Simonet v. Smithkline Beecham Corp.

• Decision Date: 03 August 2007
• Docket Number: Civil No. 06-1230 (GAG).
• Citation: 506 F.Supp.2d 77
• Parties: Alma SIMONET, on behalf of Herself and all others similarly situated, Plaintiff, v. SMITHKLINE BEECHAM CORP. d/b/a GlaxoSmithKline, et al., Defendants.
• Court: U.S. District Court — District of Puerto Rico

506 F.Supp.2d 77

Alma SIMONET, on behalf of Herself and all others similarly situated, Plaintiff, v. SMITHKLINE BEECHAM CORP. d/b/a GlaxoSmithKline, et al., Defendants.

Civil No. 06-1230 (GAG).

United States District Court, D. Puerto Rico.

August 3, 2007.

COPYRIGHT MATERIAL OMITTED

COPYRIGHT MATERIAL OMITTED

Carlos R. Ramirez, Esq., John F. Nevares, Esq., San Juan, PR, for Plaintiff.

Rossell Barrios-Amy, Esq., San Juan, PR, for Defendant.

OPINION AND ORDER

GUSTAVO A. GELPI, District Judge.

Alma Simonet ("Simonet"), the only named plaintiff in this proposed nationwide consumer class action, filed suit on March 6, 2006 against Defendants SmithKline Beecham Corporation d/b/a GlaxoSmithKline, GlaxoSmithKline Puerto Rico, Inc., and SB Pharmco Puerto Rico, Inc. (collectively "GSK") alleging claims under several state law theories. She invoked the court's diversity jurisdiction under 28 U.S.C. § 1332. On June 29, 2006, Simonet filed her Amended, Supplemental and Restated Class Action Complaint and Jury Demand ("Amended Complaint") (Docket No. 26). Plaintiff's claims arise out of the purchase and ingestion of allegedly defective Paxil® CR ("PaxilCR") tablets. Counts One and Two of the Amended Complaint assert negligence and strict liability claims. Counts Three and Four seek economic recovery under breach of warranty theories. Count Five alleges fraudulent misrepresentation, while Count Six asserts a fraudulent concealment claim. Finally, Count Seven seeks damages under the consumer protection statutes enacted in Puerto Rico and the United States.

GSK moved to dismiss Simonet's fraud claims under Rule 9(b) under the Federal Rules of Civil Procedure and all other claims under Rule 12(b)(6) for failure to state a claim upon which relief can be granted (Docket No. 33). Simonet duly opposed the motion (Docket No. 43). GSK and Simonet filed a reply (Docket No. 52) and a surreply (Docket No. 60), respectively. The parties also submitted additional briefing (Docket Nos. 61, 66) regarding Simonet's claim for statutory consumer protection damages. After reviewing the relevant information and applicable law, the court DENIES IN PART and GRANTS IN PART GSK's motion to dismiss (Docket No. 33).

I. 12(b)(6) Motion to Dismiss Standard

Pursuant to Rule 12(b)(6), the court must deny a motion to dismiss for failure to state a claim on which relief may be granted "unless it appears beyond doubt that the plaintiff can prove no set of facts in support of his claim which would entitle him to relief." Conley v. Gibson, 355 U.S. 41, 45-46, 78 S.Ct. 99, 2 L.Ed.2d 80 (1957); see also Epstein v. C.R. Bard, Inc., 460 F.3d 183, 187 (1st Cir.2006). When considering a Rule 12(b)(6) motion to dismiss, the court must accept as true all well-pled factual allegations in the complaint and draw all reasonable inference in the plaintiff's favor.¹ See Swierkiewicz v. Sorema N.A., 534 U.S. 506, 514, 122 S.Ct. 992, 152 L.Ed.2d 1 (2002).

GSK's motion to dismiss primarily attacks the sufficiency of the claims asserted by Simonet, the only named plaintiff. The court has not yet certified a class in this proposed class action. At this stage of the litigation, the court must dismiss the complaint in its entirety if the named plaintiff has no cause of action in her own right. A named plaintiff who cannot establish her own case may not seek relief on behalf of other class members. See O'Shea v. Littleton, 414 U.S. 488, 494, 94 S.Ct. 669, 38 L.Ed.2d 674 (1974); Britt v. McKenney, 529 F.2d 44, 45 (1st Cir.1976). Therefore, if Simonet's Amended Complaint fails to state a claim upon which relief can be granted, then Rule 12(b)(6) mandates dismissal of the class action complaint in its entirety.

II. Factual Allegations

GSK manufactures and sells paroxetine under the name PaxilCR. PaxilCR is a pharmaceutical drug prescribed to treat depression, anxiety, and other mental health disorders. The "CR" in the drug's title is an abbreviation for "controlled release." As the name suggests, PaxilCR tablets are intended to deliver the active ingredient over a period of time and not all at once. Additionally, an enteric coat on the tablets delays the release of the active ingredient until the tablets have left the stomach. Before and after the United States Food and Drug Administration ("FDA") discovered violations of good manufacturing practice ("GMP") regulations in the manufacture of PaxilCR, GSK circulated marketing materials, including package inserts, prescribing information, and the Physicians Desk Reference ("PDR"), that represented PaxilCR tablets as safe and effective for treatment of patients and that described the controlled release effect. Notwithstanding, Simonet ingested PaxilCR tablets that provided neither the controlled release effect nor effective treatment.

GSK manufactures PaxilCR at a facility in Cidra, Puerto Rico. Since 1996, the Cidra manufacturing facility has failed to achieve consistent compliance with current GMP regulations imposed by the FDA. In July 2002, the FDA issued a warning letter to GSK identifying specific GMP violations found during an earlier inspection. The letter requested correction of the violations. GSK, in response, promised to take remedial steps. Subsequent FDA inspections in 2003 uncovered similar and additional GMP violations, which the FDA reported to GSK. Between December 2003 and May 2004, GSK again promised corrections.

FDA inspections conducted in September, October, and November 2004 revealed that GMP violations persisted. During its late 2004 inspections, the FDA discovered that PaxilCR tablets could split apart and patients could receive a portion of the tablets that lacks the active ingredient or a portion that contains the active ingredient but does not have the controlled release effect. GSK once again promised to correct the GMP violations. GSK also submitted data and corrective plans to the FDA.

The FDA determined that GSK's proposed corrective actions would not remedy the GMP violations. The FDA concluded that the PaxilCR tablets were adulterated within the meaning of the Federal Food, Drug, and Cosmetic Act ("the Act"), 28 U.S.C. § 351(a)(2)(B). Additionally, the FDA determined that GSK could not assure that the tablets met the safety requirements of the Act or that the drugs exhibited the identity, strength, quality, and purity they purport to possess. Consequently, on March 4, 2005, the FDA initiated seizures of PaxilCR tablets manufactured at the Cidra facility. The same day, the FDA issued a press release notifying the press of the seizures. The press release stated that the FDA was not aware of any health hazard to consumers and that patients should continue taking PaxilCR On April 27, 2005, the FDA and GSK entered into a consent decree.

Simonet was prescribed, purchased, and took defective PaxilCR tablets between 1996 and March 4, 2006. She ingested defective PaxilCR tablets that split apart. When the tablets split apart, the enteric coat broke up and the tablets released the active ingredient while still in her stomach. She either received the active ingredient without the benefit of controlled release or received only the controlled release ingredients and not the active ingredient. The defective PaxilCR tablets did not provide the intended therapy. As a result of ingesting defective tablets, Simonet continued to suffer the symptoms of their illnesses and incurred expenses and economic losses.

GSK's representations in their marketing materials were material reasons why Simonet was prescribed, purchased, and took. PaxilCR tablets. PaxilCR marketing materials included representations that the tablets were of a merchantable quality, fit, safe, and otherwise not injurious to the health and well-being of consumers. The marketing materials also represented that the tablets are capable of providing the appropriate therapy. In addition, the materials described PaxilCR as an enteric film-coated, controlled release tablet that must be swallowed whole to provide the controlled release effect. The defective PaxilCR tablets Simonet ingested did not adhere to the representations made in the marketing materials.

III. Discussion

In accordance with the approach taken by Simonet and GSK, the court applies Puerto Rico law for purposes of evaluating whether the Amended Complaint states a claim upon which relief may be granted.

A. Counts One and Two: Negligence and Strict Liability

GSK first argues that the economic loss rule bars Simonet's negligence and strict liability claims. See Isla Nena Air Servs., Inc. v. Cessna Aircraft Co., 449 F.3d 85, 87 (1st Cir.2006), aff'g 380 F.Supp.2d 74 (D.P.R.2005) (explaining economic loss rule and applying rule to Puerto Rico law claim). Simonet does not seek economic damages with respect to her negligence and strict liability claims; she seeks only a declaration of GSK's liability for personal injury damages caused by defective PaxilCR tablets. See Docket No. 26, p. 27; Docket No. 43, pp. 10-13. Consequently, the economic loss rule is inapplicable.

GSK next contends that the court should dismiss Simonet's negligence and strict liability claims because she failed to identify a compensable personal injury suffered by herself or any other class member. In order to survive a motion to dismiss her negligence and strict liability claims, Simonet must allege that GSK's conduct caused her some personal harm. See Fremaint v. Ford Motor Co., 258 F.Supp.2d 24, 27 (D.P.R.2003) (setting forth elements of negligence cause of action); Carballo Rodríguez v. Clark Equip. Co., 147 F.Supp.2d 66, 71 (D.P.R.2001) (discussing elements of strict products liability claim). Simonet's Amended Complaint, GSK argues, leaves GSK guessing as to what personal injuries Simonet suffered and how and why she suffered them. Simonet disagrees and points to specific language in her Amended Complaint stating that she "ingested defective Paxil CR® tablets that split apart." Docket No. 26, ¶¶ 30, 34....