$500 Million Jury Verdict Leveled Against Teva Pharmaceutical Industries and Baxter International in Propofol Lawsuit
A District Court jury in Clark County Nevada ordered Teva Pharmaceutical Industries and Baxter to pay a combined $500 million in punitive damages to a plaintiff who contracted Hepatitis C during an endoscopy procedure after vials of the drug Propofol were allegedly reused on him. The verdict comes on top of the $5.1 million in compensatory damages awarded to the plaintiff and his wife.
Attorneys for the plaintiffs originally offered to settle the case for $1.7 million but the offer was rejected by the defendants.
The bulk of the verdict was against Teva Pharmaceutical who was ordered to pay $356 million in punitive damages, while Baxter International was ordered to pay only $144 million (Teva manufactures Propofol and Baxter distributes Propofol).
The lawsuit claimed that the plaintiff contracted Hepatitis C as a direct result of product misuse related to unsafe clinical practices from reuse of 50 mL vials of propofol.
Propofol is a short-acting, intravenously administered hypnotic agent often used during the induction and maintenance of general anesthesia. It is also commonly used as sedation for mechanically ventilated adults, and for procedural sedation during colonoscopy and endoscopy.
According to attorneysfor the plaintiff, the 50 mL Propofol vials manufactured and distributed by Teva and Baxter were packaged with inadequate warnings against re-using or “double-dipping’ for more then one patient. Nurses were alleged to have administited multiple doses of the drug one patient, then used the remaining amounts of the 50 mL vial on other patients. The plaintiffs said that Teva and Baxter knowingly manufactured and distributed 50 ML vials of propofol to these endoscopy centers, fully aware that only 10 ML vials were needed. The plaintiffs also maintained that this encouraged multi-dosing.
At least nine and possibly as many as 114 other patients were infected with the Hepatitis C during a 2008 outbreak. Additionally fifty thousand other patients were notified that they might be infected.
Teva Pharmaceutical Industries Ltd. is a global pharmaceutical company specializing in the development, production and marketing of generic and proprietary branded pharmaceuticals and active pharmaceutical ingredients. Teva is among the top 15 pharmaceutical companies and among the largest generic pharmaceutical companies in the world. The Company enjoys a firmly established international presence, operating through a carefully tailored network of worldwide subsidiaries. Headquartered in Israel, above 80% of Teva’s sales, which totaled US$13.9 billion in 2009, are in North America and Europe. Teva has over 35,000 employees worldwide and production facilities in Israel, North America, Europe and Latin America.
Baxter International is valued at more than $26 billion and netted $2.2 billion in 2009.
Teva and the drug Propofol were also the subject of a recent recall. On Dec 10, 2009 the FDA warned Teva Pharmaceutical of “significant” manufacturing violations in their California manufacturing facility that makes Propofol. Inspectors found that Teva had not screened every lot of their raw materials for bacterial endotoxins.
The FDA had previously issued an alert in June of 2007 regarding reports of clusters of patients who have experienced chills, fever, and body aches shortly after receiving propofol for sedation or general anesthesia.
Teva voluntarily recalled two lots of Propofol Injectable Emulsion 10 mg/mL 100 mL vials on 7/17/2009 due to presence of elevated endotoxins. Customers were instructed to cease using the product and return it to their distributor. A shortage of Propofol followed the 2009 recall.