Teva in the dock again for hepatitis link to propofol
pharmafile | August 30, 2011 | News story | Manufacturing and Production | Teva, manufacturing and production news, propofol
Teva’s decision to shut down a manufacturing facility for the anaesthetic propofol has become a focal point in a US lawsuit alleging the firm shares responsibility for patients in Nevada contracting hepatitis C.
The drugmaker, along with distributors Baxter and McKesson, is accused of selling propofol in large (50ml) vials that ‘encouraged’ staff at clinics to reuse the container in multiple procedures, even though the product was indicated only for single-use. The companies are also said to be at fault because they did not specifically warn clinic staff about the dangers of taking multiple doses from the same vial.
The pharmaceutical companies have responded by placing the blame at the door of the clinics, whose employees should have been aware of the risks of reusing the vials.
In the latest twist, testimony suggests that Teva shut down production of propofol three weeks after a jury awarded more than $500 million in compensatory and punitive damages to plaintiff Henry Chanin, in the first case of more than 300 pending lawsuits to come to trial.
The disclosure came from Teva vice president Craig Lea under examination by the plaintiffs’ attorney Robert Eglet. In a statement, Eglet said production was stopped due to “public outcry”. It is notable however that Teva’s decision to stop production at the facility in Irvine, California, also followed a warning letter from the US FDA citing a number of quality control and compliance issues at the plant, which was eventually shut down.
The latest case involves plaintiff and Las Vegas resident Anne Arnold, who was exposed to the hepatitis C virus when a contaminated 50ml infusion vial of propofol was reused during a colonoscopy procedure at the Endoscopy Center of Southern Nevada in July 2007.
The plaintiff’s attorney maintains that 50ml infusion vials of propofol are meant for long-term sedation of patients, not short out-patient procedures like colonoscopies.
Teva has already agreed to settle about a third of the hepatitis C-related suits, according to a recent Securities & Exchange Commission filing, and has set aside undisclosed funds to cover the costs of those settlements.
A verdict in the latest case is expected within the next few weeks.
Phil Taylor
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