Rodríguez-Surís v. Montesinos

935 F. Supp. 71, 1996 U.S. Dist. LEXIS 12252, 1996 WL 482706
CourtDistrict Court, D. Puerto Rico
DecidedAugust 19, 1996
DocketCivil Nos. 93-2236 (DRD), 93-2237 to 93-2239
StatusPublished
Cited by4 cases

This text of 935 F. Supp. 71 (Rodríguez-Surís v. Montesinos) is published on Counsel Stack Legal Research, covering District Court, D. Puerto Rico primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Rodríguez-Surís v. Montesinos, 935 F. Supp. 71, 1996 U.S. Dist. LEXIS 12252, 1996 WL 482706 (prd 1996).

Opinion

OPINION AND ORDER

DOMINGUEZ, District Judge.

In this diversity tort action, co-defendant Collagen Corporation1 (“Collagen”) filed a motion for summary judgment (Docket # 55) in which Collagen argues that: 1) plaintiffs’ claims against Collagen are preempted by the Medical Device Amendments to the Food, Drug and Cosmetics Act of 1976 (“MDA”), 21 U.S.C. § 360k; 2) plaintiffs’ damages were caused by an unforeseeable misuse of Collagen’s product by co-defendant [75]*75Bertha Montesinos2 (“Montesinos”) which Collagen cannot be held liable; and 3) plaintiffs’ complaints are time-barred by the statute of limitations. Plaintiffs filed an opposition (Docket # 62) to Collagen’s motion, to which Collagen replied (Docket # 67). for

Collagen had previously filed a motion for summary judgment (Docket #11) on June 28, 1994, petitioning the Court to decide the identical preemption argument as presented in this motion. The Court denied the motion on August 9, 1994 (Docket # 20).3 Because the one-year limitation term expired prior to the time plaintiffs filed the instant action, the Court now grants Collagen’s motion for summary judgment denying plaintiffs’ claims as time-barred. Further, because the claims against Montesinos appear to be equally vulnerable to the statute of limitations defense, the Court hereby grants plaintiffs twenty (20) days, which term will expire on September 10, 1996, to show cause why the Court should not grant summary judgment in favor of Montesinos on the grounds that all of the plaintiffs’ claims against her are also time-barred.

I — BACKGROUND

Collagen manufactures and distributes products made from a purified form of bovine (cow) collagen developed in the early seventies by a group of biochemists and physicians at Stanford University. Collagen is a natural protein found throughout the body which provides support for skin, muscle, tendons and bone tissues. Fibers of collagen are woven together like threads in a fabric to form a framework into which new cells may grow. Due to the similarities between the collagen in cows and that found in human skin, bovine collagen has been used in various medical applications such as sutures and heart valves. Two of Collagen’s bovine collagen products, Zyderm and Zyplast, are injected under the skin to correct or improve soft tissue deficiencies that may have arisen in the human body. Zyderm and Zyplast are regulated under the MDA, pursuant to which Congress granted the Food and Drug Administration (“FDA”) regulatory authority over medical devices.4 21 U.S.C. § 360c-l. By its terms, the MDA applies solely to medical devices, not to drugs, cosmetics, or foods. Id. Zyderm, Zyderm Implant II, and Zyplast are classified as class III medical devices by the FDA. 21 U.S.C. § 360c(a)(l)(C). These devices require FDA approval and may only be sold to and used by trained and approved physicians. 21 U.S.C. § 360c-j. By June 1985, Collagen had received FDA approval to market Zyderm, Zyderm Implant II, and Zyplast. During 1991 and 1992, the FDA conducted another review of Collagen’s premarket approval application (“PMA”) to assess the adequacy of the safety and effectiveness of the information therein, as well as the appropriateness of the FDA approval decision. 21 U.S.C. § 360c(a)(l). After a thorough review, the FDA concluded that its initial approval of the Zyderm PMA was appropriate.

Between the months of July and November of 1989, plaintiffs,5 separately and independently, went to Montesinos’ apartment located at 1367 Wilson St., Santurce, Puerto Rico, where Montesinos administered the collagen injections, which are the subject of this action. Montesinos is not a licensed physician and represented herself as a cosmetologist. The only material Montesinos admits injecting into the plaintiffs is Zyderm which she obtained from a licensed physician in Miami, Doctor Mario Aguado, without Colla[76]*76gen’s knowledge or authorization.6 (Docket #62 Exh. 3 p. 21, Montesinos’ deposition). After receiving their respective injections, each of the plaintiffs developed hard nodules, reddish in color, at the sites of the injections. Montesinos told the plaintiffs that the irritation and nodules were temporary and would eventually disappear. On the contrary, the nodules persisted and remained hard. Consequently, this action was filed against Mon-tesinos and Collagen on September 1, 1993, almost four (4) years after plaintiffs’ received their injuring injection.

II — ANALYSIS

A. THE SUMMARY JUDGMENT STANDARD

Both plaintiffs and defendants in their motions refer to documents (i.e., depositions, medical reports, letters, etc.) outside the pleadings. Because the Court shall consider these supplementary materials, the summary judgment standard is the appropriate standard. See Garita Hotel Ltd. v. Ponce Federal Bank, 958 F.2d 15, 19 (1st Cir.1992).7

A district court may grant summary judgment when the requisite documents that possess evidentiary force “show that there is no genuine issue as to any material fact and the moving party is entitled to judgment as a matter of law.” Fed. R.Civ.P. 56(c). See McCarthy v. Northwest Airlines, Inc., 56 F.3d 313, 315 (1st Cir.1995), (citing Coyne v. Taber Partners I, 53 F.3d 454, 457-58 (1st Cir.1995)). The intricacies and general standards of Rule 56 have been documented by the First Circuit Court of Appeals in a “cascade of cases.”8 “Once a properly documented motion has engaged the gears of Rule 56, the party to whom the motion is directed can shut down the machinery only by showing that a trial worthy issue exists.” McCarthy, 56 F.3d at 315 (citing National Amusements, 43 F.3d at 735). “In applying these criteria, we recognize that ‘genuineness and materiality are not infinitely elastic euphemisms that may be stretched to fit whatever pererrations catch a litigant’s fancy.’ ” See Roche v. John Hancock Mut. Life Ins. Co., 81 F.3d 249, 253 (1996) (citing Blackie v. Maine, 75 F.3d 716, 721 (1st Cir.1996)).

A material fact is one that might affect the outcome of the suit under the governing law. “[T]he 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.” Medina-Muñoz, 896 F.2d at 8 (emphasis in original) (quoting Anderson v. Liberty Lobby, Inc., 477 U.S. 242

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Bluebook (online)
935 F. Supp. 71, 1996 U.S. Dist. LEXIS 12252, 1996 WL 482706, Counsel Stack Legal Research, https://law.counselstack.com/opinion/rodriguez-suris-v-montesinos-prd-1996.