Court prepares to hear hepatitis C cases

Or shortened.

Did it come as most experts believe, including the Centers for Disease Control, from multiple use of vials of the sedative propofol, which had been contaminated by syringes used on patients with hepatitis C?

Or, as lawyers for companies that make and sell propofol allege, could the patients have been infected by the clinics’ improper cleaning and disinfecting of endoscopic instruments, and the recycling of medical and cleaning equipment meant to be used only once?

What juries decide about the source of infection, however, could mean millions (if not billions) of dollars to both the drugmakers and scores of plaintiffs. Already, two companies have been stung by a single $500 million judgment. It is on appeal.

On March 7, the Nevada Supreme Court will hear both theories, then determine what transmission theories juries in other cases can hear.

Harvard law professor Alan Dershowitz, who is shaping the drug firms’ legal arguments, says the showdown is significant for all Nevada citizens: “We’re asking the courts to consider all of the factors available that could have contributed to this terrible outbreak of hepatitis.”

In court filings, however, plaintiffs’ lawyers liken the companies’ new theory to child’s play: “This defense is aptly called: Eeny, meeny, miny, mo, pick an instrument we don’t know.”

The Desai endoscopy centers were a mess. Health agency and criminal investigators found violations that flouted accepted medical standards, endangering as many as 63,000 Southern Nevadans.

Those actions also might have been criminal.

Desai, a gastroenterologist, and two of his former nurse anesthetists, were to face trial next month on a variety of charges stemming from the questionable practices at his clinics in 2007.

Last week, however, District Judge Jackie Glass ordered the doctor admitted to the state’s mental health hospital in Sparks after a court-appointed psychiatrist and psychologist found him mentally incompetent to stand trial.

Desai’s attorneys claim he is unable to assist in his defense because of strokes in 2007 and 2008. Desai will undergo further evaluation in Northern Nevada in mid-March, postponing his trial.

And two civil lawsuits involving four patients have ground to a halt after Clark County judges proffered differing rulings on whether Teva Parenteral Medicines Inc. and Baxter Healthcare Corporation, which made and sold propofol, could introduce their new theory about how the hepatitis C virus was transmitted between clinic patients.

Enter the Nevada Supreme Court, and a decision with stakes that could be astronomical.

Nine cases have been linked to Desai’s clinics, and more than 100 others are closely linked to it. Testing was unable to accurately determine whether hundreds more contracted hepatitis C before, during or after their colonoscopies and other procedures at the endoscopy centers.

Last May, Henry Chanin, 62, a private school headmaster infected with the virus at one of Desai’s clinics, won a $500 million punitive judgment against Teva and Baxter on product liability claims.

‘dirty scope’ theory

All told, some 250 infected patients, along with thousands of others claiming mental distress, have cases against the drug firms at various points in the legal pipeline. And most of those pleadings center on the CDC’s belief that patients were infected by microscopic contamination passed through dirty syringes.

Plaintiffs’ lawyers explain it this way:

It generally takes about 10 milliliters of propofol for each colonoscopy, and the clinics were using 50-milliliter vials produced by Teva and sold by Baxter. If a patient needed more of the sedative, which is not uncommon, a nurse would reuse the original syringe, injecting a new needle back into the 50-milliliter vial and thus contaminating it.

When the nurse used the same vial for the next patients, any contamination, in this case the hepatitis C virus, spread to them.

In the Chanin case, lawyers for both pharmaceutical companies agreed that was the likely method of contamination. But they argued against their clients’ liability, since the vials (sold in 10-, 20- and 50-milliliter sizes) were labeled for single-patient use only, to eliminate just such a risk.

Prosecutors and plaintiffs’ attorneys allege that Desai’s clinics reused the 50-milliliter vials on multiple patients to save money.

The Chanin jury found that by marketing and selling the larger vial, Teva and Baxter negligently contributed to the multiple use despite the labeling.

Since the verdict, however, Teva and Baxter attorneys say new evidence could remove their clients’ liability. They cite testimony given to the county grand jury that indicted Desai and the two nurse anesthetists on racketeering and criminal patient neglect charges.

Their “dirty scope” theory, outlined in court filings, contradicts the methodical conclusions of local and national health officials, and the lawyers argue that civil juries should be allowed to consider other contamination possibilities.

A December 2009 report by the Southern Nevada Health District about the hepatitis C outbreak included the CDC’s rejection of other possible transmission factors.

They “were examined and ruled out, including the reprocessing or reuse of the endoscopes, the use or reuse of biopsy equipment, reuse of disposable equipment (such as bite blocks), staff-to-patient transmission, and the IV placement process,” the report said.

“Although a problem of the reuse of detergent in the reprocessing of endoscopes was identified, this problem was not thought to pose a risk for disease transmission between patients; the endoscopes were cleaned with a brush, and the rest of the cleaning process was sufficient to sanitize the equipment. In addition, no infected patients had procedures performed with the same endoscope as the source patient.”

Las Vegas attorney Robert Eglet, who represents both Chanin and infected patients in the cases on hold, said the drug company arguments are meant to deflect attention away from the companies’ own culpability in the hepatitis outbreak.

Teva and Baxter lawyers also contend that District Judge Jessie Walsh made glaring errors in the Chanin trial that prevented the jury from hearing key evidence favorable to the companies.

Walsh was randomly assigned the case in 2009. But months earlier in 2008, Eglet and his personal injury law firm contributed $40,000 to the judge’s re-election campaign, records show.

The companies have shied away from referring to the campaign contributions, but they contend Walsh unfairly refused to let jurors hear evidence of wrong­doing by the clinic’s staff. They also argue she should have let jurors hear that the U.S. Food and Drug Administration approved the language on the propofol packaging.

The doctor and nurses who performed Chanin’s colonoscopy settled mal­practice claims before trial. The medical staff has also settled with plaintiffs in the cases now on hold.

‘systematic misconduct’ alleged

Teva’s lead trial lawyer, Mark Tully of Boston, says the Chanin verdict likely would have been different had Walsh allowed all of the evidence. Tully said the drug companies want a fairer shake .

“It goes without saying that we would like the juries in these cases to hear all of the facts before making a determination,” Tully said.

That includes letting in evidence of what the drug company lawyers call “systematic misconduct” by clinic staff, much of which was not available until after the Chanin trial in June.

The grand jury heard testimony from nearly three dozen witnesses, including two of Desai’s clinic partners, who were given immunity from prosecution.

Drug company lawyers argue the indictments show “extreme disregard for patient welfare and obvious departures from basic medical safety practices.”

Testimony revealed Desai and his staff were ill equipped to handle the high-volume business at his lead clinic, the Endoscopy Center of Southern Nevada.

The grand jury was also told that Desai instituted cost-cutting measures that included reusing single-use equipment; workers were not properly trained how to clean endoscopic equipment; and surgery rooms, where as many as 100 procedures a day were conducted, were in­adequately cleaned between procedures.

In court documents filed in one case up for Nevada Supreme Court review, Eglet and another plaintiffs’ lawyer, Will Kemp, contend the “dirty scope” theory is “unsupported by expert medical testimony to a reasonable degree of probability.”

Centers for Disease Control investigators actually witnessed the multidosing of propofol and documented that it was a regular practice, they wrote.

Clark County district judges Kathleen Delaney and Timothy Williams took opposing views of the new premise.

Delaney said the drug companies could present their alternative outbreak theory in a case involving James Williams, 60, a former Sierra Health Services executive, and Joanne Allen, 65 . And Delaney said she would allow the drug companies to call a nationally known gastroenterology nurse to testify to his conclusions about the use of dirty endoscopic instruments at the clinics.

As that trial approached, Eglet and Kemp filed an emergency petition asking the state Supreme Court to halt the trial and review Delaney’s ruling. Days before the start of the trial, the high court agreed to hear the matter.

Williams, however, refused to allow the drug companies to call the nurse and other witnesses to advance the “dirty scope” theory in the case of Maria Pagan, 82, a retired seamstress who now lives in Houston, and William Bilger, 63, a retired insurance company employee. The ruling prompted the companies to ask the state Supreme Court to halt that case as well.

With the conflicting rulings, the state Supreme Court put off that trial, too.

Reporter Brian Haynes contributed to this story. Contact reporter Jeff German at jgerman@reviewjournal.com or 380-8135.