Wednesday, December 9, 2015
Clinic Seeks to Block Saint Thomas' Consultant's Subpoena
By Walter F. Roche Jr.
A Nashville clinic where dozens of patients were injected with fungus tainted steroids is asking a federal judge to block a subpoena seeking records of a key consultant.
Lawyers for the Saint Thomas Outpatient Neurosurgical Center are asking a federal judge to issue a protective order effectively blocking or limiting a subpoena issued to Michael O'Neal, a pharmacist and consultant who has worked for the clinic for nearly a decade.
In multiple filings in U.S. District Court in Boston, Mass., the Saint Thomas lawyers argued that a Tennessee law, specifically protects from disclosure the information sought by victims of a 2012 fungal meningitis outbreak.
Lawyers for victims contend the records are essential in gathering information on how and why the Nashville clinic came to purchase the tainted drugs and inject them in unsuspecting patients.
The filings come in a group of cases filed in behalf of victims of the 2012 outbreak caused, according to state and federal regulators, by fungus tainted vials of methylprednisolone acetate from the defunct New England Compounding Center.
The outbreak sickened 778 patients, killing 76 of them. Most of Tennessee's 153 known victims were treated at the Saint Thomas outpatient clinic. Sixteen of those patients died.
In the filings Saint Thomas' lawyers, from the firm of Gideon and Cooper, noted that a Nashville judge already has ruled in a related case that the records are covered by the Tennessee Patient Safety and Quality Improvement Act of 2011.
In an affidavit, also filed with the court, O'Neal stated that his role was to conduct monthly inspections at the Nashville outpatient clinic and to provide advice to the facility director.
According to his filing he first went to work as a consultant to the clinic in 2000. He said his contract was revised in 2007.
Both O'Neal and Debra Schamberg, the facility director at the time of the outbreak, stated in separate filings, that his duties were expressly related to quality control and patient safety as they related to pharmaceuticals.
Saint Thomas lawyers stated that were the federal court not to block the subpoena it "will render the Tennessee law ineffective" along with the ruling by Nashville Circuit Court Judge Joseph Binkley.
Binkley's order, the clinic filing contends, "barred the discovery of O'Neal's reports and communications" with the clinic.
"If allowed the," the motion states, it "would let the genie out of the bottle and there is no way that genie could be put back in."
The brief states that both state and federal statutes were drafted to encourage health providers to thoroughly review quality control matters without fear that those efforts could late be used as evidence against them.
"Confidentiality in these functions is essential," the filing states.
Saint Thomas' lawyers also argued that the subpoena was "sweeping and indiscriminate" and covered documents dating back long before the outbreak.