Class I Recall for Stryker’s OASYS Midline Occiput Plate

On August 29, 2013, the FDA and Stryker notified healthcare providers of a class I recall of Stryker’s OASYS Midline Occiput Plate.  This most serious type of recall was issued because of reports of fracture of the pin that connects the implant's head to the plate body. According to their website, Stryker is one of the world’s [...]

September 3rd, 2013|Drug and Medical Device Litigation|0 Comments

Baxter Healthcare Facilities Cited For Multiple Violations by the FDA

The FDA has sent Baxter International a warning letter laying out problems it found during inspections at a plant in North Carolina and in Jayuya, Puerto Rico.  Previously, both the Puerto Rico and North Carolina locations have had violations during FDA inspections.  The North Carolina plant had violations first noted in August of 2012 while [...]

July 1st, 2013|Drug and Medical Device Litigation|0 Comments

510(k); Pathway for Safer drugs or Recipe for Disaster

Recent medical disasters such as the DePuy ASR, DePuy Pinnacle, and transvaginal mesh cases have revealed that medical devices were approved for use without adequate clinical data based on a grandfathering type provision in the FDA called a 510(k) process, where a new device that is cleared as "substantially equivalent" as a previously approved device [...]

Why Is the FDA Having Another Hearing on Avandia?

On June 5-6, 2013, the FDA will convene an advisory committee meeting on Avandia, a drug which was removed in most countries in 2010 and placed under severe restrictions in the US. Avandia, a project of GSK (GlaxoSmithkline), was the subject of extreme medical controversy and massive litigation in both the MDL and in State [...]