Adesina v. Aladan Corp.

• Decision Date: 07 July 2006
• Docket Number: No. 98 Civ. 5535(JFK).,98 Civ. 5535(JFK).
• Citation: 438 F.Supp.2d 329
• Parties: Lynora ADESINA et al., Plaintiff, v. ALADAN CORPORATION et al., Defendants.
• Court: U.S. District Court — Southern District of New York

438 F.Supp.2d 329

Lynora ADESINA et al., Plaintiff, v. ALADAN CORPORATION et al., Defendants.

No. 98 Civ. 5535(JFK).

United States District Court, S.D. New York.

July 7, 2006.

COPYRIGHT MATERIAL OMITTED

COPYRIGHT MATERIAL OMITTED

Ronald R. Benjamin, Law Office of Ronald R. Benjamin, Binghamton, NY, for Plaintiff Lynora Adesina.

Anthony G. Brazil, Matthew L. Marshall, Morris Polich & Purdy, LLP, Los Angeles, CA, for Defendant Aladan Corp.

OPINION AND ORDER

KEENAN, District Judge.

INTRODUCTION

This products liability case arises from Plaintiffs use of latex gloves manufactured by Defendant that allegedly caused Plaintiff to suffer serious health consequences. Defendant Aladan brings six motions: four motions for summary judgment or partial summary judgment, and two motions to exclude the testimony of Plaintiffs expert witnesses. For the reasons discussed below, Defendant's four summary judgment motions are denied, and Defendant's two motions to exclude expert testimony are denied in part and granted in part.

BACKGROUND

This case was originally filed in New York State Supreme Court, then removed to the Southern District of New York, then transferred by the Multi-District Litigation ("MDL") Panel to the Eastern District of Pennsylvania, and finally remanded back to the Southern District of New York by the MDL panel.

Although the complaint was brought by two plaintiffs against several defendants, the only parties now remaining in the case are the parties to the present motions: Plaintiff Lenora Adesina and Defendant Aladan Corporation ("Aladan").

Ms. Adesina formerly worked as a nurse, providing home health care services. To perform this job, between September 1992 and March 1997, Ms. Adesina used natural rubber latex ("NRL") gloves manufactured by Aladan. (Def.'s 56.1 Statement (Failure Warn) ¶¶ 1-2; Pl.'s 56.1 Statement (Failure Warn) ¶¶ 1-2.)

Over time, Ms. Adesina allegedly developed an allergy to natural rubber latex and suffered adverse health consequences as a result of her reaction to the natural rubber latex in the gloves. (Compl. ¶ 14.) In March 1997, she was diagnosed with Type I latex allergy, as well as Type IV contact dermatitis (Def's 56.1 Statement ¶ 5; Pl.'s 56.1 Statement ¶ 5), and has suffered injuries including asthma, rashes, skin infections and difficulty breathing (Compl. ¶ 4).

As a result of her alleged allergies, Ms. Adesina sued Aladan, charging (1) negligence and gross negligence, (2) strict liability, (3) failure to warn and misrepresentation, and (4) breach of implied and express warranties.¹ She seeks $5 million in compensatory damages and $10 million in punitive damages.

In the six motions now before the Court, Aladan argues that (i) Plaintiffs failure to warn claims are preempted by federal law; (ii) Plaintiffs failure to warn claims should be dismissed on the merits; (iii) Plaintiffs claims should be dismissed because Plaintiff offers no admissible evidence of latex allergy; (iv) the testimony of Dr. Ellen Epstein should be excluded under Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579, 113 S.Ct. 2786, 125 L.Ed.2d 469 (1993); (v) Plaintiffs claims should be dismissed because Plaintiff offers no admissible evidence of a product defect; and (vi) the testimony of Charles Kyper should be excluded under Daubert.

Plaintiff opposes the motions. The Court addresses each motion in turn below.

DISCUSSION

I. Motion for Partial Summary Judgment Contending Preemption of Failure to Warn Claims

Latex gloves are medical devices under the framework established by the Medical Device Amendments to the Food, Drug, and Cosmetic Act of 1938. See 21 C.F.R. § 880.6250. In 1993, the Food and Drug Administration ("FDA") published a 200-page manual titled Regulatory Requirements for Medical Gloves: A Workshop Manual ("Glove Manual"). This manual contains an extensive list of device-specific requirements concerning latex gloves. (Def.'s 56.1 Statement ¶ 4; Pl.'s Am. 56.1 Statement ¶ 4.)

Aladan moves for partial summary judgment on all four counts in plaintiffs complaint to the extent each of the four counts encompasses a failure to warn claim. In Aladan's opinion, "the heart of Mrs. Adesina's allegations is that Defendants'[sic] products were defective in that they failed to contain warnings advising of a potential for developing latex allergy."² (Def.'s Mem. 2.) Aladan argues that Ms. Adesina's claims are preempted by the Glove Manual and the Food, Drug, and Cosmetic Act because her claims impose warning and labeling requirements on Aladan under state tort law, which are different from, or in addition to, those required by the FDA. (Def's Mem. L. 2.) The Court, drawing all inferences in favor of Ms. Adesina, the non-movant, as is required on a motion for summary judgment, finds that Ms. Adesina's claims are not preempted.

A. Summary Judgment Standard

A motion for summary judgment may be granted under Rule 56 of the Federal Rules of Civil Procedure if the entire record demonstrates that "there is no genuine issue as to any material fact and ... the moving party is entitled to judgment as a matter of law." Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 250, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986). When viewing the evidence, the Court must "assess the record in the light most favorable to the nonmovant and ... draw all reasonable inferences in its favor." Del. & Hudson Ry. Co. v. Consol. Rail Corp., 902 F.2d 174, 177 (2d Cir.1990); see McLee v. Chrysler Corp., 109 F.3d 130, 134 (2d Cir.1997); see also Anderson, 477 U.S. at 255, 106 S.Ct. 2505. "[A]t the summary judgment stage the judge's function is not himself to weigh the evidence and determine the truth of the matter but to determine whether there is a genuine issue for trial." Anderson, 477 U.S. at 249, 106 S.Ct. 2505. To survive a motion for summary judgment, the plaintiff "need only present evidence from which a jury might return a verdict in his favor. If he does so, there is a genuine issue of fact that requires a trial." Id. at 257, 106 S.Ct. 2505.

B. Relevant Statutory and Regulatory Regime

Congress's first major foray into the field of public health was the Food and Drug Act of 1906, "a broad prohibition against the manufacture or shipment in interstate commerce of any adulterated or misbranded food or drug." Medtronic, Inc. v. Lohr, 518 U.S. 470, 475, 116 S.Ct. 2240, 135 L.Ed.2d 700 (1996). The scope of the Food and Drug Act was broadened in 1938 "to include misbranded or adulterated medical devices and cosmetics," and the Act was appropriately renamed the Food, Drug, and Cosmetic Act ("FDCA"). Id. Almost forty years later, Congress expanded the law again and passed the amendments at issue here, the Medical Device Amendments of 1976 ("MDA"), which authorize control over the introduction of new medical devices. Id. at 475-76, 116 S.Ct. 2240.

1. The Medical Device Amendments

Under the MDA, medical devices are categorized into three classes. Id. at 476, 116 S.Ct. 2240. Class I devices pose "no unreasonable risk of illness or injury" to the public, and as such are subject to minimal regulation. Id. at 476-77, 116 S.Ct. 2240. Potentially more harmful devices are designated as Class II, and must comply with a somewhat higher level of federal regulation. Id. at 477, 116 S.Ct. 2240. Class III devices either "presen[t] a potential unreasonable risk of illness or injury," or are "purported or represented to be for a use in supporting or sustaining human life or for a use which is of substantial importance in preventing impairment of human health." Id. at 477, 116 S.Ct. 2240 (internal citations omitted). Because Class III devices pose a greater potential risk, such devices are subject to rigorous regulation under the MDA. Id. Defendant contends, and Plaintiff does not dispute, that latex gloves are Class I devices under this framework. (Pl.'s Mem. L. 1; Def.'s 56.1 Statement ¶ 3.)

To bring a new Class I or Class II device to market, a manufacturer must satisfy a limited review by submitting pre-market notification to the FDA, pursuant to 21 U.S.C. § 360(k).³ Medtronic, 518 U.S. at 478, 116 S.Ct. 2240. The FDA spends approximately twenty hours on this review process. Id. at 478-79, 116 S.Ct. 2240. Contrast this with the 1200 hours the FDA spends reviewing a new Class III device for pre-market approval ("PMA process"). Id. Although, in circumstances where a Class III device is "substantially equivalent" to one already on the market, the manufacturer of the device need not seek pre-market approval, but instead can enter the market via the more lenient § 360(k) pre-market notification process. Id. at 478, 116 S.Ct. 2240.

2. The Glove Manual

In 1992, the FDA published the Glove Manual, which "covers the basic regulatory requirements" and serves as a "reference source for information" for manufacturers of latex gloves. Glove Manual, Preface at iii. According to the Glove Manual itself, it is "one of several used in the Division of Small Manufacturers Assistance Latex Device Workshops," and "[t]he educational information in this manual is not an official statement binding on the FDA." Glove Manual, Abstract at iv. The Glove Manual contains "information on the regulatory requirements for patient examination gloves, surgeon's gloves, and non-medical gloves," id. at 1-2, and gives guidance for glove labeling, including items that are "required," id. at 2-3, items that are "recommended," id., and "additional labeling claims," including "hypoallergenicity," id. at 3-6.

C. Preemption Doctrine

1. Constitutional Background

The preemption doctrine, speaking as a matter of Constitutional theory, lives a double life. The Supremacy Clause, U.S. Const. Art. VI, cl. 2, confirms that "the laws of the United States ... shall be the supreme Law of the Land." The Tenth Amendment, however, reserves "powers not delegated to the United States by the Constitution ... to the States respectively, or to the people." Between these two poles lies the...