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Stryker Hip Component Recall Undermines Defense in Metal-On-Metal Lawsuits

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Stryker Corp.’s recent recall of hip device components is expected to undermine the device maker’s defense in metal-on-metal hip implant lawsuits. Stryker recently recalled its Rejuvenate Modular and ABG II modular-neck hip stems.

Some hip implant device makers can also expect to be hit hard by the news. At the center of a debacle involving the safety and longevity of metal-on-metal hip implant devices, many manufacturers maintain that their devices are safe, despite unprecedented early failure rates and patient surgeries to remove faulty devices. Sryker’s recall of two metal hip replacement components calls into question device makers’ arguments with similar injuries seen in these components and in implants involved in litigation.

According to Stryker Corp., which issued its recall Friday, ceasing worldwide distribution of the devices, the Rejuvenate and ABG II modular-neck stems could fret or corrode, which could lead to injuries to the body’s tissue and cause pain or swelling.

Stryker is not the only metal-on-metal hip device maker to implement a recall of its products, noted Law 360. Johnson & Johnson’s DePuy Orthopaedics Inc. unit and Smith & Nephew PLC have recalled hip devices and DePuy and Wright Medical Technology Inc. face multidistrict litigation over injuries patients allege are the result of being implanted with these devices. Plaintiffs suing Biomet Inc. have also recently filed an application to consolidate their lawsuits, said Law 360; other lawsuits are expected.

At a U.S. Food & Drug Administration advisory panel convened last month, some device makers argued that their all-metal implants were sufficiently dissimilar to be considered a class and should be viewed on a case-by-case basis; an explanation that believed to be a preview of potential defense strategies. At least one attorney from a national law firm that represents victims of alleged metal-on-metal hip implant injuries expressed dismay at these statements. NewsInferno wrote that, according to Daniel Burke, Senior Litigation Counsel at Parker Waichman LLP, the comments were in direct conflict with the way in which most metal-on-metal hips have been cleared for sale by the FDA.

“It is ironic that when they file with the FDA for a 510k, fast-track approval, the manufacturers claim their new metal-on-metal hip implant is substantially similar to others on the market,” Mr. Burke said in a statement issued by Parker Waichman LLP. “Now they say metal-on-metal hips should be individually evaluated when it comes to failures, without having subjected their own devices to more stringent analysis during the approval process.”

According to the Parker Waichman’s statement, the majority of metal-on-metal hip replacement devices used in total hip replacements were cleared for sale through the FDA’s 510(k) protocols, which allows manufacturers to forgo human testing if they can show a device is similar to a predicate product already brought to market. Mr. Burke believes that had metal-on-metal hip implants been subjected to more stringent premarket scrutiny, safety issues may have caught and sales prevented.

Stryker explained that its products are constructed with a metal neck within a metal stem. Other implants at the center of numerous lawsuits, are constructed with a metal ball that rubs against a metal socket, explained Law 360. Although there are differences, tissue injuries are that same. Attorneys point out that the potential for metal poisoning appears to be the same and that Stryker’s recall could prove damaging to device makers arguing that their devices are safe.

“While modular-neck stems provide surgeons with an option to correct certain aspects of a patient’s anatomy and hip biomechanics, given the potential risks associated with fretting and corrosion at the modular neck junction, Stryker Orthopaedics decided to take this voluntary action,” executive Stuart Simpson said in a statement.

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