including Virginia, New Jersey and Tennessee.
Those signing on to the bill also include some who, like Griffith, have received campaign contributions from the compounding pharmacists political action committee known as COMP PAC.
U.S. Rep Chris Stewart, a Utah Republican, has received $10,000 in contributions from COMP PAC in the past two years. Rep. Earl Carter, R-Georgia, got $5,000  and Rep. Pete Session, R-Texas, got $1,000 in 2016.
Others joining on to the bill include Reps. Chris Collins, R-NY, Ted Poe, R-TX, Frank LoBiondo, R-NJ, David Roe, R-TN, Mac Thornberry, R-TX, Andy Biggs, R-AZ, Cathy McMorris, R-WA, Gregg Harper, R-MS, David Young, R-IA, Paul Gosar, R-AZ, Collin Peterson, D-MN, David Brat, R-VA, Neal Dunn, R-FL, Brian Babin, R-TX and Joyce Beatty, D-OH.
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Prosecutors Seek $13.2 Million Cadden Judgment

By Walter F. Roche Jr.

Federal prosecutors are seeking a $13.2 million judgment against a former drug company president who is now serving a nine year sentence in a federal prison in Pennsylvania.
In papers filed today, the U.S. Attorney in Boston, Mass. said the revised request was in line with guidance issued earlier this week by the U.S. Department of Justice. The guidance was issued as a result of a recent U.S. Supreme Court ruling limiting forfeiture orders.
The $13.2 million is down considerably from the $132.8 million prosecutors originally sought in a forfeiture order against Barry J. Cadden. Cadden, 50,  was convicted in late March on racketeering and mail fraud charges following a 10-week trial. He was acquitted on charges of second degree murder.
In the two-page filing today prosecutors said the $13.2 million represented "the amount of proceeds he (Cadden) obtained directly and indirectly" from the criminal enterprise.
Cadden was the president of the New England Compounding Center, the now defunct drug compounding firm blamed for a deadly 2012 fungal meningitis outbreak.
The government motion notes that a related appeal to the First Circuit Court of Appeals has been stayed clearing the way for the U.S. District Court to rule on the judgment request.
Cadden through his attorneys has argued that any forfeiture or judgment should be limited to a little under $250,000. Prosecutors originally sought a $132.8 million forfeiture order but then revised it downward to $75 million.
In related action, U.S. District Judge Richard G. Stearns has granted a motion by a co-defendant in the case to travel out-of-state while he awaits trial.
Scott M. Connolly was granted permission to travel to Leavittown, N.Y. for two days this month on "a family business matter" and to travel to South Setauket, N.Y. in early October to visit family.
Connolly has been charged with racketeering and conspiracy. He, Cadden and 12 others were indicted in late 2014 following a two-year federal probe of the fungal meningitis outbreak.
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2nd Wave of Checks Enroute to Victims

By Walter F. Roche Jr.

A second wave of checks to victims of a deadly meningitis outbreak has begun to arrive and for some, at least, it includes an unexpected bonus.
The checks coming from a more than $150 million settlement fund are going to lawyers representing victims and survivors of the 2012 fungal meningitis outbreak that sickened 778 patients in more than 20 states, killing at least 76 of them.
Interviews with lawyers and victims or survivors of victims show the checks that began arriving late last week are between 17 and 20 percent higher than expected. Previously victims had been told that the second payments would be the same or less than the first payments, which went out earlier this year.
The timing of the payments from the settlement fund are in line with a recent report the administrator had filed with Senior U.S. District Court Judge Rya Zobel. Lynne Riley, the trustee, told the court the second wave of payments would be going out by the end of summer.
The notices being sent also indicate that victims may get yet a third payment, but those checks may not be issued for three to four years. The third payment would come from tax refunds expected by the former owners of the New England Compounding Center, the company blamed for the deadly outbreak.
An attorney representing Riley told Zobel the delay was necessary because the IRS  could reverse itself and recoup the refunds.
The settlement fund was created in the bankruptcy of NECC. It includes payments from the owners of the now defunct company and related parties, including insurance carriers.
The payments from the national settlement fund are separate from payments some victims will or have already received from health care providers who purchased steroids from NECC.  Those include a settlement with the Saint Thomas Outpatient Neurosurgical Center in Nashville, Tenn.
Second payments from that Tennessee settlement have yet to be made. Initial payments from the fund, estimated at more than $20 million, came last month.
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