Friday, September 22, 2017

Key Outbreak Witness Hammered

By Walter F. Roche Jr.

BOSTON, Mass.-A key prosecution witness was hammered today by the lawyer for his former boss in the trial of a drug compounder charged with racketeering and second degree murder.
For some two hours in U.S. District Court, Joseph Connolly, a pharmacy technician, once employed by the New England Compounding Center, was questioned on everything from his motivation for agreeing to testify for the prosecution to the details of a 1995 auto accident that left him in a coma for five days.
Questioning Connolly was Robert Shekatoff, part of the defense team for Glenn A. Chin, 49, who faces the racketeering, mail fraud and 25 counts of second degree murder.
Before the cross examination Connolly, under questioning by Assistant U.S. Attorney Amanda Strachan, detailed repeated instances in which NECC shipped drugs that were outdated and  untested and how they were instructed to generate fictitious reports about environmental monitoring at the company's Framingham, Mass. facility.
NECC has been blamed by state and federal regulators for causing a deadly 2012 fungal meningitis outbreak that took the lives of 76 patients in 20 states. Chin has been charged with second degree murder in 25 of those deaths, including five in Tennessee.
Co-defendant Barry Cadden, who was NECC's president and chief pharmacist, is already serving a nine year sentence following his conviction of racketeering and mail fraud charges. He was acquitted on the murder charges.
Shekatoff repeatedly asked Connolly why he didn't just quit his NECC job if he was so appalled by what was going on there.
"But you didn't resign," said Shekatoff, after one testy exchange.
"I should have," said Connolly.
Connolly said he had two small children at the time and didn't even consider leaving the job.
Connolly did describe how he and other NECC employees were called into a break room in early October 2012 and told the company was shutting down because five Tennessee patients already had died after being treated with spinal steroids from NECC.
Though they were told the shutdown was temporary, it soon became permanent.
Earlier Connolly testified about how Chin came to be in charge of the two clean rooms where high risk drugs, like the methylprednisolone acetate, were prepared and placed in vials.
Connolly said it was Chin who actually compounded the spinal steroid.
Though Connolly insisted he had no opinion about Chin when he was promoted to oversee the cleanrooms, Shekatoff asked whether Connolly didn't share the opinion of two fellow workers who immediately questioned Chin's competence.
Under Shekatoff's questioning, Connolly acknowledged that he and some of his NECC colleagues held weekly get-togethers.
"You thought you were the smartest man in the room," Shekatoff asserted.
Connolly responded that he didn't think so, though he did eventually conclude Chin was unqualified.
Shekatoff also questioned Connolly about' statements he made to federal investigators when the outbreak investigation first began.
He said Connolly told the officials from the U.S. Food and Drug Administration that the three most likely causes of the outbreak were Chin, non sterile stoppers used in preparing the steroid or vials that were not properly prepared.
Connolly said he named Chin because it was Chin who actually compounded the methylprednisolone acetate.
The cross examination will continue on Monday.
 

Thursday, September 21, 2017

Outbreak Judge OKS $6.2 Million in Legal Fees


By Walter F. Roche Jr.

Boston, Mass. - A federal judge said today that she will approve a request to pay $6.2 million in fees and expenses for attorneys who worked on a massive civil case stemming from the 2012 fungal meningitis outbreak.
The payment from a so-called common benefit fund will go to lawyers representing victims of the deadly outbreak which sickened 778 patients, killing 76 of them.
U.S. District Judge Rya Zobel said she would approve the request during a one hour status conference today in her fifth floor courtroom.
During the same session a report was issued showing that a little over $136.6  million has been distributed to victims of the outbreak or their survivors from a trust fund. The fund was created under the bankruptcy of the company blamed for the outbreak. The New England Compounding Center shipped contaminated steroids to health providers across the country.
The $6.2 million Zobel promised to approve is the second and final installment on the payment of some $12.4 million in legal fees and expenses.
In a separate but related matter, Ben Gastel, a Nashville, Tenn. attorney, told Zobel payments from a separate fund have gone to 107 of 114 victims who were injected with fungus laden steroids at the Saint Thomas Outpatient Neurosurgical Center, also in Nashville.
Details of the Saint Thomas settlement have been filed under seal but Zobel did say she will approve fees of $26,300 from that settlement to a firm hired to administer the fund and issue checks.
Though status reports in the multi-district litigation have been held on monthly basis, Zobel set the next hearing for Dec. 19.
"You are coming to the end of this matter," Zobel said, noting that most of the issues in the litigation have been resolved.

Outbreak Victim's Daughter Details His Final Hours


Boston, Mass. - Holding back tears, the daughter of one of the first victims of the deadly fungal meningitis outbreak described his final fight for survival in a Nashville hospital.
Karen Talbott, the daughter of Kentucky Judge Eddie Lovelace, said doctors could not explain how or why the healthy 78-year-old suffered an unusual stroke centered in the middle of his brain.
His death came in early September of 2012, weeks before the public learned that a deadly fungal meningitis outbreak was taking lives in some 20 states.
"We thought it was just a stroke," Talbott told the jury in U.S. District Court. That panel is hearing testimony in the racketeering and second degree murder trial of Glenn Chin, a supervising pharmacist at the New England Compounding Center which produced thousands of vials of a spinal steroid laced with fungus.
Lovelace, who regularly walked five or six miles a day, was in a car accident earlier in the year and suffered a back injury. The fatal injections were supposed to relieve his pain, Talbott said.
She testified that it was only after state and federal officials publicly announced the growing outbreak, that she and her family figured out what took his life.
Lovelace, she said, had received three injections of methylprednisolone acetate at Nashville's Saint Thomas Outpatient Neurosurgical Center in the months before his death.
Talbott said that when they heard early October news reports about the outbreak they immediately suspected what had caused the judge's death.
His body was exhumed and the diagnosis was confirmed.
She said a grand daughter was the first to notice that Lovelace was having difficulty understanding and one day he fell walking out of the courthouse.
"He was complaining he had a headache," she said.
After he fell twice in one morning and complained his fingers were numb, she said they decided to take him to a local hospital, which quickly transferred him to Nashville.
She said doctors were baffled and couldn't explain why he would have an unusual stroke when he didn't have stroke risk factors
Though he rallied briefly, even asking when he could go back to work, his condition deteriorated. She said it broke her heart when she had to restrain the one arm he still could move because he kept pulling out a breathing tube.
Earlier in the Thursday court session, the doctor who unknowingly injected Lovelace with the contaminated steroid, told the court the epidural steroid injections acted as a powerful anti-inflammatory agent.
Using a model provided by federal prosecutors, Dr. John Culclasure described and demonstrated the two methods of injecting the steroid into the affected area of the spine.
As the deaths among his patients grew, Culclasure said he became worried that his method of injecting the steroid might be the cause.
Other possible sources of contamination were a dye used to target the injection, a numbing drug and the steroid itself, he testified.
Under questioning, Culclasure estimated he had performed some 50,000 spinal injections in his career. He said that the Saint Thomas clinic began using steroids from NECC after experiencing supply problems. He said the procedure takes about 5 to 7 minutes and the clinic does 150 to 160 such injections a week.
He said 116 of the clinic's patients were sickened and 13 died.
He said the NECC version of the steroid, unlike the brand used previously was made without preservatives. He said the clinic, which was shut down for weeks after the outbreak, now uses steroids containing preservatives.
Calling the events "a slow moving mass casualty," he said he went to visit some of his patients who had been stricken with fungal meningitis and was surprised by their reaction.
"I thought they would be very worried and upset. They were not. They were worried about us," Culclasure said.
Contact: wfrochejr999@gmail.com




Wednesday, September 20, 2017

2nd Checks Sent to 1,760 Outbreak Victims

By Walter F. Roche Jr.

Boston, Mass.-The trustee of a fund for victims of the 2012 fungal meningitis outbreak says that second checks have been approved for 1,760 claimants, according to documents filed today in U.S. District Court.
According to the report from Lynne F. Riley, a total of $136.6 million in victims' payments have now been approved. In addition to the second payments that total includes 1,836 initial checks to victims deemed qualified.
The payments are coming from funds amassed in the bankruptcy of the New England Compounding Center, the now defunct Massachusetts firm blamed for the outbreak.
Riley reported that all appeals have now been processed either by Epiq, the company hired to administer the fund or the federal judge assigned to handle appeals. As a result a total of 2,036 claims have been fully or partially approved, 41 were deemed invalid and two were withdrawn.
In an earlier report Riley stated that a third payment to victims will come at a later date following the resolution of tax issues.
In addition to the payments from the so-called national settlement, Riley said that 226 checks have been approved for payment from funds derived from settlements with individual clinics where victims were injected with fungus contaminated steroids.
Still other clinic settlements, including one in Nashville, are being handled separately and not by Riley.
In another filing today attorneys asked a federal judge to approve a payment of $26,129 to the company administering the Nashville settlement. Other details of the Nashville settlement with the Saint Thomas Outpatient Neurosurgical Center have been filed under seal.
The 2012 outbreak sickened some 778 patients in at least 20 states. Seventy-six of those have died.
The report comes as a supervising pharmacist for NECC is in trial on racketeering and second degree murder charges.
Testimony continued today in the trial of Glenn Chin. A codefendant, Barry J. Cadden, is already serving a nine-year federal prison sentence. He was convicted of racketeering and mail fraud but cleared of 25 counts of second degree murder.
Contact: wfrochejr999@gmail.com

Tuesday, September 19, 2017

First Suspicion in Outbreak Focused on Nashville

By Walter F. Roche Jr.

Boston, Mass. -- A top federal health official testified today that he first thought that the cause of a growing and deadly outbreak would be found in the Nashville clinic where the first case of fungal meningitis was reported.
Dr. Benjamin Park, testifying as the lead witness in the racketeering and second degree murder trial of Glenn Chin, said that while he first suspected the outbreak was limited to the Saint Thomas Outpatient Neurosurgical Center in Nashville, Tenn. he soon learned the outbreak traced back to the Massachusetts drug compounding firm that shipped contaminated steroids to clinics in 23 states, including Tennessee.
Park testified after Assistant U.S. Attorney George Varghese told jurors it was Chin who was responsible for sending out contaminated drugs that killed the 25 patients in seven states.
Citing the case of Kentucky Judge Eddie Lovelace, who was injected at the Nashville clinic, Varghese said it was Chin who certified that the vials of methylprednisolone acetate were sterile.
Instead, he said, they were contaminated with deadly fungi that traveled to Lovelace's brain eating blood vessels and causing a massive stroke.
Chin's legal team made an immediate call for a mistrial because he said Varghese had given jutors misinformation about the standards required of the New England Compounding Center, which employed Chin as a supervisory pharmacist.
U.S. District Judge Richard G. Stearns denied the mistrial motion but then clarified for jurors the source of the standards NECC was expected to meet.
Stephen Weymouth, Chin's lawyer said in his opening statement that prosecutors were attempting to portray Chin as "a horrible villain" who was responsible for the outbreak.
Citing statements by prosecutors in the recent trial of codefendant Barry J. Cadden, Weymouth noted that they called NECC "Cadden's baby" and that they repeatedly claimed that everything that happened at the now defunct Framingham, Mass. company happened because Cadden ordered it.
Cadden was convicted of racketeering and mail fraud charges but cleared of the same 25 second degree murder charges now facing Chin. Cadden was given a nine year prison sentence.
Park, an official of the U.S. Centers for Disease Control and Prevention who also testified in the Cadden trial, said the first word of a possible outbreak came from Dr. Marion Kainer of the Tennessee Health Department. In a call in early September of 2012, Kainer told the CDC a patient had died after being injected with a spinal steroid at the Nashville clinic.
As additional cases were reported, Park said he became more and more concerned. He said the strokes were in an unusual area at the center of the brain.
He said there were a lot of common denominators in the initial cases which caused him to think something was going wrong at the Nashville clinic. He said that feeling was reinforced after a conference call with Cadden and another NECC officer who told the CDC there had been no other complaints from NECC customers.
A turning point came when a new case was reported at a North Carolina clinic on Sept. 26. That clinic also had purchased steroids from NECC and the victim suffered the same unusual stroke.
"This told us it was outside the (Nashville) clinic," Park said.
While relieved they had found the source, Park said he also learned that some 14,000 doses of suspect steroids already had been injected in patients in 23 states.
"I was quite scared," Park said.
On cross examination by Weymouth, Park was challenged on his comparison of the meningitis outbreak with an ebola epidemic that killed thousands of victims.
Weymouth also presented records showing thousands of vials of NECC drugs were shipped and injected in patients without any evidence of injury. He also raised questions about the lack of evidence that one of the three lots of suspect steroids actually harmed anyone.
In his opening statement Weymouth said the second degree murder charges were unjustified.
"It's not murder," he said, adding "he (Chin) did make mistakes for sure."
Instead he said that despite the intensive federal investigation, the exact fungus contained in the steroids was never found at NECC.
"No one could determine exactly what happened in that clean room," he said.
In his opening statement Varghese showed jurors an email from Cadden to Chin in which he reported a "fungal bloom" had been detected in the clean room. That was just one day before one of the suspect lots was prepared.
Nonetheless, Varghese said, NECC failed to inform federal investigators about that finding when the investigation was underway.
And the prosecutor said there were multiple other problems with NECC drugs including some contaminated with bacteria and others made with outdated components.
He cited an email from Chin to Cadden in which he described one component of a juvenile cancer drug this way.
"When I say old, I mean old," Chin wrote.
"They used it anyway," Varghese concluded.




Monday, September 18, 2017

Chin Seeks to Block Prosecution Testimony


Walter F. Roche Jr.

Contending they have nothing to do with the case against his client, the attorney for the pharmacist facing 25 counts of second degree murder, is asking that federal prosecutors be barred from putting on two witnesses who testified in a related case.
The lawyer for Glenn Chin is asking U.S. District Judge Richard G. Stearns to bar prosecutors from putting Ken Boneau and Michele Adelina on the witness stand in a trial due to start tomorrow in U.S. District Court in Boston, Mass.
In his motion Stephen Weymouth said the two witnesses knew little or nothing about Chin, who was a supervising pharmacist for the defunct New England Compounding Center, the company blamed for a deadly 2012 fungal meningitis outbreak.
Stephen Weymouth, Chin's attorney, noted that Boneau and Adelina were prosecution witnesses in the trial of Barry Cadden, who was part owner and president of NECC. Cadden was convicted of racketeering, conspiracy and mail fraud, but was cleared on second degree murder charges.
Weymouth's motion charges that Chin had nothing to do with the creation of a series of training videos used for NECC's sales force. Adelina testified at Cadden's trial that he was involved in the taping of those training tapes.
The motion states that Chin also had nothing to do with the NECC promotional materials that Boneau testified about in the Cadden trial.
The U.S. Attorney responded by stating that witnesses' testimony should be allowed because their statements would help establish the existence of a conspiracy, in which Chin was a party, to deceive NECC's customers about the quality and sterility of NECC's products.
The charges against Cadden and Chin stem from the criminal probe of the 2012 fungal meningitis outbreak which sickened 778 patients in 20 states, killing 76 of them. The now defunct NECC shipped thousands of contaminated vials of methylprednisolone acetate to health providers across the country.
Cadden is now serving a nine year prison sentence following his March conviction on 57 felony counts.
Contact: wfrochejr999@gmail.com

Sunday, September 17, 2017

Outbreak Victims to Attend Chin Trial


By Walter F. Roche Jr.

Several victims of a deadly fungal meningitis outbreak will be on hand in a Boston, Mass. courtroom when federal prosecutors begin Tuesday to present their case against a pharmacist charged with second degree murder in the death of 25 patients.
Some of the victims or their survivors will be attending as guests of the federal government while others plan to attend at their own expense.
They will be coming from several states including Kentucky, Florida, Indiana and Georgia. The outbreak, caused by spinal steroids contaminated with deadly fungi, sickened 778 patients in more than 20 states. Seventy-six of them died.
Those slated to attend include the family of Eddie Lovelace, a Kentucky judge who died after getting a spinal injection at a Nashville, Tenn. clinic. Others include a retired police officer from Indiana and an X-Ray technician from New Jersey.
Susan Engel Edwards, who was sickened after an injection at a Minnesota clinic, said she is scheduled to observe the trial in early October. She now lives in Georgia.
Several victims already attended the trial of co-defendant Barry Cadden, the former president of the New England Compounding Center, the now defunct company that produced the tainted steroids. Cadden, who was found guilty of racketeering and conspiracy charges, is serving a nine-year prison sentence.
Dawn Elliott, an Indiana victim of the outbreak, is hoping to attend. Injected five times with tainted steroids, Elliott was on hand for a good portion of the Cadden trial.
The Chin trial is expected to include testimony from former NECC employees, some of who testified at the Cadden trial.
Chin was a supervising pharmacist at NECC and he was in charge of the clean room where contaminated methylprednisolone acetate was produced.
Contact: wfrochejr999@gmail.com






Thursday, September 14, 2017

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.
Contact: wfrochejr999@gmail.com

Monday, September 4, 2017

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.
Contact: wfrochejr999@gmail.com

Friday, September 1, 2017

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.
Contact: wfrochejr999@gmail.com

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)
ProductNDCLot Number

Saturday, August 26, 2017

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.
Contact: wfrochejr999@gmail.com.

Friday, August 25, 2017

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.
Contact: wfrochejr999@gmail.com

Monday, August 21, 2017

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.
Contact: wfrochejr999@gmail.com

Friday, August 18, 2017

PA Death Prompts Probe

Friday, August 18, 2017

Hershey Hospital Cited in Death of Six-Year Old

By Walter F. Roche Jr.

A Hershey hospital has been cited by Pennsylvania health officials for failing to report the unexpected death of a six-year-old boy and failure to follow expected standards of care in treating him.
According to a lengthy state inspection report, the Milton S. Hershey Medical Center only notified the Pennsylvania Health Department of the death after an anonymous informant had reported the Jan. 11 death months after it occurred. Under state law and regulations the death should have been reported within 24 hours of its occurrence.
In response to questions about the citation, the medical center issued a statement acknowledging the delay in reporting the incident and also the fact that there was a 10 hour gap in the recording of the patient's temperature.
"The facility failed to meet the emergency needs of a patient with acceptable standards of practice," the inspection report states.
The boy, who was brought to the hospital's emergency room on Jan. 10, was placed in a warming device due to a low temperature. He had a temperature of 107.6 degrees when he was found unresponsive the next day.
"There were no vitals,"the inspection report states, adding that hospital staffers acknowledged the warming device, called a Bair Hugger," had been on high all night.
He was pronounced dead at 5:39 p.m. on Jan. 11.
In addition to the failure to report the death, the hospital was cited for failing to adequately train employees and failing to follow the warming device manufacturer's guidelines calling for temperature checks every 10 to 20 minutes.
In its statement, the medical center said management did not become aware of the incident until notified by the state following the anonymous complaint to the state Patient Safety Authority.
"This situation raised serious issues, and our response has been equally serious" the hospital said in its statement.
Acknowledging that the state found a total of five violations, the medical center
termed the incident an "unacceptable failure" and said corrective action was initiated  as soon as it received notice of the anonymous complaint.
 The state sent inspectors to the hospital on April 12 and they completed their review the next day. Because the inspectors declared a state of "immediate jeopardy," the hospital was required to respond immediately with a corrective action plan. The "immediate jeopardy" was lifted on April 13.
In its statement the hospital said the boy was suffering from "ongoing, complex and life limiting health issues" and "presumed sepsis" when he was brought to the emergency room in January.
After he was found unresponsive the next day, he was taken to the the hospital's pediatric intensive care unit but died later in the day.
The hospital said its own investigation found "an agency nurse was overseeing the child's care during the 10-hour gap in temperature documentation, and no one involved in the child's care reported the incident to our Patient Safety Department."
In its inspection report, the state said that the nurse in question said she knew she took the patient's temperature but forgot to document it.
"I did not have the computer with me. I was probably busy with something else," she told the inspectors.
The state found that although the nurse had been hired a year earlier, there were no evaluations in her file and core competency for use of the warming device "was not completed."
According to the hospital statement, the facility now limits the use of the warming devices to operating rooms "where patients are continuously attended."
Other steps include training for staffers, including those hired through an agency, on the use of such devices and audits to ensure serious incidents are properly reported.
"As an organization that holds itself accountable for providing the highest quality care while protecting the safety of patients, employees and visitors, we recognize this situation was an unacceptable failure," the hospital said in its statement.
Contact: wfrochejr999@gmail.com

Compounded Drug Recall in Progress

Vital Rx, Inc. d/b/a Atlantic Pharmacy and Compounding Issues Voluntary Nationwide Recall of all Compounded Injectable Prescription Medications Due to Lack of Sterility Assurance

For Immediate Release

August 17, 2017

Contact

Announcement

Vital Rx, Inc. d/b/a Atlantic Pharmacy and Compounding is voluntarily recalling all lots of all compounded injectable prescription medications to the consumer level. The compounded injectable prescription medications have been found to lack sterility assurance. Atlantic Pharmacy and Compounding became aware of this issue during an FDA (Food and Drug Administration) inspection of the pharmacy.

Risk Statement: The compounded injectable prescription medications potentially could result in adverse effects.  To date, Vital Rx, Inc. d/b/a Atlantic Pharmacy and Compounding has not received any reports of adverse events related to this recall.
The compounded injectable prescription is packaged in sterile vials for injection.
Vital Rx, Inc. d/b/a Atlantic Pharmacy and Compounding is notifying its patients by U.S. Mail and is requesting that all unexpired lots of compounded injectable prescription medications be destroyed immediately upon receipt of the notification. Patients that have compounded injectable prescription medications which are being recalled should stop using the compounded injectable prescription medications and discard any remaining unused medication.
Patients should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
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Product Photos

  • Example label Atlantic Pharmacy & Compounding, Pompano Beach, FL

Saturday, August 12, 2017

Outbreak Victim's Dad Outraged by Congressional Proposal

By Walter F. Roche Jr.

Nearly five years ago a 16 year-old high school football star suffering from back pains went to a Roanoke, Va. clinic where he was injected with a steroid.
About a month later and a week after starring in a game for Cave Spring High School, Zac Foutz was completely incapacitated after being hit with excruciating pain and high sensitivity to light. On Oct. 28, 2012 he was admitted to a local hospital suffering from fungal meningitis.
Hit with  powerful antifungal medications, Foutz remained hospitalized for more than two weeks.
Now Zac has recovered and is listed as a 250 6'4'' tight end at Liberty University.
But that is a small part of the story.
Zac's illness motivated his father, Ben, a medical supply salesman, to become deeply involved in efforts to see that what happened to Zac and more than 750 other victims of the 2012 outbreak never happens again. As Ben Foutz noted, Virginia was particularly hard hit
Federal officials say some 758 patients were sickened and 76 died as a result of being injected with fungus riddled steroids from a Framingham, Mass. drug compounder.
Working with Republican U.S. Rep. Morgan Griffith, who represents a neighboring district, Ben Foutz followed developments in congress, including a 2012 congressional hearing in which Griffith made a specific reference to Zac and his illness.
Eventually a bill tightening regulation of drug compounders like the New England Compounding Center was passed and then signed into law by then President Obama.
Griffith hailed the passage and even took some credit, saying that the final bill was based on a bill he filed.
For that reason Foutz said he was taken aback and angry when he learned last week that Griffith had  just filed "a very flawed" bill that would eliminate a key provision of the 2013 law.
The Griffith bill, strongly backed by a national association of drug compounders, would eliminate a requirement that drug compounders have patient specific prescriptions for each and every drug they compound.
"I will admit my bias," Foutz said in an email, "I am the father of a victim. I am emotionally attached to this issue."
"I want people in our great country to get the medication they need, but I expect those medications to be safe, effective and regulated."
Foutz said that when he spoke to Griffith, the representative told him that he now felt the U.S. Food  and Drug Administration was preventing local drug compounders from providing needed drugs and that regulation of drug compounders should be left to state regulatory boards.
At the 2012 hearing, Griffith was one of several committee members to charge the FDA with failing in its duty to regulate drug compounders.
"Now he feels the FDA has too much authority," Foutz wrote.
He said that when he pushed Griffith for the reason he reversed himself, Griffith said that he didn't have the bill in front of him and would have to get back to him later.
Foutz is still waiting.
Contact: wfrochejr999@gmail.com




Monday, August 7, 2017

Cadden Reports to Western PA Facility

By Walter F. Roche Jr.

Pharmacist Barry J.Cadden has reported to a federal prison in Western Pennsylvania to begin serving a nine year sentence following his conviction on 57 counts of racketeering, conspiracy and mail fraud.
Cadden, the one time president of a now defunct Massachusetts drug compounding firm, was sentenced in June by U.S. District Judge Richard G. Stearns. Federal prosecutors had sought
a 45-year prison term and Cadden had asked for a three year sentence.
Cadden's 10 week trial ended on March 22 when the jury returned a split verdict. While convicting him of racketeering and mail fraud, the jurors acquitted the 50-year-old pharmacist on 25 counts of second degree murder.
FCI Loretto, located near Altoona, Penn., is a low security prison which includes a prison camp. Cadden was assigned to the prison section of the facility not the prison camp.
Cadden was one of 14 employees and owners of the New England Compounding Center who were indicted in late 2014 following a two year federal probe of the deadly 2012 fungal meningitis outbreak. Fungus contaminated drugs from NECC caused the outbreak which sickened 778 patients, killing at least 76 of them.
Cadden had asked to serve his sentence at the federal prison near Ayer, Mass., less than an hour from his Wrentham, Mass. home. Loretto, PA is some 490 miles from Wrentham, Mass.
Cadden has already served notice that he is appealing his conviction.
Codefendant Glenn Chin is scheduled to go on trial in September. Chin, like Cadden was charged with 25 counts of second degree murder, along with racketeering and mail fraud charges.
Other defendants are expected to be tried after the Chin trial has ended.
Stearns has issued orders limiting the length of the Chin trial to a little over a month, in an apparent effort to avert a repeat of the 10-week marathon Cadden trial.
The Loretto federal prison, once the site of a Catholic seminary, has had some well known inmates including John Rowland, a former governor of Connecticut, who was convicted on corruption charges. Others have included a New York assemblyman and a New England mafia boss.




Cadden Prison Assignment Unclear

By Walter F. Roche Jr.

The location of the convicted drug executive due to begin serving a nine-year prison sentence today remains unclear and officials, including his attorneys, did not respond to requests for comment.
Barry J. Cadden, 50, of Wrentham, Mass.,was due to report today to the federal Bureau of Prisons, to begin serving the sentence imposed on June 26 by U.S. District Judge Richard G. Stearns.
Cadden, the former president of the defunct New England Compounding Center, was convicted of 57 counts of racketeering, conspiracy and mail fraud on March 22.
He was cleared on 25 counts of second degree murder.
Cadden was one of 14 indicted by a federal grand jury in late 2014 following a two year probe of a deadly fungal meningitis outbreak caused by drugs shipped from NECC's Framingham, Mass. headquarters.
Cadden, through his attorney, had asked Stearns to recommend that he serve his sentence at Fort Devens, a federal prison about an hour from his home.
The BOP web site lists Cadden as a prospective inmate, but states "Not in BOP Custody"
Cadden has appealed his conviction to the First Circuit Court of Appeals.
Inquiries today to Cadden's attorney, the federal Bureau of Prisons and federal prosecutors went unanswered.
Contact: wfrochejr999@gmail.com


Friday, August 4, 2017

Compounding Bill Could Bring Outbreak Recurrence

By Walter F. Roche Jr.



"Our job is to find out how this happened and then to make sure it doesn't happen again." U.S. Rep. H. Morgan Griffith Sept. 12, 2013



A Virginia congressman who said his district was among the hardest hit in the nation by the 2012 fungal meningitis outbreak, is now seeking to strip a key provision of the law passed to prevent a recurrence  of that deadly public health crisis.
U.S. Rep. H. Morgan Griffith filed a bill recently that would eliminate a requirement that drug compounders obtain a patient specific prescription before compounding even a single dose of a drug.
Dr. Michael Carome of Public Citizen said in an interview this week that passage of the Griffith bill would "clearly guarantee" a recurrence of the 2012 outbreak which sickened 778 patients in 23 states, killing at least 76 of them.
Griffith did not respond to requests for comment.
In the wake of the outbreak Griffith, a Republican whose district is in Southwest Virginia, made a point of stressing how his district was "particularly hard hit."
At a Nov. 14, 2012 congressional hearing on the outbreak he said two deaths already had been reported and as many as 1,415 area residents had been notified they had been injected with contaminated steroids from the same drug compounder, the New England Compounding Center.
He recounted a telephone conversation he had with the father of a 16-year-old, the youngest known victim of the outbreak.
Griffith told those at the hearing that it was unclear whether the teenager would recover despite his youth.
When the current law won final congressional approval, Griffith hailed its passage.
The new Griffith bill was immediately endorsed by the International Academy of Compounding Pharmacists, a group that lobbies in behalf of compounding pharmacists.
The group's political action committee donated $5,000 to Griffith's campaign committee 15 days after he filed the bill.
Carome noted that his organization did not support the 2013 law, because it created a new category of mass drug producers, known as outsourcers, that do not need to meet the same standards as major drug producers.
"We opposed the creation of that new category," he said.
But,  Carome noted, the new law does require the mass compounders to follow standards known as GMP or Good Manufacturing Practices. He said that requirement would not apply to compounders under the Griffith proposal.
"This bill would allow any compounder to mass produce," he said, adding that it was clear that the bill was filed at the behest of the compounders association.
Griffith was a major participant in the Nov. 14, 2012 hearing before the subcommittee on oversight and investigations during which  committee members grilled officials of the U.S. Food and Drug Administration about its failure to prevent the fungal meningitis outbreak.
Contact: wfrochejr999@gmail.com





Wednesday, August 2, 2017

Proposal Would Loosen Compounding Regulation


By Walter F. Roche Jr.

Fifteen days after filing a bill to loosen federal regulation of drug compounders, a Virginia congressman got $5,000 in contributions from the political action committee formed by drug compounders.
Records at the Federal Election Commission show the $5,000 was donated to the campaign fund of H. Morgan Griffith, a Virginia Republican, on June 27. It wasn't the first contribution by the political action committee for the International Association of Compounding Pharmacists to Morgan. He also got  $5,000 in the previous election cycle.
On June 12, the day the bill was filed the IACP issued a press release praising Morgan and U.S. Rep. Henry Cuellar, a Texas Democrat, for filing the bill entitled "Preserving Patient Access to Compounded Medications.
Charging that the U.S. Food and Drug Administration has been misinterpreting a new law, the Drug Quality and Security Act, passed in 2013, the IACP says the FDA is asserting "regulatory authority over the practice of pharmacy and medicine in a way Congress never intended."
As a result, the IACP says, patients are being deprived of easy access to drugs compounded by local pharmacists.
That new statute was passed in the wake of a deadly fungal meningitis outbreak that sickened 758 patients killing 76 of them. Many of the victims resided in Griffith's district which includes parts of Roanoke County
Dr. Richard Carome of Public Citizen already is warning that passage of the Morgan/Cuellar proposal will likely lead to a repeat of the 2012 outbreak.
That outbreak was caused by a Massachusetts drug compounding firm, the New England Compounding Center in Framingham, Mass.
Next week the former president of NECC is scheduled to begin serving a nine year prison sentence  following his March conviction on racketeering, conspiracy and mail fraud charges.
Carome has charged that the main effect of the IACP proposal is to eliminate a requirement that there be a patient specific prescription before a drug can be compounded by a state licensed pharmacist.
Under the 2013 law congress created a new category of drug producers who can compound drugs without patient specific prescriptions but they must first register with the FDA and meet certain requirements.
Morgan 's proposal would create a loophole negating the effect of that requirement, Carome has charged.
The IACP, which holds an annual fundraiser in Washington, DC, has regularly supported congressional candidates backing their positions. FEC records show the IACP PAC raised $48,825 between Jan. 1 and June 30 of this year.
Contact: wfrochejr999@gmail.com








IACP Applauds the Leadership of Congressmen Griffith and Cuellar in Introducing Bill HR 2871

Wednesday, June 14, 2017   (0 Comments)
Posted by: Dagmar Anderson
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IACP Applauds the Leadership of Congressmen Griffith and Cuellar in Introducing Bill HR 2871
The “Preserving Patient Access to Compounded Medications Act of 2017†is a bipartisan effort to preserve patient access to vital compounded medications.

WASHINGTON – June 13, 2017 - The International Academy of Compounding Pharmacists (IACP) strongly supports new legislation, introduced by U.S. Congressmen Morgan Griffith (VA) and Henry Cuellar (TX), HR 2871 – The Preserving Patient Access to Compounded Medications Act of 2017, formally introduced on June 12, 2017. More than 300 compounding pharmacists traveled to Washington, D.C. on behalf of their patients and physicians to meet with their respective congressional representatives to discuss the Bill’s content, and to urge them to co-sponsor HR 2871.
  
IACP President Baylor Rice, RPh, FIACP, says, “On behalf of the International Academy of Compounding Pharmacists and the patients we serve, thank you, Congressman Griffith and Congressman Cuellar, for your leadership in introducing the bipartisan legislation, HR 2871 - The Preserving Patient Access to Compounded Medications Act.

This important bill will help protect access to medications physicians rely upon for their patients. It will help clarify the Drug Quality & Security Act (DQSA) in a way that will better align the statute with congressional intent and better balance public safety and patient access. We applaud your dedication on behalf of patients, physicians, pharmacists, and other healthcare providers who are united in a mission to preserve patient safety and access to needed compounded medications pursuant to state and federal laws and regulations.â€
  
IACP consistently has said that maintaining access to potentially life-saving compounded medications is not only vital for patients; but, is consistent with the legislative intent of the DQSA. While reinforcing Section 503A of the Food, Drug and Cosmetic Act (FDCA) through the passage of the DQSA, Congress came together in a bipartisan and bicameral fashion to make clear that pharmacists’ ability to provide compounded medications for a physician’s administration to or treatment of a patient within their practice should be left to the States.

IACP, working with the DQSA Coalition, has worked with the FDA and Congress on improving the agency’s compounding policies in a way that better balances public safety with patient access to critical medications. Unfortunately, despite these efforts, FDA continues to misinterpret the DQSA and assert regulatory authority over the practice of pharmacy and medicine in a way Congress never intended.  Congress has, in the last two appropriations bills  (FY16 and FY17), included report language directing the FDA to alter their policies on compounding to align with congressional intent and the language of the statute.  FDA has, to date, ignored those congressional directives and continues to substitute their desired regulatory authority over compounding.

As such, it’s vital that Congress support HR 2871 in order to preserve patient access to compounded medications by directing FDA to act within Congressional intent.

About IACP

The International Academy of Compounding Pharmacists (IACP) is an association representing more than 4,000 pharmacists, technicians, students, and members of the compounding community who focus upon the specialty practice of pharmacy compounding. Compounding pharmacists work directly with prescribers including physicians, nurse practitioners and veterinarians to create customized medication solutions for patients and animals whose healthcare needs cannot be met by manufactured medications. IACP's mission of protecting, promoting and advancing personalized medication solutions is critical for patient healthcare.  Visit www.iacprx.org to learn more and to find a compounding pharmacist near you.

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Monday, July 31, 2017

Virginia Outbreak Settlement Approved


By Walter F. Roche Jr.

A federal judge has approved the $235,811 settlement of a suit brought by the family of a Virginia victim of the 2012 fungal meningitis outbreak who died on Jan. 6, 2013.
Under the approval by U.S. District Judge Rya Zobel, the two daughters and the spouse of the victim will each get $37,134.
The suit was filed against Insight Imaging and related companies involved in injecting the victim with fungus contaminated steroids.
Just last week the family of another Roanoke area victim filed documents showing a $916,951 settlement of their claim.
In the latest settlement legal fees totaling $94,324 will go the firm of Crandall and Kett, which represented the victim's survivors. An additional $8,674 will go for legal expenses and $21,409 will go to reimburse the federal Medicare program.
The suit was one of hundreds filed in the wake of the 2012 fungal meningitis outbreak which sickened 758 patients, killing 76 of them.
Contact: wfrochejr999@gmail.com

Thursday, July 27, 2017

Infections Reported Following Joint Injections

From The CDC


Outbreak of Septic Arthritis Associated with Intra-Articular Injections at an Outpatient Practice — New Jersey, 2017


Kathleen Ross, MPH1,2; Jason Mehr, MPH1; Barbara Carothers1; Rebecca Greeley, MPH1; Isaac Benowitz, MD3; Lisa McHugh, MPH1; David Henry, MPH4; Lisa DiFedele, MPH1; Eric Adler, MPH1; Shereen Naqvi4; Edward Lifshitz, MD1; Christina Tan, MD1; Barbara Montana, MD1 (View author affiliations)
View suggested citation

Summary

What is already known about this topic?
Single-use medications, including pharmacy bulk packaged (PBP) products, typically lack antimicrobial preservatives and can become contaminated and serve as a source of microorganisms when handled inappropriately. Use of a PBP product as a multiple-dose container outside of pharmacy conditions could contaminate the container and serve as a source of pathogens for multiple patients.
What is added by this report?
In March 2017, an outbreak of 41 cases of septic arthritis associated with intra-articular injections administered at an outpatient practice occurred in New Jersey. A public health investigation identified multiple breaches of recommended infection prevention practices during the preparation and administration of PBP products, which are intended for single-use, in accordance with standards outlined by the United States Pharmacopeial Convention.
What are the implications for public health practice?
No additional septic arthritis cases were identified after infection prevention recommendations were implemented within the practice. The findings from this investigation highlight the need for better adherence to and oversight of basic infection prevention recommendations and sterile compounding standards in outpatient settings.

On March 6, 2017, the New Jersey Department of Health (NJDOH) was notified of three cases of septic arthritis in patients who had received intra-articular injections for osteoarthritic knee pain at a private outpatient practice. The practice voluntarily closed the next day. NJDOH, in conjunction with the local health department and the New Jersey Board of Medical Examiners, conducted an investigation and identified 41 cases of septic arthritis associated with intra-articular injections administered during 250 patient visits at the same practice, including 30 (73%) patients who required surgery. Bacterial cultures of synovial fluid or tissue from 15 (37%) patients were positive; all recovered organisms were oral flora. An infection prevention assessment of the practice identified multiple breaches of recommended infection prevention practices, including inadequate hand hygiene, inappropriate use of pharmacy bulk packaged (PBP) products as multiple-dose containers and handling PBP products outside of required pharmacy conditions, and preparation of syringes up to 4 days in advance of their intended use. No additional septic arthritis cases were identified after infection prevention recommendations were implemented within the practice.

Investigation and Response

On March 6, 2017, Monmouth County Regional Health Commission No. 1 (MCRHC) notified NJDOH that three patients were hospitalized for septic arthritis after receiving intra-articular injections for osteoarthritis pain relief at practice A, a private outpatient facility where procedures were performed by two staff physicians with the aid of two medical assistants. On March 7, practice A voluntarily closed in response to a large number of reports of severe knee pain and swelling. On March 8, NJDOH notified the New Jersey Board of Medical Examiners, which oversees physician licensure, to facilitate and coordinate a joint investigation.
A confirmed case of septic arthritis was defined as any one of the following in a patient who received intra-articular injections at practice A during March 1–6, 2017: 1) isolation of any microorganism from synovial fluid or tissue collected from the injected joint, 2) positive Gram stain of synovial fluid, 3) synovial fluid white blood cell count of >20,000/mm3, and 4) recipient of intravenous antibiotics or surgical debridement for a clinical diagnosis of septic arthritis.
Among 250 patient visits involving knee intra-articular injections at practice A during March 1–6, NJDOH identified 41 confirmed cases (16%) of septic arthritis. Patients had been scheduled over 3 consecutive clinic days (March 1, March 2, and March 6) with no apparent clustering by appointment time; the same physician administered all injections on these 3 days. Information on time of symptom onset was available for 38 (93%) of 41 patients and ranged from zero to 65* days after injection; 35 (92%) of the 38 patients developed symptoms within 48 hours of the procedure. Thirty (73%) of the 41 patients required surgery.
All 41 patients had synovial fluid or knee tissue obtained during surgery collected for culture, and cultures were positive for 15 (37%) patients. Bacteria recovered included Streptococcus mitis-oralis (10 patients), Abiotrophia defectiva (two), Staphylococcus aureus (two), Actinomyces odontolyticus (one), alpha-hemolytic Streptococcus (one), Eikenella corrodens (one), Haemophilus parainfluenzae (one), Neisseria oralis (one), Streptococcus gordonii (one), Streptococcus intermedius-milleri (one), Streptococcus sanguinis (one), and Veillonella (one); five patients had polymicrobial infections. Cultures from 26 (63%) patients were negative. All recovered organisms are commonly found in oral flora (1,2). In addition to bacteria recovered from culture of synovial fluid or tissue, Staphylococcus aureus was isolated from the blood of two patients.
On March 13, MCRHC, NJDOH, and the New Jersey Division of Consumer Affairs representing the New Jersey Board of Medical Examiners conducted an unannounced visit to practice A to inspect the premises, interview staff members, observe infection prevention practices, and review records. Because the practice remained closed to patients at this time, mock procedures were observed during the visit.
Multiple breaches in infection prevention recommendations were identified. Staff members did not have access to a handwashing sink, and alcohol-based hand rub was not available in medication preparation or treatment areas. Staff members, operating under the mistaken belief that PBP products could be used as multiple-dose containers outside of pharmacy conditions (e.g., use of a laminar flow hood, appropriate garbing, staff training, and environmental monitoring), accessed a 50 mL PBP container of contrast material up to 50 times to prepare syringes for multiple patients, with the septum of the container cleaned with alcohol only before the initial draw. Staff members prepared injections in a separate room, away from the patient treatment area; however, pharmacy conditions necessary for batch preparation of syringes and use of PBP products were not in place. In addition, injectable medications were drawn into syringes by medical assistants up to 4 days in advance of procedures, contrary to the recommended practice of administering medication from single-dose vials within 1 hour of preparation (3).
Injections were initiated using a needle and syringe filled with local anesthetic. After injecting the anesthetic, the physician removed the syringe, leaving the needle within the intra-articular space. A second syringe containing contrast material from the PBP container was then attached to the needle hub and used to facilitate fluoroscopic needle placement. This was followed by replacement with a third syringe containing a glucocorticoid or hyaluronic acid–based product. The physician did not wear a face mask during joint injection procedures and used nonsterile gloves to manipulate the needle hub during procedures.
Practice A was advised to immediately stop batch preparation of syringes and use of PBP products for multiple patients and to hire an infection preventionist to assess staff competency and ensure that hand hygiene, standard precautions, and safe injection practices were followed. No additional cases occurred after these measures were implemented.

Discussion

An investigation of 41 cases of septic arthritis associated with intra-articular injections at an outpatient practice in New Jersey identified multiple breaches of recommended infection prevention practices during the preparation and administration of PBP products, which are intended for use in a pharmacy setting, using standards outlined by the United States Pharmacopeial Convention (USP) (3,4). PBP products are restricted to preparation of admixtures only in a suitable work area as defined by USP, such as in a laminar flow hood, and handled in accordance with sterile compounding standards outlined by the manufacturer and USP (3,4). CDC guidelines call for medications labeled as “single-dose” or “single-use” to be used for only one patient (5,6). Single-use medications, including PBP products, typically lack antimicrobial preservatives and can become contaminated and serve as a source of microorganisms when handled inappropriately (6). Use of a PBP product as a multiple-dose container outside of pharmacy conditions could contaminate the container and serve as a source of pathogens for multiple patients. Because practice A used a single PBP container of contrast material for as many as 50 patients, contamination of only a single container could account for the large number of cases identified in this outbreak.
Proper hand hygiene should be performed before handling any medications. In addition, batch preparation of medication for future administration should be performed in accordance with sterile compounding standards recommended by USP (3).
In this outbreak, all pathogens isolated were oral flora. CDC recommends that health care personnel wear face masks for spinal injection procedures that require injection of material or insertion of a catheter into epidural or subdural spaces (e.g., myelogram, administration of spinal or epidural anesthesia, or intrathecal chemotherapy) (5). Multiple outbreaks have demonstrated the risk for bacterial meningitis associated with droplet transmission of oral flora from health care personnel to patients during spinal injection procedures. The Association for Professionals in Infection Control and Epidemiology recommends the use of a face mask to contain respiratory droplets when preparing and injecting material into an intra-articular space (7). The use of multiple syringes with a single intra-articular needle could serve as a conduit for organisms to enter directly into the joint space if the needle hub is left exposed to potential respiratory droplets. Although this is a potential mechanism for a single case, it is unlikely to explain the large number of cases identified in this outbreak.
No additional septic arthritis cases were identified after infection prevention recommendations were implemented within the practice. The findings from this investigation highlight the need for better adherence to and oversight of basic infection prevention recommendations and sterile compounding standards in outpatient settings (8,9).

Conflict of Interest

No conflicts of interest were reported.

Corresponding author: Kathleen Ross, Kathleen.Ross@

Tuesday, July 25, 2017

Cadden Says Any Forfeiture Should Be Limited

By Walter F. Roche Jr.

The convicted pharmacist and drug executive facing a nine-year jail term says any money forfeiture should be limited to a little under $250,000 and not the $75 million sought by federal prosecutors.
In a 10-page filing in U.S. District Court in Boston, Mass., Barry J. Cadden's lawyers also argued that the court does not even have jurisdiction to order forfeiture because Cadden has filed formal notice that he is appealing his conviction to the 1st Circuit Court of Appeals.
Cadden contends in the filing that the total proceeds from the racketeering activities on which he was convicted were only about $1.4 million, not the $75 million claimed by federal prosecutors.
"The appropriate starting point for the court's forfeiture calculation is the analysis the court undertook for determining the loss amount for the purpose of sentencing," the filing states.
In addition Cadden's lawyer charged that the government ignored a recent U.S. Supreme Court ruling placing limits on some forfeiture orders.
"The government makes no genuine attempt to satisfy the rule of proportionality," the filing continues, noting that Cadden only owned 17.5 percent of the New England Compounding Center, the company blamed for a deadly 2012 fungal meningitis outbreak.
"The NECC enterprise is defunct and Mr. Cadden has no interest in it," the filing states.
Cadden has been ordered to report to the federal Bureau of Prisons on Aug. 7 to begin serving his sentence. He was convicted on March 22 of 57 counts of racketeering, conspiracy and mail fraud.
Cadden has asked to serve his sentence at a federal prison in central Massachusetts.not far from his Wrentham, Mass. home.


Sterile Drugs Subject to Recall


Safety


Cantrell Drug Company Issues Voluntary Recall of Select Sterile Drug Products Due to Lack of Sterility Assurance

For Immediate Release

November 18, 2016

Contact

Consumers

Cantrell Drug Company
877-666-5222

Media

David Ball
david@ballcg.com
617-243-9950

Announcement

Little Rock, AK - Cantrell Drug Company is voluntarily recalling certain unexpired sterile drug products due to lack of sterility assurance.
The recalled products, distributed nationwide to health care facilities from May 25 to October 31, 2016, are the following:
Drug Product Name NDC Lot Number Manufacture Date Beyond Use Date
CALCIUM CHLORIDE 1 G ADDED TO 5% DEXTROSE 50 ML BAG 52533-175-37 169170 10/15/2016 1/5/2017
CALCIUM CHLORIDE 10 G IN 0.9% SODIUM CHLORIDE 500 ML BAG 52533-102-09 168032 9/12/2016 12/11/2016
CALCIUM CHLORIDE 10% INJECTION SOLUTION 10 ML VIAL n/a 169924 10/26/2016 4/15/2017
FENTANYL CITRATE 10 MCG/ML IN 0.9% SODIUM CHLORIDE 150 ML BAG 52533-024-35 9002 9/6/2016 3/5/2017
FENTANYL CITRATE 10 MCG/ML IN 0.9% SODIUM CHLORIDE 250 ML BAG 52533-024-61 8990 8/31/2016 2/27/2017
FENTANYL CITRATE 2 MCG/ML & BUPIVACAINE HCL 0.125% IN 0.9% SODIUM CHLORIDE 100 ML BAG
52533-080-75 8942 8/23/2016 2/19/2017
FENTANYL CITRATE 2 MCG/ML & BUPIVACAINE HCL 0.125% IN 0.9% SODIUM CHLORIDE 250 ML BAG 52533-080-61 9029 9/12/2016 3/11/2017
FENTANYL CITRATE 2 MCG/ML & BUPIVACAINE HCL 0.125% IN 0.9% SODIUM CHLORIDE 100 ML BAG 52533-080-75 9207 10/19/2016 04/17/2017
GLYCOPYRROLATE 0.2 MG/ML INJECTION SOLUTION 5 ML SYRINGE 52533-028-15 9006 9/7/2016 1/20/2017
GLYCOPYRROLATE 0.2 MG/ML INJECTION SOLUTION 5 ML SYRINGE 52533-028-15 8757 7/18/2016 11/30/2016
GLYCOPYRROLATE 0.2 MG/ML INJECTION SOLUTION 5 ML SYRINGE 52533-028-15 8954 8/24/2016 1/6/2017
GLYCOPYRROLATE 0.2 MG/ML INJECTION SOLUTION 5 ML SYRINGE 52533-028-15 9174 10/11/2016 2/20/2017
HEPARIN SODIUM 0.5 USP UNITS/ML IN 0.45% SODIUM CHLORIDE 2 ML SYRINGE 52533-148-16 9220 10/20/2016 4/18/2017
HEPARIN SODIUM 5,000 USP UNITS ADDED TO 0.9% SODIUM CHLORIDE 1,000 ML BAG 52533-097-24 167081 8/18/2016 2/14/2017
HYDROMORPHONE HCL 0.2 MG/ML IN 0.9% SODIUM CHLORIDE 30 ML SYRINGE 52533-002-03 8742 7/13/2016 1/9/2017
HYDROMORPHONE HCL 1 MG/ML IN 0.9% SODIUM CHLORIDE 30 ML PCA VIAL 52533-006-10 163941 6/21/2016 11/30/2016
HYDROMORPHONE HCL 1 MG/ML IN 0.9% SODIUM CHLORIDE 50 ML SYRINGE 52533-006-04 9016 9/9/2016 3/7/2017
LIDOCAINE HCL 1% INJECTION SOLUTION 10 ML SYRINGE n/a 165538 7/19/2016 1/8/2017
MIDAZOLAM HCL 1 MG/ML IN 0.9% SODIUM CHLORIDE 50 ML SYRINGE 52533-001-04 169619 10/20/2016 2/7/2017
MORPHINE SULFATE 1 MG/ML IN 0.9% SODIUM CHLORIDE 100 ML BAG 52533-160-75 8625 6/18/2016 12/15/2016
NEOSTIGMINE METHYLSULFATE 1 MG/ML INJECTION SOLUTION 5 ML SYRINGE 52533-046-15 8997 9/2/2016 12/1/2016
NEOSTIGMINE METHYLSULFATE 1 MG/ML INJECTION SOLUTION 5 ML SYRINGE 52533-046-15 9246 10/26/2016 1/23/2017
OXYTOCIN 30 USP UNITS ADDED TO 0.9% SODIUM CHLORIDE 500 ML BAG 52533-056-30 9210 10/19/2016 1/17/2017
PHENYLEPHRINE HCL 100 MCG/ML IN 0.9% SODIUM CHLORIDE 10 ML SYRINGE 52533-171-12 8502 5/25/2016 11/21/2016
PHENYLEPHRINE HCL 100 MCG/ML IN 0.9% SODIUM CHLORIDE 10 ML SYRINGE 52533-171-12 8962 8/25/2016 2/21/2017
ROCURONIUM BROMIDE 10 MG/ML INJECTION SOLUTION 5 ML SYRINGE 52533-064-15 8995 9/1/2016 2/28/2017
ROPIVACAINE HCL 0.25% IN 0.9% SODIUM CHLORIDE 100 ML BAG 52533-185-75 169064 10/20/2016 1/2/2017
SUCCINYLCHOLINE CHLORIDE 20 MG/ML INJECTION SOLUTION 10 ML SYRINGE 52533-067-12 169262 10/11/2016 1/8/2017
SUCCINYLCHOLINE CHLORIDE 20 MG/ML INJECTION SOLUTION 10 ML SYRINGE 52533-067-12 169812 10/24/2016 1/19/2017
Administration of a drug product intended to be sterile that is not sterile could result in serious infections that may be life-threatening.  The company has not received any reports of adverse events, but is issuing this recall out of an abundance of caution following a recent inspection of the company’s facility.
Cantrell Drug Company will begin notifying its customers by email and phone and is arranging for the return of all recalled products.  Consumers who have product subject to the recall should stop using it and contact the company.
“Because patient safety is our top priority, we immediately began addressing the issues raised and are working closely with health officials,” said Dell McCarley, Chairman & CEO of Cantrell Drug Company.  “We have received no reports of injury or illness, and it’s important to note that all of our sterile products are tested for sterility before they are shipped.  We deeply regret the impact this voluntary recall has on providers and patients, but our culture is one of safety first and we take absolutely no chances.”
To return medication or request assistance related to this recall, contact Cantrell Drug Company at 877-666-5222, Monday through Friday between 9 a.m. and 5 p.m. CST.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
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Page Last Updated: 11/21/2016
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