Teva settles majority of US propofol HCV exposure lawsuits
This article was originally published in Scrip
Teva Pharmaceutical Industries is settling the vast majority of lawsuits arising out of claims relating to a product of Teva Parenteral Medicines and a hepatitis C outbreak in Southern Nevada. Just a handful of cases remain open. Patients claimed they developed hepatitis C virus (HCV) from vials of the anaesthesia drug propofol, which had become contaminated after being reused in colonoscopy procedures.
Teva, which no longer makes propofol, had Baxter and McKesson as US distributors. All of the companies argued that the vials were clearly marked for single-use only and that the doctors and nurses were to blame for the contamination. Teva signed an indemnity agreement accepting financial responsibility for the cases.
The exact settlements are confidential; Teva had lost some cases and was facing large dollar amounts in both compensatory and punitive damages as many cases became tied up in the legal system, and this can often lead to a global settlement. Teva said in a filing with the US SEC on 17 February that it has paid or set aside approximately $270 million to cover over a hundred cases. An additional $15 million is also being set aside for the cases.
In the SEC filing, Teva said that the plaintiffs in the trials claim they were infected with HCV as a result of reuse by medical practitioners of single-use vials of propofol on more than one patient. "Certain of the medical practitioners are currently the subject of criminal proceedings relating to their alleged reuse of single patient vials", the company stated. "At all relevant times, the label for Teva's propofol product has stated that it is for single-patient use only and that strict aseptic techniques must be followed at all times when using the product".
In some of the suits the plaintiffs had accused Teva of marketing only larger, more profitable vials of propofol to the outpatient clinics, knowing that the centres may attempt to reuse them to cut costs. Teva denied the accusations and insisted the blame for contamination is the fault of the health care professionals.