First Zimmer Durom Cup Lawsuit Heads to Trial
The trial for the first Zimmer Durom Cup lawsuit to be heard by a jury began last Monday, on November 1, in the St. Clair County Circuit Court of Illinois. John Pugliese’s case will serve as a test to help both parties gauge the jury reaction to the testimony and allegations that will likely be presented in most of the other cases.
Pugliese was implanted with a Zimmer Durom Cup in 2008, but claims he began to experience debilitating side effects shortly after, causing a need for early revision surgery.
A second Zimmer hip trial is scheduled to begin in Los Angeles, CA on January 20, 2015. The trial first federal Zimmer Durom Cup lawsuit is expected to begin in April 2015.
Zimmer hip MDL
More than 350 product liability lawsuits have been filed across the country by plaintiffs who have suffered from Durom hip complications. At least 300 of the lawsuits have been joined together under multidistrict litigation in the District of New Jersey.
The MDL was founded on June 9, 2010, under the direction of U.S. District Judge Susan D. Wigenton.Plaintiffs accuse Zimmer of a variety of wrongdoings, including negligence for not issuing a permanent recall for the implant, failing to properly market and test the product and not warning the medical community and patients of the Durom Cup’s potentially dangerous side effects.
Plaintiffs joined together under MDL 2158 have experienced a number of adverse health reactions from the implant, many citing metallosis, premature failure of the device, loosening of components and tissue damage.
Zimmer Durom Cup
The Zimmer Durom Cup hit the market in 2006 as an innovative new hip replacement option. The product was marketed as a way to avoid many issues linked to traditional hip replacement products, including limited range of motion, instability and wear and tear of hip bearings. Unfortunately, concerns regarding the safety of the product began shortly after it was introduced.
Zimmer temporarily stopped selling the device in July 2008, to make adjustments to the warnings and instructions on the device, ensuring doctors received sufficient training on surgical techniques required to properly implant the artificial hip. The action was strictly for Durom Cups implanted in the U.S., as the company noted that marketing and distribution wouldn’t be impacted in other countries.
The company issued a letter to U.S. surgeons on July 22, 2008 that “strongly recommended” surgeons stop implanting the device in patients until receiving additional instructions and training. Zimmer noted that product labeling would be updated to offer more detailed instructions on implanting the Durom Cup in patients.
“We have identified that the more successful users consistently execute crucial technique steps for Durom Cups in a specific manner,” states the letter. “The steps include but are not limited to the line-to-line reaming, use of trials in every case, proper cup position for this device, appropriate impaction techniques, and no repositioning.”
Roughly 12,000 patients received the Durom Cup system during the two-year period of 2006 to 2008. In 2008, Zimmer announced an estimate that some doctors experienced premature failure rates up to 5.7 percent, but claims have suggested the actual rates may be as high as 20 to 30 percent.
- Zimmer, Surgeon Letter http://www.zimmer.com/content/pdf/en-US/DUROM-SURGEON-LETTER-07-22-08.pdf
- U.S Food and Drug Administration, Recalls http://www.fda.gov/medicaldevices/productsandmedicalprocedures/implantsandprosthetics/metalonmetalhipimplants/ucm241770.htm