Appeals court shoots down Synthes bid to unseal grand jury records in Norian bone cement trial

Johnson & Johnson (NYSE:JNJ) subsidiary DePuy Synthes lost its bid to have some rand jury records unsealed for a wrongful death lawsuit brought over its Norian bone cements. At least 5 patients died during otherwise routine operations after the Norian cement was used off-label in their spine surgeries. The bone cement was initially developed by a company called Norian, which Synthes bought in 1999 for about $50 million. Synthes, in turn, was acquired by J&J for $21.3 billion in 2012. The FDA approved Norian for use in arm bones and portions of the skull, but in 2007 required Synthes to put a warning label on the product about its contra-indication for spine surgeries. Lawsuits filed by the families of the patients who died allege that Synthes knew as early as 2002 that Norian was unsafe for use in the spine due to its propensity to form clots in the bloodstream. Synthes paid paid $22.5 million in fines and was forced to sell Norian to settle federal criminal charges that it ran an off-label promotion scheme for the cement. Four Synthes executives – Michael Huggins, Thomas Higgins, John Walsh and Richard Bohner – were sentenced to prison terms after pleading guilty to misdemeanor charges over the scheme. A series of wrongful death lawsuits followed, brought by the families of deceased patients; Synthes settled one of those cases after a jury cleared the doctor and medical center also named as defendants. In the case of two other patients who died ...
Source: Mass Device - Category: Medical Devices Authors: Tags: Legal News Orthopedics depuysynthes johnsonandjohnson Norian Corp. Source Type: news