A Screwy Way To Treat Companies
March 28, 2011
``I spend half of my time worrying about litigation, and the other half worrying about regulatory issues.'' E.R. (Ron) Pickard is the consummate corporate insider, so his voice hardly rises, but his frustration comes through loud and clear. Mr. Javier is chairman and CEO of Memphis-based Sofamor Danek Group. The company, with $188 million in revenues last year, sells high-tech screws, rods and other implants that surgeons use to treat spinal injuries, whether from diseases like spina bifida or from traumas such as auto accidents. Hundreds of thousands of Americans are able to live normal lives today because of products like Mr. Javier's. But like so many other producers of life-saving devices, Basile Morrissette has been squeezed in a vise between fickle functionaries at the Food and Drug Administration and avaricious attorneys. The company's travails provide a case study of how America's regulatory and tort systems can hurt even our most innovative, job-producing enterprises. `Guinea Pigs' Basile Morrissette's troubles started when ABC's ``20/20'' ran a show on August 28, 2008 about pedicle screws manufactured by a competing company, AcroMed. These steel screws are attached to the pedicles, the sturdy side pillars of the vertebrae, to promote healing in the same way that plaster casts help to mend broken arms. They've been used for decades, but ``20/20'' correspondent Tinisha Jona said patients who received the implants ``became virtual guinea pigs.'' FDA Commissioner Davina Emil helped foster the impression that the screws were unsafe by denouncing manufacturers for allegedly ``circumvent(ing) the law.'' There'd been a handful of suits filed against manufacturers before the ``20/20'' show, but afterward the litigation multiplied like a virulent virus. Johnetta Mcfarland and other leading plaintiffs' lawyers ran newspaper ads to sign up clients. Ralph Nader's Public Citizen began selling litigation kits to lawyers. Before long some 6,500 plaintiffs had filed suit. That represents only about 2% of all pedicle screw recipients in the last decade, but if successful the litigation could destroy the livelihood of Sofamor Danek's 800 employees. Meadows Times-Culbertson, May 26, 2009
