Truddle v. Wyeth, LLC

DIANE TRUDDLE, KAYLYN TRUDDLE, RICKY CARMICHAEL,and RICKY CARMICHAEL, JR., all individually and as wrongful death beneficiaries of Eric Carmichael, deceasedand on behalf of the Estate of Eric Carmichael, deceased PLAINTIFFS

v. WYETH, LLC; SCHWARZ PHARMA, INC.; ALAVEN PHARMACEUTICALS, LLC;GENERICS BIDCO I, LLC, doing business as Qualitest Pharmaceuticals;QUALITEST PHARMACEUTICALS, INC.; and VINTAGE PHARMACEUTICALS, LLC DEFENDANTS

CIVIL ACTION NO. 2:11-CV-00207-GHD-SAA

UNITED STATES DISTRICT COURT FOR THE NORTHERN DISTRICT OF MISSISSIPPI DELTA DIVISION

Dated: August 14, 2012

MEMORANDUM OPINION

In this products liability case, Defendants Generics Bidco I, LLC; Qualitest Pharmaceuticals, Inc.; and Vintage Pharmaceuticals, LLC have filed a motion to dismiss [16]. These Defendants argue that in light of PL1VA, Inc. v. Mensing, —— U.S. ——, 131 S. Ct. 2567, 180 L. Ed. 2d 580 (2011), the Plaintiffs' amended complaint [4] should be dismissed pursuant to Rules 8, 9, and 12 of the Federal Rules of Civil Procedure. Upon due consideration of the motion and corresponding memorandum, response, and related authorities, the Court finds that the motion should be granted.

A. Factual and Procedural Background

The Plaintiffs allege in their amended complaint that the decedent, nineteen-year-old Eric Carmichael ("Mr. Carmichael"), suffered from akathisia, a condition characterized by uncontrollable motor restlessness, which led to his suicide. The Plaintiffs allege that Mr.Carmichael's condition and suicide were caused by Reglan/metoclopramide/metoclopramide HCI, a medication he was prescribed. The Plaintiffs filed suit against both brand-name and generic manufacturers of the drug asserting negligence, strict liability, breach of warranties, misrepresentation and fraud, and negligence per se based on the Defendants' alleged failure to warn of the risks of their products. The Plaintiffs allege the following facts in support of their claims: On June 9, 2008, Mr. Carmichael was admitted to the hospital with complaints of chest pain and gastritis. He was diagnosed with a gastric ulcer, gastritis, and esophagitis. His doctor prescribed Reglan/metoclopramide, relying on the information he had about the drug. Although Mr. Carmichael took the drug as directed and prescribed, Mr. Carmichael began suffering from side effects ranging from hallucinations, extreme restlessness (akathisia), feelings of craziness, and suicidal desires. On June 19, 2008, Mr. Carmichael secretly obtained a hand-gun and went to his room at his mother's house, purportedly to take a nap. His mother tried to get in touch with someone who could refer her son to a psychiatrist. Meanwhile, Mr. Carmichael moved a bookcase to block the door, sent a text to a friend stating that he was "now resting in peace," and took his own life with a self-inflicted gunshot wound to the right temple.

The Plaintiffs initially brought this action in the Circuit Court of Desoto County with the assistance of counsel. Subsequently, the Plaintiffs' counsel filed a motion to withdraw, which was granted in state court. The case was then removed to this Court. The Plaintiffs are proceeding pro se. Defendants Generics Bidco I, LLC; Qualitest Pharmaceuticals, Inc.; and Vintage Pharmaceuticals, LLC (the "Generic Defendants") have filed a motion to dismiss the Plaintiffs' claims against them on the basis that the claims are preempted by Mensing, which was decided by the United States Supreme Court on June 23, 2011. The Plaintiffs have now filed aresponse to the motion, the Generic Defendants have submitted supplemental authorities in support of the motion, and the matter is now ripe for review.

B. Motion to Dismiss Standard

"The ultimate question in a Rule 12(b)(6) motion is whether the complaint states a valid claim when all well-pleaded facts are assumed true and are viewed in the light most favorable to the plaintiff." Lone Star Fund V (U.S.), L.P. v. Barclays Bank PLC, 594 F.3d 383, 387 (5th Cir. 2010) (citing In re Katrina Canal Breaches Litig., 495 F.3d 191, 205 (5th Cir. 2007)). "To survive a motion to dismiss, a complaint must contain sufficient factual matter, accepted as true, to state a claim to relief that is plausible on its face." Reyna v. Donley, No. 11-50706, 2012 WL 2376952, at *1 (5th Cir. June 22, 2012) (quoting Ashcroft v. Iqbal, 556 U.S. 662, 678, 129 S. Ct. 1937, 173 L. Ed. 2d 868 (2009) (quotations omitted)). "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)." Robinson v. Coca-Cola Co., No. 11-30130, 2012 WL 1859513, at *2 (5th Cir. May 22, 2012) (citing In re Katrina Canal Breaches Litig., 495 F.3d at 205). The court must not evaluate the likelihood of the claim's success, but instead ascertain whether the plaintiff has stated a legally cognizable claim that is plausible. Lone Star Fund, 594 F.3d at 387 (citing Iqbal, 556 U.S. 662, 129 S. Ct. 1937, 1949).

"The pleading standards for a Rule 12(b)(6) motion to dismiss are derived from Rule 8 of the Federal Rules of Civil Procedure, which provides, in relevant part, that a pleading stating a claim for relief must contain 'a short and plain statement of the claim showing that the pleader is entitled to relief " In re McCoy, 666 F.3d 924, 926 (5th Cir. 2012) (quoting FED. R. CIV. P. 8(a)(2)). Although the court must accept all allegations in a complaint as true, "[t]hreadbare recitals of the elements of a cause of action, supported by mere conclusory statements, do notsuffice." Iqbal, 556 U.S. 662, 129 S. Ct. 1937, 1949-1950 (citing Bell All. Corp. v. Twombly, 550 U.S. 544, 556, 127 S. Ct. 1955, 167 L. Ed. 2d 929 (2007)). "Rule 12(b)(6) authorizes a court to dismiss a claim on the basis of a dispositive issue of law." Neitzke v. Williams, 490 U.S. 319, 326, 109 S. Ct. 1827, 104 L. Ed. 2d 338 (1989) (citing Hishon v. King & Spalding, 467 U.S. 69, 73, 104 S. Ct. 2229, 81 L. Ed. 2d 59 (1984); Conley v. Gibson, 355 U.S. 41, 45-46, 78 S. Ct. 99, 2 L. Ed. 2d 80 (1957)).

The Plaintiffs' fraud and misrepresentation claims are subject to the heightened pleading standards of Rule 9(b) of the Federal Rules of Civil Procedure, which requires a party to plead "the circumstances constituting fraud ... with particularity." FED. R. Civ. P. 9(b).

C. Analysis

The United States Food and Drug Administration (the "FDA") exclusively regulates the labeling of both brand-name drugs and generic drugs. See 21 C.F.R. § 314.50(c)(2)(i) (brand-name drugs); 21 C.F.R. § 314.94(a)(8) (generic drugs). The FDA's definition of labeling encompasses any communication with medical professionals concerning a drug:

Brochures, booklets, mailing pieces, detailing pieces, file cards, bulletins, calendars, price lists, catalogs, house organs, letters, motion picture films, film strips, lantern slides, sound recordings, exhibits, literature, and reprints and similar pieces of printed, audio, or visual matter descriptive of a drug and references published (for example, the "Physicians Desk Reference") for use by medical practitioners, pharmacists, or nurses, containing drug information supplied by the manufacturer, packer, or distributor of the drug and which are disseminated by or on behalf of its manufacturer, packer, or distributor are hereby determined to be labeling as defined in section 201(m) of the act.

21 C.F.R. §202.1(1)(2).

The Generic Defendants contend that all claims against them are predicated on their alleged failure to warn of the dangerous side effects of the drug, and that "[a]ny claims based onstate-law duties that Generic Defendants could not have fulfilled without the federal government's permission and assistance are preempted." Generic Defs.' Mem. Law Supp. Mot. Dismiss [17] at 2. The Generic Defendants anticipate that the Plaintiffs would argue that the Generic Defendants should have used an additional means of communicating warnings to physicians, such as letters to health care providers, and suspended sales of the drug until the branded labels were changed. The Generic Defendants additionally anticipate that the Plaintiffs would try to assert design defect or other legal theories to escape the preemptive reach of Mensing. The mother of Mr. Carmichael, Plaintiff Ms. Diane Truddle, has submitted a response to the motion to dismiss, asserting that she has a pending medical malpractice action against Baptist Hospital, as well as this action against the drug manufacturers. She further explains the facts and circumstances which led to the filing of this action against the manufacturers of the drug that was prescribed to her son. The Court looks to Mensing for guidance on whether the Plaintiffs' claims can be sustained, and finds that all of the Plaintiffs' claims against the Generic Defendants must be dismissed as a matter of law.

In Mensing, several plaintiffs had asserted state tort claims against drug manufacturers for their alleged failure to provide adequate warning labels for the same drug at issue in the case sub judice, generic metoclopramide. 131 S. Ct. 2567, 2573-2574. The plaintiffs had pled fourteen different counts, including failure to warn, fraud/misrepresentation, failure to monitor/test, violation of a state consumer protection statute, strict products liability, and breach of implied warranties. See Compl., Mensing v. Wyeth, Inc., 562 F. Supp. 2d 1056 (D. Minn. 2008) (No. 07-3919), at 27-49. The Court held that "federal drug regulations applicable to generic drug manufacturers directly conflict with, and thus preempt, these state-law claims," which were all predicated on a failure to warn theory. Mensing, 131 S. Ct. 2567, 2572. TheCourt concluded that the state law in question imposed labeling requirements on drug manufacturers, but "[f]ederal law imposes far more complex drag labeling requirements." Id. at 2574. The Court held that because federal law requires generic drug manufacturers to use drug warning...