Holloway v. Abbvie Inc.

CourtDistrict Court, M.D. Louisiana
DecidedFebruary 7, 2024
Docket3:23-cv-00692
StatusUnknown

This text of Holloway v. Abbvie Inc. (Holloway v. Abbvie Inc.) is published on Counsel Stack Legal Research, covering District Court, M.D. Louisiana primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Holloway v. Abbvie Inc., (M.D. La. 2024).

Opinion

UNITED STATES DISTRICT COURT

MIDDLE DISTRICT OF LOUISIANA

TESSA HOLLOWAY CIVIL ACTION

VERSUS NO. 23-692-RLB

ABBVIE, INC., ET AL. CONSENT

ORDER

Before the Court is Defendant’s Motion to Dismiss (R. Doc. 3). It is opposed by Tessa Holloway (“Plaintiff”). (R. Doc. 5). AbbVie Inc., Allergan, Inc., Allergan Unlimited Company, and Zeltiq Aesthetics, Inc. (“Defendants”) have replied to Plaintiff’s opposition. (R. Doc. 7). I. Background On June 21, 2023, Plaintiff commenced the captioned action in the 19th Judicial District Court of the Parish of East Baton Rouge, Louisiana. (R. Doc. 1-2). Plaintiff brings claims under the Louisiana Products Liability Act (the “LPLA”) against Defendants for their alleged failure to adequately notify CoolSculpting providers of the allegedly rising risks of CoolSculpting patients suffering from Paradoxical Hyperplasia (“PH”). (R. Doc. 1-2). In her Petition for Damages (the “Petition”), Plaintiff makes claims under each of the LPLA liability theories: (1) manufacturing defect; (2) design defect; (3) failure to warn; and (4) breach of express warranty. Broussard v. Proctor & Gamble Co., 463 F. Supp. 2d 596, 603 (W.D. La. 2006). (R. Doc. 1-2). The relevant factual allegations in the Petition, accepted as true for the purposes of resolving Defendants’ Motion to Dismiss, are as follows: • Zeltiq Aesthetics, Inc., owned by Allergan Unlimited Company, and Allergan Inc., which are owned by Abb Vie, Inc., “created, designed, manufactured, labeled, marketed, advertised, distributed, and sold the CoolSculpting® system medical device” (the “CSMD”). (R. Doc. 1-2 at ¶ 3).

• The CSMD, “a Class II prescription medical device[,]” uses “Cryolipolysis®, a non- invasive procedure” to freeze and kill fat cells. (R. Doc. 1-2 at ¶¶ 5, 7). • “At all material times, Defendants provided documents and forms to CoolSculpting® providers to use when administering the CoolSculpting® procedure to patients, including consent forms with vague language about” PH. (R. Doc. 1-2 at ¶ 21).

• PH is “an enlargement and hardening of tissue in the treated area, which is the opposite effect of the medical device’s advertised purpose[;] the only method of treatment is invasive surgery.” (R. Doc. 1-2 at ¶ 25).

• “[S]ince 2011, Defendants . . . received reports of consumers developing PH after CoolSculpting®. . . . Defendants named the condition ‘Paradoxical Hyperplasia’ and in 2012, Defendants created [a] diagnosis criteria for the condition.” (R. Doc. 1-2 at ¶ 29).

• “Defendants estimate[ed] in 2013 the [PH] incident rate [was] 1 in 3,500 patients[;] however, the number of people developing the condition was increasing [and Defendants] did not notify CoolSculpting® providers, the public, or the FDA about the substantial increase in incidence rate.” (R. Doc. 1-2 at ¶ 34).

• “Defendants never notified . . . providers about its post-market discovery of PH or what it knew about the deforming condition that it received since 2011. Defendants strategically used an inaccurate 2014 JAMA article in its training materials[.]” (R. Doc. 1-2 at ¶ 36).

• “Defendants manipulated the calculation of the incidence rate and stated inaccurate incidence rate statistics to CoolSculpting® providers and instructed its employees to use the words ‘rare’ when referring to PH in their communications with CoolSculpting® providers, the public, and the FDA.” (R. Doc. 1-2 at ¶ 38).

• “On June 21, 2022, Plaintiff underwent CoolSculpting® treatment at Z Aesthetic Dermatology [in] Baton Rouge, Louisiana[, and a]fter several follow-up appointments . . . Plaintiff[ received a] PH diagnosis [from] Dr. Zedlitz[ that] was confirmed per the Defendants’ ‘Clinical Event Form - Paradoxical Hyperplasia Checklist’ and . . . the medical team for Defendants[.]” (R. Doc. 1-2 at ¶¶ 44, 45, 46, 47).

• “As a result of Defendants’ systemic failure to adequately warn CoolSculpting® providers about the danger of the [CSMD], Plaintiff’s CoolSculpting® provider was not adequately warned of the severity, permanence, and likelihood of PH, the adverse effect of CoolSculpting®, and the invasive and aggressive surgical treatments required to manage PH[, so that a]s a result of Defendants’ conduct, Plaintiff was not properly informed about PH prior to undergoing CoolSculpting®.” (R. Doc. 1-2 at ¶¶ 49, 50).

• “Had Plaintiff been properly informed of the extent of PH’s seriousness, incidence, permanence, and the true likelihood that she would develop this condition that results in the exact opposite effect of the device’s advertised purpose, Plaintiff would not have undergone the CoolSculpting® procedure.” (R. Doc. 1-2 at ¶ 51).

II. Arguments of the Parties Defendants argue that because Plaintiff has not adequately alleged any of her LPLA theories of liability, her case should be dismissed. (R. Docs. 3, 3-1). Regarding Plaintiff’s failure to warn claims, Defendants argue that the learned intermediary doctrine1 applies and that the CSMD manual (the “Manual”)2 sent to providers gives adequate warnings regarding PH. (R. Docs. 3-1, 3-2). Defendants point out that, in the context of summary judgment, the Eleventh Circuit has already held that, as a matter of law, the Manual warnings are “objectively ‘accurate, clear, and unambiguous’ to warn medical professionals[.]” Cates v. Zeltiq Aesthetics, Inc., 73 F.

4th 1342, 2023 WL 4671283, at *4 (11th Cir. 2023) (internal citations omitted). (R. Doc. 3-1). The Manual states that PH is a “Rare Adverse Event” and it is described as “[v]isibly enlarged tissue volume within the treatment area, which may develop two or five months after treatment.” (R. Doc. 3-2). The Manual also states that “[s]urgical intervention may be required” if PH occurs, notes that six PH cases were reported out of 4,792 studies, and cites three scholarly articles addressing PH occurring after Cryolipolysis. (R. Doc. 3-2). Plaintiff agrees with Defendants that the learned intermediary doctrine applies but argues it would be premature to dismiss the case based on Cates when “there has been no discovery [revealing what] documents and verbal assurances were relayed to Dr. Zedlitz[,]” Plaintiff’s

provider. (R. Doc. 5). Plaintiff primarily relies on McNeil v. Wyeth, 462 F. 3d 364, 368 (5th Cir. 2006) (Fifth Circuit applied the Texas rule of sending adequacy questions to the jury when a drug warning noted that a condition was a risk but failed to note that the risk was higher if the drug was used long-term.), and Brown v. Glaxo, Inc., 1999-1531 (La. App. 1 Cir. 11/15/00), 790 So. 2d 35, 40-41, writ denied, 2000-3457 (La. 2/9/01), 785 So. 2d 827, and writ denied, 2001-

1 Marks v. OHMEDA, Inc., 2003-1446 (La. App. 3 Cir. 3/31/04), 871 So. 2d 1148, 1157, writ denied, 2004-1653 (La. 10/8/04), 883 So. 2d 1019, and writ denied, 2004-1617 (La. 10/8/04), 883 So. 2d 1020 (citation omitted) (“[A] drug [or device] manufacturer has a duty to warn the prescribing doctor, rather than the patient, of . . . risks[.]”).

2 This Court considered the Manual in its review of the facts because documents “a defendant attaches to a motion to dismiss are considered part of the pleadings if they are referred to in the plaintiff’s complaint and are central to her claim[.]’” Collins v. Morgan Stanley Dean Witter, 224 F. 3d 496, 498-99 (5th Cir. 2000) (Citation omitted); See Maloney Gaming Mgmt., L.L.C. v. St. Tammany Par., 456 F. App’x 336, 340-41 (5th Cir. 2011). 0035 (La. 2/9/01), 785 So.

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