DANIEL P. JORDAN, III, District Judge.
This products-liability case is before the Court on the Motion [5] of Defendants Immunex Corporation, Amgen Inc., and Pfizer Inc. ("Defendants") to dismiss the Complaint [1] filed in this action. Plaintiff John Deese opposes the motion [7]. For the reasons stated below, the Court finds that Plaintiff's Complaint fails to state a claim but that he should be allowed leave to amend as to the failure-to-warn claims.
In 2001, Deese was prescribed and began taking the drug Enbrel for treatment of rheumatoid arthritis.
In June 2011, Deese brought the instant lawsuit against Immunex Corporation, which, according to Deese, manufactures Enbrel. He also sued Amgen, Inc. and Pfizer, Inc. as Enbrel's marketers during all or part of the time he took the drug.
In considering a motion under Rule 12(b)(6), the "court accepts `all well-pleaded facts as true, viewing them in the light most favorable to the plaintiff.'" Martin K. Eby Constr. Co. v. Dallas Area Rapid Transit, 369 F.3d 464, 467 (5th Cir. 2004) (quoting Jones v. Greninger, 188 F.3d 322, 324 (5th Cir. 1999)). However, "the tenet that a court must accept as true all of the allegations contained in a complaint is inapplicable to legal conclusions. Threadbare recitals of the elements of a cause of action, supported by mere conclusory statements, do not suffice." Ashcroft v. Iqbal, 556 U.S. 662, 129 S.Ct. 1937, 1949 (2009) (citing Bell Atl. Corp. v. Twombly, 550 U.S. 544, 555 (2007)). To overcome a Rule 12(b)(6) motion, a plaintiff must plead "enough facts to state a claim to relief that is plausible on its face." Twombly, 550 U.S. at 570. That "demands more than an unadorned, the-defendant-unlawfully-harmed-me accusation." Iqbal, 129 S.Ct. at 1949. "Factual allegations must be enough to raise a right to relief above the speculative level, on the assumption that all the allegations in the complaint are true (even if doubtful in fact)." Twombly, 550 U.S. at 555 (citations and footnote omitted). "A claim has facial plausibility when the plaintiff pleads factual content that allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged." Iqbal, 129 S.Ct. at 1949. It follows that "where the well-pleaded facts do not permit the court to infer more than the mere possibility of misconduct, the complaint has alleged—but it has not `show[n]'—`that the pleader is entitled to relief.'" Id. at 1950 (quoting Fed. R. Civ. P. 8(a)(2)).
The Supreme Court's recent examination of the issue in Iqbal provides a framework for examining the sufficiency of a complaint. First, the district court may "begin by identifying pleadings that, because they are no more than conclusions, are not entitled to the assumption of truth." Id. Second, "[w]hen there are well-pleaded factual allegations, a court should assume their veracity and then determine whether they plausibly give rise to an entitlement to relief." Id.
Finally, "a plaintiff's failure to meet the specific pleading requirements should not automatically or inflexibility result in dismissal of the complaint with prejudice to re-filing." Hart v. Bayer Corp., 199 F.3d 239, 248 n.6 (5th Cir. 2000) (citation omitted). Thus, "[a]lthough a court may dismiss the claim, it should not do so without granting leave to amend, unless the defect is simply incurable or the plaintiff has failed to plead with particularity after being afforded repeated opportunities to do so." Id. On the other hand, the Fifth Circuit has often observed that a "bare request [to amend] in an opposition to a motion to dismiss—without any indication of the particular grounds on which the amendment is sought—does not constitute a motion within the contemplation of Rule 15(a)." Parham v. Clinton, 374 F. App'x 503, 505-06 (5th Cir. 2010) (citations omitted, punctuation edited) (affirming dismissal without leave to amend).
Defendants seek dismissal of Deese's design and manufacturing defect claims, arguing Deese fails to allege any facts supporting these claims. The Mississippi Products Liability Act ("MPLA") provides a remedy if, when a product left the manufacturer or seller:
Miss. Code Ann. § 11-1-63(a)(i)(1), (3). A plaintiff must also prove: "(ii) The defective condition rendered the product unreasonably dangerous to the user or consumer; and (iii) The defective and unreasonably dangerous condition of the product proximately caused the damages for which recovery is sought." Id. § 11-1-63(a)(ii)-(iii). For a defective design claim under (a)(i)(3), the plaintiff must further prove that, at the time the product left the control of the manufacturer or seller:
Id. § 11-1-63(f).
Deese claims that Defendants "designed and manufactured" and "marketed and distributed, an unreasonably dangerous pharmaceutical product," that was "unsafe and harmful to Plaintiff." Compl. [1] ¶ 17. "As a direct and proximate result of Defendants' wrongful design, manufacture and distribution of this unreasonably dangerous pharmaceutical product," Deese allegedly suffered serious injuries. Id. ¶ 18. Deese fails to offer any factual support for these conclusory allegations, however. Iqbal, 129 S.Ct. at 1949 ("A pleading that offers `labels and conclusions' or `a formulaic recitation of the elements of a cause of action will not do." (citing Twombly, 550 U.S. at 555)). Additionally, Deese fails to allege how Enbrel "deviated in a material way" from manufacturer's specifications or from other units, as required to show a manufacturing defect claim under the MPLA. Miss. Code Ann. § 11-1-63(a)(i)(1); see also Funk v. Stryker Corp., 631 F.3d 777, 782 (5th Cir. 2011). Neither does Deese allege what was defective about Enbrel's design, that Defendants knew or should have known about the danger, or that there was a feasible design alternative—all required to show a design defect claim. Miss. Code Ann. § 11-1-63(f).
In his Response, Deese makes a passing reference to manufacturing or design defects, but he otherwise fails to address the manufacturing and design defect claims. Instead, he essentially accepts Defendants' assessment that this is a "failure-to-warn" case, and because Deese offers no indication of the particular grounds supporting a manufacturing or design defect claim in an amended complaint, those claims are dismissed with prejudice.
Defendants seek dismissal of Deese's failure-to-warn claims, as well. Under the MPLA, a manufacturer or seller is liable if "[t]he product was defective because it failed to contain adequate warnings or instructions." Miss. Code Ann. § 11-1-63(a)(i)(2). The plaintiff must prove that, at the time the product left the control of the manufacturer or seller, "the manufacturer or seller knew or in light of reasonably available knowledge should have known about the danger that caused the damage for which recovery is sought and that the ordinary user or consumer would not realize its dangerous condition." Id. § 11-1-63(c)(i). A warning is "adequate" if it:
Id. § 11-1-63(c)(ii). Plaintiff must also prove that the failure to warn "rendered the product unreasonably dangerous to the user or consumer" and that "[t]he defective and unreasonably dangerous condition of the product proximately caused the damages for which recovery is sought." Id. § 11-1-63(a)(ii)-(iii); see also Thomas v. Hoffman-LaRoche, Inc., 949 F.2d 806, 811 (5th Cir. 1992) (finding under Mississippi law, "a product may be unreasonably dangerous if the manufacturer fails to warn of a non-obvious risk associated with the normal use of the product" (citing Wyeth Labs., Inc. v. Fortenberry, 530 So.2d 688, 691-92 (Miss. 1988)).
When the product is a prescription drug, Mississippi follows the "learned intermediary doctrine" which holds that "the manufacturer's failure to warn the patient of the product's risks does not render the product defective or unreasonably dangerous so long as the manufacturer adequately warns the learned intermediary." Janssen Pharm., Inc. v. Bailey, 878 So.2d 31, 58 (Miss. 2004) (citing Thomas, 949 F.2d at 811)). Under this doctrine, "[a] drug manufacturer has a duty to adequately warn the prescribing physician of any known adverse effects which might result from use of its prescription drugs," but the "duty to warn only extends to physicians and not to laymen." See Wyeth, 530 So. 2d at 691 (citation and quotation marks omitted)).
Deese alleges that Defendants "failed to timely and adequately warn not only Deese of the potential for Enbrel to cause such malignancies [such as Deese's high-grade B-cell lymphoma] during his therapy period, but likewise failed to apprise Plaintiff's treating physicians of the same so that they could, in combination, make an informed decision as to the relative safety and/or efficacy of such Enbrel therapy." Compl. [1] ¶ 17. "As a direct and proximate result of Defendants'. . . collective failure to properly warn of the [unreasonably dangerous pharmaceutical product]," Deese suffered serious injuries. Id. ¶ 18.
As a preliminary matter, the Court finds that, under Mississippi's learned intermediary doctrine, the relevant question is whether Defendants adequately warned Deese's prescribing physician of the adverse effects of Enbrel, not whether Deese himself was adequately warned.
As for the alleged inadequacies, Deese offered the following averments:
Compl. [1] ¶ 11 (incorporated by reference into product liability claim at ¶ 15). These contentions address the nature and location of the "warnings" and how Deese believes they were inadequate. The Court finds that they are minimally sufficient to place Defendants on notice of the alleged inadequacies.
That said, the claim is not completely stated. For example, Deese alleges that the failure to warn prevented Deese and his physician from "mak[ing] an informed decision as to the relative safety and/or efficacy of such Enbrel therapy," but he falls short of alleging that an adequate warning would have kept his physician from prescribing Enbrel. See Janssen Pharm., Inc., 878 So. 2d at 58 ("The Plaintiffs bear the burden of establishing that [the drug] was the cause of their injuries and that `an adequate warning would have convinced the treating physician not to prescribe the product for the [P]laintiff[s].'") (citation omitted). Thus, causation has not been sufficiently pleaded.
Although the failure-to-warn claims fall short in some respects, the Court concludes that Deese should be given the opportunity to amend his Complaint with respect to these claims. See, e.g., Hart, 199 F.3d at 248 n.6.
First, Deese alleges Defendants are liable in negligence for breaching their duty "to design, adequately test, manufacture, market and/or distribute Enbrel as a prescription medication [for] the treatment of rheumatoid arthritis in a reasonably safe, prudent and responsible manner." Compl. [1] ¶ 13. To the extent Deese's negligence claim alleges a defective design or manufacturing defect when Enbrel left the manufacturer, his negligence claim fails for the same reasons the MPLA claims failed. McSwain v. Sunrise Med., Inc., 689 F.Supp.2d 835, 846 (S.D. Miss. 2010) ("[T]he finding for the claims brought under the MPLA can be dispositive as to the product-based negligence claims such as negligent failure to warn and negligent design."); see supra. As for breach of a duty to adequately test, Deese generically mentions negligent testing in his Response but fails to offer any facts or arguments supporting such a claim.
Second, Deese claims Defendants are liable in negligence for breaching their "duty to determine any dangerous and potentially life-threatening adverse consequences and thereafter warn both Deese and his treating physicians of the same so that an informed decision could be made by both patient and physician as to the efficacy and relative safety of such treatment." Compl. [1] ¶ 13. This claim tracks Deese's failure-to-warn claim under the MPLA, and should be treated the same. The claim is dismissed with leave to amend. See supra.
Defendants seek dismissal of Deese's breach of express warranty claim. Though Deese fails to specify a common law or statutory basis for this claim, the MPLA recognizes a claim where a product:
Miss. Code Ann. § 11-1-63(a)(i)(4), (ii)-(iii). Deese alleges that "Defendants . . . through their advertising, marketing and product labeling, expressly warranted that Enbrel was reasonably safe for use as a prescription treatment for persons suffering from rheumatoid arthritis such as Deese," and that Defendants "breached these warranties . . . by providing him with a prescription medical product that was in fact more dangerous and detrimental to his overall health and well-being than the rheumatoid arthritis for which he consumed the medication." Compl. [1] ¶ 20. Deese's Complaint fails to identify, however, any express warranty or express factual representation made by Defendants that they allegedly breached. Nor does Deese address his express warranty claim in his Response or challenge Defendants' assessment of that claim under the MPLA. Thus, Deese's express warranty claim does not allege enough facts to state a claim to relief that is plausible on its face and should be dismissed with prejudice. Iqbal, 129 S. Ct. at 1949; Twombly, 550 U.S. at 570.
Finally, Defendants seek dismissal of Deese's breach-of-implied-warranty claims. To show breach of an implied warranty of merchantability, a plaintiff must show a product was not "merchantable" as defined by statute:
Miss. Code Ann. § 75-2-314(2). To properly state a claim of breach of an implied warranty of fitness for a particular purpose, "the plaintiff must prove that (1) the seller at the time of the contracting had reason to know the particular purpose for which the goods were required; (2) the reliance by the plaintiff as buyer upon the skill or judgment of the seller to select suitable goods, and (3) the goods were unfit for the particular purpose." McSwain, 689 F. Supp. 2d at 849 (citing Watson Quality Ford, Inc. v. Casanova, 999 So.2d 830, 835 (Miss. 2008)); see Miss. Code Ann. § 75-2-315.
Here, Deese alleges:
Compl. [1] at ¶ 20. Defendants argue there is no factual support for this claim, and, to the extent it rehashes Deese's failure-to-warn claim under the MPLA, it suffers from the same defects that claim does. Defs.' Mem. [6] at 10-12. Deese fails to respond to Defendants' arguments, and the Court finds them well taken. Deese's breach-of-implied-warranty claims are therefore dismissed with prejudice.
In his Response, Deese seeks alternative relief should the Court find his Complaint lacking. Deese first asks the Court to "hold Defendants' dispositive motion in abeyance for a reasonable period of time so as to allow the parties and their counsel to complete basic formal discovery." Pl.'s Resp. [7] ¶ 7. The request is denied. "Rule 8 marks a notable and generous departure from the hyper-technical, code-pleading regime of a prior era, but it does not unlock the doors of discovery for a plaintiff armed with nothing more than conclusions." Iqbal, 129 S.Ct. at 1950.
Deese next asks the Court to "grant him leave to amend the allegations" in the Complaint, "incorporating by reference the factual assertions and/or documentation set forth in [his] Response and the supporting Memorandum Brief." Pl.'s Resp. [7] ¶ 7.
For the foregoing reasons, the Court finds Defendants' Motion to Dismiss [5] should be granted. Plaintiff Deese's failure-to-warn claims under the MPLA and under a negligence theory are dismissed without prejudice. All other claims are dismissed with prejudice. Deese is granted leave to amend his failure-to-warn claims within 30 days of the entry of this Order. Failure to file an amended complaint or otherwise respond to this Order within that time will result in the entry of judgment in favor of Defendants.
Defs.' Mot. [5] Ex. A at 16.
The 2003 Package Insert added the following to the "Warnings" section:
Defs.' Mot. [5] Ex. B at 15.
Then, in the "Adverse Reactions" section, the 2003 insert notes:
Id. at 19-20.