Florida Woman Takes on Zimmer Holdings in Defective Durom Cup Lawsuit
Norma Babycos, a Florida resident, filed a defective Durom Cup lawsuit on August 26, 2014 against Zimmer Holdings, Inc. and its subsidiary, Zimmer, Inc. in United States District Court, District of New Jersey. The lawsuit was consolidated into Durom Hip Cup Products Liability Litigation, MDL No. 2158 before Judge Susan D. Wigenton, alleging that Zimmer had full knowledge of the serious risks of the faulty design and manufacture of the Durom Cup, yet willfully misrepresented the safety of the hip replacement device to both the medical community and the public.
As a hip replacement candidate, Ms. Babycos initially believed Zimmer’s marketing outreach that she would achieve a significant improvement in her quality of life by agreeing to its implantation.
The plaintiff had the device implanted in July 2006, but began to suffer from increasingly debilitating pain. After years of soreness and discomfort, she was advised to have the device removed and underwent hip revision surgery in May 2013.
Her defective Durom Cup lawsuit claims that the plaintiff “has sustained, and will continue to sustain severe physical injuries, severe emotional distress, mental anguish, economic losses, and other damages.”
Durom Cup’s problematic past
Zimmer Holdings, Inc. was founded in 1927 and is one of the largest manufacturers of orthopaedic devices in the world. It built its enormous success by giving physicians a wide range of prosthetic options in both design and materials to offer their orthopaedic patients who are seeking implants. Zimmer makes at least eleven different hip replacement systems for various applications.
The Zimmer Durom Acetabular Component, also known as the Durom Cup, was approved by the FDA in 2006 for a new generation of younger patients seeking a more advanced hip replacement design with a wider range of motion. Over 12,000 Durom Hip devices were implanted between 2006 and 2008, but reports of problems such as pain, swelling, and tissue damage caused by loosening of the components and a higher than expected rate of revisions began surfacing.
Metallosis, a leaching of metal particles into the bloodstream due to degrading of the chromium alloy construction of the Durom Cup, was also reported.
In April 2008, Dr. Larry Dorr, a former consultant to Zimmer and prominent Los Angeles surgeon, called Zimmer out in an unusual public warning to the American Association of Hip and Knee Surgeons about his concerns of the rate of failure of the Durom Cup. His warning was at first ignored by Zimmer, but they finally agreed to investigate his concerns in May of that year.
Zimmer blames physicians for problems with Durom Cup
After investigating over 3000 Durom Cup cases, Zimmer directed surgeons to temporarily stop implantations, but then decided to end the suspension after two months, deciding that the product was not defective. Instead, Zimmer said that the surgeons doing the implantations needed more training on how to handle the surgery correctly. Dr. Dorr didn’t waver from his original assessment. He said the implant technique is not at fault saying, “It’s a bad device.”
The FDA agreed and issued a Class II recall in the fall of 2008 for 19,000 Durom Hip devices, calling Zimmer’s labeling of the device “false and misleading”.
Zimmer hip settlements will top $600M
Early on, the revision rate for the Durom Cup was estimated to be from 1 to 5%, but a 2011 review revealed a failure rate as high as 15%. That percentage is now considered conservative, with some lawsuits estimating a 30% failure rate.
By 2012, Zimmer had paid almost $400 million in Durom Cup settlements and expects to pay over $230 million more by the end of 2014.
The plaintiff in this suit seeks damages for both economic and non-economic losses, medical expenses, loss of earnings, disfigurement, pain and suffering, mental anguish and emotional distress. Punitive and/or exemplary damages are also sought.
- New York Times, Complaints Undermine Hip Device, http://www.nytimes.com/2008/07/24/business/24hip.html?_r=0
- New York Times, Complaints Soar on Hip Implants as Dangers are Studied, http://www.nytimes.com/2011/08/23/business/complaints-soar-on-hip-implants-as-dangers-are-studied.html?pagewanted=all&_r=0
- Reuters, Zimmer Durom Cup Hip Implant Recall Lawsuit Filed By North Carolina Resident, http://www.reuters.com/article/2010/11/10/idUS147023+10-Nov-2010+BW20101110