Friday, July 31, 2015

Magistrate Bars NECC Insiders' Depositions

By Walter F. Roche Jr.

A federal magistrate judge has ruled that the owners of a defunct Massachusetts drug compounding firm cannot be forced to undergo questioning in a series of civil suits while they are under indictment in a closely related criminal case.
In a 22-page decision handed down today Magistrate Judge Jennifer Boal concluded that five owners and principals of the New England Compounding Center, who are also under criminal indictment, do not have to appear immediately for depositions under subpoenas issued by lawyers for a group of Tennessee health clinics.
"The court is persuaded that the depositions of the insider defendants in the criminal case should not go forward at this time," Boal wrote.
Citing the "significant overlap" between the civil  and criminal cases, Boal concluded that questioning in a depositions "will necessarily implicate their fifth amendment rights."
The decision means Barry Cadden, Carla Conigliaro, Gregory Conigliaro, Douglas Conigliaro and NECC 's chief pharmacist Glenn Chin will not have to appear to answer questions posed by lawyers for the Saint Thomas Outpatient Neurosurgical Center and two other Tennessee clinics.
The Caddens and the Conigliaros are related by marriage and owned NECC.
As Boal noted, clinic attorneys had argued that the depositions were necessary to pursue claims that other parties, and not the clinics, were responsible for a nationwide fungal meningitis outbreak that killed 76 people. Those claims are being made under Tennessee's comparative negligence statute.
Boal's ruling was hailed by attorneys representing victims of the 2012 outbreak.
"The court order respects the constitutional rights of the accused. The order also helps move the civil cases toward trial despite the repeated attempts by some defendants to cause delay and to blame everyone else for their wrongful conduct but themselves," said Nashville attorney Mark Chalos.
Boal, however, declined to bar the depositions of Lisa Conigliaro and Steven Higgins, an employee of an affiliated company. The two have not been indicted. Boal noted that the two would still be able to invoke fifth amendment rights in response to individual questions.
Boal also ruled that officials of the U.S. Food and Drug Administration did not have to testify although the agency will be required to respond to requests for documents from clinic lawyers.
"A protective order precluding the FDA's deposition until  resolution of the criminal case is appropriate," Boal wrote.
Late last year a federal grand jury handed down a 131-count indictment against 14 owners, officers and employees of NECC. A trial has been scheduled for April 2016. 
Finally the magistrate judge ruled that the court appointed bankruptcy trustee for NECC does not have to designate a witness to testify in a deposition as a representative of the now defunct company.

Wednesday, July 29, 2015

Philadelphia Hospital Cited for ER Delays

By Walter F. Roche Jr.

By Walter F. Roche Jr.

Pennsylvania Health Department inspectors have cited Philadelphia's Saint Christopher's Hospital for Children for excessive delays in providing care to patients who came for emergency care.
In a report recently made public, the state found that one patient who showed up at 9:29 p.m. wasn't seen by a doctor until 1:16 a.m. the following day.
In fact the inspectors found that there were excessive delays for emergency room patients to get basic triage.
In the report dated June 6, the inspectors stated "it was determined that the facility failed to ensure prompt examination for 5 of 10 patients presenting at the emergency room for treatment.
Cited by the state was a requirement that hospitals with emergency departments "shall provide prompt examination or treatment, or both, to all persons who come or are brought into the hospital in need of such treatment, irrespective of ability to pay.
 "Such treatment shall be of the highest type consistent with the facilities available and with the standards established in the medical community of which the hospital is a part," the report adds.
Patients, inspectors found, waited from 40 minutes to an hour and 11 minutes before getting initial triage.
Some patients, they found, apparently gave up and left.
The waits to get actual treatment and be reassessed were even longer, with seven of 10 emergency room patients facing extensive delays. Those included the patient who didn't see a physician until 1:16 a.m. the next day.
 Officials of the hospital filed a plan of correction with the state in which it promised to take several steps to speed up the process. The plan includes increased monitoring of any backups and the assignment of additional nurses when needed.
Saint Christopher's spokeswoman Kelsey Jacobsen said the corrective action plan has been accepted by the state and "includes the methods by which the hospital will be measuring the effectiveness of our corrective actions."
 She said state inspectors have not yet shown up for a followup visit to the facility, which is part of the Tenet Healthcare Corp..
 The corrective action plan includes increased monitoring of any ER backups and the assignment of additional nurses when needed.
"If any patients are found to be waiting more than 10 minutes for a registered nurse assessment, an additional nurse (RN) with triage training will be deployed to the waiting area to perform an assessment of those patients and assign a preliminary acuity (ESI) level," the plan states.
Also included are new procedures to improve "patient flow."
The hospital promised to conduct audits of records to ensure that the problems were not repeated.
The inspection was based on a review of record of patients who showed up at the hospital's emergency room on the evening of May 2.
The report was completed on June 5, but, by standard department policy, was not released to the public until 41 days later.


Tuesday, July 28, 2015

Nashville Patients' Records Exposed on Internet

By Walter F. Roche Jr.

Two unnamed dental patients from the Nashville area inadvertently had personal health information posted on the web site of a Minnesota testing company for some 18 months.
In a legal notice published last week in a Nashville based newspaper, OralDNA Labs/Access Genetics disclosed that the names of the two patients, the names of their dentists and the tests performed were posted on the internet.
Curt Tokach, chief financial officer for the company, said that the patient data was posted inadvertently in a screen shot on a Frequently Asked Questions page on the company web site.
He said the legal notice was published because the company no longer had current contact information for the two patients.
He stressed that no test results or other personal data, such as social security numbers, were disclosed.
"Upon discovery of the breach," the legal notice states, "we immediately removed the PHI (protected health information) to protect the patients from any further unauthorized access."
According to the notice the two patients underwent periodontal  testing between Jan. 1, 2013 and Jan. 15, 2013.
The data was "available for viewing" on the company website from Nov. 15, 2013 to May 26, 2015 when it was discovered.
Calling the incident unfortunate, Tokach stressed that only the two patients' data was disclosed.

Monday, July 27, 2015

Judge Sets Tentative Trial Date in Meningitis Suits

By Walter F. Roche Jr.

A federal judge has set a tentative trial date of March 28, 2016 for what could be the first of a series of key trials in suits brought by victims of the 2012 fungal meningitis outbreak against health care providers, including a Nashville, Tenn. clinic.
In an order issued earlier this month U.S. District Judge Rya W. Zobel also set a strict schedule for the completion of pretrial matters, such as the discovery of key evidence and deposition of witnesses.
But before any trial Zobel must still rule on two key issues including whether trials will be held in Boston or in Nashville and other locations where victims were injected with fungus laden spinal steroids.
In a series of briefs filed recently in the case, lawyers for the plaintiffs have argued that the trials should be held in Boston, in part because they contend that will speed the process toward a conclusion bringing some measure of relief for victims who have been kept waiting for two years.
Attorneys for the Saint Thomas Hospital and related Nashville parties, however, contend the trials should be held in Tennessee.
The 2012 outbreak caused by tainted vials of methylprednisolone acetate shipped from a defunct Massachusetts drug compounder sickened 778 patients in some 20 states. Seventy-six of them died.
The civil trials being overseen by Zobel are separate from a bankruptcy case for the drug compounder, the New England Compounding Center. The bankruptcy was resolved recently and the assets are set to be distributed to victims, hopefully by the end of the calendar year.
The cases being overseen by Zobel are separate actions against health care providers who purchased the drugs from NECC and administered them to victims.
Zobel also must rule on whether the trials will be held under the provisions of the Tennessee or Massachusetts liability laws.
"Properly understood, Tennessee is the only state implicated," lawyers for the health care providers stated in a recent brief.
Zobel's decision on that matter will be key because Tennessee law, court records show, allows defendants to reduce the amount they may have to pay based on the comparative fault of other parties.
Nashville attorney George Nolan argued in a recent brief that the process of establishing comparative negligence would simply erode the amount of funds available to victims.
Nolan also stated that the cases should be tried in Boston because the bankruptcy and the civil actions are still linked and the cases have been properly in that jurisdiction for more than two years.
"Defendants cannot legitimately suggest that this district court (Zobel's) magically lost subject matter jurisdiction simply because the NECC Chapter 11 plan has now been confirmed," he wrote.
Lawyers for the defendants, however, argued that, "There is no basis for applying foreign laws to any part of this dispute."
"It makes no sense," the brief adds, "to try Tennessee-centric cases to a Boston jury."
Zobel's tentative trial schedule also hinges on whether so called bellweather or representative cases are to be held in her court.
If she determines that bellweather cases cannot be held, Zobel, according to her order, will send the cases back to their home districts, including Tennessee, New Jersey and Maryland
The next step in the litigation will be a status conference in Boston which Zobel has scheduled for next week.
Court records show there are 89 pending cases against Nashville defendants, 24 against the Specialty Surgery Center in Crossville, Tenn., 40 against Premier, a New Jersey clinic and eight against Box Hill Surgery Center in Abingdon, Md.

Saturday, July 25, 2015

Compounded Drug Recall

Tuesday, July 14, 2015

Judge Approves Hiring NECC Consultant

 By Walter F. Roche Jr.

A federal bankruptcy judge Tuesday approved the hiring of a consultant to provide continued assistance in the liquidation of the drug compounding firm blamed for a nationwide fungal meningitis outbreak.
 U.S. Judge Henry J. Boroff approved the hiring of Stephen B. Darr of Huron Consulting to assist in the liquidation of the New England Compounding Center. The hiring has been requested by Paul D.Moore who served as trustee during the NECC bankruptcy and is now overseeing the liquidation.
Darr will be paid $425 an hour for his services.
The approval came during a late afternoon session before Boroff.
Boroff delayed till October action on the request of a California woman to file an admittedly late claim in the bankruptcy proceedings. Lidia Tashima, who said she was sickened by an NECC drug at a Visalia, Calif. health clinic in 2012, said through her attorney that she never received notice of a Jan. 15, 2014 deadline for filing claims.
Boroff continued the hearing on her request to Oct. 14.
In requesting Darr's hiring, Moore said the consultant had previously work on the bankruptcy while employed at Mesirow Financial Consulting, which will continue to provide services.
He cited Darr's "diverse experience and extensive knowledge in the field of bankruptcy and taxation."
Moore said Darr will be paid at the same rate as he was at Mesirow and not his new rate of $825 an hour at Huron. The approval is retroactive to May 15.
Under the liquidation plan previously approved by Boroff more than $200 million is expected to be available for victims and creditors of NECC. State and federal regulators have concluded that NECC was responsible for shipping thousands of fungus tainted vials of a spinal steroid to health facilities across the country.
The 2012 outbreak of fungal meningitis sickened 778 patients, killing 76 of them.

Wednesday, July 1, 2015

April 2016 Trial Date Set for Meningitis Outbreak Defendants

By Walter F. Roche Jr.

Victims of the 2012 nationwide fungal meningitis outbreak apparently will have to wait another 10 months before those charged with causing the outbreak are brought to trial.
The hundreds of victims of the fatal outbreak received notice this week that an April 4, 2016 trial date has been set in the case.
In an indictment made public late last year 14 officers, employees and owners of the New England Compounding Center were charged with crimes ranging from mail fraud to second degree murder following a lengthy grand jury probe of the outbreak.
Two of the defendants, Barry Cadden and Glen Chin, were each charged with 25 counts of second degree murder. All the defendants have entered not guilty pleas.
Earlier this month federal agents seized a boat and a car from Cadden, who lives in the Boston suburbs.
The NECC criminal cases have been assigned to U.S. District Judge Richard G. Stearns .
Though the criminal trial may not get underway till next year, victims of the outbreak may get some financial relief before the end of the year as a result of NECC's  recently resolved bankruptcy case. More than $200 million is expected to be available to victims and a limited number of creditors.
Paul Moore, the trustee in the NECC bankruptcy, has stated that he is hopeful victims can begin collecting their shares of the victims' fund before the end of the calendar year.