STOCKHOLM (Reuters) - Swiss dental implant maker Nobel Biocare has been sued by a California dentist seeking class-action status on behalf of dentists whose patients have suffered complications such as bone loss from one of its products.
A company spokesman said on Monday the NobelDirect dental implant was safe and that Nobel Biocare would fight the lawsuit, which was filed on June 30 in the U.S. District court in Los Angeles.
The suit by Jason M Yamada seeks compensation for dentists who have had to perform surgery on their patients, or pay for restorative surgery, after complications from the implants, which it said were defectively designed.
“Because of Nobel’s practices, plaintiff and the class members now face a flood of complaints from injured dental patients who have needed, and will need, immediate intervention to remove the defective implants,” the lawyers Lopez McHugh and Audet & Partners wrote in the 26-page complaint.
The suit proposed a class action to cover thousands of dentists in the U.S. who have used the NobelDirect implant, adding that Nobel Biocare had knowledge of the defect, but marketed the implant as safe and effective.
The Swedish Medical Products Agency investigated the same implants in 2005 to 2006 after complaints about bone loss. The company got approval to continue sales, but the agency told it to revise instructions and marketing material.
Nobel Biocare spokesman Nicolas Weidmann said NobelDirect was probably the most well documented product in the entire industry as a result of the Swedish investigation, and that it was safe if correctly used.
“We have very, very comprehensive material and data, including the clearance from the SMPA in Sweden, that the product is absolutely safe,” he told Reuters.
“We have the information to prove that NobelDirect is a good product, is a safe product, and in that respect we will fight against the lawsuit, definitely.”
Reporting by Sven Nordenstam, additional reporting by Steve Gorman in Los Angeles, editing by Will Waterman