Motion to dismiss still pending in CoolSculpting putative class action

By Karen Kidd | Apr 16, 2018

LOS ANGELES (Legal Newsline) – A federal judge has not yet issued an order promised more than two months ago on a motion to dismiss an amended putative class action lawsuit claiming a California company negligently misrepresents its weight-loss-by-freezing product.

Following a hearing in early February in which counsel was given leave to respond to a tentative ruling, U.S. District Court Judge Dolly M. Gee announced she would issue a written order on a motion to dismiss filed by the defendant in the case, Zeltiq Aesthetics Inc. The putative class action against Zeltiq initially was filed last May in U.S. District Court for California's Central District by consumers Carmen Otero and Abbey Lerman.

Otero and Lerman alleged in their initial and amended complaints that Zeltiq, based in Pleasanton and marketer and licenser of the cryolipolysis procedure CoolSculpting, negligently misrepresents and makes false claims about its medical treatment product. Specifically, the two plaintiffs allege the company falsely advertises its CoolSculpting to be approved by the U.S. Food and Drug Administration.

CoolSculpting is a non-invasive fat reduction procedure that allegedly works by "freezing unwanted fat away," according to claims on the company's website.

On Jan. 12, plaintiffs filed a 25-page opposition to Zeltiq's motion to dismiss, urging the motion "be denied in its entirety," claiming Zeltiq "knew or should have known that its representations could mislead customers." 

The plaintiffs' opposition cited a Zeltiq advertising campaign on television, radio, in print, social media and other outlets to drive demand for CoolSculpting.

"Plaintiffs allege that defendant acknowledges that 'FDA Clearance' is material - both implicitly by the prominent use of this in their advertising, and explicitly in a recent lawsuit filed against competitors whose products Zeltiq alleges are 'falsely touted as providing the same treatments as Zeltiq's CoolSculpting devise' and are described 'using explicit references to facts that apply exclusively to Zeltiq, such as 'patented', 'clinically proved' or 'FDA-approved'," the filed opposition said.

In its motion to dismiss filed Jan. 2, Zeltiq said the Otero and Lerman case against it cannot "survive dismissal" because they don't claim "that any allegedly omitted information posed a safety concern to consumers and that Zeltiq was aware of the safety concern."

"Here, plaintiffs do not even attempt to do so," Zeltiq said in its motion to dismiss. "While they contend that FDA-Approved devices go through more rigorous testing than FDA-Cleared devices, that cannot be a safety concern, as the FDA has determined that Class II devices like the CoolSculpting system need never undergo the FDA Approval process."

Zeltiq's January motion to dismiss is not the first it has filed in Otero and Lerman's allegations against the company. In August, Zeltiq filed a motion to dismiss the initial case, saying the case must fail because CoolSculpting did receive FDA clearance. Counsel for the defense countered that the phrase Zeltiq uses in its advertisement is "FDA approved," rather than "FDA cleared" and argued "approved" is a far more difficult FDA standard to meet than "cleared."

In that first motion to dismiss, Zeltiq claimed it "had no duty to educate consumers on parameters of the 510(k) process or clarify that FDA Cleared is not the same as FDA Approved."

In early September, plaintiffs' counsel filed its opposition to Zeltiq's motion to dismiss the case, but Gee took the motion under submission and in November granted the motion while also granting plaintiffs leave to file an amended complaint, which they did on Dec. 12.

Just after the New Year, Zeltiq filed its motion to dismiss the amended lawsuit and on Jan. 12 plaintiffs filed their opposition to that motion. Gee's promise of a written order was issued Feb. 2. 

Want to get notified whenever we write about any of these organizations ?

Sign-up Next time we write about any of these organizations, we'll email you a link to the story. You may edit your settings or unsubscribe at any time.

Organizations in this Story

U.S. District Court for the Central District of California US Food & Drug Administration Zeltiq Aesthetisc, Inc.

More News

The Record Network