Elmazouni v. Mylan, Inc.

220 F. Supp. 3d 736, 91 U.C.C. Rep. Serv. 2d (West) 341, 2016 U.S. Dist. LEXIS 166286, 2016 WL 7105021
CourtDistrict Court, N.D. Texas
DecidedDecember 1, 2016
DocketCase No. 3:16-cv-00574-M
StatusPublished
Cited by10 cases

This text of 220 F. Supp. 3d 736 (Elmazouni v. Mylan, Inc.) is published on Counsel Stack Legal Research, covering District Court, N.D. Texas primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Elmazouni v. Mylan, Inc., 220 F. Supp. 3d 736, 91 U.C.C. Rep. Serv. 2d (West) 341, 2016 U.S. Dist. LEXIS 166286, 2016 WL 7105021 (N.D. Tex. 2016).

Opinion

MEMORANDUM OPINION AND ORDER

BARBARA M. G. LYN, CHIEF JUDGE

Before the Court is a Rule 12(b)(6) Motion to Dismiss [ECF # 5], filed by Defendants Mylan, Inc., Mylan Pharmaceuticals, Inc., and Mylan Technologies, Inc. For the reasons stated, the Motion is GRANTED.

Background

This is a product liability action arising out.of the death of Lisa Elmazouni (“Decedent”), allegedly as a result of the toxic effects of fentanyl, a Schedule II controlled substance used for the treatment of persistent, chronic pain. PI. Compl. [ECF # 1] at 5, ¶¶ 4.03-4.04. Plaintiffs are Decedent’s husband, Abdelmajid Elmazouni, and his children, who bring this action individually and as the heirs and/or legal representatives of Decedent and her estate. Id. at 2, ¶¶ 1.01-1.02. By their Original Complaint, Plaintiffs allege that, during Decedent’s [739]*739hospital admission on February 24, 2014, a doctor wrote her a prescription for fenta-nyl patches, marketed and sold by Defendants (the “Mylan patch”). Id. at 4, ¶¶ 4.02-4.03 & 5, ¶ 4.06. Plaintiffs allege that Decedent filled the prescription on February 26, 2014, and used the Mylan patch from February 27, 2014 to March 1, 2014, during which time she was readmitted to the hospital due to continued, increasing pain. Id. at 5, ¶4.06. Plaintiffs further allege that, following her discharge from the hospital on March 1, 2014, Decedent experienced complications, including increased pain, severe constipation, and bloating. Id. at 6, ¶ 4.08. On March 2, 2014, an ambulance transported Decedent back to the hospital, where she arrived not breathing and unconscious. Id. Decedent died later that day. Id. Plaintiffs allege that Decedent had a fatal fentanyl blood concentration at the time of her dpath, and her autopsy report states that she died as a result of the toxic effects of fentanyl. Id.

According to Plaintiffs, the Mylan patch is designed to transmit a specific amount of fentanyl into a patient through the skin, at a certain rate over an extended period of time. Id. at 5, ¶4.04. Plaintiffs allege, however, that the Mylan patch is unreasonably dangerous because it can and does function improperly, causing lethal levels of fentanyl in patients using the Mylan patch. Id., ¶ 4.05. Plaintiffs allege that Defendants were aware of and had knowledge that certain of the Mylan patches were defective and had the propensity to cause severe injury and death. Id. at 6, ¶ 4.07. Based on the facts alleged, Plaintiffs assert seven causes of action against Defendants: (1) strict product liability under Section 402A and 402B of the Restatement (Second) of Torts; (2) negligence; (3) negligent representation; (4) breach of the implied warranty of fitness; (5) violations of the Texas Deceptive Trade Practices Act (“DTPA”); (6) violations of Texas Business and Commerce Code Section 2.314(b)(1)-(b)(6); and (7) gross negligence.1

Defendants move to dismiss Plaintiffs’ Original Complaint for failure to state a claim. Defendants argue that Plaintiffs’ allegations are insufficient to satisfy federal pleading standards and that several of Plaintiffs’ claims are foreclosed by Texas law, including Plaintiffs’ strict liability and DTPA claims. Defendants further argue that all of Plaintiffs’ claims relating to the design of the Mylan patch and its accompanying warnings are preempted by federal law.

The issues have been fully briefed, and Defendants’ Motion to Dismiss is ripe for determination.

Legal Standards

Rule 8(a) requires that a pleading contain “a short and plain' statement of the claim showing that the pleader is entitled to relief.” Fed. R. Civ. P. 8(a)(2). To survive a Rule 12(b)(6) motion to dismiss, a plaintiff must plead “enough facts to state a claim to relief that is plausible on' its face.” Bell Atl. Corp. v. Twombly, 550 U.S. 544, 570, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007). To satisfy plausibility, a plaintiff must plead “factual content that allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged.” Ashcroft v. Iqbal, 556 U.S. 662, 678, 129 S.Ct. 1937, 173 L.Ed.2d 868 (2009). The plausibility standard requires more than a sheer possibility that a defen[740]*740dant acted unlawfully, and a plaintiffs factual allegations “must be enough to raise a right to relief above the speculative level.” Twombly, 550 U.S. at 555, 127 S.Ct. 1955.

Analysis

Preliminary Matters

Defendants ask the Court to take judicial notice of the content of two documents submitted in support of their Motion to Dismiss: (1) a copy of a letter from the Food and Drug Administration (“FDA”) dated January 28, 2015, approving Defendants’ Abbreviated New Drug Application to market the Mylan patch (“Approval Letter”); and (2) a copy of the Full Prescribing Information for the My-lan patch (the “Label”). See Def. App. [ECF # 7] 1-3; id. at 4-13. The Approval Letter states the FDA determined that the Mylan patch, a generic fentanyl transder-mal system, was “bioequivalent” and “therapeutically equivalent” to the reference listed drug, Duragesic Transdermal Systems, manufactured by Alza Corp. See id. at 1. The Approval Letter further states the FDA concluded the Mylan patch is “safe and effective for use as recommended in the submitted labeling.” Id. The Label for the Mylan patch provides that the product is “intended for the management of persistent, moderate to severe chronic pain in opioid-tolerant patients 2 years of age and older when a continuous, around-the-clock analgesic is needed for an extended period of time.” Id. at 4. The Label also includes a “black box” warning that states:

Fatal respiratory depression could occur in patients who are not opioid-tolerant and in patients that are opioid-tolerant even if fentanyl trans-dermal systems is not misused or abused.

Id.

When ruling on a motion to dismiss pursuant to Rule 12(b)(6), the Court must take the allegations in the complaint as true and resolve any ambiguities or doubts as to the claims’ sufficiency in favor of the plaintiff. Jones v. Alcoa, Inc., 339 F.3d 359, 362 (5th Cir. 2003). “However, courts may also consider matters of which they may take judicial notice.” Lovelace v. Software Spectrum, Inc., 78 F.3d 1015, 1017-18 (5th Cir. 1996) (taking judicial notice of public disclosure documents in a securities fraud case); see also Fed. R. Evid. 201(f) (“Judicial notice may be taken at any stage of the proceeding.”). Courts may take judicial notice of an “adjudicative fact” if the fact “is not subject to reasonable dispute because it (1) is generally known within the trial court’s territorial jurisdiction; or (2) can be accurately and readily determined from sources whose accuracy cannot reasonably be questioned.” Fed. R. Evid. 201(b).

Free access — add to your briefcase to read the full text and ask questions with AI

Related

Cite This Page — Counsel Stack

Bluebook (online)
220 F. Supp. 3d 736, 91 U.C.C. Rep. Serv. 2d (West) 341, 2016 U.S. Dist. LEXIS 166286, 2016 WL 7105021, Counsel Stack Legal Research, https://law.counselstack.com/opinion/elmazouni-v-mylan-inc-txnd-2016.