"while the Company updated labelling to provide more detailed surgical technique instructions to surgeons and implements its surgical training program in the US"
The Durom Cup was first sold in the US in 2006, and was implanted in more than 12 000 patients over a two-year period. The complaint estimates that the failure rate of the Durom Cup so far is between 20% and 30%. The true failure rate will ultimately be much higher as the device gradually fails over time, and doctors and their patients come to realise that their implants are failing.
"The quality of life physically and mentally, today and in the future, for me and my family has been permanently damaged by the defective Zimmer Durom Cup I received in 2006," stated William Kokoszka of Meriden, Connecticut. "Zimmer should be accountable for its negligence and disregard for the safety of patients implanted with the Zimmer Durom Cup."
In July 2008, two years after Kokoszka received his Durom Cup, Zimmer issued a "temporary suspension" of sales of the Durom Cup device because of the unacceptable failure rate. "Rather than functioning in the intended manner, the Durom Cup implant resists bone growth and becomes loose or pops free from the hip," stated attorney Fleishman. "As a result, a large number of Zimmer hip patients have experienced severe pain and have been forced, as was Mr. Kokoszka, to undergo a painful and invasive revision surgery to remove the failed Durom Cup and replace it with a device that works."
A "metal-on-metal" implant, such as the Durom Cup, is not cemented or screwed in place during implantation. Instead, it is designed to bond naturally to the patient's hip bone.
After the product was introduced in the United States, Zimmer began receiving complaints from physicians that its Durom Cup was failing. "Despite warnings from leading orthopaedic surgeons, Zimmer continued to aggressively market the Durom Cup in 2007 and into 2008, blaming surgeons for the growing failure rate," explained Fleishman.
In July 2008, Zimmer announced that it was temporarily suspending sales of the Durom Cup in the United States. In its announcement, Zimmer stated that the suspension was necessary "while the Company updated labelling to provide more detailed surgical technique instructions to surgeons and implements its surgical training program in the US"
Zimmer denies any "evidence of a defect" with the Durom Cup and has thus far refused to issue a recall notice in accordance with procedures established by the Food and Drug Administration.
The lawsuit, entitled Kokoszka v. Zimmer Holdings, Inc. and Zimmer, Inc, was filed yesterday in federal court in Hartford, Connecticut.
Source: Lieff Cabraser Heimann & Bernstein, LLP
