Widow of First to Die in Fungal Meningitis Outbreak Joins Suit

By Walter F. Roche Jr.

On June 19, 2012 70-year-old Kenneth Denesha visited a Florida pain clinic for an injection of a steroid to ease extreme pain in his neck and shoulder. Less than a month later he was dead, the first of 64 to die in a nationwide fungal meningitis outbreak.
Now Denesha's widow, Amy, has joined hundreds of other victims of the outbreak and their survivors in a massive lawsuit before a federal judge in Boston. The outbreak also sickened 751 patients in 20 states.
Though the outbreak would not become public until several months later, Denesha's death on July 15, 2012 is the earliest recorded by the U. S. Centers for Disease Control and Prevention for the outbreak later blamed on a Massachusetts drug compounding drug firm.
A retired drill operator and a one time high school wrestling and football player, Denesha collapsed just two days before his death while cutting his lawn. He died July 15, 2012 in a Florida hospice.
Though it was first assumed he had died of a massive stroke, his family only later learned that it was the June injection of methylprednisolone acetate that killed him.
In addition to his wife he left three children, four stepchildren and two siblings.
According to the recently filed lawsuit, Denesha got the June 2012 injection at the Florida Pain Clinic and it was administered by Dr. Stephen T. Pyles. Neither Pyles or the pain clinic are named as defendants in the 45-page amended complaint.
CDC spokeswoman Christine Pearson said this week in an email response to questions that the July 15 Florida death was the earliest recorded in the outbreak.
The company blamed for the outbreak, the New England Compounding Center, shutdown and filed for bankruptcy on Dec. 21, 2012.
The Denesha lawsuit charges the owners of NECC and affiliated companies with gross negligence, wrongful death and violations of state consumer protection statutes.
"Kenneth Denesha died as the direct and proximate result of the contaminated steroid injection," the complaint states.
The first public notice of the outbreak would not come until late September of 2012 when Tennessee state health officials reported a cluster of deaths from fungal meningitis among patients, it turned out, who had recent steroid injections in the back or neck.
The first Tennessee victim to die was Eddie C. Lovelace, a Kentucky judge who had traveled to a Nashville clinic for a steroid injection. He died Sept. 17, 2012. The last Tennessee victim to die, according to court filings, was Gokulbhai Patel, who passed away on Jan. 13, 2013.
While 15 Tennessee patients and seven from Florida died in the outbreak, Michigan with 19 deaths had the most victims.
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NECC Bankruptcy Plan Could Come in Two Weeks

By Walter F. Roche Jr.

A proposed bankruptcy plan which could provide millions of dollars in relief to victims of a nationwide fungal meningitis outbreak could be filed within the next two weeks, according to the attorney for the bankruptcy trustee.
"We are very, very close," Michael Gottfried, the attorney representing trustee Paul D. Moore, told U.S. District Judge Rya Zobel in an hour long court session Thursday in Boston.
He added that the plan could be filed in early November, which would be a little over two years after the fatal outbreak became public.
Previously Moore disclosed that an agreement had been reached with some of the defendants and insurance companies on a plan that would provide over $100 million for victims and creditors.
Gottfried did not provide any additional information on a settlement plan Thursday.
Zobel is presiding over hundreds of civil cases stemming from the outbreak which killed 64 patients and sickened 751.
The bankruptcy case of the New England Compounding is pending before a separate judge, but the plan will be the source of funds for the victims and other creditors seeking compensation. State and federal regulators have concluded that NECC caused the outbreak by shipping fungus tainted steroids to health facilities across the country.
Also appearing at the afternoon session were attorneys for Tennessee victims of the outbreak and the Saint Thomas Outpatient Neurosurgical Center and two other Tennessee facilities where patients were injected with spinal steroids supplied by NECC.
Gerard Stranch, representing Tennessee victims, told Zobel that a major dispute has been developing over the scheduling of depositions in which key figures will be questioned under oath. He said he will likely be asking the court's assistance in resolving the matter.
Stranch said another issue that will have to be resolved is whether the Saint Thomas parties must disclose details of one of their agreements with insurance carriers. Lawyers for the Nashville facility contend the information does not have to be provided.
Zobel also heard arguments over whether equipment and other materials from NECC must be preserved for possible use in the cases. Zobel did not rule on that matter.
The bankruptcy trustee had argued that the cost of maintaining the items, such as a 10 foot long bench, was too burdensome.
Lawyers for Saint Thomas, which wants some items preserved, stated that they were working on an agreement that would not draw on the assets in the bankruptcy case.
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Long Delays Likely in Drug Compounding Criminal Trial

By Walter F. Roche Jr.

Citing 637,000 pages of evidence and some 1.1 million internal emails, prosecutors and the lawyer for drug compounder Glenn Chin have agreed to waive speedy trial rules in the first criminal case stemming from a nationwide fungal meningitis outbreak.
In a four-page joint document filed today in U.S. District Court in Boston, Mass. the lawyers asked a federal judge to waive rules that could force a trial in the case in a little over two months. The motion was signed by Stephen J. Weymouth, Chin's attorney and Assistant U.S. Attorney Amanda Strachan.
Chin, the one-time supervisory pharmacist for the defunct New England Compounding Center, is charged with mail fraud in the probe of a nationwide fungal meningitis outbreak that killed 64 patients and sickened 751.
State and federal regulators have concluded that NECC caused the outbreak by distributing thousands of vials of fungus tainted steroids to health facilities around the country.
According to the filing the investigation into Chin and other officials of NECC is "ongoing."
"The United States produced initial discovery of 607,000 documents," the report states, adding that Chin's lawyer received those records between Oct. 9 and Oct. 21.
In addition prosecutors provided Weymouth with eight electronic databases including 1.1 million internal NECC emails.
"The United States is aware of its continuing duty to disclose newly discovered evidence or material," the filing states, adding that currently there are no pending discovery requests.
The report notes that a magistrate judge already has approved a protective order barring the release of those discovery materials to third parties.
Stating that the case is "sufficiently unusual and complex" to waive normal time limits, the report states, "The parties anticipate that it will take a significant period of time to review the substantial discovery in this case."
The 2012 fungal meningitis outbreak also has prompted hundreds of civil suits that have been merged before a federal judge. A hearing on those cases is scheduled for tomorrow before U.S. District Judge Rya Zobel. Dozens of new cases from New Jersey victims were recently added to the docket.
NECC was shutdown in 2012 and its owners filled for bankruptcy later that year. That case is still pending.

Research Project Tracks Victims of Meningitis Outbreak

Unusual and alarming levels

"As far as long term effects, we don't have a handle on it. This is a difficult situation. These patients have a lot of other problems. It is kind of a perfect storm

CDC said we wouldn't be able to detect it in the blood.
It is strictly a research protocol and not a clinical study.. We get referrals from physicians.
Found fungal traces in 20 to 30 percent of the samples. Nucleic acid
A lot have unexplained problems

Judge in Meningitis Cases Approves Trustee's Plan

By Walter F. Roche Jr.

A federal judge in Boston has given her assent to a proposed $100 million settlement of claims against a Massachusetts drug compounding firm by approving a procedural plan proposed by the bankruptcy trustee for the defunct pharmaceutical firm.

In two separate orders issued Thursday, Judge Rya W. Zobel rejected claims by lawyers for Nashville's Saint Thomas Outpatient Neurosurgical Center that the trustee's plan to limit depositions and halt further action against some of the defendants in dozens of pending civil suits was "overly broad and vague."

Zobel noted that the trustee, Paul Moore, had argued that the limits were "critical to the implementation" of proposed settlements with the owners of the New England Compounding Center and related parties.

Those settlements with NECC's owners, insurers and other related parties emerged in a parallel bankruptcy case, also in federal court in Massachusetts.

NECC, according to state and federal regulators, shipped fungus tainted steroids to medical facilities across the country, including the Saint Thomas clinic, triggering the outbreak of fungal meningitis that killed 64 patients and sickened 751.

"I find that the trustee's proposed order is sufficiently clear and reasonable," Zobel wrote, adding that it does not prevent lawyers from the Nashville clinic from pursuing affirmative defenses.
"The court has determined that the requested stay of these proceedings and limitation of discovery with respect to the settling parties is warranted," she concluded in a five-page order.

Zobel did, however, order a stay effectively stopping the clock on statutory claims that might otherwise expire.

Lawyers for victims of the outbreak, many of them in Tennessee, said they were pleased with Zobel's decision.

“We are glad that discovery is moving forward and we are focusing on the clinics in Tennessee.  We look forward to presenting our case to a jury as soon as possible,” said Gerard Stranch, one of the attorneys representing victims of the fatal 2012 outbreak.
Saint Thomas' attorney Chris Tardio said, "The decision allows us to begin the process of discovering how NECC contaminated these medications despite promising their customers that they followed the proper safety standards. We have asked for that opportunity, and the decision allows us to do that."
Zobel is presiding over hundreds of cases stemming from the outbreak that were merged in her court. The number of those cases Zobel is overseeing has been steadily increasing as statutes of limitations in affected states are running out. 
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Victims of Outbreak Seek Saint Thomas' Insurance Policies

Lawyers for victims of the 2012 fungal meningitis outbreak are asking a federal judge to order Saint Thomas Health and related entities to provide full details of insurance policies that could benefit their clients.
In a motion filed Friday in U.S. District Court in Boston, attorney J. Gerard Stranch of Nashville charged that Saint Thomas officials have steadfastly refused to provide copies of their insurance agreements.
In the motion and an accompanying brief, the plaintiffs' attorneys noted that a federal magistrate judge already had ordered disclosure of the coverage details.
While some general information was provided, critical details, including copies of actual insurance agreements have not been provided, the motion states.
Lawyers for the victims contend that knowing the available coverage is critical in efforts to reach a settlement.
"Plaintiffs first asked for insurance information almost 14 months ago," the filing states.
The motion comes in a massive case combining claims by hundreds of victims of the outbreak caused by tainted spinal steroids. Most of the Tennessee victims were injected at the Saint Thomas Outpatient Neurosurgical Center in Nashville.

Meningitis Outbreak Prosecutor Seeks Order to Protect Probe Records

By Walter F. Roche Jr.

The U.S. Attorney prosecuting a pharmacist charged in the probe of a fatal fungal meningitis outbreak is asking a judge to order that records relating to the investigation be kept confidential.
The motion for a protective order was filed Thursday in U.S. District Court in Boston by U.S. Attorney Carmen Ortiz.
The move comes in the criminal case against Glenn Chin, 46, who worked as a pharmacist for the New England Compounding Center. Chin, a Canton, Mass. resident who has been charged with mail fraud, has entered a not guilty plea to the charge.
Under Ortiz' motion Chin's lawyers would be barred from disclosing to third parties any information about the investigation provided by prosecutors during the discovery phase of the criminal case.
Chin's lawyers, according to the filing, are not opposed to the order.
Ortiz said in the filing that disclosure of the investigation details to third parties "could jeopardize the ongoing criminal investigation."
"Some of the discovery materials," the motion states, "would inform potential targets or subjects of the status and direction of the ongoing criminal investigation."
In addition Ortiz wrote that the same discovery material could reveal the identities of government witnesses.
Finally, Ortiz' motion states,  the discovery information includes specific health information on victims who received  tainted steroid injections at Michigan Pain Specialists.
The protective order proposed by Ortiz would require that once the Chin case is completed the discovery materials would have to either be destroyed or returned to the federal government.
The 2012 outbreak sickened some 751 patients. Sixty-four of them died. Michigan and Tennessee were among the hardest hit of the 20 states where victims were treated.
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Clinic Lawyers Say Any Blame for Outbreak Should Be Shared

By Walter F. Roche Jr.

Lawyers for the Saint Thomas Outpatient Neurosurgical Center have named nearly a dozen other parties, including three government agencies, who they say should share any blame for a fatal 2012 fungal meningitis outbreak.
In a 113-page filing in U.S. District Court in Boston, Mass. Tuesday the attorneys for the Nashville clinic and other Tennessee defendants listed a testing company and the supplier of bulk chemical compounds along with a half dozen other parties, as bearing some responsibility for the outbreak.
The filing came in a series of suits which have been merged before U.S. District Judge Rya Zobel.
At the same time clinic lawyers said the facility and other defendants "complied with the laws and regulations applicable to them and with industry standards."
They also stated that the defendants had no reason to suspect that the steroids shipped by a now shuttered drug compounder, the New England Compounding Center, were tainted with fungus.
The outbreak led to the deaths of 64 patients while 751 were sickened. Tennessee was among the hardest hit with 16 deaths.
The filing also names state agencies in Tennessee and Massachusetts along with the U.S. Food and Drug Administration as sharing in the blame and calls the outbreak "a colossal regulatory failure."
The FDA failed to act against NECC even though the drug firm's activities "fell squarely within FDA's definition of its own regulatory authority,"clinic lawyers charged.
Others named as bearing possible liability by Saint Thomas lawyers were an organization that provided training for NECC employees and sold the company the "recipe" for the steroid drug, a heating contractor and the company that installed clean rooms for NECC.
The filing charges that Medisca, the firm that supplied NECC with the bulk materials for its products should have known NECC was not in compliance with the law simply because of the high volume of base chemicals it was purchasing.
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