A proposed settlement of a lawsuit brought against Nobel Biocare regarding its NobelDirect dental implants has hit a snag.
It was previously reported that the company would pay up to $1.3 million to settle a $450 million lawsuit brought against it three years ago by a California dentist who said the company had misrepresented the safety of the implants.
The lawsuit, which was filed in June 2010 by Jason Yamada, DDS, of Torrance, CA, in the U.S. District Court for the Central District of California, sought compensation for dentists who had to perform surgery on their patients or pay for restorative surgery due to complications from the implants. The plaintiff alleged that Nobel Biocare knew that the implants were "defectively designed" but marketed them as safe and effective.
Now Nobel Biocare has raised issues with the settlement agreement, arguing that a claims form process advocated by the plaintiffs would force Nobel to "not comply with the medical device reporting requirements" of the U.S Food and Drug Administration (FDA), according to a story on Law360.com. According to Nobel, the FDA requires implant manufacturers to report when a dental implant may have been a factor in an injury.
A federal judge has now ordered both parties to submit additional briefings on whether their settlement agreement was a binding one and has instructed them to return to the negotiating table, the Law360.com story noted.
