Rodriguez v. Gilead Scis., Inc.
| Decision Date | 16 January 2015 |
| Docket Number | CIVIL ACTION NO. 2:14-CV-324 |
| Parties | ELISANDRO RODRIGUEZ, Plaintiff, v. GILEAD SCIENCES, INC., et al, Defendants. |
| Court | U.S. District Court — Southern District of Texas |
Before the Court are: (1) Defendant Gilead Sciences, Inc.'s (Gilead's) Motion to Dismiss (D.E. 5); and (2) Texas Liver Institute, Inc. f/k/a Alamo Medical Research, Ltd. (TLI) and Eric Lawitz's (Lawitz's) 12(b)(6) Motion to Dismiss (D.E. 6). In connection with Plaintiff's Motion to Remand (D.E. 14), the Court found that Plaintiff had not stated a cognizable claim against either TLI or Lawitz and that those Defendants were improperly joined. D.E. 25. Plaintiff has taken the position that TLI and Lawitz are already dismissed from this case and declined to respond to the TLI/Lawitz motion. D.E. 32, p. 5. For the reasons expressed in this Court's prior Order (D.E. 25), the TLI/Lawitz motion is GRANTED. For the reasons set out below, the Gilead motion is GRANTED IN PART with respect to the design defect claims and DENIED IN PART with respect to the learned intermediary doctrine and the statutory presumption of non-liability.
Plaintiff Elisandro Rodriguez (Rodriguez) seeks compensation for permanent heart damage he allegedly suffered as a result of participating in a clinical trial for thetreatment of hepatitis C (HCV) with the pharmaceutical, Sofosbuvir/Ledipasvir (S/L). D.E. 1-2. Gilead conducted the clinical trial in which Rodriguez participated, as required for obtaining the approval of the United States Food and Drug Administration (FDA) for the marketing of S/L. Gilead also designed and manufactured the S/L that was administered to Rodriguez.
Rodriguez alleges that Gilead, "[i]n its quest to be first and to grab a portion of the $20 billion a year market," turned Rodriguez's treating physician into nothing more than a conduit for gaining Rodriguez's participation in the clinical trial. D.E. 1-2, p. 4. According to Rodriguez, with speed and greed overriding medical judgment, and with full knowledge, Gilead's S/L was foisted upon him despite it being a defective product, ultimately causing his heart damage. Rodriguez's claims sound in: (a) negligence (breach of duty to make product reasonably safe through testing and warning); (b) product liability-defective design; (c) product liability-marketing defect (failure to warn); (d) breach of express warranty; and (e) breach of implied warranty. D.E. 1-2. Despite the number of theories, there are two categories of complaints: (1) the product was not safely designed; and (2) the product was not accompanied by sufficient warnings or did not live up to the literature used to market it. Neither in his pleading nor in his response to the motion has Rodriguez articulated a theory of liability that falls outside these two groups.1
Gilead seeks dismissal of all of Rodriguez's claims related to a defective design, whether couched as negligence, strict product liability, or breach of warranty, because Rodriguez failed to allege facts that would support a finding of a safer alternative design. With respect to failure to warn or inform, again under any theory, Gilead claims that it is insulated by the learned intermediary doctrine and the presumption of non-liability associated with FDA oversight.
Under a motion to dismiss predicated upon Rule 12(b)(6), the test of pleadings is devised to balance a party's right to redress against the interests of all parties and the court in minimizing expenditure of time, money, and resources. Bell Atlantic Corp. v. Twombly, 550 U.S. 544, 558 (2007). See also, Ashcroft v. Iqbal, 556 U.S. 662 (2009). Federal Rule of Civil Procedure 8(a)(2) requires only "a short and plain statement of the claim showing that the pleader is entitled to relief." Furthermore, "Pleadings must be construed so as to do justice." Rule 8(e). The requirement that the pleader show that he is entitled to relief requires "more than labels and conclusions[;] a formulaic recitation of the elements of a cause of action will not do." Twombly, 550 U.S. at 555 (citing Papasan v. Allain, 478 U.S. 265, 286 (1986)).
Factual allegations are required, sufficient to raise the entitlement to relief above the level of mere speculation. Twombly, 550 U.S. at 555. Those factual allegations must then be taken as true, even if doubtful. Id. In other words, the pleader must make allegations that take the claim from "conclusory" to "factual" and beyond "possible" to"plausible." Id., 550 U.S. at 557. The Twombly court stated, "[W]e do not require heightened fact pleading of specifics, but only enough facts to state a claim to relief that is plausible on its face." 550 U.S. at 570.
The Court, elaborating on Twombly, stated, "The plausibility standard is not akin to a 'probability requirement,' but it asks for more than a sheer possibility that a defendant has acted unlawfully. Iqbal, 556 U.S. at 678. "Threadbare recitals of the elements of a cause of action, supported by mere conclusory statements, do not suffice." Id. In dismissing the claim in Iqbal, the Court stated, "It is the conclusory nature of respondent's allegations, rather than their extravagantly fanciful nature, that disentitles them to the presumption of truth." 556 U.S. at 681. These principles apply to Gilead's challenge to Rodriguez's design defect claims.
A motion to dismiss for failure to state a claim upon which relief can be granted can be based not only on an omission in a plaintiff's claims but on the inclusion of factual assertions that contradict a claim or support an affirmative defense, such as limitations. Even if some allegations support a claim, if other allegations negate the claim on its face, then the pleading does not survive the 12(b)(6) review.
A complaint is subject to dismissal for failure to state a claim if the allegations, taken as true, show the plaintiff is not entitled to relief. If the allegations, for example, show that relief is barred by the applicable statute of limitations, the complaint is subject to dismissal for failure to state a claim; that does not make the statute of limitations any less an affirmative defense, see Fed. Rule Civ. Proc. 8(c). Whether a particular ground for opposing a claim may be the basis for dismissal for failure to state a claim depends on whether the allegations in the complaint suffice to establish that ground, not on the nature of the ground in the abstract.
Jones v. Bock, 549 U.S. 199, 215 (2007). This principle applies to Gilead's arguments regarding the learned intermediary doctrine and the presumption of non-liability arising from FDA regulation.
Gilead asserts that Rodriguez is required to plead a safer alternative design when stating a design defect claim under Texas law. The Supreme Court of Texas has held that, according to the Texas products liability statute, "Section 82.005 reflects the trend in our common-law jurisprudence of elevating the availability of a safer alternative design from a factor to be considered in the risk-utility analysis to a requisite element of a cause of action for defective design." Hernandez v. Tokai Corp., 2 S.W.3d 251, 256 (Tex. 1999). See also, Caterpillar, Inc. v. Shears, 911 S.W.2d 379, 384 (Tex. 1995) (); Brockert v. Wyeth Pharmaceuticals, Inc., 287 S.W.3d 760, 769 (Tex. App.—Houston [14th Dist.] 2009, no pet.). See also Dyer v. Danek Medical, Inc., 115 F. Supp. 2d 732, 738 (N.D. Tex. 2000) (). According to Gilead, Rodriguez failed to plead any facts that would support a finding that there was a safer alternative design. Having failed to satisfy this pleading requirement, Gilead seeks dismissal of all design defect claims, however cast.
Rodriguez argues that the cases upon which Gilead relies were cases that evaluated the evidence either at summary judgment or after trial and that they state aproof requirement rather than a pleading requirement. There is certainly a difference in the respective purposes of pleading and proof requirements. However, the proof requirement, insofar as it prescribes an element of a claim under Texas law, mandates the way in which such a claim must be pled under federal law, consistent with Twombly and Iqbal. Rodriguez does not dispute that a safer alternative design is a necessary component to a design defect claim.
This Court is bound to apply Texas law to substantive matters when sitting, as we are here, in diversity jurisdiction. In contrast, with respect to procedural matters including pleading requirements, this Court applies federal law. E.g., Hanna v. Plumer, 380 U.S. 460, 471 (1965); Erie R. Co. v. Tompkins, 304 U.S. 64, 92 (1938); Affholder, Inc. v. S. Rock, Inc., 746 F.2d 305, 310 (5th Cir. 1984). Recognizing that a safer alternative design is a necessary element to a substantive design defect claim under Texas substantive law, federal procedural law requires that the pleading allege sufficient facts to support the plausibility of that element. Twombly, supra. In defending against Gilead's challenge to his pleading, Rodriguez sets out a litany of conclusory allegations from his pleading, none of which relate to a safer alternative design. D.E. 32, p. 8. Instead, they address global dangerousness, poor quality, or marketing issues. Because Rodriguez has failed to plead any facts related to a safer alternative design, the Court DISMISSES all claims, under any theory, related to design defects.
Rodriguez has asked for an opportunity to amend and cure this defect in the event that the Court dismisses the claims as pled. Gilead opposes this request, faulting Rodriguez for failing to amend during the time that the motion has been pending. TheCourt, cognizant that the Court had stayed the parties'...
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