Whitson v. Safeskin Corp., Inc.
| Decision Date | 25 March 2004 |
| Docket Number | No. 3:03 CV 746.,3:03 CV 746. |
| Citation | 313 F.Supp.2d 473 |
| Parties | Jean M. WHITSON and Randy S. Whitson, Plaintiffs v. SAFESKIN CORPORATION, INC., Surgikos, Inc., Johnson & Johnson, and Johnson & Johnson Medical, Inc., Defendants |
| Court | U.S. District Court — Middle District of Pennsylvania |
David S. Shrager, Shrager, McDaid, Loftus Flum & Spivey, Philadelphia, PA, for Plaintiffs.
Melissa Wojtylak, Walter Swayze, III, Segal McCambridge Singer & Mahoney, LTD., Nancy Harris Marvel, Drinker, Biddle & Reath LLP, Philadelphia, PA, David B. Sudzus, Kelley, Drye and Warren, Chicago, IL, for Defendants.
Before the court for disposition is the defendants' motion for summary judgment. The motion has been fully briefed and argued and is ripe for disposition. For the following reasons, we will grant the defendants' motion.
Plaintiff Jean Whitson was employed as a registered nurse at Hanover General Hospital in Hanover, Pennsylvania, from April 21, 1990 to June 25, 1997. As a nurse, she used and was exposed to natural rubber latex gloves. As a consequence of her exposure to latex gloves, Ms. Whitson has suffered a permanent hypersensitivity to products containing the natural latex protein. Ms. Whitson alleges that she was exposed and sensitized to natural rubber latex in gloves that were predominantly manufactured and/or distributed by Safeskin Corporation, Inc. and Johnson & Johnson Medical ("defendants").
Plaintiffs commenced this action on December 29, 1997, by filing a complaint that asserts counts in Negligence, Strict Products Liability, Failure to Warn, Breach of Express and Implied Warranties, Fraudulent Concealment, and Loss of Consortium. On March 9, 2001, the Honorable Edmund V. Ludwig of the Eastern District of Pennsylvania entered an Order granting in part Defendants' Motion for Summary Judgment, finding that plaintiffs' tort claims were time-barred under Pennsylvania's two-year statute of limitations, and that plaintiffs' express and implied warranty claims were similarly time-barred with respect to glove sales prior to December 27, 1993, based on Pennsylvania's four-year statute of limitations governing warranty actions.2 Upon plaintiffs' motion for reconsideration, the Eastern District Court vacated its March 9, 2001 Order with respect to plaintiffs' loss of consortium claim only.
The claims remaining in this matter are for breach of an implied warranty for the Safeskin and Johnson & Johnson gloves sold to Hanover Hospital between December 27, 1993 and December 27, 1997, and loss of consortium. Defendants have filed a motion for summary judgment on these remaining claims, bringing the case to its present posture.
The Court has jurisdiction over this dispute pursuant to the diversity jurisdiction statute, 28 U.S.C. § 1332. Because the Court is sitting in diversity, the substantive law of Pennsylvania shall apply. Chamberlain v. Giampapa, 210 F.3d 154, 158 (3d Cir.2000) (citing Erie R.R. v. Tompkins, 304 U.S. 64, 78, 58 S.Ct. 817, 82 L.Ed. 1188 (1938)).
The granting of summary judgment is proper "if the pleadings, depositions, answers to interrogatories, and admissions on file, together with the affidavits, if any, show that there is no genuine issue as to any material fact and that the moving party is entitled to judgment as a matter of law." See Knabe v. Boury, 114 F.3d 407, 410 n. 4 (3d Cir.1997) (citing FED. R. CIV. P. 56(c)). "[T]his standard provides that the mere existence of some alleged factual dispute between the parties will not defeat an otherwise properly supported motion for summary judgment; the requirement is that there be no genuine issue of material fact." Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 247-48, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986) (emphasis in original).
In considering a motion for summary judgment, the court must examine the facts in the light most favorable to the party opposing the motion. International Raw Materials, Ltd. v. Stauffer Chemical Co., 898 F.2d 946, 949 (3d Cir.1990). The burden is on the moving party to demonstrate that the evidence is such that a reasonable jury could not return a verdict for the non-moving party. Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986). A fact is material when it might affect the outcome of the suit under the governing law. Id. Where the non-moving party will bear the burden of proof at trial, the party moving for summary judgment may meet its burden by showing that the evidentiary materials of record, if reduced to admissible evidence, would be insufficient to carry the non-movant's burden of proof at trial. Celotex v. Catrett, 477 U.S. 317, 322, 106 S.Ct. 2548, 91 L.Ed.2d 265 (1986). Once the moving party satisfies its burden, the burden shifts to the nonmoving party, who must go beyond its pleadings, and designate specific facts by the use of affidavits, depositions, admissions, or answers to interrogatories showing that there is a genuine issue for trial. Id. at 324, 106 S.Ct. 2548.
Plaintiffs contend that the defendants have breached their implied warranties of fitness and merchantability under the Uniform Commercial Code (UCC). The UCC, as adopted in Pennsylvania, provides that:
a warranty that the goods shall be merchantable is implied in a contract for their sale if the seller is a merchant with respect to goods of that kind .... Goods to be merchantable must be at least such as:
(1) pass without objection in the trade under the contract description;
(2) in the case of fungible goods, are of fair average quality within the description;
(3) are fit for the ordinary purposes for which such goods are used;
(4) run, within the variations permitted by the agreement, of even kind, quality and quantity within each unit and among all units involved;
(5) are adequately contained, packaged, and labeled as the agreement may require; and
(6) conform to the promises or affirmations of fact made on the container or label if any.
See 13 Pa.C.S. § 2314(a); (b).
Defendants do not dispute that they are "merchants," and that the latex gloves are "products," which are subject to the UCC. Defendants, however, put forth several arguments in support of their motion for summary judgment. First, defendants argue that plaintiffs' implied warranty claim is preempted by the Medical Device Amendments (MDA) to the Food, Drug and Cosmetic Act. 21 U.S.C. §§ 360c — 360k. Second, defendants argue that the implied warranty theory is not applicable to the facts of the present case. Finally, defendants argue that plaintiffs' loss of consortium claim is based on tort theory, and therefore must be dismissed as untimely. We will discuss each of defendants' arguments seriatim.
Medical devices, including latex gloves, are regulated by the federal Food and Drug Administration (FDA) through the Medical Device Amendments (MDA) to the Food, Drug and Cosmetic Act. See 21 U.S.C. §§ 360c — 360k. Under the MDA, disposable latex patient examination gloves, such as those used by Plaintiff Jean Whitson, are classified as Class I medical devices. 21 C.F.R. § 880.6250. "Class I devices are those devices which pose little or no threat to public health." Burgstahler v. AcroMed Corp., 448 Pa.Super. 26, 670 A.2d 658, 661 (1995). The MDA contains an express preemption provision, which states that:
(a) Except as provided in subsection (b) of this section, no state or political subdivision of a state may establish or continue in effect with respect to a device intended for human use any requirement —
(1) which is different from, or in addition to, any requirement applicable under this chapter to the device, and
(2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device or to any other matter included in a requirement applicable to the device under this chapter.
21 U.S.C.360k(a).
Under FDA regulations, state law is preempted "only when the FDA has established specific counterpart regulations or ... other specific requirements applicable to a particular device." Medtronic v. Lohr, 518 U.S. 470, 498, 116 S.Ct. 2240, 135 L.Ed.2d 700 (1996) (citing 21 CFR § 808.1(d)(1995)).
The FDA has established specific labeling requirements for latex gloves in a manual, "Regulatory Requirements for Medical Gloves: A Workshop Manual" (hereafter "Glove Manual"), which was published by the FDA in May 1993. See Glove Manual, Defendants' Exhibit "E." In this Manual, the FDA sets forth requirements for the labeling on patient examination gloves. See Glove Manual, pp. 3-2 to 3-9. These requirements deal with specific issues, such as identification of the glove manufacturer or distributor, quantity statements, latex identification, and significant labeling changes that would require the submission of a new 510(k),3 such as the inclusion of hypoallergenicity claims or the addition of antimicrobials. See Glove Manual, Exhibit "E," at pp. 3-2 to 3-9.4
Defendants argue that, according to the MDA, the plaintiffs' claims for implied warranties are preempted by the FDA's requirements related to glove labeling, since they seek a determination that the gloves should have contained labeling that was different from, or additional to, the FDA's mandated language. After careful review, we agree.
In Medtronic, the Supreme Court considered the MDA's preemptive effect on common law negligence and strict liability claims relating to a Class III medical device which entered the marketplace via the 510(k) process. See Medtronic, 518 U.S 470, 116 S.Ct. 2240, 135 L.Ed.2d 700. Although the claims brought against the medical device manufacturer in Medtronic did not include UCC breach of warranty claims, as in the present case, the Supreme Court nonetheless delineated factors that must be present for preemption to occur with respect to devices like latex patient examination gloves.5 Id. The Supreme...
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