Court rules drug companies can offer other theories in hepatitis cases

The Supreme Court had been asked to rule on whether juries could hear theories other than the one embraced by health officials: that the disease was spread when medication vials, contaminated by syringes used on infected patients, were reused. The vials were labeled as single use, and a jury ruled against the drug companies, awarding $500 million to an infected patient.

The court ruled that the drug companies being sued can put witnesses on the stand to describe unsanitary conditions at the clinics. But only certified experts will be allowed to give their opinion regarding another mode of transmission of the disease.

The ruling will guide the dozens of civil trials related to the 2008 hepatitis outbreak. One trial is scheduled to start next week, and a handful of other trials for a dozen more infected people are on the docket before the end of the year.

Lower courts had been divided over whether alternative theories could be introduced. Dozen of civil cases were put on hold while the state high court ruled.

Justices were asked whether experts in cleaning and sanitizing medical equipment, particularly a Dallas nurse, could testify in the trials. Lawyers planned to use expert testimony to help defend drug companies.

Justices ruled the nurse can testify that former Dr. Dipak Desai and his employees failed to sterilize scopes used in endoscopy procedures.

The same nurse, however, is not qualified to testify that the use of dirty instruments is how patients were exposed to hepatitis C after undergoing procedures at one of three clinics Desai owned before 2009, justices ruled. The nurse’s knowledge base isn’t sufficient to render an opinion, the ruling said.

Defense attorneys have three options to challenge the claims of people who were infected: through cross-examination of the plaintiff’s experts; through contradicting those expert witnesses with their own; or by arguing an alternative theory of how they were infected, such as from dirty equipment.

To win using the third option, the law requires them to prove their theory to a reasonable degree of medical probability. In other words, they will have to convince jurors that it is more likely that Desai’s patients contracted the virus through a contaminated scope and not a contaminated vial.

After the first infections were discovered, the Southern Nevada Health District sent about 50,000 letters to people at risk of exposure. Nine cases were definitively traced through DNA testing to Desai’s clinics, and more than 100 others have been closely linked.

The court’s decision comes four months after justices heard arguments in two cases in which the presiding district judges issued conflicting opinions on what evidence would be allowed.

In one case, Judge Timothy Williams said a nurse could not testify and offer an alternative theory of contamination.

In another case, Judge Kathleen Delaney ruled the nurse could testify. The high court in its ruling found Delaney erred in making that determination because the nurse might have the expertise to testify about cleaning procedures but cannot say with any degree of certainty that those substandard protocols resulted in the spread of the virus.

In court papers, Dallas nurse David Hambrick said cleaning fluid used at one of Desai’s clinics — fluid designed to be used no more than twice — was used so often it was a murky “primordial soup of bacteria, blood, fecal matter, stool, viruses … and just a disgusting mess.”

Hambrick, a registered nurse, is manager of the gastroenterology lab at Methodist Dallas Medical Center and also has served as director of the Society of Gastroenterology Nurses and Associates.

Defense attorneys never raised the alternate cause theory in the first trial stemming from the hepatitis outbreak. A jury awarded a record $500 million to hepatitis sufferer Henry Chanin to be paid by drug companies Teva Parenteral Medicines and Baxter Healthcare in May 2010. Teva manufactured the sedative propofol, and Baxter distributed the product.

The companies’ lawyers are challenging. At the first trial, they agreed Chanin probably contracted the disease from an infected vial of propofol through misuse, a cause the Centers for Disease Control and the county health department also found to be the most likely source.

“They agreed that was how Mr. Chanin was infected,” Chanin attorney Robert Eglet said. “Then they saw how the jury reacted, and they are now going with the dirty scope theory.”

Eglet and Will Kemp, who represented Chanin’s wife, Lorraine, successfully convinced jurors the drug companies knew for years that small clinics like Desai’s were using single-use vials of propofol on multiple patients as a cost-saving measure.

Judge Jessie Walsh barred defense attorneys in that trial from discussing the cleaning standards at the clinics.

Evidence of negligence by law must be excluded from strict product liability cases, Eglet said, because jurors must focus solely on the product and whether it is defective or dangerous.

In the Chanin case, Eglet argued the companies failed to properly label the larger vials and that they failed to warn clinics of the dangers associated with using the vials on more than one patient.

Eglet said Israel-based Teva made hundreds of millions of dollars making the larger vials and deliberately pushed selling the larger ones knowing they were being misused “around the world.”

The money was saved on the production line where workers produced twice as much product making the larger vials in half the time it took to produce smaller vials, according to testimony delivered in the Chanin trial.

“It was all about money,” he said.

The attorneys who represented the drug companies declined to comment for this story.

The Clark County grand jury last year indicted Desai and two nurses on felony criminal counts related to the outbreak.

Desai was deemed incompetent to stand trial, and the court sent him to a state mental hospital for evaluation. If he is found able to assist in his defense, the criminal trial will start in March.