A national class-action lawsuit was filed Tuesday March 6, 2001 in Detroit's federal court against Sulzer Medica USA, Inc. and Sulzer Orthopedics, Inc., claiming money damages as a result of the defendants' defective hip implant that was recalled on December 5, 2000.

Detroit law firm Charfoos & Christensen filed this first of its kind suit in Michigan in Federal Court on behalf of Susan Jarrell of Sparta, Michigan, and the class of people who also received these defective implants. Ms. Jarrell underwent hip replacement surgery in June, 2000. Sulzer's Inter-Op acetabular shell was used.

An estimated 17,500 persons received the defective implant, Sulzer's Inter-Op acetabular shell, almost 90% of whom reside in the United States. The shells were primarily sold after October, 1999, and a small number of lots were sold after July, 1997.

Ms. Jarrell has filed claims for strict liability for a defective product, breach of warranty, negligence and strict liability for failure to warn. The complaint also seeks medical monitoring for the class.

Commenting on the lawsuit, J. Douglas Peters, Charfoos & Christensen, P.C. shareholder, said "If Sulzer had been receiving reports of problems since October, 1999, we wonder why doctors and the public were not informed until December, 2000. Many patients could have been spared needless pain and suffering and would not be facing the prospect of a second surgery to replace the defective prosthesis."

The class action complaint alleges that a lubricant used in the manufacturing process of the Inter-Op Shells was inadequately removed from the shell surface during the cleaning process. The lubricant residue prevents the implant from properly bonding with the bone, causing the shells to loosen. It can cause inflammation and pain and prevent the patient's bones from fusing normally with the hip implant. Plaintiff also alleges that Sulzer failed to issue any warning of the defect to her, physicians or the general public.

Since October, 1999, Sulzer received 61 reports of loosening of the shells. The company said that small amounts of mineral-oil based lubricants in the machines used in the manufacturing process may remain on the implant surface after the cleaning process. In January a company press release announced new multi-stepped procedures to address the problem.