This is the Order approving the Class Action Notice. Here is an excerpt:
Preliminarily, the parties have agreed on the form and content of the proposed notice. (Defs.’ Report 3; Pl.’s Report 2.) The proposed notice is attached to Plaintiff’s Report as Exhibit A. The Court has reviewed the proposed notice and finds that it is the best notice that is practicable under the circumstances. It meets the standards of Federal Rule of Civil Procedure 23(c)(2)(B), as it clearly and concisely states in plain and easily understood language (1) the nature of the action; (2) the definition of the class certified; (3) the class claims, issues or defenses; (4) that a class member may enter an appearance through an attorney if the member so desires; (5) that the Court will exclude from the class any member who requests exclusion; (6) the time and manner for requesting exclusion; and (7) the binding effect of a class judgment on members under Federal Ruleof Civil Procedure 23(c)(3). Accordingly, the Court approves the proposed notice.
You may download the entire document, in PDF format, here.
This is the court-approved class action notice. Here is an excerpt:
A dentist has sued Nobel Biocare Holding, AG, Nobel Biocare AB, and Nobel Biocare USA, LLC (togetherthe “Defendants” or “Nobel”). The Judge for the case has certified the claims as a “Class Action.” You may be amember of the Class. Please read this notice carefully. This Document contains critical information regarding the Class Action lawsuit.
Please click here to download the entire document in PDF format.
This is the First Amended Complaint, which was filed on October 21, 2010: 
This is the order granting Plaintiff’s Motion for Class Cert.
The class is:
All dentists in the United States who have purchased any NobelDirect dental implant other than the “NobelDirect Groovy.”
The entire document may be downloaded here.
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.
Read more: http://uk.reuters.com/article/idUKTRE6641BV20100705
A dentist from California is suing Nobel Biocare, a Swiss company that manufactures dental implants.
Jason Yamada is acting on behalf of a number of dentists and their patients; in a 26 page file, Yamada’s lawyers listed the complaints of a number of dentists and patients and stated that Nobel Biocare had manufactured faulty and defective dental implants, which had caused patients to suffer negative side-effects and complications. As a result of complications caused by Nobel Biocare’s dental implants, patients were also forced to pay for restorative dental care, according to Mr Yamada. The suit also states that Nobel Biocare was aware of the defects, but was marketing their product as a safe and effective restorative device.
Nobel Biocare had previously arranged for Dr. Jason M. Yamada to speak at an educational conference in Houston on August 7, 2010, and to give two lectures in Boston on October 21, and 22, 2010.
Nobel Biocare has now unilaterally canceled those lectures. Please see the counsel letter to Nobel Biocare in regards to this matter.
Objectives: The aim of this prospective study was to evaluate the Nobel Direct and Nobel Perfect one-piece implants (OPIs) when used for immediate function. Material and methods: Forty-eight patients were provided with 115 OPIs for loading with a provisional crown or a bridge within 24 h and followed for at least 12 months with clinical conditions by the same team with 380 two-piece implants (TPIs) for immediate loading in the mandible and maxilla served as the reference group.
Results: Six (5.2%) OPIs failed during the follow-up due to extensive bone loss. Five (1.3%) implants failed in the reference group. After 1 year, the mean marginal bone loss was 2.1 mm (SD 1.3) for OPIs and 0.8 mm (SD 1) for TPIs. 20% of OPIs showed more than 3 mm of bone loss compared with 0.6% for TPIs. When compensating for vertical placement depth, OPIs still showed a lower marginal bone level and thus more exposed threads than TPIs.
Depending on the criteria used, the success rate for OPIs was 46.1% or 72.2% compared with 85% or 91.6% for TPIs.
Conclusions: The Nobel Directs and Nobel Perfects OPIs show lower success rates and more bone resorption than TPIs after 1 year in function. Factors such as implant design, insertion depth, rough surface towards the mucosa, in situ preparation and immediate loading may have an influence on the clinical outcome.
Direct loading of Nobel Direct and Nobel Perfect one-piece implants: a 1-year prospective clinical and radiographic study. Read more: http://nobeldirect-litigation.com/wp-content/uploads/2010/07/DirectLoadingPaper.pdf
The Swedish Medical Products Agency investigation of the dental implants NobelDirect and NobelPerfect show that there can be deficiencies in the instructions for use for the products.The MPA decision directs Nobel Biocare to clearly describe possible causes for the breakdown of the jawbone in the instructions for use and training programs. In addition, the company must describe how the risk for breakdown can be avoided. In sales and promotion information and instructions for use, the company shall indicate the user qualifications and skills required so that a dentist can use the implants safely. Nobel Biocare may not actively market the dental implants until the information activities are carried out.
Read more: http://www.osseotech.com/?page=14
Introduction: The Nobel Direct® implant (Nobel Biocare AB, Göteborg, Sweden) was developed to minimize marginal bone resorption and to result in “soft tissue integration” for an optimized aesthetic outcome. However, conflicting results have been presented in the literature. The aim of this present study was to evaluate the clinical and microbiologic outcomes of Nobel Direct implants.
Materials and Methods: Ten partially edentulous subjects without evidence of active periodontitis (mean age 55 years) received 12 Nobel Direct implants. Implants were loaded with single crowns after a healing period of 3 to 6 months. Treatment outcomes were assessed at month 24. Routine clinical assessments, intraoral radiographs, and microbiologic samplings were made. Histologic analysis of one failing implant and chemical spectroscopy around three unused implants was performed. Paired Wilcoxon signed-rank test was used for the evaluation of bone loss; otherwise, descriptive analysis was performed.
Results: Implants were functionally loaded after 3 to 6 months. At 2 years, the mean bone loss of remaining implants was 2.0 mm (SD ± 1.1 mm; range: 0.0–3.4 mm). Three out of 12 implants with an early mean bone loss >3 mm were lost. The surviving implants showed increasing bone loss between 6 and 24 months (p = .028). Only 3 out of the 12 implants were considered successful and showed bone loss of <1.7 mm after 2 years. High rates of pathogens, including Aggregatibacter actinomycetemcomitans, Fusobacterium spp., Porphyromonas gingivalis, Pseudomonas aeruginosa, and Tanerella forsythia, were found. Chemical spectroscopy revealed, despite the normal signals from Ti, O, and C, also peaks of P, F, S, N, and Ca. A normal histologic image of osseointegration was observed in the apical part of the retrieved implant.
Conclusion: Radiographic evidence and 25% implant failures are indications of a low success rate. High counts and prevalence of significant pathogens were found at surviving implants. Although extensive bone loss had occurred in the coronal part, the apical portion of the implant showed some bone to implant integration.
Two-Year Outcome with Nobel Direct® Implants: A Retrospective Radiographic and Microbiologic Study in 10 Patients. Read more: http://www3.interscience.wiley.com/journal/121402770/abstract
