Zimmer Holdings Inc., maker of hip-replacement devices, recalled its Durom Cup hip replacement implant. They then set aside $271.7 million for lawsuits filed by patients who needed additional surgery after having the company’s Durom Cup implanted.
Originally, Zimmer only accepted legal claims for surgeries performed before July 22, 2008, and those with a revision surgery performed within two years after the original implant. Zimmer estimated that as of September 30, 2011, the remaining liability for surgeries performed before July 22, 2008 was $142.6 million.
Zimmer later was forced to revise its stance to include all claims for surgeries performed globally before July 22, 2008, regardless of the amount of time between the revision surgery and the original implant.
In its November 2011 statement of earnings, Zimmer said it planned to record any provisions for Durom Cup claims in which the original surgery was performed after the 2008 deadline as part of its product liability accruals. By September 2011, Zimmer had provisions totaling $10.2 million for those post-deadline claims.
Zimmer also stated in its earnings filing that it expected to pay the majority of the Durom Cup-related claims within the next three years. However, the Company also added that the number of legal claims and the amount it pays to settle these claims may be more than anticipated.
Zimmer Durom Cup Lawsuits
The Durom Acetabular Component – or Durom Cup, as it is commonly known – is constructed of a single sheet of cobalt chromium alloy metal. It was developed to be used in total hip replacement surgery in conjunction with larger diameter replacement heads for the thigh bone.
The device has a pure titanium plasma-sprayed coating that fixes it in place. In compliance with Food and Drug Administration (FDA) regulations, the Durom Cup sold in the United States was slightly different than those sold abroad in that its structure had a slightly thicker coating.
Zimmer voluntarily suspended sales of the Durom Cup in July 2008, but it was reintroduced to the market a few months later.
FDA Warnings and Study Results
The FDA advises patients to be aware that metal-on-metal devices are not suited for everyone. There are some specific factors that determine if a patient is a good candidate or not.
If a patient meets any of the following criteria, they should not be given a metal-on-metal implant:
- Kidney problems
- Allergy or sensitivity to metals
- Suppressed immune system
- Receiving high doses of corticosteroids
- Child-bearing age
In addition, the FDA notes that people with smaller body frames may be at greater risk for adverse reactions and device failure if they receive a metal-on-metal implant.
Analysis Disproves Metal-on-Metal Superiority
A study published in BMJ (British Medical Journal) reported an analysis of 18 studies that reviewed implanted hip devices that featured various surfaces. The studies comprised 3,139 patients and more than 830,000 operations.
The analysis documented a discovery of what physicians call functional outcomes – a person’s ability to perform daily, routine activities and ability quality-of-life events were the same between patients with the metal-on-metal hip implants and traditional hip implants. This signifies that manufacturer claims of the superiority of the newer, supposedly superior metal-on-metal devices are not true.
The three largest national registries for devices – in Australia, New Zealand and England/Wales – provided data that showed there were higher rates of revision surgery associated with metal-on-metal implants compared with traditional metal-on-polyethylene implants.
In addition, 17 of the 18 studies reported a higher incidence of hip dislocation in patients who received metal-on-metal implants.
Another published in the Journal of Bone and Joint Surgery found that the concentrations of chromium and cobalt ions in the blood of 64 patients after one year of having received the Durom metal-on-metal surface replacement was 1.61 micrograms per liter of whole blood for chromium and 0.67 of a microgram per liter of whole blood for cobalt.
The researchers concluded that the levels of metal ions released into the blood may be specific to the Durom hip resurfacing implant and are a product of its manufacturing process.
How Courts Handle Zimmer Lawsuits
On June 9, 2010, the Judicial Panel on Multidistrict Litigation (MDL) consolidated certain cases regarding the Zimmer Durom Cup that were filed in various court districts in the U.S. and issued a Transfer Order for these cases to be sent to the federal District Court in New Jersey for pretrial proceedings. The panel said any additional cases transferred to the court would be consolidated with others.