Monday, May 10, 2010

Lawyer calls drug vials 'weapons of mass infection'

The drug companies that produced and sold the sedative linked to Southern Nevada's hepatitis C outbreak provided large vials of medication to endoscopy centers despite their risk to public safety, a lawyer charged Friday.

"These drug companies knew that these were weapons of mass infection. They knew what was going on in these endoscopy centers. ... They knew it for years and years and years, and they did nothing to stop it," Robert Eglet told a jury during closing arguments in the first trial stemming from the outbreak.

Eglet represents Henry Chanin, 62, who was infected with hepatitis C during a 2006 colonoscopy at the Desert Shadow Endoscopy Center, one of two clinics linked to Southern Nevada's hepatitis C outbreak.

Chanin, headmaster at The Meadows School, and his wife, Lorraine, are suing Teva Parenteral Medicine and Baxter Healthcare Services, which made and sold the drug propofol, on several product liability claims.

After hearing two weeks of trial testimony, the jury began deliberations late Friday afternoon to decide whether the companies should he held liable for Henry Chanin's infection.

His case was one of nine linked to two Las Vegas endoscopy clinics by health officials, who in 2008 notified 50,000 patients about possible exposure to hepatitis, HIV and other blood-borne diseases because of unsafe injection practices at the clinics. Hundreds of patients have filed lawsuits as a result of the outbreak.

Officials blamed the local outbreak on nurse anesthetists reusing single-dose drug vials between patients after the vials had become contaminated by the nurses reusing syringes on the same patient.

Eglet said the companies knew of the temptation to reuse the large 50 milliliter vials of propofol, which contained four to five times the amount needed for a typical 10-minute colonoscopy.

"They knew they were going to be 'double dipping' on this between patients," he said.

Teva and Baxter should have known about the dangers because propofol was associated with seven previous hepatitis C outbreaks that infected 148 people, he said.

Eglet also pointed to a report Teva wrote to the U.S. Food and Drug Administration in 2000 to get approval to make 10 milliliter vials of propofol. The report acknowledged that some medical workers were reusing the larger vials among patients to avoid throwing away unused anesthetic.

The smaller vials would improve patient safety undergoing endoscopic procedures because there would be less leftover anesthetic to tempt medical workers to reuse the vials, the report stated.

Teva made the 10 milliliter vials until 2007, when it stopped production in part because the smaller vials cost more to make than the larger vials, Teva executive Craig Lea testified at trial.

Based on their knowledge of previous misuse of the larger vials, the drug companies should be held liable because the misuse was "reasonably foreseeable," Eglet said.

The lawsuit originally named the doctor and nurses who performed Henry Chanin's colonoscopy, but their insurance company settled the medical malpractice claim last month, preventing the drug companies from shifting blame.

"They cannot point the finger at somebody who is not here," Eglet said.

The Chanins' suit also claims warning labels on propofol inadequately warned of the dangers of reusing the vials.

Drug company lawyer Mark Tully defended his clients, saying there was nothing defective about the propofol, which worked exactly as it was supposed to during Chanin's colonoscopy.

He said Teva made the 10 milliliter vials until 2007, when they were discontinued because doctors preferred to buy 20 and 50 milliliter vials. It was up to the medical professionals to decide which size was appropriate because the amount of propofol needed varies by procedure length and patient size, he said.

"There are uses for 20s and 50s that are entirely acceptable," Tully said.

He also dismissed the 148 hepatitis C cases Chanins' lawyers connected to propofol, pointing out that all of those infections were blamed on poor techniques for maintaining a sterile environment, such as reusing syringes and improperly cleaning scopes, which were warned against in the drug packaging.

"There are risks with using propofol, and the way to avoid those risks is to use proper aseptic technique and only use the vial on one patient," Tully said, noting that every propofol vial had "single-patient use" written in red letters.

Since being infected with the hepatitis C virus, which makes the liver swell and stops it from working correctly, Henry Chanin has lived with the constant worry of infecting his wife. The couple have stopped doing anything that might spread bodily fluids, from sharing a glass of wine to having sex. He also deals with lingering side effects of fatigue and joint pain two years after undergoing chemotherapy-like treatment for hepatitis C.

Eglet asked the jury to award him $8.5 million in damages to account for economic losses and his suffering. Lorraine Chanin's lawyer, Will Kemp, asked the jury to award her between $1.6 million and $2.3 million.

Eglet also encouraged the jury to levy punitive damages against the drug companies because of their conscious disregard for public safety in the name of profits.

"You can't put them in jail. We can't do other things," Eglet said. "The only thing we can do, quite frankly, is hit them where they take notice ... with money."

Egypt Bars Israeli Doctor from Int'l Conference in Cairo

Egypt has barred an Israeli hematology expert from attending an international conference set to take place this month in Cairo despite the longstanding peace treaty between the two nations.

Dr. Uri Seligsohn, Professor of Hematology at Tel HaShomer's Sheba Medical Center, has been unable to obtain a visa from the Egyptian government in order to attend the conference, scheduled for May 22-25. It was Seligsohn who had supported a decision to approve Cairo as the location for the meeting site, two years ago.

He is chairman of the Education Committee of the International Society on Thrombosis and Haemostasis (ISTH), the organization that is sponsoring its 56th Scientific and Standardization Committee (SSC) meeting, which he intended to attend.

The professor told the Hebrew-language Ma'ariv newspaper over the weekend that at the time, he “thought that there were ties of peace and friendship between Israel and Egypt,” and that “with the help of the conference we would be able to develop the Egyptian medical system – but unfortunately I was wrong.

“Apparently the Egyptians are uncomfortable that a Jew and an Israeli doctor should come to their conferences.

“Since it became known that the Egyptians refuse to approve my entry there has been a tremendous commotion among researchers and doctors around the world,” he said, according to IMRA (Independent Media Review and Analysis), which translated the report. “I know of many researchers who have canceled their attendance at the conference. The management of the organization has announced that this move will have serious ramifications for scientists in Egypt.” (