$182.6M Verdict in Sacks Propofol Hepatitis Case

Posted by msch on Oct 25, 2011 3:52:00 PM

Robert Eglet Will Kemp Mark Tully Philip HymansonSacks v. Teva & Baxter (Las Vegas, Nevada)

A Las Vegas jury awarded $182.6M in compensatory and punitive damages against Pharmaceutical maker Teva, and two of Teva's distributors, Baxter and McKesson.

The case involved a 2008 Hepatitis C outbreak in Las Vegas among patients at a group of Endoscopy clinics owned by subsequently indicted physcian Dipak Desai. The clinics improperly used containers of the anesthetic Propofol for multiple patients.  This "double-dosing" allowed blood-borne pathogens -- Hepatitis C virus in particular -- to be transferred among patients.

For the plaintiffs, Robert Eglet (Mainor Eglet) argued that Teva should not have supplied "jumbo" 50 ml Propofol vials to endoscopy clinics that would only be performing brief procedures typically requiring 20ml or less of the anaesthetic, because the larger vials created a substantial risk that the clinic would re-use vials rather than dispose of the mostly-full vials after each procedure. According to Mr. Eglet, Teva used the larger vials because it was more profitable to do so, even though the pharmaceutical companies knew of the risk that endoscopy clinics would double-dose if given the larger vials. Similar outbreaks had previously occurred at other endoscopy centers.

Also for the plaintiffs, Will Kemp (Kemp Jones & Coulthard) told the jury, "In 1995, the most prestigious medical journal in the world says 'eliminate or modify the 50ml vial,'" and yet Teva failed to do so. A drug manufacturer has a continuous duty to monitor the medical literature and other sources of information, Mr. Kemp explained. However, Teva was unaware of many articles, including a report from the Centers for Disease Control, indicating that larger anesthesia vials created a health risk. Morever, said Mr. Kemp, Teva's failure to monitor had a demonstrable impact, because after they learned of the risks, endoscopy center physicians stopped ordering the larger vials.

On behalf of the manufacturer, Teva, Mark Tully (Goodwin Proctor) told the jury that there is nothing unique about a 50ml vial that causes it to be misused. Any size vial can be misused. However, said Mr. Tully, large vials can also be broken down into smaller syringes, which lets them be divided between multiple patients without risk. So the risk to patients is not created by the vial size or the desire to multi-dose, but the by "outrageous" and unanticipated misuse at the endoscopy center.

Moreover, said Mr. Tully, colonoscopies seldom require less than 10ml, and often require more than 20ml. Whether it was injection practices, or failing to clean and disinfect medical equipment, it was the clinic that was responsible. The pharmaceutical companies were simply the wrong defendants for the case.

On behalf of the distributors, McKesson and Baxter, defense attorney Philip Hymanson (Greenberg Traurig) told the jury that the plaintiffs were simply going after deep pockets, because no one knows for sure what happened in the endoscopy centers -- whether the infection resulted from Propofol or from dirty endoscopes. But regardless of the mechanism, the real cause was the culture of unsafe practices in the endoscopy center, said Mr. Hymanson. The Propofol was manufacturered and delivered properly. The clinics were able to purchase any size vial, and any size vial could have been used safely -- or unsafely, if the clinic did not follow proper procedures. A Dear Doctor letter would not have made a difference, said Mr. Hymanson.

The jury found that with respect to all three plaintiffs -- Anne Arnold, Anthony Devito, and Richard Sacks -- that the Propofol vials were not defectively designed, but that Teva had violated its duty to monitor; that Teva, Baxter and McKesson had failed to send a Dear Doctor letter; and that Teva, Baxter, and McKesson had breached the implied warranty of fitness for a particular purpose.

The jury found that compensatory damages, loss of consortium damages, and punitive damages were warranted.

The jury awarded $20.1M in compensatory damages ($8.5M to Ann Arnold, $900K to James Arnold, $5M to Anthony Devito, $700K to Donna Devito, and $5M to Richard Sacks).

The jury awarded punitive damages of $162.5M ($89.375M against Teva, $55.250M against Baxter, and $17.875M against McKesson).

Harry Hull CDC Epidemiologist

CVN webcast the Sacks v. Teva trial live, gavel-to-gavel.

Topics: Products Liability, Endoscopy Center Cases, Pharmaceutical