HCV outbreak jury’s $162.5 million verdict: The death of common sense

January 12th, 2015

The infamous 2008 hepatitis C virus (HCV) outbreak in a Las Vegas endoscopy clinic was caused primarily by health care workers using blatantly unsafe needle practices that included the reuse of single-dose vials on multiple patients, according to an investigation by the Centers for Disease Control Prevention.

In the words of prosecutor Capt. Jack Ross in A Few Good Men, “These are the facts of the case and they are undisputed.”

Or are they?

As originally described to Hospital Infection Control & Prevention (See HIC, April 2008, cover story) the practices at the long-shuttered clinic involved using a syringe to administer propofol anesthetic to an endoscopy patient, then changing the needle — but not the syringe — before drawing up additional medication to be used on the same patient. The process of redrawing medication using the same syringe could have contaminated the medication vial. The same vial of anesthetic then was used for a second patient with a clean needle and syringe. Infection preventionists are all too familiar with contamination of multidose vials, but the anesthetic vials being used in the clinic were packaged as single use.

In that regard, consider what an investigator told us as the outbreak was reported: “We are talking about a vial that is only intended for single use,” said Joseph Perz, PhD, acting team leader for prevention in the CDC division of healthcare quality promotion. “Just because the catalogue may have the larger size [single-use] vial, which is appropriate for some procedures — doesn't mean that it is appropriate to order that vial and use it for multiple patients. It wasn't designed that way and that in itself is a violation."

We revisit this finding – that the vials were not “designed” to be used that way – in noting this news update: After deliberating about six hours over two days, a jury has awarded a $162.5 million verdict against the companies that made and distributed the drugs and vials, including Teva Parenteral Medicines Inc., Baxter Healthcare Corp. and McKesson Medical-Surgical, the Las Vegas Review-Journal reports. The patient lawsuit, like dozens of others still heading toward trial, involved product liability claims against the drug companies, which are already in the process of appealing the verdicts. “Teva should not be held liable for the blatant disregard for patient safety by medical professionals at their facility,” Teva said in a statement. “While the mistreatment of patients is unacceptable, it was not Teva's fault."

The jury disagreed; I disagree with them. According to the press reports, jurors did not think that the vials were defective, but decided the drug companies failed to do enough to prevent their product from being misused. Given the history of hepatitis outbreaks related to needles and vials, perhaps the companies should have been more aggressively proactive in warning of potential misuse of their products. But this ultimately, is the death of common sense.

Whether motivated by greed or acting out of ignorance, health care workers treating patients must ultimately accept responsibility for such a blatant disregard of basic infection prevention. To blame the product companies is like tracing a case of arson back to the manufacturer of an accelerant used in the crime. How are these companies to make their products foolproof if -- as has been evidenced yet again -- fools are so ingenious?

The verdict does not necessarily signal an exoneration of those who took the vials and needles to hand. Indeed, the mood of this jury and the anger of the infected patients does not bode well for the clinic health care workers still awaiting trial in the case.