Zimmer Hip Lawsuit Alleges 13 Separate Counts of Wrongdoing

Zimmer Holdings Inc. is being sued by plaintiff John A. O’Neal of Colorado for more than $75,000 related to injuries sustained following a Durom Cup hip implant in 2009. O’Neal was implanted with a Zimmer Durom Cup in his right hip at Memorial Health Systems in Colorado Springs.

Severe Zimmer hip complications

According to the lawsuit, the plaintiff suffered severe pain and discomfort following the surgery and had elevated metal in his bloodstream.  Three years later, he underwent a revision surgery to replace the defective implant and alleviate some of the Zimmer hip complications. As of May 28, 2013, the plaintiff is suing for physical and emotional damages, disability, disfigurement, medical and hospital expenses, rehabilitative and pharmaceutical costs, lost wages and loss of future earnings.

The Zimmer hip lawsuit states, “Had Defendants not concealed the known defects, the early failure rate, the known complications, and the unreasonable risks associated with the use of the Durom Cup, the plaintiff would not have consented to the Durom Cup being used in his total hip arthroplasty.”

The plaintiff is suing Zimmer Holdings Inc. on 13 separate counts, including:

• Strict liability – failure to warn and instruct
• Strict liability – design defect
• Strict liability – manufacturing defect and failure to adhere to quality controls
• Negligence
• Negligence, per se
• Breach of implied warranty
• Breach of express warranty
• Negligent misrepresentation
• Intentional misrepresentation
• Constructive fraud
• Unfair and deceptive trade practices
• Unjust enrichment, and
• Punitive damages

Evidence presented in the Zimmer hip lawsuit

The Durom Cup was launched for hip resurfacing procedures in Europe in 2003. Two years later, they submitted a Section 510(k) Premarket Notification and passed FDA clearance to release a similar product in the United States, although the coating on the device had a different structure and slightly greater thickness. No clinical studies were submitted before the device was approved, but rather, the company stated that “non-clinical analysis demonstrates that the device is safe and effective.”

According to the Zimmer hip lawsuit, “Zimmer failed to recognize the deficiencies of the Durom Cup due to poor and inadequate quality assurance procedures, including failure of Zimmer to implement appropriate physical, manual, x-ray, microscopic, and other inspections of the Durom Cup. Zimmer failed to implement or utilize adequate safeguards, tests, inspections, monitoring, and quality assessments to ensure safety of the defective device.”

The Zimmer hip lawsuit also cited studies conducted by Dr. Lawrence Dorr M.D., a world-renowned orthopedic surgeon at the Good Samaritan Hospital in Los Angeles, which found the failure rate of the Zimmer Durom Cup to be 24% over a four-year period. This failure rate is much higher than Zimmer’s predicted failure rate of 5.7%.

Back in 2007, Dorr warned Zimmer of the high failure rate while working as a paid consultant for the company. He said x-rays showed that the implant was loosening from the bone rather than fusing to it, causing crippling pain in patients. In April 2008, he advised his colleagues to discontinue the use of this product. Zimmer agreed to look into Dr. Dorr’s claim, but continued to sell the product to an additional 1,300 patients during the investigation.

They concluded that the failures were related to improper technique by the surgeons. In July 2008, the company voluntarily issued a temporary suspension of Durom Cup sales due to mounting pressure. The Durom hip replacement was placed back on the market several weeks later with revised surgical instructions.