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Clements v. Sanofi-Aventis, U.S., Inc.

United States District Court, D. New Jersey

June 11, 2015

SANOFI-AVENTIS, U.S., INC., AVENTIS PHARMACEUTICALS, INC., and JOHN DOE A to Z, individually, jointly, and/or severally, Defendants.


KEVIN McNULTY, District Judge.

This is a personal injury action brought by plaintiff Victoria Clements for injuries allegedly sustained following the administration of Sculptra, a medical device consisting of an injectable substance intended to treat the loss of facial fat. Now before the Court is the motion of the defendants (collectively, "Sanofi") for summary judgment. For the reasons set forth below, the motion is denied as presented, but granted to the extent that the complaint is dismissed without prejudice.

Sanofi has styled its motion as one for summary judgment under Federal Rule of Civil Procedure 56. Plaintiff Clements has not submitted a responsive Statement of Material Facts Not in Dispute, as required by Local Rule 56.1(a). Nor has Clements really made any substantial factual showing in opposition to Sanofi's summary judgment motion. Clements's explanation is that she has not had the opportunity to complete discovery, and that Sanofi's summary judgment motion is therefore premature.

If Clements's explanation were properly presented, and if I accepted it, I might simply terminate Sanofi's motion and permit discovery to proceed. Sanofi's contentions, however, are arguments of law. For example, Sanofi argues that the state law causes of action pled in the complaint are either preempted by federal law or subsumed by the New Jersey Products Liability Act. Such contentions, directed to the face of the complaint, are appropriate for consideration under the standards for a Rule 12(b)(6) motion to dismiss. The only extrinsic facts relevant to such a motion pertain to the FDA approvals of Sanofi's medical device. Those approvals are admitted by the plaintiff in her brief, and in any event are readily susceptible of judicial notice. See p. 4 n.2, infra. I also observe that Clements's complaint is not pleaded with the factual specificity required by the Federal Rules. I therefore may profitably treat this as the equivalent of a motion to dismiss.[1]

The complaint as presented should be dismissed. I conclude, however, that neither summary judgment nor a dismissal with prejudice would be procedurally fair. This state-law complaint was removed from state court to federal court by Sanofi. When Clements filed it, she was not reasonably on notice that she would be held to federal pleading standards. Her brief in opposition to Sanofi's motion also asserts facts, not pled in the complaint, that she says would support a non-preempted claim. I do not rule on those contentions in advance. I do, however, provide that this order of dismissal is without prejudice to the filing of an amended complaint within 30 days.


Statutory Background

Congress passed the Medical Device Amendments (MDA) to the FDCA in 1976 to impose uniform requirements for the introduction of new medical devices into the market. See 21 U.S.C. § 301 et seq. The MDA established three levels of federal oversight depending on the risks presented by a particular medical device. The devices that receive the highest level of scrutiny are Class III medical devices: those "purported or represented to be for a use in supporting human life or for a use which is of substantial importance in preventing impairment of human health, or presents a potential unreasonable risk of illness or injury." 21 U.S.C. § 360(1)(c)(ii).

The MDA subjects Class III medical devices to a rigorous premarket approval ("PMA") process. The PMA process is designed to "provide reasonable assurance" of the device's safety and efficacy. 21 U.S.C. § 360(a)(C)(II). PMA review requires, among other things, the following:

[F]ull reports of all studies and investigation of the device's safety and effectiveness that have been published or should reasonably be known to the applicant; a "full statement" of the device's "components, ingredients, and properties and of the principle or principles of operation"; "a full description of the methods used in, and the facilities and the facilities and controls used for, the manufacture, processing, and when, when relevant, packing and installation of, such device"; samples or device components required by the FDA; and a specimen of the proposed labeling.

Riegel v. Medtronic, Inc., 552 U.S. 312, 317 (2008) (quoting 21 U.S.C. § 360e(c)(1)). PMA review also requires the Food and Drug Administration ("FDA") to "determine that the [device's] proposed labeling is neither false nor misleading." Id. at 318 (quoting 21 U.S.C. § 360e(d)(1)(A)). A manufacturer cannot manufacture or sell a device unless it receives PMA. Once a device has been approved, "the MDA forbids the manufacturer to make, without FDA permission, changes in design specifications, manufacturing processes, labeling, or any other attribute, that would affect safety or effectiveness." Id. at 319.

FDA Approval of Sculptra[2]

Sculptra, a Class III medical device, was approved through the PMA process on August 3, 2004, after a nine-month review. (Def. Statement of Undisputed Facts Pursuant to Local Rule 56.1, Dkt. No. 9-1, ¶ 1) Sculptra was initially approved "for the restoration and/or correction of the signs of lipoatrophy - commonly known as facial fat loss - in people with human immunodeficiency virus (HIV')". ( Id. )

On July 28, 2006, Sanofi filed a supplemental PMA application to allow Sculptra to be used for cosmetic purposes, regardless of whether its recipients suffered from HIV. ( Id. at ¶ 2)

On July 28, 2009, after a three-year review, the FDA granted PMA, approving Sculptra's use in "immune competent people as a single regimen for correction of shall to deep nasolabial fold contour deficiencies and other facial wrinkles in which deep dermal grip pattern injection technique is appropriate." ( Id. ) Although marketed under a different name - "Sculptra Aesthetic" - Sanofi states that the device is identical to Sculptra. ( Id. at ¶ 5)

The FDA has never revoked, suspended, or otherwise interrupted its approval of Sculptra or Sculptra Aesthetic. ( Id. at ¶ 4)

Clements's Use of Sculptra

The facts in this section are not contained in the Complaint. I refer to them as background, and also because they are relevant to my decision that the dismissal of the complaint should be without prejudice.

According to Clements's brief, in 2004 Sculptra was approved for use on HIV/AIDS patients. (Dkt. No. 14 at 5) She alleges that the defendants acknowledged this single approved use in a pamphlet. ( Id. at 6) Defendants, however, were allegedly determined that Sculptra would be prescribed "off-label" for cosmetic use as a "wrinkle-buster." ( Id. at 7)

In 2007, Clements was prescribed Sculptra. ( Id. at 8) She alleges in her brief (and her complaint) that she relied on unspecified representations that the product was safe and effective. ( Id. ) In an interrogatory response, Clements added that she "relied upon the oral representation of Dr. Marilyn Berzin, " her dermatologist. (Decl. of Michael Rato in Support of Def.'s Mot. for Summ. J. ("Rato Decl."), Ex. F, Dkt. No. 9-9, at 8-9).

Sanofi confirms that Clements's dermatologists were Drs. Marilyn Berzin and Dale Isaacson. (Rato Decl., Ex. E, Dkt. No. 9-8, at 2) Sanofi attaches a consent form, dated October 26, 2007, allegedly signed by Clements. ( Id. ) That form, entitled "Informed Consent for Sculptra® Therapy, " states, inter alia : "Sculptra therapy has been approved by the United States Food and Drug Administration (FDA) for the restoration and/or correction of facial fat loss (lipoatrophy) in people with HIV. Sculptra® therapy has not been specifically approved by the FDA for aesthetic (cosmetic) use. " ( Id. at 3) (emphasis added).

Clements states in her brief that Sculptra was not approved for cosmetic use until two years after it was prescribed to her, i.e., in 2009. (Dkt. No. 14, at 9).

The Present Action

Clements commenced this action on April 2, 2013, in the Superior Court of New Jersey, Essex County. The Complaint (Dkt. No. 1-2) asserts against Sanofi state-law causes of action for breach of express and implied warranty (Count I), negligence (Count II), strict liability (Count III), violations of the New Jersey Products Liability Act (Count IV), and punitive damages deriving from those violations (Count V).

Clements's complaint is virtually devoid of relevant facts. Count One, for example, recites that Sanofi is the manufacturer of Sculptra. It alleges that Clements used the product at an unspecified "aforementioned time and place." It alleges in boilerplate fashion that Sanofi "warranted, both implied and expressed, that such product was reasonably safe, fit and suitable for its intended use and reasonably foreseeable misuses and was of merchantable quality"; that she relied on those warranties; and that the Sanofi breached such warranties, causing her damage. The other counts follow the same pattern. They recite the bare legal elements of causes of action, with no supporting facts.

On March 6, 2014, Sanofi removed this action to federal court. Some limited discovery occurred. On May 29, 2014, Sanofi filed this motion for summary judgment. (Dkt. No. 9) In support, Sanofi submitted a memorandum of law; a properly supported statement of undisputed facts pursuant to Local Rule 56.1; and a declaration attaching certain exhibits, including publicly filed documents evidencing the FDA's premarket approval of Sculptra, as well as certain medical records and Clements's response to initial interrogatories. (Dkt. No. 9-3)

In response, Clements filed a memorandum of law. (Dkt. No. 14) She did not file affidavits of potential witnesses or sponsors of exhibits. Nor did she file the statement of uncontested facts required by Local Rule 56.1. Rather, Clements's counsel attached to her brief a copy of "a 24-page pamphlet for Sculptra entitled Prescribing Information.'" ( Id. at 6; see also Ex. A, Dkt. No. 14-3) Also attached to the brief is a copy of what appears to be an affidavit of Dr. Amy Newburger, filed in a New York state court case. (Ex. B, Dkt. No. 14-3) Newburger's affidavit states, inter alia, that a Sanofi sales person ...

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