Goodell DeVries Prevails in Manufacturer’s Ten-Year Class-Certification Battle with Purchasers of Prescription Medical Device

By: GDLD | 7.25.17 | Case Results

A team of Goodell DeVries class-action litigators led by Rick Barnes, Linda Woolf, and Derek Stikeleather has successfully defeated Plaintiffs’ motion for class certification in a decade-long class action pending in The United States District Court for the Eastern District of Pennsylvania. Center City Periodontists v. Dentsply International Inc., Civ. No. 10-774. The Center City plaintiffs originally moved for class certification in 2007, alleging that the defendant manufacturer’s ultrasonic scaler, a Class II prescription medical device that dentists and professional hygienists use to clean teeth, was “unsafe” and sold in breach of its warranty. The proposed class of Pennsylvania and New Jersey dentists who purchased the device also brought a statutory consumer-fraud claim, alleging that dentists were unaware of the natural formation of biofilm in the device’s waterlines and their professional responsibility to chemically treat the lines to maintain the device’s output-water quality.

Plaintiffs’ case was deconstructed over several years. The original case was dismissed in 2010 on Goodell DeVries’ motion because of Plaintiffs’ pleading errors. After Plaintiffs re-filed their claims, additional motions pared the case down to one count for breach of express warranty, based on the device’s written Directions for Use. The consumer-fraud claim was dismissed in 2013 because the ultrasonic scaler is not sold to the public. And the tort claim was later dismissed because Plaintiffs had not alleged that the purportedly “unsafe” device had ever injured anyone, despite millions of uses, only that it was mislabeled. Goodell DeVries also challenged Plaintiffs’ damages and FDA experts under Daubert. In 2016, the Court conducted six days of class-certification hearings, taking live testimony from the class representatives and  experts on dentistry, infection control, microbiology, FDA regulations, and economic damages.

Judge Darnell Jones III’s 36-page opinion, issued July 25, 2017, denied class certification on several bases and excluded Plaintiffs’ challenged experts. It found that Plaintiffs failed to meet three of Rule 23(a)’s four requirements (typicality, adequacy, and numerosity) and both of Rule 23(b)(3)’s more rigorous requirements of (i) a predominance of common questions over individualized ones and (ii) the superiority of class treatment over other possible remedies. Judge Jones also found that the proposed class and subclasses were not objectively ascertainable as required by Third Circuit law. 

In his opinion, Judge Jones also pointed out the claims’ many weaknesses on the merits. He rejected Plaintiffs’ contention that the device did not contain “accurate and adequate instructions” because the manufacturer did not expressly warrant that the Directions alone contained all necessary instructions to control biofilm. Instead, it reminded them of the need to follow applicable CDC recommendations. Judge Jones recognized that professional dentists are expected to supplement the Directions with their professional judgment and their legal duty to comply with evolving CDC recommendations and ADA guidelines.  Given the context of the sale of a prescription medical device to licensed and trained professionals, Judge Jones found that that the Directions were more than adequate.