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Nevada Hepatitis Cases Don’t Need CDC Insight

(CN) - Employees for the Centers for Disease Control and Prevention need not testify about their investigation of a hepatitis C outbreak in Las Vegas, a federal judge ruled.

Patients claim that they contracted, or were exposed to, hepatitis C because doctors reused single-use vials of Propofol to anesthetize them for endoscopies. Since such procedures generally require 20 ml vials, the patients accused drugmakers of negligently distributing propofol in 50 ml vials.

The Southern Nevada Health District and the CDC investigated the outbreak and determined that hospital staff routinely reused syringes during individual procedures to withdraw anesthesia from the vials, and reused the vials to provide medication for multiple patients.

As they fight negligence lawsuits in Clark County Court, Teva Peranteral Medicines and McKesson Medical Surgical had sought to compel the testimony of investigators. They looked specifically to four CDC employees: Scott Holmberg, Gayle Fischer Langley, Joseph Perz and Melissa Schaefer.

They argued that the requested testimony would clarify issues regarding the investigation that led to the report, including information about interviews with the clinic personnel and information about patient care at the clinics observed.

Bolstering their claims that "the CDC employees who investigated the hepatitis C outbreak ... are the only source of certain information about the practices at the clinics that could have spread Hepatitis C," the drugmakers say that the clinics have been shuttered, and that some personnel at the clinics have either been criminally indicted or are invoking their Fifth Amendment rights against self-incrimination.

One certified registered nurse anesthesiologist, for example, has been criminally indicted and is no longer providing any information, they say. As such, his injection practices can allegedly be obtained only from the interviewing CDC investigators.

CDC Director Dr. Thomas Frieden advised companies in writing that their request fell short of the legal test, that the sought-after testimony is available by other means and that CDC participation in the case would not substantially promote agency objectives.

Noting that the CDC employees would be able to testify only as to what is in the May 15, 2008, report, Frieden said access to the report negated the need for their testimony.

The pharmaceutical companies called the refusal arbitrary and capricious, disputing the agency's claim that the testimony can be found in the agency's subsequent report.

They filed suit in Washington to compel such testimony, but U.S. District Judge Robert Wilkins sided with the agency in an unpublished opinion Tuesday.

"Dr. Frieden acted rationally in concluding that the testimony sought by plaintiff was available by other means," Wilkins wrote.

Frieden also correctly noted that there were other, non-CDC-employed medical professionals involved in the investigation who could answer questions regarding their report.

"There is nothing arbitrary or capricious about Dr. Frieden's conclusion that the information sought by plaintiffs" could be found in the report or obtained from other medical professionals, Wilkins wrote.

The judge also disagreed that the pharmaceutical companies had failed to give a reasoned explanation for its determination.

"Plaintiffs have cited to no regulatory provision or other authority that requires the CDC to provide a comprehensive and exhaustive analysis of why it reached each conclusion," the 12-page decision states. "In fact, it is the requesting party's burden to demonstrate that allowing the testimony is in the CDC's interest. Plaintiffs have clearly not done so in this case. ... Plaintiffs have not established how permitting the CDC employees to testify serves anyone's interests other than the plaintiffs' interest in bolstering their case in the pending state court proceedings."

Frieden also correctly pointed to the potential cumulative impact of allowing such a request, especially considering the numerous state court cases related to the outbreak, according to the ruling.

"A primary concern in this case is minimizing the disruption of employees' official duties," Wilkins wrote.

"Dr. Frieden has a broad mandate to promote the objectives of the agency, which, as a general matter, does not allow its employees to give depositions or trial testimony in private litigation," he added.

Wilkins also cited the CDC's policy that it "maintain strict impartiality with respect to private litigants and to minimize the disruption of official duties."

Last September, the Nevada Supreme Court refused to block employees of the Southern Nevada Health District from being called as witnesses at multiple trials involving the outbreak.

In October 2011, a jury ordered Teva, McKesson and Baxter Healthcare to pay $162 million in punitive damages for negligently distributing vials of Propofol. That award in Clark County Court is on top of the $20 million in compensatory damages ordered a year earlier against the three pharmaceutical companies.

After seven weeks of testimony, Teva was ordered to pay $89.4 million, Baxter was ordered to pay $55.3 million, and McKesson was to pay $17.9 million.

A May 2010 case caused one jury to award more than $500 million against Teva. In that case, Henry Chanin, a headmaster at a private school, alleged that he got hepatitis C during a colonoscopy where doctors reused a vial of Propofol.

The Southern Nevada Health District linked cases of the outbreak to Dr. Dipak Desai's Endoscopy Center of Southern Nevada. The agency notified more than 50,000 former patients to get tested.

After a patient, Rodolfo Meana, died of complications from hepatitis C allegedly contracted at Desai's clinic, the doctor and his two anesthetists, Keith Mathahs and Ronald Lakeman, face second-degree murder charges. The trial is scheduled for Oct. 28, 2013.

An Aug. 10 murder indictment accuses all three of introducing the virus into Meana's body while he underwent a colonoscopy in September 2007.

Meana was among seven that the Southern Nevada Health District genetically linked to Desai's Endoscopy Center of Southern Nevada. Officials also linked two other cases to Desai's other facilities, and described another 106 additional cases as "possibly linked."

Desai, Mathahs and Lakeman also face 28 felony charges, from racketeering and patient neglect, at an Oct. 22 trial.

In September, the Chapter 7 trustee for Desai's estate, William Leonard Jr., challenged Desai's request for a bankruptcy discharge. He claims that Desai, who filed for Chapter 11 to fight creditors, has cited ill health in refusing to provide financial information for his bankruptcy.

After the outbreak, defense lawyers said Desai was ill because of a series of strokes.

Desai spent six weeks under observations at the Nevada's mental health hospital in Northern Nevada, and medical experts reportedly concluded that the doctor was exaggerating his condition.

A Clark County judge found Desai competent to strand trial earlier this year.

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