Hip Implant Lawsuit Moved to Federal Court, Judge Recuses Herself


. By Gordon Gibb

A defective hip implant lawsuit removed to federal court in early December of last year has the distinction of having a federal judge in Florida remove herself from the case because of a perceived conflict inherent to a family member working for the law firm that represented the defendants in the suit.

The family member, or the relationship to Her Honor, was not identified. However, US District Judge Virginia M. Hernandez Covington recused herself from the case, noting that recusal was not mandatory but thought it to be an appropriate response nonetheless.

The plaintiff in the case is Ricky Ortwein, who filed a hip implant lawsuit following the alleged failure of a Pinnacle Acetabular Cup System manufactured by DePuy Orthopaedics and Johnson & Johnson, which he received in 2008. According to court documents, the plaintiff underwent testing that revealed, five years later, elevated levels of cobalt and chromium, suggesting metallurgical toxicity. Pain associated with the joint eventually led to revision surgery for Ortwein with a different hip implant, in order to rid his body of the allegedly problematic hip implant and the associated toxicity.

Part of Ortwein’s allegations surround the 510(k) clearance maintained by the US Food and Drug Administration (FDA), which allows for new or updated medical devices with a design similar to that already on the market to bypass traditional rounds of lengthy and expensive clinical trials.

“Had defendants conducted clinical trials of the Pinnacle device before it was first released on the market in the early 2000s, they would have discovered at that time what they ultimately learned in and around 2007 - that the Pinnacle device results in a high percentage of patients developing metallosis, biological toxicity and an early and high failure rate,” the lawsuit states.

The plaintiff states in his DePuy hip implant lawsuit that DePuy learned in 2007 that the metal-on-metal joints associated with the DePuy Pinnacle implant were prone to premature wear, in so doing casting off small metal particles capable of inflaming surrounding tissue and introducing metallurgical toxicity to the bloodstream. Ortwein claims in his lawsuit that even upon learning of the potentiality of metallurgical toxicity, DePuy continued to vend the Pinnacle Acetabular Cup System. Had DePuy pulled the device from the market at that time, Ortwein might have been spared the failed hip implant pain and suffering associated with the allegedly defective Pinnacle Acetabular Cup System, which he received as indicated in 2008.

There are some 1,300 complaints in the FDA’s Adverse Event database, pertaining to the Pinnacle Acetabular Cup System, the lawsuit states.

The case is Ricky Ortwein v. DePuy Orthopaedics Inc. et al., Case number 8:15-cv-02812, in the US District Court for the Middle District of Florida.


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