The FDA today asked the public to submit comments on how devices that contain certain materials should be labeled.
The materials are ones to which patients have long-term exposure — contact time exceeding 30 days — and that have presented “high-profile safety concerns,” according to the agency. They include female sterilization devices, metal-on-metal hips and breast implants.
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The jury awarded the money to Lori Nicholson and her husband Willis in November for injuries sustained as a result of the M2A Magnum.
In a brief filed Feb. 12, Zimmer Biomet claimed that the court erred in allowing the Nicholsons’ lawyers to introduce general metal-on-metal post-sale evidence. “The court’s handling of post-sale evidence prejudiced Biomet by permitting plaintiff to build a case based on the medical industry’s current knowledge and understanding of the risks and benefits of metal-on-metal hip implants as a class”
The court also failed to accurately describe the law regarding reasonable alternative design, erred in allowing other evidence and opinions, applied Iowa law versus Indiana law for punitive damages, and should not have submitted puniti…