Final Rulings Issued Before Cadden Trial

By Walter F. Roche Jr.

With jury selection set to begin in just days, a federal judge has ruled on a series of last minute motions in the trial on murder charges of the chief pharmacist for the company blamed for a deadly fungal meningitis outbreak.
U.S. District Judge Richard G. Stearns ruled that prosecutors cannot present evidence on a decade old case in which a patient died after being injected with a drug produced by the New England Compounding Center.
Prosecutors wanted to present details of the death in the upcoming trial of Barry Cadden, the part-owner and chief pharmacist for NECC. Jury selection in his second degree murder case is scheduled to begin Wednesday in Stearns' Boston, Mass. courtroom.
Barred by Stearns ruling are details of the 2004 death of New York resident William Koch who succumbed following an injection of a steroid produced by NECC. Koch's family later sued NECC and the case was settled out of court.
Stearns concluded the Koch case was too old and the details too inconclusive to be presented to jurors considering the 25 counts of second degree murder against Cadden.
The 25 victims were among at least 77 who died in the outbreak caused by fungus ridden methylprednisolone acetate (MPA) shipped by NECC to health providers in some 20 states.
Cited by Stearns in the Koch ruling was "the lack of conclusive evidence that the death at issue was caused by contaminated MPA, the absence of any finding or admission of liability" and the lack of any allegation against Cadden personally
In other rulings Stearns granted an extension till Wednesday for Cadden's lawyer to file proposed jury instructions and agreed that prosecutors will not be allowed to present evidence of Cadden's wealth, though they will be allowed to detail Cadden's ownership interest in NECC.
He also granted Cadden's motion to file some unspecified evidence under seal.
The 2012 fungal meningitis outbreak sickened some 778 patients, including the 77 that died.
Cadden is one of 14 NECC connected individuals named in a 2014 indictment by a federal grand jury following a two year federal investigation of the deadly outbreak. Two of the 14 have entered guilty pleas to reduced charges, while two others had charges dismissed.
Glenn Chin, who was a supervisory pharmacist at NECC, is scheduled to go on trial when Cadden's case is completed. Like Cadden he is facing racketeering and second degree murder charges.
The eight remaining defendants will face trial when Chin's case is completed.
Contact: wfrochejr999@gmail.com

Victims Awaiting Word on Trial Attendance

By Walter F. Roche Jr.

With time running out victims of the 2012 fungal meningitis outbreak are awaiting word on whether they will be able to attend the upcoming criminal trials of employees and owners of the shuttered drug compounding firm blamed for the deadly outbreak.
The trial of Barry Cadden, the chief pharmacist and part owner of the New England Compounding Center, is set to begin with jury selection on Jan. 4. Opening arguments have been set for Jan. 9.
Cadden is facing multiple charges of second degree murder along with racketeering and other charges.
Co-defendant Glenn Chin, who also faces 25 second degree murder charges, will go on trial as soon as the Cadden trial is completed. Both trials will take place in U.S. District Court in Boston, Mass.
The U.S. Attorney's office has contacted victims or victims' survivors and asked them to fill out a questionnaire indicating whether they want to attend the trial. The victims and survivors are spread out over some 20 states.
The questionnaire states that the trial is estimated to run three to four months and indicates there may be a limit on the number of days victims will be able to attend. Other questions include whether or not the victim will be attending alone or with a relative or support person.
The questionnaire was sent out before U.S. District Judge Richard G. Stearns granted a motion by Cadden to sever his trial from Chin's.
Initially the office had indicated victims had the option of witnessing the trial in person or on closed circuit television in a local federal court house. More recently, however, victims were informed that the closed circuit option would not be available.
In the latest communication victims were told a decision would be made soon on how many could attend and how long they would be able to do so. Travel and accommodations will be paid for by the government.
Another question for victims is whether or not they'll be allowed to attend both the Cadden and Chin trials.
A third trial for the remaining eight defendants is set for early April.
Cadden's trial is likely to be shorter as his attorney has stated he will not dispute the prosecution's claim that drugs shipped from NECC caused the death and illnesses. Chin, meanwhile, has stated that he only recently learned that Cadden plans to blame him, and him alone, for the shipment of fungus loaded steroids.
The 2012 fungal meningitis outbreak sickened some 778 patients. At least 77 of them died.
Contact: wfrochejr999@gmail.com

Judge Denies Cadden Dismissal Motion

By Walter F. Roche Jr.

U.S. District Judge Richard G. Stearns has denied a last minute dismissal motion on second degree murder charges filed in behalf of Barry Cadden, the former part owner of a drug company blamed for a deadly fungal meningitis outbreak.
In an order issued in U.S. District Court in Boston, Mass. Stearns concluded that the indictment of Cadden "states the essential elements of second degree murder."
Bruce A. Singal, Cadden's attorney, filed the dismissal motion earlier this month. Cadden is scheduled to go on trial Jan. 4 on charges including 25 counts of second degree murder. Singal had argued there was insufficient evidence to prove the murder allegations.
He also had asked Stearns, for a second time, to force the U.S. Attorney to disclose the specific instructions prosecutors gave to the grand jury that issued the indictment in late 2014.
"There is no potential deficiency with the legal instructions to the grand jury that cannot be cured at trial," Stearns added.
The judge, in a separate brief decision, defended a recent decision separating the trials of Cadden and codefendant Glenn Chin, who also faces the second degree murder charges.
Stearns wrote that the severance order will stand, citing the competing defenses raised by the two defendants. He said that a decision on what evidence of the deaths will be allowed at trial could be addressed either at trial or by a motion to limit the death evidence.
Cadden previously agreed to stipulate that the 25 deaths were caused by the injection of those patients with drugs produced at the New England Compounding Center, the entity blamed by health regulators for the outbreak.
He also deferred action on a motion by prosecutors to block from the Cadden trial evidence of a settlement of civil suits brought by outbreak victims. Cadden and other former owners of NECC contributed nearly $50 million to that settlement.
"The court is not certain, in any event, what use defendant would have for the evidence as it might otherwise tend to imply an admission of guilt," Stearns concluded.
Chin's trial is set to begin as soon as Cadden's is completed. Other NECC defendants are scheduled for trial in April.
Contact: wfrochejr999@gmail.com

Judge Denies Cadden Dismissal Motion

By Walter F. Roche Jr.

U.S. District Judge Richard G. Stearns has denied a last minute dismissal motion on second degree murder charges filed in behalf of Barry Cadden, the former part owner of a drug company blamed for a deadly fungal meningitis outbreak.
In an order issued in U.S. District Court in Boston, Mass. Stearns concluded that the indictment of Cadden "states the essential elements of second degree murder."
Bruce A. Singal, Cadden's attorney, filed the dismissal motion earlier this month. Cadden is scheduled to go on trial Jan. 4 on charges including 25 counts of second degree murder. Singal had argued there was insufficient evidence to prove the murder allegations.
He also had asked Stearns, for a second time, to force the U.S. Attorney to disclose the specific instructions prosecutors gave to the grand jury that issued the indictment in late 2014.
"There is no potential deficiency with the legal instructions to the grand jury that cannot be cured at trial," Stearns added.
The judge, in a separate brief decision, defended a recent decision separating the trials of Cadden and codefendant Glenn Chin, who also faces the second degree murder charges.
Stearns wrote that the severance order will stand, citing the competing defenses raised by the two defendants. He said that a decision on what evidence of the deaths will be allowed at trial could be addressed either at trial or by a motion to limit the death evidence.
Cadden previously agreed to stipulate that the 25 deaths were caused by the injection of those patients with drugs produced at the New England Compounding Center, the entity blamed by health regulators for the outbreak.
He also deferred action on a motion by prosecutors to block from the Cadden trial evidence of a settlement of civil suits brought by outbreak victims. Cadden and other former owners of NECC contributed nearly $50 million to that settlement.
"The court is not certain, in any event, what use defendant would have for the evidence as it might otherwise tend to imply an admission of guilt," Stearns concluded.
Chin's trial is set to begin as soon as Cadden's is completed. Other NECC defendants are scheduled for trial in April.
Contact: wfrochejr999@gmail.com

Key NECC Defendant Enters Guilty Plea

By Walter F. Roche Jr.

A key figure in the investigation of a deadly fungal meningitis outbreak has entered a guilty plea and has agreed to give critical testimony in upcoming trials against his former colleagues.
The guilty plea to conspiracy to defraud the U.S. Food and Drug Administration was entered by Robert Ronzio, 42, the former national sales manager for the New England Compounding Center, the company that shipped thousands of vials of steroids laden with deadly fungus.
Ronzio, a North Providence, R.I. resident, admitted to working with other sales staffers to create phony lists of patients who supposedly had been issued valid prescriptions for the steroids NECC was shipping to health facilities across the country.
"Specifically Ronzio admitted that NECC sales representatives requested that customers send in a list of patient names with their orders," federal prosecutors said in announcing the plea deal.
The ruse was designed "to make it appear to federal and state regulators that NECC was dispensing drugs pursuant to valid patient-specific prescriptions when in fact it was not."
Evidence produced in related civil cases showed that the patient names submitted by one clinic included "Donald Duck"
Ronzio's plea was entered before U.S. District Judge Richard G. Stearns who set a Sept. 27 date for sentencing. The maximum sentence for the single charge is five years and a fine of $250,000, but prosecutors have agreed to recommend a lighter sentence dependent on Ronzio's continued cooperation.
 Ronzio's scheduled sentencing will be well after nine other defendants, including Barry Cadden and Glenn Chin, will have faced trial. Cadden is scheduled to go on trial Jan. 4 on charges including 25 counts of second degree murder. Chin's trial on the same murder charges will begin as soon as Cadden's ends.
The 2012 outbreak sickened 778 patients killing at least 77 of them.
According to prosecutors Ronzio has admitted that Cadden, the chief pharmacist and part owner of NECC created ratios of patient names to match the number of doses being shipped to specific customers.
"The MAX total number of units per patient must make sense," Cadden told Ronzio, according to prosecutors, adding "I must be able to logically explain to a regulator why we processed X# of units per patient."
"Ronzio admitted the reason for these work-around methods was to maintain NECC's status as a pharmacy and avoid heightened regulatory oversight of the FDA," prosecutors stated, adding that NECC was actually acting as a drug manufacturer.
Ronzio, Cadden and Chin were among 14 named in a 131 count indictment issued by a federal grand jury in late 2014 following a two year federal probe. According to the indictment Ronzio sent an email to sales staffers at an affiliated company, Medical Sales Management, warning them to avoid using certain terms that would trigger federal charges.
In one email, entitled "HUUUUUUGGE IMPORTANCE," Ronzio wrote, "Do not give ratios. It's the wrong thing to say period!!!! I cannot stress this enough to all of you. Its (cq) will be a fatal error for you."
Two of the 14 defendants recently entered guilty pleas to reduced charges. Two others had charges dismissed. Besides Cadden and Chin, the remaining defendants are scheduled for trial in April.
Contact: wfrochejr999@gmail.com

Judge Approves Payment of Legal Fees

By Walter F. Roche Jr.

A federal judge has approved the payment of legal fees and expenses totaling $6.25 million for a group of lawyers who represented victims of the deadly 2012 fungal meningitis outbreak.
In a two-page order issued Monday U.S. District Judge Rya Zobel approved the compromise payment request that was hammered out during a Dec. 8 session in her Boston, Mass. courtroom. Under that compromise the attorneys will get only 50 per cent of the originally requested amount of $12.5 million.
Zobel had suggested the 50 per cent figure after lawyers for some of the victims raised questions about lawyers getting all of their fees while victims were only getting half of what they eventually expect to collect.
The payments will come from a trust fund estimated to range from $130 million to $157 million that was amassed in the bankruptcy of the New England Compounding Center, the defunct company blamed for the outbreak that took the lives of 77 people.
Zobel's order authorizes the trustee of the fund, Lynne F. Riley, to distribute the lawyers' payments only if "all or virtually" all of the initial payments have been made to qualified victims. Outbreak victims had to submit documentation by a Dec. 15 deadline in order to be assured payment before the end of the calendar year.
The lawyers getting paid from a so-called common benefit fund were credited with doing work that benefited all the victims of the meningitis outbreak.
According to a report from Riley filed Dec. 8, payments had been made to 462 victims. Another 28 had been finally approved for a total of 490. A total of 2,340 claims were filed but 177 of them had been finally rejected. She reported that 1,981 had been fully or partially approved.
The average payment for the 462 who had received checks was $15,828.64. The payments to victims as of that date totaled $7.3 million.
Contact: wfrochejr999@gmail.com

Judge Sets Dates in NECC Criminal Case

By Walter F. Roche Jr.

Opening arguments in the murder case against Barry Cadden, part owner of a defunct drug company, are tentatively scheduled for Jan. 9 in U.S. District Court in Boston, Mass.
In a recent order U.S. District Judge Richard G. Stearns also set aside three days, Jan. 4-6, for jury selection in the case.
In addition Stearns has ruled that the trial of Cadden's co-defendant, Glenn Chin, will follow immediately after the Cadden case has concluded.
The scheduling order follows Stearns decision last week to grant the two defendants separate trials.
Cadden's lawyer, Bruce A. Singal, requested that the two cases be severed in a sealed motion.
In his decision Stearns cited the conflicting strategies of the two, both facing 25 counts of second degree murder among other charges.
Cadden and Chin are among 14 indicted in late 2014 following a two year investigation of a fungal meningitis outbreak that sickened 778 patients in some 20 states. At least 77 of them died.
Cadden, through his lawyer, has conceded that 25 of those deaths were caused by doses of methylprednisolone acetate shipped from the New England Compounding Center in Framingham, Mass. State and federal officials concluded the vials of the steroid were infested with fungus due to unsanitary conditions at NECC.
Cadden, however, has indicated he intends to blame Chin  and others for the deadly outbreak of fungal meningitis.
Stearns cited the "antagonistic defenses" as a factor leading to his reluctant decision to split the two cases.
Cadden was a party owner of NECC, while Chin was a supervising pharmacist.
Two of the remaining defendants have entered guilty pleas to reduced charges, while two others had charges dismissed.
The remaining defendants are scheduled for trial in April.
Contact:wfrochejr999@gmail.com

Judge Agrees To Sever Cadden, Chin Trials

By Walter F. Roche Jr.

Calling it a rare case in which antagonistic defenses requires a separation, a federal judge has ruled that the two main defendants in the criminal case stemming from a deadly fungal meningitis outbreak will have separate back-to-back trials.
In a three-page decision issued today U.S. District Judge Richard G. Stearns ordered that Barry Cadden will go on trial beginning Jan. 4 on 25 counts of second degree murder, while Glenn Chin, who is facing the same charges, will face trial immediately afterwards.
The severance request by Cadden's lawyer, Bruce A. Singal, was filed under seal, but a subsequent court hearing and filings that were never sealed make it clear that Cadden plans to blame Chin for the 2012 outbreak which killed 77 patients across the country.
"The motion to sever is allowed, albeit reluctantly," Stearns wrote, adding that his decision would mean there will be three separate trials stemming from the 2014 indictment. Cadden, Chin and the other defendants were employees or part owners of the New England Compounding Center, the Framingham, Mass. company blamed for the outbreak.
"This is one of the rare cases in which antagonistic defenses coupled with an imbalance of evidence, require the severance of the trials of Barry Cadden and codefendant Glenn Chin," Stearns wrote noting that "as a rule severance is not favored when two defendants are charged together with the same crimes."
Cadden, then a licensed pharmacist, was an officer and part-owner of NECC, while Chin was a supervising pharmacist.
Stearns said his concerns over the conflicting defense strategies was heightened "by the prejudicial effect  of the introduction of causation evidence related to the often agonizing deaths" of the 25 deceased victims.
"The defense strategy convinces me that there is a serious risk that a joint trial would compromise a specific trial right of one of the defendants or prevent the jury from making a reliable judgment about guilt or innocence," Stearns concluded.
In addition to Cadden and Chin, eight other defendants are scheduled to go on trial in early April. Two others already pleaded guilty to reduced charges while two defendants had charges dismissed.
Contact:wfrochejr999@gmail.com

Key Defendant Files 11th Hour Dismissal Motion

By Walter F. Roche Jr.

Acting at the 11th hour, a key defendant in the criminal case stemming from a deadly fungal meningitis outbreak, is asking a judge, once again, to dismiss 25 counts of second degree murder.
Acknowledging that the deadline for such motions has long since passed, the lawyer for Barry Cadden is charging that the murder counts in the 2014 indictment are fatally defective because they fail to show that Cadden caused any of the 25 deaths.
In a two-page motion and a 13-page memorandum, attorney Bruce A. Singal also is repeating an already rejected request to force prosecutors to disclose the instructions given to the grand jury that indicted Cadden and 13 others in late 2014.
Cadden and co-defendant Glenn Chin are scheduled to go on trial Jan. 5 on the second degree murder charges. Cadden was a part owner and Chin a supervising pharmacist at the New England Compounding Center, the firm that shipped thousands of vials of fungus riddled steroids to health facilities across the country.
In the motion filed today, Cadden contends that it is Chin who should be held liable, not him.
"For each of the three lots (of drugs) at issue, it is Chin rather than Cadden who is alleged to have performed unlawful  acts," the motion states.
In addition the indictment, the motion states, does not properly allege the core elements of a second degree murder case."
 The motion contends that the facts cited in the indictment about long term problems at the New England Compounding Center, refute the contention that Cadden was "reasonably certain" that the three deadly lot of methylprednisolone acetate would kill anyone. Despite the long term poor conditions there had been no prior deaths, Singal argued.
The motion comes as U.S. District Judge Richard Stearns is considering a motion to separate the trials of Cadden and Chin. He previously denied a motion to dismiss the murder charges. He also denied a motion to force prosecutors to provide copies of their grand jury instructions.
Two other defendants have entered guilty pleas to reduced charges. Two others have had charges dismissed. The remaining defendants are scheduled to go on trial in April.
Contact: wfrochejr999@gmail.com

Revised NECC Lawyers' Fee Motion Filed

By Walter F. Roche Jr.

A revised motion that would authorize payment of some $6.25 million in lawyers' fees and expenses by the end of the calendar year was filed today in the federal court case stemming from the deadly 2012 fungal meningitis outbreak.
Under the motion the payment of the fees and expenses would be contingent on the payment of partial claims to all or virtually all of the outbreak victims who provide needed information by a Dec. 15 deadline.
The payment of only half of the $12.5 million in fees and expenses had been suggested as a compromise by U.S. District Judge Rya Zobel during a hearing last week in her Boston, Mass. courtroom.
The fees and expenses would go to law firms who did work benefiting all of the victims of the outbreak whose claims can be verified.
According to a report filed last week payments have been approved for 462 of more than 2,000 victims. The payments represent about 50 percent of what victims can expect to receive from a fund totaling between $130 and $157 million.
 The 2012 outbreak caused by fungus laden drugs shipped from a now defunct Framingham, Mass. drug compounding firm sickened some 778 patients, killing at least 77 of them.
The legal fees and victims' payments are coming from a fund amassed in the bankruptcy of NECC.
In a parallel criminal case, two NECC officials are scheduled to go on trial in early January on second degree murder and related charges. Other NECC owners and employees are scheduled for an April trial.
Contact: wfrochejr999@gmail.com

Judge Mulls Motion to Sever NECC Criminal Cases

By Walter F. Roche Jr.

The two key defendants in the criminal case stemming from a deadly fungal meningitis outbreak could be tried separately under a sealed motion now being considered by a federal judge.
Records in U.S. District Court in Boston, Mass. show a motion was filed to have Barry Cadden and Glenn Chin tried separately. Cadden and Chin are facing 25 counts of second degree murder under an indictment issued nearly two years ago.
The two are scheduled to be tried together in early January before U.S. District Judge Richard G. Stearns.
Though the two had agreed to a joint trial, papers filed recently by Chin's lawyer, charge that Chin had only recently learned that Cadden planned to blame him and him alone for the deaths.
Earlier this week Cadden's lawyers filed a motion to sever the two cases, but the motion was filed under seal.
After a hearing today, Stearns took the matter under advisement.
Chin and Cadden were among 14 people connected to the New England Compounding Center to be indicted following a two year probe of the deadly 2012 fungal meningitis outbreak. Two defendants already have entered guilty pleas to vastly reduced charges. Two others had charges dismissed.
The remaining defendants are scheduled to go on trial in April.
The outbreak sickened 778 patients who were injected with fungus laden methylprednisolone acetate, shipped in thousands of vials from NECC's Framingham, Mass. facility to health providers across the country.
Contact: wfrochejr999@gmail.com

Checks Mailed to 462 Outbreak Victims

 Average payment corrected


By Walter F. Roche Jr.

The trustee of a national fund to pay victims of the deadly 2012 fungal meningitis outbreak has issued checks to 462 of 2,340 who filed claims, according to a report filed today in U.S. District Court in Boston, Mass.
The total value of the issued checks, according to Lynne Riley, the trustee, is $7.3 million. An additional 28 victims have been cleared for payment and checks are being issued to them, pushing the total number of checks to 490.
According to the data provided the average payment thus far was  $15,828.64. The payments represent about half of what each victim can expect to receive when all of the funds are disbursed.
In a hearing today before U.S. District Judge Rya Zobel, Thomas Sobol, the lead attorney for plaintiffs, said 177 claims have been finally denied, while 1,981 have been either fully or partially approved. A small number of claims are still under appeal,
He said further information is needed for some of the remaining claims and if victims respond by Dec. 15, they can expect checks by the end of the year,
The victims' fund has been estimated to total $130 million to $157 million. It was amassed during the bankruptcy of the New England Compounding Center, the company blamed for the 2012 fungal meningitis outbreak which sickened 778 patients, killing 77 of them.
Nashville, Tenn. attorney Mark Chalos reported that all victims with claims against the Saint Thomas Outpatient Neurosurgical Center have agreed to accept a negotiated settlement. He said an administrator has been hired and payments are expected to go out early next year.
The amount of that settlement has not been made public but is believed to be in excess of $20 million.
Zobel also got updates on the status of claims from victims in New Jersey, Maryland and Minnesota.
Sobol also presented a defense of the payment of $12.5 million in legal fees and expenses to lawyers who performed work in the case benefiting all of the victims. His motion called for those fees to be paid by the end of the year.
But George Nolan, a Nashville, Tenn. lawyer, cited long delays and complicated filing requirements that were delaying payments to many victims including clients of his firm. He said the fact that lawyers would be getting full payments while victims continued to wait was causing "a great deal of controversy" among many victims.
Zobel then proposed a compromise under which lawyers would get half of their fees by the end of the year, with the other half to be distributed sometime next year.
Sobol agreed to draw up a motion to implement her suggestion.

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Fungal Infections

http://www.medicaldaily.com/deadly-fungal-infections-what-they-do-and-how-your-body-fights-them-405729

Prosecutors Detail NECC Murder Charge Evidence

By Walter F. Roche Jr.

Two former officials of the New England Compounding Center showed a "wanton and willful disregard for human life" that directly caused the death of 25 victims, federal prosecutors charged in U.S. District Court in Boston, Mass.
In an eight-page filing today, Assistant U.S. Attorney William D. Weinreb wrote that the conditions inside NECC's Framingham, Mass. facility were so bad that one public health official called it "a fungal zoo."
Bacteria and multiple forms of fungus were still found by federal inspectors in so-called clean rooms even after an "extraordinary" two-day clean up attempt by NECC staffers and a private contracting firm.
Four types of fungus were found in 150 patients injected with NECC drugs, the prosecutors charged, adding that drugs that were supposed to be sterile were produced with unsterile and expired components.
The filing comes as the two former NECC officials, Barry Cadden and Glen Chin, are just a month away from trial on 25 counts of second degree murder, racketeering and conspiracy. Weinreb urged U.S. District Judge Richard G. Stearns to reject a motion by the two defendants to hold a court hearing to force prosecutors to provide additional evidence to justify the 25 murder counts.
The two were indicted following a federal grand jury probe of the deadly 2012 fungal meningitis outbreak caused by fungus ridden drugs from NECC. Cadden was a part owner and chief pharmacist for NECC and Chin was a supervising pharmacist.
Earlier this week Stearns flatly rejected a request from Chin to delay his trial to early Spring.
Calling the motion for a hearing"a last ditch attempt to avoid judgment by their peers," the prosecution argued that no hearing was necessary and the charges should now go to a jury.
The evidence, the prosecutor stated, "will show that the defendants actions fell so far below the required standards of pharmacy care in producing these drugs that it was unconscionable that the defendants identified these drugs as sterile and dispensed them for use on patients."
In addition to the spinal steroid (methylprednisolone acetate) blamed for the deadly outbreak, prosecutors said federal investigators found 23 other species of fungus in other drugs produced by NECC including betamethasone, triamcinolone and cardioplegia
"This was not an unfortunate unexplainable tragedy, an accident or a mere coincidence as the defendants have stated in their various court filings in this case; this was second degree murder," the filing states.
Cited was a comment made by an NECC supervisor to a worker who had raised questions about the safety of the drugs being produced.
"You don't understand," the supervisor said. "You don't have money. When you have money, you always want more."
The actions by Cadden and Chin were "deliberate and intentional and prioritized profit over patient safety," the filing concludes.
Contact: wfrochejr999@gmail.com

Motion To Delay NECC Criminal Trial Swiftly Denied

By Walter F. Roche Jr.

Without a hearing or even waiting for federal prosecutors to respond, the judge presiding over the criminal trials stemming from a deadly fungal meningitis outbreak has denied a motion by a key defendant to delay his trial on murder charges for three months.
In a brief order issued today U.S. District Judge Richard G. Stearns denied the delay request filed by Glenn Chin, the former pharmacist who is facing 25 counts of second degree murder.
Chin, in a motion filed late last week, had cited the need to review reams of new documents provided by prosecutors and a repository of related documents from a civil case while his trial date was barely a month away.
Chin, through his lawyer, Stephen Weymouth, had also argued that his codefendant, Barry Cadden, had gained access to the civil suit documents years earlier, giving him an unfair advantage.
Stearns, however, noted that Cadden, who is also facing second degree murder charges, had no obligation to share evidence with a codefendant.
Chin and Cadden are two of 14 persons connected to the New England Compounding Pharmacy, the defunct Framingham, Mass. drug firm blamed for the 2012 nationwide fungal meningitis outbreak which sickened 778 patients across the country. At least 77 of those patients died.
Chin had also charged that he had only recently learned that Cadden, relying on evidence from the civil case, intended to place all the blame for the outbreak on him.
Stearns ruled that regardless of whether the evidence might reflect badly on Chin, Cadden was under no obligation to make Chin aware of it.
Unlike prosecutors, Stearns wrote, "Cadden has no corresponding duty to disclose materials on which he intends to rely in his own defense, even if these may to some extent reflect adversely on Chin."
In any case, Stearns concluded, "it is highly unlikely that the document repository in the parallel civil litigation includes anything that has not already been produced in the millions of documents turned over by the government."
Stearns decision means Cadden and Chin will go on trial as previously scheduled early next year.
In addition to the second degree murder charges the two are facing charges of racketeering, conspiracy and mail fraud.
Cadden was a part owner and chief pharmacist for NECC, while Chin was a supervising pharmacist.
Two of the original 14 NECC defendants have pleaded guilty to reduced charges and avoided any jail time. Two others, including Chin's wife, have had all charges dismissed, but the U.S. Attorney has appealed that decision to the First Circuit Court of appeals.
The remaining defendants are scheduled for trial in April.
Contact: wfrochejr999@gmail.com

Claims Notices Going to Saint Thomas Victims

By Walter F. Roche Jr.



The administrator of a settlement fund for Nashville, Tenn. area victims of the 2012 fungal meningitis outbreak has begun notifying victims that they must formally submit their claims by the end of the year.
The victims will be sharing in a settlement in excess of $20 million reached in negotiations with the Saint Thomas Outpatient Neurosurgical Center, where they were injected with fungus tainted spinal steroids shipped from a  now shuttered Massachusetts drug compounding firm.
Attorneys for victims confirmed today that their clients had begun to receive letters, which were mailed out earlier this week.
Details of the settlement have not been made public. The agreement with Saint Thomas Health and the Howell Allen Clinic, the co-owners of the outpatient neurosurgical center, came before any of the more than 100 cases could go to trial.
Attorneys for both sides have declined to discuss any details, citing confidentiality agreements.
The Nashville notices come as victims from across the country, including the Nashville area, are getting notices of awards from a national settlement fund created in the bankruptcy of the New England Compounding Center. According to state and federal regulators NECC was the source of the contaminated vials of methylprednisolone acetate.
In a related development federal prosecutors in Boston, Mass. have filed notice that they are appealing the recent decision by U.S. District Judge Richard Stearns to dismiss charges against three former NECC employees. The appeal will be made to the First Circuit Court of Appeals
Stearns dismissed charges against Kathy Chin, Michelle Thomas and Alla Stepanets. The three were among 14 owners and employees of NECC indicted in late 2014 after a lengthy grand jury investigation of the 2012 outbreak.
Stearns concluded that the roles played by the three did not reach the threshold required for criminal charges.
The two defendants facing the most serious charges, 25 counts of second degree murder, are scheduled to go on trial early next year. Glenn Chin and Barry Cadden have entered not guilty pleas to the second degree murder and other charges.
Contact: wfrochejr999@gmail.com

US Attorney Appeals NEC Dismissals

By Walter F. Roche Jr.

Federal prosecutors are appealing a judge's decision

NOTICE OF APPEAL
Notice is hereby given that the United States of America (the prosecution in the above- captioned case) hereby appeals to the United States Court of Appeals for the First Circuit from the District Court’s (Stearns, J.) (1) October 4, 2016 Memorandum and Order on Defendants’ Motions to Dismiss, which dismissed Counts 104-107 and 108-109 as they relate to Ms. Chin and Ms. Thomas (docket number 675, entered on the docket on October 4, 2016); (2) October 4, 2016 electronic order dismissing Counts 96-98, 101-103, and 108, relating to Ms. Stepanets (docket number 678, entered on the docket on October 4, 2016), and (3) from the Court’s November 16, 2016 denial of the government’s motion for reconsideration (docket number 725, entered on the docket on November 16, 2016).

NECC Defendant Seeks Three Month Trial Delay

By Walter F. Roche Jr.

Charging that his codefendant is planning to blame him alone for actions leading to a deadly fungal meningitis outbreak, one of the men facing 25 counts of second degree murder is asking for a delay in his trial until early Spring.
Glenn Chin, citing a mountain of newly discovered evidence, submitted the request today for the delay in his Jan. 2 trial on charges stemming from the 2012 outbreak which sickened 778 patients, killing 77 of them.
Stating that his codefendant, Barry Cadden, "is more than willing to save himself at the expense of his employee," the motion  charges that Cadden will be attempting to "place the blame solely and exclusively on Glenn Chin."
Cadden and Chin were charged with the second degree murder and racketeering  charges in late 2014 following a lengthy federal investigation of the New England Compounding Center, the defunct Framingham, Mass. company blamed for shipping thousands of fungus riddled steroids to health providers across the country.
The three-page motion charges that while Cadden, part owner of NECC, has had access to thousands of documents from a civil case for four years, Chin's lawyer only learned of their existence in October.
"Cadden will use these documents to show that Cadden had nothing to do with the alleged contamination of the products manufactured by NECC," the motion states.
The split between Cadden and Chin, NECC's supervisory pharmacists, comes only days after lawyers for the two defendants filed a joint motion seeking to force federal prosecutors to disclose evidence that would justify the second degree murder charges.
Filed by his attorney Stephen Weymouth, Chin's motion today also cites "12 million pages of discovery" provided by prosecutors, including 3.1 million in 15 increments over the past year alone. In addition prosecutors produced 70 grand jury transcripts.
But it is the newly discovered documents from a repository created in related civil litigation that the motion says "are crucial to Chin especially in the context of what Cadden intends to do at trial."
The motion charges that Cadden will "use every single document in his possession" to lay the blame on Chin.
"The fact that Cadden has had these documents for four years, while Chin is reviewing the documents for the first time is not fair and places Chin in a very difficult position," the motion states, adding that Chin now must defend himself "in this life and death case" facing not only the federal government but also his former boss.
The evidence in the civil case, according to the motion, includes testimony from dozens of witnesses including David Kessler, former head of the U.S. Food and Drug Administration.
As the motion notes, Cadden had access to the civil trial documents because he was one of the original defendants. His attorneys recently sought and obtained permission from the judge in the civil case to use the documents in his defense against criminal charges.
Weymouth stated in the motion that he had not discussed his request with federal prosecutors, but he expected them to oppose it.
U.S. District Judge Richard J. Stearns, who is presiding over the case, indicated when setting the Jan. 2 trial date that he would not be receptive to any further delays.
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Virginia Firm Joins Motion Seeking Delayed Fees

By Walter F. Roche Jr.

A Virginia law firm representing some 33 victims of the 2012 fungal meningitis outbreak is lending its support to a motion to delay the payment of lawyers fees until the victims themselves get an initial payment from a trust fund.
In a two-page filing today in U.S. District Court in Boston, Mass. the two lawyers asked U.S. District Rya Zobel to withhold payment of $12.5 million in legal fees and expenses until at least 90 percent of the outbreak victims have received an initial payment.
"It is manifestly inappropriate for fees and costs to be distributed ... when so many approved claimants, several affected individuals and families, have received nothing," the filing states.
John E. Lichenstein and Gregory Lyons of the Lichenstein Law Group in Roanoke, Va. signed the filing.
Earlier this week eight lawyers for victims from Tennessee, Indiana and Virginia filed a similar motion asking Zobel to put a hold on lawyers fees until the court appointed trustee certifies that 90 percent of the victims have received a payment.
That motion also asks Zobel to order the trustee, Lynne Riley, to file detailed monthly reports on the number of checks sent out and a breakdown of the category of each of the recipients. Under a court approved plan payments to victims are based on the severity of the illness and other factors, such as length of hospitalization.
The payments will come from a so-called national settlement fund created during the bankruptcy of the New England Compounding Center, the defunct drug firm blamed for the deadly 2012 outbreak.
Some 778 patients were sickened, many suffering fungal meningitis. At least 77 died from fungus riddled steroids shipped by NECC.
In the motion filed today, Lichenstein and Lyons wrote, "Many of these clients suffered catastrophic injury and permanent disability from the resulting fungal meningitis and secondary infections; others died."
According to the attorneys thus far only two of their clients have received a payment from the trust fund, which could total some $157 million.
"All those who survived live with uncertainty and fear of developing fungal disease or of having it recur.
A motion to pay the $12.5 million is pending before Zobel and it is scheduled for consideration at a Dec. 8 hearing.

Delay Sought in $12.5 Million Lawyers' Fees

By Walter F. Roche Jr.

A group of attorneys is asking a federal judge to delay the payment of $12.5 million in lawyers fees until victims of the 2012 meningitis outbreak get their first payments from a trust fund.
Two motions filed Tuesday in U.S. District Court in Boston, Mass. seek the payment delay and detailed periodic reports on the amount of money being distributed to outbreak victims.
"Lawyers should not be paid before victims," the motion states, citing the "inordinate delay in settlement payments."
The motions follow a request filed Monday seeking payment of the $12.5 million in so-called common benefit fees earmarked for those lawyers who performed services leading to the creation of the trust fund. That motion is set for consideration at a Dec. 8 hearing before U.S. District Judge Rya Zobel.
Noting that the original motion in support of the fees was based on the assumption that most victims would already have been paid previously, the motion cites the slow pace of payments thus far. Only 14 percent of the victims received an initial payment, according to the motion.
"Given the slow pace of benefit payments, it seems very unlikely that virtually all the claimants will have first received their first payment by the time the plaintiff steering committee's motion to disburse common benefit funds is heard during the Dec. 8 status conference," the motion states.
The motion was signed by eight attorneys: George Nolan, Daniel Clayton, Douglas Jones,
Jason Denton and Rebecca Blair from Tennessee,  J. Scott Sexton from Virginia, Douglas Small of Indiana  and J. Kyle Roby of Kentucky.
Stating that paying lawyers before victims "would be unwise for several reasons," the motion warns that doing so would offend innocent victims and undermine public confidence.
Citing the data provided thus far, the motion states that it appears the tort trustee has been paying smaller claims "before claims of those who died or were seriously injured."
According to the motion the average payment thus far was $19,780.
In addition to seeking the delay in fee payments, the motion asks the court to order Lynne Riley, the trustee of the victims fund, to file monthly reports detailing the amount distributed including a breakdown of the amount going to each category of victims.
The trust fund or national settlement fund, estimated at $130 million to $157 million, was created under the bankruptcy of the New England Compounding Center, the company blamed for the fungal meningitis outbreak that sickened 778 patients, killing at least 77 of them.
The national settlement fund is part of some $200 million in funds earmarked for victims. The additional funding comes from settlements with healthcare providers who injected patients with contaminated NECC steroids

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Lawyers Submit $12.5 Million NECC Fee Request

By Walter F. Roche Jr.

Lawyers for victims of a deadly 2012 meningitis outbreak are formally seeking approval for payment of $12.5 million in fees and expenses including three last minute additions.
A proposed order authorizing the payments was submitted today in U.S. District Court in Boston, Mass. and it is expected to be considered at a Dec. 8 hearing before U. S. District Judge Rya Zobel.
The fees would go to lawyers who served on a plaintiffs steering committee in the litigation stemming from the fungal meningitis outbreak. If approved the payments will come out of a $200 million fund created in the bankruptcy of the New England Compounding Center, the now defunct firm blamed for the deadly outbreak.
In submitting the proposed order, lead attorney Thomas Sobol noted that no objections were filed to the payment proposal since it was introduced over a month ago.
New fees included in the motion total  $8,398.90 and are earmarked for accounting and other services.
In a development in a related criminal case, the two defendants charged with 25 counts of second degree murder are asking for a hearing before U.S. District Judge Richard Stearns in an attempt to force prosecutors to disclose what evidence they plan to present to support the homicide charges.
Barry Cadden and Glen Chin were indicted on those charges and others following a lengthy investigation of NECC by a federal grand jury. The two are scheduled for trial early next year. Lawyers for Cadden and Chin wrote in a 10-page memorandum that they had reviewed 12 million pages of evidence and reviewed notes from hundreds of interviews but found nothing that would justify a second degree murder charge.
"It is increasingly evident that there is no ...evidence," the motion states.
The two attorneys did concede there was evidence "supporting the conclusion that these people died as a result of being injected with methylprednisolone acetate that was compounded at NECC and became contaminated."
"But," the memo states, "there is no evidence of anything Cadden or Chin did to cause the contamination of these drugs."
Charging that prosecutors overreached in an effort to "craft the biggest possible case," Cadden and Chin's attorneys cited grand jury testimony of an investigator for the U.S. Food and Drug Administration who acknowledged that he was just speculating about the possible source of the contamination. 
The FDA, the motion states, was "unable to find any of the fungus believed to be responsible for the contamination" despite a thorough examination of NECC's Framingham, Mass. facilities.
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Drug Compounding Regulation Still Murky

By Walter F. Roche Jr.

A report by the U.S. General Accountability Office finds that a new federal law aimed at closing a loophole that allowed wide scale unregulated drug compounding has left many questions unanswered three years after its enactment.
The 70-page report, based largely on the responses to a survey of state pharmacy boards and other interested parties, found that neither the state boards or the U.S. Food and  Drug Administration can even determine the volume of compounded drugs being produced.
Meanwhile, the report states, the FDA, although it has collected massive amounts of data from newly authorized mass drug compounders, has not figured out how to compile that data into useful information.
The 2013 law, the Drug Quality and Security Act, was prompted by the 2012 fungal meningitis outbreak caused by a rogue Massachusetts drug compounding firm that had shipped thousands of vials of fungus laden steroids to health providers across the country.
Records in a criminal case stemming from a grand jury probe of the outbreak show 778 patients were sickened, many with a debilitating bouts of fungal meningitis. According to a filing in the criminal case 76 of those patients died. The deaths have continued, however, boosting that count even higher.
The new law authorized for the first time the licensing of mass compound drug manufacturers who can produce compound drugs without a patient specific prescription.
"Nearly all the states reported that they did not collect data on the volume of compounded drugs," the report states, adding that in 18 states regulators did not know whether, under the new law, general practice physicians could legally compound drugs in their offices.
"Notably, nearly all of the states we surveyed reported having drug  compounding law or policies for
pharmacists, but not for physicians," the report states. 
The GAO reported that as of April 22 of this year 40 of 59, or nearly 70 per cent of mass drug compounding firms had not provided some or all of the data the federal agency had requested.
And while the FDA says the new law does not allow it, 39 states reported that "anticipatory compounding of both sterile and non-sterile drugs is authorized or allowed in their state." Only one state reported that it was illegal.
In other areas, the GAO found that 21 states now require specialized training of inspectors who are assigned to inspect drug compounding facilities and inspections are conducted as often as annually or as long as five years, according to the survey results.
Thirteen states reported imposing monetary penalties on drug compounders in 2014, while a dozen did so in 2015.
The FDA, according to the report, had conducted 75 inspections at 59 mass drug compounding facilities as of April 16 and issued 24 warning letters. There were 15 voluntary recalls of compounded drugs during the same period.
Dr. Michael Carome of Public Citizen, a nonprofit advocacy group, said that while he has seen some improvement in drug compounding the violations being reported by the FDA at so-called outsourcing facilities are concerning.
What is troubling is the high percentage of outsourcing facilities inspected by the FDA that have received warning letters describing serious problems in the production of sterile compounded drugs," Carome said, noting that those warning letters have come as the FDA has "ramped up" its inspections of those mass producers of compounded drugs.

A new report by the Government Accountability Office (GAO) finds that while the US Food and Drug Administration (FDA) has taken steps to improve its oversight of drug compounders, challenges at both the state- and FDA-level remain.

Background

Unlike traditional drugmakers, drug compounders are exempt from certain requirements of the Federal Food, Drug and Cosmetic (FD&C) Act. These exemptions allow compounders operating under section 503A of the act to produce drugs without complying with current good manufacturing practice (cGMP) and certain labeling requirements, and sell those drugs without marketing approval from FDA.
The safety of compounded drugs has been a high profile issue for FDA since an outbreak of fungal meningitis linked to a Massachusetts-based compounder killed 64 people in 2012.
In response to the outbreak, Congress passed the Drug Quality and Security Act (DQSA), which amended the Federal Food, Drug and Cosmetic Act (FD&C Act) to clarify requirements for compounders and created a pathway for compounders to register with FDA as outsourcing facilities.
Under the DQSA, registered outsourcing facilities operating under section 503B of the FD&C Act must follow cGMP requirements and are required to report adverse events to FDA for the drugs they produce in order to maintain exemptions for labeling and approval requirements.

GAO Report

Since the passage of the DQSA, GAO says FDA has made progress toward its new and clarified responsibilities with regard to drug compounding.
According to GAO, the agency has conducted more than 300 inspections of compounding facilities between May 2012 and April 2016, 75 of which were of registered outsourcing facilities. Many of these inspections led to action by FDA, including issuing numerous Form 483s and warning letters to compounders.
"These 75 inspections were at 59 of the 91 facilities that had registered with FDA," GAO writes. However, according to GAO, "many of the entities that were registered as outsourcing facilities withdrew their outsourcing facility registration submission before the agency scheduled an inspection, and others were not yet operating when the agency attempted to inspect them."
GAO says it also found that FDA generally met its obligations to publish guidance and other documents related to compounding, some of which were required under the DQSA.
In total, FDA has finalized seven guidance documents and 10 draft guidances related to compounding since 2014.
However, despite FDA's actions, GAO found that some stakeholders felt the agency was slow to publish guidance.
"Some stakeholder organizations said the amount of time it takes FDA to finalize the guidance and other documents … is challenging," GAO writes, noting that FDA cited the number of comments it received contributed to the delay.
However, overall, states appear to be content with the level of communication, with roughly three quarters of states saying they are either very or somewhat satisfied, or at least neither satisfied nor dissatisfied with the agency.
Another issue, GAO says, is that the data being collected by FDA and states paints an incomplete picture of the extent of drug compounding.
"According to FDA officials, there is no good source for data on the extent of drug compounding and who is doing it except for data on outsourcing facilities," GAO writes. Despite requirements for outsourcing facilities to provide FDA with data on the number of units of drugs they produce every six months, FDA told GAO that "not all outsourcing facilities provided these reports and the data provided were not yet collected and maintained in a standard format."
Furthermore, FDA told GAO that most registered outsourcing facilities have failed to submit all the required data to the agency. "As of April 22, 2016, 40 of the 59 outsourcing facilities had not provided some or all required reports," GAO writes.
As such, GAO says it was unable to look at aggregate data for drugs produced by registered outsourcing facilities for the report.
Going forward, FDA told GAO it plans to update its electronic reporting system so that future reports can be submitted electronically in a standardized format.
GAO
- See more at: http://www.raps.org/Regulatory-Focus/News/2016/11/18/26217/GAO-Report-Highlights-Ongoing-Challenges-in-Oversight-of-Drug-Compounders/#sthash.GB3fObCd.dpuf

Magistrate Denies Direct Access to Meningitis Files

By Walter F. Roche Jr.

A federal magistrate has ruled that if a defendant facing 25 counts of second degree murder wants access to related civil court files, he'll have to get them from a co-defendant also facing second degree murder charges.
Magistrate Jennifer Boal, in a ruling issued in U.S. District Court, denied a motion by Glenn Chin to get access to files amassed in related civil cases stemming from the 2012 fungal meningitis outbreak.
Boal in a prior ruling had granted co-defendant Barry Cadden limited access to the meningitis outbreak files.
In announcing the denial, Boal added, " the court clarifies" that its Sept, 29, 2016 order allowing Barry Cadden permission to use the files "includes the ability to share those materials with his co-defendants in the course of preparation for trial."
The ruling comes despite the fact that prosecutors had filed a motion in support of granting Chin and the other remaining defendants access to the civil litigation files.
Noting that they had originally opposed granting Cadden access to the files, Assistant U.S. Attorney William Weinreb wrote, "Nevertheless, in light of its earlier order, this court should make the same materials Cadden possesses available to the government and the other criminal defendants as well."
The ruling comes as the trial date for Cadden and Chin is fast approaching. Their trial is scheduled for Jan. 2, 2017. The other remaining defendants are scheduled for trial on lesser charges in April.
Chin and Cadden are both charged with 25 counts of second degree murder along with racketeering and mail and wire fraud charges.
Boal's order granting Cadden access to the now confidential files, limited him to those records amassed while Cadden was still a defendant in the civil actions.
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10 Outbreak Suits Against TN Clinic Dismissed

By Walter F. Roche Jr.

A federal judge has dismissed 10 suits filed in behalf of victims of the 2012 fungal meningitis outbreak against a Crossville, Tenn. clinic because the complaints failed to comply with Tennessee's health care liability statute.
In a decision handed down today in U.S. District Court in Boston, Mass., U.S. District Judge Rya Zobel concluded that 10 of the claims against the Specialty Surgery Center did not include certificates of good faith when health care liability claims were initiated, a requirement under Tennessee's health care liability law.
Zobel, however, denied dismissal motions in another five cases because lawyers in those cases filed the required certificates when they amended their original complaints to include claims under the state's health care liability law.
The Crossville clinic was one of three Tennessee locations where patients were injected with fungus laden steroids that triggered a nationwide fungal meningitis outbreak, sickening 778 patients and killing 77 of them.
All 15 cases that were the subject of Zobel's ruling today were initially filed with claims under Tennessee's product liability law.
In the five cases in which dismissal was denied, Zobel noted certificates of good faith were not included when the suits were first filed, but when those cases were amended to include health care liability claims, the certificates were attached.
Two of the remaining cases were amended to include health care liability claims but the certificates were not filed until about a month later.
"Their failure to file them (certificates of good faith) with their initial amended complaint was a fatal error that requires dismissal with prejudice," Zobel wrote.
In another eight cases Zobel found that certificates of good faith were never filed. Though the attorneys argued that there were "extraordinary circumstances" to explain the missing certificates, Zobel wrote that the lawyers offered "no explanation to show good cause as to why nine months later they still have not done so."
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NECC Judge Upholds Dismissals

By Walter F. Roche Jr.

The judge presiding over the criminal cases stemming from a deadly meningitis outbreak has flatly rejected an appeal by prosecutors to reverse his dismissal of charges against three defendants.
U.S. District Judge Richard Stearns concluded that the reconsideration motion "for the most part raises no new issues. It merely elaborates on arguments that it previously made."
Stearns said that despite the arguments by the U.S. Attorney, the charges against Alla Stepanets, Kathy S. Chin and Michelle Thomas did not meet the requirements of federal law.
In his original ruling Stearns, who presides in U.S. District Court in Boston, Mass., dismissed the charges against the three licensed pharmacists because he said they were merely checking outgoing orders and not legally dispensing prescription drugs.
"There is nothing about this clerical task (as alleged) that calls upon the professional judgment of a pharmacist," Stearns wrote.
The three were among 14 people indicted in late 2014 following a federal grand jury probe of the 2012 fungal meningitis outbreak caused by fungus laden steroids shipped from a now defunct Framingham, Mass. drug company, the New England Compounding Center
Calling one of the arguments by prosecutors "the latest red herring," Stearns scoffed at the idea that his decision could endanger the public health.
"This of course is not true," he concluded.
He also rejected what he described as the only new prosecution argument, that the three should have known something illegal was going on because some of the names on the prescriptions were clearly false.
"This is a dubious proposition," Stearns wrote."As the law has long made clear, mere presence at the scene of a crime, even when coupled with knowledge that a crime is being committed by others, is not sufficient to establish aiding and abetting."
Though all charges against Chin and Thomas were dismissed, Stepanets still faces trial on charges of conspiracy to defraud the federal government.
Chin is the wife of Glenn Chin, who was indicted on 25 counts of second degree murder in the same case. Glenn Chin and Barry Cadden, a former part owner of NECC who faces the same second degree murder charges, are scheduled for trial early next year.
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Prosecutor Wants All NECC Defendants to Get Civil Data

By Walter F. Roche Jr.

Federal prosecutors say that now that one defendant has been granted access to a repository of files, all the defendants in the fungal meningitis criminal case should be granted the same opportunity.
In a two-page filing this week in U.S. District Court in Boston, Mass. Assistant U.S. Attorney William Weinreb said that since the court has granted access to files in a related civil case to Barry Cadden, other defendants, including Glen Chin, should be given the same access.
Cadden and Chin are facing 25 counts of second degree murder in the criminal case stemming from the 2012 fungal meningitis outbreak caused by the New England Compounding Center.
In the filing this week Weinreb noted that prosecutors had opposed giving Cadden access to the civil suit files, accusing his lawyers of trying to do an end run around the normal discovery rules in criminal cases.
Despite those objections,  U.S. District Judge Rya Zobel ruled Cadden could have access to and use the civil file repository in his defense, subject to approval of the judge presiding over the criminal case.
The files at issue were gathered in a series of civil suits filed in the aftermath of the deadly 2012 outbreak. Cadden was originally one of the defendants in that civil case but the claims against him were eventually dropped.
In his filing Weinreb noted that neither Cadden or Chin "ever contributed to the repository nor participated in the (cases's) discovery. Indeed Chin was not even a party to the suit."
"Nevertheless," the filing states, "in light of its earlier order, this court should make the same materials Cadden possesses available to the government and the other criminal defendants as well."
The prior order granting Cadden access to the civil litigation data did limit him to data collected prior to his dismissal from the civil case.
Cadden and Chin are scheduled to go on trial on Jan. 5 of next year, while the remaining defendants have an April 2017 trial date.
The 2012 outbreak was caused by fungus laden steroid drugs produced by NECC and shipped to health care providers across the country. Cadden was part owner of NECC and Chin was a supervising pharmacist.
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Forfeitures Ordered Against NECC Defendants

By Walter F. Roche Jr.


The majority owner of the drug compounding firm blamed for a deadly outbreak and her husband have forfeited an additional $124,068.75 following their sentencing Wednesday in U.S. District Court in Boston, Mass.
Court records show the forfeiture orders were signed by U.S. District Judge Richard G. Stearns at the same time he imposed fines and probation for Carla and Douglas Conigliaro. Both had entered guilty pleas to one count of structuring bank withdrawals to avoid a report being filed with the federal government.
The forfeiture order against Douglas Conigliaro was for $119,467.60. His wife forfeited  $4,600.75. The two were also fined a total of $59,500.
Carla Conigliaro was the majority owner of the New England Compounding Center, the Framingham, Mass. firm blamed for the 2012 fungal meningitis outbreak that killed 77 patients and sickened another 701.
According to court records the Conigliaros made a flurry of withdrawals from bank accounts in the midst of a federal grand jury investigation of the outbreak.
Stearns imposed no jail time but ordered a year of probation for Carla Conigliaro and two years probation for Douglas.
The sentence conformed to a plea agreement with the two defendants under which more serious charges were dropped.
Federal prosecutors say that despite her majority ownership, Carla Conigliaro was not involved in the day to day operations of NECC. State and federal regulators concluded that fungus ridden steroids shipped by NECC caused the deadly outbreak.
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Conigliaros Get Fines and Probation

By Walter F. Roche Jr.

A federal judge today sentenced the majority owner of a defunct drug compounding firm blamed for a deadly fungal meningitis outbreak to one year of probation and a $4,500 fine
The sentence was imposed by U.S. District Judge Richard Stearns against Carla Conigliaro, 53, of Dedham, Mass. the majority owner of the New England Compounding Center.
Her husband, Douglas Conigliaro, 55, who headed a related sale company, was sentenced to two years probation and a $55,000 fine.
The sentences were the same as recommended by federal prosecutors under a plea agreement in which they entered guilty pleas to violating a federal law requiring that bank withdrawals in excess of $10,000 be reported to the federal government.
They admitted to structuring withdrawals under $10,000 from bank accounts to avoid triggering the reporting requirement.
Under the plea deal Carla Conigliaro pleaded guilty to violating the structuring law with withdrawals totaling $4,600.75 while her husband admitted to $119,647 in structured withdrawals.
As part of that agreement federal prosecutors agreed to drop several additional structuring charges.
Though she was the majority shareholder and a board member, prosecutors said she was not involved in the day-to-day operations of NECC.
NECC has been blamed for the 2012 fungal meningitis outbreak that sickened 778 patients across the country, killing at least 77 of them.
The company shipped thousands of vials of fungus riddled methylprednisolone acetate to health providers across the country.
Another NECC owner, Barry Cadden, and a top company pharmacist, Glen Chin, are scheduled to go on trial on Jan. 5 on second degree murder charges. Others indicted following a federal grand jury probe of the outbreak, are scheduled for trial in April on lesser charges.
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Indiana Appeals Court Rules Malpractice Law Governs Outbreak Claims

By Walter F. Roche Jr.

The Indiana Court of Appeals has ruled that claims of victims of the 2012 fungal meningitis outbreak against health providers who injected them with deadly fungus laden steroids must be pursued under the state's restrictive medical malpractice law and not the less restrictive general negligence law.
In a lengthy decision issued today the court affirmed lower court decisions finding that the claims stemming from the outbreak cannot be considered under general negligence statutes but under the laws governing medical malpractice.
Indiana's Insurance Commissioner, who had intervened in the case, had argued that the claims were governed by general negligence statutes and further contended that applying the dozens of claims to the state malpractice law would bankrupt the state fund known as the Patients Compensation Fund (PCF) established to pay malpractice claims.
At issue was the decision by two Indiana health care providers to purchase preservative free methylprednisolone acetate from a Massachusetts firm, the New England Compounding Center.
State and federal regulators ultimately concluded that steroids shipped by NECC to health care providers across the country were the cause of the outbreak which sickened 778 patients, killing 77 of them.
The case decided by the court includes claims by 112 victims or their survivors. The state malpractice law caps claims for injury or death to $1,250,000. It caps the liability of an individual health provider at $250,000 with the PCF to pay the balance of any award.
In the decision issued Monday the court concluded that the decision of health providers to purchase a preservative free product was a professional judgment covered by the state malpractice statute.
"We have little trouble concluding that the selection of preservative-free MPA—in particular, preservative-free MPA made by NECC—in favor of MPA with preservatives from other suppliers, were actions that involved the exercise of professional medical skill and judgment, i.e., they qualify as the practice of medicine."
As to the Insurance Commissioner's concerns about the impact on the state malpractice fund, the court said that was not their concern.
"Even if we assume that the claims in this case will result in payouts sufficient to threaten the viability of the PCF (which is by no means a foregone conclusion), we are not free to ignore the law in an attempt to save it," the ruling states.








Bradford, Judge.
Case Summary2
[1]    Beginning in 2012, patients around the country began suffering meningitis after being injected with preservative-free methylprednisolone acetate (“MPA”), a steroid purchased from New England Compounding Pharmacy, Inc., a/k/a the New England Compounding Center (“NECC”). It was soon discovered that some lots of MPA had become contaminated with fungus. This consolidated appeal concerns claims brought by injured patients (or those suing on their behalf) (collectively, “the Plaintiffs”) against Anonymous Clinic in St. Joseph County and Orthopedic and Sports Medicine Center of Northern Indiana (“OSMC”) and affiliated entities in Elkhart County (collectively, “the Defendants”). Plaintiffs contend that the Defendants were negligent in choosing to administer preservative-free MPA and in failing to properly
2 We heard oral argument in this case on October 19, 2016. We would like to commend all counsel on the high quality of their written and oral advocacy.
Court of Appeals of Indiana | Opinion 71A03-1512-CT-2199 | November 7, 2016    Page 3 of 28
evaluate NECC before using it as a supplier. Some of the Plaintiffs brought suit without using the procedures laid out in the Indiana Medical Malpractice Act (“the MMA”), and Defendants moved either for dismissal or summary judgment on the basis that Plaintiffs’ claims were claims of medical malpractice.
[2]    Stephen W. Robertson, acting in his capacity as Commissioner of Indiana Department of Insurance, which administers the Indiana Patient’s Compensation Fund (“the PCF”) intervened, arguing that Plaintiffs’ claims were of general negligence and therefore not subject to the provisions of the MMA. The trial courts ultimately agreed with Defendants and Plaintiffs (who had reversed their initial position) that Plaintiffs’ claims were governed by the MMA. In this consolidated appeal, the PCF contends that the trial courts erred in concluding that Plaintiffs’ claims are claims of medical malpractice. Plaintiffs, Defendants, and Amici Curiae (health-care providers facing similar claims in other cases), contend that Plaintiffs’ claims are subject to the MMA as they involve actions informed by the exercise of professional medical judgment. Because we conclude that Plaintiffs’ claims are subject to the MMA, we affirm the judgments of the trial courts and remand for further proceedings consistent with this opinion.
Facts and Procedural History
Court of Appeals of Indiana | Opinion 71A03-1512-CT-2199 | November 7, 2016    Page 4 of 28
[3]
I. St. Joseph County Litigation
The St. Joseph Superior Court set forth the facts underlying the claims filed in St. Joseph County in its order dismissing Plaintiffs’ claims:
PRELIMINARY DETERMINATIONS OF FACT 1.    This proceeding arises as a result of an outbreak of
fungal meningitis, fungal infections and other related complications that affected individuals in at least twenty states and caused, at a minimum, 64 deaths. The outbreak resulted in deaths and injuries to Hoosiers and Michigan residents who received treatment in Indiana. Indiana and Michigan were hit particularly hard. The [Centers for Disease Control] identified 93 cases of Hoosiers diagnosed with fungal infections linked to contaminated epidural injections, with 11 of those resulting in death. Michigan was the hardest hit state, with a case count of 264, and 11 of those resulting in death. There are many more individuals who received a contaminated injection who suffered injury from the injection, but who have not been identified as a “case” by the CDC.
2.    Plaintiffs are individuals or their representatives who suffered injury or death as a direct result of being administered one or more contaminated epidural injections. ....
Plaintiffs also include the spouses of certain individuals who received such contaminated injections. Those plaintiffs who received services from [Anonymous Clinic] sought treatment of back pain and related spinal conditions. Such services included physical therapy, epidural injections, pain medications and surgery. Each of the patient-plaintiffs was a “patient”, as defined by the MMA, of [Defendants] when they received their epidural steroid injections.
3.    [Anonymous Clinic is a] qualified health care provider under MMA which was and is engaged in the business of providing health care and selling medical related products. The plaintiffs’ complaints, filed before the St. Joseph Circuit and
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Superior Courts, each allege a claim arising out of the patient- health care provider relationship.
4.    The intervening party in this litigation is the Patient’s Compensation Fund (hereafter referred to as “PCF”). Under the provisions of the Indiana Medical Malpractice Act (hereafter referred to as “MMA”), the PCF is responsible for payment of a plaintiff’s claim which is determined by trial or through settlement to be a recoverable claim and where the health care provider in question, through its insurer, had paid as required under the MMA.
5.    Plaintiffs’ proposed complaints filed with the IDOI ... pleaded factual allegations about the patient-health care provider relationship each plaintiff had with [Anonymous Clinic]. Each proposed complaint alleges that the plaintiff was “injected with a contaminated epidural product” when he or she was treated at [Anonymous Clinic].
6.    Plaintiffs allege in 1998, Gregory Conigliaro and Barry Cadden co-founded the New England Compounding Pharmacy, Inc., known as New England Compounding Center (‘‘NECC”), in Massachusetts. Other members of the Conigliaro and Cadden families came to be involved with NECC either as owners, officers or employees. Other related entities to NECC were established by the Conigliaros and Barry Cadden, including Medical Sales Management, Inc., Ameridose, LLC and Alaunus Pharmaceutical, LLC in the State of Massachusetts.
7.    Plaintiffs allege NECC operated as a compounding pharmacy. Plaintiffs assert that compounding pharmacies are prohibited from mass production of pharmaceutical products but may only produce products that have a particular demand need, such as a drug for a patient who is allergic to an ingredient in a mass produced, FDA regulated product or a pharmaceutical product that is no longer manufactured.
8.    Plaintiffs allege [Anonymous Clinic] purchased preservative-free methylprednisolone acetate (“MPA”) from NECC. MPA is a steroidal product that can be injected into the area of the lumbar spine to provide pain relief to individuals who suffer with low back pain and related symptoms.
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9.    Plaintiffs allege there are particular safety and product quality risks associated with purchasing pharmaceuticals from a compounding pharmacy. The risk is heightened for those pharmaceutical products that are made without preservatives, due to the increased risk of their being or becoming contaminated.
10.    Plaintiffs allege an outbreak of fungal meningitis, lumbar fungal infections and related injuries and complications arose in September, 2012. [CDC] was notified by the Tennessee Department of Health of a patient who developed fungal meningitis after receiving an epidural steroidal injection. Additional patients developing fungal meningitis were next identified in Massachusetts and the outbreak continued spreading to 19 states, including Indiana and Michigan. The outbreak was the result of patients receiving one or more contaminated injections from three different lots of MPA compounded by NECC (lot numbers 05212012@68, 06292012@29 and 08102012@51) or from another contaminated NECC medication.
11.    Plaintiffs allege The Food and Drug Administration (“FDA”) and the Massachusetts Department of Public Health (“MDPH’’) began investigating NECC, along with the involvement of other state and federal agencies. On September 26, 2012, NECC recalled the three lots of MPA found to be contaminated. The suspected lots contained 17,676 dosage vials. Of this number, more than 14,000 were used for injections. Only about 3,000 doses were returned through the recall process.
12.    Plaintiffs allege the investigation of NECC revealed black particulate matter in sealed, returned vials of MPA. Vials also contained a greenish black foreign matter and others a white filamentous material. Sterility analysis later confirmed the presence of “viable microbial growth” in all of the 50 vials tested.
Appellant’s App. pp. 93-97 (record citations omitted).
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[4]    A total of six claims against Anonymous Clinic were consolidated to address the threshold legal issue of whether the claims are claims of general negligence or are subject to the MMA. On May 15, 2015, in the consolidated action captioned In re Steroid Litigation, Anonymous Clinic filed a motion to dismiss all of the Plaintiffs’ claims for lack of subject matter jurisdiction on that basis that MMA requirements had not been met.
[5]    On June 26, 2015, the PCF filed a response to the motion to dismiss, opposing it on the ground that the MMA did not apply to Plaintiffs’ claims. Also on June 26, 2015, Plaintiffs reversed their earlier position and filed a response urging the trial court to conclude that their claims were covered by the MMA. On August 27, 2015, the St. Joseph Superior Court heard oral argument on Anonymous Clinic’s motion to dismiss.
[6]    On October 12, 2015, the St. Joseph Superior Court granted Anonymous Clinic’s motion to dismiss in part, concluding that Plaintiffs’ claims were governed by the MMA. The St. Joseph Superior Court stayed proceedings until compliance with MMA procedures could be accomplished. On November 12, 2015, the PCF moved the St. Joseph Superior Court to certify the case for interlocutory appeal, which motion was granted on November 16. This court accepted jurisdiction.
II. Elkhart County
[7]    The Elkhart Superior Court set forth the facts underlying the claims filed in Elkhart County in its order entering summary judgment in favor of OSMC:
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FINDINGS OF FACT 1. Plaintiffs are residents of Indiana and Michigan. 2. OSMC operates medical clinics in Indiana. 3. Medical Protective provides medical malpractice insurance
to OSMC. 4. Broadly, the medical malpractice insurance coverage policy
requires Medical Protective to defend and indemnify OSMC “[i]n any claim based upon professional services,” subject to four exclusions:
a. Criminal acts and willful torts, b. Claims that fall under OSMC’s general liability policy, c. Punitive damages, or damages above and beyond compensatory damages, and d. Any amounts that exceed policy limits.
5. The New England Compounding Center (“NECC”) was a compounding pharmacy located in Massachusetts.
6. In 2005, OSMC began purchasing betamethasone and hyaluronidase from New England Compounding Center.
7. OSMC began purchasing drugs from NECC after Elkhart General Hospital, which is not a party to this case, began ordering compounded pharmaceuticals from NECC.
8. Before Elkhart General Hospital ordered pharmaceuticals from NECC, two pharmacists from the hospital traveled to NECC’s facilities.
9. Dr. Gene W. Grove, Sr., M.D. works as the medical director of OSMC and as chairman of the pharmacy and therapeutics board at Elkhart General Hospital.
10. While acting as chairman of the pharmacy and therapeutics board, Dr. Grove became aware that the Elkhart General Hospital medical staff had authorized NECC as a supplier.
11. OSMC hires Elkhart Hospital pharmacists to act as consultants.
12. OSMC’s trust in Elkhart General Hospital’s vetting process for pharmaceutical suppliers played a role in OSMC’s authorization of NECC as a supplier.
13. In 2006, OSMC decided to use preservative-free [MPA]. Court of Appeals of Indiana | Opinion 71A03-1512-CT-2199 | November 7, 2016    Page 9 of 28
14. Physicians at OSMC determined that preservative-free steroids are safer for patients because preservatives may cause arachnoiditis and damage the spinal cord.
15. Commercial drug manufacturers do not produce MPA in a preservative-free form.
16. OSMC decided to purchase preservative-free MPA from NECC because OSMC was already purchasing betamethasone and hyaluronidase from NECC.
17. OSMC did not seek other potential suppliers of preservative-free MPA.
18. The medical board at OSMC authorized the use of preservative-free MPA.
19. The medical board at OSMC authorized NECC as a supplier of medications.
20. Plaintiffs allege that compounding pharmacies may not mass produce pharmaceuticals, but rather must produce drugs for individual patients.
21. Mass producers of pharmaceuticals must receive special licenses and are subject to greater FDA oversight.
22. Drugs acquired from a compounding pharmacy generally involve greater risk than drugs acquired from a mass producer.
23. In 2012, the [CDC] began investigating an outbreak of fungal meningitis, lumbar fungal infections, and similar diseases. 24. The CDC traced the outbreak to three lots of preservative-
free MPA that NECC produced. 25. Approximately 17,676 vials of preservative-free MPA
originated from the contaminated lots. 26. A recall was issued, and only approximately 3,000 vials
were returned, with approximately 14,000 doses having been previously administered.
27. A number of the returned vials contained visible particulate and other foreign matter.
28. Fifty (50) of the returned vials were tested for sterility, and all of them contained viable microbial growth.
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[8]    Beginning on October 27, 2014, several Plaintiffs sued OSMC to recover for injuries allegedly suffered because of the injection of defective MPA.3    On May 15, 2015, the PCF moved for summary judgment on the ground that the Plaintiffs’ claims were not covered by the MMA. Also on May 15, 2015, OSMC moved for summary judgment, asserting that the Plaintiffs’ claims were covered by the MMA. On June 25, 2015, Plaintiffs responded to the summary judgment motions, seeking a determination that their claims were covered by the MMA. On August 7, 2015, the Elkhart Superior Court heard oral arguments on the summary judgment motions. On November 13, 2015, the Elkhart Superior Court issued its order entering summary declaratory judgment in favor of OSMC on the ground that the MMA applies to Plaintiffs’ claims.
III. Appellate Procedure
[9]    On February 17, 2016, Plaintiffs moved this court to consolidate the St. Joseph appeal with the Elkhart appeal, a motion the PCF did not oppose. On March 7, 2016, this court granted the motion to consolidate the appeals, consolidating appellate cause numbers 20A03-1512-CT-2148 and 71A03-1512-CT-2199 under the latter cause number.
Discussion and Decision
3 At the time of the Elkhart Superior Court’s order, a total of twenty-six cases were before the court involving the same question about whether the MMA applied to their claims.
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[10]    All agree that the only issue in this appeal is whether Plaintiffs’ allegations against Anonymous Clinic and OSMC are claims of general negligence or are covered by the provisions of the MMA. The parties also agree that the issue, as ultimately one of jurisdiction, is to be reviewed de novo by this court. See Kondamuri v. Kondamuri, 799 N.E.2d 1153, 1156 (Ind. Ct. App. 2003) (“A court’s jurisdiction either exists or does not, and the question of a court’s jurisdiction is therefore a question of law that is not entrusted to the trial court’s discretion but rather is reviewed de novo.”), trans. denied.
I. Background—The MMA
[11]    Plaintiffs, Defendants, and Amici Curiae argue that Plaintiffs’ claims are covered by the MMA while the PCF argues that they are not.
[T]he MMA [is] a statute that applies to claims of personal injury or death proximately caused by a “health care provider,” as that term is defined in the MMA.... We will usually refer to this type of claim in this opinion as “medical malpractice” or just “malpractice.” The MMA did not create or establish the medical malpractice claim; it only imposed procedural requirements on the prosecution of them. Chamberlain v. Walpole, 822 N.E.2d 959, 961 (Ind. 2005).
One of the requirements of the MMA is that a proposed medical malpractice complaint first be filed with the Department of Insurance for review by a medical panel before the complaint is filed in court.
Ellenwine v. Fairley, 846 N.E.2d 657, 660 (Ind. 2006). The MMA ... set up a system under which health care providers
meeting qualifications set forth in the act (“Qualified Provider”) Court of Appeals of Indiana | Opinion 71A03-1512-CT-2199 | November 7, 2016    Page 12 of 28
would enjoy certain benefits, including a limitation on liability. For an act of malpractice occurring after June 30, 1999, the total amount recoverable for an injury or death is now capped at $1,250,000. See Ind. Code § 34-18-14-3(a)(3). A Qualified Provider’s liability for an occurrence of malpractice is now limited to $250,000. See Ind. Code § 34-18-14-3(b). Any remaining amount due from a judgment or settlement is to be paid from the Fund. See Ind. Code § 34-18-14-3(c).
In re Stephens, 867 N.E.2d 148, 150 (Ind. 2007).
[12]    At the heart of both the Elkhart and St. Joseph Superior Courts’ decisions is their conclusion that the MMA governs Plaintiffs’ claims against Defendants. Defendants and Amici Curiae, who are also health care providers under the MMA, wish to have this court declare Plaintiffs’ claims subject to the MMA. Plaintiffs, despite the fact that they would face the additional procedural burdens of compliance with the MMA as well as the limitations on recovery, take the same position. The PCF contends that Plaintiffs’ claims are claims of general negligence, not governed by the MMA.
II. The Arguments
[13]    Pursuant to Indiana Code section 34-18-2-13, “‘Health care’ means an act or treatment performed or furnished, or that should have been performed or furnished, by a health care provider for, to, or on behalf of a patient during the patient’s medical care, treatment, or confinement.” The question is whether the negligence alleged against Defendants qualifies as “health care.” If so, Plaintiffs’ claims are subject to the MMA; if not, they are claims of general negligence.
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[14]    In the brief in support of the PCF’s summary judgment motion filed in Elkhart Superior Court, it characterized Plaintiffs’ arguments as follows:
Instead, the gravamen of plaintiffs’ underlying complaints is that OSMC [was] negligent in procuring preservative-free [MPA] from NECC. Based on a review of the underlying complaints and the deposition testimony of [OSMC]’s representatives, the PCF anticipates that plaintiffs’ arguments related to whether the MMA applies to their claims will fall into two broad categories - namely, (1) the decision to use a preservative-free [MPA], and (2) the decision to purchase that product from NECC.
Appellant’s App. p. 277.
[15]    In the PCF’s motion in St. Joseph Superior Court, it characterizes the Plaintiffs’ claims as follows:
Instead, the gravamen of plaintiffs’ underlying complaints is that [Anonymous Clinic was] negligent in procuring preservative-free [MPA] from NECC. The “question of whether a given course of treatment was medically proper and within the appropriate, standard” is the “quintessence of a malpractice case.” Howard Reg’l Health Sys. v. Gordon, 952 N.E.2d 182, 185 (Ind. 2011). But, noticeably absent in this case is any allegation that the “course of treatment” was improper or improperly administered. Instead, plaintiffs allege that the course of treatment was tainted by a third party who allowed the medications to become contaminated. This factual scenario is fundamentally different from the allegations that state a claim for medical malpractice.
The complaint allegations relevant to [Anonymous Clinic] fall into two broad categories - namely, (1) the decision to use a preservative-free [MPA], and (2) the decision to purchase that product from NECC.
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Appellant’s App. pp. 996-97. So, the question is whether deciding to use preservative-free MPA and deciding to purchase it from NECC constitute “health care” under the MMA. If so, the alleged negligence in those areas would be subject to the MMA. If not, such claims would be claims of general negligence.
A. Legal Arguments
[16]    The PCF contends that the general procurement of products that will eventually be used in the course of treatment does not qualify as “health care” under the MMA. The OSMC and Anonymous Clinic argue that Plaintiffs’ allegations are covered by the MMA. Amici point out that the U.S. District Court for the District of Massachusetts, which is hearing hundreds of similar cases in federal multidistrict litigation (“the MDL Court”), has determined similar claims to be claims of professional negligence, and urges this court to do the same.
[17]    “The [MMA] is not all-inclusive as to claims against medical providers, and a claim against a medical provider sounding in general negligence or premises liability rather than medical malpractice is outside the [MMA].” Peters v. Cummins Mental Health, Inc., 790 N.E.2d 572, 576 (Ind. Ct. App. 2003), trans. denied.
The Act covers “curative or salutary conduct of a health care provider acting within his or her professional capacity, but not conduct unrelated to the promotion of a patient’s health or the provider’s exercise of professional expertise, skill, or judgment.” Howard Reg’l Health Sys. v. Gordon, 952 N.E.2d 182, 185 (Ind. 2011) (emphasis added) (citation and quotation marks omitted).
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When deciding whether a claim falls under the provisions of the Act, “we are guided by the substance of a claim to determine the applicability of the Act.” Doe by Roe v. Madison Ctr. Hosp., 652 N.E.2d 101, 104 (Ind. Ct. App. 1995).... [W]e reiterate that the “fact that the alleged misconduct occurs in a healthcare facility” or that “the injured party was a patient at the facility,” is not dispositive in determining whether the claim sounds in medical malpractice. Madison Ctr., Inc. v. R.R.K., 853 N.E.2d 1286, 1288 (Ind. Ct. App. 2006), trans. denied. “[T]he test is whether the claim is based on the provider’s behavior or practices while acting in his professional capacity as a provider of medical services.” Id. (quotation marks omitted). We also noted more recently that:
A case sounds in ordinary negligence [rather than medical negligence] where the factual issues are capable of resolution by a jury without application of the standard of care prevalent in the local medical community. By contrast, a claim falls under the Medical Malpractice Act where there is a causal connection between the conduct complained of and the nature of the patient-health care provider relationship.
B.R. ex rel. Todd v. State, 1 N.E.3d 708, 714-15 (Ind. Ct. App. 2013) (citations omitted), trans. denied.
Terry v. Cmty. Health Network, Inc., 17 N.E.3d 389, 393 (Ind. Ct. App. 2014).
Indiana courts understand the Malpractice Act to cover “curative or salutary conduct of a health care provider acting within his or her professional capacity,” Murphy v. Mortell, 684 N.E.2d 1185, 1188 (Ind. Ct. App. 1997), but not conduct “unrelated to the promotion of a patient’s health or the provider’s exercise of professional expertise, skill, or judgment.” Collins v. Thakkar, 552 N.E.2d 507, 510 (Ind. Ct. App. 1990). To determine whether the
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Act is applicable, the court looks to the substance of a claim. Van Sice v. Sentany, 595 N.E.2d 264 (Ind. Ct. App. 1992). Thus, regardless of what label a plaintiff uses, claims that boil down to a “question of whether a given course of treatment was medically proper and within the appropriate standard” are the “quintessence of a malpractice case.” Id. at 267 (plaintiff’s claims of fraud and battery fell within the Malpractice Act because the first was essentially a claim that the defendant failed to adhere to a standard of care and the second was a claim that the defendant did not obtain informed consent for a procedure); Popovich v. Danielson, 896 N.E.2d 1196, 1202-04 (Ind. Ct. App. 2008) (though styled as assault and battery, fraud, breach of contract, and defamation, all plaintiff’s claims involved defendant’s exercise of professional judgment and involved actions taken while providing medical care and thus the requirements of the Act applied).
By contrast, to fall outside the Malpractice Act a health care provider’s actions must be demonstrably unrelated to the promotion of the plaintiff’s health or an exercise of the provider’s professional expertise, skill, or judgment. Kuester v. Inman, 758 N.E.2d 96 (Ind. Ct. App. 2001); Collins, 552 N.E.2d at 510 (Ind. Ct. App. 1990) (Act held inapplicable in cases where the conduct involved was “unrelated to the promotion of a patient’s health or the provider’s exercise of professional expertise, skill or judgment”).
Howard Reg’l Health Sys. v. Gordon, 952 N.E.2d 182, 185-86 (Ind. 2011). 1. Harts and Pluard
[18]    The PCF relies primarily on two Indiana cases to support its argument that alleged negligence in this case is not governed by the MMA. The first of these cases is Harts v. Caylor-Nickel Hosp., Inc., 553 N.E.2d 874 (Ind. Ct. App. 1990), trans. denied, in which the elderly plaintiff was injured when the railing allegedly
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collapsed on his hospital bed, causing him to fall out. Id. at 875-76. Harts argued, and the court agreed, that his claim against the hospital was not subject to the MMA. Id. at 879. In so doing, the Harts court relied on our earlier decision in Winona Memorial Found. of Indianapolis v. Lomax, 465 N.E.2d 731 (Ind. Ct. App. 1984):
“Such matters as the maintenance of reasonably safe premises are within the common knowledge and experience of the average person. Health care providers, who must make up the medical review panel..., are no more qualified as experts on such matters than the average juror.    And as we have stated: ‘When ... the matters at issue are within the common knowledge and experience of the jury, expert testimony regarding the exercise of reasonable care is improper and should be excluded.’ Emig v. Physicians’ Physical Therapy Service, Inc., 432 N.E.2d [52, 53 (Ind. Ct. App. 1982)] (citing Rosenbalm v. Winski, (1975) 165 Ind. App. 378, 332 N.E.2d 249).”
Harts, 553 N.E.2d at 879-80 (quoting Lomax, 465 N.E.2d at 740) (emphasis in Harts, first ellipsis added).
[19]    Noting that Harts’s allegations were limited to a claim that the hospital’s employees failed to properly restrain or secure the guardrail on his bed, we concluded that
[t]he tenor of Harts’ complaint taken as a whole clearly supports an allegation of ordinary negligence. We cannot say that these allegations were part and parcel of diagnosis and treatment which would subject his claim to coverage under the Act. He did not allege any breach of duty directly associated with medical negligence that was integral to the rendering of medical treatment that would subject his claim to the Medical Malpractice Act.
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Harts, 553 N.E.2d at 879.
[20]    The PCF also relies on our decision in Pluard ex rel. Pluard v. Patients Compensation Fund, 705 N.E.2d 1035 (Ind. Ct. App. 1999), trans. denied. Infant Pluard was injured when a surgical lamp detached from a wall and fell on him, striking him in the head. Id. at 1036. After settling with the hospital, Pluard sought to recover excess damages from the PCF, which countered that the tort that caused Pluard’s injuries was not governed by the MMA. Id. We ruled in favor of the PCF, concluding that
[t]he nurses’ assistant’s manipulation of the light, while very close in time to the light’s falling on Pluard, has not been alleged to have caused his injury. Pluard was injured because the light fell on him; the light fell on him because it was not properly attached to the wall. Put another way, the duty to secure the light, and even the nurses’ assistant’s duty to position it, did not involve a health care decision involving the exercise of professional skill or judgment. Instead, it involved the general duty to maintain safe premises and equipment. As such, it involves issues capable of resolution without application of the standard of care prevalent in the local medical community, and thus, is outside the purview of the Act, which requires convening a panel of medical experts for the purpose of judging a completely different kind of question. Even when we view the evidence in the light most favorable to Pluard, and accept the proposition that the light fixture’s fall was sufficiently proximate in time as to make it part of the ongoing care of Pluard, the nurses’ assistant being under the direction of the surgeon, it still was not an event that required the exercise of professional skill and judgment.
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[21]    The PCF contends that the court’s focus in Harts and Pluard was on whether the product was defective or misused during treatment. Specifically, the PCF asserts that the decisions stand for the proposition that if the product is defective, the claim falls outside the MMA, and, if the product is misused, the claims are governed by the MMA. It would follow, then, that because there have been no allegations that the Defendants misused the MPA, Plaintiffs’ claims fall outside the MMA. We are not persuaded, however, that the PCF’s position is a reasonable reading of Harts and Pluard.
[22]    A fair reading of both decisions indicates that the court’s true focus in both cases was on whether the issues were capable of resolution without referring to the medical standard of care; if so, the claims would not be subject to the MMA. The Harts court stated that “[w]hen ... the matters at issue are within the common knowledge and experience of the jury, expert testimony regarding the exercise of reasonable care is improper and should be excluded.” Harts, 553 N.E.2d at 879 (quoting Lomax, 465 N.E.2d at 740). The Pluard court also based its conclusion on this distinction, determining that the case involved “issues capable of resolution without application of the standard of care prevalent in the local medical community, and thus, is outside the purview of the Act, which requires convening a panel of medical experts for the purpose of judging a completely different kind of question.” Pluard, 705 N.E.2d at 1038. Contrary to the PCF’s assertion, Harts and Pluard stand for the proposition that matters are not subject to the MMA when they can be resolved without reference to the local medical standard of care.
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[23]    With this in mind, we turn to Plaintiffs’ specific allegations. Plaintiffs have alleged that Defendants negligently decided to purchase preservative-free MPA from NECC and also negligently failed to properly investigate and evaluate NECC’s manufacturing procedures. The PCF asserts that these allegations are not covered by the MMA. We have little trouble concluding that the selection of preservative-free MPA—in particular, preservative-free MPA made by NECC—in favor of MPA with preservatives from other suppliers, were actions that involved the exercise of professional medical skill and judgment, i.e., they qualify as the practice of medicine.
[24]    We have observed that “[t]he practice of medicine may be said to consist in three things: First, in judging the nature, character, and symptoms of the disease; second, in determining the proper remedy for the disease; third, in giving or prescribing the application of the remedy to the disease.” Fowler v. Norways Sanitorium, 112 Ind. App. 347, 42 N.E.2d 415, 420 (Ind. Ct. App. 1942) (quoting Underwood v. Scott, 23 P. 942, 943 (Kan. 1890)) (superseded by statute on other grounds as recognized by Sloan v. Metro. Health Council of Indpls., Inc., 516 N.E.2d 1104, 1106 (Ind. Ct. App. 1987)). We conclude that the allegations in this case clearly fall under the second aspect of the practice of medicine—selection of the proper remedy.
[25]    As mentioned, MPA is injected into the lumbar spinal region of patients to relieve lower back pain. In Anonymous Clinic’s case, the decision to administer preservative-free MPA was made by a physician, Dr. Kathryn Park, on the basis that preservatives can be neurotoxic. In OSMC’s case, the decision Court of Appeals of Indiana | Opinion 71A03-1512-CT-2199 | November 7, 2016    Page 21 of 28
to purchase preservative-free MPA from NECC was made by its medical board, which consisted of Dr. Gene Grove and other physicians on OSMC’s board. Physicians at SMC determined that the preservatives in question could cause arachnoiditis and damage the spinal cord. Selection of preservative-free MPA clearly involved the practice of medicine.
[26]    We also conclude that the decision to purchase preservative-free MPA from NECC was an integral part of the remedy-selection process. For Anonymous Clinic, the decision to purchase from NECC was made by Dr. Park because NECC was, as far as she knew, the only supplier of preservative-free MPA; Anonymous Clinic had used other NECC products for years without problems; and NECC had a good reputation among other physicians. Put another way, Anonymous Clinic’s medical decision to administer preservative-free MPA necessarily involved an evaluation of NECC’s suitability as a supplier because it represented the only source known to the clinic. It is reasonable to assume that Dr. Park evaluated NECC’s suitability in light of Anonymous Clinic’s long- standing relationship with NECC and its reputation.
[27]    In the case of OSMC, the decision to source the MPA from NECC was also the result of a long-standing relationship. In 2005, OSMC began purchasing betamethasone and hyaluronidase from NECC after Elkhart General Hospital began ordering compounded pharmaceuticals from NECC. As it happens, in addition to being on the medical board of OSMC, Dr. Grove was chairman of the pharmacy and therapeutics board at Elkhart General and had become aware that the Elkhart General medical staff had authorized NECC as a
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supplier. The record reflects that OSMC’s trust in Elkhart General’s vetting process for pharmaceutical suppliers played a role in OSMC’s subsequent authorization of NECC as a supplier. It is reasonable to assume that OSMC weighed the potential benefits of using preservative-free MPA from NECC against the potential risks and determined that purchasing the medication from NECC was a reasonable approach. This decision is obviously one that was made using professional judgment. In summary, pursuant to this court’s holdings in Harts and Pluard, the line between MMA claims and non-MMA claims divides them into situations that can be understood without the assistance of expert testimony and those that cannot be, and the claims in this case fall into the latter category.4
4    Plaintiffs and OSMC bring our attention to two Indiana cases in which the court concluded that claims involving allegedly defective products provided by medical providers to patients were nonetheless subject to the MMA. See St. Mary Med. Ctr., Inc. v. Casko, 639 N.E.2d 312, 315 (Ind. Ct. App. 1994); and Dove by Dove v. Ruff, 558 N.E.2d 836 (Ind. Ct. App. 1990), trans. denied.
It is worth noting, however, that in Casko and Dove, the plaintiffs were attempting to have their cases treated as products liability claims, while the PCF is attempting to have the claims here treated as general negligence. In the first situation, the question is whether the product was used as part of medical treatment and in the second, whether the actions of the health care providers cannot be understood by laypersons without expert testimony. While the holdings in Casko and Dove are certainly not inconsistent with our conclusion in this case, the issues resolved are different and the reasoning is not particularly helpful here.
Amici, who are health care providers and defendants in several cases involving defective MPA, note that the U.S. District Court for the District of Massachusetts (“the MDL Court”) is currently overseeing multi-district litigation (“MDL”) from jurisdictions nationwide involving steroids made by NECC in In re: New England Compounding Pharmacy, Inc., Products Liability Litigation, No. 1:13-md-02419 (D. Mass.). The MDL Court has dismissed claims regarding defective MPA under other states’ laws. As with Casko and Dove, however, the plaintiffs’ claims in those cases are all claims of products liability, unlike the negligence claims brought in this case. Consequently, the MDL Court’s reasoning is no more helpful in this case than the courts’ reasoning in Casko and Dove.
Finally, the Amici have compiled a table of cases in their brief from other jurisdictions addressing the question of whether the delivery of a product in the context of medical treatment can support a products liability claim or whether the claim is one of medical malpractice. The Amici note that twenty-three of twenty-five jurisdictions to consider the question have determined the claim before it to be one of
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2. Lack of Causal Connection
[28]    The PCF also contends that there is no causal connection shown in this case between the treatment of any individual patient and the exercise of medical judgment by any Defendants. The PCF’s argument is apparently that the decisions by Defendants to purchase preservative-free MPA from NECC, even if they did involve the exercise of medical judgment, occurred years before any of Plaintiffs received their treatments and were therefore made outside the provider-patient relationship. This position would seem to be based on the proposition that only decisions made by providers with specific patients in mind can be subject to the MMA. The language of the MMA is not so restrictive. “‘Health care’ means an act or treatment performed or furnished, or that should have been performed or furnished, by a health care provider for, to, or on behalf of a patient during the patient’s medical care, treatment, or confinement.” Ind. Code § 34-18-2-13. Nothing in the statutory language exempts decisions made by a health care provider regarding a general course of treatment for a particular class of patient. We conclude that general decisions that later affect particular patients are not exempt from the provisions of the MMA for an alleged lack of causal connection.
medical malpractice and not products liability. Suffice it to say that, as with Casko, Dove, and the decisions rendered by the MDL Court, all of the holdings rely on the concept that medical treatment is primarily a service and not a sale of products and do not address negligence theories of the type brought in this case.
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B. Policy Arguments
[29]    The PCF points out that, pursuant to the MMA, the total recovery in any malpractice action is $1,250,000 per injury or death. Ind. Code § 34-18-14- 3(a)(3). Moreover, the MMA caps the health care provider’s malpractice liability at $250,000 per occurrence. Ind. Code § 34-18-14-3(b). Amounts in excess of this are payable from the PCF upon petition. Ind. Code §§ 34-18-14- 3(c), -15–3. Also, subject to certain terms and conditions,
[i]f an annual aggregate [of $750,0005] for a health care provider qualified under this article has been paid by or on behalf of the health care provider, all amounts that may subsequently become due and payable to a claimant arising out of an act of malpractice of the health care provider occurring during the year in which the annual aggregate was exhausted shall be paid from the patient’s compensation fund[.]
Ind. Code § 34-18-6-6(a).
[30]    The PCF notes that OSMC faces approximately 100 individual claims while Anonymous Clinic faces approximately twelve individual claims. Assuming that Defendants are found liable for negligence following trial in all or many of these cases, the potential exposure could be significant. The PCF asserts that the General Assembly did not contemplate making the PCF the insurer of the safety of practically all products used in health care and suggests that a decision
5    It does not seem to be disputed that all Defendants have annual aggregates of $750,000 each pursuant to Indiana Code section 34-18-4-1(1)(C)(i), which provides that “[i]f the health care provider is a health facility, the minimum annual aggregate insurance amount is as follows:... For health facilities with not more than one hundred (100) beds, three (3) times [$250,000.]”
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against it would subject it to strict liability in this and similar cases. The PCF further argues, essentially, that the allegedly increased potential liability it would face due to cases such as this would result in increased surcharges from healthcare providers to fund the PCF and jeopardize their ability to obtain affordable medical malpractice insurance.
[31]    Defendants counter that a determination that this case is governed by the MMA does not thwart but, rather, furthers the legislative intent. Defendants argue that the MMA was designed as a comprehensive medical liability insurance arrangement that struck a balance between ensuring both that (1) the patients injured by professional negligence receive at least some compensation and (2) health care providers can continue to provide affordable health care. Anonymous Clinic also argues that the PCF mischaracterizes Plaintiffs’ claims as product liability and that the PCF would not be subject to strict liability for defective products used in medical care. OSMC also points out that a statutory mechanism, i.e., Indiana Code section 34-18-5-4, already exists for increasing the surcharge on health care provides to maintain the PCF’s liquidity in the event of large payouts. In a nutshell, Defendants argue that even if the claims at issue in this case were to drain the PCF entirely, it is not this court’s place to ensure the PCF’s liquidity; this court’s only job is to decide if the claims before it are governed by the MMA. To the extent that there may be a public policy question with the MMA and the PCF, it is the General Assembly’s decision to address the question.
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[32]    The Defendants and Plaintiffs have the much more defensible position here, namely that ensuring the PCF’s continued liquidity is not this court’s job. If, pursuant to the MMA’s plain language and under current precedent, the Plaintiff’s claims should be governed by the MMA, we should rule as such, whatever the consequences. See, e.g., Ind. Dep’t of Envtl. Mgmt. v. Chem. Waste Mgmt., Inc., 643 N.E.2d 331, 338 (Ind. 1994) (“The General Assembly has decided to concentrate the State’s energies on regulating commercial waste disposal facilities and it is not our job to second guess such decisions.”). Even if we assume that the claims in this case will result in payouts sufficient to threaten the viability of the PCF (which is by no means a foregone conclusion), we are not free to ignore the law in an attempt to save it.
Conclusion
[33]    There is really only one issue before the court in this case, whether alleged negligence by a medical provider in selecting a certain drug from a particular supplier are claims subject to the MMA or sound in general negligence. Indiana law stands for the proposition that if allegations cannot be understood by laypersons without resort to expert testimony, the claims are governed by the MMA. We conclude the claims in this case, i.e., that Defendants were allegedly negligent in choosing to purchase and administer preservative-free MPA and in choosing NECC without proper vetting, are allegations that claim negligence in decisions that were made using professional expertise. Because we conclude that Plaintiffs’ claims are governed by the provisions of the MMA,
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we affirm the judgment of the trial courts and remand for further proceedings consistent with this opinion.
[34]    We affirm and remand for further proceedings. Pyle, J., and Altice, J., concur.
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