For the second time in a year and a half, Teva Pharmaceuticals and Baxter Healthcare have a lost a trial in which a jury determined they contributed to a 2008 hepatitis outbreak in Nevada due to the way the Propofol medication was marketed. Another defendant was McKesson, the big distributor. The jury awarded three people a total of $20 million, although punitive damages are not yet decided.
In this latest trial, Richard Sacks, Anthony DeVito and Anne Arnold argued Teva intentionally sold outsized vials to encourage doctors to reuse them, even though there was a risk of spreading hepatitis C and other diseases. They contended they contracted the illness during colonoscopies. If the name propofol is familiar, by the way, this is the same sedative given Michael Jackson before he died.
Teva faces about 300 lawsuits resulting from the hepatitis C outbreak. And as Bloomberg News notes, investigations by Nevada health officials and the Centers for Disease Control and Prevention blamed the reuse of Propofol vials for infecting patients. Some 50,000 patients were notified about possible exposure to hepatitis, HIV and other blood-borne diseases because of unsafe injection practices at two clinics. Last year, criminal charges were filed against a doctor who ran one of the clinics.
Last year, a Nevada jury awarded $5 million in compensatory damages and $500 million in punitive damages to a man who contracted hepatitis C. He charged the sedative lacked appropriate warnings and the drugmakers should not have provided large vials of the anesthetic to endoscopy centers. Teva is appealing the verdict (back story).
The lawyers for the plaintiffs who won the most recent trial are reportedly seeking $600 million in punitive damages. Baxter, by the way, was named as a defendant because the company sold the drug for Teva until 2009. Recently, Baxter won a ruling that forces Teva to assume its liability in these lawsuits.
3 Comments
I have two observations:
1) Having heard the constant VERTEX ads about HEP C, this should be a marketing opportunity for them.
2) The punititive damages (500 million and 600 million USD)would seem outlandish, except that in the NY market it is comparable to the Yankees budget for 2 'shortstops' - on reflection, make all three figures ABSURD!
Just an observation, in order to contaminate a re-useable vial, wouldn't the provider have to also be re-using the syringe? Am I missing something here?
Cassandra, these cases of HepC apparently occured in 2009 or after. However, the product labeling as far back as 2007 clearly states that th:at because of concerns with microbial contamination thet the product was intended for single use administration only:
"DIPRIVAN Injectable Emulsion should be prepared for single-patient use only. Any unused portions of DIPRIVAN Injectable Emulsion, reservoirs, dedicated administration tubing and/or solution scontaining DIPRIVAN Injectable Emulsion must be discarded at the end of the anesthetic procedure or at 6 hours, whichever occurs sooner. The IV line should be flushed every 6 hours and at the end of the anesthetic procedure to remove residual DIPRIVAN Injectable Emulsion".
Thus re-use should not even be a consideration.