The QMN Weekly Bulletin

Synthes Slapped With Wrongful Deaths Suit, FDA Warning Letter

April 6, 2012

Swiss devicemaker Synthes faces trouble from two sides, with an FDA warning letter posted just days after the company was sued by the families of two patients who died on the operating table during illegal clinical trials.

The elderly patients died in 2003 and 2004 after bone cement made by Synthes’ Norian subsidiary was injected into their spines, allegedly causing their blood pressure to plummet. Their families filed suit in Contra Costa [Calif.] County Superior Court in late February.

According to the complaint, Synthes did not warn the patients or their families of possible risks of the bone cement and kept the families and the FDA in the dark when they learned of the deaths.

This death was a serious adverse event that resulted in a warning letter but devicemakers often see warnings for less-serious slip ups as well. It might be good to ask yourself what marketing mistake hit 10 devicemakers with warning letters in 2011? Or if simply trending your quality data won’t prevent a warning letter — what will?

You’re far less of a target for warning letters and 483s when you have answers to questions like these. Here’s where to find them.

FDA Device Enforcement: An Analysis of Warning Letter Trends gives you access — and insight — into all device warning letters published in 2011.

Remember, there are more audits now than ever. If you’re targeted, you’ll be facing better-trained inspectors. Learn from other’s mistakes and order this book today!