Centralization Sought for 3M Lava Ultimate Lawsuits Over Dental Crown Problems

Dentists nationwide are pursuing lawsuits against 3M over its Lava Ultimate dental crowns, alleging that the products do not stay bonded to patients’ teeth. 

Plaintiffs are calling for two class action lawsuits filed over 3M Lava Ultimate dental crowns to be consolidated for pretrial proceedings before one federal judge in a motion to transfer (PDF) filed on June 8 before the U.S. Judicial Panel on Multidistrict Litigation. The dentists present claims against 3M for “misrepresenting the durability, efficacy, reliability and fitness of its Lava Ultimate products for use in dental crowns.”

The dentists argue that consolidation of the 3M Lava Ultimate lawsuits would reduce duplicative discovery into common issues in the cases, prevent contradictory rulings by different judges, and serve the convenience of the court, the parties and witnesses. Plaintiffs have called for the cases to be consolidated as part of an MDL, or Multidistrict Litigation, in the Minnesota federal court where one of the cases is filed. The other is filed in the U.S. District Court for the Southern District of Florida.

According to the lawsuits, hundreds of thousands of defective dental crowns sold by 3M and its subsidiary 3M ESPE have failed, indicating that the dental crowns had a failure rate as high as 50%.

3M launched Lava Ultimate in 2011, after gaining approval through the FDA’s 510(k) fast-track approval process, which only requires that a product be substantially equivalent to one currently on the market. 3M claimed that the product was fracture-resistant, aesthetically pleasing and could be milled to fit while the patient was in the dentist chair.

However, according to the lawsuits over problems with the dental crowns, 3M admitted in June 2015 that the Lava Ultimate was defective and inappropriate for restorative crowns. That disclosure came only after hundreds of thousands had been sold nationwide.

The lawsuits claim that the dental crown problems were immediately apparent, and that 3M knew or should have known about the risk of failure but withheld information.

“Shortly after hitting the market in 2011, prosthetic crowns made using Lava Ultimate began debonding at an alarming rate,” the lawsuit notes. “The debonding failures were due to defects in Lava Ultimate. Lava Ultimate exhibits poor bond strength in general, irrespective of the different application protocols that 3M recommended. The poor bond strength was exacerbated by, among other things, the material’s flexibility. All of 3M’s Lava Ultimate products have this defect.”

The company sent a letter to dentists on June 12, 2015, alerting them to the problem and advising them not to use Lava Ultimate for crowns. On June 15, 2015, the FDA classified the letter as a Class II recall.

According to the lawsuit, 3M had distributed more than 1 million Lava Ultimate restorative kits at the time of the recall.

The lawsuits present claims for breach of warranty, violation of consumer protection laws, product liability, design defect, manufacturing defect, failure to warn, and unjust enrichment. The class action lawsuits seek to represent all dentists who used Lava Ultimate for crowns on their patients.