Medical device company Synthes and former executives have been sued in California over the deaths of two patients who, according to the lawsuit, died after clinical trials of a Synthes’ then subsidiary Norian’s bone cement product that were not approved by the Food and Drug Administration, the Philadelphia Inquirer reports.
Synthes executives were sentenced to prison terms late last year over charges related to the case as first reported here in June 2009.
The elderly patients “died after their blood pressure dropped precipitously and doctors could not revive them, though the bone cement could not be definitively identified as the cause of death,” the Inquirer said.
Synthes was acquired by Johnson & Johnson last year in a move which remains under inspection by Europe’s competition commission until its findings are released next month. Norian’s assets were themselves acquired in May 2011 by Kensey Nash.
Source: Philadelphia Inquirer