Cates v. Zeltiq Aesthetics, Inc.

• Decision Date: 19 April 2021
• Docket Number: Case No. 6:19-cv-1670-PGB-LRH
• Citation: 535 F.Supp.3d 1222
• Parties: Terrance Nelson CATES, Plaintiff, v. ZELTIQ AESTHETICS, INC., Defendant.
• Court: U.S. District Court — Middle District of Florida

535 F.Supp.3d 1222

Terrance Nelson CATES, Plaintiff,

v.ZELTIQ AESTHETICS, INC., Defendant.

Case No. 6:19-cv-1670-PGB-LRH

United States District Court, M.D. Florida, Orlando Division.

Signed April 19, 2021

Louiza Tarassova, The Law Office of Louiza Tarassova, PA, Winter Park, FL, for Plaintiff.

Aimee Tecla Canty, Brian T. Guthrie, Shook, Hardy & Bacon LLP, Tampa, FL, Alyson B. Jones, Pro Hac Vice, Orlando R. Richmond, Sr., Pro Hac Vice, Butler Snow, LLP, Ridgeland, MS, Anita Modak-Truran, Pro Hac Vice, Butler Snow LLP, Nashville, TN, James C. Suozzo, Pro Hac Vice, Law Office of Robert J. McGuirl, Park Ridge, NJ, Nils Burton Snell, Pro Hac Vice, Butler Snow, LLP, Fort Washington, PA, for Defendant.

ORDER

PAUL G. BYRON, UNITED STATES DISTRICT JUDGE

This cause comes before the Court on Defendant's Motion for Summary Judgment. (Doc. 112 (the "Motion ")). Plaintiff responded in opposition (Doc. 117), and Defendant filed a reply (Doc. 122). Upon consideration, the Motion is due to be granted.

I. BACKGROUND

Defendant is the manufacturer of CoolSculpting, a medical device that supplies intense cooling to targeted areas of the body to induce lipolysis (i.e. , the breakdown of subcutaneous fat cells). (Doc. 119, ¶ 1). In most cases, these damaged fat cells are eliminated from the body through its normal processes. (Doc. 27, ¶ 9). However, a known possible side effect of CoolSculpting treatment is Paradoxical Hyperplasia ("PH ")¹ —an enlargement and hardening of tissue in the treated area. (Id. ¶¶ 38–39). PH requires surgical intervention because it does not resolve on its own. (Id. ¶ 44).

The United States Food and Drug Administration ("FDA ") cleared CoolSculpting as a Class II medical device for the performance of cryolipolysis. (Doc. 119, ¶¶ 2–5). FDA regulations provide that, "[a]s a prescription device [CoolSculpting] is exempt from having adequate directions for lay use. Labeling must include, however, adequate information for practitioner use of the device [and] should include an appropriate warning if there is reasonable evidence of an association of a serious hazard with the use of the device." (Id. ¶¶ 6, 8).

Advanced registered nurse practitioner Isis Bucci ("NP Bucci ") was authorized to perform CoolSculpting treatments under the general supervision of Dr. Ayyaz Shah. (Doc. 112, ¶ 10). NP Bucci performed Plaintiff's CoolSculpting treatments on February 15, 2018, and on May 18, 2018. (Id. ¶ 11). Plaintiff alleges that he experienced PH after his CoolSculpting treatments. (Doc. 27, ¶ 97).²

Plaintiff initiated this action on August 27, 2019. (Doc. 1). The Amended Complaint includes five causes of action: strict products liability based on defective design (Count I), strict products liability based on failure to warn (Count II), negligence (Count III), negligent misrepresentation (Count IV), and fraudulent misrepresentation and concealment (Count V). (Doc. 27).³ Plaintiff also seeks punitive damages. (Id. ¶¶ 165–168).

Defendant now moves for summary judgment on all Counts. (Doc. 112).

II. STANDARD OF REVIEW

A court may only "grant summary judgment if the movant shows that there is no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law." FED. R. CIV. P. 56(a). The moving party bears the initial burden of "citing to particular parts of materials in the record, including depositions, documents, electronically stored information, affidavits or declarations, stipulations ..., admissions, interrogatory answers, or other materials" to support its position that it is entitled to summary judgment. FED. R. CIV. P. 56(c)(1)(A). "The burden then shifts to the non-moving party, who must go beyond the pleadings, and present affirmative evidence to show that a genuine issue of material fact exists." Porter v. Ray , 461 F.3d 1315, 1320 (11th Cir. 2006). "The court need consider only the cited materials" when resolving a motion for summary judgment. FED. R. CIV. P. 56(c)(3) ; see also HRCC, LTD v. Hard Rock Café Int'l (USA), Inc. , 703 F. App'x 814, 816–17 (11th Cir. 2017) (per curiam) (holding that a district court does not err by limiting its review to the evidence cited by the parties in their summary judgment briefs).⁴

An issue of fact is "genuine" only if "a reasonable jury could return a verdict for the nonmoving party." Anderson v. Liberty Lobby, Inc. , 477 U.S. 242, 248, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986). In determining whether a genuine dispute of material fact exists, the Court must read the evidence and draw all factual inferences therefrom in the light most favorable to the non-moving party and must resolve any reasonable doubts in the non-movant's favor. Skop v. City of Atlanta , 485 F.3d 1130, 1136 (11th Cir. 2007). But, "[a] mere ‘scintilla’ of evidence supporting the opposing party's position will not suffice; there must be enough of a showing that the jury could reasonably find for that party." Brooks v. Cnty. Comm'n of Jefferson Cnty. , 446 F.3d 1160, 1162 (11th Cir. 2006) (quoting Walker v. Darby , 911 F.2d 1573, 1577 (11th Cir. 1990) ).

III. DISCUSSION

Defendant raises several arguments in favor of summary judgment. First, Defendant argues that Plaintiff's failure to warn claim must fail because: (1) Defendant's warnings were adequate as a matter of law, and (2) even if they were not, Plaintiff failed to produce evidence that inadequate warnings proximately caused his injuries. Second, Defendant argues that Plaintiff failed to produce evidence that the CoolSculpting device was defective. Third, Defendant argues that Plaintiff's remaining claims must fail because they are all predicated upon the inadequacy of Defendant's warnings. Finally, Defendant argues that Plaintiff's claims are preempted by federal law and that Plaintiff cannot support a claim for punitive damages.

A. Failure to Warn (Count II)

"Under Florida law, to succeed on a failure to warn claim a plaintiff must show (1) that the product warning was inadequate; (2) that the inadequacy proximately caused her injury; and (3) that she in fact suffered an injury from using a product." Eghnayem v. Bos. Sci. Corp. , 873 F.3d 1304, 1321–23 (11th Cir. 2017) (citing Hoffmann-La Roche Inc. v. Mason , 27 So. 3d 75, 77 (Fla. 1st DCA 2009) ). Defendant argues that Plaintiff cannot prove that: (1) CoolSculpting's product warnings were inadequate for prescribers, and (2) Plaintiff's prescriber would not have recommended CoolSculpting had adequate warnings been provided.

In cases involving prescription drugs and medical devices, Florida courts have long followed the learned intermediary doctrine, under which a manufacturer's duty to warn is directed to the healthcare provider, not the patient. See id. ; Buckner v. Allergan Pharms., Inc. , 400 So. 2d 820, 822 (Fla. 5th DCA 1981) ; Felix v. Hoffmann-LaRoche, Inc. , 540 So. 2d 102, 104 (Fla. 1989) ; Beale v. Biomet, Inc. , 492 F. Supp. 2d 1360, 1367–68 (S.D. Fla. 2007).⁵ CoolSculpting is a prescription medical device available only through a licensed healthcare practitioner, so the learned intermediary doctrine applies.⁶

"While in many instances the adequacy of warnings ... is a question of fact," the Florida Supreme Court has held that "it can become a question of law where the warning is accurate, clear, and unambiguous." Felix , 540 So. 2d at 105. "When a warning is designed to inform a ‘learned intermediary,’ it is somewhat easier to establish the adequacy of the warning because it will be read and considered by a trained expert." Hayes v. Spartan Chem. Co. , 622 So. 2d 1352, 1354 (Fla. 2d DCA 1993).

"To warn adequately, the product label must make apparent the potential harmful consequences." Farias v. Mr. Heater, Inc. , 684 F.3d 1231, 1233 (11th Cir. 2012) (quoting Scheman-Gonzalez v. Saber Mfg. Co. , 816 So. 2d 1133, 1139 (Fla. 4th DCA 2002) ). "A drug manufacturer is ‘only required to warn the prescribing physician of the possibility that the drug may cause the injury alleged by the plaintiff. ’ " Silverstein v. Boehringer Ingelheim Pharms., Inc. , No. 10-civ-81188, 2020 WL 6110909, at *40 (S.D. Fla. Oct 7, 2020) (quoting Small v. Amgen, Inc. , 134 F. Supp. 3d 1358, 1367 (M.D. Fla. 2015) ). The manufacturer "need not warn about the specific manner in which the injury may occur." Id. (citing Pierre v. Intuitive Surgical, Inc. , 476 F. Supp. 3d 1260, 1279 (S.D. Fla. 2020) ). Likewise, the manufacturer need not warn of "subsequent measures medical professionals may employ to treat [such] injuries." Dye , 470 F. Supp. 3d at 1341.

Before addressing the content of Defendant's warnings, the Court must begin by discussing what we know about PH—and what we do not.⁷ "Macroscopically, PAH is characterized by the formation of a large, painless, firm, partially mobile mass that develops at the [CoolSculpting] treatment site where the applicators of the cryolipolysis machine were applied to the body." (Doc. 117-25, p. 3). On a microscopic level, the affected area appears to have an "increased number of adipocytes [i.e. , fat cells], fibrosis [i.e. , thickening/ scarring of connective tissue] and scar tissue in the treated areas." (Doc. 117-23, p. 4).

PH generally appears three to six months following CoolSculpting treatments. (Id. ). Beyond that, the underlying mechanism for the development of PH is unknown. Although several explanations have been speculated,⁸ "the exact pathophysiology of the formation of PAH remains a mystery." (Doc. 117-25, pp. 3–4).⁹ Every scientific article cited by Plaintiff characterizes PH as "rare." (Docs. 117-23, 117-24, 117-25, 117-26, 117-31).

PH does not resolve on its own, so removal of the affected tissue requires surgical intervention.¹⁰ "Treatment must be performed only when the [affected] tissues have softened, usually between 6 and 9 months after cryolipolysis [rather than] during the initial firm inflammatory phase." (Doc. 117-23, p. 5). "Power-assisted liposuction

is the preferred method of treatment, but in some cases, abdominoplasty [i.e. , a...