Sedative manufacturer might share liability in hepatitis cases

By Steve Kanigher

Monday, Feb. 1, 2010 | 2 a.m.

Attorneys who represent former patients of the shuttered Endoscopy Center of Southern Nevada say that a sworn deposition from a drug company executive will help them prove that his company, which makes the sedative propofol used at the clinic, was partly responsible for the valley’s hepatitis C outbreak.

If proved in court, the drug’s role could expose its manufacturer to damages in connection with the outbreak, which unnerved the region when it was announced in February 2008.

In his deposition, Craig Lea, a marketing vice president of Teva Parenteral Medicines in Irvine, Calif., said that a version of the medication for dogs and cats, known by the brand name Rapinovet, has clearer instructions than the milky white propofol used in humans.

One major difference, he said: the Rapinovet label states that the entire contents of the vial should be drawn into sterile syringes, whereas the propofol label is not as specific.

That distinction may go to the issue of how the clinic’s staff used single-use vials for more than one patient, leading to the infection of others.

Lea’s deposition was taken in May but hadn’t been available until last week. Portions were deleted to protect certain company secrets and operations.

The Southern Nevada Health District found that as many as 63,000 patients could have been exposed to infection through reuse of propofol vials and syringes. Plaintiffs’ attorneys, who will begin trying Endoscopy Center cases in April, plan to argue that Teva failed to properly instruct medical professionals on propofol’s use, contributing to the spread of potentially deadly blood-borne pathogens.

Las Vegas attorney Will Kemp and fellow plaintiffs’ attorney Robert Cottle of Las Vegas said the clinic used 20-milliliter and 50-milliliter vials of propofol, with the larger vials more apt to be reused. With the average adult endoscopy requiring only 10 milliliters — give or take a few milliliters depending on the size of the patient — they said clinic personnel were encouraged to reuse the 50-milliliter vials for multiple patients to avoid having to discard unused propofol.

“Hospitals account for all the propofol that they use,” Cottle said. “In this case, no one was counting the milliliters that were used. No one was counting the waste because no one at the clinic wanted to waste any propofol.”

It was precisely to avoid the possible reuse of large vials that Teva at one time made a single-use, 10-milliliter vial intended for procedures such as endoscopies.

Lea confirmed as much when he said 50-milliliter vials are intended to be used only by one patient for medical procedures that can last many hours, as opposed to endoscopies, which can take less than a half-hour.

“I think a smaller vial size is more ... probably more appropriate for that, for a shorter duration case,” Lea said. A short time later, he said that the vials are labeled for single-dose use because “you’re trying to minimize the amount of product you’re throwing away.” He also answered affirmatively when Kemp asked whether the 10-milliliter vials would reduce the temptation and opportunity for dosing multiple patients from a single propofol container.

Kemp also read into the record a written statement from Lea indicating that the 10-milliliter vials would “enhance patient safety.”

Lea, though, said Teva discontinued the 10-milliliter vials, making the 20-milliliter propofol vials the smallest manufactured by that company and available for endoscopies. Kemp and Cottle are left to question why the clinics even needed or were sold 50-milliliter vials.

“It’s a shared responsibility,” Kemp said of the hepatitis outbreak. “If Teva hadn’t shared the 50-milliliter vials with the Endoscopy Center, the temptation wouldn’t have been there to reuse the vials.”

Teva is part of a massive company, Israeli-based Teva Pharmaceutical Industries, with deep pockets. Teva Pharmaceutical, one of the world’s largest manufacturers of generic drugs, trades on Nasdaq and has a market value exceeding $50 billion.