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July 20, 2018

Birmingham Hip Implant Preservation Protocol Approved

The District Judge presiding over hundreds of hip replacement lawsuits regarding significant issues with the Smith & Nephew Birmingham Hip Resurfacing System approved specific protocols this week for preserving explanted devices.

Currently there are more than 400 lawsuits against Smith & Nephew in the federal court system over allegations that its metal-on-metal hip designs are patently defective and prone to early failure, necessitating risky revision surgeries to repair the damage, as well as remove and replace the faulty implant. Due to Smith & Nephew’s aggressive marketing techniques and the exceedingly high number of hip replacement surgeries each year, most experts anticipate the litigation could expand exceedingly fast in the coming months.

In May 2017, the Judicial Panel on Multidistrict Litigation (JPML) centralized all federal lawsuits involving Smith & Nephew Birmingham Hip Resurfacing (BHR) system defects. The panel centralized pretrial proceedings before Judge Catherine C. Blake in the District of Maryland as part of a federal multidistrict litigation (MDL) to reduce duplicate discovery and circumvent conflicting pretrial rulings that could further delay these injured individuals from taking Smith & Nephew to task for concealing its hip implants' dangerous defects to maximize profits from the devices.

Birmingham Hip Implant Preservation Protocol

Judge Blake issued the case management order Tuesday, approving essential protocol for managing explanted Birmingham Resurfacing implants, dictating how parties and the court will identify, preserve, and handle the evidence going forward.

According to the order, the court expects the parties to make “good faith efforts” to preserve any explanted systems in their possession, as well as those in the possession of non-party medical practitioners, facilities, and hospitals. Furthermore, they are to extend this same effort to preserve any blood, fluid, tissue or serum samples.

Judge Blake also ruled that the parties cannot conduct any testing or analysis without an agreement by all parties or a court order. The court strictly prohibits destructive testing that would damage or destroy evidence without the written consent of all parties or a court order.

Smith & Nephew’s Birmingham hip implant was among the first metal-on-metal hip replacement systems to hit the market. However, serious concerns about the devices' safety were raised before its FDA approval. Wright Medical even tried to stop the device from receiving FDA approval. In 2006, the company filed a citizen’s petition with the FDA, asking the agency to reject the BHR’s application due to substantial concerns over the adequacy of the clinical trials Smith & Nephew was using to obtain premarket approval.

As part of the pretrial proceedings, the court will soon select a small group of representative test cases to prepare for early trial dates. These bellwether trials allow the parties to evaluate the relative strengths and weaknesses of their positions and may eventually help guide Birmingham hip settlement negotiations.

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